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Article 56
|
1. The AI Office shall encourage and facilitate the drawing up of codes of practice at Union level in order to contribute to the proper application of this Regulation, taking into account international approaches.
2. The AI Office and the Board shall aim to ensure that the codes of practice cover at least the obligations provided for in Articles 53 and 55, including the following issues:
(a) the means to ensure that the information referred to in Article 53(1), points (a) and (b), is kept up to date in light of market and technological developments;
(a)
the means to ensure that the information referred to in Article 53(1), points (a) and (b), is kept up to date in light of market and technological developments;
(b) the adequate level of detail for the summary about the content used for training;
(b)
the adequate level of detail for the summary about the content used for training;
(c) the identification of the type and nature of the systemic risks at Union level, including their sources, where appropriate;
(c)
the identification of the type and nature of the systemic risks at Union level, including their sources, where appropriate;
(d) the measures, procedures and modalities for the assessment and management of the systemic risks at Union level, including the documentation thereof, which shall be proportionate to the risks, take into consideration their severity and probability and take into account the specific challenges of tackling those risks in light of the possible ways in which such risks may emerge and materialise along the AI value chain.
(d)
the measures, procedures and modalities for the assessment and management of the systemic risks at Union level, including the documentation thereof, which shall be proportionate to the risks, take into consideration their severity and probability and take into account the specific challenges of tackling those risks in light of the possible ways in which such risks may emerge and materialise along the AI value chain.
3. The AI Office may invite all providers of general-purpose AI models, as well as relevant national competent authorities, to participate in the drawing-up of codes of practice. Civil society organisations, industry, academia and other relevant stakeholders, such as downstream providers and independent experts, may support the process.
4. The AI Office and the Board shall aim to ensure that the codes of practice clearly set out their specific objectives and contain commitments or measures, including key performance indicators as appropriate, to ensure the achievement of those objectives, and that they take due account of the needs and interests of all interested parties, including affected persons, at Union level.
5. The AI Office shall aim to ensure that participants to the codes of practice report regularly to the AI Office on the implementation of the commitments and the measures taken and their outcomes, including as measured against the key performance indicators as appropriate. Key performance indicators and reporting commitments shall reflect differences in size and capacity between various participants.
6. The AI Office and the Board shall regularly monitor and evaluate the achievement of the objectives of the codes of practice by the participants and their contribution to the proper application of this Regulation. The AI Office and the Board shall assess whether the codes of practice cover the obligations provided for in Articles 53 and 55, and shall regularly monitor and evaluate the achievement of their objectives. They shall publish their assessment of the adequacy of the codes of practice.
The Commission may, by way of an implementing act, approve a code of practice and give it a general validity within the Union. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 98(2).
7. The AI Office may invite all providers of general-purpose AI models to adhere to the codes of practice. For providers of general-purpose AI models not presenting systemic risks this adherence may be limited to the obligations provided for in Article 53, unless they declare explicitly their interest to join the full code.
8. The AI Office shall, as appropriate, also encourage and facilitate the review and adaptation of the codes of practice, in particular in light of emerging standards. The AI Office shall assist in the assessment of available standards.
9. Codes of practice shall be ready at the latest by 2 May 2025. The AI Office shall take the necessary steps, including inviting providers pursuant to paragraph 7.
If, by 2 August 2025, a code of practice cannot be finalised, or if the AI Office deems it is not adequate following its assessment under paragraph 6 of this Article, the Commission may provide, by means of implementing acts, common rules for the implementation of the obligations provided for in Articles 53 and 55, including the issues set out in paragraph 2 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).
|
office shall encourage facilitate drawing code practice union level order contribute proper application regulation taking account international approach office board shall aim ensure code practice cover least obligation provided article including following issue mean ensure information referred article point kept date light market technological development mean ensure information referred article point kept date light market technological development adequate level detail summary content used training adequate level detail summary content used training identification type nature systemic risk union level including source appropriate identification type nature systemic risk union level including source appropriate measure procedure modality assessment management systemic risk union level including documentation thereof shall proportionate risk take consideration severity probability take account specific challenge tackling risk light possible way risk may emerge materialise along value chain measure procedure modality assessment management systemic risk union level including documentation thereof shall proportionate risk take consideration severity probability take account specific challenge tackling risk light possible way risk may emerge materialise along value chain office may invite provider general purpose model well relevant national competent authority participate drawing code practice civil society organisation industry academia relevant stakeholder downstream provider independent expert may support process office board shall aim ensure code practice clearly set specific objective contain commitment measure including key performance indicator appropriate ensure achievement objective take due account need interest interested party including affected person union level office shall aim ensure participant code practice report regularly office implementation commitment measure taken outcome including measured key performance indicator appropriate key performance indicator reporting commitment shall reflect difference size capacity various participant office board shall regularly monitor evaluate achievement objective code practice participant contribution proper application regulation office board shall assess whether code practice cover obligation provided article shall regularly monitor evaluate achievement objective shall publish assessment adequacy code practice commission may way implementing act approve code practice give general validity within union implementing act shall adopted accordance examination procedure referred article office may invite provider general purpose model adhere code practice provider general purpose model presenting systemic risk adherence may limited obligation provided article unless declare explicitly interest join full code office shall appropriate also encourage facilitate review adaptation code practice particular light emerging standard office shall assist assessment available standard code practice shall ready latest may 2025 office shall take necessary step including inviting provider pursuant paragraph august 2025 code practice finalised office deems adequate following assessment paragraph article commission may provide mean implementing act common rule implementation obligation provided article including issue set paragraph article implementing act shall adopted accordance examination procedure referred article
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 51
|
1. A general-purpose AI model shall be classified as a general-purpose AI model with systemic risk if it meets any of the following conditions:
(a) it has high impact capabilities evaluated on the basis of appropriate technical tools and methodologies, including indicators and benchmarks;
(a)
it has high impact capabilities evaluated on the basis of appropriate technical tools and methodologies, including indicators and benchmarks;
(b) based on a decision of the Commission,ex officioor following a qualified alert from the scientific panel, it has capabilities or an impact equivalent to those set out in point (a) having regard to the criteria set out in Annex XIII.
(b)
based on a decision of the Commission,ex officioor following a qualified alert from the scientific panel, it has capabilities or an impact equivalent to those set out in point (a) having regard to the criteria set out in Annex XIII.
2. A general-purpose AI model shall be presumed to have high impact capabilities pursuant to paragraph 1, point (a), when the cumulative amount of computation used for its training measured in floating point operations is greater than 10.
3. The Commission shall adopt delegated acts in accordance with Article 97 to amend the thresholds listed in paragraphs 1 and 2 of this Article, as well as to supplement benchmarks and indicators in light of evolving technological developments, such as algorithmic improvements or increased hardware efficiency, when necessary, for these thresholds to reflect the state of the art.
|
general purpose model shall classified general purpose model systemic risk meet following condition high impact capability evaluated basis appropriate technical tool methodology including indicator benchmark high impact capability evaluated basis appropriate technical tool methodology including indicator benchmark based decision commission officioor following qualified alert scientific panel capability impact equivalent set point regard criterion set annex xiii based decision commission officioor following qualified alert scientific panel capability impact equivalent set point regard criterion set annex xiii general purpose model shall presumed high impact capability pursuant paragraph point cumulative amount computation used training measured floating point operation greater commission shall adopt delegated act accordance article amend threshold listed paragraph article well supplement benchmark indicator light evolving technological development algorithmic improvement increased hardware efficiency necessary threshold reflect state art
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 52
|
1. Where a general-purpose AI model meets the condition referred to in Article 51(1), point (a), the relevant provider shall notify the Commission without delay and in any event within two weeks after that requirement is met or it becomes known that it will be met. That notification shall include the information necessary to demonstrate that the relevant requirement has been met. If the Commission becomes aware of a general-purpose AI model presenting systemic risks of which it has not been notified, it may decide to designate it as a model with systemic risk.
2. The provider of a general-purpose AI model that meets the condition referred to in Article 51(1), point (a), may present, with its notification, sufficiently substantiated arguments to demonstrate that, exceptionally, although it meets that requirement, the general-purpose AI model does not present, due to its specific characteristics, systemic risks and therefore should not be classified as a general-purpose AI model with systemic risk.
3. Where the Commission concludes that the arguments submitted pursuant to paragraph 2 are not sufficiently substantiated and the relevant provider was not able to demonstrate that the general-purpose AI model does not present, due to its specific characteristics, systemic risks, it shall reject those arguments, and the general-purpose AI model shall be considered to be a general-purpose AI model with systemic risk.
4. The Commission may designate a general-purpose AI model as presenting systemic risks,ex officioor following a qualified alert from the scientific panel pursuant to Article 90(1), point (a), on the basis of criteria set out in Annex XIII.
The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annex XIII by specifying and updating the criteria set out in that Annex.
5. Upon a reasoned request of a provider whose model has been designated as a general-purpose AI model with systemic risk pursuant to paragraph 4, the Commission shall take the request into account and may decide to reassess whether the general-purpose AI model can still be considered to present systemic risks on the basis of the criteria set out in Annex XIII. Such a request shall contain objective, detailed and new reasons that have arisen since the designation decision. Providers may request reassessment at the earliest six months after the designation decision. Where the Commission, following its reassessment, decides to maintain the designation as a general-purpose AI model with systemic risk, providers may request reassessment at the earliest six months after that decision.
6. The Commission shall ensure that a list of general-purpose AI models with systemic risk is published and shall keep that list up to date, without prejudice to the need to observe and protect intellectual property rights and confidential business information or trade secrets in accordance with Union and national law.
|
general purpose model meet condition referred article point relevant provider shall notify commission without delay event within two week requirement met becomes known met notification shall include information necessary demonstrate relevant requirement met commission becomes aware general purpose model presenting systemic risk notified may decide designate model systemic risk provider general purpose model meet condition referred article point may present notification sufficiently substantiated argument demonstrate exceptionally although meet requirement general purpose model present due specific characteristic systemic risk therefore classified general purpose model systemic risk commission concludes argument submitted pursuant paragraph sufficiently substantiated relevant provider able demonstrate general purpose model present due specific characteristic systemic risk shall reject argument general purpose model shall considered general purpose model systemic risk commission may designate general purpose model presenting systemic risk officioor following qualified alert scientific panel pursuant article point basis criterion set annex xiii commission empowered adopt delegated act accordance article order amend annex xiii specifying updating criterion set annex upon reasoned request provider whose model designated general purpose model systemic risk pursuant paragraph commission shall take request account may decide reassess whether general purpose model still considered present systemic risk basis criterion set annex xiii request shall contain objective detailed new reason arisen since designation decision provider may request reassessment earliest six month designation decision commission following reassessment decides maintain designation general purpose model systemic risk provider may request reassessment earliest six month decision commission shall ensure list general purpose model systemic risk published shall keep list date without prejudice need observe protect intellectual property right confidential business information trade secret accordance union national law
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 53
|
1. Providers of general-purpose AI models shall:
(a) draw up and keep up-to-date the technical documentation of the model, including its training and testing process and the results of its evaluation, which shall contain, at a minimum, the information set out in Annex XI for the purpose of providing it, upon request, to the AI Office and the national competent authorities;
(a)
draw up and keep up-to-date the technical documentation of the model, including its training and testing process and the results of its evaluation, which shall contain, at a minimum, the information set out in Annex XI for the purpose of providing it, upon request, to the AI Office and the national competent authorities;
(b) draw up, keep up-to-date and make available information and documentation to providers of AI systems who intend to integrate the general-purpose AI model into their AI systems. Without prejudice to the need to observe and protect intellectual property rights and confidential business information or trade secrets in accordance with Union and national law, the information and documentation shall: (i) enable providers of AI systems to have a good understanding of the capabilities and limitations of the general-purpose AI model and to comply with their obligations pursuant to this Regulation; and (ii) contain, at a minimum, the elements set out in Annex XII;
(b)
draw up, keep up-to-date and make available information and documentation to providers of AI systems who intend to integrate the general-purpose AI model into their AI systems. Without prejudice to the need to observe and protect intellectual property rights and confidential business information or trade secrets in accordance with Union and national law, the information and documentation shall:
(i) enable providers of AI systems to have a good understanding of the capabilities and limitations of the general-purpose AI model and to comply with their obligations pursuant to this Regulation; and
(i)
enable providers of AI systems to have a good understanding of the capabilities and limitations of the general-purpose AI model and to comply with their obligations pursuant to this Regulation; and
(ii) contain, at a minimum, the elements set out in Annex XII;
(ii)
contain, at a minimum, the elements set out in Annex XII;
(c) put in place a policy to comply with Union law on copyright and related rights, and in particular to identify and comply with, including through state-of-the-art technologies, a reservation of rights expressed pursuant to Article 4(3) of Directive (EU) 2019/790;
(c)
put in place a policy to comply with Union law on copyright and related rights, and in particular to identify and comply with, including through state-of-the-art technologies, a reservation of rights expressed pursuant to Article 4(3) of Directive (EU) 2019/790;
(d) draw up and make publicly available a sufficiently detailed summary about the content used for training of the general-purpose AI model, according to a template provided by the AI Office.
(d)
draw up and make publicly available a sufficiently detailed summary about the content used for training of the general-purpose AI model, according to a template provided by the AI Office.
2. The obligations set out in paragraph 1, points (a) and (b), shall not apply to providers of AI models that are released under a free and open-source licence that allows for the access, usage, modification, and distribution of the model, and whose parameters, including the weights, the information on the model architecture, and the information on model usage, are made publicly available. This exception shall not apply to general-purpose AI models with systemic risks.
3. Providers of general-purpose AI models shall cooperate as necessary with the Commission and the national competent authorities in the exercise of their competences and powers pursuant to this Regulation.
4. Providers of general-purpose AI models may rely on codes of practice within the meaning of Article 56 to demonstrate compliance with the obligations set out in paragraph 1 of this Article, until a harmonised standard is published. Compliance with European harmonised standards grants providers the presumption of conformity to the extent that those standards cover those obligations. Providers of general-purpose AI models who do not adhere to an approved code of practice or do not comply with a European harmonised standard shall demonstrate alternative adequate means of compliance for assessment by the Commission.
5. For the purpose of facilitating compliance with Annex XI, in particular points 2 (d) and (e) thereof, the Commission is empowered to adopt delegated acts in accordance with Article 97 to detail measurement and calculation methodologies with a view to allowing for comparable and verifiable documentation.
6. The Commission is empowered to adopt delegated acts in accordance with Article 97(2) to amend Annexes XI and XII in light of evolving technological developments.
7. Any information or documentation obtained pursuant to this Article, including trade secrets, shall be treated in accordance with the confidentiality obligations set out in Article 78.
|
provider general purpose model shall draw keep date technical documentation model including training testing process result evaluation shall contain minimum information set annex purpose providing upon request office national competent authority draw keep date technical documentation model including training testing process result evaluation shall contain minimum information set annex purpose providing upon request office national competent authority draw keep date make available information documentation provider system intend integrate general purpose model system without prejudice need observe protect intellectual property right confidential business information trade secret accordance union national law information documentation shall enable provider system good understanding capability limitation general purpose model comply obligation pursuant regulation contain minimum element set annex xii draw keep date make available information documentation provider system intend integrate general purpose model system without prejudice need observe protect intellectual property right confidential business information trade secret accordance union national law information documentation shall enable provider system good understanding capability limitation general purpose model comply obligation pursuant regulation enable provider system good understanding capability limitation general purpose model comply obligation pursuant regulation contain minimum element set annex xii contain minimum element set annex xii put place policy comply union law copyright related right particular identify comply including state art technology reservation right expressed pursuant article directive 2019 790 put place policy comply union law copyright related right particular identify comply including state art technology reservation right expressed pursuant article directive 2019 790 draw make publicly available sufficiently detailed summary content used training general purpose model according template provided office draw make publicly available sufficiently detailed summary content used training general purpose model according template provided office obligation set paragraph point shall apply provider model released free open source licence allows access usage modification distribution model whose parameter including weight information model architecture information model usage made publicly available exception shall apply general purpose model systemic risk provider general purpose model shall cooperate necessary commission national competent authority exercise competence power pursuant regulation provider general purpose model may rely code practice within meaning article demonstrate compliance obligation set paragraph article harmonised standard published compliance european harmonised standard grant provider presumption conformity extent standard cover obligation provider general purpose model adhere approved code practice comply european harmonised standard shall demonstrate alternative adequate mean compliance assessment commission purpose facilitating compliance annex particular point thereof commission empowered adopt delegated act accordance article detail measurement calculation methodology view allowing comparable verifiable documentation commission empowered adopt delegated act accordance article amend annex xii light evolving technological development information documentation obtained pursuant article including trade secret shall treated accordance confidentiality obligation set article
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 54
|
1. Prior to placing a general-purpose AI model on the Union market, providers established in third countries shall, by written mandate, appoint an authorised representative which is established in the Union.
2. The provider shall enable its authorised representative to perform the tasks specified in the mandate received from the provider.
3. The authorised representative shall perform the tasks specified in the mandate received from the provider. It shall provide a copy of the mandate to the AI Office upon request, in one of the official languages of the institutions of the Union. For the purposes of this Regulation, the mandate shall empower the authorised representative to carry out the following tasks:
(a) verify that the technical documentation specified in Annex XI has been drawn up and all obligations referred to in Article 53 and, where applicable, Article 55 have been fulfilled by the provider;
(a)
verify that the technical documentation specified in Annex XI has been drawn up and all obligations referred to in Article 53 and, where applicable, Article 55 have been fulfilled by the provider;
(b) keep a copy of the technical documentation specified in Annex XI at the disposal of the AI Office and national competent authorities, for a period of 10 years after the general-purpose AI model has been placed on the market, and the contact details of the provider that appointed the authorised representative;
(b)
keep a copy of the technical documentation specified in Annex XI at the disposal of the AI Office and national competent authorities, for a period of 10 years after the general-purpose AI model has been placed on the market, and the contact details of the provider that appointed the authorised representative;
(c) provide the AI Office, upon a reasoned request, with all the information and documentation, including that referred to in point (b), necessary to demonstrate compliance with the obligations in this Chapter;
(c)
provide the AI Office, upon a reasoned request, with all the information and documentation, including that referred to in point (b), necessary to demonstrate compliance with the obligations in this Chapter;
(d) cooperate with the AI Office and competent authorities, upon a reasoned request, in any action they take in relation to the general-purpose AI model, including when the model is integrated into AI systems placed on the market or put into service in the Union.
(d)
cooperate with the AI Office and competent authorities, upon a reasoned request, in any action they take in relation to the general-purpose AI model, including when the model is integrated into AI systems placed on the market or put into service in the Union.
4. The mandate shall empower the authorised representative to be addressed, in addition to or instead of the provider, by the AI Office or the competent authorities, on all issues related to ensuring compliance with this Regulation.
5. The authorised representative shall terminate the mandate if it considers or has reason to consider the provider to be acting contrary to its obligations pursuant to this Regulation. In such a case, it shall also immediately inform the AI Office about the termination of the mandate and the reasons therefor.
6. The obligation set out in this Article shall not apply to providers of general-purpose AI models that are released under a free and open-source licence that allows for the access, usage, modification, and distribution of the model, and whose parameters, including the weights, the information on the model architecture, and the information on model usage, are made publicly available, unless the general-purpose AI models present systemic risks.
|
prior placing general purpose model union market provider established third country shall written mandate appoint authorised representative established union provider shall enable authorised representative perform task specified mandate received provider authorised representative shall perform task specified mandate received provider shall provide copy mandate office upon request one official language institution union purpose regulation mandate shall empower authorised representative carry following task verify technical documentation specified annex drawn obligation referred article applicable article fulfilled provider verify technical documentation specified annex drawn obligation referred article applicable article fulfilled provider keep copy technical documentation specified annex disposal office national competent authority period year general purpose model placed market contact detail provider appointed authorised representative keep copy technical documentation specified annex disposal office national competent authority period year general purpose model placed market contact detail provider appointed authorised representative provide office upon reasoned request information documentation including referred point necessary demonstrate compliance obligation chapter provide office upon reasoned request information documentation including referred point necessary demonstrate compliance obligation chapter cooperate office competent authority upon reasoned request action take relation general purpose model including model integrated system placed market put service union cooperate office competent authority upon reasoned request action take relation general purpose model including model integrated system placed market put service union mandate shall empower authorised representative addressed addition instead provider office competent authority issue related ensuring compliance regulation authorised representative shall terminate mandate considers reason consider provider acting contrary obligation pursuant regulation case shall also immediately inform office termination mandate reason therefor obligation set article shall apply provider general purpose model released free open source licence allows access usage modification distribution model whose parameter including weight information model architecture information model usage made publicly available unless general purpose model present systemic risk
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 55
|
1. In addition to the obligations listed in Articles 53 and 54, providers of general-purpose AI models with systemic risk shall:
(a) perform model evaluation in accordance with standardised protocols and tools reflecting the state of the art, including conducting and documenting adversarial testing of the model with a view to identifying and mitigating systemic risks;
(a)
perform model evaluation in accordance with standardised protocols and tools reflecting the state of the art, including conducting and documenting adversarial testing of the model with a view to identifying and mitigating systemic risks;
(b) assess and mitigate possible systemic risks at Union level, including their sources, that may stem from the development, the placing on the market, or the use of general-purpose AI models with systemic risk;
(b)
assess and mitigate possible systemic risks at Union level, including their sources, that may stem from the development, the placing on the market, or the use of general-purpose AI models with systemic risk;
(c) keep track of, document, and report, without undue delay, to the AI Office and, as appropriate, to national competent authorities, relevant information about serious incidents and possible corrective measures to address them;
(c)
keep track of, document, and report, without undue delay, to the AI Office and, as appropriate, to national competent authorities, relevant information about serious incidents and possible corrective measures to address them;
(d) ensure an adequate level of cybersecurity protection for the general-purpose AI model with systemic risk and the physical infrastructure of the model.
(d)
ensure an adequate level of cybersecurity protection for the general-purpose AI model with systemic risk and the physical infrastructure of the model.
2. Providers of general-purpose AI models with systemic risk may rely on codes of practice within the meaning of Article 56 to demonstrate compliance with the obligations set out in paragraph 1 of this Article, until a harmonised standard is published. Compliance with European harmonised standards grants providers the presumption of conformity to the extent that those standards cover those obligations. Providers of general-purpose AI models with systemic risks who do not adhere to an approved code of practice or do not comply with a European harmonised standard shall demonstrate alternative adequate means of compliance for assessment by the Commission.
3. Any information or documentation obtained pursuant to this Article, including trade secrets, shall be treated in accordance with the confidentiality obligations set out in Article 78.
|
addition obligation listed article provider general purpose model systemic risk shall perform model evaluation accordance standardised protocol tool reflecting state art including conducting documenting adversarial testing model view identifying mitigating systemic risk perform model evaluation accordance standardised protocol tool reflecting state art including conducting documenting adversarial testing model view identifying mitigating systemic risk assess mitigate possible systemic risk union level including source may stem development placing market use general purpose model systemic risk assess mitigate possible systemic risk union level including source may stem development placing market use general purpose model systemic risk keep track document report without undue delay office appropriate national competent authority relevant information serious incident possible corrective measure address keep track document report without undue delay office appropriate national competent authority relevant information serious incident possible corrective measure address ensure adequate level cybersecurity protection general purpose model systemic risk physical infrastructure model ensure adequate level cybersecurity protection general purpose model systemic risk physical infrastructure model provider general purpose model systemic risk may rely code practice within meaning article demonstrate compliance obligation set paragraph article harmonised standard published compliance european harmonised standard grant provider presumption conformity extent standard cover obligation provider general purpose model systemic risk adhere approved code practice comply european harmonised standard shall demonstrate alternative adequate mean compliance assessment commission information documentation obtained pursuant article including trade secret shall treated accordance confidentiality obligation set article
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 56
|
1. The AI Office shall encourage and facilitate the drawing up of codes of practice at Union level in order to contribute to the proper application of this Regulation, taking into account international approaches.
2. The AI Office and the Board shall aim to ensure that the codes of practice cover at least the obligations provided for in Articles 53 and 55, including the following issues:
(a) the means to ensure that the information referred to in Article 53(1), points (a) and (b), is kept up to date in light of market and technological developments;
(a)
the means to ensure that the information referred to in Article 53(1), points (a) and (b), is kept up to date in light of market and technological developments;
(b) the adequate level of detail for the summary about the content used for training;
(b)
the adequate level of detail for the summary about the content used for training;
(c) the identification of the type and nature of the systemic risks at Union level, including their sources, where appropriate;
(c)
the identification of the type and nature of the systemic risks at Union level, including their sources, where appropriate;
(d) the measures, procedures and modalities for the assessment and management of the systemic risks at Union level, including the documentation thereof, which shall be proportionate to the risks, take into consideration their severity and probability and take into account the specific challenges of tackling those risks in light of the possible ways in which such risks may emerge and materialise along the AI value chain.
(d)
the measures, procedures and modalities for the assessment and management of the systemic risks at Union level, including the documentation thereof, which shall be proportionate to the risks, take into consideration their severity and probability and take into account the specific challenges of tackling those risks in light of the possible ways in which such risks may emerge and materialise along the AI value chain.
3. The AI Office may invite all providers of general-purpose AI models, as well as relevant national competent authorities, to participate in the drawing-up of codes of practice. Civil society organisations, industry, academia and other relevant stakeholders, such as downstream providers and independent experts, may support the process.
4. The AI Office and the Board shall aim to ensure that the codes of practice clearly set out their specific objectives and contain commitments or measures, including key performance indicators as appropriate, to ensure the achievement of those objectives, and that they take due account of the needs and interests of all interested parties, including affected persons, at Union level.
5. The AI Office shall aim to ensure that participants to the codes of practice report regularly to the AI Office on the implementation of the commitments and the measures taken and their outcomes, including as measured against the key performance indicators as appropriate. Key performance indicators and reporting commitments shall reflect differences in size and capacity between various participants.
6. The AI Office and the Board shall regularly monitor and evaluate the achievement of the objectives of the codes of practice by the participants and their contribution to the proper application of this Regulation. The AI Office and the Board shall assess whether the codes of practice cover the obligations provided for in Articles 53 and 55, and shall regularly monitor and evaluate the achievement of their objectives. They shall publish their assessment of the adequacy of the codes of practice.
The Commission may, by way of an implementing act, approve a code of practice and give it a general validity within the Union. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 98(2).
7. The AI Office may invite all providers of general-purpose AI models to adhere to the codes of practice. For providers of general-purpose AI models not presenting systemic risks this adherence may be limited to the obligations provided for in Article 53, unless they declare explicitly their interest to join the full code.
8. The AI Office shall, as appropriate, also encourage and facilitate the review and adaptation of the codes of practice, in particular in light of emerging standards. The AI Office shall assist in the assessment of available standards.
9. Codes of practice shall be ready at the latest by 2 May 2025. The AI Office shall take the necessary steps, including inviting providers pursuant to paragraph 7.
If, by 2 August 2025, a code of practice cannot be finalised, or if the AI Office deems it is not adequate following its assessment under paragraph 6 of this Article, the Commission may provide, by means of implementing acts, common rules for the implementation of the obligations provided for in Articles 53 and 55, including the issues set out in paragraph 2 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).
|
office shall encourage facilitate drawing code practice union level order contribute proper application regulation taking account international approach office board shall aim ensure code practice cover least obligation provided article including following issue mean ensure information referred article point kept date light market technological development mean ensure information referred article point kept date light market technological development adequate level detail summary content used training adequate level detail summary content used training identification type nature systemic risk union level including source appropriate identification type nature systemic risk union level including source appropriate measure procedure modality assessment management systemic risk union level including documentation thereof shall proportionate risk take consideration severity probability take account specific challenge tackling risk light possible way risk may emerge materialise along value chain measure procedure modality assessment management systemic risk union level including documentation thereof shall proportionate risk take consideration severity probability take account specific challenge tackling risk light possible way risk may emerge materialise along value chain office may invite provider general purpose model well relevant national competent authority participate drawing code practice civil society organisation industry academia relevant stakeholder downstream provider independent expert may support process office board shall aim ensure code practice clearly set specific objective contain commitment measure including key performance indicator appropriate ensure achievement objective take due account need interest interested party including affected person union level office shall aim ensure participant code practice report regularly office implementation commitment measure taken outcome including measured key performance indicator appropriate key performance indicator reporting commitment shall reflect difference size capacity various participant office board shall regularly monitor evaluate achievement objective code practice participant contribution proper application regulation office board shall assess whether code practice cover obligation provided article shall regularly monitor evaluate achievement objective shall publish assessment adequacy code practice commission may way implementing act approve code practice give general validity within union implementing act shall adopted accordance examination procedure referred article office may invite provider general purpose model adhere code practice provider general purpose model presenting systemic risk adherence may limited obligation provided article unless declare explicitly interest join full code office shall appropriate also encourage facilitate review adaptation code practice particular light emerging standard office shall assist assessment available standard code practice shall ready latest may 2025 office shall take necessary step including inviting provider pursuant paragraph august 2025 code practice finalised office deems adequate following assessment paragraph article commission may provide mean implementing act common rule implementation obligation provided article including issue set paragraph article implementing act shall adopted accordance examination procedure referred article
|
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all-MiniLM-L6-v2
| 384 |
Article 57
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1. Member States shall ensure that their competent authorities establish at least one AI regulatory sandbox at national level, which shall be operational by 2 August 2026. That sandbox may also be established jointly with the competent authorities of other Member States. The Commission may provide technical support, advice and tools for the establishment and operation of AI regulatory sandboxes.
The obligation under the first subparagraph may also be fulfilled by participating in an existing sandbox in so far as that participation provides an equivalent level of national coverage for the participating Member States.
2. Additional AI regulatory sandboxes at regional or local level, or established jointly with the competent authorities of other Member States may also be established.
3. The European Data Protection Supervisor may also establish an AI regulatory sandbox for Union institutions, bodies, offices and agencies, and may exercise the roles and the tasks of national competent authorities in accordance with this Chapter.
4. Member States shall ensure that the competent authorities referred to in paragraphs 1 and 2 allocate sufficient resources to comply with this Article effectively and in a timely manner. Where appropriate, national competent authorities shall cooperate with other relevant authorities, and may allow for the involvement of other actors within the AI ecosystem. This Article shall not affect other regulatory sandboxes established under Union or national law. Member States shall ensure an appropriate level of cooperation between the authorities supervising those other sandboxes and the national competent authorities.
5. AI regulatory sandboxes established under paragraph 1 shall provide for a controlled environment that fosters innovation and facilitates the development, training, testing and validation of innovative AI systems for a limited time before their being placed on the market or put into service pursuant to a specific sandbox plan agreed between the providers or prospective providers and the competent authority. Such sandboxes may include testing in real world conditions supervised therein.
6. Competent authorities shall provide, as appropriate, guidance, supervision and support within the AI regulatory sandbox with a view to identifying risks, in particular to fundamental rights, health and safety, testing, mitigation measures, and their effectiveness in relation to the obligations and requirements of this Regulation and, where relevant, other Union and national law supervised within the sandbox.
7. Competent authorities shall provide providers and prospective providers participating in the AI regulatory sandbox with guidance on regulatory expectations and how to fulfil the requirements and obligations set out in this Regulation.
Upon request of the provider or prospective provider of the AI system, the competent authority shall provide a written proof of the activities successfully carried out in the sandbox. The competent authority shall also provide an exit report detailing the activities carried out in the sandbox and the related results and learning outcomes. Providers may use such documentation to demonstrate their compliance with this Regulation through the conformity assessment process or relevant market surveillance activities. In this regard, the exit reports and the written proof provided by the national competent authority shall be taken positively into account by market surveillance authorities and notified bodies, with a view to accelerating conformity assessment procedures to a reasonable extent.
8. Subject to the confidentiality provisions in Article 78, and with the agreement of the provider or prospective provider, the Commission and the Board shall be authorised to access the exit reports and shall take them into account, as appropriate, when exercising their tasks under this Regulation. If both the provider or prospective provider and the national competent authority explicitly agree, the exit report may be made publicly available through the single information platform referred to in this Article.
9. The establishment of AI regulatory sandboxes shall aim to contribute to the following objectives:
(a) improving legal certainty to achieve regulatory compliance with this Regulation or, where relevant, other applicable Union and national law;
(a)
improving legal certainty to achieve regulatory compliance with this Regulation or, where relevant, other applicable Union and national law;
(b) supporting the sharing of best practices through cooperation with the authorities involved in the AI regulatory sandbox;
(b)
supporting the sharing of best practices through cooperation with the authorities involved in the AI regulatory sandbox;
(c) fostering innovation and competitiveness and facilitating the development of an AI ecosystem;
(c)
fostering innovation and competitiveness and facilitating the development of an AI ecosystem;
(d) contributing to evidence-based regulatory learning;
(d)
contributing to evidence-based regulatory learning;
(e) facilitating and accelerating access to the Union market for AI systems, in particular when provided by SMEs, including start-ups.
(e)
facilitating and accelerating access to the Union market for AI systems, in particular when provided by SMEs, including start-ups.
10. National competent authorities shall ensure that, to the extent the innovative AI systems involve the processing of personal data or otherwise fall under the supervisory remit of other national authorities or competent authorities providing or supporting access to data, the national data protection authorities and those other national or competent authorities are associated with the operation of the AI regulatory sandbox and involved in the supervision of those aspects to the extent of their respective tasks and powers.
11. The AI regulatory sandboxes shall not affect the supervisory or corrective powers of the competent authorities supervising the sandboxes, including at regional or local level. Any significant risks to health and safety and fundamental rights identified during the development and testing of such AI systems shall result in an adequate mitigation. National competent authorities shall have the power to temporarily or permanently suspend the testing process, or the participation in the sandbox if no effective mitigation is possible, and shall inform the AI Office of such decision. National competent authorities shall exercise their supervisory powers within the limits of the relevant law, using their discretionary powers when implementing legal provisions in respect of a specific AI regulatory sandbox project, with the objective of supporting innovation in AI in the Union.
12. Providers and prospective providers participating in the AI regulatory sandbox shall remain liable under applicable Union and national liability law for any damage inflicted on third parties as a result of the experimentation taking place in the sandbox. However, provided that the prospective providers observe the specific plan and the terms and conditions for their participation and follow in good faith the guidance given by the national competent authority, no administrative fines shall be imposed by the authorities for infringements of this Regulation. Where other competent authorities responsible for other Union and national law were actively involved in the supervision of the AI system in the sandbox and provided guidance for compliance, no administrative fines shall be imposed regarding that law.
13. The AI regulatory sandboxes shall be designed and implemented in such a way that, where relevant, they facilitate cross-border cooperation between national competent authorities.
14. National competent authorities shall coordinate their activities and cooperate within the framework of the Board.
15. National competent authorities shall inform the AI Office and the Board of the establishment of a sandbox, and may ask them for support and guidance. The AI Office shall make publicly available a list of planned and existing sandboxes and keep it up to date in order to encourage more interaction in the AI regulatory sandboxes and cross-border cooperation.
16. National competent authorities shall submit annual reports to the AI Office and to the Board, from one year after the establishment of the AI regulatory sandbox and every year thereafter until its termination, and a final report. Those reports shall provide information on the progress and results of the implementation of those sandboxes, including best practices, incidents, lessons learnt and recommendations on their setup and, where relevant, on the application and possible revision of this Regulation, including its delegated and implementing acts, and on the application of other Union law supervised by the competent authorities within the sandbox. The national competent authorities shall make those annual reports or abstracts thereof available to the public, online. The Commission shall, where appropriate, take the annual reports into account when exercising its tasks under this Regulation.
17. The Commission shall develop a single and dedicated interface containing all relevant information related to AI regulatory sandboxes to allow stakeholders to interact with AI regulatory sandboxes and to raise enquiries with competent authorities, and to seek non-binding guidance on the conformity of innovative products, services, business models embedding AI technologies, in accordance with Article 62(1), point (c). The Commission shall proactively coordinate with national competent authorities, where relevant.
|
member state shall ensure competent authority establish least one regulatory sandbox national level shall operational august 2026 sandbox may also established jointly competent authority member state commission may provide technical support advice tool establishment operation regulatory sandbox obligation first subparagraph may also fulfilled participating existing sandbox far participation provides equivalent level national coverage participating member state additional regulatory sandbox regional local level established jointly competent authority member state may also established european data protection supervisor may also establish regulatory sandbox union institution body office agency may exercise role task national competent authority accordance chapter member state shall ensure competent authority referred paragraph allocate sufficient resource comply article effectively timely manner appropriate national competent authority shall cooperate relevant authority may allow involvement actor within ecosystem article shall affect regulatory sandbox established union national law member state shall ensure appropriate level cooperation authority supervising sandbox national competent authority regulatory sandbox established paragraph shall provide controlled environment foster innovation facilitates development training testing validation innovative system limited time placed market put service pursuant specific sandbox plan agreed provider prospective provider competent authority sandbox may include testing real world condition supervised therein competent authority shall provide appropriate guidance supervision support within regulatory sandbox view identifying risk particular fundamental right health safety testing mitigation measure effectiveness relation obligation requirement regulation relevant union national law supervised within sandbox competent authority shall provide provider prospective provider participating regulatory sandbox guidance regulatory expectation fulfil requirement obligation set regulation upon request provider prospective provider system competent authority shall provide written proof activity successfully carried sandbox competent authority shall also provide exit report detailing activity carried sandbox related result learning outcome provider may use documentation demonstrate compliance regulation conformity assessment process relevant market surveillance activity regard exit report written proof provided national competent authority shall taken positively account market surveillance authority notified body view accelerating conformity assessment procedure reasonable extent subject confidentiality provision article agreement provider prospective provider commission board shall authorised access exit report shall take account appropriate exercising task regulation provider prospective provider national competent authority explicitly agree exit report may made publicly available single information platform referred article establishment regulatory sandbox shall aim contribute following objective improving legal certainty achieve regulatory compliance regulation relevant applicable union national law improving legal certainty achieve regulatory compliance regulation relevant applicable union national law supporting sharing best practice cooperation authority involved regulatory sandbox supporting sharing best practice cooperation authority involved regulatory sandbox fostering innovation competitiveness facilitating development ecosystem fostering innovation competitiveness facilitating development ecosystem contributing evidence based regulatory learning contributing evidence based regulatory learning facilitating accelerating access union market system particular provided smes including start ups facilitating accelerating access union market system particular provided smes including start ups national competent authority shall ensure extent innovative system involve processing personal data otherwise fall supervisory remit national authority competent authority providing supporting access data national data protection authority national competent authority associated operation regulatory sandbox involved supervision aspect extent respective task power regulatory sandbox shall affect supervisory corrective power competent authority supervising sandbox including regional local level significant risk health safety fundamental right identified development testing system shall result adequate mitigation national competent authority shall power temporarily permanently suspend testing process participation sandbox effective mitigation possible shall inform office decision national competent authority shall exercise supervisory power within limit relevant law using discretionary power implementing legal provision respect specific regulatory sandbox project objective supporting innovation union provider prospective provider participating regulatory sandbox shall remain liable applicable union national liability law damage inflicted third party result experimentation taking place sandbox however provided prospective provider observe specific plan term condition participation follow good faith guidance given national competent authority administrative fine shall imposed authority infringement regulation competent authority responsible union national law actively involved supervision system sandbox provided guidance compliance administrative fine shall imposed regarding law regulatory sandbox shall designed implemented way relevant facilitate cross border cooperation national competent authority national competent authority shall coordinate activity cooperate within framework board national competent authority shall inform office board establishment sandbox may ask support guidance office shall make publicly available list planned existing sandbox keep date order encourage interaction regulatory sandbox cross border cooperation national competent authority shall submit annual report office board one year establishment regulatory sandbox every year thereafter termination final report report shall provide information progress result implementation sandbox including best practice incident lesson learnt recommendation setup relevant application possible revision regulation including delegated implementing act application union law supervised competent authority within sandbox national competent authority shall make annual report abstract thereof available public online commission shall appropriate take annual report account exercising task regulation commission shall develop single dedicated interface containing relevant information related regulatory sandbox allow stakeholder interact regulatory sandbox raise enquiry competent authority seek non binding guidance conformity innovative product service business model embedding technology accordance article point commission shall proactively coordinate national competent authority relevant
|
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all-MiniLM-L6-v2
| 384 |
Article 58
|
1. In order to avoid fragmentation across the Union, the Commission shall adopt implementing acts specifying the detailed arrangements for the establishment, development, implementation, operation and supervision of the AI regulatory sandboxes. The implementing acts shall include common principles on the following issues:
(a) eligibility and selection criteria for participation in the AI regulatory sandbox;
(a)
eligibility and selection criteria for participation in the AI regulatory sandbox;
(b) procedures for the application, participation, monitoring, exiting from and termination of the AI regulatory sandbox, including the sandbox plan and the exit report;
(b)
procedures for the application, participation, monitoring, exiting from and termination of the AI regulatory sandbox, including the sandbox plan and the exit report;
(c) the terms and conditions applicable to the participants.
(c)
the terms and conditions applicable to the participants.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).
2. The implementing acts referred to in paragraph 1 shall ensure:
(a) that AI regulatory sandboxes are open to any applying provider or prospective provider of an AI system who fulfils eligibility and selection criteria, which shall be transparent and fair, and that national competent authorities inform applicants of their decision within three months of the application;
(a)
that AI regulatory sandboxes are open to any applying provider or prospective provider of an AI system who fulfils eligibility and selection criteria, which shall be transparent and fair, and that national competent authorities inform applicants of their decision within three months of the application;
(b) that AI regulatory sandboxes allow broad and equal access and keep up with demand for participation; providers and prospective providers may also submit applications in partnerships with deployers and other relevant third parties;
(b)
that AI regulatory sandboxes allow broad and equal access and keep up with demand for participation; providers and prospective providers may also submit applications in partnerships with deployers and other relevant third parties;
(c) that the detailed arrangements for, and conditions concerning AI regulatory sandboxes support, to the best extent possible, flexibility for national competent authorities to establish and operate their AI regulatory sandboxes;
(c)
that the detailed arrangements for, and conditions concerning AI regulatory sandboxes support, to the best extent possible, flexibility for national competent authorities to establish and operate their AI regulatory sandboxes;
(d) that access to the AI regulatory sandboxes is free of charge for SMEs, including start-ups, without prejudice to exceptional costs that national competent authorities may recover in a fair and proportionate manner;
(d)
that access to the AI regulatory sandboxes is free of charge for SMEs, including start-ups, without prejudice to exceptional costs that national competent authorities may recover in a fair and proportionate manner;
(e) that they facilitate providers and prospective providers, by means of the learning outcomes of the AI regulatory sandboxes, in complying with conformity assessment obligations under this Regulation and the voluntary application of the codes of conduct referred to in Article 95;
(e)
that they facilitate providers and prospective providers, by means of the learning outcomes of the AI regulatory sandboxes, in complying with conformity assessment obligations under this Regulation and the voluntary application of the codes of conduct referred to in Article 95;
(f) that AI regulatory sandboxes facilitate the involvement of other relevant actors within the AI ecosystem, such as notified bodies and standardisation organisations, SMEs, including start-ups, enterprises, innovators, testing and experimentation facilities, research and experimentation labs and European Digital Innovation Hubs, centres of excellence, individual researchers, in order to allow and facilitate cooperation with the public and private sectors;
(f)
that AI regulatory sandboxes facilitate the involvement of other relevant actors within the AI ecosystem, such as notified bodies and standardisation organisations, SMEs, including start-ups, enterprises, innovators, testing and experimentation facilities, research and experimentation labs and European Digital Innovation Hubs, centres of excellence, individual researchers, in order to allow and facilitate cooperation with the public and private sectors;
(g) that procedures, processes and administrative requirements for application, selection, participation and exiting the AI regulatory sandbox are simple, easily intelligible, and clearly communicated in order to facilitate the participation of SMEs, including start-ups, with limited legal and administrative capacities and are streamlined across the Union, in order to avoid fragmentation and that participation in an AI regulatory sandbox established by a Member State, or by the European Data Protection Supervisor is mutually and uniformly recognised and carries the same legal effects across the Union;
(g)
that procedures, processes and administrative requirements for application, selection, participation and exiting the AI regulatory sandbox are simple, easily intelligible, and clearly communicated in order to facilitate the participation of SMEs, including start-ups, with limited legal and administrative capacities and are streamlined across the Union, in order to avoid fragmentation and that participation in an AI regulatory sandbox established by a Member State, or by the European Data Protection Supervisor is mutually and uniformly recognised and carries the same legal effects across the Union;
(h) that participation in the AI regulatory sandbox is limited to a period that is appropriate to the complexity and scale of the project and that may be extended by the national competent authority;
(h)
that participation in the AI regulatory sandbox is limited to a period that is appropriate to the complexity and scale of the project and that may be extended by the national competent authority;
(i) that AI regulatory sandboxes facilitate the development of tools and infrastructure for testing, benchmarking, assessing and explaining dimensions of AI systems relevant for regulatory learning, such as accuracy, robustness and cybersecurity, as well as measures to mitigate risks to fundamental rights and society at large.
(i)
that AI regulatory sandboxes facilitate the development of tools and infrastructure for testing, benchmarking, assessing and explaining dimensions of AI systems relevant for regulatory learning, such as accuracy, robustness and cybersecurity, as well as measures to mitigate risks to fundamental rights and society at large.
3. Prospective providers in the AI regulatory sandboxes, in particular SMEs and start-ups, shall be directed, where relevant, to pre-deployment services such as guidance on the implementation of this Regulation, to other value-adding services such as help with standardisation documents and certification, testing and experimentation facilities, European Digital Innovation Hubs and centres of excellence.
4. Where national competent authorities consider authorising testing in real world conditions supervised within the framework of an AI regulatory sandbox to be established under this Article, they shall specifically agree the terms and conditions of such testing and, in particular, the appropriate safeguards with the participants, with a view to protecting fundamental rights, health and safety. Where appropriate, they shall cooperate with other national competent authorities with a view to ensuring consistent practices across the Union.
|
order avoid fragmentation across union commission shall adopt implementing act specifying detailed arrangement establishment development implementation operation supervision regulatory sandbox implementing act shall include common principle following issue eligibility selection criterion participation regulatory sandbox eligibility selection criterion participation regulatory sandbox procedure application participation monitoring exiting termination regulatory sandbox including sandbox plan exit report procedure application participation monitoring exiting termination regulatory sandbox including sandbox plan exit report term condition applicable participant term condition applicable participant implementing act shall adopted accordance examination procedure referred article implementing act referred paragraph shall ensure regulatory sandbox open applying provider prospective provider system fulfils eligibility selection criterion shall transparent fair national competent authority inform applicant decision within three month application regulatory sandbox open applying provider prospective provider system fulfils eligibility selection criterion shall transparent fair national competent authority inform applicant decision within three month application regulatory sandbox allow broad equal access keep demand participation provider prospective provider may also submit application partnership deployers relevant third party regulatory sandbox allow broad equal access keep demand participation provider prospective provider may also submit application partnership deployers relevant third party detailed arrangement condition concerning regulatory sandbox support best extent possible flexibility national competent authority establish operate regulatory sandbox detailed arrangement condition concerning regulatory sandbox support best extent possible flexibility national competent authority establish operate regulatory sandbox access regulatory sandbox free charge smes including start ups without prejudice exceptional cost national competent authority may recover fair proportionate manner access regulatory sandbox free charge smes including start ups without prejudice exceptional cost national competent authority may recover fair proportionate manner facilitate provider prospective provider mean learning outcome regulatory sandbox complying conformity assessment obligation regulation voluntary application code conduct referred article facilitate provider prospective provider mean learning outcome regulatory sandbox complying conformity assessment obligation regulation voluntary application code conduct referred article regulatory sandbox facilitate involvement relevant actor within ecosystem notified body standardisation organisation smes including start ups enterprise innovator testing experimentation facility research experimentation lab european digital innovation hub centre excellence individual researcher order allow facilitate cooperation public private sector regulatory sandbox facilitate involvement relevant actor within ecosystem notified body standardisation organisation smes including start ups enterprise innovator testing experimentation facility research experimentation lab european digital innovation hub centre excellence individual researcher order allow facilitate cooperation public private sector procedure process administrative requirement application selection participation exiting regulatory sandbox simple easily intelligible clearly communicated order facilitate participation smes including start ups limited legal administrative capacity streamlined across union order avoid fragmentation participation regulatory sandbox established member state european data protection supervisor mutually uniformly recognised carry legal effect across union procedure process administrative requirement application selection participation exiting regulatory sandbox simple easily intelligible clearly communicated order facilitate participation smes including start ups limited legal administrative capacity streamlined across union order avoid fragmentation participation regulatory sandbox established member state european data protection supervisor mutually uniformly recognised carry legal effect across union participation regulatory sandbox limited period appropriate complexity scale project may extended national competent authority participation regulatory sandbox limited period appropriate complexity scale project may extended national competent authority regulatory sandbox facilitate development tool infrastructure testing benchmarking assessing explaining dimension system relevant regulatory learning accuracy robustness cybersecurity well measure mitigate risk fundamental right society large regulatory sandbox facilitate development tool infrastructure testing benchmarking assessing explaining dimension system relevant regulatory learning accuracy robustness cybersecurity well measure mitigate risk fundamental right society large prospective provider regulatory sandbox particular smes start ups shall directed relevant pre deployment service guidance implementation regulation value adding service help standardisation document certification testing experimentation facility european digital innovation hub centre excellence national competent authority consider authorising testing real world condition supervised within framework regulatory sandbox established article shall specifically agree term condition testing particular appropriate safeguard participant view protecting fundamental right health safety appropriate shall cooperate national competent authority view ensuring consistent practice across union
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 59
|
1. In the AI regulatory sandbox, personal data lawfully collected for other purposes may be processed solely for the purpose of developing, training and testing certain AI systems in the sandbox when all of the following conditions are met:
(a) AI systems shall be developed for safeguarding substantial public interest by a public authority or another natural or legal person and in one or more of the following areas: (i) public safety and public health, including disease detection, diagnosis prevention, control and treatment and improvement of health care systems; (ii) a high level of protection and improvement of the quality of the environment, protection of biodiversity, protection against pollution, green transition measures, climate change mitigation and adaptation measures; (iii) energy sustainability; (iv) safety and resilience of transport systems and mobility, critical infrastructure and networks; (v) efficiency and quality of public administration and public services;
(a)
AI systems shall be developed for safeguarding substantial public interest by a public authority or another natural or legal person and in one or more of the following areas:
(i) public safety and public health, including disease detection, diagnosis prevention, control and treatment and improvement of health care systems;
(i)
public safety and public health, including disease detection, diagnosis prevention, control and treatment and improvement of health care systems;
(ii) a high level of protection and improvement of the quality of the environment, protection of biodiversity, protection against pollution, green transition measures, climate change mitigation and adaptation measures;
(ii)
a high level of protection and improvement of the quality of the environment, protection of biodiversity, protection against pollution, green transition measures, climate change mitigation and adaptation measures;
(iii) energy sustainability;
(iii)
energy sustainability;
(iv) safety and resilience of transport systems and mobility, critical infrastructure and networks;
(iv)
safety and resilience of transport systems and mobility, critical infrastructure and networks;
(v) efficiency and quality of public administration and public services;
(v)
efficiency and quality of public administration and public services;
(b) the data processed are necessary for complying with one or more of the requirements referred to in Chapter III, Section 2 where those requirements cannot effectively be fulfilled by processing anonymised, synthetic or other non-personal data;
(b)
the data processed are necessary for complying with one or more of the requirements referred to in Chapter III, Section 2 where those requirements cannot effectively be fulfilled by processing anonymised, synthetic or other non-personal data;
(c) there are effective monitoring mechanisms to identify if any high risks to the rights and freedoms of the data subjects, as referred to in Article 35 of Regulation (EU) 2016/679 and in Article 39 of Regulation (EU) 2018/1725, may arise during the sandbox experimentation, as well as response mechanisms to promptly mitigate those risks and, where necessary, stop the processing;
(c)
there are effective monitoring mechanisms to identify if any high risks to the rights and freedoms of the data subjects, as referred to in Article 35 of Regulation (EU) 2016/679 and in Article 39 of Regulation (EU) 2018/1725, may arise during the sandbox experimentation, as well as response mechanisms to promptly mitigate those risks and, where necessary, stop the processing;
(d) any personal data to be processed in the context of the sandbox are in a functionally separate, isolated and protected data processing environment under the control of the prospective provider and only authorised persons have access to those data;
(d)
any personal data to be processed in the context of the sandbox are in a functionally separate, isolated and protected data processing environment under the control of the prospective provider and only authorised persons have access to those data;
(e) providers can further share the originally collected data only in accordance with Union data protection law; any personal data created in the sandbox cannot be shared outside the sandbox;
(e)
providers can further share the originally collected data only in accordance with Union data protection law; any personal data created in the sandbox cannot be shared outside the sandbox;
(f) any processing of personal data in the context of the sandbox neither leads to measures or decisions affecting the data subjects nor does it affect the application of their rights laid down in Union law on the protection of personal data;
(f)
any processing of personal data in the context of the sandbox neither leads to measures or decisions affecting the data subjects nor does it affect the application of their rights laid down in Union law on the protection of personal data;
(g) any personal data processed in the context of the sandbox are protected by means of appropriate technical and organisational measures and deleted once the participation in the sandbox has terminated or the personal data has reached the end of its retention period;
(g)
any personal data processed in the context of the sandbox are protected by means of appropriate technical and organisational measures and deleted once the participation in the sandbox has terminated or the personal data has reached the end of its retention period;
(h) the logs of the processing of personal data in the context of the sandbox are kept for the duration of the participation in the sandbox, unless provided otherwise by Union or national law;
(h)
the logs of the processing of personal data in the context of the sandbox are kept for the duration of the participation in the sandbox, unless provided otherwise by Union or national law;
(i) a complete and detailed description of the process and rationale behind the training, testing and validation of the AI system is kept together with the testing results as part of the technical documentation referred to in Annex IV;
(i)
a complete and detailed description of the process and rationale behind the training, testing and validation of the AI system is kept together with the testing results as part of the technical documentation referred to in Annex IV;
(j) a short summary of the AI project developed in the sandbox, its objectives and expected results is published on the website of the competent authorities; this obligation shall not cover sensitive operational data in relation to the activities of law enforcement, border control, immigration or asylum authorities.
(j)
a short summary of the AI project developed in the sandbox, its objectives and expected results is published on the website of the competent authorities; this obligation shall not cover sensitive operational data in relation to the activities of law enforcement, border control, immigration or asylum authorities.
2. For the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including safeguarding against and preventing threats to public security, under the control and responsibility of law enforcement authorities, the processing of personal data in AI regulatory sandboxes shall be based on a specific Union or national law and subject to the same cumulative conditions as referred to in paragraph 1.
3. Paragraph 1 is without prejudice to Union or national law which excludes processing of personal data for other purposes than those explicitly mentioned in that law, as well as to Union or national law laying down the basis for the processing of personal data which is necessary for the purpose of developing, testing or training of innovative AI systems or any other legal basis, in compliance with Union law on the protection of personal data.
|
regulatory sandbox personal data lawfully collected purpose may processed solely purpose developing training testing certain system sandbox following condition met system shall developed safeguarding substantial public interest public authority another natural legal person one following area public safety public health including disease detection diagnosis prevention control treatment improvement health care system high level protection improvement quality environment protection biodiversity protection pollution green transition measure climate change mitigation adaptation measure iii energy sustainability safety resilience transport system mobility critical infrastructure network efficiency quality public administration public service system shall developed safeguarding substantial public interest public authority another natural legal person one following area public safety public health including disease detection diagnosis prevention control treatment improvement health care system public safety public health including disease detection diagnosis prevention control treatment improvement health care system high level protection improvement quality environment protection biodiversity protection pollution green transition measure climate change mitigation adaptation measure high level protection improvement quality environment protection biodiversity protection pollution green transition measure climate change mitigation adaptation measure iii energy sustainability iii energy sustainability safety resilience transport system mobility critical infrastructure network safety resilience transport system mobility critical infrastructure network efficiency quality public administration public service efficiency quality public administration public service data processed necessary complying one requirement referred chapter iii section requirement effectively fulfilled processing anonymised synthetic non personal data data processed necessary complying one requirement referred chapter iii section requirement effectively fulfilled processing anonymised synthetic non personal data effective monitoring mechanism identify high risk right freedom data subject referred article regulation 2016 679 article regulation 2018 1725 may arise sandbox experimentation well response mechanism promptly mitigate risk necessary stop processing effective monitoring mechanism identify high risk right freedom data subject referred article regulation 2016 679 article regulation 2018 1725 may arise sandbox experimentation well response mechanism promptly mitigate risk necessary stop processing personal data processed context sandbox functionally separate isolated protected data processing environment control prospective provider authorised person access data personal data processed context sandbox functionally separate isolated protected data processing environment control prospective provider authorised person access data provider share originally collected data accordance union data protection law personal data created sandbox shared outside sandbox provider share originally collected data accordance union data protection law personal data created sandbox shared outside sandbox processing personal data context sandbox neither lead measure decision affecting data subject affect application right laid union law protection personal data processing personal data context sandbox neither lead measure decision affecting data subject affect application right laid union law protection personal data personal data processed context sandbox protected mean appropriate technical organisational measure deleted participation sandbox terminated personal data reached end retention period personal data processed context sandbox protected mean appropriate technical organisational measure deleted participation sandbox terminated personal data reached end retention period log processing personal data context sandbox kept duration participation sandbox unless provided otherwise union national law log processing personal data context sandbox kept duration participation sandbox unless provided otherwise union national law complete detailed description process rationale behind training testing validation system kept together testing result part technical documentation referred annex complete detailed description process rationale behind training testing validation system kept together testing result part technical documentation referred annex short summary project developed sandbox objective expected result published website competent authority obligation shall cover sensitive operational data relation activity law enforcement border control immigration asylum authority short summary project developed sandbox objective expected result published website competent authority obligation shall cover sensitive operational data relation activity law enforcement border control immigration asylum authority purpose prevention investigation detection prosecution criminal offence execution criminal penalty including safeguarding preventing threat public security control responsibility law enforcement authority processing personal data regulatory sandbox shall based specific union national law subject cumulative condition referred paragraph paragraph without prejudice union national law excludes processing personal data purpose explicitly mentioned law well union national law laying basis processing personal data necessary purpose developing testing training innovative system legal basis compliance union law protection personal data
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 60
|
1. Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes may be conducted by providers or prospective providers of high-risk AI systems listed in Annex III, in accordance with this Article and the real-world testing plan referred to in this Article, without prejudice to the prohibitions under Article 5.
The Commission shall, by means of implementing acts, specify the detailed elements of the real-world testing plan. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).
This paragraph shall be without prejudice to Union or national law on the testing in real world conditions of high-risk AI systems related to products covered by Union harmonisation legislation listed in Annex I.
2. Providers or prospective providers may conduct testing of high-risk AI systems referred to in Annex III in real world conditions at any time before the placing on the market or the putting into service of the AI system on their own or in partnership with one or more deployers or prospective deployers.
3. The testing of high-risk AI systems in real world conditions under this Article shall be without prejudice to any ethical review that is required by Union or national law.
4. Providers or prospective providers may conduct the testing in real world conditions only where all of the following conditions are met:
(a) the provider or prospective provider has drawn up a real-world testing plan and submitted it to the market surveillance authority in the Member State where the testing in real world conditions is to be conducted;
(a)
the provider or prospective provider has drawn up a real-world testing plan and submitted it to the market surveillance authority in the Member State where the testing in real world conditions is to be conducted;
(b) the market surveillance authority in the Member State where the testing in real world conditions is to be conducted has approved the testing in real world conditions and the real-world testing plan; where the market surveillance authority has not provided an answer within 30 days, the testing in real world conditions and the real-world testing plan shall be understood to have been approved; where national law does not provide for a tacit approval, the testing in real world conditions shall remain subject to an authorisation;
(b)
the market surveillance authority in the Member State where the testing in real world conditions is to be conducted has approved the testing in real world conditions and the real-world testing plan; where the market surveillance authority has not provided an answer within 30 days, the testing in real world conditions and the real-world testing plan shall be understood to have been approved; where national law does not provide for a tacit approval, the testing in real world conditions shall remain subject to an authorisation;
(c) the provider or prospective provider, with the exception of providers or prospective providers of high-risk AI systems referred to in points 1, 6 and 7 of Annex III in the areas of law enforcement, migration, asylum and border control management, and high-risk AI systems referred to in point 2 of Annex III has registered the testing in real world conditions in accordance with Article 71(4) with a Union-wide unique single identification number and with the information specified in Annex IX; the provider or prospective provider of high-risk AI systems referred to in points 1, 6 and 7 of Annex III in the areas of law enforcement, migration, asylum and border control management, has registered the testing in real-world conditions in the secure non-public section of the EU database according to Article 49(4), point (d), with a Union-wide unique single identification number and with the information specified therein; the provider or prospective provider of high-risk AI systems referred to in point 2 of Annex III has registered the testing in real-world conditions in accordance with Article 49(5);
(c)
the provider or prospective provider, with the exception of providers or prospective providers of high-risk AI systems referred to in points 1, 6 and 7 of Annex III in the areas of law enforcement, migration, asylum and border control management, and high-risk AI systems referred to in point 2 of Annex III has registered the testing in real world conditions in accordance with Article 71(4) with a Union-wide unique single identification number and with the information specified in Annex IX; the provider or prospective provider of high-risk AI systems referred to in points 1, 6 and 7 of Annex III in the areas of law enforcement, migration, asylum and border control management, has registered the testing in real-world conditions in the secure non-public section of the EU database according to Article 49(4), point (d), with a Union-wide unique single identification number and with the information specified therein; the provider or prospective provider of high-risk AI systems referred to in point 2 of Annex III has registered the testing in real-world conditions in accordance with Article 49(5);
(d) the provider or prospective provider conducting the testing in real world conditions is established in the Union or has appointed a legal representative who is established in the Union;
(d)
the provider or prospective provider conducting the testing in real world conditions is established in the Union or has appointed a legal representative who is established in the Union;
(e) data collected and processed for the purpose of the testing in real world conditions shall be transferred to third countries only provided that appropriate and applicable safeguards under Union law are implemented;
(e)
data collected and processed for the purpose of the testing in real world conditions shall be transferred to third countries only provided that appropriate and applicable safeguards under Union law are implemented;
(f) the testing in real world conditions does not last longer than necessary to achieve its objectives and in any case not longer than six months, which may be extended for an additional period of six months, subject to prior notification by the provider or prospective provider to the market surveillance authority, accompanied by an explanation of the need for such an extension;
(f)
the testing in real world conditions does not last longer than necessary to achieve its objectives and in any case not longer than six months, which may be extended for an additional period of six months, subject to prior notification by the provider or prospective provider to the market surveillance authority, accompanied by an explanation of the need for such an extension;
(g) the subjects of the testing in real world conditions who are persons belonging to vulnerable groups due to their age or disability, are appropriately protected;
(g)
the subjects of the testing in real world conditions who are persons belonging to vulnerable groups due to their age or disability, are appropriately protected;
(h) where a provider or prospective provider organises the testing in real world conditions in cooperation with one or more deployers or prospective deployers, the latter have been informed of all aspects of the testing that are relevant to their decision to participate, and given the relevant instructions for use of the AI system referred to in Article 13; the provider or prospective provider and the deployer or prospective deployer shall conclude an agreement specifying their roles and responsibilities with a view to ensuring compliance with the provisions for testing in real world conditions under this Regulation and under other applicable Union and national law;
(h)
where a provider or prospective provider organises the testing in real world conditions in cooperation with one or more deployers or prospective deployers, the latter have been informed of all aspects of the testing that are relevant to their decision to participate, and given the relevant instructions for use of the AI system referred to in Article 13; the provider or prospective provider and the deployer or prospective deployer shall conclude an agreement specifying their roles and responsibilities with a view to ensuring compliance with the provisions for testing in real world conditions under this Regulation and under other applicable Union and national law;
(i) the subjects of the testing in real world conditions have given informed consent in accordance with Article 61, or in the case of law enforcement, where the seeking of informed consent would prevent the AI system from being tested, the testing itself and the outcome of the testing in the real world conditions shall not have any negative effect on the subjects, and their personal data shall be deleted after the test is performed;
(i)
the subjects of the testing in real world conditions have given informed consent in accordance with Article 61, or in the case of law enforcement, where the seeking of informed consent would prevent the AI system from being tested, the testing itself and the outcome of the testing in the real world conditions shall not have any negative effect on the subjects, and their personal data shall be deleted after the test is performed;
(j) the testing in real world conditions is effectively overseen by the provider or prospective provider, as well as by deployers or prospective deployers through persons who are suitably qualified in the relevant field and have the necessary capacity, training and authority to perform their tasks;
(j)
the testing in real world conditions is effectively overseen by the provider or prospective provider, as well as by deployers or prospective deployers through persons who are suitably qualified in the relevant field and have the necessary capacity, training and authority to perform their tasks;
(k) the predictions, recommendations or decisions of the AI system can be effectively reversed and disregarded.
(k)
the predictions, recommendations or decisions of the AI system can be effectively reversed and disregarded.
5. Any subjects of the testing in real world conditions, or their legally designated representative, as appropriate, may, without any resulting detriment and without having to provide any justification, withdraw from the testing at any time by revoking their informed consent and may request the immediate and permanent deletion of their personal data. The withdrawal of the informed consent shall not affect the activities already carried out.
6. In accordance with Article 75, Member States shall confer on their market surveillance authorities the powers of requiring providers and prospective providers to provide information, of carrying out unannounced remote or on-site inspections, and of performing checks on the conduct of the testing in real world conditions and the related high-risk AI systems. Market surveillance authorities shall use those powers to ensure the safe development of testing in real world conditions.
7. Any serious incident identified in the course of the testing in real world conditions shall be reported to the national market surveillance authority in accordance with Article 73. The provider or prospective provider shall adopt immediate mitigation measures or, failing that, shall suspend the testing in real world conditions until such mitigation takes place, or otherwise terminate it. The provider or prospective provider shall establish a procedure for the prompt recall of the AI system upon such termination of the testing in real world conditions.
8. Providers or prospective providers shall notify the national market surveillance authority in the Member State where the testing in real world conditions is to be conducted of the suspension or termination of the testing in real world conditions and of the final outcomes.
9. The provider or prospective provider shall be liable under applicable Union and national liability law for any damage caused in the course of their testing in real world conditions.
|
testing high risk system real world condition outside regulatory sandbox may conducted provider prospective provider high risk system listed annex iii accordance article real world testing plan referred article without prejudice prohibition article commission shall mean implementing act specify detailed element real world testing plan implementing act shall adopted accordance examination procedure referred article paragraph shall without prejudice union national law testing real world condition high risk system related product covered union harmonisation legislation listed annex provider prospective provider may conduct testing high risk system referred annex iii real world condition time placing market putting service system partnership one deployers prospective deployers testing high risk system real world condition article shall without prejudice ethical review required union national law provider prospective provider may conduct testing real world condition following condition met provider prospective provider drawn real world testing plan submitted market surveillance authority member state testing real world condition conducted provider prospective provider drawn real world testing plan submitted market surveillance authority member state testing real world condition conducted market surveillance authority member state testing real world condition conducted approved testing real world condition real world testing plan market surveillance authority provided answer within day testing real world condition real world testing plan shall understood approved national law provide tacit approval testing real world condition shall remain subject authorisation market surveillance authority member state testing real world condition conducted approved testing real world condition real world testing plan market surveillance authority provided answer within day testing real world condition real world testing plan shall understood approved national law provide tacit approval testing real world condition shall remain subject authorisation provider prospective provider exception provider prospective provider high risk system referred point annex iii area law enforcement migration asylum border control management high risk system referred point annex iii registered testing real world condition accordance article union wide unique single identification number information specified annex provider prospective provider high risk system referred point annex iii area law enforcement migration asylum border control management registered testing real world condition secure non public section database according article point union wide unique single identification number information specified therein provider prospective provider high risk system referred point annex iii registered testing real world condition accordance article provider prospective provider exception provider prospective provider high risk system referred point annex iii area law enforcement migration asylum border control management high risk system referred point annex iii registered testing real world condition accordance article union wide unique single identification number information specified annex provider prospective provider high risk system referred point annex iii area law enforcement migration asylum border control management registered testing real world condition secure non public section database according article point union wide unique single identification number information specified therein provider prospective provider high risk system referred point annex iii registered testing real world condition accordance article provider prospective provider conducting testing real world condition established union appointed legal representative established union provider prospective provider conducting testing real world condition established union appointed legal representative established union data collected processed purpose testing real world condition shall transferred third country provided appropriate applicable safeguard union law implemented data collected processed purpose testing real world condition shall transferred third country provided appropriate applicable safeguard union law implemented testing real world condition last longer necessary achieve objective case longer six month may extended additional period six month subject prior notification provider prospective provider market surveillance authority accompanied explanation need extension testing real world condition last longer necessary achieve objective case longer six month may extended additional period six month subject prior notification provider prospective provider market surveillance authority accompanied explanation need extension subject testing real world condition person belonging vulnerable group due age disability appropriately protected subject testing real world condition person belonging vulnerable group due age disability appropriately protected provider prospective provider organises testing real world condition cooperation one deployers prospective deployers latter informed aspect testing relevant decision participate given relevant instruction use system referred article provider prospective provider deployer prospective deployer shall conclude agreement specifying role responsibility view ensuring compliance provision testing real world condition regulation applicable union national law provider prospective provider organises testing real world condition cooperation one deployers prospective deployers latter informed aspect testing relevant decision participate given relevant instruction use system referred article provider prospective provider deployer prospective deployer shall conclude agreement specifying role responsibility view ensuring compliance provision testing real world condition regulation applicable union national law subject testing real world condition given informed consent accordance article case law enforcement seeking informed consent would prevent system tested testing outcome testing real world condition shall negative effect subject personal data shall deleted test performed subject testing real world condition given informed consent accordance article case law enforcement seeking informed consent would prevent system tested testing outcome testing real world condition shall negative effect subject personal data shall deleted test performed testing real world condition effectively overseen provider prospective provider well deployers prospective deployers person suitably qualified relevant field necessary capacity training authority perform task testing real world condition effectively overseen provider prospective provider well deployers prospective deployers person suitably qualified relevant field necessary capacity training authority perform task prediction recommendation decision system effectively reversed disregarded prediction recommendation decision system effectively reversed disregarded subject testing real world condition legally designated representative appropriate may without resulting detriment without provide justification withdraw testing time revoking informed consent may request immediate permanent deletion personal data withdrawal informed consent shall affect activity already carried accordance article member state shall confer market surveillance authority power requiring provider prospective provider provide information carrying unannounced remote site inspection performing check conduct testing real world condition related high risk system market surveillance authority shall use power ensure safe development testing real world condition serious incident identified course testing real world condition shall reported national market surveillance authority accordance article provider prospective provider shall adopt immediate mitigation measure failing shall suspend testing real world condition mitigation take place otherwise terminate provider prospective provider shall establish procedure prompt recall system upon termination testing real world condition provider prospective provider shall notify national market surveillance authority member state testing real world condition conducted suspension termination testing real world condition final outcome provider prospective provider shall liable applicable union national liability law damage caused course testing real world condition
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 61
|
1. For the purpose of testing in real world conditions under Article 60, freely-given informed consent shall be obtained from the subjects of testing prior to their participation in such testing and after their having been duly informed with concise, clear, relevant, and understandable information regarding:
(a) the nature and objectives of the testing in real world conditions and the possible inconvenience that may be linked to their participation;
(a)
the nature and objectives of the testing in real world conditions and the possible inconvenience that may be linked to their participation;
(b) the conditions under which the testing in real world conditions is to be conducted, including the expected duration of the subject or subjects’ participation;
(b)
the conditions under which the testing in real world conditions is to be conducted, including the expected duration of the subject or subjects’ participation;
(c) their rights, and the guarantees regarding their participation, in particular their right to refuse to participate in, and the right to withdraw from, testing in real world conditions at any time without any resulting detriment and without having to provide any justification;
(c)
their rights, and the guarantees regarding their participation, in particular their right to refuse to participate in, and the right to withdraw from, testing in real world conditions at any time without any resulting detriment and without having to provide any justification;
(d) the arrangements for requesting the reversal or the disregarding of the predictions, recommendations or decisions of the AI system;
(d)
the arrangements for requesting the reversal or the disregarding of the predictions, recommendations or decisions of the AI system;
(e) the Union-wide unique single identification number of the testing in real world conditions in accordance with Article 60(4) point (c), and the contact details of the provider or its legal representative from whom further information can be obtained.
(e)
the Union-wide unique single identification number of the testing in real world conditions in accordance with Article 60(4) point (c), and the contact details of the provider or its legal representative from whom further information can be obtained.
2. The informed consent shall be dated and documented and a copy shall be given to the subjects of testing or their legal representative.
|
purpose testing real world condition article freely given informed consent shall obtained subject testing prior participation testing duly informed concise clear relevant understandable information regarding nature objective testing real world condition possible inconvenience may linked participation nature objective testing real world condition possible inconvenience may linked participation condition testing real world condition conducted including expected duration subject subject participation condition testing real world condition conducted including expected duration subject subject participation right guarantee regarding participation particular right refuse participate right withdraw testing real world condition time without resulting detriment without provide justification right guarantee regarding participation particular right refuse participate right withdraw testing real world condition time without resulting detriment without provide justification arrangement requesting reversal disregarding prediction recommendation decision system arrangement requesting reversal disregarding prediction recommendation decision system union wide unique single identification number testing real world condition accordance article point contact detail provider legal representative information obtained union wide unique single identification number testing real world condition accordance article point contact detail provider legal representative information obtained informed consent shall dated documented copy shall given subject testing legal representative
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 62
|
1. Member States shall undertake the following actions:
(a) provide SMEs, including start-ups, having a registered office or a branch in the Union, with priority access to the AI regulatory sandboxes, to the extent that they fulfil the eligibility conditions and selection criteria; the priority access shall not preclude other SMEs, including start-ups, other than those referred to in this paragraph from access to the AI regulatory sandbox, provided that they also fulfil the eligibility conditions and selection criteria;
(a)
provide SMEs, including start-ups, having a registered office or a branch in the Union, with priority access to the AI regulatory sandboxes, to the extent that they fulfil the eligibility conditions and selection criteria; the priority access shall not preclude other SMEs, including start-ups, other than those referred to in this paragraph from access to the AI regulatory sandbox, provided that they also fulfil the eligibility conditions and selection criteria;
(b) organise specific awareness raising and training activities on the application of this Regulation tailored to the needs of SMEs including start-ups, deployers and, as appropriate, local public authorities;
(b)
organise specific awareness raising and training activities on the application of this Regulation tailored to the needs of SMEs including start-ups, deployers and, as appropriate, local public authorities;
(c) utilise existing dedicated channels and where appropriate, establish new ones for communication with SMEs including start-ups, deployers, other innovators and, as appropriate, local public authorities to provide advice and respond to queries about the implementation of this Regulation, including as regards participation in AI regulatory sandboxes;
(c)
utilise existing dedicated channels and where appropriate, establish new ones for communication with SMEs including start-ups, deployers, other innovators and, as appropriate, local public authorities to provide advice and respond to queries about the implementation of this Regulation, including as regards participation in AI regulatory sandboxes;
(d) facilitate the participation of SMEs and other relevant stakeholders in the standardisation development process.
(d)
facilitate the participation of SMEs and other relevant stakeholders in the standardisation development process.
2. The specific interests and needs of the SME providers, including start-ups, shall be taken into account when setting the fees for conformity assessment under Article 43, reducing those fees proportionately to their size, market size and other relevant indicators.
3. The AI Office shall undertake the following actions:
(a) provide standardised templates for areas covered by this Regulation, as specified by the Board in its request;
(a)
provide standardised templates for areas covered by this Regulation, as specified by the Board in its request;
(b) develop and maintain a single information platform providing easy to use information in relation to this Regulation for all operators across the Union;
(b)
develop and maintain a single information platform providing easy to use information in relation to this Regulation for all operators across the Union;
(c) organise appropriate communication campaigns to raise awareness about the obligations arising from this Regulation;
(c)
organise appropriate communication campaigns to raise awareness about the obligations arising from this Regulation;
(d) evaluate and promote the convergence of best practices in public procurement procedures in relation to AI systems.
(d)
evaluate and promote the convergence of best practices in public procurement procedures in relation to AI systems.
|
member state shall undertake following action provide smes including start ups registered office branch union priority access regulatory sandbox extent fulfil eligibility condition selection criterion priority access shall preclude smes including start ups referred paragraph access regulatory sandbox provided also fulfil eligibility condition selection criterion provide smes including start ups registered office branch union priority access regulatory sandbox extent fulfil eligibility condition selection criterion priority access shall preclude smes including start ups referred paragraph access regulatory sandbox provided also fulfil eligibility condition selection criterion organise specific awareness raising training activity application regulation tailored need smes including start ups deployers appropriate local public authority organise specific awareness raising training activity application regulation tailored need smes including start ups deployers appropriate local public authority utilise existing dedicated channel appropriate establish new one communication smes including start ups deployers innovator appropriate local public authority provide advice respond query implementation regulation including regard participation regulatory sandbox utilise existing dedicated channel appropriate establish new one communication smes including start ups deployers innovator appropriate local public authority provide advice respond query implementation regulation including regard participation regulatory sandbox facilitate participation smes relevant stakeholder standardisation development process facilitate participation smes relevant stakeholder standardisation development process specific interest need sme provider including start ups shall taken account setting fee conformity assessment article reducing fee proportionately size market size relevant indicator office shall undertake following action provide standardised template area covered regulation specified board request provide standardised template area covered regulation specified board request develop maintain single information platform providing easy use information relation regulation operator across union develop maintain single information platform providing easy use information relation regulation operator across union organise appropriate communication campaign raise awareness obligation arising regulation organise appropriate communication campaign raise awareness obligation arising regulation evaluate promote convergence best practice public procurement procedure relation system evaluate promote convergence best practice public procurement procedure relation system
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 63
|
1. Microenterprises within the meaning of Recommendation 2003/361/EC may comply with certain elements of the quality management system required by Article 17 of this Regulation in a simplified manner, provided that they do not have partner enterprises or linked enterprises within the meaning of that Recommendation. For that purpose, the Commission shall develop guidelines on the elements of the quality management system which may be complied with in a simplified manner considering the needs of microenterprises, without affecting the level of protection or the need for compliance with the requirements in respect of high-risk AI systems.
2. Paragraph 1 of this Article shall not be interpreted as exempting those operators from fulfilling any other requirements or obligations laid down in this Regulation, including those established in Articles 9, 10, 11, 12, 13, 14, 15, 72 and 73.
|
microenterprises within meaning recommendation 2003 361 may comply certain element quality management system required article regulation simplified manner provided partner enterprise linked enterprise within meaning recommendation purpose commission shall develop guideline element quality management system may complied simplified manner considering need microenterprises without affecting level protection need compliance requirement respect high risk system paragraph article shall interpreted exempting operator fulfilling requirement obligation laid regulation including established article
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 64
|
1. The Commission shall develop Union expertise and capabilities in the field of AI through the AI Office.
2. Member States shall facilitate the tasks entrusted to the AI Office, as reflected in this Regulation.
|
commission shall develop union expertise capability field office member state shall facilitate task entrusted office reflected regulation
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 65
|
1. A European Artificial Intelligence Board (the ‘Board’) is hereby established.
2. The Board shall be composed of one representative per Member State. The European Data Protection Supervisor shall participate as observer. The AI Office shall also attend the Board’s meetings, without taking part in the votes. Other national and Union authorities, bodies or experts may be invited to the meetings by the Board on a case by case basis, where the issues discussed are of relevance for them.
3. Each representative shall be designated by their Member State for a period of three years, renewable once.
4. Member States shall ensure that their representatives on the Board:
(a) have the relevant competences and powers in their Member State so as to contribute actively to the achievement of the Board’s tasks referred to in Article 66;
(a)
have the relevant competences and powers in their Member State so as to contribute actively to the achievement of the Board’s tasks referred to in Article 66;
(b) are designated as a single contact point vis-à-vis the Board and, where appropriate, taking into account Member States’ needs, as a single contact point for stakeholders;
(b)
are designated as a single contact point vis-à-vis the Board and, where appropriate, taking into account Member States’ needs, as a single contact point for stakeholders;
(c) are empowered to facilitate consistency and coordination between national competent authorities in their Member State as regards the implementation of this Regulation, including through the collection of relevant data and information for the purpose of fulfilling their tasks on the Board.
(c)
are empowered to facilitate consistency and coordination between national competent authorities in their Member State as regards the implementation of this Regulation, including through the collection of relevant data and information for the purpose of fulfilling their tasks on the Board.
5. The designated representatives of the Member States shall adopt the Board’s rules of procedure by a two-thirds majority. The rules of procedure shall, in particular, lay down procedures for the selection process, the duration of the mandate of, and specifications of the tasks of, the Chair, detailed arrangements for voting, and the organisation of the Board’s activities and those of its sub-groups.
6. The Board shall establish two standing sub-groups to provide a platform for cooperation and exchange among market surveillance authorities and notifying authorities about issues related to market surveillance and notified bodies respectively.
The standing sub-group for market surveillance should act as the administrative cooperation group (ADCO) for this Regulation within the meaning of Article 30 of Regulation (EU) 2019/1020.
The Board may establish other standing or temporary sub-groups as appropriate for the purpose of examining specific issues. Where appropriate, representatives of the advisory forum referred to in Article 67 may be invited to such sub-groups or to specific meetings of those subgroups as observers.
7. The Board shall be organised and operated so as to safeguard the objectivity and impartiality of its activities.
8. The Board shall be chaired by one of the representatives of the Member States. The AI Office shall provide the secretariat for the Board, convene the meetings upon request of the Chair, and prepare the agenda in accordance with the tasks of the Board pursuant to this Regulation and its rules of procedure.
|
european artificial intelligence board board hereby established board shall composed one representative per member state european data protection supervisor shall participate observer office shall also attend board meeting without taking part vote national union authority body expert may invited meeting board case case basis issue discussed relevance representative shall designated member state period three year renewable member state shall ensure representative board relevant competence power member state contribute actively achievement board task referred article relevant competence power member state contribute actively achievement board task referred article designated single contact point vi vi board appropriate taking account member state need single contact point stakeholder designated single contact point vi vi board appropriate taking account member state need single contact point stakeholder empowered facilitate consistency coordination national competent authority member state regard implementation regulation including collection relevant data information purpose fulfilling task board empowered facilitate consistency coordination national competent authority member state regard implementation regulation including collection relevant data information purpose fulfilling task board designated representative member state shall adopt board rule procedure two third majority rule procedure shall particular lay procedure selection process duration mandate specification task chair detailed arrangement voting organisation board activity sub group board shall establish two standing sub group provide platform cooperation exchange among market surveillance authority notifying authority issue related market surveillance notified body respectively standing sub group market surveillance act administrative cooperation group adco regulation within meaning article regulation 2019 1020 board may establish standing temporary sub group appropriate purpose examining specific issue appropriate representative advisory forum referred article may invited sub group specific meeting subgroup observer board shall organised operated safeguard objectivity impartiality activity board shall chaired one representative member state office shall provide secretariat board convene meeting upon request chair prepare agenda accordance task board pursuant regulation rule procedure
|
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all-MiniLM-L6-v2
| 384 |
Article 66
|
The Board shall advise and assist the Commission and the Member States in order to facilitate the consistent and effective application of this Regulation. To that end, the Board may in particular:
(a) contribute to the coordination among national competent authorities responsible for the application of this Regulation and, in cooperation with and subject to the agreement of the market surveillance authorities concerned, support joint activities of market surveillance authorities referred to in Article 74(11);
(a)
contribute to the coordination among national competent authorities responsible for the application of this Regulation and, in cooperation with and subject to the agreement of the market surveillance authorities concerned, support joint activities of market surveillance authorities referred to in Article 74(11);
(b) collect and share technical and regulatory expertise and best practices among Member States;
(b)
collect and share technical and regulatory expertise and best practices among Member States;
(c) provide advice on the implementation of this Regulation, in particular as regards the enforcement of rules on general-purpose AI models;
(c)
provide advice on the implementation of this Regulation, in particular as regards the enforcement of rules on general-purpose AI models;
(d) contribute to the harmonisation of administrative practices in the Member States, including in relation to the derogation from the conformity assessment procedures referred to in Article 46, the functioning of AI regulatory sandboxes, and testing in real world conditions referred to in Articles 57, 59 and 60;
(d)
contribute to the harmonisation of administrative practices in the Member States, including in relation to the derogation from the conformity assessment procedures referred to in Article 46, the functioning of AI regulatory sandboxes, and testing in real world conditions referred to in Articles 57, 59 and 60;
(e) at the request of the Commission or on its own initiative, issue recommendations and written opinions on any relevant matters related to the implementation of this Regulation and to its consistent and effective application, including: (i) on the development and application of codes of conduct and codes of practice pursuant to this Regulation, as well as of the Commission’s guidelines; (ii) the evaluation and review of this Regulation pursuant to Article 112, including as regards the serious incident reports referred to in Article 73, and the functioning of the EU database referred to in Article 71, the preparation of the delegated or implementing acts, and as regards possible alignments of this Regulation with the Union harmonisation legislation listed in Annex I; (iii) on technical specifications or existing standards regarding the requirements set out in Chapter III, Section 2; (iv) on the use of harmonised standards or common specifications referred to in Articles 40 and 41; (v) trends, such as European global competitiveness in AI, the uptake of AI in the Union, and the development of digital skills; (vi) trends on the evolving typology of AI value chains, in particular on the resulting implications in terms of accountability; (vii) on the potential need for amendment to Annex III in accordance with Article 7, and on the potential need for possible revision of Article 5 pursuant to Article 112, taking into account relevant available evidence and the latest developments in technology;
(e)
at the request of the Commission or on its own initiative, issue recommendations and written opinions on any relevant matters related to the implementation of this Regulation and to its consistent and effective application, including:
(i) on the development and application of codes of conduct and codes of practice pursuant to this Regulation, as well as of the Commission’s guidelines;
(i)
on the development and application of codes of conduct and codes of practice pursuant to this Regulation, as well as of the Commission’s guidelines;
(ii) the evaluation and review of this Regulation pursuant to Article 112, including as regards the serious incident reports referred to in Article 73, and the functioning of the EU database referred to in Article 71, the preparation of the delegated or implementing acts, and as regards possible alignments of this Regulation with the Union harmonisation legislation listed in Annex I;
(ii)
the evaluation and review of this Regulation pursuant to Article 112, including as regards the serious incident reports referred to in Article 73, and the functioning of the EU database referred to in Article 71, the preparation of the delegated or implementing acts, and as regards possible alignments of this Regulation with the Union harmonisation legislation listed in Annex I;
(iii) on technical specifications or existing standards regarding the requirements set out in Chapter III, Section 2;
(iii)
on technical specifications or existing standards regarding the requirements set out in Chapter III, Section 2;
(iv) on the use of harmonised standards or common specifications referred to in Articles 40 and 41;
(iv)
on the use of harmonised standards or common specifications referred to in Articles 40 and 41;
(v) trends, such as European global competitiveness in AI, the uptake of AI in the Union, and the development of digital skills;
(v)
trends, such as European global competitiveness in AI, the uptake of AI in the Union, and the development of digital skills;
(vi) trends on the evolving typology of AI value chains, in particular on the resulting implications in terms of accountability;
(vi)
trends on the evolving typology of AI value chains, in particular on the resulting implications in terms of accountability;
(vii) on the potential need for amendment to Annex III in accordance with Article 7, and on the potential need for possible revision of Article 5 pursuant to Article 112, taking into account relevant available evidence and the latest developments in technology;
(vii)
on the potential need for amendment to Annex III in accordance with Article 7, and on the potential need for possible revision of Article 5 pursuant to Article 112, taking into account relevant available evidence and the latest developments in technology;
(f) support the Commission in promoting AI literacy, public awareness and understanding of the benefits, risks, safeguards and rights and obligations in relation to the use of AI systems;
(f)
support the Commission in promoting AI literacy, public awareness and understanding of the benefits, risks, safeguards and rights and obligations in relation to the use of AI systems;
(g) facilitate the development of common criteria and a shared understanding among market operators and competent authorities of the relevant concepts provided for in this Regulation, including by contributing to the development of benchmarks;
(g)
facilitate the development of common criteria and a shared understanding among market operators and competent authorities of the relevant concepts provided for in this Regulation, including by contributing to the development of benchmarks;
(h) cooperate, as appropriate, with other Union institutions, bodies, offices and agencies, as well as relevant Union expert groups and networks, in particular in the fields of product safety, cybersecurity, competition, digital and media services, financial services, consumer protection, data and fundamental rights protection;
(h)
cooperate, as appropriate, with other Union institutions, bodies, offices and agencies, as well as relevant Union expert groups and networks, in particular in the fields of product safety, cybersecurity, competition, digital and media services, financial services, consumer protection, data and fundamental rights protection;
(i) contribute to effective cooperation with the competent authorities of third countries and with international organisations;
(i)
contribute to effective cooperation with the competent authorities of third countries and with international organisations;
(j) assist national competent authorities and the Commission in developing the organisational and technical expertise required for the implementation of this Regulation, including by contributing to the assessment of training needs for staff of Member States involved in implementing this Regulation;
(j)
assist national competent authorities and the Commission in developing the organisational and technical expertise required for the implementation of this Regulation, including by contributing to the assessment of training needs for staff of Member States involved in implementing this Regulation;
(k) assist the AI Office in supporting national competent authorities in the establishment and development of AI regulatory sandboxes, and facilitate cooperation and information-sharing among AI regulatory sandboxes;
(k)
assist the AI Office in supporting national competent authorities in the establishment and development of AI regulatory sandboxes, and facilitate cooperation and information-sharing among AI regulatory sandboxes;
(l) contribute to, and provide relevant advice on, the development of guidance documents;
(l)
contribute to, and provide relevant advice on, the development of guidance documents;
(m) advise the Commission in relation to international matters on AI;
(m)
advise the Commission in relation to international matters on AI;
(n) provide opinions to the Commission on the qualified alerts regarding general-purpose AI models;
(n)
provide opinions to the Commission on the qualified alerts regarding general-purpose AI models;
(o) receive opinions by the Member States on qualified alerts regarding general-purpose AI models, and on national experiences and practices on the monitoring and enforcement of AI systems, in particular systems integrating the general-purpose AI models.
(o)
receive opinions by the Member States on qualified alerts regarding general-purpose AI models, and on national experiences and practices on the monitoring and enforcement of AI systems, in particular systems integrating the general-purpose AI models.
|
board shall advise assist commission member state order facilitate consistent effective application regulation end board may particular contribute coordination among national competent authority responsible application regulation cooperation subject agreement market surveillance authority concerned support joint activity market surveillance authority referred article contribute coordination among national competent authority responsible application regulation cooperation subject agreement market surveillance authority concerned support joint activity market surveillance authority referred article collect share technical regulatory expertise best practice among member state collect share technical regulatory expertise best practice among member state provide advice implementation regulation particular regard enforcement rule general purpose model provide advice implementation regulation particular regard enforcement rule general purpose model contribute harmonisation administrative practice member state including relation derogation conformity assessment procedure referred article functioning regulatory sandbox testing real world condition referred article contribute harmonisation administrative practice member state including relation derogation conformity assessment procedure referred article functioning regulatory sandbox testing real world condition referred article request commission initiative issue recommendation written opinion relevant matter related implementation regulation consistent effective application including development application code conduct code practice pursuant regulation well commission guideline evaluation review regulation pursuant article 112 including regard serious incident report referred article functioning database referred article preparation delegated implementing act regard possible alignment regulation union harmonisation legislation listed annex iii technical specification existing standard regarding requirement set chapter iii section use harmonised standard common specification referred article trend european global competitiveness uptake union development digital skill trend evolving typology value chain particular resulting implication term accountability vii potential need amendment annex iii accordance article potential need possible revision article pursuant article 112 taking account relevant available evidence latest development technology request commission initiative issue recommendation written opinion relevant matter related implementation regulation consistent effective application including development application code conduct code practice pursuant regulation well commission guideline development application code conduct code practice pursuant regulation well commission guideline evaluation review regulation pursuant article 112 including regard serious incident report referred article functioning database referred article preparation delegated implementing act regard possible alignment regulation union harmonisation legislation listed annex evaluation review regulation pursuant article 112 including regard serious incident report referred article functioning database referred article preparation delegated implementing act regard possible alignment regulation union harmonisation legislation listed annex iii technical specification existing standard regarding requirement set chapter iii section iii technical specification existing standard regarding requirement set chapter iii section use harmonised standard common specification referred article use harmonised standard common specification referred article trend european global competitiveness uptake union development digital skill trend european global competitiveness uptake union development digital skill trend evolving typology value chain particular resulting implication term accountability trend evolving typology value chain particular resulting implication term accountability vii potential need amendment annex iii accordance article potential need possible revision article pursuant article 112 taking account relevant available evidence latest development technology vii potential need amendment annex iii accordance article potential need possible revision article pursuant article 112 taking account relevant available evidence latest development technology support commission promoting literacy public awareness understanding benefit risk safeguard right obligation relation use system support commission promoting literacy public awareness understanding benefit risk safeguard right obligation relation use system facilitate development common criterion shared understanding among market operator competent authority relevant concept provided regulation including contributing development benchmark facilitate development common criterion shared understanding among market operator competent authority relevant concept provided regulation including contributing development benchmark cooperate appropriate union institution body office agency well relevant union expert group network particular field product safety cybersecurity competition digital medium service financial service consumer protection data fundamental right protection cooperate appropriate union institution body office agency well relevant union expert group network particular field product safety cybersecurity competition digital medium service financial service consumer protection data fundamental right protection contribute effective cooperation competent authority third country international organisation contribute effective cooperation competent authority third country international organisation assist national competent authority commission developing organisational technical expertise required implementation regulation including contributing assessment training need staff member state involved implementing regulation assist national competent authority commission developing organisational technical expertise required implementation regulation including contributing assessment training need staff member state involved implementing regulation assist office supporting national competent authority establishment development regulatory sandbox facilitate cooperation information sharing among regulatory sandbox assist office supporting national competent authority establishment development regulatory sandbox facilitate cooperation information sharing among regulatory sandbox contribute provide relevant advice development guidance document contribute provide relevant advice development guidance document advise commission relation international matter advise commission relation international matter provide opinion commission qualified alert regarding general purpose model provide opinion commission qualified alert regarding general purpose model receive opinion member state qualified alert regarding general purpose model national experience practice monitoring enforcement system particular system integrating general purpose model receive opinion member state qualified alert regarding general purpose model national experience practice monitoring enforcement system particular system integrating general purpose model
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 67
|
1. An advisory forum shall be established to provide technical expertise and advise the Board and the Commission, and to contribute to their tasks under this Regulation.
2. The membership of the advisory forum shall represent a balanced selection of stakeholders, including industry, start-ups, SMEs, civil society and academia. The membership of the advisory forum shall be balanced with regard to commercial and non-commercial interests and, within the category of commercial interests, with regard to SMEs and other undertakings.
3. The Commission shall appoint the members of the advisory forum, in accordance with the criteria set out in paragraph 2, from amongst stakeholders with recognised expertise in the field of AI.
4. The term of office of the members of the advisory forum shall be two years, which may be extended by up to no more than four years.
5. The Fundamental Rights Agency, ENISA, the European Committee for Standardization (CEN), the European Committee for Electrotechnical Standardization (CENELEC), and the European Telecommunications Standards Institute (ETSI) shall be permanent members of the advisory forum.
6. The advisory forum shall draw up its rules of procedure. It shall elect two co-chairs from among its members, in accordance with criteria set out in paragraph 2. The term of office of the co-chairs shall be two years, renewable once.
7. The advisory forum shall hold meetings at least twice a year. The advisory forum may invite experts and other stakeholders to its meetings.
8. The advisory forum may prepare opinions, recommendations and written contributions at the request of the Board or the Commission.
9. The advisory forum may establish standing or temporary sub-groups as appropriate for the purpose of examining specific questions related to the objectives of this Regulation.
10. The advisory forum shall prepare an annual report on its activities. That report shall be made publicly available.
|
advisory forum shall established provide technical expertise advise board commission contribute task regulation membership advisory forum shall represent balanced selection stakeholder including industry start ups smes civil society academia membership advisory forum shall balanced regard commercial non commercial interest within category commercial interest regard smes undertaking commission shall appoint member advisory forum accordance criterion set paragraph amongst stakeholder recognised expertise field term office member advisory forum shall two year may extended four year fundamental right agency enisa european committee standardization cen european committee electrotechnical standardization cenelec european telecommunication standard institute etsi shall permanent member advisory forum advisory forum shall draw rule procedure shall elect two chair among member accordance criterion set paragraph term office chair shall two year renewable advisory forum shall hold meeting least twice year advisory forum may invite expert stakeholder meeting advisory forum may prepare opinion recommendation written contribution request board commission advisory forum may establish standing temporary sub group appropriate purpose examining specific question related objective regulation advisory forum shall prepare annual report activity report shall made publicly available
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 68
|
1. The Commission shall, by means of an implementing act, make provisions on the establishment of a scientific panel of independent experts (the ‘scientific panel’) intended to support the enforcement activities under this Regulation. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 98(2).
2. The scientific panel shall consist of experts selected by the Commission on the basis of up-to-date scientific or technical expertise in the field of AI necessary for the tasks set out in paragraph 3, and shall be able to demonstrate meeting all of the following conditions:
(a) having particular expertise and competence and scientific or technical expertise in the field of AI;
(a)
having particular expertise and competence and scientific or technical expertise in the field of AI;
(b) independence from any provider of AI systems or general-purpose AI models;
(b)
independence from any provider of AI systems or general-purpose AI models;
(c) an ability to carry out activities diligently, accurately and objectively.
(c)
an ability to carry out activities diligently, accurately and objectively.
The Commission, in consultation with the Board, shall determine the number of experts on the panel in accordance with the required needs and shall ensure fair gender and geographical representation.
3. The scientific panel shall advise and support the AI Office, in particular with regard to the following tasks:
(a) supporting the implementation and enforcement of this Regulation as regards general-purpose AI models and systems, in particular by: (i) alerting the AI Office of possible systemic risks at Union level of general-purpose AI models, in accordance with Article 90; (ii) contributing to the development of tools and methodologies for evaluating capabilities of general-purpose AI models and systems, including through benchmarks; (iii) providing advice on the classification of general-purpose AI models with systemic risk; (iv) providing advice on the classification of various general-purpose AI models and systems; (v) contributing to the development of tools and templates;
(a)
supporting the implementation and enforcement of this Regulation as regards general-purpose AI models and systems, in particular by:
(i) alerting the AI Office of possible systemic risks at Union level of general-purpose AI models, in accordance with Article 90;
(i)
alerting the AI Office of possible systemic risks at Union level of general-purpose AI models, in accordance with Article 90;
(ii) contributing to the development of tools and methodologies for evaluating capabilities of general-purpose AI models and systems, including through benchmarks;
(ii)
contributing to the development of tools and methodologies for evaluating capabilities of general-purpose AI models and systems, including through benchmarks;
(iii) providing advice on the classification of general-purpose AI models with systemic risk;
(iii)
providing advice on the classification of general-purpose AI models with systemic risk;
(iv) providing advice on the classification of various general-purpose AI models and systems;
(iv)
providing advice on the classification of various general-purpose AI models and systems;
(v) contributing to the development of tools and templates;
(v)
contributing to the development of tools and templates;
(b) supporting the work of market surveillance authorities, at their request;
(b)
supporting the work of market surveillance authorities, at their request;
(c) supporting cross-border market surveillance activities as referred to in Article 74(11), without prejudice to the powers of market surveillance authorities;
(c)
supporting cross-border market surveillance activities as referred to in Article 74(11), without prejudice to the powers of market surveillance authorities;
(d) supporting the AI Office in carrying out its duties in the context of the Union safeguard procedure pursuant to Article 81.
(d)
supporting the AI Office in carrying out its duties in the context of the Union safeguard procedure pursuant to Article 81.
4. The experts on the scientific panel shall perform their tasks with impartiality and objectivity, and shall ensure the confidentiality of information and data obtained in carrying out their tasks and activities. They shall neither seek nor take instructions from anyone when exercising their tasks under paragraph 3. Each expert shall draw up a declaration of interests, which shall be made publicly available. The AI Office shall establish systems and procedures to actively manage and prevent potential conflicts of interest.
5. The implementing act referred to in paragraph 1 shall include provisions on the conditions, procedures and detailed arrangements for the scientific panel and its members to issue alerts, and to request the assistance of the AI Office for the performance of the tasks of the scientific panel.
|
commission shall mean implementing act make provision establishment scientific panel independent expert scientific panel intended support enforcement activity regulation implementing act shall adopted accordance examination procedure referred article scientific panel shall consist expert selected commission basis date scientific technical expertise field necessary task set paragraph shall able demonstrate meeting following condition particular expertise competence scientific technical expertise field particular expertise competence scientific technical expertise field independence provider system general purpose model independence provider system general purpose model ability carry activity diligently accurately objectively ability carry activity diligently accurately objectively commission consultation board shall determine number expert panel accordance required need shall ensure fair gender geographical representation scientific panel shall advise support office particular regard following task supporting implementation enforcement regulation regard general purpose model system particular alerting office possible systemic risk union level general purpose model accordance article contributing development tool methodology evaluating capability general purpose model system including benchmark iii providing advice classification general purpose model systemic risk providing advice classification various general purpose model system contributing development tool template supporting implementation enforcement regulation regard general purpose model system particular alerting office possible systemic risk union level general purpose model accordance article alerting office possible systemic risk union level general purpose model accordance article contributing development tool methodology evaluating capability general purpose model system including benchmark contributing development tool methodology evaluating capability general purpose model system including benchmark iii providing advice classification general purpose model systemic risk iii providing advice classification general purpose model systemic risk providing advice classification various general purpose model system providing advice classification various general purpose model system contributing development tool template contributing development tool template supporting work market surveillance authority request supporting work market surveillance authority request supporting cross border market surveillance activity referred article without prejudice power market surveillance authority supporting cross border market surveillance activity referred article without prejudice power market surveillance authority supporting office carrying duty context union safeguard procedure pursuant article supporting office carrying duty context union safeguard procedure pursuant article expert scientific panel shall perform task impartiality objectivity shall ensure confidentiality information data obtained carrying task activity shall neither seek take instruction anyone exercising task paragraph expert shall draw declaration interest shall made publicly available office shall establish system procedure actively manage prevent potential conflict interest implementing act referred paragraph shall include provision condition procedure detailed arrangement scientific panel member issue alert request assistance office performance task scientific panel
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 69
|
1. Member States may call upon experts of the scientific panel to support their enforcement activities under this Regulation.
2. The Member States may be required to pay fees for the advice and support provided by the experts. The structure and the level of fees as well as the scale and structure of recoverable costs shall be set out in the implementing act referred to in Article 68(1), taking into account the objectives of the adequate implementation of this Regulation, cost-effectiveness and the necessity of ensuring effective access to experts for all Member States.
3. The Commission shall facilitate timely access to the experts by the Member States, as needed, and ensure that the combination of support activities carried out by Union AI testing support pursuant to Article 84 and experts pursuant to this Article is efficiently organised and provides the best possible added value.
|
member state may call upon expert scientific panel support enforcement activity regulation member state may required pay fee advice support provided expert structure level fee well scale structure recoverable cost shall set implementing act referred article taking account objective adequate implementation regulation cost effectiveness necessity ensuring effective access expert member state commission shall facilitate timely access expert member state needed ensure combination support activity carried union testing support pursuant article expert pursuant article efficiently organised provides best possible added value
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 70
|
1. Each Member State shall establish or designate as national competent authorities at least one notifying authority and at least one market surveillance authority for the purposes of this Regulation. Those national competent authorities shall exercise their powers independently, impartially and without bias so as to safeguard the objectivity of their activities and tasks, and to ensure the application and implementation of this Regulation. The members of those authorities shall refrain from any action incompatible with their duties. Provided that those principles are observed, such activities and tasks may be performed by one or more designated authorities, in accordance with the organisational needs of the Member State.
2. Member States shall communicate to the Commission the identity of the notifying authorities and the market surveillance authorities and the tasks of those authorities, as well as any subsequent changes thereto. Member States shall make publicly available information on how competent authorities and single points of contact can be contacted, through electronic communication means by 2 August 2025. Member States shall designate a market surveillance authority to act as the single point of contact for this Regulation, and shall notify the Commission of the identity of the single point of contact. The Commission shall make a list of the single points of contact publicly available.
3. Member States shall ensure that their national competent authorities are provided with adequate technical, financial and human resources, and with infrastructure to fulfil their tasks effectively under this Regulation. In particular, the national competent authorities shall have a sufficient number of personnel permanently available whose competences and expertise shall include an in-depth understanding of AI technologies, data and data computing, personal data protection, cybersecurity, fundamental rights, health and safety risks and knowledge of existing standards and legal requirements. Member States shall assess and, if necessary, update competence and resource requirements referred to in this paragraph on an annual basis.
4. National competent authorities shall take appropriate measures to ensure an adequate level of cybersecurity.
5. When performing their tasks, the national competent authorities shall act in accordance with the confidentiality obligations set out in Article 78.
6. By 2 August 2025, and once every two years thereafter, Member States shall report to the Commission on the status of the financial and human resources of the national competent authorities, with an assessment of their adequacy. The Commission shall transmit that information to the Board for discussion and possible recommendations.
7. The Commission shall facilitate the exchange of experience between national competent authorities.
8. National competent authorities may provide guidance and advice on the implementation of this Regulation, in particular to SMEs including start-ups, taking into account the guidance and advice of the Board and the Commission, as appropriate. Whenever national competent authorities intend to provide guidance and advice with regard to an AI system in areas covered by other Union law, the national competent authorities under that Union law shall be consulted, as appropriate.
9. Where Union institutions, bodies, offices or agencies fall within the scope of this Regulation, the European Data Protection Supervisor shall act as the competent authority for their supervision.
|
member state shall establish designate national competent authority least one notifying authority least one market surveillance authority purpose regulation national competent authority shall exercise power independently impartially without bias safeguard objectivity activity task ensure application implementation regulation member authority shall refrain action incompatible duty provided principle observed activity task may performed one designated authority accordance organisational need member state member state shall communicate commission identity notifying authority market surveillance authority task authority well subsequent change thereto member state shall make publicly available information competent authority single point contact contacted electronic communication mean august 2025 member state shall designate market surveillance authority act single point contact regulation shall notify commission identity single point contact commission shall make list single point contact publicly available member state shall ensure national competent authority provided adequate technical financial human resource infrastructure fulfil task effectively regulation particular national competent authority shall sufficient number personnel permanently available whose competence expertise shall include depth understanding technology data data computing personal data protection cybersecurity fundamental right health safety risk knowledge existing standard legal requirement member state shall assess necessary update competence resource requirement referred paragraph annual basis national competent authority shall take appropriate measure ensure adequate level cybersecurity performing task national competent authority shall act accordance confidentiality obligation set article august 2025 every two year thereafter member state shall report commission status financial human resource national competent authority assessment adequacy commission shall transmit information board discussion possible recommendation commission shall facilitate exchange experience national competent authority national competent authority may provide guidance advice implementation regulation particular smes including start ups taking account guidance advice board commission appropriate whenever national competent authority intend provide guidance advice regard system area covered union law national competent authority union law shall consulted appropriate union institution body office agency fall within scope regulation european data protection supervisor shall act competent authority supervision
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 64
|
1. The Commission shall develop Union expertise and capabilities in the field of AI through the AI Office.
2. Member States shall facilitate the tasks entrusted to the AI Office, as reflected in this Regulation.
|
commission shall develop union expertise capability field office member state shall facilitate task entrusted office reflected regulation
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 65
|
1. A European Artificial Intelligence Board (the ‘Board’) is hereby established.
2. The Board shall be composed of one representative per Member State. The European Data Protection Supervisor shall participate as observer. The AI Office shall also attend the Board’s meetings, without taking part in the votes. Other national and Union authorities, bodies or experts may be invited to the meetings by the Board on a case by case basis, where the issues discussed are of relevance for them.
3. Each representative shall be designated by their Member State for a period of three years, renewable once.
4. Member States shall ensure that their representatives on the Board:
(a) have the relevant competences and powers in their Member State so as to contribute actively to the achievement of the Board’s tasks referred to in Article 66;
(a)
have the relevant competences and powers in their Member State so as to contribute actively to the achievement of the Board’s tasks referred to in Article 66;
(b) are designated as a single contact point vis-à-vis the Board and, where appropriate, taking into account Member States’ needs, as a single contact point for stakeholders;
(b)
are designated as a single contact point vis-à-vis the Board and, where appropriate, taking into account Member States’ needs, as a single contact point for stakeholders;
(c) are empowered to facilitate consistency and coordination between national competent authorities in their Member State as regards the implementation of this Regulation, including through the collection of relevant data and information for the purpose of fulfilling their tasks on the Board.
(c)
are empowered to facilitate consistency and coordination between national competent authorities in their Member State as regards the implementation of this Regulation, including through the collection of relevant data and information for the purpose of fulfilling their tasks on the Board.
5. The designated representatives of the Member States shall adopt the Board’s rules of procedure by a two-thirds majority. The rules of procedure shall, in particular, lay down procedures for the selection process, the duration of the mandate of, and specifications of the tasks of, the Chair, detailed arrangements for voting, and the organisation of the Board’s activities and those of its sub-groups.
6. The Board shall establish two standing sub-groups to provide a platform for cooperation and exchange among market surveillance authorities and notifying authorities about issues related to market surveillance and notified bodies respectively.
The standing sub-group for market surveillance should act as the administrative cooperation group (ADCO) for this Regulation within the meaning of Article 30 of Regulation (EU) 2019/1020.
The Board may establish other standing or temporary sub-groups as appropriate for the purpose of examining specific issues. Where appropriate, representatives of the advisory forum referred to in Article 67 may be invited to such sub-groups or to specific meetings of those subgroups as observers.
7. The Board shall be organised and operated so as to safeguard the objectivity and impartiality of its activities.
8. The Board shall be chaired by one of the representatives of the Member States. The AI Office shall provide the secretariat for the Board, convene the meetings upon request of the Chair, and prepare the agenda in accordance with the tasks of the Board pursuant to this Regulation and its rules of procedure.
|
european artificial intelligence board board hereby established board shall composed one representative per member state european data protection supervisor shall participate observer office shall also attend board meeting without taking part vote national union authority body expert may invited meeting board case case basis issue discussed relevance representative shall designated member state period three year renewable member state shall ensure representative board relevant competence power member state contribute actively achievement board task referred article relevant competence power member state contribute actively achievement board task referred article designated single contact point vi vi board appropriate taking account member state need single contact point stakeholder designated single contact point vi vi board appropriate taking account member state need single contact point stakeholder empowered facilitate consistency coordination national competent authority member state regard implementation regulation including collection relevant data information purpose fulfilling task board empowered facilitate consistency coordination national competent authority member state regard implementation regulation including collection relevant data information purpose fulfilling task board designated representative member state shall adopt board rule procedure two third majority rule procedure shall particular lay procedure selection process duration mandate specification task chair detailed arrangement voting organisation board activity sub group board shall establish two standing sub group provide platform cooperation exchange among market surveillance authority notifying authority issue related market surveillance notified body respectively standing sub group market surveillance act administrative cooperation group adco regulation within meaning article regulation 2019 1020 board may establish standing temporary sub group appropriate purpose examining specific issue appropriate representative advisory forum referred article may invited sub group specific meeting subgroup observer board shall organised operated safeguard objectivity impartiality activity board shall chaired one representative member state office shall provide secretariat board convene meeting upon request chair prepare agenda accordance task board pursuant regulation rule procedure
|
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all-MiniLM-L6-v2
| 384 |
Article 66
|
The Board shall advise and assist the Commission and the Member States in order to facilitate the consistent and effective application of this Regulation. To that end, the Board may in particular:
(a) contribute to the coordination among national competent authorities responsible for the application of this Regulation and, in cooperation with and subject to the agreement of the market surveillance authorities concerned, support joint activities of market surveillance authorities referred to in Article 74(11);
(a)
contribute to the coordination among national competent authorities responsible for the application of this Regulation and, in cooperation with and subject to the agreement of the market surveillance authorities concerned, support joint activities of market surveillance authorities referred to in Article 74(11);
(b) collect and share technical and regulatory expertise and best practices among Member States;
(b)
collect and share technical and regulatory expertise and best practices among Member States;
(c) provide advice on the implementation of this Regulation, in particular as regards the enforcement of rules on general-purpose AI models;
(c)
provide advice on the implementation of this Regulation, in particular as regards the enforcement of rules on general-purpose AI models;
(d) contribute to the harmonisation of administrative practices in the Member States, including in relation to the derogation from the conformity assessment procedures referred to in Article 46, the functioning of AI regulatory sandboxes, and testing in real world conditions referred to in Articles 57, 59 and 60;
(d)
contribute to the harmonisation of administrative practices in the Member States, including in relation to the derogation from the conformity assessment procedures referred to in Article 46, the functioning of AI regulatory sandboxes, and testing in real world conditions referred to in Articles 57, 59 and 60;
(e) at the request of the Commission or on its own initiative, issue recommendations and written opinions on any relevant matters related to the implementation of this Regulation and to its consistent and effective application, including: (i) on the development and application of codes of conduct and codes of practice pursuant to this Regulation, as well as of the Commission’s guidelines; (ii) the evaluation and review of this Regulation pursuant to Article 112, including as regards the serious incident reports referred to in Article 73, and the functioning of the EU database referred to in Article 71, the preparation of the delegated or implementing acts, and as regards possible alignments of this Regulation with the Union harmonisation legislation listed in Annex I; (iii) on technical specifications or existing standards regarding the requirements set out in Chapter III, Section 2; (iv) on the use of harmonised standards or common specifications referred to in Articles 40 and 41; (v) trends, such as European global competitiveness in AI, the uptake of AI in the Union, and the development of digital skills; (vi) trends on the evolving typology of AI value chains, in particular on the resulting implications in terms of accountability; (vii) on the potential need for amendment to Annex III in accordance with Article 7, and on the potential need for possible revision of Article 5 pursuant to Article 112, taking into account relevant available evidence and the latest developments in technology;
(e)
at the request of the Commission or on its own initiative, issue recommendations and written opinions on any relevant matters related to the implementation of this Regulation and to its consistent and effective application, including:
(i) on the development and application of codes of conduct and codes of practice pursuant to this Regulation, as well as of the Commission’s guidelines;
(i)
on the development and application of codes of conduct and codes of practice pursuant to this Regulation, as well as of the Commission’s guidelines;
(ii) the evaluation and review of this Regulation pursuant to Article 112, including as regards the serious incident reports referred to in Article 73, and the functioning of the EU database referred to in Article 71, the preparation of the delegated or implementing acts, and as regards possible alignments of this Regulation with the Union harmonisation legislation listed in Annex I;
(ii)
the evaluation and review of this Regulation pursuant to Article 112, including as regards the serious incident reports referred to in Article 73, and the functioning of the EU database referred to in Article 71, the preparation of the delegated or implementing acts, and as regards possible alignments of this Regulation with the Union harmonisation legislation listed in Annex I;
(iii) on technical specifications or existing standards regarding the requirements set out in Chapter III, Section 2;
(iii)
on technical specifications or existing standards regarding the requirements set out in Chapter III, Section 2;
(iv) on the use of harmonised standards or common specifications referred to in Articles 40 and 41;
(iv)
on the use of harmonised standards or common specifications referred to in Articles 40 and 41;
(v) trends, such as European global competitiveness in AI, the uptake of AI in the Union, and the development of digital skills;
(v)
trends, such as European global competitiveness in AI, the uptake of AI in the Union, and the development of digital skills;
(vi) trends on the evolving typology of AI value chains, in particular on the resulting implications in terms of accountability;
(vi)
trends on the evolving typology of AI value chains, in particular on the resulting implications in terms of accountability;
(vii) on the potential need for amendment to Annex III in accordance with Article 7, and on the potential need for possible revision of Article 5 pursuant to Article 112, taking into account relevant available evidence and the latest developments in technology;
(vii)
on the potential need for amendment to Annex III in accordance with Article 7, and on the potential need for possible revision of Article 5 pursuant to Article 112, taking into account relevant available evidence and the latest developments in technology;
(f) support the Commission in promoting AI literacy, public awareness and understanding of the benefits, risks, safeguards and rights and obligations in relation to the use of AI systems;
(f)
support the Commission in promoting AI literacy, public awareness and understanding of the benefits, risks, safeguards and rights and obligations in relation to the use of AI systems;
(g) facilitate the development of common criteria and a shared understanding among market operators and competent authorities of the relevant concepts provided for in this Regulation, including by contributing to the development of benchmarks;
(g)
facilitate the development of common criteria and a shared understanding among market operators and competent authorities of the relevant concepts provided for in this Regulation, including by contributing to the development of benchmarks;
(h) cooperate, as appropriate, with other Union institutions, bodies, offices and agencies, as well as relevant Union expert groups and networks, in particular in the fields of product safety, cybersecurity, competition, digital and media services, financial services, consumer protection, data and fundamental rights protection;
(h)
cooperate, as appropriate, with other Union institutions, bodies, offices and agencies, as well as relevant Union expert groups and networks, in particular in the fields of product safety, cybersecurity, competition, digital and media services, financial services, consumer protection, data and fundamental rights protection;
(i) contribute to effective cooperation with the competent authorities of third countries and with international organisations;
(i)
contribute to effective cooperation with the competent authorities of third countries and with international organisations;
(j) assist national competent authorities and the Commission in developing the organisational and technical expertise required for the implementation of this Regulation, including by contributing to the assessment of training needs for staff of Member States involved in implementing this Regulation;
(j)
assist national competent authorities and the Commission in developing the organisational and technical expertise required for the implementation of this Regulation, including by contributing to the assessment of training needs for staff of Member States involved in implementing this Regulation;
(k) assist the AI Office in supporting national competent authorities in the establishment and development of AI regulatory sandboxes, and facilitate cooperation and information-sharing among AI regulatory sandboxes;
(k)
assist the AI Office in supporting national competent authorities in the establishment and development of AI regulatory sandboxes, and facilitate cooperation and information-sharing among AI regulatory sandboxes;
(l) contribute to, and provide relevant advice on, the development of guidance documents;
(l)
contribute to, and provide relevant advice on, the development of guidance documents;
(m) advise the Commission in relation to international matters on AI;
(m)
advise the Commission in relation to international matters on AI;
(n) provide opinions to the Commission on the qualified alerts regarding general-purpose AI models;
(n)
provide opinions to the Commission on the qualified alerts regarding general-purpose AI models;
(o) receive opinions by the Member States on qualified alerts regarding general-purpose AI models, and on national experiences and practices on the monitoring and enforcement of AI systems, in particular systems integrating the general-purpose AI models.
(o)
receive opinions by the Member States on qualified alerts regarding general-purpose AI models, and on national experiences and practices on the monitoring and enforcement of AI systems, in particular systems integrating the general-purpose AI models.
|
board shall advise assist commission member state order facilitate consistent effective application regulation end board may particular contribute coordination among national competent authority responsible application regulation cooperation subject agreement market surveillance authority concerned support joint activity market surveillance authority referred article contribute coordination among national competent authority responsible application regulation cooperation subject agreement market surveillance authority concerned support joint activity market surveillance authority referred article collect share technical regulatory expertise best practice among member state collect share technical regulatory expertise best practice among member state provide advice implementation regulation particular regard enforcement rule general purpose model provide advice implementation regulation particular regard enforcement rule general purpose model contribute harmonisation administrative practice member state including relation derogation conformity assessment procedure referred article functioning regulatory sandbox testing real world condition referred article contribute harmonisation administrative practice member state including relation derogation conformity assessment procedure referred article functioning regulatory sandbox testing real world condition referred article request commission initiative issue recommendation written opinion relevant matter related implementation regulation consistent effective application including development application code conduct code practice pursuant regulation well commission guideline evaluation review regulation pursuant article 112 including regard serious incident report referred article functioning database referred article preparation delegated implementing act regard possible alignment regulation union harmonisation legislation listed annex iii technical specification existing standard regarding requirement set chapter iii section use harmonised standard common specification referred article trend european global competitiveness uptake union development digital skill trend evolving typology value chain particular resulting implication term accountability vii potential need amendment annex iii accordance article potential need possible revision article pursuant article 112 taking account relevant available evidence latest development technology request commission initiative issue recommendation written opinion relevant matter related implementation regulation consistent effective application including development application code conduct code practice pursuant regulation well commission guideline development application code conduct code practice pursuant regulation well commission guideline evaluation review regulation pursuant article 112 including regard serious incident report referred article functioning database referred article preparation delegated implementing act regard possible alignment regulation union harmonisation legislation listed annex evaluation review regulation pursuant article 112 including regard serious incident report referred article functioning database referred article preparation delegated implementing act regard possible alignment regulation union harmonisation legislation listed annex iii technical specification existing standard regarding requirement set chapter iii section iii technical specification existing standard regarding requirement set chapter iii section use harmonised standard common specification referred article use harmonised standard common specification referred article trend european global competitiveness uptake union development digital skill trend european global competitiveness uptake union development digital skill trend evolving typology value chain particular resulting implication term accountability trend evolving typology value chain particular resulting implication term accountability vii potential need amendment annex iii accordance article potential need possible revision article pursuant article 112 taking account relevant available evidence latest development technology vii potential need amendment annex iii accordance article potential need possible revision article pursuant article 112 taking account relevant available evidence latest development technology support commission promoting literacy public awareness understanding benefit risk safeguard right obligation relation use system support commission promoting literacy public awareness understanding benefit risk safeguard right obligation relation use system facilitate development common criterion shared understanding among market operator competent authority relevant concept provided regulation including contributing development benchmark facilitate development common criterion shared understanding among market operator competent authority relevant concept provided regulation including contributing development benchmark cooperate appropriate union institution body office agency well relevant union expert group network particular field product safety cybersecurity competition digital medium service financial service consumer protection data fundamental right protection cooperate appropriate union institution body office agency well relevant union expert group network particular field product safety cybersecurity competition digital medium service financial service consumer protection data fundamental right protection contribute effective cooperation competent authority third country international organisation contribute effective cooperation competent authority third country international organisation assist national competent authority commission developing organisational technical expertise required implementation regulation including contributing assessment training need staff member state involved implementing regulation assist national competent authority commission developing organisational technical expertise required implementation regulation including contributing assessment training need staff member state involved implementing regulation assist office supporting national competent authority establishment development regulatory sandbox facilitate cooperation information sharing among regulatory sandbox assist office supporting national competent authority establishment development regulatory sandbox facilitate cooperation information sharing among regulatory sandbox contribute provide relevant advice development guidance document contribute provide relevant advice development guidance document advise commission relation international matter advise commission relation international matter provide opinion commission qualified alert regarding general purpose model provide opinion commission qualified alert regarding general purpose model receive opinion member state qualified alert regarding general purpose model national experience practice monitoring enforcement system particular system integrating general purpose model receive opinion member state qualified alert regarding general purpose model national experience practice monitoring enforcement system particular system integrating general purpose model
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 67
|
1. An advisory forum shall be established to provide technical expertise and advise the Board and the Commission, and to contribute to their tasks under this Regulation.
2. The membership of the advisory forum shall represent a balanced selection of stakeholders, including industry, start-ups, SMEs, civil society and academia. The membership of the advisory forum shall be balanced with regard to commercial and non-commercial interests and, within the category of commercial interests, with regard to SMEs and other undertakings.
3. The Commission shall appoint the members of the advisory forum, in accordance with the criteria set out in paragraph 2, from amongst stakeholders with recognised expertise in the field of AI.
4. The term of office of the members of the advisory forum shall be two years, which may be extended by up to no more than four years.
5. The Fundamental Rights Agency, ENISA, the European Committee for Standardization (CEN), the European Committee for Electrotechnical Standardization (CENELEC), and the European Telecommunications Standards Institute (ETSI) shall be permanent members of the advisory forum.
6. The advisory forum shall draw up its rules of procedure. It shall elect two co-chairs from among its members, in accordance with criteria set out in paragraph 2. The term of office of the co-chairs shall be two years, renewable once.
7. The advisory forum shall hold meetings at least twice a year. The advisory forum may invite experts and other stakeholders to its meetings.
8. The advisory forum may prepare opinions, recommendations and written contributions at the request of the Board or the Commission.
9. The advisory forum may establish standing or temporary sub-groups as appropriate for the purpose of examining specific questions related to the objectives of this Regulation.
10. The advisory forum shall prepare an annual report on its activities. That report shall be made publicly available.
|
advisory forum shall established provide technical expertise advise board commission contribute task regulation membership advisory forum shall represent balanced selection stakeholder including industry start ups smes civil society academia membership advisory forum shall balanced regard commercial non commercial interest within category commercial interest regard smes undertaking commission shall appoint member advisory forum accordance criterion set paragraph amongst stakeholder recognised expertise field term office member advisory forum shall two year may extended four year fundamental right agency enisa european committee standardization cen european committee electrotechnical standardization cenelec european telecommunication standard institute etsi shall permanent member advisory forum advisory forum shall draw rule procedure shall elect two chair among member accordance criterion set paragraph term office chair shall two year renewable advisory forum shall hold meeting least twice year advisory forum may invite expert stakeholder meeting advisory forum may prepare opinion recommendation written contribution request board commission advisory forum may establish standing temporary sub group appropriate purpose examining specific question related objective regulation advisory forum shall prepare annual report activity report shall made publicly available
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 68
|
1. The Commission shall, by means of an implementing act, make provisions on the establishment of a scientific panel of independent experts (the ‘scientific panel’) intended to support the enforcement activities under this Regulation. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 98(2).
2. The scientific panel shall consist of experts selected by the Commission on the basis of up-to-date scientific or technical expertise in the field of AI necessary for the tasks set out in paragraph 3, and shall be able to demonstrate meeting all of the following conditions:
(a) having particular expertise and competence and scientific or technical expertise in the field of AI;
(a)
having particular expertise and competence and scientific or technical expertise in the field of AI;
(b) independence from any provider of AI systems or general-purpose AI models;
(b)
independence from any provider of AI systems or general-purpose AI models;
(c) an ability to carry out activities diligently, accurately and objectively.
(c)
an ability to carry out activities diligently, accurately and objectively.
The Commission, in consultation with the Board, shall determine the number of experts on the panel in accordance with the required needs and shall ensure fair gender and geographical representation.
3. The scientific panel shall advise and support the AI Office, in particular with regard to the following tasks:
(a) supporting the implementation and enforcement of this Regulation as regards general-purpose AI models and systems, in particular by: (i) alerting the AI Office of possible systemic risks at Union level of general-purpose AI models, in accordance with Article 90; (ii) contributing to the development of tools and methodologies for evaluating capabilities of general-purpose AI models and systems, including through benchmarks; (iii) providing advice on the classification of general-purpose AI models with systemic risk; (iv) providing advice on the classification of various general-purpose AI models and systems; (v) contributing to the development of tools and templates;
(a)
supporting the implementation and enforcement of this Regulation as regards general-purpose AI models and systems, in particular by:
(i) alerting the AI Office of possible systemic risks at Union level of general-purpose AI models, in accordance with Article 90;
(i)
alerting the AI Office of possible systemic risks at Union level of general-purpose AI models, in accordance with Article 90;
(ii) contributing to the development of tools and methodologies for evaluating capabilities of general-purpose AI models and systems, including through benchmarks;
(ii)
contributing to the development of tools and methodologies for evaluating capabilities of general-purpose AI models and systems, including through benchmarks;
(iii) providing advice on the classification of general-purpose AI models with systemic risk;
(iii)
providing advice on the classification of general-purpose AI models with systemic risk;
(iv) providing advice on the classification of various general-purpose AI models and systems;
(iv)
providing advice on the classification of various general-purpose AI models and systems;
(v) contributing to the development of tools and templates;
(v)
contributing to the development of tools and templates;
(b) supporting the work of market surveillance authorities, at their request;
(b)
supporting the work of market surveillance authorities, at their request;
(c) supporting cross-border market surveillance activities as referred to in Article 74(11), without prejudice to the powers of market surveillance authorities;
(c)
supporting cross-border market surveillance activities as referred to in Article 74(11), without prejudice to the powers of market surveillance authorities;
(d) supporting the AI Office in carrying out its duties in the context of the Union safeguard procedure pursuant to Article 81.
(d)
supporting the AI Office in carrying out its duties in the context of the Union safeguard procedure pursuant to Article 81.
4. The experts on the scientific panel shall perform their tasks with impartiality and objectivity, and shall ensure the confidentiality of information and data obtained in carrying out their tasks and activities. They shall neither seek nor take instructions from anyone when exercising their tasks under paragraph 3. Each expert shall draw up a declaration of interests, which shall be made publicly available. The AI Office shall establish systems and procedures to actively manage and prevent potential conflicts of interest.
5. The implementing act referred to in paragraph 1 shall include provisions on the conditions, procedures and detailed arrangements for the scientific panel and its members to issue alerts, and to request the assistance of the AI Office for the performance of the tasks of the scientific panel.
|
commission shall mean implementing act make provision establishment scientific panel independent expert scientific panel intended support enforcement activity regulation implementing act shall adopted accordance examination procedure referred article scientific panel shall consist expert selected commission basis date scientific technical expertise field necessary task set paragraph shall able demonstrate meeting following condition particular expertise competence scientific technical expertise field particular expertise competence scientific technical expertise field independence provider system general purpose model independence provider system general purpose model ability carry activity diligently accurately objectively ability carry activity diligently accurately objectively commission consultation board shall determine number expert panel accordance required need shall ensure fair gender geographical representation scientific panel shall advise support office particular regard following task supporting implementation enforcement regulation regard general purpose model system particular alerting office possible systemic risk union level general purpose model accordance article contributing development tool methodology evaluating capability general purpose model system including benchmark iii providing advice classification general purpose model systemic risk providing advice classification various general purpose model system contributing development tool template supporting implementation enforcement regulation regard general purpose model system particular alerting office possible systemic risk union level general purpose model accordance article alerting office possible systemic risk union level general purpose model accordance article contributing development tool methodology evaluating capability general purpose model system including benchmark contributing development tool methodology evaluating capability general purpose model system including benchmark iii providing advice classification general purpose model systemic risk iii providing advice classification general purpose model systemic risk providing advice classification various general purpose model system providing advice classification various general purpose model system contributing development tool template contributing development tool template supporting work market surveillance authority request supporting work market surveillance authority request supporting cross border market surveillance activity referred article without prejudice power market surveillance authority supporting cross border market surveillance activity referred article without prejudice power market surveillance authority supporting office carrying duty context union safeguard procedure pursuant article supporting office carrying duty context union safeguard procedure pursuant article expert scientific panel shall perform task impartiality objectivity shall ensure confidentiality information data obtained carrying task activity shall neither seek take instruction anyone exercising task paragraph expert shall draw declaration interest shall made publicly available office shall establish system procedure actively manage prevent potential conflict interest implementing act referred paragraph shall include provision condition procedure detailed arrangement scientific panel member issue alert request assistance office performance task scientific panel
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 69
|
1. Member States may call upon experts of the scientific panel to support their enforcement activities under this Regulation.
2. The Member States may be required to pay fees for the advice and support provided by the experts. The structure and the level of fees as well as the scale and structure of recoverable costs shall be set out in the implementing act referred to in Article 68(1), taking into account the objectives of the adequate implementation of this Regulation, cost-effectiveness and the necessity of ensuring effective access to experts for all Member States.
3. The Commission shall facilitate timely access to the experts by the Member States, as needed, and ensure that the combination of support activities carried out by Union AI testing support pursuant to Article 84 and experts pursuant to this Article is efficiently organised and provides the best possible added value.
|
member state may call upon expert scientific panel support enforcement activity regulation member state may required pay fee advice support provided expert structure level fee well scale structure recoverable cost shall set implementing act referred article taking account objective adequate implementation regulation cost effectiveness necessity ensuring effective access expert member state commission shall facilitate timely access expert member state needed ensure combination support activity carried union testing support pursuant article expert pursuant article efficiently organised provides best possible added value
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 70
|
1. Each Member State shall establish or designate as national competent authorities at least one notifying authority and at least one market surveillance authority for the purposes of this Regulation. Those national competent authorities shall exercise their powers independently, impartially and without bias so as to safeguard the objectivity of their activities and tasks, and to ensure the application and implementation of this Regulation. The members of those authorities shall refrain from any action incompatible with their duties. Provided that those principles are observed, such activities and tasks may be performed by one or more designated authorities, in accordance with the organisational needs of the Member State.
2. Member States shall communicate to the Commission the identity of the notifying authorities and the market surveillance authorities and the tasks of those authorities, as well as any subsequent changes thereto. Member States shall make publicly available information on how competent authorities and single points of contact can be contacted, through electronic communication means by 2 August 2025. Member States shall designate a market surveillance authority to act as the single point of contact for this Regulation, and shall notify the Commission of the identity of the single point of contact. The Commission shall make a list of the single points of contact publicly available.
3. Member States shall ensure that their national competent authorities are provided with adequate technical, financial and human resources, and with infrastructure to fulfil their tasks effectively under this Regulation. In particular, the national competent authorities shall have a sufficient number of personnel permanently available whose competences and expertise shall include an in-depth understanding of AI technologies, data and data computing, personal data protection, cybersecurity, fundamental rights, health and safety risks and knowledge of existing standards and legal requirements. Member States shall assess and, if necessary, update competence and resource requirements referred to in this paragraph on an annual basis.
4. National competent authorities shall take appropriate measures to ensure an adequate level of cybersecurity.
5. When performing their tasks, the national competent authorities shall act in accordance with the confidentiality obligations set out in Article 78.
6. By 2 August 2025, and once every two years thereafter, Member States shall report to the Commission on the status of the financial and human resources of the national competent authorities, with an assessment of their adequacy. The Commission shall transmit that information to the Board for discussion and possible recommendations.
7. The Commission shall facilitate the exchange of experience between national competent authorities.
8. National competent authorities may provide guidance and advice on the implementation of this Regulation, in particular to SMEs including start-ups, taking into account the guidance and advice of the Board and the Commission, as appropriate. Whenever national competent authorities intend to provide guidance and advice with regard to an AI system in areas covered by other Union law, the national competent authorities under that Union law shall be consulted, as appropriate.
9. Where Union institutions, bodies, offices or agencies fall within the scope of this Regulation, the European Data Protection Supervisor shall act as the competent authority for their supervision.
|
member state shall establish designate national competent authority least one notifying authority least one market surveillance authority purpose regulation national competent authority shall exercise power independently impartially without bias safeguard objectivity activity task ensure application implementation regulation member authority shall refrain action incompatible duty provided principle observed activity task may performed one designated authority accordance organisational need member state member state shall communicate commission identity notifying authority market surveillance authority task authority well subsequent change thereto member state shall make publicly available information competent authority single point contact contacted electronic communication mean august 2025 member state shall designate market surveillance authority act single point contact regulation shall notify commission identity single point contact commission shall make list single point contact publicly available member state shall ensure national competent authority provided adequate technical financial human resource infrastructure fulfil task effectively regulation particular national competent authority shall sufficient number personnel permanently available whose competence expertise shall include depth understanding technology data data computing personal data protection cybersecurity fundamental right health safety risk knowledge existing standard legal requirement member state shall assess necessary update competence resource requirement referred paragraph annual basis national competent authority shall take appropriate measure ensure adequate level cybersecurity performing task national competent authority shall act accordance confidentiality obligation set article august 2025 every two year thereafter member state shall report commission status financial human resource national competent authority assessment adequacy commission shall transmit information board discussion possible recommendation commission shall facilitate exchange experience national competent authority national competent authority may provide guidance advice implementation regulation particular smes including start ups taking account guidance advice board commission appropriate whenever national competent authority intend provide guidance advice regard system area covered union law national competent authority union law shall consulted appropriate union institution body office agency fall within scope regulation european data protection supervisor shall act competent authority supervision
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 71
|
1. The Commission shall, in collaboration with the Member States, set up and maintain an EU database containing information referred to in paragraphs 2 and 3 of this Article concerning high-risk AI systems referred to in Article 6(2) which are registered in accordance with Articles 49 and 60 and AI systems that are not considered as high-risk pursuant to Article 6(3) and which are registered in accordance with Article 6(4) and Article 49. When setting the functional specifications of such database, the Commission shall consult the relevant experts, and when updating the functional specifications of such database, the Commission shall consult the Board.
2. The data listed in Sections A and B of Annex VIII shall be entered into the EU database by the provider or, where applicable, by the authorised representative.
3. The data listed in Section C of Annex VIII shall be entered into the EU database by the deployer who is, or who acts on behalf of, a public authority, agency or body, in accordance with Article 49(3) and (4).
4. With the exception of the section referred to in Article 49(4) and Article 60(4), point (c), the information contained in the EU database registered in accordance with Article 49 shall be accessible and publicly available in a user-friendly manner. The information should be easily navigable and machine-readable. The information registered in accordance with Article 60 shall be accessible only to market surveillance authorities and the Commission, unless the prospective provider or provider has given consent for also making the information accessible the public.
5. The EU database shall contain personal data only in so far as necessary for collecting and processing information in accordance with this Regulation. That information shall include the names and contact details of natural persons who are responsible for registering the system and have the legal authority to represent the provider or the deployer, as applicable.
6. The Commission shall be the controller of the EU database. It shall make available to providers, prospective providers and deployers adequate technical and administrative support. The EU database shall comply with the applicable accessibility requirements.
|
commission shall collaboration member state set maintain database containing information referred paragraph article concerning high risk system referred article registered accordance article system considered high risk pursuant article registered accordance article article setting functional specification database commission shall consult relevant expert updating functional specification database commission shall consult board data listed section annex viii shall entered database provider applicable authorised representative data listed section annex viii shall entered database deployer act behalf public authority agency body accordance article exception section referred article article point information contained database registered accordance article shall accessible publicly available user friendly manner information easily navigable machine readable information registered accordance article shall accessible market surveillance authority commission unless prospective provider provider given consent also making information accessible public database shall contain personal data far necessary collecting processing information accordance regulation information shall include name contact detail natural person responsible registering system legal authority represent provider deployer applicable commission shall controller database shall make available provider prospective provider deployers adequate technical administrative support database shall comply applicable accessibility requirement
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 72
|
1. Providers shall establish and document a post-market monitoring system in a manner that is proportionate to the nature of the AI technologies and the risks of the high-risk AI system.
2. The post-market monitoring system shall actively and systematically collect, document and analyse relevant data which may be provided by deployers or which may be collected through other sources on the performance of high-risk AI systems throughout their lifetime, and which allow the provider to evaluate the continuous compliance of AI systems with the requirements set out in Chapter III, Section 2. Where relevant, post-market monitoring shall include an analysis of the interaction with other AI systems. This obligation shall not cover sensitive operational data of deployers which are law-enforcement authorities.
3. The post-market monitoring system shall be based on a post-market monitoring plan. The post-market monitoring plan shall be part of the technical documentation referred to in Annex IV. The Commission shall adopt an implementing act laying down detailed provisions establishing a template for the post-market monitoring plan and the list of elements to be included in the plan by 2 February 2026. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 98(2).
4. For high-risk AI systems covered by the Union harmonisation legislation listed in Section A of Annex I, where a post-market monitoring system and plan are already established under that legislation, in order to ensure consistency, avoid duplications and minimise additional burdens, providers shall have a choice of integrating, as appropriate, the necessary elements described in paragraphs 1, 2 and 3 using the template referred in paragraph 3 into systems and plans already existing under that legislation, provided that it achieves an equivalent level of protection.
The first subparagraph of this paragraph shall also apply to high-risk AI systems referred to in point 5 of Annex III placed on the market or put into service by financial institutions that are subject to requirements under Union financial services law regarding their internal governance, arrangements or processes.
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provider shall establish document post market monitoring system manner proportionate nature technology risk high risk system post market monitoring system shall actively systematically collect document analyse relevant data may provided deployers may collected source performance high risk system throughout lifetime allow provider evaluate continuous compliance system requirement set chapter iii section relevant post market monitoring shall include analysis interaction system obligation shall cover sensitive operational data deployers law enforcement authority post market monitoring system shall based post market monitoring plan post market monitoring plan shall part technical documentation referred annex commission shall adopt implementing act laying detailed provision establishing template post market monitoring plan list element included plan february 2026 implementing act shall adopted accordance examination procedure referred article high risk system covered union harmonisation legislation listed section annex post market monitoring system plan already established legislation order ensure consistency avoid duplication minimise additional burden provider shall choice integrating appropriate necessary element described paragraph using template referred paragraph system plan already existing legislation provided achieves equivalent level protection first subparagraph paragraph shall also apply high risk system referred point annex iii placed market put service financial institution subject requirement union financial service law regarding internal governance arrangement process
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 73
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1. Providers of high-risk AI systems placed on the Union market shall report any serious incident to the market surveillance authorities of the Member States where that incident occurred.
2. The report referred to in paragraph 1 shall be made immediately after the provider has established a causal link between the AI system and the serious incident or the reasonable likelihood of such a link, and, in any event, not later than 15 days after the provider or, where applicable, the deployer, becomes aware of the serious incident.
The period for the reporting referred to in the first subparagraph shall take account of the severity of the serious incident.
3. Notwithstanding paragraph 2 of this Article, in the event of a widespread infringement or a serious incident as defined in Article 3, point (49)(b), the report referred to in paragraph 1 of this Article shall be provided immediately, and not later than two days after the provider or, where applicable, the deployer becomes aware of that incident.
4. Notwithstanding paragraph 2, in the event of the death of a person, the report shall be provided immediately after the provider or the deployer has established, or as soon as it suspects, a causal relationship between the high-risk AI system and the serious incident, but not later than 10 days after the date on which the provider or, where applicable, the deployer becomes aware of the serious incident.
5. Where necessary to ensure timely reporting, the provider or, where applicable, the deployer, may submit an initial report that is incomplete, followed by a complete report.
6. Following the reporting of a serious incident pursuant to paragraph 1, the provider shall, without delay, perform the necessary investigations in relation to the serious incident and the AI system concerned. This shall include a risk assessment of the incident, and corrective action.
The provider shall cooperate with the competent authorities, and where relevant with the notified body concerned, during the investigations referred to in the first subparagraph, and shall not perform any investigation which involves altering the AI system concerned in a way which may affect any subsequent evaluation of the causes of the incident, prior to informing the competent authorities of such action.
7. Upon receiving a notification related to a serious incident referred to in Article 3, point (49)(c), the relevant market surveillance authority shall inform the national public authorities or bodies referred to in Article 77(1). The Commission shall develop dedicated guidance to facilitate compliance with the obligations set out in paragraph 1 of this Article. That guidance shall be issued by 2 August 2025, and shall be assessed regularly.
8. The market surveillance authority shall take appropriate measures, as provided for in Article 19 of Regulation (EU) 2019/1020, within seven days from the date it received the notification referred to in paragraph 1 of this Article, and shall follow the notification procedures as provided in that Regulation.
9. For high-risk AI systems referred to in Annex III that are placed on the market or put into service by providers that are subject to Union legislative instruments laying down reporting obligations equivalent to those set out in this Regulation, the notification of serious incidents shall be limited to those referred to in Article 3, point (49)(c).
10. For high-risk AI systems which are safety components of devices, or are themselves devices, covered by Regulations (EU) 2017/745 and (EU) 2017/746, the notification of serious incidents shall be limited to those referred to in Article 3, point (49)(c) of this Regulation, and shall be made to the national competent authority chosen for that purpose by the Member States where the incident occurred.
11. National competent authorities shall immediately notify the Commission of any serious incident, whether or not they have taken action on it, in accordance with Article 20 of Regulation (EU) 2019/1020.
|
provider high risk system placed union market shall report serious incident market surveillance authority member state incident occurred report referred paragraph shall made immediately provider established causal link system serious incident reasonable likelihood link event later day provider applicable deployer becomes aware serious incident period reporting referred first subparagraph shall take account severity serious incident notwithstanding paragraph article event widespread infringement serious incident defined article point report referred paragraph article shall provided immediately later two day provider applicable deployer becomes aware incident notwithstanding paragraph event death person report shall provided immediately provider deployer established soon suspect causal relationship high risk system serious incident later day date provider applicable deployer becomes aware serious incident necessary ensure timely reporting provider applicable deployer may submit initial report incomplete followed complete report following reporting serious incident pursuant paragraph provider shall without delay perform necessary investigation relation serious incident system concerned shall include risk assessment incident corrective action provider shall cooperate competent authority relevant notified body concerned investigation referred first subparagraph shall perform investigation involves altering system concerned way may affect subsequent evaluation cause incident prior informing competent authority action upon receiving notification related serious incident referred article point relevant market surveillance authority shall inform national public authority body referred article commission shall develop dedicated guidance facilitate compliance obligation set paragraph article guidance shall issued august 2025 shall assessed regularly market surveillance authority shall take appropriate measure provided article regulation 2019 1020 within seven day date received notification referred paragraph article shall follow notification procedure provided regulation high risk system referred annex iii placed market put service provider subject union legislative instrument laying reporting obligation equivalent set regulation notification serious incident shall limited referred article point high risk system safety component device device covered regulation 2017 745 2017 746 notification serious incident shall limited referred article point regulation shall made national competent authority chosen purpose member state incident occurred national competent authority shall immediately notify commission serious incident whether taken action accordance article regulation 2019 1020
|
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all-MiniLM-L6-v2
| 384 |
Article 74
|
1. Regulation (EU) 2019/1020 shall apply to AI systems covered by this Regulation. For the purposes of the effective enforcement of this Regulation:
(a) any reference to an economic operator under Regulation (EU) 2019/1020 shall be understood as including all operators identified in Article 2(1) of this Regulation;
(a)
any reference to an economic operator under Regulation (EU) 2019/1020 shall be understood as including all operators identified in Article 2(1) of this Regulation;
(b) any reference to a product under Regulation (EU) 2019/1020 shall be understood as including all AI systems falling within the scope of this Regulation.
(b)
any reference to a product under Regulation (EU) 2019/1020 shall be understood as including all AI systems falling within the scope of this Regulation.
2. As part of their reporting obligations under Article 34(4) of Regulation (EU) 2019/1020, the market surveillance authorities shall report annually to the Commission and relevant national competition authorities any information identified in the course of market surveillance activities that may be of potential interest for the application of Union law on competition rules. They shall also annually report to the Commission about the use of prohibited practices that occurred during that year and about the measures taken.
3. For high-risk AI systems related to products covered by the Union harmonisation legislation listed in Section A of Annex I, the market surveillance authority for the purposes of this Regulation shall be the authority responsible for market surveillance activities designated under those legal acts.
By derogation from the first subparagraph, and in appropriate circumstances, Member States may designate another relevant authority to act as a market surveillance authority, provided they ensure coordination with the relevant sectoral market surveillance authorities responsible for the enforcement of the Union harmonisation legislation listed in Annex I.
4. The procedures referred to in Articles 79 to 83 of this Regulation shall not apply to AI systems related to products covered by the Union harmonisation legislation listed in section A of Annex I, where such legal acts already provide for procedures ensuring an equivalent level of protection and having the same objective. In such cases, the relevant sectoral procedures shall apply instead.
5. Without prejudice to the powers of market surveillance authorities under Article 14 of Regulation (EU) 2019/1020, for the purpose of ensuring the effective enforcement of this Regulation, market surveillance authorities may exercise the powers referred to in Article 14(4), points (d) and (j), of that Regulation remotely, as appropriate.
6. For high-risk AI systems placed on the market, put into service, or used by financial institutions regulated by Union financial services law, the market surveillance authority for the purposes of this Regulation shall be the relevant national authority responsible for the financial supervision of those institutions under that legislation in so far as the placing on the market, putting into service, or the use of the AI system is in direct connection with the provision of those financial services.
7. By way of derogation from paragraph 6, in appropriate circumstances, and provided that coordination is ensured, another relevant authority may be identified by the Member State as market surveillance authority for the purposes of this Regulation.
National market surveillance authorities supervising regulated credit institutions regulated under Directive 2013/36/EU, which are participating in the Single Supervisory Mechanism established by Regulation (EU) No 1024/2013, should report, without delay, to the European Central Bank any information identified in the course of their market surveillance activities that may be of potential interest for the prudential supervisory tasks of the European Central Bank specified in that Regulation.
8. For high-risk AI systems listed in point 1 of Annex III to this Regulation, in so far as the systems are used for law enforcement purposes, border management and justice and democracy, and for high-risk AI systems listed in points 6, 7 and 8 of Annex III to this Regulation, Member States shall designate as market surveillance authorities for the purposes of this Regulation either the competent data protection supervisory authorities under Regulation (EU) 2016/679 or Directive (EU) 2016/680, or any other authority designated pursuant to the same conditions laid down in Articles 41 to 44 of Directive (EU) 2016/680. Market surveillance activities shall in no way affect the independence of judicial authorities, or otherwise interfere with their activities when acting in their judicial capacity.
9. Where Union institutions, bodies, offices or agencies fall within the scope of this Regulation, the European Data Protection Supervisor shall act as their market surveillance authority, except in relation to the Court of Justice of the European Union acting in its judicial capacity.
10. Member States shall facilitate coordination between market surveillance authorities designated under this Regulation and other relevant national authorities or bodies which supervise the application of Union harmonisation legislation listed in Annex I, or in other Union law, that might be relevant for the high-risk AI systems referred to in Annex III.
11. Market surveillance authorities and the Commission shall be able to propose joint activities, including joint investigations, to be conducted by either market surveillance authorities or market surveillance authorities jointly with the Commission, that have the aim of promoting compliance, identifying non-compliance, raising awareness or providing guidance in relation to this Regulation with respect to specific categories of high-risk AI systems that are found to present a serious risk across two or more Member States in accordance with Article 9 of Regulation (EU) 2019/1020. The AI Office shall provide coordination support for joint investigations.
12. Without prejudice to the powers provided for under Regulation (EU) 2019/1020, and where relevant and limited to what is necessary to fulfil their tasks, the market surveillance authorities shall be granted full access by providers to the documentation as well as the training, validation and testing data sets used for the development of high-risk AI systems, including, where appropriate and subject to security safeguards, through application programming interfaces (API) or other relevant technical means and tools enabling remote access.
13. Market surveillance authorities shall be granted access to the source code of the high-risk AI system upon a reasoned request and only when both of the following conditions are fulfilled:
(a) access to source code is necessary to assess the conformity of a high-risk AI system with the requirements set out in Chapter III, Section 2; and
(a)
access to source code is necessary to assess the conformity of a high-risk AI system with the requirements set out in Chapter III, Section 2; and
(b) testing or auditing procedures and verifications based on the data and documentation provided by the provider have been exhausted or proved insufficient.
(b)
testing or auditing procedures and verifications based on the data and documentation provided by the provider have been exhausted or proved insufficient.
14. Any information or documentation obtained by market surveillance authorities shall be treated in accordance with the confidentiality obligations set out in Article 78.
|
regulation 2019 1020 shall apply system covered regulation purpose effective enforcement regulation reference economic operator regulation 2019 1020 shall understood including operator identified article regulation reference economic operator regulation 2019 1020 shall understood including operator identified article regulation reference product regulation 2019 1020 shall understood including system falling within scope regulation reference product regulation 2019 1020 shall understood including system falling within scope regulation part reporting obligation article regulation 2019 1020 market surveillance authority shall report annually commission relevant national competition authority information identified course market surveillance activity may potential interest application union law competition rule shall also annually report commission use prohibited practice occurred year measure taken high risk system related product covered union harmonisation legislation listed section annex market surveillance authority purpose regulation shall authority responsible market surveillance activity designated legal act derogation first subparagraph appropriate circumstance member state may designate another relevant authority act market surveillance authority provided ensure coordination relevant sectoral market surveillance authority responsible enforcement union harmonisation legislation listed annex procedure referred article regulation shall apply system related product covered union harmonisation legislation listed section annex legal act already provide procedure ensuring equivalent level protection objective case relevant sectoral procedure shall apply instead without prejudice power market surveillance authority article regulation 2019 1020 purpose ensuring effective enforcement regulation market surveillance authority may exercise power referred article point regulation remotely appropriate high risk system placed market put service used financial institution regulated union financial service law market surveillance authority purpose regulation shall relevant national authority responsible financial supervision institution legislation far placing market putting service use system direct connection provision financial service way derogation paragraph appropriate circumstance provided coordination ensured another relevant authority may identified member state market surveillance authority purpose regulation national market surveillance authority supervising regulated credit institution regulated directive 2013 participating single supervisory mechanism established regulation 1024 2013 report without delay european central bank information identified course market surveillance activity may potential interest prudential supervisory task european central bank specified regulation high risk system listed point annex iii regulation far system used law enforcement purpose border management justice democracy high risk system listed point annex iii regulation member state shall designate market surveillance authority purpose regulation either competent data protection supervisory authority regulation 2016 679 directive 2016 680 authority designated pursuant condition laid article directive 2016 680 market surveillance activity shall way affect independence judicial authority otherwise interfere activity acting judicial capacity union institution body office agency fall within scope regulation european data protection supervisor shall act market surveillance authority except relation court justice european union acting judicial capacity member state shall facilitate coordination market surveillance authority designated regulation relevant national authority body supervise application union harmonisation legislation listed annex union law might relevant high risk system referred annex iii market surveillance authority commission shall able propose joint activity including joint investigation conducted either market surveillance authority market surveillance authority jointly commission aim promoting compliance identifying non compliance raising awareness providing guidance relation regulation respect specific category high risk system found present serious risk across two member state accordance article regulation 2019 1020 office shall provide coordination support joint investigation without prejudice power provided regulation 2019 1020 relevant limited necessary fulfil task market surveillance authority shall granted full access provider documentation well training validation testing data set used development high risk system including appropriate subject security safeguard application programming interface api relevant technical mean tool enabling remote access market surveillance authority shall granted access source code high risk system upon reasoned request following condition fulfilled access source code necessary assess conformity high risk system requirement set chapter iii section access source code necessary assess conformity high risk system requirement set chapter iii section testing auditing procedure verification based data documentation provided provider exhausted proved insufficient testing auditing procedure verification based data documentation provided provider exhausted proved insufficient information documentation obtained market surveillance authority shall treated accordance confidentiality obligation set article
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 75
|
1. Where an AI system is based on a general-purpose AI model, and the model and the system are developed by the same provider, the AI Office shall have powers to monitor and supervise compliance of that AI system with obligations under this Regulation. To carry out its monitoring and supervision tasks, the AI Office shall have all the powers of a market surveillance authority provided for in this Section and Regulation (EU) 2019/1020.
2. Where the relevant market surveillance authorities have sufficient reason to consider general-purpose AI systems that can be used directly by deployers for at least one purpose that is classified as high-risk pursuant to this Regulation to be non-compliant with the requirements laid down in this Regulation, they shall cooperate with the AI Office to carry out compliance evaluations, and shall inform the Board and other market surveillance authorities accordingly.
3. Where a market surveillance authority is unable to conclude its investigation of the high-risk AI system because of its inability to access certain information related to the general-purpose AI model despite having made all appropriate efforts to obtain that information, it may submit a reasoned request to the AI Office, by which access to that information shall be enforced. In that case, the AI Office shall supply to the applicant authority without delay, and in any event within 30 days, any information that the AI Office considers to be relevant in order to establish whether a high-risk AI system is non-compliant. Market surveillance authorities shall safeguard the confidentiality of the information that they obtain in accordance with Article 78 of this Regulation. The procedure provided for in Chapter VI of Regulation (EU) 2019/1020 shall applymutatis mutandis.
|
system based general purpose model model system developed provider office shall power monitor supervise compliance system obligation regulation carry monitoring supervision task office shall power market surveillance authority provided section regulation 2019 1020 relevant market surveillance authority sufficient reason consider general purpose system used directly deployers least one purpose classified high risk pursuant regulation non compliant requirement laid regulation shall cooperate office carry compliance evaluation shall inform board market surveillance authority accordingly market surveillance authority unable conclude investigation high risk system inability access certain information related general purpose model despite made appropriate effort obtain information may submit reasoned request office access information shall enforced case office shall supply applicant authority without delay event within day information office considers relevant order establish whether high risk system non compliant market surveillance authority shall safeguard confidentiality information obtain accordance article regulation procedure provided chapter regulation 2019 1020 shall applymutatis mutandis
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 76
|
1. Market surveillance authorities shall have competences and powers to ensure that testing in real world conditions is in accordance with this Regulation.
2. Where testing in real world conditions is conducted for AI systems that are supervised within an AI regulatory sandbox under Article 58, the market surveillance authorities shall verify the compliance with Article 60 as part of their supervisory role for the AI regulatory sandbox. Those authorities may, as appropriate, allow the testing in real world conditions to be conducted by the provider or prospective provider, in derogation from the conditions set out in Article 60(4), points (f) and (g).
3. Where a market surveillance authority has been informed by the prospective provider, the provider or any third party of a serious incident or has other grounds for considering that the conditions set out in Articles 60 and 61 are not met, it may take either of the following decisions on its territory, as appropriate:
(a) to suspend or terminate the testing in real world conditions;
(a)
to suspend or terminate the testing in real world conditions;
(b) to require the provider or prospective provider and the deployer or prospective deployer to modify any aspect of the testing in real world conditions.
(b)
to require the provider or prospective provider and the deployer or prospective deployer to modify any aspect of the testing in real world conditions.
4. Where a market surveillance authority has taken a decision referred to in paragraph 3 of this Article, or has issued an objection within the meaning of Article 60(4), point (b), the decision or the objection shall indicate the grounds therefor and how the provider or prospective provider can challenge the decision or objection.
5. Where applicable, where a market surveillance authority has taken a decision referred to in paragraph 3, it shall communicate the grounds therefor to the market surveillance authorities of other Member States in which the AI system has been tested in accordance with the testing plan.
|
market surveillance authority shall competence power ensure testing real world condition accordance regulation testing real world condition conducted system supervised within regulatory sandbox article market surveillance authority shall verify compliance article part supervisory role regulatory sandbox authority may appropriate allow testing real world condition conducted provider prospective provider derogation condition set article point market surveillance authority informed prospective provider provider third party serious incident ground considering condition set article met may take either following decision territory appropriate suspend terminate testing real world condition suspend terminate testing real world condition require provider prospective provider deployer prospective deployer modify aspect testing real world condition require provider prospective provider deployer prospective deployer modify aspect testing real world condition market surveillance authority taken decision referred paragraph article issued objection within meaning article point decision objection shall indicate ground therefor provider prospective provider challenge decision objection applicable market surveillance authority taken decision referred paragraph shall communicate ground therefor market surveillance authority member state system tested accordance testing plan
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 77
|
1. National public authorities or bodies which supervise or enforce the respect of obligations under Union law protecting fundamental rights, including the right to non-discrimination, in relation to the use of high-risk AI systems referred to in Annex III shall have the power to request and access any documentation created or maintained under this Regulation in accessible language and format when access to that documentation is necessary for effectively fulfilling their mandates within the limits of their jurisdiction. The relevant public authority or body shall inform the market surveillance authority of the Member State concerned of any such request.
2. By 2 November 2024, each Member State shall identify the public authorities or bodies referred to in paragraph 1 and make a list of them publicly available. Member States shall notify the list to the Commission and to the other Member States, and shall keep the list up to date.
3. Where the documentation referred to in paragraph 1 is insufficient to ascertain whether an infringement of obligations under Union law protecting fundamental rights has occurred, the public authority or body referred to in paragraph 1 may make a reasoned request to the market surveillance authority, to organise testing of the high-risk AI system through technical means. The market surveillance authority shall organise the testing with the close involvement of the requesting public authority or body within a reasonable time following the request.
4. Any information or documentation obtained by the national public authorities or bodies referred to in paragraph 1 of this Article pursuant to this Article shall be treated in accordance with the confidentiality obligations set out in Article 78.
|
national public authority body supervise enforce respect obligation union law protecting fundamental right including right non discrimination relation use high risk system referred annex iii shall power request access documentation created maintained regulation accessible language format access documentation necessary effectively fulfilling mandate within limit jurisdiction relevant public authority body shall inform market surveillance authority member state concerned request november 2024 member state shall identify public authority body referred paragraph make list publicly available member state shall notify list commission member state shall keep list date documentation referred paragraph insufficient ascertain whether infringement obligation union law protecting fundamental right occurred public authority body referred paragraph may make reasoned request market surveillance authority organise testing high risk system technical mean market surveillance authority shall organise testing close involvement requesting public authority body within reasonable time following request information documentation obtained national public authority body referred paragraph article pursuant article shall treated accordance confidentiality obligation set article
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 78
|
1. The Commission, market surveillance authorities and notified bodies and any other natural or legal person involved in the application of this Regulation shall, in accordance with Union or national law, respect the confidentiality of information and data obtained in carrying out their tasks and activities in such a manner as to protect, in particular:
(a) the intellectual property rights and confidential business information or trade secrets of a natural or legal person, including source code, except in the cases referred to in Article 5 of Directive (EU) 2016/943 of the European Parliament and of the Council();
(a)
the intellectual property rights and confidential business information or trade secrets of a natural or legal person, including source code, except in the cases referred to in Article 5 of Directive (EU) 2016/943 of the European Parliament and of the Council();
(b) the effective implementation of this Regulation, in particular for the purposes of inspections, investigations or audits;
(b)
the effective implementation of this Regulation, in particular for the purposes of inspections, investigations or audits;
(c) public and national security interests;
(c)
public and national security interests;
(d) the conduct of criminal or administrative proceedings;
(d)
the conduct of criminal or administrative proceedings;
(e) information classified pursuant to Union or national law.
(e)
information classified pursuant to Union or national law.
2. The authorities involved in the application of this Regulation pursuant to paragraph 1 shall request only data that is strictly necessary for the assessment of the risk posed by AI systems and for the exercise of their powers in accordance with this Regulation and with Regulation (EU) 2019/1020. They shall put in place adequate and effective cybersecurity measures to protect the security and confidentiality of the information and data obtained, and shall delete the data collected as soon as it is no longer needed for the purpose for which it was obtained, in accordance with applicable Union or national law.
3. Without prejudice to paragraphs 1 and 2, information exchanged on a confidential basis between the national competent authorities or between national competent authorities and the Commission shall not be disclosed without prior consultation of the originating national competent authority and the deployer when high-risk AI systems referred to in point 1, 6 or 7 of Annex III are used by law enforcement, border control, immigration or asylum authorities and when such disclosure would jeopardise public and national security interests. This exchange of information shall not cover sensitive operational data in relation to the activities of law enforcement, border control, immigration or asylum authorities.
When the law enforcement, immigration or asylum authorities are providers of high-risk AI systems referred to in point 1, 6 or 7 of Annex III, the technical documentation referred to in Annex IV shall remain within the premises of those authorities. Those authorities shall ensure that the market surveillance authorities referred to in Article 74(8) and (9), as applicable, can, upon request, immediately access the documentation or obtain a copy thereof. Only staff of the market surveillance authority holding the appropriate level of security clearance shall be allowed to access that documentation or any copy thereof.
4. Paragraphs 1, 2 and 3 shall not affect the rights or obligations of the Commission, Member States and their relevant authorities, as well as those of notified bodies, with regard to the exchange of information and the dissemination of warnings, including in the context of cross-border cooperation, nor shall they affect the obligations of the parties concerned to provide information under criminal law of the Member States.
5. The Commission and Member States may exchange, where necessary and in accordance with relevant provisions of international and trade agreements, confidential information with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements guaranteeing an adequate level of confidentiality.
|
commission market surveillance authority notified body natural legal person involved application regulation shall accordance union national law respect confidentiality information data obtained carrying task activity manner protect particular intellectual property right confidential business information trade secret natural legal person including source code except case referred article directive 2016 943 european parliament council intellectual property right confidential business information trade secret natural legal person including source code except case referred article directive 2016 943 european parliament council effective implementation regulation particular purpose inspection investigation audit effective implementation regulation particular purpose inspection investigation audit public national security interest public national security interest conduct criminal administrative proceeding conduct criminal administrative proceeding information classified pursuant union national law information classified pursuant union national law authority involved application regulation pursuant paragraph shall request data strictly necessary assessment risk posed system exercise power accordance regulation regulation 2019 1020 shall put place adequate effective cybersecurity measure protect security confidentiality information data obtained shall delete data collected soon longer needed purpose obtained accordance applicable union national law without prejudice paragraph information exchanged confidential basis national competent authority national competent authority commission shall disclosed without prior consultation originating national competent authority deployer high risk system referred point annex iii used law enforcement border control immigration asylum authority disclosure would jeopardise public national security interest exchange information shall cover sensitive operational data relation activity law enforcement border control immigration asylum authority law enforcement immigration asylum authority provider high risk system referred point annex iii technical documentation referred annex shall remain within premise authority authority shall ensure market surveillance authority referred article applicable upon request immediately access documentation obtain copy thereof staff market surveillance authority holding appropriate level security clearance shall allowed access documentation copy thereof paragraph shall affect right obligation commission member state relevant authority well notified body regard exchange information dissemination warning including context cross border cooperation shall affect obligation party concerned provide information criminal law member state commission member state may exchange necessary accordance relevant provision international trade agreement confidential information regulatory authority third country concluded bilateral multilateral confidentiality arrangement guaranteeing adequate level confidentiality
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 79
|
1. AI systems presenting a risk shall be understood as a ‘product presenting a risk’ as defined in Article 3, point 19 of Regulation (EU) 2019/1020, in so far as they present risks to the health or safety, or to fundamental rights, of persons.
2. Where the market surveillance authority of a Member State has sufficient reason to consider an AI system to present a risk as referred to in paragraph 1 of this Article, it shall carry out an evaluation of the AI system concerned in respect of its compliance with all the requirements and obligations laid down in this Regulation. Particular attention shall be given to AI systems presenting a risk to vulnerable groups. Where risks to fundamental rights are identified, the market surveillance authority shall also inform and fully cooperate with the relevant national public authorities or bodies referred to in Article 77(1). The relevant operators shall cooperate as necessary with the market surveillance authority and with the other national public authorities or bodies referred to in Article 77(1).
Where, in the course of that evaluation, the market surveillance authority or, where applicable the market surveillance authority in cooperation with the national public authority referred to in Article 77(1), finds that the AI system does not comply with the requirements and obligations laid down in this Regulation, it shall without undue delay require the relevant operator to take all appropriate corrective actions to bring the AI system into compliance, to withdraw the AI system from the market, or to recall it within a period the market surveillance authority may prescribe, and in any event within the shorter of 15 working days, or as provided for in the relevant Union harmonisation legislation.
The market surveillance authority shall inform the relevant notified body accordingly. Article 18 of Regulation (EU) 2019/1020 shall apply to the measures referred to in the second subparagraph of this paragraph.
3. Where the market surveillance authority considers that the non-compliance is not restricted to its national territory, it shall inform the Commission and the other Member States without undue delay of the results of the evaluation and of the actions which it has required the operator to take.
4. The operator shall ensure that all appropriate corrective action is taken in respect of all the AI systems concerned that it has made available on the Union market.
5. Where the operator of an AI system does not take adequate corrective action within the period referred to in paragraph 2, the market surveillance authority shall take all appropriate provisional measures to prohibit or restrict the AI system’s being made available on its national market or put into service, to withdraw the product or the standalone AI system from that market or to recall it. That authority shall without undue delay notify the Commission and the other Member States of those measures.
6. The notification referred to in paragraph 5 shall include all available details, in particular the information necessary for the identification of the non-compliant AI system, the origin of the AI system and the supply chain, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant operator. In particular, the market surveillance authorities shall indicate whether the non-compliance is due to one or more of the following:
(a) non-compliance with the prohibition of the AI practices referred to in Article 5;
(a)
non-compliance with the prohibition of the AI practices referred to in Article 5;
(b) a failure of a high-risk AI system to meet requirements set out in Chapter III, Section 2;
(b)
a failure of a high-risk AI system to meet requirements set out in Chapter III, Section 2;
(c) shortcomings in the harmonised standards or common specifications referred to in Articles 40 and 41 conferring a presumption of conformity;
(c)
shortcomings in the harmonised standards or common specifications referred to in Articles 40 and 41 conferring a presumption of conformity;
(d) non-compliance with Article 50.
(d)
non-compliance with Article 50.
7. The market surveillance authorities other than the market surveillance authority of the Member State initiating the procedure shall, without undue delay, inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the AI system concerned, and, in the event of disagreement with the notified national measure, of their objections.
8. Where, within three months of receipt of the notification referred to in paragraph 5 of this Article, no objection has been raised by either a market surveillance authority of a Member State or by the Commission in respect of a provisional measure taken by a market surveillance authority of another Member State, that measure shall be deemed justified. This shall be without prejudice to the procedural rights of the concerned operator in accordance with Article 18 of Regulation (EU) 2019/1020. The three-month period referred to in this paragraph shall be reduced to 30 days in the event of non-compliance with the prohibition of the AI practices referred to in Article 5 of this Regulation.
9. The market surveillance authorities shall ensure that appropriate restrictive measures are taken in respect of the product or the AI system concerned, such as withdrawal of the product or the AI system from their market, without undue delay.
|
system presenting risk shall understood product presenting risk defined article point regulation 2019 1020 far present risk health safety fundamental right person market surveillance authority member state sufficient reason consider system present risk referred paragraph article shall carry evaluation system concerned respect compliance requirement obligation laid regulation particular attention shall given system presenting risk vulnerable group risk fundamental right identified market surveillance authority shall also inform fully cooperate relevant national public authority body referred article relevant operator shall cooperate necessary market surveillance authority national public authority body referred article course evaluation market surveillance authority applicable market surveillance authority cooperation national public authority referred article find system comply requirement obligation laid regulation shall without undue delay require relevant operator take appropriate corrective action bring system compliance withdraw system market recall within period market surveillance authority may prescribe event within shorter working day provided relevant union harmonisation legislation market surveillance authority shall inform relevant notified body accordingly article regulation 2019 1020 shall apply measure referred second subparagraph paragraph market surveillance authority considers non compliance restricted national territory shall inform commission member state without undue delay result evaluation action required operator take operator shall ensure appropriate corrective action taken respect system concerned made available union market operator system take adequate corrective action within period referred paragraph market surveillance authority shall take appropriate provisional measure prohibit restrict system made available national market put service withdraw product standalone system market recall authority shall without undue delay notify commission member state measure notification referred paragraph shall include available detail particular information necessary identification non compliant system origin system supply chain nature non compliance alleged risk involved nature duration national measure taken argument put forward relevant operator particular market surveillance authority shall indicate whether non compliance due one following non compliance prohibition practice referred article non compliance prohibition practice referred article failure high risk system meet requirement set chapter iii section failure high risk system meet requirement set chapter iii section shortcoming harmonised standard common specification referred article conferring presumption conformity shortcoming harmonised standard common specification referred article conferring presumption conformity non compliance article non compliance article market surveillance authority market surveillance authority member state initiating procedure shall without undue delay inform commission member state measure adopted additional information disposal relating non compliance system concerned event disagreement notified national measure objection within three month receipt notification referred paragraph article objection raised either market surveillance authority member state commission respect provisional measure taken market surveillance authority another member state measure shall deemed justified shall without prejudice procedural right concerned operator accordance article regulation 2019 1020 three month period referred paragraph shall reduced day event non compliance prohibition practice referred article regulation market surveillance authority shall ensure appropriate restrictive measure taken respect product system concerned withdrawal product system market without undue delay
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 80
|
1. Where a market surveillance authority has sufficient reason to consider that an AI system classified by the provider as non-high-risk pursuant to Article 6(3) is indeed high-risk, the market surveillance authority shall carry out an evaluation of the AI system concerned in respect of its classification as a high-risk AI system based on the conditions set out in Article 6(3) and the Commission guidelines.
2. Where, in the course of that evaluation, the market surveillance authority finds that the AI system concerned is high-risk, it shall without undue delay require the relevant provider to take all necessary actions to bring the AI system into compliance with the requirements and obligations laid down in this Regulation, as well as take appropriate corrective action within a period the market surveillance authority may prescribe.
3. Where the market surveillance authority considers that the use of the AI system concerned is not restricted to its national territory, it shall inform the Commission and the other Member States without undue delay of the results of the evaluation and of the actions which it has required the provider to take.
4. The provider shall ensure that all necessary action is taken to bring the AI system into compliance with the requirements and obligations laid down in this Regulation. Where the provider of an AI system concerned does not bring the AI system into compliance with those requirements and obligations within the period referred to in paragraph 2 of this Article, the provider shall be subject to fines in accordance with Article 99.
5. The provider shall ensure that all appropriate corrective action is taken in respect of all the AI systems concerned that it has made available on the Union market.
6. Where the provider of the AI system concerned does not take adequate corrective action within the period referred to in paragraph 2 of this Article, Article 79(5) to (9) shall apply.
7. Where, in the course of the evaluation pursuant to paragraph 1 of this Article, the market surveillance authority establishes that the AI system was misclassified by the provider as non-high-risk in order to circumvent the application of requirements in Chapter III, Section 2, the provider shall be subject to fines in accordance with Article 99.
8. In exercising their power to monitor the application of this Article, and in accordance with Article 11 of Regulation (EU) 2019/1020, market surveillance authorities may perform appropriate checks, taking into account in particular information stored in the EU database referred to in Article 71 of this Regulation.
|
market surveillance authority sufficient reason consider system classified provider non high risk pursuant article indeed high risk market surveillance authority shall carry evaluation system concerned respect classification high risk system based condition set article commission guideline course evaluation market surveillance authority find system concerned high risk shall without undue delay require relevant provider take necessary action bring system compliance requirement obligation laid regulation well take appropriate corrective action within period market surveillance authority may prescribe market surveillance authority considers use system concerned restricted national territory shall inform commission member state without undue delay result evaluation action required provider take provider shall ensure necessary action taken bring system compliance requirement obligation laid regulation provider system concerned bring system compliance requirement obligation within period referred paragraph article provider shall subject fine accordance article provider shall ensure appropriate corrective action taken respect system concerned made available union market provider system concerned take adequate corrective action within period referred paragraph article article shall apply course evaluation pursuant paragraph article market surveillance authority establishes system misclassified provider non high risk order circumvent application requirement chapter iii section provider shall subject fine accordance article exercising power monitor application article accordance article regulation 2019 1020 market surveillance authority may perform appropriate check taking account particular information stored database referred article regulation
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 81
|
1. Where, within three months of receipt of the notification referred to in Article 79(5), or within 30 days in the case of non-compliance with the prohibition of the AI practices referred to in Article 5, objections are raised by the market surveillance authority of a Member State to a measure taken by another market surveillance authority, or where the Commission considers the measure to be contrary to Union law, the Commission shall without undue delay enter into consultation with the market surveillance authority of the relevant Member State and the operator or operators, and shall evaluate the national measure. On the basis of the results of that evaluation, the Commission shall, within six months, or within 60 days in the case of non-compliance with the prohibition of the AI practices referred to in Article 5, starting from the notification referred to in Article 79(5), decide whether the national measure is justified and shall notify its decision to the market surveillance authority of the Member State concerned. The Commission shall also inform all other market surveillance authorities of its decision.
2. Where the Commission considers the measure taken by the relevant Member State to be justified, all Member States shall ensure that they take appropriate restrictive measures in respect of the AI system concerned, such as requiring the withdrawal of the AI system from their market without undue delay, and shall inform the Commission accordingly. Where the Commission considers the national measure to be unjustified, the Member State concerned shall withdraw the measure and shall inform the Commission accordingly.
3. Where the national measure is considered justified and the non-compliance of the AI system is attributed to shortcomings in the harmonised standards or common specifications referred to in Articles 40 and 41 of this Regulation, the Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012.
|
within three month receipt notification referred article within day case non compliance prohibition practice referred article objection raised market surveillance authority member state measure taken another market surveillance authority commission considers measure contrary union law commission shall without undue delay enter consultation market surveillance authority relevant member state operator operator shall evaluate national measure basis result evaluation commission shall within six month within day case non compliance prohibition practice referred article starting notification referred article decide whether national measure justified shall notify decision market surveillance authority member state concerned commission shall also inform market surveillance authority decision commission considers measure taken relevant member state justified member state shall ensure take appropriate restrictive measure respect system concerned requiring withdrawal system market without undue delay shall inform commission accordingly commission considers national measure unjustified member state concerned shall withdraw measure shall inform commission accordingly national measure considered justified non compliance system attributed shortcoming harmonised standard common specification referred article regulation commission shall apply procedure provided article regulation 1025 2012
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 82
|
1. Where, having performed an evaluation under Article 79, after consulting the relevant national public authority referred to in Article 77(1), the market surveillance authority of a Member State finds that although a high-risk AI system complies with this Regulation, it nevertheless presents a risk to the health or safety of persons, to fundamental rights, or to other aspects of public interest protection, it shall require the relevant operator to take all appropriate measures to ensure that the AI system concerned, when placed on the market or put into service, no longer presents that risk without undue delay, within a period it may prescribe.
2. The provider or other relevant operator shall ensure that corrective action is taken in respect of all the AI systems concerned that it has made available on the Union market within the timeline prescribed by the market surveillance authority of the Member State referred to in paragraph 1.
3. The Member States shall immediately inform the Commission and the other Member States of a finding under paragraph 1. That information shall include all available details, in particular the data necessary for the identification of the AI system concerned, the origin and the supply chain of the AI system, the nature of the risk involved and the nature and duration of the national measures taken.
4. The Commission shall without undue delay enter into consultation with the Member States concerned and the relevant operators, and shall evaluate the national measures taken. On the basis of the results of that evaluation, the Commission shall decide whether the measure is justified and, where necessary, propose other appropriate measures.
5. The Commission shall immediately communicate its decision to the Member States concerned and to the relevant operators. It shall also inform the other Member States.
|
performed evaluation article consulting relevant national public authority referred article market surveillance authority member state find although high risk system complies regulation nevertheless present risk health safety person fundamental right aspect public interest protection shall require relevant operator take appropriate measure ensure system concerned placed market put service longer present risk without undue delay within period may prescribe provider relevant operator shall ensure corrective action taken respect system concerned made available union market within timeline prescribed market surveillance authority member state referred paragraph member state shall immediately inform commission member state finding paragraph information shall include available detail particular data necessary identification system concerned origin supply chain system nature risk involved nature duration national measure taken commission shall without undue delay enter consultation member state concerned relevant operator shall evaluate national measure taken basis result evaluation commission shall decide whether measure justified necessary propose appropriate measure commission shall immediately communicate decision member state concerned relevant operator shall also inform member state
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 83
|
1. Where the market surveillance authority of a Member State makes one of the following findings, it shall require the relevant provider to put an end to the non-compliance concerned, within a period it may prescribe:
(a) the CE marking has been affixed in violation of Article 48;
(a)
the CE marking has been affixed in violation of Article 48;
(b) the CE marking has not been affixed;
(b)
the CE marking has not been affixed;
(c) the EU declaration of conformity referred to in Article 47 has not been drawn up;
(c)
the EU declaration of conformity referred to in Article 47 has not been drawn up;
(d) the EU declaration of conformity referred to in Article 47 has not been drawn up correctly;
(d)
the EU declaration of conformity referred to in Article 47 has not been drawn up correctly;
(e) the registration in the EU database referred to in Article 71 has not been carried out;
(e)
the registration in the EU database referred to in Article 71 has not been carried out;
(f) where applicable, no authorised representative has been appointed;
(f)
where applicable, no authorised representative has been appointed;
(g) technical documentation is not available.
(g)
technical documentation is not available.
2. Where the non-compliance referred to in paragraph 1 persists, the market surveillance authority of the Member State concerned shall take appropriate and proportionate measures to restrict or prohibit the high-risk AI system being made available on the market or to ensure that it is recalled or withdrawn from the market without delay.
|
market surveillance authority member state make one following finding shall require relevant provider put end non compliance concerned within period may prescribe marking affixed violation article marking affixed violation article marking affixed marking affixed declaration conformity referred article drawn declaration conformity referred article drawn declaration conformity referred article drawn correctly declaration conformity referred article drawn correctly registration database referred article carried registration database referred article carried applicable authorised representative appointed applicable authorised representative appointed technical documentation available technical documentation available non compliance referred paragraph persists market surveillance authority member state concerned shall take appropriate proportionate measure restrict prohibit high risk system made available market ensure recalled withdrawn market without delay
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 84
|
1. The Commission shall designate one or more Union AI testing support structures to perform the tasks listed under Article 21(6) of Regulation (EU) 2019/1020 in the area of AI.
2. Without prejudice to the tasks referred to in paragraph 1, Union AI testing support structures shall also provide independent technical or scientific advice at the request of the Board, the Commission, or of market surveillance authorities.
|
commission shall designate one union testing support structure perform task listed article regulation 2019 1020 area without prejudice task referred paragraph union testing support structure shall also provide independent technical scientific advice request board commission market surveillance authority
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 85
|
Without prejudice to other administrative or judicial remedies, any natural or legal person having grounds to consider that there has been an infringement of the provisions of this Regulation may submit complaints to the relevant market surveillance authority.
In accordance with Regulation (EU) 2019/1020, such complaints shall be taken into account for the purpose of conducting market surveillance activities, and shall be handled in line with the dedicated procedures established therefor by the market surveillance authorities.
|
without prejudice administrative judicial remedy natural legal person ground consider infringement provision regulation may submit complaint relevant market surveillance authority accordance regulation 2019 1020 complaint shall taken account purpose conducting market surveillance activity shall handled line dedicated procedure established therefor market surveillance authority
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 86
|
1. Any affected person subject to a decision which is taken by the deployer on the basis of the output from a high-risk AI system listed in Annex III, with the exception of systems listed under point 2 thereof, and which produces legal effects or similarly significantly affects that person in a way that they consider to have an adverse impact on their health, safety or fundamental rights shall have the right to obtain from the deployer clear and meaningful explanations of the role of the AI system in the decision-making procedure and the main elements of the decision taken.
2. Paragraph 1 shall not apply to the use of AI systems for which exceptions from, or restrictions to, the obligation under that paragraph follow from Union or national law in compliance with Union law.
3. This Article shall apply only to the extent that the right referred to in paragraph 1 is not otherwise provided for under Union law.
|
affected person subject decision taken deployer basis output high risk system listed annex iii exception system listed point thereof produce legal effect similarly significantly affect person way consider adverse impact health safety fundamental right shall right obtain deployer clear meaningful explanation role system decision making procedure main element decision taken paragraph shall apply use system exception restriction obligation paragraph follow union national law compliance union law article shall apply extent right referred paragraph otherwise provided union law
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 87
|
Directive (EU) 2019/1937 shall apply to the reporting of infringements of this Regulation and the protection of persons reporting such infringements.
|
directive 2019 1937 shall apply reporting infringement regulation protection person reporting infringement
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 88
|
1. The Commission shall have exclusive powers to supervise and enforce Chapter V, taking into account the procedural guarantees under Article 94. The Commission shall entrust the implementation of these tasks to the AI Office, without prejudice to the powers of organisation of the Commission and the division of competences between Member States and the Union based on the Treaties.
2. Without prejudice to Article 75(3), market surveillance authorities may request the Commission to exercise the powers laid down in this Section, where that is necessary and proportionate to assist with the fulfilment of their tasks under this Regulation.
|
commission shall exclusive power supervise enforce chapter taking account procedural guarantee article commission shall entrust implementation task office without prejudice power organisation commission division competence member state union based treaty without prejudice article market surveillance authority may request commission exercise power laid section necessary proportionate assist fulfilment task regulation
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 89
|
1. For the purpose of carrying out the tasks assigned to it under this Section, the AI Office may take the necessary actions to monitor the effective implementation and compliance with this Regulation by providers of general-purpose AI models, including their adherence to approved codes of practice.
2. Downstream providers shall have the right to lodge a complaint alleging an infringement of this Regulation. A complaint shall be duly reasoned and indicate at least:
(a) the point of contact of the provider of the general-purpose AI model concerned;
(a)
the point of contact of the provider of the general-purpose AI model concerned;
(b) a description of the relevant facts, the provisions of this Regulation concerned, and the reason why the downstream provider considers that the provider of the general-purpose AI model concerned infringed this Regulation;
(b)
a description of the relevant facts, the provisions of this Regulation concerned, and the reason why the downstream provider considers that the provider of the general-purpose AI model concerned infringed this Regulation;
(c) any other information that the downstream provider that sent the request considers relevant, including, where appropriate, information gathered on its own initiative.
(c)
any other information that the downstream provider that sent the request considers relevant, including, where appropriate, information gathered on its own initiative.
|
purpose carrying task assigned section office may take necessary action monitor effective implementation compliance regulation provider general purpose model including adherence approved code practice downstream provider shall right lodge complaint alleging infringement regulation complaint shall duly reasoned indicate least point contact provider general purpose model concerned point contact provider general purpose model concerned description relevant fact provision regulation concerned reason downstream provider considers provider general purpose model concerned infringed regulation description relevant fact provision regulation concerned reason downstream provider considers provider general purpose model concerned infringed regulation information downstream provider sent request considers relevant including appropriate information gathered initiative information downstream provider sent request considers relevant including appropriate information gathered initiative
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 90
|
1. The scientific panel may provide a qualified alert to the AI Office where it has reason to suspect that:
(a) a general-purpose AI model poses concrete identifiable risk at Union level; or
(a)
a general-purpose AI model poses concrete identifiable risk at Union level; or
(b) a general-purpose AI model meets the conditions referred to in Article 51.
(b)
a general-purpose AI model meets the conditions referred to in Article 51.
2. Upon such qualified alert, the Commission, through the AI Office and after having informed the Board, may exercise the powers laid down in this Section for the purpose of assessing the matter. The AI Office shall inform the Board of any measure according to Articles 91 to 94.
3. A qualified alert shall be duly reasoned and indicate at least:
(a) the point of contact of the provider of the general-purpose AI model with systemic risk concerned;
(a)
the point of contact of the provider of the general-purpose AI model with systemic risk concerned;
(b) a description of the relevant facts and the reasons for the alert by the scientific panel;
(b)
a description of the relevant facts and the reasons for the alert by the scientific panel;
(c) any other information that the scientific panel considers to be relevant, including, where appropriate, information gathered on its own initiative.
(c)
any other information that the scientific panel considers to be relevant, including, where appropriate, information gathered on its own initiative.
|
scientific panel may provide qualified alert office reason suspect general purpose model pose concrete identifiable risk union level general purpose model pose concrete identifiable risk union level general purpose model meet condition referred article general purpose model meet condition referred article upon qualified alert commission office informed board may exercise power laid section purpose assessing matter office shall inform board measure according article qualified alert shall duly reasoned indicate least point contact provider general purpose model systemic risk concerned point contact provider general purpose model systemic risk concerned description relevant fact reason alert scientific panel description relevant fact reason alert scientific panel information scientific panel considers relevant including appropriate information gathered initiative information scientific panel considers relevant including appropriate information gathered initiative
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 91
|
1. The Commission may request the provider of the general-purpose AI model concerned to provide the documentation drawn up by the provider in accordance with Articles 53 and 55, or any additional information that is necessary for the purpose of assessing compliance of the provider with this Regulation.
2. Before sending the request for information, the AI Office may initiate a structured dialogue with the provider of the general-purpose AI model.
3. Upon a duly substantiated request from the scientific panel, the Commission may issue a request for information to a provider of a general-purpose AI model, where the access to information is necessary and proportionate for the fulfilment of the tasks of the scientific panel under Article 68(2).
4. The request for information shall state the legal basis and the purpose of the request, specify what information is required, set a period within which the information is to be provided, and indicate the fines provided for in Article 101 for supplying incorrect, incomplete or misleading information.
5. The provider of the general-purpose AI model concerned, or its representative shall supply the information requested. In the case of legal persons, companies or firms, or where the provider has no legal personality, the persons authorised to represent them by law or by their statutes, shall supply the information requested on behalf of the provider of the general-purpose AI model concerned. Lawyers duly authorised to act may supply information on behalf of their clients. The clients shall nevertheless remain fully responsible if the information supplied is incomplete, incorrect or misleading.
|
commission may request provider general purpose model concerned provide documentation drawn provider accordance article additional information necessary purpose assessing compliance provider regulation sending request information office may initiate structured dialogue provider general purpose model upon duly substantiated request scientific panel commission may issue request information provider general purpose model access information necessary proportionate fulfilment task scientific panel article request information shall state legal basis purpose request specify information required set period within information provided indicate fine provided article 101 supplying incorrect incomplete misleading information provider general purpose model concerned representative shall supply information requested case legal person company firm provider legal personality person authorised represent law statute shall supply information requested behalf provider general purpose model concerned lawyer duly authorised act may supply information behalf client client shall nevertheless remain fully responsible information supplied incomplete incorrect misleading
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 92
|
1. The AI Office, after consulting the Board, may conduct evaluations of the general-purpose AI model concerned:
(a) to assess compliance of the provider with obligations under this Regulation, where the information gathered pursuant to Article 91 is insufficient; or
(a)
to assess compliance of the provider with obligations under this Regulation, where the information gathered pursuant to Article 91 is insufficient; or
(b) to investigate systemic risks at Union level of general-purpose AI models with systemic risk, in particular following a qualified alert from the scientific panel in accordance with Article 90(1), point (a).
(b)
to investigate systemic risks at Union level of general-purpose AI models with systemic risk, in particular following a qualified alert from the scientific panel in accordance with Article 90(1), point (a).
2. The Commission may decide to appoint independent experts to carry out evaluations on its behalf, including from the scientific panel established pursuant to Article 68. Independent experts appointed for this task shall meet the criteria outlined in Article 68(2).
3. For the purposes of paragraph 1, the Commission may request access to the general-purpose AI model concerned through APIs or further appropriate technical means and tools, including source code.
4. The request for access shall state the legal basis, the purpose and reasons of the request and set the period within which the access is to be provided, and the fines provided for in Article 101 for failure to provide access.
5. The providers of the general-purpose AI model concerned or its representative shall supply the information requested. In the case of legal persons, companies or firms, or where the provider has no legal personality, the persons authorised to represent them by law or by their statutes, shall provide the access requested on behalf of the provider of the general-purpose AI model concerned.
6. The Commission shall adopt implementing acts setting out the detailed arrangements and the conditions for the evaluations, including the detailed arrangements for involving independent experts, and the procedure for the selection thereof. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).
7. Prior to requesting access to the general-purpose AI model concerned, the AI Office may initiate a structured dialogue with the provider of the general-purpose AI model to gather more information on the internal testing of the model, internal safeguards for preventing systemic risks, and other internal procedures and measures the provider has taken to mitigate such risks.
|
office consulting board may conduct evaluation general purpose model concerned assess compliance provider obligation regulation information gathered pursuant article insufficient assess compliance provider obligation regulation information gathered pursuant article insufficient investigate systemic risk union level general purpose model systemic risk particular following qualified alert scientific panel accordance article point investigate systemic risk union level general purpose model systemic risk particular following qualified alert scientific panel accordance article point commission may decide appoint independent expert carry evaluation behalf including scientific panel established pursuant article independent expert appointed task shall meet criterion outlined article purpose paragraph commission may request access general purpose model concerned apis appropriate technical mean tool including source code request access shall state legal basis purpose reason request set period within access provided fine provided article 101 failure provide access provider general purpose model concerned representative shall supply information requested case legal person company firm provider legal personality person authorised represent law statute shall provide access requested behalf provider general purpose model concerned commission shall adopt implementing act setting detailed arrangement condition evaluation including detailed arrangement involving independent expert procedure selection thereof implementing act shall adopted accordance examination procedure referred article prior requesting access general purpose model concerned office may initiate structured dialogue provider general purpose model gather information internal testing model internal safeguard preventing systemic risk internal procedure measure provider taken mitigate risk
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 93
|
1. Where necessary and appropriate, the Commission may request providers to:
(a) take appropriate measures to comply with the obligations set out in Articles 53 and 54;
(a)
take appropriate measures to comply with the obligations set out in Articles 53 and 54;
(b) implement mitigation measures, where the evaluation carried out in accordance with Article 92 has given rise to serious and substantiated concern of a systemic risk at Union level;
(b)
implement mitigation measures, where the evaluation carried out in accordance with Article 92 has given rise to serious and substantiated concern of a systemic risk at Union level;
(c) restrict the making available on the market, withdraw or recall the model.
(c)
restrict the making available on the market, withdraw or recall the model.
2. Before a measure is requested, the AI Office may initiate a structured dialogue with the provider of the general-purpose AI model.
3. If, during the structured dialogue referred to in paragraph 2, the provider of the general-purpose AI model with systemic risk offers commitments to implement mitigation measures to address a systemic risk at Union level, the Commission may, by decision, make those commitments binding and declare that there are no further grounds for action.
|
necessary appropriate commission may request provider take appropriate measure comply obligation set article take appropriate measure comply obligation set article implement mitigation measure evaluation carried accordance article given rise serious substantiated concern systemic risk union level implement mitigation measure evaluation carried accordance article given rise serious substantiated concern systemic risk union level restrict making available market withdraw recall model restrict making available market withdraw recall model measure requested office may initiate structured dialogue provider general purpose model structured dialogue referred paragraph provider general purpose model systemic risk offer commitment implement mitigation measure address systemic risk union level commission may decision make commitment binding declare ground action
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 94
|
Article 18 of Regulation (EU) 2019/1020 shall applymutatis mutandisto the providers of the general-purpose AI model, without prejudice to more specific procedural rights provided for in this Regulation.
|
article regulation 2019 1020 shall applymutatis mutandisto provider general purpose model without prejudice specific procedural right provided regulation
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 72
|
1. Providers shall establish and document a post-market monitoring system in a manner that is proportionate to the nature of the AI technologies and the risks of the high-risk AI system.
2. The post-market monitoring system shall actively and systematically collect, document and analyse relevant data which may be provided by deployers or which may be collected through other sources on the performance of high-risk AI systems throughout their lifetime, and which allow the provider to evaluate the continuous compliance of AI systems with the requirements set out in Chapter III, Section 2. Where relevant, post-market monitoring shall include an analysis of the interaction with other AI systems. This obligation shall not cover sensitive operational data of deployers which are law-enforcement authorities.
3. The post-market monitoring system shall be based on a post-market monitoring plan. The post-market monitoring plan shall be part of the technical documentation referred to in Annex IV. The Commission shall adopt an implementing act laying down detailed provisions establishing a template for the post-market monitoring plan and the list of elements to be included in the plan by 2 February 2026. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 98(2).
4. For high-risk AI systems covered by the Union harmonisation legislation listed in Section A of Annex I, where a post-market monitoring system and plan are already established under that legislation, in order to ensure consistency, avoid duplications and minimise additional burdens, providers shall have a choice of integrating, as appropriate, the necessary elements described in paragraphs 1, 2 and 3 using the template referred in paragraph 3 into systems and plans already existing under that legislation, provided that it achieves an equivalent level of protection.
The first subparagraph of this paragraph shall also apply to high-risk AI systems referred to in point 5 of Annex III placed on the market or put into service by financial institutions that are subject to requirements under Union financial services law regarding their internal governance, arrangements or processes.
|
provider shall establish document post market monitoring system manner proportionate nature technology risk high risk system post market monitoring system shall actively systematically collect document analyse relevant data may provided deployers may collected source performance high risk system throughout lifetime allow provider evaluate continuous compliance system requirement set chapter iii section relevant post market monitoring shall include analysis interaction system obligation shall cover sensitive operational data deployers law enforcement authority post market monitoring system shall based post market monitoring plan post market monitoring plan shall part technical documentation referred annex commission shall adopt implementing act laying detailed provision establishing template post market monitoring plan list element included plan february 2026 implementing act shall adopted accordance examination procedure referred article high risk system covered union harmonisation legislation listed section annex post market monitoring system plan already established legislation order ensure consistency avoid duplication minimise additional burden provider shall choice integrating appropriate necessary element described paragraph using template referred paragraph system plan already existing legislation provided achieves equivalent level protection first subparagraph paragraph shall also apply high risk system referred point annex iii placed market put service financial institution subject requirement union financial service law regarding internal governance arrangement process
|
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all-MiniLM-L6-v2
| 384 |
Article 73
|
1. Providers of high-risk AI systems placed on the Union market shall report any serious incident to the market surveillance authorities of the Member States where that incident occurred.
2. The report referred to in paragraph 1 shall be made immediately after the provider has established a causal link between the AI system and the serious incident or the reasonable likelihood of such a link, and, in any event, not later than 15 days after the provider or, where applicable, the deployer, becomes aware of the serious incident.
The period for the reporting referred to in the first subparagraph shall take account of the severity of the serious incident.
3. Notwithstanding paragraph 2 of this Article, in the event of a widespread infringement or a serious incident as defined in Article 3, point (49)(b), the report referred to in paragraph 1 of this Article shall be provided immediately, and not later than two days after the provider or, where applicable, the deployer becomes aware of that incident.
4. Notwithstanding paragraph 2, in the event of the death of a person, the report shall be provided immediately after the provider or the deployer has established, or as soon as it suspects, a causal relationship between the high-risk AI system and the serious incident, but not later than 10 days after the date on which the provider or, where applicable, the deployer becomes aware of the serious incident.
5. Where necessary to ensure timely reporting, the provider or, where applicable, the deployer, may submit an initial report that is incomplete, followed by a complete report.
6. Following the reporting of a serious incident pursuant to paragraph 1, the provider shall, without delay, perform the necessary investigations in relation to the serious incident and the AI system concerned. This shall include a risk assessment of the incident, and corrective action.
The provider shall cooperate with the competent authorities, and where relevant with the notified body concerned, during the investigations referred to in the first subparagraph, and shall not perform any investigation which involves altering the AI system concerned in a way which may affect any subsequent evaluation of the causes of the incident, prior to informing the competent authorities of such action.
7. Upon receiving a notification related to a serious incident referred to in Article 3, point (49)(c), the relevant market surveillance authority shall inform the national public authorities or bodies referred to in Article 77(1). The Commission shall develop dedicated guidance to facilitate compliance with the obligations set out in paragraph 1 of this Article. That guidance shall be issued by 2 August 2025, and shall be assessed regularly.
8. The market surveillance authority shall take appropriate measures, as provided for in Article 19 of Regulation (EU) 2019/1020, within seven days from the date it received the notification referred to in paragraph 1 of this Article, and shall follow the notification procedures as provided in that Regulation.
9. For high-risk AI systems referred to in Annex III that are placed on the market or put into service by providers that are subject to Union legislative instruments laying down reporting obligations equivalent to those set out in this Regulation, the notification of serious incidents shall be limited to those referred to in Article 3, point (49)(c).
10. For high-risk AI systems which are safety components of devices, or are themselves devices, covered by Regulations (EU) 2017/745 and (EU) 2017/746, the notification of serious incidents shall be limited to those referred to in Article 3, point (49)(c) of this Regulation, and shall be made to the national competent authority chosen for that purpose by the Member States where the incident occurred.
11. National competent authorities shall immediately notify the Commission of any serious incident, whether or not they have taken action on it, in accordance with Article 20 of Regulation (EU) 2019/1020.
|
provider high risk system placed union market shall report serious incident market surveillance authority member state incident occurred report referred paragraph shall made immediately provider established causal link system serious incident reasonable likelihood link event later day provider applicable deployer becomes aware serious incident period reporting referred first subparagraph shall take account severity serious incident notwithstanding paragraph article event widespread infringement serious incident defined article point report referred paragraph article shall provided immediately later two day provider applicable deployer becomes aware incident notwithstanding paragraph event death person report shall provided immediately provider deployer established soon suspect causal relationship high risk system serious incident later day date provider applicable deployer becomes aware serious incident necessary ensure timely reporting provider applicable deployer may submit initial report incomplete followed complete report following reporting serious incident pursuant paragraph provider shall without delay perform necessary investigation relation serious incident system concerned shall include risk assessment incident corrective action provider shall cooperate competent authority relevant notified body concerned investigation referred first subparagraph shall perform investigation involves altering system concerned way may affect subsequent evaluation cause incident prior informing competent authority action upon receiving notification related serious incident referred article point relevant market surveillance authority shall inform national public authority body referred article commission shall develop dedicated guidance facilitate compliance obligation set paragraph article guidance shall issued august 2025 shall assessed regularly market surveillance authority shall take appropriate measure provided article regulation 2019 1020 within seven day date received notification referred paragraph article shall follow notification procedure provided regulation high risk system referred annex iii placed market put service provider subject union legislative instrument laying reporting obligation equivalent set regulation notification serious incident shall limited referred article point high risk system safety component device device covered regulation 2017 745 2017 746 notification serious incident shall limited referred article point regulation shall made national competent authority chosen purpose member state incident occurred national competent authority shall immediately notify commission serious incident whether taken action accordance article regulation 2019 1020
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 74
|
1. Regulation (EU) 2019/1020 shall apply to AI systems covered by this Regulation. For the purposes of the effective enforcement of this Regulation:
(a) any reference to an economic operator under Regulation (EU) 2019/1020 shall be understood as including all operators identified in Article 2(1) of this Regulation;
(a)
any reference to an economic operator under Regulation (EU) 2019/1020 shall be understood as including all operators identified in Article 2(1) of this Regulation;
(b) any reference to a product under Regulation (EU) 2019/1020 shall be understood as including all AI systems falling within the scope of this Regulation.
(b)
any reference to a product under Regulation (EU) 2019/1020 shall be understood as including all AI systems falling within the scope of this Regulation.
2. As part of their reporting obligations under Article 34(4) of Regulation (EU) 2019/1020, the market surveillance authorities shall report annually to the Commission and relevant national competition authorities any information identified in the course of market surveillance activities that may be of potential interest for the application of Union law on competition rules. They shall also annually report to the Commission about the use of prohibited practices that occurred during that year and about the measures taken.
3. For high-risk AI systems related to products covered by the Union harmonisation legislation listed in Section A of Annex I, the market surveillance authority for the purposes of this Regulation shall be the authority responsible for market surveillance activities designated under those legal acts.
By derogation from the first subparagraph, and in appropriate circumstances, Member States may designate another relevant authority to act as a market surveillance authority, provided they ensure coordination with the relevant sectoral market surveillance authorities responsible for the enforcement of the Union harmonisation legislation listed in Annex I.
4. The procedures referred to in Articles 79 to 83 of this Regulation shall not apply to AI systems related to products covered by the Union harmonisation legislation listed in section A of Annex I, where such legal acts already provide for procedures ensuring an equivalent level of protection and having the same objective. In such cases, the relevant sectoral procedures shall apply instead.
5. Without prejudice to the powers of market surveillance authorities under Article 14 of Regulation (EU) 2019/1020, for the purpose of ensuring the effective enforcement of this Regulation, market surveillance authorities may exercise the powers referred to in Article 14(4), points (d) and (j), of that Regulation remotely, as appropriate.
6. For high-risk AI systems placed on the market, put into service, or used by financial institutions regulated by Union financial services law, the market surveillance authority for the purposes of this Regulation shall be the relevant national authority responsible for the financial supervision of those institutions under that legislation in so far as the placing on the market, putting into service, or the use of the AI system is in direct connection with the provision of those financial services.
7. By way of derogation from paragraph 6, in appropriate circumstances, and provided that coordination is ensured, another relevant authority may be identified by the Member State as market surveillance authority for the purposes of this Regulation.
National market surveillance authorities supervising regulated credit institutions regulated under Directive 2013/36/EU, which are participating in the Single Supervisory Mechanism established by Regulation (EU) No 1024/2013, should report, without delay, to the European Central Bank any information identified in the course of their market surveillance activities that may be of potential interest for the prudential supervisory tasks of the European Central Bank specified in that Regulation.
8. For high-risk AI systems listed in point 1 of Annex III to this Regulation, in so far as the systems are used for law enforcement purposes, border management and justice and democracy, and for high-risk AI systems listed in points 6, 7 and 8 of Annex III to this Regulation, Member States shall designate as market surveillance authorities for the purposes of this Regulation either the competent data protection supervisory authorities under Regulation (EU) 2016/679 or Directive (EU) 2016/680, or any other authority designated pursuant to the same conditions laid down in Articles 41 to 44 of Directive (EU) 2016/680. Market surveillance activities shall in no way affect the independence of judicial authorities, or otherwise interfere with their activities when acting in their judicial capacity.
9. Where Union institutions, bodies, offices or agencies fall within the scope of this Regulation, the European Data Protection Supervisor shall act as their market surveillance authority, except in relation to the Court of Justice of the European Union acting in its judicial capacity.
10. Member States shall facilitate coordination between market surveillance authorities designated under this Regulation and other relevant national authorities or bodies which supervise the application of Union harmonisation legislation listed in Annex I, or in other Union law, that might be relevant for the high-risk AI systems referred to in Annex III.
11. Market surveillance authorities and the Commission shall be able to propose joint activities, including joint investigations, to be conducted by either market surveillance authorities or market surveillance authorities jointly with the Commission, that have the aim of promoting compliance, identifying non-compliance, raising awareness or providing guidance in relation to this Regulation with respect to specific categories of high-risk AI systems that are found to present a serious risk across two or more Member States in accordance with Article 9 of Regulation (EU) 2019/1020. The AI Office shall provide coordination support for joint investigations.
12. Without prejudice to the powers provided for under Regulation (EU) 2019/1020, and where relevant and limited to what is necessary to fulfil their tasks, the market surveillance authorities shall be granted full access by providers to the documentation as well as the training, validation and testing data sets used for the development of high-risk AI systems, including, where appropriate and subject to security safeguards, through application programming interfaces (API) or other relevant technical means and tools enabling remote access.
13. Market surveillance authorities shall be granted access to the source code of the high-risk AI system upon a reasoned request and only when both of the following conditions are fulfilled:
(a) access to source code is necessary to assess the conformity of a high-risk AI system with the requirements set out in Chapter III, Section 2; and
(a)
access to source code is necessary to assess the conformity of a high-risk AI system with the requirements set out in Chapter III, Section 2; and
(b) testing or auditing procedures and verifications based on the data and documentation provided by the provider have been exhausted or proved insufficient.
(b)
testing or auditing procedures and verifications based on the data and documentation provided by the provider have been exhausted or proved insufficient.
14. Any information or documentation obtained by market surveillance authorities shall be treated in accordance with the confidentiality obligations set out in Article 78.
|
regulation 2019 1020 shall apply system covered regulation purpose effective enforcement regulation reference economic operator regulation 2019 1020 shall understood including operator identified article regulation reference economic operator regulation 2019 1020 shall understood including operator identified article regulation reference product regulation 2019 1020 shall understood including system falling within scope regulation reference product regulation 2019 1020 shall understood including system falling within scope regulation part reporting obligation article regulation 2019 1020 market surveillance authority shall report annually commission relevant national competition authority information identified course market surveillance activity may potential interest application union law competition rule shall also annually report commission use prohibited practice occurred year measure taken high risk system related product covered union harmonisation legislation listed section annex market surveillance authority purpose regulation shall authority responsible market surveillance activity designated legal act derogation first subparagraph appropriate circumstance member state may designate another relevant authority act market surveillance authority provided ensure coordination relevant sectoral market surveillance authority responsible enforcement union harmonisation legislation listed annex procedure referred article regulation shall apply system related product covered union harmonisation legislation listed section annex legal act already provide procedure ensuring equivalent level protection objective case relevant sectoral procedure shall apply instead without prejudice power market surveillance authority article regulation 2019 1020 purpose ensuring effective enforcement regulation market surveillance authority may exercise power referred article point regulation remotely appropriate high risk system placed market put service used financial institution regulated union financial service law market surveillance authority purpose regulation shall relevant national authority responsible financial supervision institution legislation far placing market putting service use system direct connection provision financial service way derogation paragraph appropriate circumstance provided coordination ensured another relevant authority may identified member state market surveillance authority purpose regulation national market surveillance authority supervising regulated credit institution regulated directive 2013 participating single supervisory mechanism established regulation 1024 2013 report without delay european central bank information identified course market surveillance activity may potential interest prudential supervisory task european central bank specified regulation high risk system listed point annex iii regulation far system used law enforcement purpose border management justice democracy high risk system listed point annex iii regulation member state shall designate market surveillance authority purpose regulation either competent data protection supervisory authority regulation 2016 679 directive 2016 680 authority designated pursuant condition laid article directive 2016 680 market surveillance activity shall way affect independence judicial authority otherwise interfere activity acting judicial capacity union institution body office agency fall within scope regulation european data protection supervisor shall act market surveillance authority except relation court justice european union acting judicial capacity member state shall facilitate coordination market surveillance authority designated regulation relevant national authority body supervise application union harmonisation legislation listed annex union law might relevant high risk system referred annex iii market surveillance authority commission shall able propose joint activity including joint investigation conducted either market surveillance authority market surveillance authority jointly commission aim promoting compliance identifying non compliance raising awareness providing guidance relation regulation respect specific category high risk system found present serious risk across two member state accordance article regulation 2019 1020 office shall provide coordination support joint investigation without prejudice power provided regulation 2019 1020 relevant limited necessary fulfil task market surveillance authority shall granted full access provider documentation well training validation testing data set used development high risk system including appropriate subject security safeguard application programming interface api relevant technical mean tool enabling remote access market surveillance authority shall granted access source code high risk system upon reasoned request following condition fulfilled access source code necessary assess conformity high risk system requirement set chapter iii section access source code necessary assess conformity high risk system requirement set chapter iii section testing auditing procedure verification based data documentation provided provider exhausted proved insufficient testing auditing procedure verification based data documentation provided provider exhausted proved insufficient information documentation obtained market surveillance authority shall treated accordance confidentiality obligation set article
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 75
|
1. Where an AI system is based on a general-purpose AI model, and the model and the system are developed by the same provider, the AI Office shall have powers to monitor and supervise compliance of that AI system with obligations under this Regulation. To carry out its monitoring and supervision tasks, the AI Office shall have all the powers of a market surveillance authority provided for in this Section and Regulation (EU) 2019/1020.
2. Where the relevant market surveillance authorities have sufficient reason to consider general-purpose AI systems that can be used directly by deployers for at least one purpose that is classified as high-risk pursuant to this Regulation to be non-compliant with the requirements laid down in this Regulation, they shall cooperate with the AI Office to carry out compliance evaluations, and shall inform the Board and other market surveillance authorities accordingly.
3. Where a market surveillance authority is unable to conclude its investigation of the high-risk AI system because of its inability to access certain information related to the general-purpose AI model despite having made all appropriate efforts to obtain that information, it may submit a reasoned request to the AI Office, by which access to that information shall be enforced. In that case, the AI Office shall supply to the applicant authority without delay, and in any event within 30 days, any information that the AI Office considers to be relevant in order to establish whether a high-risk AI system is non-compliant. Market surveillance authorities shall safeguard the confidentiality of the information that they obtain in accordance with Article 78 of this Regulation. The procedure provided for in Chapter VI of Regulation (EU) 2019/1020 shall applymutatis mutandis.
|
system based general purpose model model system developed provider office shall power monitor supervise compliance system obligation regulation carry monitoring supervision task office shall power market surveillance authority provided section regulation 2019 1020 relevant market surveillance authority sufficient reason consider general purpose system used directly deployers least one purpose classified high risk pursuant regulation non compliant requirement laid regulation shall cooperate office carry compliance evaluation shall inform board market surveillance authority accordingly market surveillance authority unable conclude investigation high risk system inability access certain information related general purpose model despite made appropriate effort obtain information may submit reasoned request office access information shall enforced case office shall supply applicant authority without delay event within day information office considers relevant order establish whether high risk system non compliant market surveillance authority shall safeguard confidentiality information obtain accordance article regulation procedure provided chapter regulation 2019 1020 shall applymutatis mutandis
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 76
|
1. Market surveillance authorities shall have competences and powers to ensure that testing in real world conditions is in accordance with this Regulation.
2. Where testing in real world conditions is conducted for AI systems that are supervised within an AI regulatory sandbox under Article 58, the market surveillance authorities shall verify the compliance with Article 60 as part of their supervisory role for the AI regulatory sandbox. Those authorities may, as appropriate, allow the testing in real world conditions to be conducted by the provider or prospective provider, in derogation from the conditions set out in Article 60(4), points (f) and (g).
3. Where a market surveillance authority has been informed by the prospective provider, the provider or any third party of a serious incident or has other grounds for considering that the conditions set out in Articles 60 and 61 are not met, it may take either of the following decisions on its territory, as appropriate:
(a) to suspend or terminate the testing in real world conditions;
(a)
to suspend or terminate the testing in real world conditions;
(b) to require the provider or prospective provider and the deployer or prospective deployer to modify any aspect of the testing in real world conditions.
(b)
to require the provider or prospective provider and the deployer or prospective deployer to modify any aspect of the testing in real world conditions.
4. Where a market surveillance authority has taken a decision referred to in paragraph 3 of this Article, or has issued an objection within the meaning of Article 60(4), point (b), the decision or the objection shall indicate the grounds therefor and how the provider or prospective provider can challenge the decision or objection.
5. Where applicable, where a market surveillance authority has taken a decision referred to in paragraph 3, it shall communicate the grounds therefor to the market surveillance authorities of other Member States in which the AI system has been tested in accordance with the testing plan.
|
market surveillance authority shall competence power ensure testing real world condition accordance regulation testing real world condition conducted system supervised within regulatory sandbox article market surveillance authority shall verify compliance article part supervisory role regulatory sandbox authority may appropriate allow testing real world condition conducted provider prospective provider derogation condition set article point market surveillance authority informed prospective provider provider third party serious incident ground considering condition set article met may take either following decision territory appropriate suspend terminate testing real world condition suspend terminate testing real world condition require provider prospective provider deployer prospective deployer modify aspect testing real world condition require provider prospective provider deployer prospective deployer modify aspect testing real world condition market surveillance authority taken decision referred paragraph article issued objection within meaning article point decision objection shall indicate ground therefor provider prospective provider challenge decision objection applicable market surveillance authority taken decision referred paragraph shall communicate ground therefor market surveillance authority member state system tested accordance testing plan
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 77
|
1. National public authorities or bodies which supervise or enforce the respect of obligations under Union law protecting fundamental rights, including the right to non-discrimination, in relation to the use of high-risk AI systems referred to in Annex III shall have the power to request and access any documentation created or maintained under this Regulation in accessible language and format when access to that documentation is necessary for effectively fulfilling their mandates within the limits of their jurisdiction. The relevant public authority or body shall inform the market surveillance authority of the Member State concerned of any such request.
2. By 2 November 2024, each Member State shall identify the public authorities or bodies referred to in paragraph 1 and make a list of them publicly available. Member States shall notify the list to the Commission and to the other Member States, and shall keep the list up to date.
3. Where the documentation referred to in paragraph 1 is insufficient to ascertain whether an infringement of obligations under Union law protecting fundamental rights has occurred, the public authority or body referred to in paragraph 1 may make a reasoned request to the market surveillance authority, to organise testing of the high-risk AI system through technical means. The market surveillance authority shall organise the testing with the close involvement of the requesting public authority or body within a reasonable time following the request.
4. Any information or documentation obtained by the national public authorities or bodies referred to in paragraph 1 of this Article pursuant to this Article shall be treated in accordance with the confidentiality obligations set out in Article 78.
|
national public authority body supervise enforce respect obligation union law protecting fundamental right including right non discrimination relation use high risk system referred annex iii shall power request access documentation created maintained regulation accessible language format access documentation necessary effectively fulfilling mandate within limit jurisdiction relevant public authority body shall inform market surveillance authority member state concerned request november 2024 member state shall identify public authority body referred paragraph make list publicly available member state shall notify list commission member state shall keep list date documentation referred paragraph insufficient ascertain whether infringement obligation union law protecting fundamental right occurred public authority body referred paragraph may make reasoned request market surveillance authority organise testing high risk system technical mean market surveillance authority shall organise testing close involvement requesting public authority body within reasonable time following request information documentation obtained national public authority body referred paragraph article pursuant article shall treated accordance confidentiality obligation set article
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 78
|
1. The Commission, market surveillance authorities and notified bodies and any other natural or legal person involved in the application of this Regulation shall, in accordance with Union or national law, respect the confidentiality of information and data obtained in carrying out their tasks and activities in such a manner as to protect, in particular:
(a) the intellectual property rights and confidential business information or trade secrets of a natural or legal person, including source code, except in the cases referred to in Article 5 of Directive (EU) 2016/943 of the European Parliament and of the Council();
(a)
the intellectual property rights and confidential business information or trade secrets of a natural or legal person, including source code, except in the cases referred to in Article 5 of Directive (EU) 2016/943 of the European Parliament and of the Council();
(b) the effective implementation of this Regulation, in particular for the purposes of inspections, investigations or audits;
(b)
the effective implementation of this Regulation, in particular for the purposes of inspections, investigations or audits;
(c) public and national security interests;
(c)
public and national security interests;
(d) the conduct of criminal or administrative proceedings;
(d)
the conduct of criminal or administrative proceedings;
(e) information classified pursuant to Union or national law.
(e)
information classified pursuant to Union or national law.
2. The authorities involved in the application of this Regulation pursuant to paragraph 1 shall request only data that is strictly necessary for the assessment of the risk posed by AI systems and for the exercise of their powers in accordance with this Regulation and with Regulation (EU) 2019/1020. They shall put in place adequate and effective cybersecurity measures to protect the security and confidentiality of the information and data obtained, and shall delete the data collected as soon as it is no longer needed for the purpose for which it was obtained, in accordance with applicable Union or national law.
3. Without prejudice to paragraphs 1 and 2, information exchanged on a confidential basis between the national competent authorities or between national competent authorities and the Commission shall not be disclosed without prior consultation of the originating national competent authority and the deployer when high-risk AI systems referred to in point 1, 6 or 7 of Annex III are used by law enforcement, border control, immigration or asylum authorities and when such disclosure would jeopardise public and national security interests. This exchange of information shall not cover sensitive operational data in relation to the activities of law enforcement, border control, immigration or asylum authorities.
When the law enforcement, immigration or asylum authorities are providers of high-risk AI systems referred to in point 1, 6 or 7 of Annex III, the technical documentation referred to in Annex IV shall remain within the premises of those authorities. Those authorities shall ensure that the market surveillance authorities referred to in Article 74(8) and (9), as applicable, can, upon request, immediately access the documentation or obtain a copy thereof. Only staff of the market surveillance authority holding the appropriate level of security clearance shall be allowed to access that documentation or any copy thereof.
4. Paragraphs 1, 2 and 3 shall not affect the rights or obligations of the Commission, Member States and their relevant authorities, as well as those of notified bodies, with regard to the exchange of information and the dissemination of warnings, including in the context of cross-border cooperation, nor shall they affect the obligations of the parties concerned to provide information under criminal law of the Member States.
5. The Commission and Member States may exchange, where necessary and in accordance with relevant provisions of international and trade agreements, confidential information with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements guaranteeing an adequate level of confidentiality.
|
commission market surveillance authority notified body natural legal person involved application regulation shall accordance union national law respect confidentiality information data obtained carrying task activity manner protect particular intellectual property right confidential business information trade secret natural legal person including source code except case referred article directive 2016 943 european parliament council intellectual property right confidential business information trade secret natural legal person including source code except case referred article directive 2016 943 european parliament council effective implementation regulation particular purpose inspection investigation audit effective implementation regulation particular purpose inspection investigation audit public national security interest public national security interest conduct criminal administrative proceeding conduct criminal administrative proceeding information classified pursuant union national law information classified pursuant union national law authority involved application regulation pursuant paragraph shall request data strictly necessary assessment risk posed system exercise power accordance regulation regulation 2019 1020 shall put place adequate effective cybersecurity measure protect security confidentiality information data obtained shall delete data collected soon longer needed purpose obtained accordance applicable union national law without prejudice paragraph information exchanged confidential basis national competent authority national competent authority commission shall disclosed without prior consultation originating national competent authority deployer high risk system referred point annex iii used law enforcement border control immigration asylum authority disclosure would jeopardise public national security interest exchange information shall cover sensitive operational data relation activity law enforcement border control immigration asylum authority law enforcement immigration asylum authority provider high risk system referred point annex iii technical documentation referred annex shall remain within premise authority authority shall ensure market surveillance authority referred article applicable upon request immediately access documentation obtain copy thereof staff market surveillance authority holding appropriate level security clearance shall allowed access documentation copy thereof paragraph shall affect right obligation commission member state relevant authority well notified body regard exchange information dissemination warning including context cross border cooperation shall affect obligation party concerned provide information criminal law member state commission member state may exchange necessary accordance relevant provision international trade agreement confidential information regulatory authority third country concluded bilateral multilateral confidentiality arrangement guaranteeing adequate level confidentiality
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 79
|
1. AI systems presenting a risk shall be understood as a ‘product presenting a risk’ as defined in Article 3, point 19 of Regulation (EU) 2019/1020, in so far as they present risks to the health or safety, or to fundamental rights, of persons.
2. Where the market surveillance authority of a Member State has sufficient reason to consider an AI system to present a risk as referred to in paragraph 1 of this Article, it shall carry out an evaluation of the AI system concerned in respect of its compliance with all the requirements and obligations laid down in this Regulation. Particular attention shall be given to AI systems presenting a risk to vulnerable groups. Where risks to fundamental rights are identified, the market surveillance authority shall also inform and fully cooperate with the relevant national public authorities or bodies referred to in Article 77(1). The relevant operators shall cooperate as necessary with the market surveillance authority and with the other national public authorities or bodies referred to in Article 77(1).
Where, in the course of that evaluation, the market surveillance authority or, where applicable the market surveillance authority in cooperation with the national public authority referred to in Article 77(1), finds that the AI system does not comply with the requirements and obligations laid down in this Regulation, it shall without undue delay require the relevant operator to take all appropriate corrective actions to bring the AI system into compliance, to withdraw the AI system from the market, or to recall it within a period the market surveillance authority may prescribe, and in any event within the shorter of 15 working days, or as provided for in the relevant Union harmonisation legislation.
The market surveillance authority shall inform the relevant notified body accordingly. Article 18 of Regulation (EU) 2019/1020 shall apply to the measures referred to in the second subparagraph of this paragraph.
3. Where the market surveillance authority considers that the non-compliance is not restricted to its national territory, it shall inform the Commission and the other Member States without undue delay of the results of the evaluation and of the actions which it has required the operator to take.
4. The operator shall ensure that all appropriate corrective action is taken in respect of all the AI systems concerned that it has made available on the Union market.
5. Where the operator of an AI system does not take adequate corrective action within the period referred to in paragraph 2, the market surveillance authority shall take all appropriate provisional measures to prohibit or restrict the AI system’s being made available on its national market or put into service, to withdraw the product or the standalone AI system from that market or to recall it. That authority shall without undue delay notify the Commission and the other Member States of those measures.
6. The notification referred to in paragraph 5 shall include all available details, in particular the information necessary for the identification of the non-compliant AI system, the origin of the AI system and the supply chain, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant operator. In particular, the market surveillance authorities shall indicate whether the non-compliance is due to one or more of the following:
(a) non-compliance with the prohibition of the AI practices referred to in Article 5;
(a)
non-compliance with the prohibition of the AI practices referred to in Article 5;
(b) a failure of a high-risk AI system to meet requirements set out in Chapter III, Section 2;
(b)
a failure of a high-risk AI system to meet requirements set out in Chapter III, Section 2;
(c) shortcomings in the harmonised standards or common specifications referred to in Articles 40 and 41 conferring a presumption of conformity;
(c)
shortcomings in the harmonised standards or common specifications referred to in Articles 40 and 41 conferring a presumption of conformity;
(d) non-compliance with Article 50.
(d)
non-compliance with Article 50.
7. The market surveillance authorities other than the market surveillance authority of the Member State initiating the procedure shall, without undue delay, inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the AI system concerned, and, in the event of disagreement with the notified national measure, of their objections.
8. Where, within three months of receipt of the notification referred to in paragraph 5 of this Article, no objection has been raised by either a market surveillance authority of a Member State or by the Commission in respect of a provisional measure taken by a market surveillance authority of another Member State, that measure shall be deemed justified. This shall be without prejudice to the procedural rights of the concerned operator in accordance with Article 18 of Regulation (EU) 2019/1020. The three-month period referred to in this paragraph shall be reduced to 30 days in the event of non-compliance with the prohibition of the AI practices referred to in Article 5 of this Regulation.
9. The market surveillance authorities shall ensure that appropriate restrictive measures are taken in respect of the product or the AI system concerned, such as withdrawal of the product or the AI system from their market, without undue delay.
|
system presenting risk shall understood product presenting risk defined article point regulation 2019 1020 far present risk health safety fundamental right person market surveillance authority member state sufficient reason consider system present risk referred paragraph article shall carry evaluation system concerned respect compliance requirement obligation laid regulation particular attention shall given system presenting risk vulnerable group risk fundamental right identified market surveillance authority shall also inform fully cooperate relevant national public authority body referred article relevant operator shall cooperate necessary market surveillance authority national public authority body referred article course evaluation market surveillance authority applicable market surveillance authority cooperation national public authority referred article find system comply requirement obligation laid regulation shall without undue delay require relevant operator take appropriate corrective action bring system compliance withdraw system market recall within period market surveillance authority may prescribe event within shorter working day provided relevant union harmonisation legislation market surveillance authority shall inform relevant notified body accordingly article regulation 2019 1020 shall apply measure referred second subparagraph paragraph market surveillance authority considers non compliance restricted national territory shall inform commission member state without undue delay result evaluation action required operator take operator shall ensure appropriate corrective action taken respect system concerned made available union market operator system take adequate corrective action within period referred paragraph market surveillance authority shall take appropriate provisional measure prohibit restrict system made available national market put service withdraw product standalone system market recall authority shall without undue delay notify commission member state measure notification referred paragraph shall include available detail particular information necessary identification non compliant system origin system supply chain nature non compliance alleged risk involved nature duration national measure taken argument put forward relevant operator particular market surveillance authority shall indicate whether non compliance due one following non compliance prohibition practice referred article non compliance prohibition practice referred article failure high risk system meet requirement set chapter iii section failure high risk system meet requirement set chapter iii section shortcoming harmonised standard common specification referred article conferring presumption conformity shortcoming harmonised standard common specification referred article conferring presumption conformity non compliance article non compliance article market surveillance authority market surveillance authority member state initiating procedure shall without undue delay inform commission member state measure adopted additional information disposal relating non compliance system concerned event disagreement notified national measure objection within three month receipt notification referred paragraph article objection raised either market surveillance authority member state commission respect provisional measure taken market surveillance authority another member state measure shall deemed justified shall without prejudice procedural right concerned operator accordance article regulation 2019 1020 three month period referred paragraph shall reduced day event non compliance prohibition practice referred article regulation market surveillance authority shall ensure appropriate restrictive measure taken respect product system concerned withdrawal product system market without undue delay
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 80
|
1. Where a market surveillance authority has sufficient reason to consider that an AI system classified by the provider as non-high-risk pursuant to Article 6(3) is indeed high-risk, the market surveillance authority shall carry out an evaluation of the AI system concerned in respect of its classification as a high-risk AI system based on the conditions set out in Article 6(3) and the Commission guidelines.
2. Where, in the course of that evaluation, the market surveillance authority finds that the AI system concerned is high-risk, it shall without undue delay require the relevant provider to take all necessary actions to bring the AI system into compliance with the requirements and obligations laid down in this Regulation, as well as take appropriate corrective action within a period the market surveillance authority may prescribe.
3. Where the market surveillance authority considers that the use of the AI system concerned is not restricted to its national territory, it shall inform the Commission and the other Member States without undue delay of the results of the evaluation and of the actions which it has required the provider to take.
4. The provider shall ensure that all necessary action is taken to bring the AI system into compliance with the requirements and obligations laid down in this Regulation. Where the provider of an AI system concerned does not bring the AI system into compliance with those requirements and obligations within the period referred to in paragraph 2 of this Article, the provider shall be subject to fines in accordance with Article 99.
5. The provider shall ensure that all appropriate corrective action is taken in respect of all the AI systems concerned that it has made available on the Union market.
6. Where the provider of the AI system concerned does not take adequate corrective action within the period referred to in paragraph 2 of this Article, Article 79(5) to (9) shall apply.
7. Where, in the course of the evaluation pursuant to paragraph 1 of this Article, the market surveillance authority establishes that the AI system was misclassified by the provider as non-high-risk in order to circumvent the application of requirements in Chapter III, Section 2, the provider shall be subject to fines in accordance with Article 99.
8. In exercising their power to monitor the application of this Article, and in accordance with Article 11 of Regulation (EU) 2019/1020, market surveillance authorities may perform appropriate checks, taking into account in particular information stored in the EU database referred to in Article 71 of this Regulation.
|
market surveillance authority sufficient reason consider system classified provider non high risk pursuant article indeed high risk market surveillance authority shall carry evaluation system concerned respect classification high risk system based condition set article commission guideline course evaluation market surveillance authority find system concerned high risk shall without undue delay require relevant provider take necessary action bring system compliance requirement obligation laid regulation well take appropriate corrective action within period market surveillance authority may prescribe market surveillance authority considers use system concerned restricted national territory shall inform commission member state without undue delay result evaluation action required provider take provider shall ensure necessary action taken bring system compliance requirement obligation laid regulation provider system concerned bring system compliance requirement obligation within period referred paragraph article provider shall subject fine accordance article provider shall ensure appropriate corrective action taken respect system concerned made available union market provider system concerned take adequate corrective action within period referred paragraph article article shall apply course evaluation pursuant paragraph article market surveillance authority establishes system misclassified provider non high risk order circumvent application requirement chapter iii section provider shall subject fine accordance article exercising power monitor application article accordance article regulation 2019 1020 market surveillance authority may perform appropriate check taking account particular information stored database referred article regulation
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 81
|
1. Where, within three months of receipt of the notification referred to in Article 79(5), or within 30 days in the case of non-compliance with the prohibition of the AI practices referred to in Article 5, objections are raised by the market surveillance authority of a Member State to a measure taken by another market surveillance authority, or where the Commission considers the measure to be contrary to Union law, the Commission shall without undue delay enter into consultation with the market surveillance authority of the relevant Member State and the operator or operators, and shall evaluate the national measure. On the basis of the results of that evaluation, the Commission shall, within six months, or within 60 days in the case of non-compliance with the prohibition of the AI practices referred to in Article 5, starting from the notification referred to in Article 79(5), decide whether the national measure is justified and shall notify its decision to the market surveillance authority of the Member State concerned. The Commission shall also inform all other market surveillance authorities of its decision.
2. Where the Commission considers the measure taken by the relevant Member State to be justified, all Member States shall ensure that they take appropriate restrictive measures in respect of the AI system concerned, such as requiring the withdrawal of the AI system from their market without undue delay, and shall inform the Commission accordingly. Where the Commission considers the national measure to be unjustified, the Member State concerned shall withdraw the measure and shall inform the Commission accordingly.
3. Where the national measure is considered justified and the non-compliance of the AI system is attributed to shortcomings in the harmonised standards or common specifications referred to in Articles 40 and 41 of this Regulation, the Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012.
|
within three month receipt notification referred article within day case non compliance prohibition practice referred article objection raised market surveillance authority member state measure taken another market surveillance authority commission considers measure contrary union law commission shall without undue delay enter consultation market surveillance authority relevant member state operator operator shall evaluate national measure basis result evaluation commission shall within six month within day case non compliance prohibition practice referred article starting notification referred article decide whether national measure justified shall notify decision market surveillance authority member state concerned commission shall also inform market surveillance authority decision commission considers measure taken relevant member state justified member state shall ensure take appropriate restrictive measure respect system concerned requiring withdrawal system market without undue delay shall inform commission accordingly commission considers national measure unjustified member state concerned shall withdraw measure shall inform commission accordingly national measure considered justified non compliance system attributed shortcoming harmonised standard common specification referred article regulation commission shall apply procedure provided article regulation 1025 2012
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 82
|
1. Where, having performed an evaluation under Article 79, after consulting the relevant national public authority referred to in Article 77(1), the market surveillance authority of a Member State finds that although a high-risk AI system complies with this Regulation, it nevertheless presents a risk to the health or safety of persons, to fundamental rights, or to other aspects of public interest protection, it shall require the relevant operator to take all appropriate measures to ensure that the AI system concerned, when placed on the market or put into service, no longer presents that risk without undue delay, within a period it may prescribe.
2. The provider or other relevant operator shall ensure that corrective action is taken in respect of all the AI systems concerned that it has made available on the Union market within the timeline prescribed by the market surveillance authority of the Member State referred to in paragraph 1.
3. The Member States shall immediately inform the Commission and the other Member States of a finding under paragraph 1. That information shall include all available details, in particular the data necessary for the identification of the AI system concerned, the origin and the supply chain of the AI system, the nature of the risk involved and the nature and duration of the national measures taken.
4. The Commission shall without undue delay enter into consultation with the Member States concerned and the relevant operators, and shall evaluate the national measures taken. On the basis of the results of that evaluation, the Commission shall decide whether the measure is justified and, where necessary, propose other appropriate measures.
5. The Commission shall immediately communicate its decision to the Member States concerned and to the relevant operators. It shall also inform the other Member States.
|
performed evaluation article consulting relevant national public authority referred article market surveillance authority member state find although high risk system complies regulation nevertheless present risk health safety person fundamental right aspect public interest protection shall require relevant operator take appropriate measure ensure system concerned placed market put service longer present risk without undue delay within period may prescribe provider relevant operator shall ensure corrective action taken respect system concerned made available union market within timeline prescribed market surveillance authority member state referred paragraph member state shall immediately inform commission member state finding paragraph information shall include available detail particular data necessary identification system concerned origin supply chain system nature risk involved nature duration national measure taken commission shall without undue delay enter consultation member state concerned relevant operator shall evaluate national measure taken basis result evaluation commission shall decide whether measure justified necessary propose appropriate measure commission shall immediately communicate decision member state concerned relevant operator shall also inform member state
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 83
|
1. Where the market surveillance authority of a Member State makes one of the following findings, it shall require the relevant provider to put an end to the non-compliance concerned, within a period it may prescribe:
(a) the CE marking has been affixed in violation of Article 48;
(a)
the CE marking has been affixed in violation of Article 48;
(b) the CE marking has not been affixed;
(b)
the CE marking has not been affixed;
(c) the EU declaration of conformity referred to in Article 47 has not been drawn up;
(c)
the EU declaration of conformity referred to in Article 47 has not been drawn up;
(d) the EU declaration of conformity referred to in Article 47 has not been drawn up correctly;
(d)
the EU declaration of conformity referred to in Article 47 has not been drawn up correctly;
(e) the registration in the EU database referred to in Article 71 has not been carried out;
(e)
the registration in the EU database referred to in Article 71 has not been carried out;
(f) where applicable, no authorised representative has been appointed;
(f)
where applicable, no authorised representative has been appointed;
(g) technical documentation is not available.
(g)
technical documentation is not available.
2. Where the non-compliance referred to in paragraph 1 persists, the market surveillance authority of the Member State concerned shall take appropriate and proportionate measures to restrict or prohibit the high-risk AI system being made available on the market or to ensure that it is recalled or withdrawn from the market without delay.
|
market surveillance authority member state make one following finding shall require relevant provider put end non compliance concerned within period may prescribe marking affixed violation article marking affixed violation article marking affixed marking affixed declaration conformity referred article drawn declaration conformity referred article drawn declaration conformity referred article drawn correctly declaration conformity referred article drawn correctly registration database referred article carried registration database referred article carried applicable authorised representative appointed applicable authorised representative appointed technical documentation available technical documentation available non compliance referred paragraph persists market surveillance authority member state concerned shall take appropriate proportionate measure restrict prohibit high risk system made available market ensure recalled withdrawn market without delay
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 84
|
1. The Commission shall designate one or more Union AI testing support structures to perform the tasks listed under Article 21(6) of Regulation (EU) 2019/1020 in the area of AI.
2. Without prejudice to the tasks referred to in paragraph 1, Union AI testing support structures shall also provide independent technical or scientific advice at the request of the Board, the Commission, or of market surveillance authorities.
|
commission shall designate one union testing support structure perform task listed article regulation 2019 1020 area without prejudice task referred paragraph union testing support structure shall also provide independent technical scientific advice request board commission market surveillance authority
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 85
|
Without prejudice to other administrative or judicial remedies, any natural or legal person having grounds to consider that there has been an infringement of the provisions of this Regulation may submit complaints to the relevant market surveillance authority.
In accordance with Regulation (EU) 2019/1020, such complaints shall be taken into account for the purpose of conducting market surveillance activities, and shall be handled in line with the dedicated procedures established therefor by the market surveillance authorities.
|
without prejudice administrative judicial remedy natural legal person ground consider infringement provision regulation may submit complaint relevant market surveillance authority accordance regulation 2019 1020 complaint shall taken account purpose conducting market surveillance activity shall handled line dedicated procedure established therefor market surveillance authority
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 86
|
1. Any affected person subject to a decision which is taken by the deployer on the basis of the output from a high-risk AI system listed in Annex III, with the exception of systems listed under point 2 thereof, and which produces legal effects or similarly significantly affects that person in a way that they consider to have an adverse impact on their health, safety or fundamental rights shall have the right to obtain from the deployer clear and meaningful explanations of the role of the AI system in the decision-making procedure and the main elements of the decision taken.
2. Paragraph 1 shall not apply to the use of AI systems for which exceptions from, or restrictions to, the obligation under that paragraph follow from Union or national law in compliance with Union law.
3. This Article shall apply only to the extent that the right referred to in paragraph 1 is not otherwise provided for under Union law.
|
affected person subject decision taken deployer basis output high risk system listed annex iii exception system listed point thereof produce legal effect similarly significantly affect person way consider adverse impact health safety fundamental right shall right obtain deployer clear meaningful explanation role system decision making procedure main element decision taken paragraph shall apply use system exception restriction obligation paragraph follow union national law compliance union law article shall apply extent right referred paragraph otherwise provided union law
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 87
|
Directive (EU) 2019/1937 shall apply to the reporting of infringements of this Regulation and the protection of persons reporting such infringements.
|
directive 2019 1937 shall apply reporting infringement regulation protection person reporting infringement
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 88
|
1. The Commission shall have exclusive powers to supervise and enforce Chapter V, taking into account the procedural guarantees under Article 94. The Commission shall entrust the implementation of these tasks to the AI Office, without prejudice to the powers of organisation of the Commission and the division of competences between Member States and the Union based on the Treaties.
2. Without prejudice to Article 75(3), market surveillance authorities may request the Commission to exercise the powers laid down in this Section, where that is necessary and proportionate to assist with the fulfilment of their tasks under this Regulation.
|
commission shall exclusive power supervise enforce chapter taking account procedural guarantee article commission shall entrust implementation task office without prejudice power organisation commission division competence member state union based treaty without prejudice article market surveillance authority may request commission exercise power laid section necessary proportionate assist fulfilment task regulation
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 89
|
1. For the purpose of carrying out the tasks assigned to it under this Section, the AI Office may take the necessary actions to monitor the effective implementation and compliance with this Regulation by providers of general-purpose AI models, including their adherence to approved codes of practice.
2. Downstream providers shall have the right to lodge a complaint alleging an infringement of this Regulation. A complaint shall be duly reasoned and indicate at least:
(a) the point of contact of the provider of the general-purpose AI model concerned;
(a)
the point of contact of the provider of the general-purpose AI model concerned;
(b) a description of the relevant facts, the provisions of this Regulation concerned, and the reason why the downstream provider considers that the provider of the general-purpose AI model concerned infringed this Regulation;
(b)
a description of the relevant facts, the provisions of this Regulation concerned, and the reason why the downstream provider considers that the provider of the general-purpose AI model concerned infringed this Regulation;
(c) any other information that the downstream provider that sent the request considers relevant, including, where appropriate, information gathered on its own initiative.
(c)
any other information that the downstream provider that sent the request considers relevant, including, where appropriate, information gathered on its own initiative.
|
purpose carrying task assigned section office may take necessary action monitor effective implementation compliance regulation provider general purpose model including adherence approved code practice downstream provider shall right lodge complaint alleging infringement regulation complaint shall duly reasoned indicate least point contact provider general purpose model concerned point contact provider general purpose model concerned description relevant fact provision regulation concerned reason downstream provider considers provider general purpose model concerned infringed regulation description relevant fact provision regulation concerned reason downstream provider considers provider general purpose model concerned infringed regulation information downstream provider sent request considers relevant including appropriate information gathered initiative information downstream provider sent request considers relevant including appropriate information gathered initiative
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 90
|
1. The scientific panel may provide a qualified alert to the AI Office where it has reason to suspect that:
(a) a general-purpose AI model poses concrete identifiable risk at Union level; or
(a)
a general-purpose AI model poses concrete identifiable risk at Union level; or
(b) a general-purpose AI model meets the conditions referred to in Article 51.
(b)
a general-purpose AI model meets the conditions referred to in Article 51.
2. Upon such qualified alert, the Commission, through the AI Office and after having informed the Board, may exercise the powers laid down in this Section for the purpose of assessing the matter. The AI Office shall inform the Board of any measure according to Articles 91 to 94.
3. A qualified alert shall be duly reasoned and indicate at least:
(a) the point of contact of the provider of the general-purpose AI model with systemic risk concerned;
(a)
the point of contact of the provider of the general-purpose AI model with systemic risk concerned;
(b) a description of the relevant facts and the reasons for the alert by the scientific panel;
(b)
a description of the relevant facts and the reasons for the alert by the scientific panel;
(c) any other information that the scientific panel considers to be relevant, including, where appropriate, information gathered on its own initiative.
(c)
any other information that the scientific panel considers to be relevant, including, where appropriate, information gathered on its own initiative.
|
scientific panel may provide qualified alert office reason suspect general purpose model pose concrete identifiable risk union level general purpose model pose concrete identifiable risk union level general purpose model meet condition referred article general purpose model meet condition referred article upon qualified alert commission office informed board may exercise power laid section purpose assessing matter office shall inform board measure according article qualified alert shall duly reasoned indicate least point contact provider general purpose model systemic risk concerned point contact provider general purpose model systemic risk concerned description relevant fact reason alert scientific panel description relevant fact reason alert scientific panel information scientific panel considers relevant including appropriate information gathered initiative information scientific panel considers relevant including appropriate information gathered initiative
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 91
|
1. The Commission may request the provider of the general-purpose AI model concerned to provide the documentation drawn up by the provider in accordance with Articles 53 and 55, or any additional information that is necessary for the purpose of assessing compliance of the provider with this Regulation.
2. Before sending the request for information, the AI Office may initiate a structured dialogue with the provider of the general-purpose AI model.
3. Upon a duly substantiated request from the scientific panel, the Commission may issue a request for information to a provider of a general-purpose AI model, where the access to information is necessary and proportionate for the fulfilment of the tasks of the scientific panel under Article 68(2).
4. The request for information shall state the legal basis and the purpose of the request, specify what information is required, set a period within which the information is to be provided, and indicate the fines provided for in Article 101 for supplying incorrect, incomplete or misleading information.
5. The provider of the general-purpose AI model concerned, or its representative shall supply the information requested. In the case of legal persons, companies or firms, or where the provider has no legal personality, the persons authorised to represent them by law or by their statutes, shall supply the information requested on behalf of the provider of the general-purpose AI model concerned. Lawyers duly authorised to act may supply information on behalf of their clients. The clients shall nevertheless remain fully responsible if the information supplied is incomplete, incorrect or misleading.
|
commission may request provider general purpose model concerned provide documentation drawn provider accordance article additional information necessary purpose assessing compliance provider regulation sending request information office may initiate structured dialogue provider general purpose model upon duly substantiated request scientific panel commission may issue request information provider general purpose model access information necessary proportionate fulfilment task scientific panel article request information shall state legal basis purpose request specify information required set period within information provided indicate fine provided article 101 supplying incorrect incomplete misleading information provider general purpose model concerned representative shall supply information requested case legal person company firm provider legal personality person authorised represent law statute shall supply information requested behalf provider general purpose model concerned lawyer duly authorised act may supply information behalf client client shall nevertheless remain fully responsible information supplied incomplete incorrect misleading
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 92
|
1. The AI Office, after consulting the Board, may conduct evaluations of the general-purpose AI model concerned:
(a) to assess compliance of the provider with obligations under this Regulation, where the information gathered pursuant to Article 91 is insufficient; or
(a)
to assess compliance of the provider with obligations under this Regulation, where the information gathered pursuant to Article 91 is insufficient; or
(b) to investigate systemic risks at Union level of general-purpose AI models with systemic risk, in particular following a qualified alert from the scientific panel in accordance with Article 90(1), point (a).
(b)
to investigate systemic risks at Union level of general-purpose AI models with systemic risk, in particular following a qualified alert from the scientific panel in accordance with Article 90(1), point (a).
2. The Commission may decide to appoint independent experts to carry out evaluations on its behalf, including from the scientific panel established pursuant to Article 68. Independent experts appointed for this task shall meet the criteria outlined in Article 68(2).
3. For the purposes of paragraph 1, the Commission may request access to the general-purpose AI model concerned through APIs or further appropriate technical means and tools, including source code.
4. The request for access shall state the legal basis, the purpose and reasons of the request and set the period within which the access is to be provided, and the fines provided for in Article 101 for failure to provide access.
5. The providers of the general-purpose AI model concerned or its representative shall supply the information requested. In the case of legal persons, companies or firms, or where the provider has no legal personality, the persons authorised to represent them by law or by their statutes, shall provide the access requested on behalf of the provider of the general-purpose AI model concerned.
6. The Commission shall adopt implementing acts setting out the detailed arrangements and the conditions for the evaluations, including the detailed arrangements for involving independent experts, and the procedure for the selection thereof. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).
7. Prior to requesting access to the general-purpose AI model concerned, the AI Office may initiate a structured dialogue with the provider of the general-purpose AI model to gather more information on the internal testing of the model, internal safeguards for preventing systemic risks, and other internal procedures and measures the provider has taken to mitigate such risks.
|
office consulting board may conduct evaluation general purpose model concerned assess compliance provider obligation regulation information gathered pursuant article insufficient assess compliance provider obligation regulation information gathered pursuant article insufficient investigate systemic risk union level general purpose model systemic risk particular following qualified alert scientific panel accordance article point investigate systemic risk union level general purpose model systemic risk particular following qualified alert scientific panel accordance article point commission may decide appoint independent expert carry evaluation behalf including scientific panel established pursuant article independent expert appointed task shall meet criterion outlined article purpose paragraph commission may request access general purpose model concerned apis appropriate technical mean tool including source code request access shall state legal basis purpose reason request set period within access provided fine provided article 101 failure provide access provider general purpose model concerned representative shall supply information requested case legal person company firm provider legal personality person authorised represent law statute shall provide access requested behalf provider general purpose model concerned commission shall adopt implementing act setting detailed arrangement condition evaluation including detailed arrangement involving independent expert procedure selection thereof implementing act shall adopted accordance examination procedure referred article prior requesting access general purpose model concerned office may initiate structured dialogue provider general purpose model gather information internal testing model internal safeguard preventing systemic risk internal procedure measure provider taken mitigate risk
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 93
|
1. Where necessary and appropriate, the Commission may request providers to:
(a) take appropriate measures to comply with the obligations set out in Articles 53 and 54;
(a)
take appropriate measures to comply with the obligations set out in Articles 53 and 54;
(b) implement mitigation measures, where the evaluation carried out in accordance with Article 92 has given rise to serious and substantiated concern of a systemic risk at Union level;
(b)
implement mitigation measures, where the evaluation carried out in accordance with Article 92 has given rise to serious and substantiated concern of a systemic risk at Union level;
(c) restrict the making available on the market, withdraw or recall the model.
(c)
restrict the making available on the market, withdraw or recall the model.
2. Before a measure is requested, the AI Office may initiate a structured dialogue with the provider of the general-purpose AI model.
3. If, during the structured dialogue referred to in paragraph 2, the provider of the general-purpose AI model with systemic risk offers commitments to implement mitigation measures to address a systemic risk at Union level, the Commission may, by decision, make those commitments binding and declare that there are no further grounds for action.
|
necessary appropriate commission may request provider take appropriate measure comply obligation set article take appropriate measure comply obligation set article implement mitigation measure evaluation carried accordance article given rise serious substantiated concern systemic risk union level implement mitigation measure evaluation carried accordance article given rise serious substantiated concern systemic risk union level restrict making available market withdraw recall model restrict making available market withdraw recall model measure requested office may initiate structured dialogue provider general purpose model structured dialogue referred paragraph provider general purpose model systemic risk offer commitment implement mitigation measure address systemic risk union level commission may decision make commitment binding declare ground action
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 94
|
Article 18 of Regulation (EU) 2019/1020 shall applymutatis mutandisto the providers of the general-purpose AI model, without prejudice to more specific procedural rights provided for in this Regulation.
|
article regulation 2019 1020 shall applymutatis mutandisto provider general purpose model without prejudice specific procedural right provided regulation
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 95
|
1. The AI Office and the Member States shall encourage and facilitate the drawing up of codes of conduct, including related governance mechanisms, intended to foster the voluntary application to AI systems, other than high-risk AI systems, of some or all of the requirements set out in Chapter III, Section 2 taking into account the available technical solutions and industry best practices allowing for the application of such requirements.
2. The AI Office and the Member States shall facilitate the drawing up of codes of conduct concerning the voluntary application, including by deployers, of specific requirements to all AI systems, on the basis of clear objectives and key performance indicators to measure the achievement of those objectives, including elements such as, but not limited to:
(a) applicable elements provided for in Union ethical guidelines for trustworthy AI;
(a)
applicable elements provided for in Union ethical guidelines for trustworthy AI;
(b) assessing and minimising the impact of AI systems on environmental sustainability, including as regards energy-efficient programming and techniques for the efficient design, training and use of AI;
(b)
assessing and minimising the impact of AI systems on environmental sustainability, including as regards energy-efficient programming and techniques for the efficient design, training and use of AI;
(c) promoting AI literacy, in particular that of persons dealing with the development, operation and use of AI;
(c)
promoting AI literacy, in particular that of persons dealing with the development, operation and use of AI;
(d) facilitating an inclusive and diverse design of AI systems, including through the establishment of inclusive and diverse development teams and the promotion of stakeholders’ participation in that process;
(d)
facilitating an inclusive and diverse design of AI systems, including through the establishment of inclusive and diverse development teams and the promotion of stakeholders’ participation in that process;
(e) assessing and preventing the negative impact of AI systems on vulnerable persons or groups of vulnerable persons, including as regards accessibility for persons with a disability, as well as on gender equality.
(e)
assessing and preventing the negative impact of AI systems on vulnerable persons or groups of vulnerable persons, including as regards accessibility for persons with a disability, as well as on gender equality.
3. Codes of conduct may be drawn up by individual providers or deployers of AI systems or by organisations representing them or by both, including with the involvement of any interested stakeholders and their representative organisations, including civil society organisations and academia. Codes of conduct may cover one or more AI systems taking into account the similarity of the intended purpose of the relevant systems.
4. The AI Office and the Member States shall take into account the specific interests and needs of SMEs, including start-ups, when encouraging and facilitating the drawing up of codes of conduct.
|
office member state shall encourage facilitate drawing code conduct including related governance mechanism intended foster voluntary application system high risk system requirement set chapter iii section taking account available technical solution industry best practice allowing application requirement office member state shall facilitate drawing code conduct concerning voluntary application including deployers specific requirement system basis clear objective key performance indicator measure achievement objective including element limited applicable element provided union ethical guideline trustworthy applicable element provided union ethical guideline trustworthy assessing minimising impact system environmental sustainability including regard energy efficient programming technique efficient design training use assessing minimising impact system environmental sustainability including regard energy efficient programming technique efficient design training use promoting literacy particular person dealing development operation use promoting literacy particular person dealing development operation use facilitating inclusive diverse design system including establishment inclusive diverse development team promotion stakeholder participation process facilitating inclusive diverse design system including establishment inclusive diverse development team promotion stakeholder participation process assessing preventing negative impact system vulnerable person group vulnerable person including regard accessibility person disability well gender equality assessing preventing negative impact system vulnerable person group vulnerable person including regard accessibility person disability well gender equality code conduct may drawn individual provider deployers system organisation representing including involvement interested stakeholder representative organisation including civil society organisation academia code conduct may cover one system taking account similarity intended purpose relevant system office member state shall take account specific interest need smes including start ups encouraging facilitating drawing code conduct
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 96
|
1. The Commission shall develop guidelines on the practical implementation of this Regulation, and in particular on:
(a) the application of the requirements and obligations referred to in Articles 8 to 15 and in Article 25;
(a)
the application of the requirements and obligations referred to in Articles 8 to 15 and in Article 25;
(b) the prohibited practices referred to in Article 5;
(b)
the prohibited practices referred to in Article 5;
(c) the practical implementation of the provisions related to substantial modification;
(c)
the practical implementation of the provisions related to substantial modification;
(d) the practical implementation of transparency obligations laid down in Article 50;
(d)
the practical implementation of transparency obligations laid down in Article 50;
(e) detailed information on the relationship of this Regulation with the Union harmonisation legislation listed in Annex I, as well as with other relevant Union law, including as regards consistency in their enforcement;
(e)
detailed information on the relationship of this Regulation with the Union harmonisation legislation listed in Annex I, as well as with other relevant Union law, including as regards consistency in their enforcement;
(f) the application of the definition of an AI system as set out in Article 3, point (1).
(f)
the application of the definition of an AI system as set out in Article 3, point (1).
When issuing such guidelines, the Commission shall pay particular attention to the needs of SMEs including start-ups, of local public authorities and of the sectors most likely to be affected by this Regulation.
The guidelines referred to in the first subparagraph of this paragraph shall take due account of the generally acknowledged state of the art on AI, as well as of relevant harmonised standards and common specifications that are referred to in Articles 40 and 41, or of those harmonised standards or technical specifications that are set out pursuant to Union harmonisation law.
2. At the request of the Member States or the AI Office, or on its own initiative, the Commission shall update guidelines previously adopted when deemed necessary.
|
commission shall develop guideline practical implementation regulation particular application requirement obligation referred article article application requirement obligation referred article article prohibited practice referred article prohibited practice referred article practical implementation provision related substantial modification practical implementation provision related substantial modification practical implementation transparency obligation laid article practical implementation transparency obligation laid article detailed information relationship regulation union harmonisation legislation listed annex well relevant union law including regard consistency enforcement detailed information relationship regulation union harmonisation legislation listed annex well relevant union law including regard consistency enforcement application definition system set article point application definition system set article point issuing guideline commission shall pay particular attention need smes including start ups local public authority sector likely affected regulation guideline referred first subparagraph paragraph shall take due account generally acknowledged state art well relevant harmonised standard common specification referred article harmonised standard technical specification set pursuant union harmonisation law request member state office initiative commission shall update guideline previously adopted deemed necessary
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 97
|
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2. The power to adopt delegated acts referred to in Article 6(6) and (7), Article 7(1) and (3), Article 11(3), Article 43(5) and (6), Article 47(5), Article 51(3), Article 52(4) and Article 53(5) and (6) shall be conferred on the Commission for a period of five years from 1 August 2024. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
3. The delegation of power referred to in Article 6(6) and (7), Article 7(1) and (3), Article 11(3), Article 43(5) and (6), Article 47(5), Article 51(3), Article 52(4) and Article 53(5) and (6) may be revoked at any time by the European Parliament or by the Council. A decision of revocation shall put an end to the delegation of power specified in that decision. It shall take effect the day following that of its publication in theOfficial Journal of the European Unionor at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.
5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
6. Any delegated act adopted pursuant to Article 6(6) or (7), Article 7(1) or (3), Article 11(3), Article 43(5) or (6), Article 47(5), Article 51(3), Article 52(4) or Article 53(5) or (6) shall enter into force only if no objection has been expressed by either the European Parliament or the Council within a period of three months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by three months at the initiative of the European Parliament or of the Council.
|
power adopt delegated act conferred commission subject condition laid article power adopt delegated act referred article article article article article article article article shall conferred commission period five year august 2024 commission shall draw report respect delegation power later nine month end five year period delegation power shall tacitly extended period identical duration unless european parliament council opposes extension later three month end period delegation power referred article article article article article article article article may revoked time european parliament council decision revocation shall put end delegation power specified decision shall take effect day following publication theofficial journal european unionor later date specified therein shall affect validity delegated act already force adopting delegated act commission shall consult expert designated member state accordance principle laid interinstitutional agreement april 2016 better law making soon adopts delegated act commission shall notify simultaneously european parliament council delegated act adopted pursuant article article article article article article article article shall enter force objection expressed either european parliament council within period three month notification act european parliament council expiry period european parliament council informed commission object period shall extended three month initiative european parliament council
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 98
|
1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
|
commission shall assisted committee committee shall committee within meaning regulation 182 2011 reference made paragraph article regulation 182 2011 shall apply
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 99
|
1. In accordance with the terms and conditions laid down in this Regulation, Member States shall lay down the rules on penalties and other enforcement measures, which may also include warnings and non-monetary measures, applicable to infringements of this Regulation by operators, and shall take all measures necessary to ensure that they are properly and effectively implemented, thereby taking into account the guidelines issued by the Commission pursuant to Article 96. The penalties provided for shall be effective, proportionate and dissuasive. They shall take into account the interests of SMEs, including start-ups, and their economic viability.
2. The Member States shall, without delay and at the latest by the date of entry into application, notify the Commission of the rules on penalties and of other enforcement measures referred to in paragraph 1, and shall notify it, without delay, of any subsequent amendment to them.
3. Non-compliance with the prohibition of the AI practices referred to in Article 5 shall be subject to administrative fines of up to EUR 35 000 000 or, if the offender is an undertaking, up to 7 % of its total worldwide annual turnover for the preceding financial year, whichever is higher.
4. Non-compliance with any of the following provisions related to operators or notified bodies, other than those laid down in Articles 5, shall be subject to administrative fines of up to EUR 15 000 000 or, if the offender is an undertaking, up to 3 % of its total worldwide annual turnover for the preceding financial year, whichever is higher:
(a) obligations of providers pursuant to Article 16;
(a)
obligations of providers pursuant to Article 16;
(b) obligations of authorised representatives pursuant to Article 22;
(b)
obligations of authorised representatives pursuant to Article 22;
(c) obligations of importers pursuant to Article 23;
(c)
obligations of importers pursuant to Article 23;
(d) obligations of distributors pursuant to Article 24;
(d)
obligations of distributors pursuant to Article 24;
(e) obligations of deployers pursuant to Article 26;
(e)
obligations of deployers pursuant to Article 26;
(f) requirements and obligations of notified bodies pursuant to Article 31, Article 33(1), (3) and (4) or Article 34;
(f)
requirements and obligations of notified bodies pursuant to Article 31, Article 33(1), (3) and (4) or Article 34;
(g) transparency obligations for providers and deployers pursuant to Article 50.
(g)
transparency obligations for providers and deployers pursuant to Article 50.
5. The supply of incorrect, incomplete or misleading information to notified bodies or national competent authorities in reply to a request shall be subject to administrative fines of up to EUR 7 500 000 or, if the offender is an undertaking, up to 1 % of its total worldwide annual turnover for the preceding financial year, whichever is higher.
6. In the case of SMEs, including start-ups, each fine referred to in this Article shall be up to the percentages or amount referred to in paragraphs 3, 4 and 5, whichever thereof is lower.
7. When deciding whether to impose an administrative fine and when deciding on the amount of the administrative fine in each individual case, all relevant circumstances of the specific situation shall be taken into account and, as appropriate, regard shall be given to the following:
(a) the nature, gravity and duration of the infringement and of its consequences, taking into account the purpose of the AI system, as well as, where appropriate, the number of affected persons and the level of damage suffered by them;
(a)
the nature, gravity and duration of the infringement and of its consequences, taking into account the purpose of the AI system, as well as, where appropriate, the number of affected persons and the level of damage suffered by them;
(b) whether administrative fines have already been applied by other market surveillance authorities to the same operator for the same infringement;
(b)
whether administrative fines have already been applied by other market surveillance authorities to the same operator for the same infringement;
(c) whether administrative fines have already been applied by other authorities to the same operator for infringements of other Union or national law, when such infringements result from the same activity or omission constituting a relevant infringement of this Regulation;
(c)
whether administrative fines have already been applied by other authorities to the same operator for infringements of other Union or national law, when such infringements result from the same activity or omission constituting a relevant infringement of this Regulation;
(d) the size, the annual turnover and market share of the operator committing the infringement;
(d)
the size, the annual turnover and market share of the operator committing the infringement;
(e) any other aggravating or mitigating factor applicable to the circumstances of the case, such as financial benefits gained, or losses avoided, directly or indirectly, from the infringement;
(e)
any other aggravating or mitigating factor applicable to the circumstances of the case, such as financial benefits gained, or losses avoided, directly or indirectly, from the infringement;
(f) the degree of cooperation with the national competent authorities, in order to remedy the infringement and mitigate the possible adverse effects of the infringement;
(f)
the degree of cooperation with the national competent authorities, in order to remedy the infringement and mitigate the possible adverse effects of the infringement;
(g) the degree of responsibility of the operator taking into account the technical and organisational measures implemented by it;
(g)
the degree of responsibility of the operator taking into account the technical and organisational measures implemented by it;
(h) the manner in which the infringement became known to the national competent authorities, in particular whether, and if so to what extent, the operator notified the infringement;
(h)
the manner in which the infringement became known to the national competent authorities, in particular whether, and if so to what extent, the operator notified the infringement;
(i) the intentional or negligent character of the infringement;
(i)
the intentional or negligent character of the infringement;
(j) any action taken by the operator to mitigate the harm suffered by the affected persons.
(j)
any action taken by the operator to mitigate the harm suffered by the affected persons.
8. Each Member State shall lay down rules on to what extent administrative fines may be imposed on public authorities and bodies established in that Member State.
9. Depending on the legal system of the Member States, the rules on administrative fines may be applied in such a manner that the fines are imposed by competent national courts or by other bodies, as applicable in those Member States. The application of such rules in those Member States shall have an equivalent effect.
10. The exercise of powers under this Article shall be subject to appropriate procedural safeguards in accordance with Union and national law, including effective judicial remedies and due process.
11. Member States shall, on an annual basis, report to the Commission about the administrative fines they have issued during that year, in accordance with this Article, and about any related litigation or judicial proceedings.
|
accordance term condition laid regulation member state shall lay rule penalty enforcement measure may also include warning non monetary measure applicable infringement regulation operator shall take measure necessary ensure properly effectively implemented thereby taking account guideline issued commission pursuant article penalty provided shall effective proportionate dissuasive shall take account interest smes including start ups economic viability member state shall without delay latest date entry application notify commission rule penalty enforcement measure referred paragraph shall notify without delay subsequent amendment non compliance prohibition practice referred article shall subject administrative fine eur 000 000 offender undertaking total worldwide annual turnover preceding financial year whichever higher non compliance following provision related operator notified body laid article shall subject administrative fine eur 000 000 offender undertaking total worldwide annual turnover preceding financial year whichever higher obligation provider pursuant article obligation provider pursuant article obligation authorised representative pursuant article obligation authorised representative pursuant article obligation importer pursuant article obligation importer pursuant article obligation distributor pursuant article obligation distributor pursuant article obligation deployers pursuant article obligation deployers pursuant article requirement obligation notified body pursuant article article article requirement obligation notified body pursuant article article article transparency obligation provider deployers pursuant article transparency obligation provider deployers pursuant article supply incorrect incomplete misleading information notified body national competent authority reply request shall subject administrative fine eur 500 000 offender undertaking total worldwide annual turnover preceding financial year whichever higher case smes including start ups fine referred article shall percentage amount referred paragraph whichever thereof lower deciding whether impose administrative fine deciding amount administrative fine individual case relevant circumstance specific situation shall taken account appropriate regard shall given following nature gravity duration infringement consequence taking account purpose system well appropriate number affected person level damage suffered nature gravity duration infringement consequence taking account purpose system well appropriate number affected person level damage suffered whether administrative fine already applied market surveillance authority operator infringement whether administrative fine already applied market surveillance authority operator infringement whether administrative fine already applied authority operator infringement union national law infringement result activity omission constituting relevant infringement regulation whether administrative fine already applied authority operator infringement union national law infringement result activity omission constituting relevant infringement regulation size annual turnover market share operator committing infringement size annual turnover market share operator committing infringement aggravating mitigating factor applicable circumstance case financial benefit gained loss avoided directly indirectly infringement aggravating mitigating factor applicable circumstance case financial benefit gained loss avoided directly indirectly infringement degree cooperation national competent authority order remedy infringement mitigate possible adverse effect infringement degree cooperation national competent authority order remedy infringement mitigate possible adverse effect infringement degree responsibility operator taking account technical organisational measure implemented degree responsibility operator taking account technical organisational measure implemented manner infringement became known national competent authority particular whether extent operator notified infringement manner infringement became known national competent authority particular whether extent operator notified infringement intentional negligent character infringement intentional negligent character infringement action taken operator mitigate harm suffered affected person action taken operator mitigate harm suffered affected person member state shall lay rule extent administrative fine may imposed public authority body established member state depending legal system member state rule administrative fine may applied manner fine imposed competent national court body applicable member state application rule member state shall equivalent effect exercise power article shall subject appropriate procedural safeguard accordance union national law including effective judicial remedy due process member state shall annual basis report commission administrative fine issued year accordance article related litigation judicial proceeding
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 100
|
1. The European Data Protection Supervisor may impose administrative fines on Union institutions, bodies, offices and agencies falling within the scope of this Regulation. When deciding whether to impose an administrative fine and when deciding on the amount of the administrative fine in each individual case, all relevant circumstances of the specific situation shall be taken into account and due regard shall be given to the following:
(a) the nature, gravity and duration of the infringement and of its consequences, taking into account the purpose of the AI system concerned, as well as, where appropriate, the number of affected persons and the level of damage suffered by them;
(a)
the nature, gravity and duration of the infringement and of its consequences, taking into account the purpose of the AI system concerned, as well as, where appropriate, the number of affected persons and the level of damage suffered by them;
(b) the degree of responsibility of the Union institution, body, office or agency, taking into account technical and organisational measures implemented by them;
(b)
the degree of responsibility of the Union institution, body, office or agency, taking into account technical and organisational measures implemented by them;
(c) any action taken by the Union institution, body, office or agency to mitigate the damage suffered by affected persons;
(c)
any action taken by the Union institution, body, office or agency to mitigate the damage suffered by affected persons;
(d) the degree of cooperation with the European Data Protection Supervisor in order to remedy the infringement and mitigate the possible adverse effects of the infringement, including compliance with any of the measures previously ordered by the European Data Protection Supervisor against the Union institution, body, office or agency concerned with regard to the same subject matter;
(d)
the degree of cooperation with the European Data Protection Supervisor in order to remedy the infringement and mitigate the possible adverse effects of the infringement, including compliance with any of the measures previously ordered by the European Data Protection Supervisor against the Union institution, body, office or agency concerned with regard to the same subject matter;
(e) any similar previous infringements by the Union institution, body, office or agency;
(e)
any similar previous infringements by the Union institution, body, office or agency;
(f) the manner in which the infringement became known to the European Data Protection Supervisor, in particular whether, and if so to what extent, the Union institution, body, office or agency notified the infringement;
(f)
the manner in which the infringement became known to the European Data Protection Supervisor, in particular whether, and if so to what extent, the Union institution, body, office or agency notified the infringement;
(g) the annual budget of the Union institution, body, office or agency.
(g)
the annual budget of the Union institution, body, office or agency.
2. Non-compliance with the prohibition of the AI practices referred to in Article 5 shall be subject to administrative fines of up to EUR 1 500 000.
3. The non-compliance of the AI system with any requirements or obligations under this Regulation, other than those laid down in Article 5, shall be subject to administrative fines of up to EUR 750 000.
4. Before taking decisions pursuant to this Article, the European Data Protection Supervisor shall give the Union institution, body, office or agency which is the subject of the proceedings conducted by the European Data Protection Supervisor the opportunity of being heard on the matter regarding the possible infringement. The European Data Protection Supervisor shall base his or her decisions only on elements and circumstances on which the parties concerned have been able to comment. Complainants, if any, shall be associated closely with the proceedings.
5. The rights of defence of the parties concerned shall be fully respected in the proceedings. They shall be entitled to have access to the European Data Protection Supervisor’s file, subject to the legitimate interest of individuals or undertakings in the protection of their personal data or business secrets.
6. Funds collected by imposition of fines in this Article shall contribute to the general budget of the Union. The fines shall not affect the effective operation of the Union institution, body, office or agency fined.
7. The European Data Protection Supervisor shall, on an annual basis, notify the Commission of the administrative fines it has imposed pursuant to this Article and of any litigation or judicial proceedings it has initiated.
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european data protection supervisor may impose administrative fine union institution body office agency falling within scope regulation deciding whether impose administrative fine deciding amount administrative fine individual case relevant circumstance specific situation shall taken account due regard shall given following nature gravity duration infringement consequence taking account purpose system concerned well appropriate number affected person level damage suffered nature gravity duration infringement consequence taking account purpose system concerned well appropriate number affected person level damage suffered degree responsibility union institution body office agency taking account technical organisational measure implemented degree responsibility union institution body office agency taking account technical organisational measure implemented action taken union institution body office agency mitigate damage suffered affected person action taken union institution body office agency mitigate damage suffered affected person degree cooperation european data protection supervisor order remedy infringement mitigate possible adverse effect infringement including compliance measure previously ordered european data protection supervisor union institution body office agency concerned regard subject matter degree cooperation european data protection supervisor order remedy infringement mitigate possible adverse effect infringement including compliance measure previously ordered european data protection supervisor union institution body office agency concerned regard subject matter similar previous infringement union institution body office agency similar previous infringement union institution body office agency manner infringement became known european data protection supervisor particular whether extent union institution body office agency notified infringement manner infringement became known european data protection supervisor particular whether extent union institution body office agency notified infringement annual budget union institution body office agency annual budget union institution body office agency non compliance prohibition practice referred article shall subject administrative fine eur 500 000 non compliance system requirement obligation regulation laid article shall subject administrative fine eur 750 000 taking decision pursuant article european data protection supervisor shall give union institution body office agency subject proceeding conducted european data protection supervisor opportunity heard matter regarding possible infringement european data protection supervisor shall base decision element circumstance party concerned able comment complainant shall associated closely proceeding right defence party concerned shall fully respected proceeding shall entitled access european data protection supervisor file subject legitimate interest individual undertaking protection personal data business secret fund collected imposition fine article shall contribute general budget union fine shall affect effective operation union institution body office agency fined european data protection supervisor shall annual basis notify commission administrative fine imposed pursuant article litigation judicial proceeding initiated
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 101
|
1. The Commission may impose on providers of general-purpose AI models fines not exceeding 3 % of their annual total worldwide turnover in the preceding financial year or EUR 15 000 000, whichever is higher., when the Commission finds that the provider intentionally or negligently:
(a) infringed the relevant provisions of this Regulation;
(a)
infringed the relevant provisions of this Regulation;
(b) failed to comply with a request for a document or for information pursuant to Article 91, or supplied incorrect, incomplete or misleading information;
(b)
failed to comply with a request for a document or for information pursuant to Article 91, or supplied incorrect, incomplete or misleading information;
(c) failed to comply with a measure requested under Article 93;
(c)
failed to comply with a measure requested under Article 93;
(d) failed to make available to the Commission access to the general-purpose AI model or general-purpose AI model with systemic risk with a view to conducting an evaluation pursuant to Article 92.
(d)
failed to make available to the Commission access to the general-purpose AI model or general-purpose AI model with systemic risk with a view to conducting an evaluation pursuant to Article 92.
In fixing the amount of the fine or periodic penalty payment, regard shall be had to the nature, gravity and duration of the infringement, taking due account of the principles of proportionality and appropriateness. The Commission shall also into account commitments made in accordance with Article 93(3) or made in relevant codes of practice in accordance with Article 56.
2. Before adopting the decision pursuant to paragraph 1, the Commission shall communicate its preliminary findings to the provider of the general-purpose AI model and give it an opportunity to be heard.
3. Fines imposed in accordance with this Article shall be effective, proportionate and dissuasive.
4. Information on fines imposed under this Article shall also be communicated to the Board as appropriate.
5. The Court of Justice of the European Union shall have unlimited jurisdiction to review decisions of the Commission fixing a fine under this Article. It may cancel, reduce or increase the fine imposed.
6. The Commission shall adopt implementing acts containing detailed arrangements and procedural safeguards for proceedings in view of the possible adoption of decisions pursuant to paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).
|
commission may impose provider general purpose model fine exceeding annual total worldwide turnover preceding financial year eur 000 000 whichever higher commission find provider intentionally negligently infringed relevant provision regulation infringed relevant provision regulation failed comply request document information pursuant article supplied incorrect incomplete misleading information failed comply request document information pursuant article supplied incorrect incomplete misleading information failed comply measure requested article failed comply measure requested article failed make available commission access general purpose model general purpose model systemic risk view conducting evaluation pursuant article failed make available commission access general purpose model general purpose model systemic risk view conducting evaluation pursuant article fixing amount fine periodic penalty payment regard shall nature gravity duration infringement taking due account principle proportionality appropriateness commission shall also account commitment made accordance article made relevant code practice accordance article adopting decision pursuant paragraph commission shall communicate preliminary finding provider general purpose model give opportunity heard fine imposed accordance article shall effective proportionate dissuasive information fine imposed article shall also communicated board appropriate court justice european union shall unlimited jurisdiction review decision commission fixing fine article may cancel reduce increase fine imposed commission shall adopt implementing act containing detailed arrangement procedural safeguard proceeding view possible adoption decision pursuant paragraph article implementing act shall adopted accordance examination procedure referred article
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 102
|
In Article 4(3) of Regulation (EC) No 300/2008, the following subparagraph is added:
‘When adopting detailed measures related to technical specifications and procedures for approval and use of security equipment concerning Artificial Intelligence systems within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council(), the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.
|
article regulation 300 2008 following subparagraph added adopting detailed measure related technical specification procedure approval use security equipment concerning artificial intelligence system within meaning regulation 2024 1689 european parliament council requirement set chapter iii section regulation shall taken account
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 103
|
In Article 17(5) of Regulation (EU) No 167/2013, the following subparagraph is added:
‘When adopting delegated acts pursuant to the first subparagraph concerning artificial intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council(), the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.
|
article regulation 167 2013 following subparagraph added adopting delegated act pursuant first subparagraph concerning artificial intelligence system safety component within meaning regulation 2024 1689 european parliament council requirement set chapter iii section regulation shall taken account
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 104
|
In Article 22(5) of Regulation (EU) No 168/2013, the following subparagraph is added:
‘When adopting delegated acts pursuant to the first subparagraph concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council(), the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.
|
article regulation 168 2013 following subparagraph added adopting delegated act pursuant first subparagraph concerning artificial intelligence system safety component within meaning regulation 2024 1689 european parliament council requirement set chapter iii section regulation shall taken account
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 105
|
In Article 8 of Directive 2014/90/EU, the following paragraph is added:
‘5. For Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council(), when carrying out its activities pursuant to paragraph 1 and when adopting technical specifications and testing standards in accordance with paragraphs 2 and 3, the Commission shall take into account the requirements set out in Chapter III, Section 2, of that Regulation.
|
article directive 2014 following paragraph added artificial intelligence system safety component within meaning regulation 2024 1689 european parliament council carrying activity pursuant paragraph adopting technical specification testing standard accordance paragraph commission shall take account requirement set chapter iii section regulation
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 106
|
In Article 5 of Directive (EU) 2016/797, the following paragraph is added:
‘12. When adopting delegated acts pursuant to paragraph 1 and implementing acts pursuant to paragraph 11 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council(), the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.
|
article directive 2016 797 following paragraph added adopting delegated act pursuant paragraph implementing act pursuant paragraph concerning artificial intelligence system safety component within meaning regulation 2024 1689 european parliament council requirement set chapter iii section regulation shall taken account
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 107
|
In Article 5 of Regulation (EU) 2018/858 the following paragraph is added:
‘4. When adopting delegated acts pursuant to paragraph 3 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council(), the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.
|
article regulation 2018 858 following paragraph added adopting delegated act pursuant paragraph concerning artificial intelligence system safety component within meaning regulation 2024 1689 european parliament council requirement set chapter iii section regulation shall taken account
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 108
|
Regulation (EU) 2018/1139 is amended as follows:
(1) in Article 17, the following paragraph is added: ‘3. Without prejudice to paragraph 2, when adopting implementing acts pursuant to paragraph 1 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council(), the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.
(1)
in Article 17, the following paragraph is added:
‘3. Without prejudice to paragraph 2, when adopting implementing acts pursuant to paragraph 1 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council(), the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.
(2) in Article 19, the following paragraph is added: ‘4. When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.’
(2)
in Article 19, the following paragraph is added:
‘4. When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.’
(3) in Article 43, the following paragraph is added: ‘4. When adopting implementing acts pursuant to paragraph 1 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.’
(3)
in Article 43, the following paragraph is added:
‘4. When adopting implementing acts pursuant to paragraph 1 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.’
(4) in Article 47, the following paragraph is added: ‘3. When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.’
(4)
in Article 47, the following paragraph is added:
‘3. When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.’
(5) in Article 57, the following subparagraph is added: ‘When adopting those implementing acts concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.’
(5)
in Article 57, the following subparagraph is added:
‘When adopting those implementing acts concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.’
(6) in Article 58, the following paragraph is added: ‘3. When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.’.
(6)
in Article 58, the following paragraph is added:
‘3. When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.’.
|
regulation 2018 1139 amended follows article following paragraph added without prejudice paragraph adopting implementing act pursuant paragraph concerning artificial intelligence system safety component within meaning regulation 2024 1689 european parliament council requirement set chapter iii section regulation shall taken account article following paragraph added without prejudice paragraph adopting implementing act pursuant paragraph concerning artificial intelligence system safety component within meaning regulation 2024 1689 european parliament council requirement set chapter iii section regulation shall taken account article following paragraph added adopting delegated act pursuant paragraph concerning artificial intelligence system safety component within meaning regulation 2024 1689 requirement set chapter iii section regulation shall taken account article following paragraph added adopting delegated act pursuant paragraph concerning artificial intelligence system safety component within meaning regulation 2024 1689 requirement set chapter iii section regulation shall taken account article following paragraph added adopting implementing act pursuant paragraph concerning artificial intelligence system safety component within meaning regulation 2024 1689 requirement set chapter iii section regulation shall taken account article following paragraph added adopting implementing act pursuant paragraph concerning artificial intelligence system safety component within meaning regulation 2024 1689 requirement set chapter iii section regulation shall taken account article following paragraph added adopting delegated act pursuant paragraph concerning artificial intelligence system safety component within meaning regulation 2024 1689 requirement set chapter iii section regulation shall taken account article following paragraph added adopting delegated act pursuant paragraph concerning artificial intelligence system safety component within meaning regulation 2024 1689 requirement set chapter iii section regulation shall taken account article following subparagraph added adopting implementing act concerning artificial intelligence system safety component within meaning regulation 2024 1689 requirement set chapter iii section regulation shall taken account article following subparagraph added adopting implementing act concerning artificial intelligence system safety component within meaning regulation 2024 1689 requirement set chapter iii section regulation shall taken account article following paragraph added adopting delegated act pursuant paragraph concerning artificial intelligence system safety component within meaning regulation 2024 1689 requirement set chapter iii section regulation shall taken account article following paragraph added adopting delegated act pursuant paragraph concerning artificial intelligence system safety component within meaning regulation 2024 1689 requirement set chapter iii section regulation shall taken account
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 109
|
In Article 11 of Regulation (EU) 2019/2144, the following paragraph is added:
‘3. When adopting the implementing acts pursuant to paragraph 2, concerning artificial intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council(), the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.
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article regulation 2019 2144 following paragraph added adopting implementing act pursuant paragraph concerning artificial intelligence system safety component within meaning regulation 2024 1689 european parliament council requirement set chapter iii section regulation shall taken account
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] |
all-MiniLM-L6-v2
| 384 |
Article 110
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In Annex I to Directive (EU) 2020/1828 of the European Parliament and of the Council(), the following point is added:
‘(68) Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj).’.
‘(68)
Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj).’.
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annex directive 2020 1828 european parliament council following point added regulation 2024 1689 european parliament council june 2024 laying harmonised rule artificial intelligence amending regulation 300 2008 167 2013 168 2013 2018 858 2018 1139 2019 2144 directive 2014 2016 797 2020 1828 artificial intelligence act 2024 1689 2024 eli http data europa eli reg 2024 1689 regulation 2024 1689 european parliament council june 2024 laying harmonised rule artificial intelligence amending regulation 300 2008 167 2013 168 2013 2018 858 2018 1139 2019 2144 directive 2014 2016 797 2020 1828 artificial intelligence act 2024 1689 2024 eli http data europa eli reg 2024 1689
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] |
all-MiniLM-L6-v2
| 384 |
Article 111
|
1. Without prejudice to the application of Article 5 as referred to in Article 113(3), point (a), AI systems which are components of the large-scale IT systems established by the legal acts listed in Annex X that have been placed on the market or put into service before 2 August 2027 shall be brought into compliance with this Regulation by 31 December 2030.
The requirements laid down in this Regulation shall be taken into account in the evaluation of each large-scale IT system established by the legal acts listed in Annex X to be undertaken as provided for in those legal acts and where those legal acts are replaced or amended.
2. Without prejudice to the application of Article 5 as referred to in Article 113(3), point (a), this Regulation shall apply to operators of high-risk AI systems, other than the systems referred to in paragraph 1 of this Article, that have been placed on the market or put into service before 2 August 2026, only if, as from that date, those systems are subject to significant changes in their designs. In any case, the providers and deployers of high-risk AI systems intended to be used by public authorities shall take the necessary steps to comply with the requirements and obligations of this Regulation by 2 August 2030.
3. Providers of general-purpose AI models that have been placed on the market before 2 August 2025 shall take the necessary steps in order to comply with the obligations laid down in this Regulation by 2 August 2027.
|
without prejudice application article referred article 113 point system component large scale system established legal act listed annex placed market put service august 2027 shall brought compliance regulation december 2030 requirement laid regulation shall taken account evaluation large scale system established legal act listed annex undertaken provided legal act legal act replaced amended without prejudice application article referred article 113 point regulation shall apply operator high risk system system referred paragraph article placed market put service august 2026 date system subject significant change design case provider deployers high risk system intended used public authority shall take necessary step comply requirement obligation regulation august 2030 provider general purpose model placed market august 2025 shall take necessary step order comply obligation laid regulation august 2027
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 112
|
1. The Commission shall assess the need for amendment of the list set out in Annex III and of the list of prohibited AI practices laid down in Article 5, once a year following the entry into force of this Regulation, and until the end of the period of the delegation of power laid down in Article 97. The Commission shall submit the findings of that assessment to the European Parliament and the Council.
2. By 2 August 2028 and every four years thereafter, the Commission shall evaluate and report to the European Parliament and to the Council on the following:
(a) the need for amendments extending existing area headings or adding new area headings in Annex III;
(a)
the need for amendments extending existing area headings or adding new area headings in Annex III;
(b) amendments to the list of AI systems requiring additional transparency measures in Article 50;
(b)
amendments to the list of AI systems requiring additional transparency measures in Article 50;
(c) amendments enhancing the effectiveness of the supervision and governance system.
(c)
amendments enhancing the effectiveness of the supervision and governance system.
3. By 2 August 2029 and every four years thereafter, the Commission shall submit a report on the evaluation and review of this Regulation to the European Parliament and to the Council. The report shall include an assessment with regard to the structure of enforcement and the possible need for a Union agency to resolve any identified shortcomings. On the basis of the findings, that report shall, where appropriate, be accompanied by a proposal for amendment of this Regulation. The reports shall be made public.
4. The reports referred to in paragraph 2 shall pay specific attention to the following:
(a) the status of the financial, technical and human resources of the national competent authorities in order to effectively perform the tasks assigned to them under this Regulation;
(a)
the status of the financial, technical and human resources of the national competent authorities in order to effectively perform the tasks assigned to them under this Regulation;
(b) the state of penalties, in particular administrative fines as referred to in Article 99(1), applied by Member States for infringements of this Regulation;
(b)
the state of penalties, in particular administrative fines as referred to in Article 99(1), applied by Member States for infringements of this Regulation;
(c) adopted harmonised standards and common specifications developed to support this Regulation;
(c)
adopted harmonised standards and common specifications developed to support this Regulation;
(d) the number of undertakings that enter the market after the entry into application of this Regulation, and how many of them are SMEs.
(d)
the number of undertakings that enter the market after the entry into application of this Regulation, and how many of them are SMEs.
5. By 2 August 2028, the Commission shall evaluate the functioning of the AI Office, whether the AI Office has been given sufficient powers and competences to fulfil its tasks, and whether it would be relevant and needed for the proper implementation and enforcement of this Regulation to upgrade the AI Office and its enforcement competences and to increase its resources. The Commission shall submit a report on its evaluation to the European Parliament and to the Council.
6. By 2 August 2028 and every four years thereafter, the Commission shall submit a report on the review of the progress on the development of standardisation deliverables on the energy-efficient development of general-purpose AI models, and asses the need for further measures or actions, including binding measures or actions. The report shall be submitted to the European Parliament and to the Council, and it shall be made public.
7. By 2 August 2028 and every three years thereafter, the Commission shall evaluate the impact and effectiveness of voluntary codes of conduct to foster the application of the requirements set out in Chapter III, Section 2 for AI systems other than high-risk AI systems and possibly other additional requirements for AI systems other than high-risk AI systems, including as regards environmental sustainability.
8. For the purposes of paragraphs 1 to 7, the Board, the Member States and national competent authorities shall provide the Commission with information upon its request and without undue delay.
9. In carrying out the evaluations and reviews referred to in paragraphs 1 to 7, the Commission shall take into account the positions and findings of the Board, of the European Parliament, of the Council, and of other relevant bodies or sources.
10. The Commission shall, if necessary, submit appropriate proposals to amend this Regulation, in particular taking into account developments in technology, the effect of AI systems on health and safety, and on fundamental rights, and in light of the state of progress in the information society.
11. To guide the evaluations and reviews referred to in paragraphs 1 to 7 of this Article, the AI Office shall undertake to develop an objective and participative methodology for the evaluation of risk levels based on the criteria outlined in the relevant Articles and the inclusion of new systems in:
(a) the list set out in Annex III, including the extension of existing area headings or the addition of new area headings in that Annex;
(a)
the list set out in Annex III, including the extension of existing area headings or the addition of new area headings in that Annex;
(b) the list of prohibited practices set out in Article 5; and
(b)
the list of prohibited practices set out in Article 5; and
(c) the list of AI systems requiring additional transparency measures pursuant to Article 50.
(c)
the list of AI systems requiring additional transparency measures pursuant to Article 50.
12. Any amendment to this Regulation pursuant to paragraph 10, or relevant delegated or implementing acts, which concerns sectoral Union harmonisation legislation listed in Section B of Annex I shall take into account the regulatory specificities of each sector, and the existing governance, conformity assessment and enforcement mechanisms and authorities established therein.
13. By 2 August 2031, the Commission shall carry out an assessment of the enforcement of this Regulation and shall report on it to the European Parliament, the Council and the European Economic and Social Committee, taking into account the first years of application of this Regulation. On the basis of the findings, that report shall, where appropriate, be accompanied by a proposal for amendment of this Regulation with regard to the structure of enforcement and the need for a Union agency to resolve any identified shortcomings.
|
commission shall assess need amendment list set annex iii list prohibited practice laid article year following entry force regulation end period delegation power laid article commission shall submit finding assessment european parliament council august 2028 every four year thereafter commission shall evaluate report european parliament council following need amendment extending existing area heading adding new area heading annex iii need amendment extending existing area heading adding new area heading annex iii amendment list system requiring additional transparency measure article amendment list system requiring additional transparency measure article amendment enhancing effectiveness supervision governance system amendment enhancing effectiveness supervision governance system august 2029 every four year thereafter commission shall submit report evaluation review regulation european parliament council report shall include assessment regard structure enforcement possible need union agency resolve identified shortcoming basis finding report shall appropriate accompanied proposal amendment regulation report shall made public report referred paragraph shall pay specific attention following status financial technical human resource national competent authority order effectively perform task assigned regulation status financial technical human resource national competent authority order effectively perform task assigned regulation state penalty particular administrative fine referred article applied member state infringement regulation state penalty particular administrative fine referred article applied member state infringement regulation adopted harmonised standard common specification developed support regulation adopted harmonised standard common specification developed support regulation number undertaking enter market entry application regulation many smes number undertaking enter market entry application regulation many smes august 2028 commission shall evaluate functioning office whether office given sufficient power competence fulfil task whether would relevant needed proper implementation enforcement regulation upgrade office enforcement competence increase resource commission shall submit report evaluation european parliament council august 2028 every four year thereafter commission shall submit report review progress development standardisation deliverable energy efficient development general purpose model ass need measure action including binding measure action report shall submitted european parliament council shall made public august 2028 every three year thereafter commission shall evaluate impact effectiveness voluntary code conduct foster application requirement set chapter iii section system high risk system possibly additional requirement system high risk system including regard environmental sustainability purpose paragraph board member state national competent authority shall provide commission information upon request without undue delay carrying evaluation review referred paragraph commission shall take account position finding board european parliament council relevant body source commission shall necessary submit appropriate proposal amend regulation particular taking account development technology effect system health safety fundamental right light state progress information society guide evaluation review referred paragraph article office shall undertake develop objective participative methodology evaluation risk level based criterion outlined relevant article inclusion new system list set annex iii including extension existing area heading addition new area heading annex list set annex iii including extension existing area heading addition new area heading annex list prohibited practice set article list prohibited practice set article list system requiring additional transparency measure pursuant article list system requiring additional transparency measure pursuant article amendment regulation pursuant paragraph relevant delegated implementing act concern sectoral union harmonisation legislation listed section annex shall take account regulatory specificity sector existing governance conformity assessment enforcement mechanism authority established therein august 2031 commission shall carry assessment enforcement regulation shall report european parliament council european economic social committee taking account first year application regulation basis finding report shall appropriate accompanied proposal amendment regulation regard structure enforcement need union agency resolve identified shortcoming
|
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] |
all-MiniLM-L6-v2
| 384 |
Article 113
|
This Regulation shall enter into force on the twentieth day following that of its publication in theOfficial Journal of the European Union.
It shall apply from 2 August 2026.
However:
(a) Chapters I and II shall apply from 2 February 2025;
(a)
Chapters I and II shall apply from 2 February 2025;
(b) Chapter III Section 4, Chapter V, Chapter VII and Chapter XII and Article 78 shall apply from 2 August 2025, with the exception of Article 101;
(b)
Chapter III Section 4, Chapter V, Chapter VII and Chapter XII and Article 78 shall apply from 2 August 2025, with the exception of Article 101;
(c) Article 6(1) and the corresponding obligations in this Regulation shall apply from 2 August 2027.
(c)
Article 6(1) and the corresponding obligations in this Regulation shall apply from 2 August 2027.
|
regulation shall enter force twentieth day following publication theofficial journal european union shall apply august 2026 however chapter shall apply february 2025 chapter shall apply february 2025 chapter iii section chapter chapter vii chapter xii article shall apply august 2025 exception article 101 chapter iii section chapter chapter vii chapter xii article shall apply august 2025 exception article 101 article corresponding obligation regulation shall apply august 2027 article corresponding obligation regulation shall apply august 2027
|
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] |
all-MiniLM-L6-v2
| 384 |
Annex I
|
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
|
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] |
all-MiniLM-L6-v2
| 384 |
|
Annex II
|
Criminal offences referred to in Article 5(1), first subparagraph, point (h)(iii):
—
terrorism,
—
trafficking in human beings,
—
sexual exploitation of children, and child pornography,
—
illicit trafficking in narcotic drugs or psychotropic substances,
—
illicit trafficking in weapons, munitions or explosives,
—
murder, grievous bodily injury,
—
illicit trade in human organs or tissue,
—
illicit trafficking in nuclear or radioactive materials,
—
kidnapping, illegal restraint or hostage-taking,
—
crimes within the jurisdiction of the International Criminal Court,
—
unlawful seizure of aircraft or ships,
—
rape,
—
environmental crime,
—
organised or armed robbery,
—
sabotage,
—
participation in a criminal organisation involved in one or more of the offences listed above.
— terrorism,
— trafficking in human beings,
— sexual exploitation of children, and child pornography,
— illicit trafficking in narcotic drugs or psychotropic substances,
— illicit trafficking in weapons, munitions or explosives,
— murder, grievous bodily injury,
— illicit trade in human organs or tissue,
— illicit trafficking in nuclear or radioactive materials,
— kidnapping, illegal restraint or hostage-taking,
— crimes within the jurisdiction of the International Criminal Court,
— unlawful seizure of aircraft or ships,
— rape,
— environmental crime,
— organised or armed robbery,
— sabotage,
— participation in a criminal organisation involved in one or more of the offences listed above.
|
criminal offence referred article first subparagraph point iii terrorism trafficking human being sexual exploitation child child pornography illicit trafficking narcotic drug psychotropic substance illicit trafficking weapon munition explosive murder grievous bodily injury illicit trade human organ tissue illicit trafficking nuclear radioactive material kidnapping illegal restraint hostage taking crime within jurisdiction international criminal court unlawful seizure aircraft ship rape environmental crime organised armed robbery sabotage participation criminal organisation involved one offence listed terrorism trafficking human being sexual exploitation child child pornography illicit trafficking narcotic drug psychotropic substance illicit trafficking weapon munition explosive murder grievous bodily injury illicit trade human organ tissue illicit trafficking nuclear radioactive material kidnapping illegal restraint hostage taking crime within jurisdiction international criminal court unlawful seizure aircraft ship rape environmental crime organised armed robbery sabotage participation criminal organisation involved one offence listed
|
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] |
all-MiniLM-L6-v2
| 384 |
Annex III
|
High-risk AI systems pursuant to Article 6(2) are the AI systems listed in any of the following areas:
1.
Biometrics, in so far as their use is permitted under relevant Union or national law:
(a)
remote biometric identification systems.
This shall not include AI systems intended to be used for biometric verification the sole purpose of which is to confirm that a specific natural person is the person he or she claims to be;
(b)
AI systems intended to be used for biometric categorisation, according to sensitive or protected attributes or characteristics based on the inference of those attributes or characteristics;
(c)
AI systems intended to be used for emotion recognition.
2.
Critical infrastructure: AI systems intended to be used as safety components in the management and operation of critical digital infrastructure, road traffic, or in the supply of water, gas, heating or electricity.
3.
Education and vocational training:
(a)
AI systems intended to be used to determine access or admission or to assign natural persons to educational and vocational training institutions at all levels;
(b)
AI systems intended to be used to evaluate learning outcomes, including when those outcomes are used to steer the learning process of natural persons in educational and vocational training institutions at all levels;
(c)
AI systems intended to be used for the purpose of assessing the appropriate level of education that an individual will receive or will be able to access, in the context of or within educational and vocational training institutions at all levels;
(d)
AI systems intended to be used for monitoring and detecting prohibited behaviour of students during tests in the context of or within educational and vocational training institutions at all levels.
4.
Employment, workers’ management and access to self-employment:
(a)
AI systems intended to be used for the recruitment or selection of natural persons, in particular to place targeted job advertisements, to analyse and filter job applications, and to evaluate candidates;
(b)
AI systems intended to be used to make decisions affecting terms of work-related relationships, the promotion or termination of work-related contractual relationships, to allocate tasks based on individual behaviour or personal traits or characteristics or to monitor and evaluate the performance and behaviour of persons in such relationships.
5.
Access to and enjoyment of essential private services and essential public services and benefits:
(a)
AI systems intended to be used by public authorities or on behalf of public authorities to evaluate the eligibility of natural persons for essential public assistance benefits and services, including healthcare services, as well as to grant, reduce, revoke, or reclaim such benefits and services;
(b)
AI systems intended to be used to evaluate the creditworthiness of natural persons or establish their credit score, with the exception of AI systems used for the purpose of detecting financial fraud;
(c)
AI systems intended to be used for risk assessment and pricing in relation to natural persons in the case of life and health insurance;
(d)
AI systems intended to evaluate and classify emergency calls by natural persons or to be used to dispatch, or to establish priority in the dispatching of, emergency first response services, including by police, firefighters and medical aid, as well as of emergency healthcare patient triage systems.
6.
Law enforcement, in so far as their use is permitted under relevant Union or national law:
(a)
AI systems intended to be used by or on behalf of law enforcement authorities, or by Union institutions, bodies, offices or agencies in support of law enforcement authorities or on their behalf to assess the risk of a natural person becoming the victim of criminal offences;
(b)
AI systems intended to be used by or on behalf of law enforcement authorities or by Union institutions, bodies, offices or agencies in support of law enforcement authorities as polygraphs or similar tools;
(c)
AI systems intended to be used by or on behalf of law enforcement authorities, or by Union institutions, bodies, offices or agencies, in support of law enforcement authorities to evaluate the reliability of evidence in the course of the investigation or prosecution of criminal offences;
(d)
AI systems intended to be used by law enforcement authorities or on their behalf or by Union institutions, bodies, offices or agencies in support of law enforcement authorities for assessing the risk of a natural person offending or re-offending not solely on the basis of the profiling of natural persons as referred to in Article 3(4) of Directive (EU) 2016/680, or to assess personality traits and characteristics or past criminal behaviour of natural persons or groups;
(e)
AI systems intended to be used by or on behalf of law enforcement authorities or by Union institutions, bodies, offices or agencies in support of law enforcement authorities for the profiling of natural persons as referred to in Article 3(4) of Directive (EU) 2016/680 in the course of the detection, investigation or prosecution of criminal offences.
7.
Migration, asylum and border control management, in so far as their use is permitted under relevant Union or national law:
(a)
AI systems intended to be used by or on behalf of competent public authorities or by Union institutions, bodies, offices or agencies as polygraphs or similar tools;
(b)
AI systems intended to be used by or on behalf of competent public authorities or by Union institutions, bodies, offices or agencies to assess a risk, including a security risk, a risk of irregular migration, or a health risk, posed by a natural person who intends to enter or who has entered into the territory of a Member State;
(c)
AI systems intended to be used by or on behalf of competent public authorities or by Union institutions, bodies, offices or agencies to assist competent public authorities for the examination of applications for asylum, visa or residence permits and for associated complaints with regard to the eligibility of the natural persons applying for a status, including related assessments of the reliability of evidence;
(d)
AI systems intended to be used by or on behalf of competent public authorities, or by Union institutions, bodies, offices or agencies, in the context of migration, asylum or border control management, for the purpose of detecting, recognising or identifying natural persons, with the exception of the verification of travel documents.
8.
Administration of justice and democratic processes:
(a)
AI systems intended to be used by a judicial authority or on their behalf to assist a judicial authority in researching and interpreting facts and the law and in applying the law to a concrete set of facts, or to be used in a similar way in alternative dispute resolution;
(b)
AI systems intended to be used for influencing the outcome of an election or referendum or the voting behaviour of natural persons in the exercise of their vote in elections or referenda. This does not include AI systems to the output of which natural persons are not directly exposed, such as tools used to organise, optimise or structure political campaigns from an administrative or logistical point of view.
1. Biometrics, in so far as their use is permitted under relevant Union or national law: (a) remote biometric identification systems. This shall not include AI systems intended to be used for biometric verification the sole purpose of which is to confirm that a specific natural person is the person he or she claims to be; (b) AI systems intended to be used for biometric categorisation, according to sensitive or protected attributes or characteristics based on the inference of those attributes or characteristics; (c) AI systems intended to be used for emotion recognition.
(a) remote biometric identification systems. This shall not include AI systems intended to be used for biometric verification the sole purpose of which is to confirm that a specific natural person is the person he or she claims to be;
(b) AI systems intended to be used for biometric categorisation, according to sensitive or protected attributes or characteristics based on the inference of those attributes or characteristics;
(c) AI systems intended to be used for emotion recognition.
2. Critical infrastructure: AI systems intended to be used as safety components in the management and operation of critical digital infrastructure, road traffic, or in the supply of water, gas, heating or electricity.
3. Education and vocational training: (a) AI systems intended to be used to determine access or admission or to assign natural persons to educational and vocational training institutions at all levels; (b) AI systems intended to be used to evaluate learning outcomes, including when those outcomes are used to steer the learning process of natural persons in educational and vocational training institutions at all levels; (c) AI systems intended to be used for the purpose of assessing the appropriate level of education that an individual will receive or will be able to access, in the context of or within educational and vocational training institutions at all levels; (d) AI systems intended to be used for monitoring and detecting prohibited behaviour of students during tests in the context of or within educational and vocational training institutions at all levels.
(a) AI systems intended to be used to determine access or admission or to assign natural persons to educational and vocational training institutions at all levels;
(b) AI systems intended to be used to evaluate learning outcomes, including when those outcomes are used to steer the learning process of natural persons in educational and vocational training institutions at all levels;
(c) AI systems intended to be used for the purpose of assessing the appropriate level of education that an individual will receive or will be able to access, in the context of or within educational and vocational training institutions at all levels;
(d) AI systems intended to be used for monitoring and detecting prohibited behaviour of students during tests in the context of or within educational and vocational training institutions at all levels.
4. Employment, workers’ management and access to self-employment: (a) AI systems intended to be used for the recruitment or selection of natural persons, in particular to place targeted job advertisements, to analyse and filter job applications, and to evaluate candidates; (b) AI systems intended to be used to make decisions affecting terms of work-related relationships, the promotion or termination of work-related contractual relationships, to allocate tasks based on individual behaviour or personal traits or characteristics or to monitor and evaluate the performance and behaviour of persons in such relationships.
(a) AI systems intended to be used for the recruitment or selection of natural persons, in particular to place targeted job advertisements, to analyse and filter job applications, and to evaluate candidates;
(b) AI systems intended to be used to make decisions affecting terms of work-related relationships, the promotion or termination of work-related contractual relationships, to allocate tasks based on individual behaviour or personal traits or characteristics or to monitor and evaluate the performance and behaviour of persons in such relationships.
5. Access to and enjoyment of essential private services and essential public services and benefits: (a) AI systems intended to be used by public authorities or on behalf of public authorities to evaluate the eligibility of natural persons for essential public assistance benefits and services, including healthcare services, as well as to grant, reduce, revoke, or reclaim such benefits and services; (b) AI systems intended to be used to evaluate the creditworthiness of natural persons or establish their credit score, with the exception of AI systems used for the purpose of detecting financial fraud; (c) AI systems intended to be used for risk assessment and pricing in relation to natural persons in the case of life and health insurance; (d) AI systems intended to evaluate and classify emergency calls by natural persons or to be used to dispatch, or to establish priority in the dispatching of, emergency first response services, including by police, firefighters and medical aid, as well as of emergency healthcare patient triage systems.
(a) AI systems intended to be used by public authorities or on behalf of public authorities to evaluate the eligibility of natural persons for essential public assistance benefits and services, including healthcare services, as well as to grant, reduce, revoke, or reclaim such benefits and services;
(b) AI systems intended to be used to evaluate the creditworthiness of natural persons or establish their credit score, with the exception of AI systems used for the purpose of detecting financial fraud;
(c) AI systems intended to be used for risk assessment and pricing in relation to natural persons in the case of life and health insurance;
(d) AI systems intended to evaluate and classify emergency calls by natural persons or to be used to dispatch, or to establish priority in the dispatching of, emergency first response services, including by police, firefighters and medical aid, as well as of emergency healthcare patient triage systems.
6. Law enforcement, in so far as their use is permitted under relevant Union or national law: (a) AI systems intended to be used by or on behalf of law enforcement authorities, or by Union institutions, bodies, offices or agencies in support of law enforcement authorities or on their behalf to assess the risk of a natural person becoming the victim of criminal offences; (b) AI systems intended to be used by or on behalf of law enforcement authorities or by Union institutions, bodies, offices or agencies in support of law enforcement authorities as polygraphs or similar tools; (c) AI systems intended to be used by or on behalf of law enforcement authorities, or by Union institutions, bodies, offices or agencies, in support of law enforcement authorities to evaluate the reliability of evidence in the course of the investigation or prosecution of criminal offences; (d) AI systems intended to be used by law enforcement authorities or on their behalf or by Union institutions, bodies, offices or agencies in support of law enforcement authorities for assessing the risk of a natural person offending or re-offending not solely on the basis of the profiling of natural persons as referred to in Article 3(4) of Directive (EU) 2016/680, or to assess personality traits and characteristics or past criminal behaviour of natural persons or groups; (e) AI systems intended to be used by or on behalf of law enforcement authorities or by Union institutions, bodies, offices or agencies in support of law enforcement authorities for the profiling of natural persons as referred to in Article 3(4) of Directive (EU) 2016/680 in the course of the detection, investigation or prosecution of criminal offences.
(a) AI systems intended to be used by or on behalf of law enforcement authorities, or by Union institutions, bodies, offices or agencies in support of law enforcement authorities or on their behalf to assess the risk of a natural person becoming the victim of criminal offences;
(b) AI systems intended to be used by or on behalf of law enforcement authorities or by Union institutions, bodies, offices or agencies in support of law enforcement authorities as polygraphs or similar tools;
(c) AI systems intended to be used by or on behalf of law enforcement authorities, or by Union institutions, bodies, offices or agencies, in support of law enforcement authorities to evaluate the reliability of evidence in the course of the investigation or prosecution of criminal offences;
(d) AI systems intended to be used by law enforcement authorities or on their behalf or by Union institutions, bodies, offices or agencies in support of law enforcement authorities for assessing the risk of a natural person offending or re-offending not solely on the basis of the profiling of natural persons as referred to in Article 3(4) of Directive (EU) 2016/680, or to assess personality traits and characteristics or past criminal behaviour of natural persons or groups;
(e) AI systems intended to be used by or on behalf of law enforcement authorities or by Union institutions, bodies, offices or agencies in support of law enforcement authorities for the profiling of natural persons as referred to in Article 3(4) of Directive (EU) 2016/680 in the course of the detection, investigation or prosecution of criminal offences.
7. Migration, asylum and border control management, in so far as their use is permitted under relevant Union or national law: (a) AI systems intended to be used by or on behalf of competent public authorities or by Union institutions, bodies, offices or agencies as polygraphs or similar tools; (b) AI systems intended to be used by or on behalf of competent public authorities or by Union institutions, bodies, offices or agencies to assess a risk, including a security risk, a risk of irregular migration, or a health risk, posed by a natural person who intends to enter or who has entered into the territory of a Member State; (c) AI systems intended to be used by or on behalf of competent public authorities or by Union institutions, bodies, offices or agencies to assist competent public authorities for the examination of applications for asylum, visa or residence permits and for associated complaints with regard to the eligibility of the natural persons applying for a status, including related assessments of the reliability of evidence; (d) AI systems intended to be used by or on behalf of competent public authorities, or by Union institutions, bodies, offices or agencies, in the context of migration, asylum or border control management, for the purpose of detecting, recognising or identifying natural persons, with the exception of the verification of travel documents.
(a) AI systems intended to be used by or on behalf of competent public authorities or by Union institutions, bodies, offices or agencies as polygraphs or similar tools;
(b) AI systems intended to be used by or on behalf of competent public authorities or by Union institutions, bodies, offices or agencies to assess a risk, including a security risk, a risk of irregular migration, or a health risk, posed by a natural person who intends to enter or who has entered into the territory of a Member State;
(c) AI systems intended to be used by or on behalf of competent public authorities or by Union institutions, bodies, offices or agencies to assist competent public authorities for the examination of applications for asylum, visa or residence permits and for associated complaints with regard to the eligibility of the natural persons applying for a status, including related assessments of the reliability of evidence;
(d) AI systems intended to be used by or on behalf of competent public authorities, or by Union institutions, bodies, offices or agencies, in the context of migration, asylum or border control management, for the purpose of detecting, recognising or identifying natural persons, with the exception of the verification of travel documents.
8. Administration of justice and democratic processes: (a) AI systems intended to be used by a judicial authority or on their behalf to assist a judicial authority in researching and interpreting facts and the law and in applying the law to a concrete set of facts, or to be used in a similar way in alternative dispute resolution; (b) AI systems intended to be used for influencing the outcome of an election or referendum or the voting behaviour of natural persons in the exercise of their vote in elections or referenda. This does not include AI systems to the output of which natural persons are not directly exposed, such as tools used to organise, optimise or structure political campaigns from an administrative or logistical point of view.
(a) AI systems intended to be used by a judicial authority or on their behalf to assist a judicial authority in researching and interpreting facts and the law and in applying the law to a concrete set of facts, or to be used in a similar way in alternative dispute resolution;
(b) AI systems intended to be used for influencing the outcome of an election or referendum or the voting behaviour of natural persons in the exercise of their vote in elections or referenda. This does not include AI systems to the output of which natural persons are not directly exposed, such as tools used to organise, optimise or structure political campaigns from an administrative or logistical point of view.
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high risk system pursuant article system listed following area biometrics far use permitted relevant union national law remote biometric identification system shall include system intended used biometric verification sole purpose confirm specific natural person person claim system intended used biometric categorisation according sensitive protected attribute characteristic based inference attribute characteristic system intended used emotion recognition critical infrastructure system intended used safety component management operation critical digital infrastructure road traffic supply water gas heating electricity education vocational training system intended used determine access admission assign natural person educational vocational training institution level system intended used evaluate learning outcome including outcome used steer learning process natural person educational vocational training institution level system intended used purpose assessing appropriate level education individual receive able access context within educational vocational training institution level system intended used monitoring detecting prohibited behaviour student test context within educational vocational training institution level employment worker management access self employment system intended used recruitment selection natural person particular place targeted job advertisement analyse filter job application evaluate candidate system intended used make decision affecting term work related relationship promotion termination work related contractual relationship allocate task based individual behaviour personal trait characteristic monitor evaluate performance behaviour person relationship access enjoyment essential private service essential public service benefit system intended used public authority behalf public authority evaluate eligibility natural person essential public assistance benefit service including healthcare service well grant reduce revoke reclaim benefit service system intended used evaluate creditworthiness natural person establish credit score exception system used purpose detecting financial fraud system intended used risk assessment pricing relation natural person case life health insurance system intended evaluate classify emergency call natural person used dispatch establish priority dispatching emergency first response service including police firefighter medical aid well emergency healthcare patient triage system law enforcement far use permitted relevant union national law system intended used behalf law enforcement authority union institution body office agency support law enforcement authority behalf assess risk natural person becoming victim criminal offence system intended used behalf law enforcement authority union institution body office agency support law enforcement authority polygraph similar tool system intended used behalf law enforcement authority union institution body office agency support law enforcement authority evaluate reliability evidence course investigation prosecution criminal offence system intended used law enforcement authority behalf union institution body office agency support law enforcement authority assessing risk natural person offending offending solely basis profiling natural person referred article directive 2016 680 assess personality trait characteristic past criminal behaviour natural person group system intended used behalf law enforcement authority union institution body office agency support law enforcement authority profiling natural person referred article directive 2016 680 course detection investigation prosecution criminal offence migration asylum border control management far use permitted relevant union national law system intended used behalf competent public authority union institution body office agency polygraph similar tool system intended used behalf competent public authority union institution body office agency assess risk including security risk risk irregular migration health risk posed natural person intends enter entered territory member state system intended used behalf competent public authority union institution body office agency assist competent public authority examination application asylum visa residence permit associated complaint regard eligibility natural person applying status including related assessment reliability evidence system intended used behalf competent public authority union institution body office agency context migration asylum border control management purpose detecting recognising identifying natural person exception verification travel document administration justice democratic process system intended used judicial authority behalf assist judicial authority researching interpreting fact law applying law concrete set fact used similar way alternative dispute resolution system intended used influencing outcome election referendum voting behaviour natural person exercise vote election referendum include system output natural person directly exposed tool used organise optimise structure political campaign administrative logistical point view biometrics far use permitted relevant union national law remote biometric identification system shall include system intended used biometric verification sole purpose confirm specific natural person person claim system intended used biometric categorisation according sensitive protected attribute characteristic based inference attribute characteristic system intended used emotion recognition remote biometric identification system shall include system intended used biometric verification sole purpose confirm specific natural person person claim system intended used biometric categorisation according sensitive protected attribute characteristic based inference attribute characteristic system intended used emotion recognition critical infrastructure system intended used safety component management operation critical digital infrastructure road traffic supply water gas heating electricity education vocational training system intended used determine access admission assign natural person educational vocational training institution level system intended used evaluate learning outcome including outcome used steer learning process natural person educational vocational training institution level system intended used purpose assessing appropriate level education individual receive able access context within educational vocational training institution level system intended used monitoring detecting prohibited behaviour student test context within educational vocational training institution level system intended used determine access admission assign natural person educational vocational training institution level system intended used evaluate learning outcome including outcome used steer learning process natural person educational vocational training institution level system intended used purpose assessing appropriate level education individual receive able access context within educational vocational training institution level system intended used monitoring detecting prohibited behaviour student test context within educational vocational training institution level employment worker management access self employment system intended used recruitment selection natural person particular place targeted job advertisement analyse filter job application evaluate candidate system intended used make decision affecting term work related relationship promotion termination work related contractual relationship allocate task based individual behaviour personal trait characteristic monitor evaluate performance behaviour person relationship system intended used recruitment selection natural person particular place targeted job advertisement analyse filter job application evaluate candidate system intended used make decision affecting term work related relationship promotion termination work related contractual relationship allocate task based individual behaviour personal trait characteristic monitor evaluate performance behaviour person relationship access enjoyment essential private service essential public service benefit system intended used public authority behalf public authority evaluate eligibility natural person essential public assistance benefit service including healthcare service well grant reduce revoke reclaim benefit service system intended used evaluate creditworthiness natural person establish credit score exception system used purpose detecting financial fraud system intended used risk assessment pricing relation natural person case life health insurance system intended evaluate classify emergency call natural person used dispatch establish priority dispatching emergency first response service including police firefighter medical aid well emergency healthcare patient triage system system intended used public authority behalf public authority evaluate eligibility natural person essential public assistance benefit service including healthcare service well grant reduce revoke reclaim benefit service system intended used evaluate creditworthiness natural person establish credit score exception system used purpose detecting financial fraud system intended used risk assessment pricing relation natural person case life health insurance system intended evaluate classify emergency call natural person used dispatch establish priority dispatching emergency first response service including police firefighter medical aid well emergency healthcare patient triage system law enforcement far use permitted relevant union national law system intended used behalf law enforcement authority union institution body office agency support law enforcement authority behalf assess risk natural person becoming victim criminal offence system intended used behalf law enforcement authority union institution body office agency support law enforcement authority polygraph similar tool system intended used behalf law enforcement authority union institution body office agency support law enforcement authority evaluate reliability evidence course investigation prosecution criminal offence system intended used law enforcement authority behalf union institution body office agency support law enforcement authority assessing risk natural person offending offending solely basis profiling natural person referred article directive 2016 680 assess personality trait characteristic past criminal behaviour natural person group system intended used behalf law enforcement authority union institution body office agency support law enforcement authority profiling natural person referred article directive 2016 680 course detection investigation prosecution criminal offence system intended used behalf law enforcement authority union institution body office agency support law enforcement authority behalf assess risk natural person becoming victim criminal offence system intended used behalf law enforcement authority union institution body office agency support law enforcement authority polygraph similar tool system intended used behalf law enforcement authority union institution body office agency support law enforcement authority evaluate reliability evidence course investigation prosecution criminal offence system intended used law enforcement authority behalf union institution body office agency support law enforcement authority assessing risk natural person offending offending solely basis profiling natural person referred article directive 2016 680 assess personality trait characteristic past criminal behaviour natural person group system intended used behalf law enforcement authority union institution body office agency support law enforcement authority profiling natural person referred article directive 2016 680 course detection investigation prosecution criminal offence migration asylum border control management far use permitted relevant union national law system intended used behalf competent public authority union institution body office agency polygraph similar tool system intended used behalf competent public authority union institution body office agency assess risk including security risk risk irregular migration health risk posed natural person intends enter entered territory member state system intended used behalf competent public authority union institution body office agency assist competent public authority examination application asylum visa residence permit associated complaint regard eligibility natural person applying status including related assessment reliability evidence system intended used behalf competent public authority union institution body office agency context migration asylum border control management purpose detecting recognising identifying natural person exception verification travel document system intended used behalf competent public authority union institution body office agency polygraph similar tool system intended used behalf competent public authority union institution body office agency assess risk including security risk risk irregular migration health risk posed natural person intends enter entered territory member state system intended used behalf competent public authority union institution body office agency assist competent public authority examination application asylum visa residence permit associated complaint regard eligibility natural person applying status including related assessment reliability evidence system intended used behalf competent public authority union institution body office agency context migration asylum border control management purpose detecting recognising identifying natural person exception verification travel document administration justice democratic process system intended used judicial authority behalf assist judicial authority researching interpreting fact law applying law concrete set fact used similar way alternative dispute resolution system intended used influencing outcome election referendum voting behaviour natural person exercise vote election referendum include system output natural person directly exposed tool used organise optimise structure political campaign administrative logistical point view system intended used judicial authority behalf assist judicial authority researching interpreting fact law applying law concrete set fact used similar way alternative dispute resolution system intended used influencing outcome election referendum voting behaviour natural person exercise vote election referendum include system output natural person directly exposed tool used organise optimise structure political campaign administrative logistical point view
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] |
all-MiniLM-L6-v2
| 384 |
Annex IV
|
The technical documentation referred to in Article 11(1) shall contain at least the following information, as applicable to the relevant AI system:
1.
A general description of the AI system including:
(a)
its intended purpose, the name of the provider and the version of the system reflecting its relation to previous versions;
(b)
how the AI system interacts with, or can be used to interact with, hardware or software, including with other AI systems, that are not part of the AI system itself, where applicable;
(c)
the versions of relevant software or firmware, and any requirements related to version updates;
(d)
the description of all the forms in which the AI system is placed on the market or put into service, such as software packages embedded into hardware, downloads, or APIs;
(e)
the description of the hardware on which the AI system is intended to run;
(f)
where the AI system is a component of products, photographs or illustrations showing external features, the marking and internal layout of those products;
(g)
a basic description of the user-interface provided to the deployer;
(h)
instructions for use for the deployer, and a basic description of the user-interface provided to the deployer, where applicable;
2.
A detailed description of the elements of the AI system and of the process for its development, including:
(a)
the methods and steps performed for the development of the AI system, including, where relevant, recourse to pre-trained systems or tools provided by third parties and how those were used, integrated or modified by the provider;
(b)
the design specifications of the system, namely the general logic of the AI system and of the algorithms; the key design choices including the rationale and assumptions made, including with regard to persons or groups of persons in respect of who, the system is intended to be used; the main classification choices; what the system is designed to optimise for, and the relevance of the different parameters; the description of the expected output and output quality of the system; the decisions about any possible trade-off made regarding the technical solutions adopted to comply with the requirements set out in Chapter III, Section 2;
(c)
the description of the system architecture explaining how software components build on or feed into each other and integrate into the overall processing; the computational resources used to develop, train, test and validate the AI system;
(d)
where relevant, the data requirements in terms of datasheets describing the training methodologies and techniques and the training data sets used, including a general description of these data sets, information about their provenance, scope and main characteristics; how the data was obtained and selected; labelling procedures (e.g. for supervised learning), data cleaning methodologies (e.g. outliers detection);
(e)
assessment of the human oversight measures needed in accordance with Article 14, including an assessment of the technical measures needed to facilitate the interpretation of the outputs of AI systems by the deployers, in accordance with Article 13(3), point (d);
(f)
where applicable, a detailed description of pre-determined changes to the AI system and its performance, together with all the relevant information related to the technical solutions adopted to ensure continuous compliance of the AI system with the relevant requirements set out in Chapter III, Section 2;
(g)
the validation and testing procedures used, including information about the validation and testing data used and their main characteristics; metrics used to measure accuracy, robustness and compliance with other relevant requirements set out in Chapter III, Section 2, as well as potentially discriminatory impacts; test logs and all test reports dated and signed by the responsible persons, including with regard to pre-determined changes as referred to under point (f);
(h)
cybersecurity measures put in place;
3.
Detailed information about the monitoring, functioning and control of the AI system, in particular with regard to: its capabilities and limitations in performance, including the degrees of accuracy for specific persons or groups of persons on which the system is intended to be used and the overall expected level of accuracy in relation to its intended purpose; the foreseeable unintended outcomes and sources of risks to health and safety, fundamental rights and discrimination in view of the intended purpose of the AI system; the human oversight measures needed in accordance with Article 14, including the technical measures put in place to facilitate the interpretation of the outputs of AI systems by the deployers; specifications on input data, as appropriate;
4.
A description of the appropriateness of the performance metrics for the specific AI system;
5.
A detailed description of the risk management system in accordance with Article 9;
6.
A description of relevant changes made by the provider to the system through its lifecycle;
7.
A list of the harmonised standards applied in full or in part the references of which have been published in theOfficial Journal of the European Union; where no such harmonised standards have been applied, a detailed description of the solutions adopted to meet the requirements set out in Chapter III, Section 2, including a list of other relevant standards and technical specifications applied;
8.
A copy of the EU declaration of conformity referred to in Article 47;
9.
A detailed description of the system in place to evaluate the AI system performance in the post-market phase in accordance with Article 72, including the post-market monitoring plan referred to in Article 72(3).
1. A general description of the AI system including: (a) its intended purpose, the name of the provider and the version of the system reflecting its relation to previous versions; (b) how the AI system interacts with, or can be used to interact with, hardware or software, including with other AI systems, that are not part of the AI system itself, where applicable; (c) the versions of relevant software or firmware, and any requirements related to version updates; (d) the description of all the forms in which the AI system is placed on the market or put into service, such as software packages embedded into hardware, downloads, or APIs; (e) the description of the hardware on which the AI system is intended to run; (f) where the AI system is a component of products, photographs or illustrations showing external features, the marking and internal layout of those products; (g) a basic description of the user-interface provided to the deployer; (h) instructions for use for the deployer, and a basic description of the user-interface provided to the deployer, where applicable;
(a) its intended purpose, the name of the provider and the version of the system reflecting its relation to previous versions;
(b) how the AI system interacts with, or can be used to interact with, hardware or software, including with other AI systems, that are not part of the AI system itself, where applicable;
(c) the versions of relevant software or firmware, and any requirements related to version updates;
(d) the description of all the forms in which the AI system is placed on the market or put into service, such as software packages embedded into hardware, downloads, or APIs;
(e) the description of the hardware on which the AI system is intended to run;
(f) where the AI system is a component of products, photographs or illustrations showing external features, the marking and internal layout of those products;
(g) a basic description of the user-interface provided to the deployer;
(h) instructions for use for the deployer, and a basic description of the user-interface provided to the deployer, where applicable;
2. A detailed description of the elements of the AI system and of the process for its development, including: (a) the methods and steps performed for the development of the AI system, including, where relevant, recourse to pre-trained systems or tools provided by third parties and how those were used, integrated or modified by the provider; (b) the design specifications of the system, namely the general logic of the AI system and of the algorithms; the key design choices including the rationale and assumptions made, including with regard to persons or groups of persons in respect of who, the system is intended to be used; the main classification choices; what the system is designed to optimise for, and the relevance of the different parameters; the description of the expected output and output quality of the system; the decisions about any possible trade-off made regarding the technical solutions adopted to comply with the requirements set out in Chapter III, Section 2; (c) the description of the system architecture explaining how software components build on or feed into each other and integrate into the overall processing; the computational resources used to develop, train, test and validate the AI system; (d) where relevant, the data requirements in terms of datasheets describing the training methodologies and techniques and the training data sets used, including a general description of these data sets, information about their provenance, scope and main characteristics; how the data was obtained and selected; labelling procedures (e.g. for supervised learning), data cleaning methodologies (e.g. outliers detection); (e) assessment of the human oversight measures needed in accordance with Article 14, including an assessment of the technical measures needed to facilitate the interpretation of the outputs of AI systems by the deployers, in accordance with Article 13(3), point (d); (f) where applicable, a detailed description of pre-determined changes to the AI system and its performance, together with all the relevant information related to the technical solutions adopted to ensure continuous compliance of the AI system with the relevant requirements set out in Chapter III, Section 2; (g) the validation and testing procedures used, including information about the validation and testing data used and their main characteristics; metrics used to measure accuracy, robustness and compliance with other relevant requirements set out in Chapter III, Section 2, as well as potentially discriminatory impacts; test logs and all test reports dated and signed by the responsible persons, including with regard to pre-determined changes as referred to under point (f); (h) cybersecurity measures put in place;
(a) the methods and steps performed for the development of the AI system, including, where relevant, recourse to pre-trained systems or tools provided by third parties and how those were used, integrated or modified by the provider;
(b) the design specifications of the system, namely the general logic of the AI system and of the algorithms; the key design choices including the rationale and assumptions made, including with regard to persons or groups of persons in respect of who, the system is intended to be used; the main classification choices; what the system is designed to optimise for, and the relevance of the different parameters; the description of the expected output and output quality of the system; the decisions about any possible trade-off made regarding the technical solutions adopted to comply with the requirements set out in Chapter III, Section 2;
(c) the description of the system architecture explaining how software components build on or feed into each other and integrate into the overall processing; the computational resources used to develop, train, test and validate the AI system;
(d) where relevant, the data requirements in terms of datasheets describing the training methodologies and techniques and the training data sets used, including a general description of these data sets, information about their provenance, scope and main characteristics; how the data was obtained and selected; labelling procedures (e.g. for supervised learning), data cleaning methodologies (e.g. outliers detection);
(e) assessment of the human oversight measures needed in accordance with Article 14, including an assessment of the technical measures needed to facilitate the interpretation of the outputs of AI systems by the deployers, in accordance with Article 13(3), point (d);
(f) where applicable, a detailed description of pre-determined changes to the AI system and its performance, together with all the relevant information related to the technical solutions adopted to ensure continuous compliance of the AI system with the relevant requirements set out in Chapter III, Section 2;
(g) the validation and testing procedures used, including information about the validation and testing data used and their main characteristics; metrics used to measure accuracy, robustness and compliance with other relevant requirements set out in Chapter III, Section 2, as well as potentially discriminatory impacts; test logs and all test reports dated and signed by the responsible persons, including with regard to pre-determined changes as referred to under point (f);
(h) cybersecurity measures put in place;
3. Detailed information about the monitoring, functioning and control of the AI system, in particular with regard to: its capabilities and limitations in performance, including the degrees of accuracy for specific persons or groups of persons on which the system is intended to be used and the overall expected level of accuracy in relation to its intended purpose; the foreseeable unintended outcomes and sources of risks to health and safety, fundamental rights and discrimination in view of the intended purpose of the AI system; the human oversight measures needed in accordance with Article 14, including the technical measures put in place to facilitate the interpretation of the outputs of AI systems by the deployers; specifications on input data, as appropriate;
4. A description of the appropriateness of the performance metrics for the specific AI system;
5. A detailed description of the risk management system in accordance with Article 9;
6. A description of relevant changes made by the provider to the system through its lifecycle;
7. A list of the harmonised standards applied in full or in part the references of which have been published in theOfficial Journal of the European Union; where no such harmonised standards have been applied, a detailed description of the solutions adopted to meet the requirements set out in Chapter III, Section 2, including a list of other relevant standards and technical specifications applied;
8. A copy of the EU declaration of conformity referred to in Article 47;
9. A detailed description of the system in place to evaluate the AI system performance in the post-market phase in accordance with Article 72, including the post-market monitoring plan referred to in Article 72(3).
|
technical documentation referred article shall contain least following information applicable relevant system general description system including intended purpose name provider version system reflecting relation previous version system interacts used interact hardware software including system part system applicable version relevant software firmware requirement related version update description form system placed market put service software package embedded hardware downloads apis description hardware system intended run system component product photograph illustration showing external feature marking internal layout product basic description user interface provided deployer instruction use deployer basic description user interface provided deployer applicable detailed description element system process development including method step performed development system including relevant recourse pre trained system tool provided third party used integrated modified provider design specification system namely general logic system algorithm key design choice including rationale assumption made including regard person group person respect system intended used main classification choice system designed optimise relevance different parameter description expected output output quality system decision possible trade made regarding technical solution adopted comply requirement set chapter iii section description system architecture explaining software component build feed integrate overall processing computational resource used develop train test validate system relevant data requirement term datasheets describing training methodology technique training data set used including general description data set information provenance scope main characteristic data obtained selected labelling procedure supervised learning data cleaning methodology outlier detection assessment human oversight measure needed accordance article including assessment technical measure needed facilitate interpretation output system deployers accordance article point applicable detailed description pre determined change system performance together relevant information related technical solution adopted ensure continuous compliance system relevant requirement set chapter iii section validation testing procedure used including information validation testing data used main characteristic metric used measure accuracy robustness compliance relevant requirement set chapter iii section well potentially discriminatory impact test log test report dated signed responsible person including regard pre determined change referred point cybersecurity measure put place detailed information monitoring functioning control system particular regard capability limitation performance including degree accuracy specific person group person system intended used overall expected level accuracy relation intended purpose foreseeable unintended outcome source risk health safety fundamental right discrimination view intended purpose system human oversight measure needed accordance article including technical measure put place facilitate interpretation output system deployers specification input data appropriate description appropriateness performance metric specific system detailed description risk management system accordance article description relevant change made provider system lifecycle list harmonised standard applied full part reference published theofficial journal european union harmonised standard applied detailed description solution adopted meet requirement set chapter iii section including list relevant standard technical specification applied copy declaration conformity referred article detailed description system place evaluate system performance post market phase accordance article including post market monitoring plan referred article general description system including intended purpose name provider version system reflecting relation previous version system interacts used interact hardware software including system part system applicable version relevant software firmware requirement related version update description form system placed market put service software package embedded hardware downloads apis description hardware system intended run system component product photograph illustration showing external feature marking internal layout product basic description user interface provided deployer instruction use deployer basic description user interface provided deployer applicable intended purpose name provider version system reflecting relation previous version system interacts used interact hardware software including system part system applicable version relevant software firmware requirement related version update description form system placed market put service software package embedded hardware downloads apis description hardware system intended run system component product photograph illustration showing external feature marking internal layout product basic description user interface provided deployer instruction use deployer basic description user interface provided deployer applicable detailed description element system process development including method step performed development system including relevant recourse pre trained system tool provided third party used integrated modified provider design specification system namely general logic system algorithm key design choice including rationale assumption made including regard person group person respect system intended used main classification choice system designed optimise relevance different parameter description expected output output quality system decision possible trade made regarding technical solution adopted comply requirement set chapter iii section description system architecture explaining software component build feed integrate overall processing computational resource used develop train test validate system relevant data requirement term datasheets describing training methodology technique training data set used including general description data set information provenance scope main characteristic data obtained selected labelling procedure supervised learning data cleaning methodology outlier detection assessment human oversight measure needed accordance article including assessment technical measure needed facilitate interpretation output system deployers accordance article point applicable detailed description pre determined change system performance together relevant information related technical solution adopted ensure continuous compliance system relevant requirement set chapter iii section validation testing procedure used including information validation testing data used main characteristic metric used measure accuracy robustness compliance relevant requirement set chapter iii section well potentially discriminatory impact test log test report dated signed responsible person including regard pre determined change referred point cybersecurity measure put place method step performed development system including relevant recourse pre trained system tool provided third party used integrated modified provider design specification system namely general logic system algorithm key design choice including rationale assumption made including regard person group person respect system intended used main classification choice system designed optimise relevance different parameter description expected output output quality system decision possible trade made regarding technical solution adopted comply requirement set chapter iii section description system architecture explaining software component build feed integrate overall processing computational resource used develop train test validate system relevant data requirement term datasheets describing training methodology technique training data set used including general description data set information provenance scope main characteristic data obtained selected labelling procedure supervised learning data cleaning methodology outlier detection assessment human oversight measure needed accordance article including assessment technical measure needed facilitate interpretation output system deployers accordance article point applicable detailed description pre determined change system performance together relevant information related technical solution adopted ensure continuous compliance system relevant requirement set chapter iii section validation testing procedure used including information validation testing data used main characteristic metric used measure accuracy robustness compliance relevant requirement set chapter iii section well potentially discriminatory impact test log test report dated signed responsible person including regard pre determined change referred point cybersecurity measure put place detailed information monitoring functioning control system particular regard capability limitation performance including degree accuracy specific person group person system intended used overall expected level accuracy relation intended purpose foreseeable unintended outcome source risk health safety fundamental right discrimination view intended purpose system human oversight measure needed accordance article including technical measure put place facilitate interpretation output system deployers specification input data appropriate description appropriateness performance metric specific system detailed description risk management system accordance article description relevant change made provider system lifecycle list harmonised standard applied full part reference published theofficial journal european union harmonised standard applied detailed description solution adopted meet requirement set chapter iii section including list relevant standard technical specification applied copy declaration conformity referred article detailed description system place evaluate system performance post market phase accordance article including post market monitoring plan referred article
|
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] |
all-MiniLM-L6-v2
| 384 |
Annex V
|
The EU declaration of conformity referred to in Article 47, shall contain all of the following information:
1.
AI system name and type and any additional unambiguous reference allowing the identification and traceability of the AI system;
2.
The name and address of the provider or, where applicable, of their authorised representative;
3.
A statement that the EU declaration of conformity referred to in Article 47 is issued under the sole responsibility of the provider;
4.
A statement that the AI system is in conformity with this Regulation and, if applicable, with any other relevant Union law that provides for the issuing of the EU declaration of conformity referred to in Article 47;
5.
Where an AI system involves the processing of personal data, a statement that that AI system complies with Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680;
6.
References to any relevant harmonised standards used or any other common specification in relation to which conformity is declared;
7.
Where applicable, the name and identification number of the notified body, a description of the conformity assessment procedure performed, and identification of the certificate issued;
8.
The place and date of issue of the declaration, the name and function of the person who signed it, as well as an indication for, or on behalf of whom, that person signed, a signature.
1. AI system name and type and any additional unambiguous reference allowing the identification and traceability of the AI system;
2. The name and address of the provider or, where applicable, of their authorised representative;
3. A statement that the EU declaration of conformity referred to in Article 47 is issued under the sole responsibility of the provider;
4. A statement that the AI system is in conformity with this Regulation and, if applicable, with any other relevant Union law that provides for the issuing of the EU declaration of conformity referred to in Article 47;
5. Where an AI system involves the processing of personal data, a statement that that AI system complies with Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680;
6. References to any relevant harmonised standards used or any other common specification in relation to which conformity is declared;
7. Where applicable, the name and identification number of the notified body, a description of the conformity assessment procedure performed, and identification of the certificate issued;
8. The place and date of issue of the declaration, the name and function of the person who signed it, as well as an indication for, or on behalf of whom, that person signed, a signature.
|
declaration conformity referred article shall contain following information system name type additional unambiguous reference allowing identification traceability system name address provider applicable authorised representative statement declaration conformity referred article issued sole responsibility provider statement system conformity regulation applicable relevant union law provides issuing declaration conformity referred article system involves processing personal data statement system complies regulation 2016 679 2018 1725 directive 2016 680 reference relevant harmonised standard used common specification relation conformity declared applicable name identification number notified body description conformity assessment procedure performed identification certificate issued place date issue declaration name function person signed well indication behalf person signed signature system name type additional unambiguous reference allowing identification traceability system name address provider applicable authorised representative statement declaration conformity referred article issued sole responsibility provider statement system conformity regulation applicable relevant union law provides issuing declaration conformity referred article system involves processing personal data statement system complies regulation 2016 679 2018 1725 directive 2016 680 reference relevant harmonised standard used common specification relation conformity declared applicable name identification number notified body description conformity assessment procedure performed identification certificate issued place date issue declaration name function person signed well indication behalf person signed signature
|
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] |
all-MiniLM-L6-v2
| 384 |
Annex VII
|
Conformity based on an assessment of the quality management system and an assessment of the technical documentation is the conformity assessment procedure based on points 2 to 5.
The approved quality management system for the design, development and testing of AI systems pursuant to Article 17 shall be examined in accordance with point 3 and shall be subject to surveillance as specified in point 5. The technical documentation of the AI system shall be examined in accordance with point 4.
3.1.
(a)
the name and address of the provider and, if the application is lodged by an authorised representative, also their name and address;
(b)
the list of AI systems covered under the same quality management system;
(c)
the technical documentation for each AI system covered under the same quality management system;
(d)
the documentation concerning the quality management system which shall cover all the aspects listed under Article 17;
(e)
a description of the procedures in place to ensure that the quality management system remains adequate and effective;
(f)
a written declaration that the same application has not been lodged with any other notified body.
3.2.
The decision shall be notified to the provider or its authorised representative.
The notification shall contain the conclusions of the assessment of the quality management system and the reasoned assessment decision.
3.3.
3.4.
The proposed changes shall be examined by the notified body, which shall decide whether the modified quality management system continues to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.
The notified body shall notify the provider of its decision. The notification shall contain the conclusions of the examination of the changes and the reasoned assessment decision.
4.1.
4.2.
(a)
the name and address of the provider;
(b)
a written declaration that the same application has not been lodged with any other notified body;
(c)
the technical documentation referred to in Annex IV.
4.3.
4.4.
4.5.
4.6.
Where the AI system is in conformity with the requirements set out in Chapter III, Section 2, the notified body shall issue a Union technical documentation assessment certificate. The certificate shall indicate the name and address of the provider, the conclusions of the examination, the conditions (if any) for its validity and the data necessary for the identification of the AI system.
The certificate and its annexes shall contain all relevant information to allow the conformity of the AI system to be evaluated, and to allow for control of the AI system while in use, where applicable.
Where the AI system is not in conformity with the requirements set out in Chapter III, Section 2, the notified body shall refuse to issue a Union technical documentation assessment certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.
Where the AI system does not meet the requirement relating to the data used to train it, re-training of the AI system will be needed prior to the application for a new conformity assessment. In this case, the reasoned assessment decision of the notified body refusing to issue the Union technical documentation assessment certificate shall contain specific considerations on the quality data used to train the AI system, in particular on the reasons for non-compliance.
4.7.
5.1.
5.2.
5.3.
3.1. (a) the name and address of the provider and, if the application is lodged by an authorised representative, also their name and address; (b) the list of AI systems covered under the same quality management system; (c) the technical documentation for each AI system covered under the same quality management system; (d) the documentation concerning the quality management system which shall cover all the aspects listed under Article 17; (e) a description of the procedures in place to ensure that the quality management system remains adequate and effective; (f) a written declaration that the same application has not been lodged with any other notified body.
(a) the name and address of the provider and, if the application is lodged by an authorised representative, also their name and address;
(b) the list of AI systems covered under the same quality management system;
(c) the technical documentation for each AI system covered under the same quality management system;
(d) the documentation concerning the quality management system which shall cover all the aspects listed under Article 17;
(e) a description of the procedures in place to ensure that the quality management system remains adequate and effective;
(f) a written declaration that the same application has not been lodged with any other notified body.
3.2. The decision shall be notified to the provider or its authorised representative. The notification shall contain the conclusions of the assessment of the quality management system and the reasoned assessment decision.
3.3.
3.4. The proposed changes shall be examined by the notified body, which shall decide whether the modified quality management system continues to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary. The notified body shall notify the provider of its decision. The notification shall contain the conclusions of the examination of the changes and the reasoned assessment decision.
4.1.
4.2. (a) the name and address of the provider; (b) a written declaration that the same application has not been lodged with any other notified body; (c) the technical documentation referred to in Annex IV.
(a) the name and address of the provider;
(b) a written declaration that the same application has not been lodged with any other notified body;
(c) the technical documentation referred to in Annex IV.
4.3.
4.4.
4.5.
4.6. Where the AI system is in conformity with the requirements set out in Chapter III, Section 2, the notified body shall issue a Union technical documentation assessment certificate. The certificate shall indicate the name and address of the provider, the conclusions of the examination, the conditions (if any) for its validity and the data necessary for the identification of the AI system. The certificate and its annexes shall contain all relevant information to allow the conformity of the AI system to be evaluated, and to allow for control of the AI system while in use, where applicable. Where the AI system is not in conformity with the requirements set out in Chapter III, Section 2, the notified body shall refuse to issue a Union technical documentation assessment certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal. Where the AI system does not meet the requirement relating to the data used to train it, re-training of the AI system will be needed prior to the application for a new conformity assessment. In this case, the reasoned assessment decision of the notified body refusing to issue the Union technical documentation assessment certificate shall contain specific considerations on the quality data used to train the AI system, in particular on the reasons for non-compliance.
4.7.
5.1.
5.2.
5.3.
|
conformity based assessment quality management system assessment technical documentation conformity assessment procedure based point approved quality management system design development testing system pursuant article shall examined accordance point shall subject surveillance specified point technical documentation system shall examined accordance point name address provider application lodged authorised representative also name address list system covered quality management system technical documentation system covered quality management system documentation concerning quality management system shall cover aspect listed article description procedure place ensure quality management system remains adequate effective written declaration application lodged notified body decision shall notified provider authorised representative notification shall contain conclusion assessment quality management system reasoned assessment decision proposed change shall examined notified body shall decide whether modified quality management system continues satisfy requirement referred point whether reassessment necessary notified body shall notify provider decision notification shall contain conclusion examination change reasoned assessment decision name address provider written declaration application lodged notified body technical documentation referred annex system conformity requirement set chapter iii section notified body shall issue union technical documentation assessment certificate certificate shall indicate name address provider conclusion examination condition validity data necessary identification system certificate annex shall contain relevant information allow conformity system evaluated allow control system use applicable system conformity requirement set chapter iii section notified body shall refuse issue union technical documentation assessment certificate shall inform applicant accordingly giving detailed reason refusal system meet requirement relating data used train training system needed prior application new conformity assessment case reasoned assessment decision notified body refusing issue union technical documentation assessment certificate shall contain specific consideration quality data used train system particular reason non compliance name address provider application lodged authorised representative also name address list system covered quality management system technical documentation system covered quality management system documentation concerning quality management system shall cover aspect listed article description procedure place ensure quality management system remains adequate effective written declaration application lodged notified body name address provider application lodged authorised representative also name address list system covered quality management system technical documentation system covered quality management system documentation concerning quality management system shall cover aspect listed article description procedure place ensure quality management system remains adequate effective written declaration application lodged notified body decision shall notified provider authorised representative notification shall contain conclusion assessment quality management system reasoned assessment decision proposed change shall examined notified body shall decide whether modified quality management system continues satisfy requirement referred point whether reassessment necessary notified body shall notify provider decision notification shall contain conclusion examination change reasoned assessment decision name address provider written declaration application lodged notified body technical documentation referred annex name address provider written declaration application lodged notified body technical documentation referred annex system conformity requirement set chapter iii section notified body shall issue union technical documentation assessment certificate certificate shall indicate name address provider conclusion examination condition validity data necessary identification system certificate annex shall contain relevant information allow conformity system evaluated allow control system use applicable system conformity requirement set chapter iii section notified body shall refuse issue union technical documentation assessment certificate shall inform applicant accordingly giving detailed reason refusal system meet requirement relating data used train training system needed prior application new conformity assessment case reasoned assessment decision notified body refusing issue union technical documentation assessment certificate shall contain specific consideration quality data used train system particular reason non compliance
|
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] |
all-MiniLM-L6-v2
| 384 |
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