Article 45 - Information obligations of notified bodies

1. Notified bodies shall inform the notifying authority of the following:

(a) any Union technical documentation assessment certificates, any supplements to those certificates, and any quality management system approvals issued in accordance with the requirements of Annex VII;

(b) any refusal, restriction, suspension or withdrawal of a Union technical documentation assessment certificate or a quality management system approval issued in accordance with the requirements of Annex VII;

(c) any circumstances affecting the scope of or conditions for notification;

(d) any request for information which they have received from market surveillance authorities regarding conformity assessment activities;

(e) on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.
2. Each notified body shall inform the other notified bodies of:

(a) quality management system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued;

(b) Union technical documentation assessment certificates or any supplements thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and/or supplements thereto which it has issued.

3. Each notified body shall provide the other notified bodies carrying out similar conformity assessment activities covering the same *types of AI systems* with relevant information on issues relating to negative and, on request, positive conformity assessment results.

4. *Notified bodies shall safeguard the confidentiality of the information that they obtain, in accordance with Article 78.*
Article 46 - Derogation from conformity assessment procedure

1. By way of derogation from Article 43 **and upon a duly justified request**, any market surveillance authority may authorise the placing on the market or the putting into service of specific high-risk AI systems within the territory of the Member State concerned, for exceptional reasons of public security or the protection of life and health of persons, environmental protection or the protection of key industrial and infrastructural assets. That authorisation shall be for a limited period while the necessary conformity assessment procedures are being carried out, **taking into account the exceptional reasons justifying the derogation**. The completion of those procedures shall be undertaken without undue delay.

2. **In a duly justified situation of urgency for exceptional reasons of public security or in the case of specific, substantial and imminent threat to the life or physical safety of natural persons, law-enforcement authorities or civil protection authorities may put a specific high-risk AI system into service without the authorisation referred to in paragraph 1, provided that such authorisation is requested during or after the use without undue delay. If the authorisation referred to in paragraph 1 is refused, the use of the high-risk AI system shall be stopped with immediate effect and all the results and outputs of such use shall be immediately discarded.**

3. The authorisation referred to in paragraph 1 shall be issued only if the market surveillance authority concludes that the high-risk AI system complies with the requirements of Section 2. The market surveillance authority shall inform the Commission and the other Member States of any authorisation issued pursuant to paragraphs 1 and 2. **This obligation shall not cover sensitive operational data in relation to the activities of law-enforcement authorities.**

4. Where, within 15 calendar days of receipt of the information referred to in paragraph 3, no objection has been raised by either a Member State or the Commission in respect of an authorisation issued by a market surveillance authority of a Member State in accordance with paragraph 1, that authorisation shall be deemed justified.

5. Where, within 15 calendar days of receipt of the notification referred to in paragraph 3, objections are raised by a Member State against an authorisation issued by a market surveillance authority of another Member State, or where the Commission considers the authorisation to be contrary to Union law, or the conclusion of the Member States regarding the compliance of the system as referred to in paragraph 3 to be unfounded, the Commission shall, without delay, enter into consultations with the relevant Member State. The operators concerned shall be consulted and have the possibility to present their views.
Having regard thereto, the Commission shall decide whether the authorisation is justified. The Commission shall address its decision to the Member State concerned and to the relevant operators.

6. Where the Commission considers the authorisation unjustified, it shall be withdrawn by the market surveillance authority of the Member State concerned.

7. For high-risk AI systems *related to products* covered by *Union harmonisation legislation listed in Section A of Annex I, only the derogations from the conformity assessment established in that Union harmonisation legislation shall apply*.

*Article 47 - EU declaration of conformity*

1. The provider shall draw up a written *machine readable, physical or electronically signed* EU declaration of conformity for each **high-risk** AI system, and keep it at the disposal of the national competent authorities for 10 years after the **high-risk** AI system has been placed on the market or put into service. The EU declaration of conformity shall identify the **high-risk** AI system for which it has been drawn **up**. A copy of the EU declaration of conformity shall be **submitted** to the relevant national competent authorities upon request.

2. The EU declaration of conformity shall state that the high-risk AI system concerned meets the requirements set out in Section 2. The EU declaration of conformity shall contain the information set out in Annex V, and shall be translated into *a language that can be easily understood* by the *national competent authorities of the* Member States in which the high-risk AI system is *placed on the market or* made available.

3. Where high-risk AI systems are subject to other Union harmonisation legislation which also requires an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all Union law applicable to the high-risk AI system. The declaration shall contain all the information required to identify the Union harmonisation legislation to which the declaration relates.

4. By drawing up the EU declaration of conformity, the provider shall assume responsibility for compliance with the requirements set out in Section 2. The provider shall keep the EU declaration of conformity up-to-date as appropriate.

5. The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annex V by updating the content of the EU declaration of conformity set out in that Annex, in order to introduce elements that become necessary in light of technical progress.
Article 48 - CE marking

1. The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
2. For high-risk AI systems provided digitally, a digital CE marking shall be used, only if it can easily be accessed via the interface from which that system is accessed or via an easily accessible machine-readable code or other electronic means.

3. The CE marking shall be affixed visibly, legibly and indelibly for high-risk AI systems. Where that is not possible or not warranted on account of the nature of the high-risk AI system, it shall be affixed to the packaging or to the accompanying documentation, as appropriate.

4. Where applicable, the CE marking shall be followed by the identification number of the notified body responsible for the conformity assessment procedures set out in Article 43. The identification number of the notified body shall be affixed by the body itself or, under its instructions, by the provider or by the provider's authorised representative. The identification number shall also be indicated in any promotional material which mentions that the high-risk AI system fulfils the requirements for CE marking.

5. Where high-risk AI systems are subject to other Union law which also provides for the affixing of the CE marking, the CE marking shall indicate that the high-risk AI system also fulfil the requirements of that other law.
Article 49 - Registration

1. Before placing on the market or putting into service a high-risk AI system listed in Annex III, with the exception of high-risk AI systems referred to in point 2 of Annex III, the provider or, where applicable, the authorised representative shall register themselves and their system in the EU database referred to in Article 71.

2. Before placing on the market or putting into service an AI system for which the provider has concluded that it is not high-risk according to Article 6(3), that provider or, where applicable, the authorised representative shall register themselves and that system in the EU database referred to in Article 71.

3. Before putting into service or using a high-risk AI system listed in Annex III, with the exception of high-risk AI systems listed in point 2 of Annex III, deployers that are public authorities, Union institutions, bodies, offices or agencies or persons acting on their behalf shall register themselves, select the system and register its use in the EU database referred to in Article 71.
4. For 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, the registration referred to in paragraphs 1, 2 and 3 of this Article shall be in a secure non-public section of the EU database referred to in Article 71 and shall include only the following information, as applicable, referred to in:

(a) section A, points 1 to 10, of Annex VIII, with the exception of points 6, 8 and 9;

(b) Section B, points 1 to 5, and points 8 and 9 of Annex VIII;

(c) section C, points 1 to 3, of Annex VIII;

(d) points 1, 2, 3 and 5, of Annex IX.

Only the Commission and national authorities referred to in Article 74(8) shall have access to the respective restricted sections of the EU database listed in the first subparagraph of this paragraph.

5. High-risk AI systems referred to in point 2 of Annex III shall be registered at national level.
# CHAPTER IV - TRANSPARENCY OBLIGATIONS FOR PROVIDERS AND DEPLOYERS OF CERTAIN AI SYSTEMS

## Article 50 - Transparency obligations for providers and deployers of certain AI systems

1. Providers shall ensure that AI systems intended to interact **directly** with natural persons are designed and developed in such a way that **the** natural persons **concerned** are informed that they are interacting with an AI system, unless this is obvious from **the point of view of a natural person who is reasonably well-informed, observant and circumspect, taking into account** the circumstances and the context of use. This obligation shall not apply to AI systems authorised by law to detect, prevent, investigate or prosecute criminal offences, **subject to appropriate safeguards for the rights and freedoms of third parties**, unless those systems are available for the public to report a criminal offence.
2. Providers of AI systems, including general-purpose AI systems, generating synthetic audio, image, video or text content, shall ensure that the outputs of the AI system are marked in a machine-readable format and detectable as artificially generated or manipulated. Providers shall ensure their technical solutions are effective, interoperable, robust and reliable as far as this is technically feasible, taking into account the specificities and limitations of various types of content, the costs of implementation and the generally acknowledged state of the art, as may be reflected in relevant technical standards. This obligation shall not apply to the extent the AI systems perform an assistive function for standard editing or do not substantially alter the input data provided by the deployer or the semantics thereof, or where authorised by law to detect, prevent, investigate or prosecute criminal offences.

3. Deployers of an emotion recognition system or a biometric categorisation system shall inform the natural persons exposed thereto of the operation of the system, and shall process the personal data in accordance with Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680, as applicable. This obligation shall not apply to AI systems used for biometric categorisation and emotion recognition, which are permitted by law to detect, prevent or investigate criminal offences, subject to appropriate safeguards for the rights and freedoms of third parties, and in accordance with Union law.

4. Deployers of an AI system that generates or manipulates image, audio or video content constituting a deep fake, shall disclose that the content has been artificially generated or manipulated. This obligation shall not apply where the use is authorised by law to detect, prevent, investigate or prosecute criminal offence. Where the content forms part of an evidently artistic, creative, satirical, fictional or analogous work or programme, the transparency obligations set out in this paragraph are limited to disclosure of the existence of such generated or manipulated content in an appropriate manner that does not hamper the display or enjoyment of the work.

Deployers of an AI system that generates or manipulates text which is published with the purpose of informing the public on matters of public interest shall disclose that the text has been artificially generated or manipulated. This obligation shall not apply where the use is authorised by law to detect, prevent, investigate or prosecute criminal offences or where the AI-generated content has undergone a process of human review or editorial control and where a natural or legal person holds editorial responsibility for the publication of the content.
5. The information referred to in paragraphs 1 to 4 shall be provided to the natural persons concerned in a clear and distinguishable manner at the latest at the time of the first interaction or exposure. The information shall conform to the applicable accessibility requirements.

6. Paragraphs 1 to 4 shall not affect the requirements and obligations set out in Chapter III, and shall be without prejudice to other transparency obligations laid down in Union or national law for deployers of AI systems.

7. The AI Office shall encourage and facilitate the drawing up of codes of practice at Union level to facilitate the effective implementation of the obligations regarding the detection and labelling of artificially generated or manipulated content. The Commission may adopt implementing acts to approve those codes of practice in accordance with the procedure laid down in Article 56 (6). If it deems the code is not adequate, the Commission may adopt an implementing act specifying common rules for the implementation of those obligations in accordance with the examination procedure laid down in Article 98(2).
# CHAPTER V - GENERAL-PURPOSE AI MODELS

## Section 1 - Classification rules

Article 51 - Classification of general-purpose AI models as general-purpose AI models with systemic risk

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;

(b) based on a decision of the Commission, ex officio or 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 $10^{25}$.

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.

Article 52 - Procedure

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 officio or 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.
# Section 2 - Obligations for providers of general-purpose AI models

## Article 53 - Obligations for providers of general-purpose AI models

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;

(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;

(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.

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.
Article 54 - Authorised representatives of providers of general-purpose AI models

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;

(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;

(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.
## Section 3 - Obligations of providers of general-purpose AI models with systemic risk

### Article 55 - Obligations of providers of general-purpose AI models with systemic risk

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;

(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;

(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.
Section 4 - Codes of practice

Article 56 - Codes of practice

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;

(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;
(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 ... [nine months from the date of entry into force of this Regulation]. The AI Office shall take the necessary steps, including inviting providers pursuant to paragraph 7.

If, by ... [12 months from the date of entry into force], 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).
# CHAPTER VI - MEASURES IN SUPPORT OF INNOVATION

## Article 57 - AI regulatory sandboxes

1. Member States shall ensure that their competent authorities establish at least one AI regulatory sandbox at national level, which shall be operational by ... [24 months from the date of entry into force of this Regulation]. 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;

(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;

(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.

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 crossborder 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 nonbinding 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.
Article 58 - Detailed arrangements for, and functioning of, AI regulatory sandboxes

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;

(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.

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;

(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;

(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;

(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;

(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.
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.
Article 59 - Further processing of personal data for developing certain AI systems in the public interest in
the AI regulatory sandbox

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;

(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;

(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;

(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;

(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;

(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.
Article 60 - Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes

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;

(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);

(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;

(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;

(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;
(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.

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.
Article 61 - Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes

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;

(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;
(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.

2. The informed consent shall be dated and documented and a copy shall be given to the subjects of testing or their legal representative.

Article 62 - Measures for providers and deployers, in particular SMEs, including start-ups

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;

(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;

(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;
(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;

(d) evaluate and promote the convergence of best practices in public procurement procedures in relation to AI systems.

Article 63 - Derogations for specific operators

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.
# CHAPTER VII - GOVERNANCE

## Section 1 - Governance at Union level

### Article 64 - AI Office

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.
Article 65 - Establishment and structure of the European Artificial Intelligence Board

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;

(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.

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.

### Article 66 - Tasks of the Board

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);

(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;

(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;

(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;

(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;

(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;

(l) contribute to, and provide relevant advice on, the development of guidance documents;

(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;

(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.

Article 67 - Advisory forum

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.

### Article 68 - Scientific panel of independent experts

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;
(b) independence from any provider of AI systems or general-purpose AI models;

(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;

(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;

(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.

Article 69 - Access to the pool of experts by the Member States

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.
## Section 2 - National competent authorities

Article 70 - Designation of national competent authorities and single points of contact

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... [12 months from the date of entry into force of this Regulation]. 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 ... [one year from the date of entry into force of this Regulation], 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.
# CHAPTER VIII - EU DATABASE FOR HIGH-RISK AI SYSTEMS

## Article 71 - EU database for high-risk AI systems listed in Annex III

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.**
# CHAPTER IX - POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE

## Section 1 - Post-market monitoring

*Article 72 - Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems*

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, postmarket monitoring shall include an analysis of the interaction with other AI systems. This obligation shall not cover sensitive operational data of deployers which are lawenforcement 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 ...* [18 months after the entry into force of this Regulation]. 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.
## Section 2 - Sharing of information on serious incidents

### Article 73 - Reporting of serious incidents

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 ... [12 months after the entry into force of this Regulation], **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.**
**Section 3 - Enforcement**

*Article 74 - Market surveillance and control of AI systems in the Union market*

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;

(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 highrisk 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,

(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.

Article 75 - Mutual assistance, market surveillance and control of general-purpose AI systems

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 apply mutatis mutandis.
Article 76 - Supervision of testing in real world conditions by market surveillance authorities

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;
(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.

Article 77 - Powers of authorities protecting fundamental rights

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 ... [three months] after the entry into force of this Regulation, 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.
Article 78 - Confidentiality

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<fnref n="55" />;

<footnote n="55">⁵⁵ Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure (OJ L 157, 15.6.2016, p. 1).</footnote>
(b) the effective implementation of this Regulation, in particular for the purposes of inspections, investigations or audits;

(c) public and national security interests;

(d) the conduct of criminal or administrative proceedings;

(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.

### Article 79 - Procedure at national level for dealing with AI systems presenting a risk

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;**

(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;

(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.
Article 80 - Procedure for dealing with AI systems classified by the provider as non-high-risk in application of Annex III

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.

Article 81 - Union safeguard procedure

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.

Article 82 - Compliant AI systems which present a risk

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.**

### Article 83 - Formal non-compliance

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;

(b) the **CE** marking has not been affixed;

(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;

(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;**

(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**.

### Article 84 - Union AI testing support structures

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.
## Section 4 - Remedies

### Article 85 - Right to lodge a complaint with a market surveillance authority

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.

### Article 86 - Right to explanation of individual decision-making

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.
Article 87 - Reporting of infringements and protection of reporting persons

Directive (EU) 2019/1937 shall apply to the reporting of infringements of this Regulation and the protection of persons reporting such infringements.
## Section 5 - Supervision, investigation, enforcement and monitoring in respect of providers of general-purpose AI models

### Article 88 - Enforcement of the obligations of providers of general-purpose AI models

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.
Article 89 - Monitoring actions

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;

(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.
Article 90 - Alerts of systemic risks by the scientific panel

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, (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;
(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.

### Article 91 - Power to request documentation and information

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.

### Article 92 - Power to conduct evaluations

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,
(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.

Article 93 - Power to request measures

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;
(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.

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.
Article 94 - Procedural rights of economic operators of the general-purpose AI model

Article 18 of Regulation (EU) 2019/1020 shall apply *mutatis mutandis* to the providers of the general-purpose AI model, without prejudice to more specific procedural rights provided for in this Regulation.
# CHAPTER X - CODES OF CONDUCT AND GUIDELINES

## Article 95 - Codes of conduct for voluntary application of specific requirements

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;

(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;

(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.

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.

Article 96 - Guidelines from the Commission on the implementation of this Regulation

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;

(b) the prohibited practices referred to in Article 5;

(c) the practical implementation of the provisions related to substantial modification;

(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;

(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.
# CHAPTER XI - DELEGATION OF POWER AND COMMITTEE PROCEDURE

## Article 97- Exercise of the delegation

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 ... [date of entry into force of this Regulation]. 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 the Official Journal of the European Union or 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.
Article 98 - Committee procedure

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.
# CHAPTER XII - PENALTIES

## Article 99 - Penalties

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 **35 000 000** EUR 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 **15 000 000** EUR 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;

(b) obligations of authorised representatives pursuant to Article 22;

(c) obligations of importers pursuant to Article 23;
(d) obligations of distributors pursuant to Article 24;

(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;

(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 7 **500 000** EUR 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*;

(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;

(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;

(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;

(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;

(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.

Article 100 - Administrative fines on Union institutions, bodies, offices and agencies

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*;

(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;*

(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;
(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.
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.*

<figure><img src="image_9.png" /></figure>

3. The non-compliance of the AI system with any requirements or obligations under this Regulation, other than those laid down in Articles 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.

### Article 101 - Fines for providers of general-purpose AI models

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;

(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;

(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).
# CHAPTER XIII - FINAL PROVISIONS

## Article 102 - Amendment to Regulation (EC) No 300/2008

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/... 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 103 - Amendment to Regulation (EU) No 167/2013

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/... 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.

<footnote>* Regulation (EU) 2024/... of the European Parliament and of the Council of ... 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, ..., ELI: ...).’</footnote>

<footnote>* Regulation (EU) 2024/... of the European Parliament and of the Council of ... 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) 2020/1828 (Artificial Intelligence Act) (OJ L, ..., ELI: ...).’</footnote>
2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, ..., ELI: ...).’

**Article 104 - Amendment to Regulation (EU) No 168/2013**

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/... 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.
* Regulation (EU) 2024/... of the European Parliament and of the Council of ... 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, ..., ELI: ...).

+

**Article 105 - Amendment to Directive 2014/90/EU**

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/... 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 106 - Amendment to Directive (EU) 2016/797**

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/... 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.

<footnote>* Regulation (EU) 2024/... of the European Parliament and of the Council of ... 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, ..., ELI: ...).’</footnote>
+

**Article 107 - Amendment to Regulation (EU) 2018/858**

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/... 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.

<footnote>* Regulation (EU) 2024/... of the European Parliament and of the Council of ... 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, ..., ELI: ...).’</footnote>
+

Article 108 - Amendments to Regulation (EU) 2018/1139

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

<footnote>* Regulation (EU) 2024/... of the European Parliament and of the Council of ... 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, ..., ELI: ...).'</footnote>
Regulation (EU) 2024/... of the European Parliament and of the Council*<fnref n="56" />, 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:

(3) in Article 43, the following paragraph is added:

(4) in Article 47, the following paragraph is added:

(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/...⁺, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.’;

<footnote>* Regulation (EU) 2024/... of the European Parliament and of the Council of ... 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, ..., ELI: ...).';</footnote>

<footnote>‘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/...⁵⁷, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.’;</footnote>

<footnote>‘4. When adopting implementing acts pursuant to paragraph 1 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/...⁵⁸, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.’;</footnote>

<footnote>‘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/...⁺, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.’;</footnote>

<footnote n="56">⁵⁶ OJ: Please insert in the text the number of this Regulation (2021/0106(COD)) and complete the corresponding footnote.</footnote>

<footnote n="57">⁵⁷ OJ: Please insert the number of this Regulation (2021/0106(COD)).</footnote>

<footnote n="58">⁵⁸ OJ: Please insert the number of this Regulation (2021/0106(COD)).</footnote>
(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/…<fnref n="59" />, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.’.

### Article 109 - Amendment to Regulation (EU) 2019/2144

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/… of the European Parliament and of the Council*<fnref n="60" />, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.

### Article 110 - Amendment to Directive (EU) 2020/1828

In Annex I to Directive (EU) 2020/1828 of the European Parliament and of the Council<fnref n="61" />, the following point is added:

‘(68) Regulation (EU) 2024/… of the European Parliament and of the Council of …<fnref n="62" /> 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, …, ELI: …)’.

<footnote>* Regulation (EU) 2024/… of the European Parliament and of the Council of … 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, …, ELI: …).’</footnote>

<footnote n="59">⁵⁹ OJ: Please insert the number of this Regulation (2021/0106(COD)).</footnote>

<footnote n="60">⁶⁰ OJ: Please insert in the text the number of this Regulation (2021/0106(COD)) and complete the corresponding footnote.</footnote>

<footnote n="61">⁶¹ Directive (EU) 2020/1828 of the European Parliament and of the Council of 25 November 2020 on representative actions for the protection of the collective interests of consumers and repealing Directive 2009/22/EC (OJ L 409, 4.12.2020, p. 1).</footnote>

<footnote n="62">⁶² OJ: Please insert in the text the date and the number of this Regulation (2021/0106(COD)).</footnote>
*Article 111 - AI systems already placed on the market or put into service and general-purpose AI models already placed on the marked*

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 ... [36 months from the date of entry into force of this Regulation] *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 ... [24 months from the date of entry into force of this Regulation], 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 ... [six years from the date of entry into force of this Regulation].

3. Providers of general-purpose AI models that have been placed on the market before ... [12 months from the date of entry into force of this Regulation] shall take the necessary steps in order to comply with the obligations laid down in this Regulation by ... [36 months] from the date of entry into force of this Regulation.

### Article 112 - Evaluation and review

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 to the Council.

2. By ... [four years from the date of entry into force of this Regulation] 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;

(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.

3. By ... [five years from the date of entry into force of this Regulation] 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;

(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;

(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 ... [four years from the date of entry into force of this Regulation)], 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 ... [four years from the date of entry into force of this Regulation)] 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 assess 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 ... [four years from the date of entry into force of this Regulation] 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;

(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.

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 ... [seven years from the date of entry into force of this Regulation], 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.

### Article 113 - Entry into force and application

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from ... [24 months from the date of entry into force of this Regulation].

However:

(a) Chapters I and II shall apply from ... [six months from the date of entry into force of this Regulation];
(b) Chapter III Section 4, Chapter V, Chapter VII and Chapter XII and Article 78 shall apply
from ... [12 months from the date of entry into force of this Regulation], with the exception of
Article 101;

(c) Article 6(1) and the corresponding obligations in this Regulation shall apply from ... [36 months from the date of entry into force of this Regulation].

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at ...,

For the European Parliament
The President

For the Council
The President
ANNEX I - List of Union harmonisation legislation

Section A. List of Union harmonisation legislation based on the New Legislative Framework

1. Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24) [as repealed by the Machinery Regulation];

2. Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (OJ L 170, 30.6.2009, p. 1);

3. Directive 2013/53/EU of the European Parliament and of the Council of 20 November 2013 on recreational craft and personal watercraft and repealing Directive 94/25/EC (OJ L 354, 28.12.2013, p. 90);

4. Directive 2014/33/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to lifts and safety components for lifts (OJ L 96, 29.3.2014, p. 251);

5. Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres (OJ L 96, 29.3.2014, p. 309);

6. Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62);

7. Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment (OJ L 189, 27.6.2014, p. 164);

8. Regulation (EU) 2016/424 of the European Parliament and of the Council of 9 March 2016 on cableway installations and repealing Directive 2000/9/EC (OJ L 81, 31.3.2016, p. 1);

9. Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (OJ L 81, 31.3.2016, p. 51);

10. Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 2016 on appliances burning gaseous fuels and repealing Directive 2009/142/EC (OJ L 81,
31.3.2016, p. 99);

11. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1);

12. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on *in vitro* diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).

Section B. List of other Union harmonisation legislation

13. Regulation (EC) No 300/2008 of the European Parliament and of the Council of 11 March 2008 on common rules in the field of civil aviation security and repealing Regulation (EC) No 2320/2002 (OJ L 97, 9.4.2008, p. 72);

14. Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the approval and market surveillance of two- or three-wheel vehicles and quadricycles (OJ L 60, 2.3.2013, p. 52);

15. Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the approval and market surveillance of agricultural and forestry vehicles (OJ L 60, 2.3.2013, p. 1);

16. Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC (OJ L 257, 28.8.2014, p. 146);

17. Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016 on the interoperability of the rail system within the European Union (OJ L 138, 26.5.2016, p. 44);

18. Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, p. 1);

19. Regulation (EU) 2019/2144 of the European Parliament and of the Council of 27 November 2019 on type-approval requirements for motor vehicles and their trailers, and systems, components and separate technical units intended for such vehicles, as regards their general safety and the protection of vehicle occupants and vulnerable road users, amending Regulation (EU) 2018/858 of
the European Parliament and of the Council and repealing Regulations (EC) No 78/2009, (EC) No 79/2009 and (EC) No 661/2009 of the
European Parliament and of the Council and Commission Regulations (EC) No 631/2009, (EU) No 406/2010, (EU) No 672/2010, (EU) No 1003/2010, (EU) No 1005/2010, (EU) No 1008/2010, (EU) No 1009/2010, (EU) No 19/2011, (EU) No 109/2011, (EU) No 458/2011, (EU) No 65/2012, (EU) No 130/2012, (EU) No 347/2012, (EU) No 351/2012, (EU) No 1230/2012 and (EU) 2015/166 (OJ L 325, 16.12.2019, p. 1);

20. Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (OJ L 212, 22.8.2018, p. 1), in so far as the design, production and placing on the market of aircrafts referred to in Article 2(1), points (a) and (b) thereof, where it concerns unmanned aircraft and their engines, propellers, parts and equipment to control them remotely, are concerned.

## ANNEX II - List of criminal offences referred to in Article 5(1), first subparagraph, point (h)(iii)

*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.
ANNEX III - High-risk AI systems referred to in Article 6(2)

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.
ANNEX IV - Technical documentation referred to in Article 11(1)

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 predetermined 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 the *Official 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).
# ANNEX V - EU declaration of conformity

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.
# ANNEX VI - Conformity assessment procedure based on internal control

1. The conformity assessment procedure based on internal control is the conformity assessment procedure based on points 2, 3 and 4.

2. The provider verifies that the established quality management system is in compliance with the requirements of Article 17.

3. The provider examines the information contained in the technical documentation in order to assess the compliance of the AI system with the relevant essential requirements set out in Chapter III, Section 2.

4. The provider also verifies that the design and development process of the AI system and its post-market monitoring as referred to in Article 72 is consistent with the technical documentation
# ANNEX VII - Conformity based on an assessment of the quality management system and an assessment of the technical documentation

## 1. Introduction

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.

## 2. Overview

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. Quality management system

### 3.1. The application of the provider shall include:

* (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 quality management system shall be assessed by the notified body, which shall determine whether it satisfies the requirements referred to in Article 17.

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. The quality management system as approved shall continue to be implemented and maintained by the provider so that it remains adequate and efficient.
3.4. Any intended change to the approved quality management system or the list of AI systems covered by the latter shall be brought to the attention of the notified body by the provider.

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. Control of the technical documentation.

4.1. In addition to the application referred to in point 3, an application with a notified body of their choice shall be lodged by the provider for the assessment of the technical documentation relating to the AI system which the provider intends to place on the market or put into service and which is covered by the quality management system referred to under point 3.

4.2. The application shall include:

(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. The technical documentation shall be examined by the notified body. Where relevant, and limited to what is necessary to fulfil its tasks, the notified body shall be granted full access to the training, validation, and testing data sets used, including, where appropriate and subject to security safeguards, through API or other relevant technical means and tools enabling remote access.

4.4. In examining the technical documentation, the notified body may require that the provider supply further evidence or carry out further tests so as to enable a proper assessment of the conformity of the AI system with the requirements set out in Chapter III, Section 2. Where the notified body is not satisfied with the tests carried out by the provider, the notified body shall itself directly carry out adequate tests, as appropriate.

4.5. Where necessary to assess the conformity of the high-risk AI system with the requirements set out in Chapter III, Section 2, after all other reasonable means to verify conformity have been exhausted and have proven to be insufficient, and upon a reasoned request, the notified body shall also be granted access to the training and trained models of the AI system, including its relevant parameters. Such access shall be subject to existing Union law on the protection of intellectual property and trade secrets.
4.6. The decision of the notified body shall be notified to the provider or its authorised representative. The notification shall contain the conclusions of the assessment of the technical documentation and the reasoned assessment decision.

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, retraining 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. Any change to the AI system that could affect the compliance of the AI system with the

requirements or its intended purpose shall be assessed by the notified body which issued the Union technical documentation assessment certificate. The provider shall inform such notified body of its intention to introduce any of the abovementioned changes, or if it otherwise becomes aware of the occurrence of such changes. The intended changes shall be assessed by the notified body, which shall decide whether those changes require a new conformity assessment in accordance with Article 43(4) or whether they could be addressed by means of a supplement to the Union technical documentation assessment certificate. In the latter case, the notified body shall assess the changes, notify the provider of its decision and, where the changes are approved, issue to the provider a supplement to the Union technical documentation assessment certificate.
5. Surveillance of the approved quality management system.

5.1. The purpose of the surveillance carried out by the notified body referred to in Point 3 is to make sure that the provider duly complies with the terms and conditions of the approved quality management system.

5.2. For assessment purposes, the provider shall allow the notified body to access the premises where the design, development, testing of the AI systems is taking place. The provider shall further share with the notified body all necessary information.

5.3. The notified body shall carry out periodic audits to make sure that the provider maintains and applies the quality management system and shall provide the provider with an audit report. In the context of those audits, the notified body may carry out additional tests of the AI systems for which a Union technical documentation assessment certificate was issued.