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

5. The Commission shall be empowered to adopt delegated acts in accordance with Article 73 for the purpose of updating the content of the EU declaration of conformity set out in Annex V in order to introduce elements that become necessary in light of technical progress.

### Article 49 - CE marking of conformity

1. The CE marking of conformity shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.

1a. For high-risk AI systems provided digitally, a digital CE marking shall be used, only if it can be easily accessed via the interface from which the AI system is accessed or via an easily accessible machine-readable code or other electronic means.

2. 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.

3. 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 its 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.

3a. 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.
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 Annex III point 2, the provider or, where applicable, the authorised representative shall register themselves and their system in the EU database referred to in Article 60.

1a. Before placing on the market or putting into service an AI system for which the provider has concluded that it is not high-risk in application of the procedure under Article 6(2a), the provider or, where applicable, the authorised representative shall register themselves and that system in the EU database referred to in Article 60.

1b. 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 Annex III, point 2, deployers who are public authorities, agencies or bodies or persons acting on their behalf shall register themselves, select the system and register its use in the EU database referred to in Article 60.

1c. For high-risk AI systems referred to Annex III, points 1, 6 and 7 in the areas of law enforcement, migration, asylum and border control management, the registration referred to in paragraphs 1 to 1b shall be done in a secure non-public section of the EU database referred to in Article 60 and include only the following information, as applicable:

- points 1 to 9 of Annex VIII, section A with the exception of points 5a, 7 and 8;

- points 1 to 3 of Annex VIII, section B;

- points 1 to 9 of Annex VIII, section X with the exception of points 6 and 7;

- points 1 to 5 of Annex VIIIa with the exception of point 4.

Only the Commission and national authorities referred to in Art. 63(5) shall have access to these restricted sections of the EU database.

1d. High risk AI systems referred to in Annex III, point 2 shall be registered at national level.
*Article 52 - Transparency obligations for providers and users of certain AI systems and GPAI models*

1. Providers shall ensure that AI systems intended to directly interact with natural persons are designed and developed in such a way that the concerned natural persons 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 and 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.

1a. Providers of AI systems, including GPAI systems, generating synthetic audio, image, video or text content, shall ensure 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 specificities and limitations of different types of content, 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 and prosecute criminal offences.

2. Deployers of an emotion recognition system or a biometric categorisation system shall inform of the operation of the system the natural persons exposed thereto and process the personal data in accordance with Regulation (EU) 2016/679, Regulation (EU) 2016/1725 and Directive (EU) 2016/280, as applicable. This obligation shall not apply to AI systems used for biometric categorization and emotion recognition, which are permitted by law to detect, prevent and investigate criminal offences, subject to appropriate safeguards for the rights and freedoms of third parties, and in compliance with Union law.
3. 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 and prosecute criminal offence. Where the content forms part of an evidently artistic, creative, satirical, fictional 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 and 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.

3a. The information referred to in paragraphs 1 to 3 shall be provided to the concerned natural persons in a clear and distinguishable manner at the latest at the time of the first interaction or exposure. The information shall respect the applicable accessibility requirements.

4. Paragraphs 1, 2 and 3 shall not affect the requirements and obligations set out in Title III of this Regulation and shall be without prejudice to other transparency obligations for users of AI systems laid down in Union or national law.

4a. 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 is empowered to adopt implementing acts to approve these codes of practice in accordance with the procedure laid down in Article 52e paragraphs 6-8. If it deems the code is not adequate, the Commission is empowered to adopt an implementing act specifying the common rules for the implementation of those obligations in accordance with the examination procedure laid down in Article 73 paragraph 2.
# TITLE VIII – A GENERAL PURPOSE AI MODELS

## Chapter 1 CLASSIFICATION RULES

### Article 52a - Classification of general purpose AI models as general purpose AI models with systemic risk

1. A general purpose AI model shall be classified as general-purpose AI model with systemic risk if it meets any of the following criteria:

(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 by the scientific panel that a general purpose AI model has capabilities or impact equivalent to those of point (a).

2. A general purpose AI model shall be presumed to have high impact capabilities pursuant to point a) of paragraph 1 when the cumulative amount of compute used for its training measured in floating point operations (FLOPs) is greater than $10^{25}$.

3. The Commission shall adopt delegated acts in accordance with Article 73(2) to amend the thresholds listed in the paragraphs above, 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.
1. Where a general purpose AI model meets the requirements referred to in points (a) of Article 52a(1), the relevant provider shall notify the Commission without delay and in any event within 2 weeks after those requirements are met or it becomes known that these requirements will be met. That notification shall include the information necessary to demonstrate that the relevant requirements have 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 requirements referred to in points (a) of Article 52a(1) may present, with its notification, sufficiently substantiated arguments to demonstrate that, exceptionally, although it meets the said requirements, the general-purpose AI model does not present, due to its specific characteristics, systemic risks and therefore should not be classified as 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 as 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 of the scientific panel pursuant to point (a) of Article 68h [Alerts of systemic risks by the scientific panel] (1) on the basis of criteria set out in Annex IXc. The Commission shall be empowered to specify and update the criteria in Annex IXc by means of delegated acts in accordance with Article 74(2).

4a. 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 IXc. Such request shall contain objective, concrete 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 general-purpose AI model with systemic risk, providers may
request reassessment at the earliest six months after this decision.

5. 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 respect and protect intellectual property rights and confidential business information or trade secrets in accordance with Union and national law.

Chapter 2 - OBLIGATIONS FOR PROVIDERS OF GENERAL PURPOSE AI MODELS

Article 52c - 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 elements set out in Annex IXa 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 in their AI system. Without prejudice to the need to respect 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 IXb.
(c) put in place a policy to respect Union copyright law in particular to identify and
respect, including through state of the art technologies, the reservations 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, with the exception of letters (c) and (d), shall not apply to providers of AI models that are made accessible to the public under a free and open 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.

2. 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.

3. Providers of general purpose AI models may rely on codes of practice within the meaning of Article 52e demonstrate compliance with the obligations in paragraph 1, until a harmonised standard is published. Compliance with a European harmonised standard grants providers the presumption of conformity. Providers of general purpose AI models with systemic risks who do not adhere to an approved code of practice shall demonstrate alternative adequate means of compliance for approval of the Commission.

4. For the purpose of facilitating compliance with Annex IXa, notably point 2, (d) and (e), the Commission shall be empowered to adopt delegated acts in accordance with Article 73 to detail measurement and calculation methodologies with a view to allow comparable and verifiable documentation.

4a. The Commission is empowered to adopt delegated acts in accordance with Article 73(2) to amend Annexes IXa and IXb in the light of the evolving technological developments.

4b. Any information and documentation obtained pursuant to the provisions of this Article, including trade secrets, shall be treated in compliance with the confidentiality obligations set out in Article 70.
1. Prior to placing a general purpose AI model on the Union market providers established outside the Union shall, by written mandate, appoint an authorised representative which is established in the Union and shall enable it to perform its tasks under this Regulation.

2. 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 purpose 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 IXa has been drawn up and all obligations referred to in Articles 52c and, where applicable, Article 52d have been fulfilled by the provider;

(b) keep a copy of the technical documentation at the disposal of the AI Office and national competent authorities, for a period ending 10 years after the model has been placed on the market and the contact details of the provider by which the authorised representative has been appointed;

(c) provide the AI Office, upon a reasoned request, with all the information and documentation, including that kept according to point (a), necessary to demonstrate the compliance with the obligations in this Title;

(d) cooperate with the AI Office and national competent authorities, upon a reasoned request, on any action the latter takes in relation to the general purpose AI model with systemic risks, including when the model is integrated into AI systems placed on the market or put into service in the Union.

3. The mandate shall empower the authorised representative to be addressed, in addition to or instead of the provider, by the AI Office or the national competent authorities, on all issues related to ensuring compliance with this Regulation.

4. The authorised representative shall terminate the mandate if it considers or has reason to consider that the provider acts contrary to its obligations under this Regulation. In such a
case, it shall also immediately inform the AI Office about the termination of the mandate
and the reasons thereof.

5. The obligation set out in this article shall not apply to providers of general purpose AI models that are made accessible to the public 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.

Chapter 3 - OBLIGATIONS FOR PROVIDERS OF GENERAL PURPOSE AI MODELS WITH
SYSTEMIC RISK

Article 52d - Obligations for providers of general purpose AI models with systemic risk

1. In addition to the obligations listed in Article 52c, 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 identify and mitigate systemic risk;

(b) assess and mitigate possible systemic risks at Union level, including their sources, that may stem from the development, placing on the market, or 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 E to demonstrate compliance with the obligations in paragraph 1, until a harmonised standard is published. Compliance with a European harmonised standard grants providers the presumption of conformity. Providers of general-purpose AI models with systemic risks who do not adhere to an approved code of practice shall demonstrate alternative adequate means of compliance for approval of the Commission.

3. Any information and documentation obtained pursuant to the provisions of this Article, including trade secrets, shall be treated in compliance with the confidentiality obligations set out in Article 70.

### Article 52e - Codes of practice

1. The AI Office shall encourage and facilitate the drawing up of codes of practice at Union level as an element to contribute to the proper application of this Regulation, taking into account international approaches.

2. The AI Office and the AI Board shall aim to ensure that the codes of practice cover, but not necessarily be limited to, the obligations provided for in Articles 52c and 52d, including the following issues:

(a) means to ensure that the information referred to in Article 52c (a) and (b) is kept up to date in the light of market and technological developments, and the adequate level of detail for the summary about the content used for training;

(b) the identification of the type and nature of the systemic risks at Union level, including their sources when appropriate;

(c) the measures, procedures and modalities for the assessment and management of the systemic risks at Union level, including the documentation thereof. The assessment and management of the systemic risks at Union level 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 the light of the possible ways in which such risks may emerge and materialize along the AI value chain.
3. The AI Office may invite the 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 take due account of the needs and interests of all interested parties, including affected persons, at Union level.

5. The AI Office may invite all providers of general purpose AI models to participate in the codes of practice. For providers of general purpose AI models not presenting systemic risks this participation should be limited to obligations foreseen in paragraph 2 point (a) of this Article, unless they declare explicitly their interest to join the full code.

6. 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 take into account differences in size and capacity between different participants.

7. The AI Office and the AI 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 52c and 52d, including the issues listed in paragraph 2 of this Article, 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 implementing acts, decide to approve the code of practice and give it a general validity within the Union. Those implementing acts shall be adopted in accordance with the examination procedure set out in Article 74(2).

8. As appropriate, the AI Office shall also encourage and facilitate 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. If, by the time the Regulation becomes applicable, a Code of Practice cannot be finalised, or if the AI Office deems it is not adequate following under paragraph 7, the Commission may provide, by means of implementing acts, common rules for the implementation of the obligations provided for in Articles 52c and 52d, including the issues set out in paragraph 2.

# TITLE V - MEASURES IN SUPPORT OF INNOVATION

## Article 53 - 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 24 months after entry into force. This sandbox may also be established jointly with one or several other Member States' competent authorities. The Commission may provide technical support, advice and tools for the establishment and operation of AI regulatory sandboxes.

The obligation established in previous paragraph can also be fulfilled by participation in an existing sandbox insofar as this participation provides equivalent level of national coverage for the participating Member States.

1a. Additional AI regulatory sandboxes at regional or local levels or jointly with other Member States' competent authorities may also be established.

1b. The European Data Protection Supervisor may also establish an AI regulatory sandbox for the EU institutions, bodies and agencies and exercise the roles and the tasks of national competent authorities in accordance with this chapter.

1c. Member States shall ensure that competent authorities referred to in paragraphs 1 and 1a 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 national or Union law. Member States shall ensure an appropriate level of cooperation between the authorities supervising those other sandboxes and the national competent authorities.
1d. AI regulatory sandboxes established under Article 53(1) of this Regulation shall, in accordance with Articles 53 and 53a, 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 placement on the market or putting into service pursuant to a specific sandbox plan agreed between the prospective providers and the competent authority. Such regulatory sandboxes may include testing in real world conditions supervised in the sandbox.

1e. Competent authorities shall provide, as appropriate, guidance, supervision and support within the 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 Member States legislation supervised within the sandbox.

1f. Competent authorities shall provide providers and prospective providers 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 the 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 accelerate conformity assessment procedures to a reasonable extent.

1fa. Subject to the confidentiality provisions in Article 70 and with the agreement of the sandbox provider/prospective provider, the European 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 provider and prospective provider and the national competent authority explicitly agree to this, the exit report can be made publicly available through the single information platform referred to in this article.

1g. The establishment of AI regulatory sandboxes shall aim to contribute to the following objectives:
(a) improve legal certainty to achieve regulatory compliance with this Regulation or, where relevant, other applicable Union and Member States legislation;

(b) support the sharing of best practices through cooperation with the authorities involved in the AI regulatory sandbox;

(c) foster innovation and competitiveness and facilitate the development of an AI ecosystem;

(d) contribute to evidence-based regulatory learning;

(e) facilitate and accelerate access to the Union market for AI systems, in particular when provided by small and medium-sized enterprises (SMEs), including startups.

2. 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 authorities are associated to the operation of the AI regulatory sandbox and involved in the supervision of those aspects to the extent of their respective tasks and powers, as applicable.

3. The AI regulatory sandboxes shall not affect the supervisory and 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 participation in the sandbox if no effective mitigation is possible and inform the AI Office of such decision. National competent authorities shall exercise their supervisory powers within the limits of the relevant legislation, using their discretionary powers when implementing legal provisions to a specific AI sandbox project, with the objective of supporting innovation in AI in the Union.

4. Providers and prospective providers in the AI regulatory sandbox shall remain liable under applicable Union and Member States liability legislation for any damage inflicted on third parties as a result of the experimentation taking place in the sandbox. However, provided that the prospective provider(s) respect 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. To the extent that other competent authorities responsible for other Union and Member States' legislation have been actively involved in the supervision of the AI
system in the sandbox and have provided guidance for compliance, no administrative fines shall be imposed regarding that legislation.

4b. 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.

5. National competent authorities shall coordinate their activities and cooperate within the framework of the Board.

5a. National competent authorities shall inform the AI Office and the Board of the establishment of a sandbox and may ask for support and guidance. A list of planned and existing AI sandboxes shall be made publicly available by the AI Office and kept up to date in order to encourage more interaction in the regulatory sandboxes and cross-border cooperation.

5b. National competent authorities shall submit to the AI Office and to the Board, annual reports, starting one year after the establishment of the AI regulatory sandbox and then every year 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 other Union law supervised within the sandbox. Those annual reports or abstracts thereof shall be made available to the public, online. The Commission shall, where appropriate, take the annual reports into account when exercising their tasks under this Regulation.

6. The Commission shall develop a single and dedicated interface containing all relevant information related to sandboxes to allow stakeholders to interact with regulatory sandboxes and to raise enquiries with competent authorities, and to seek non-binding guidance on the conformity of innovative products, services, business models embedding AI technologies, in accordance with Article 55(1)(c). The Commission shall proactively coordinate with national competent authorities, where relevant.
1. In order to avoid fragmentation across the Union, the Commission shall adopt an implementing act detailing the modalities for the establishment, development, implementation, operation and supervision of the AI regulatory sandboxes. The implementing act shall include common principles on the following issues:

(a) eligibility and selection for participation in the AI regulatory sandbox;

(b) procedure 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.

The implementing acts shall ensure that:

(a) regulatory sandboxes are open to any applying prospective provider of an AI system who fulfils eligibility and selection criteria. The criteria for accessing to the regulatory sandbox are transparent and fair and establishing authorities inform applicants of their decision within 3 months of the application;

(b) regulatory sandboxes allow broad and equal access and keep up with demand for participation; prospective providers may also submit applications in partnerships with users and other relevant third parties;

(c) the modalities and conditions concerning regulatory sandboxes shall to the best extent possible support flexibility for national competent authorities to establish and operate their AI regulatory sandboxes;

(d) access to the AI regulatory sandboxes is free of charge for SMEs and start-ups without prejudice to exceptional costs that national competent authorities may recover in a fair and proportionate manner;

(e) they facilitate prospective providers, by means of the learning outcomes of the sandboxes, to conduct the conformity assessment obligations of this Regulation or the voluntary application of the codes of conduct referred to in Article 69;

(f) regulatory sandboxes facilitate the involvement of other relevant actors within the AI ecosystem, such as notified bodies and standardisation organisations (SMEs, start-ups, enterprises, innovators, testing and experimentation facilities, research and experimentation labs and digital innovation hubs, centres of excellence, individual researchers), in order to allow and facilitate cooperation with the public and private sector;

(g) procedures, processes and administrative requirements for application, selection, participation and exiting the sandbox are simple, easily intelligible, clearly communicated in order to facilitate the participation of SMEs and start-ups with
limited legal and administrative capacities and are streamlined across the Union,
in order to avoid fragmentation and that participation in a regulatory sandbox
established by a Member State, or by the EDPS is mutually and uniformly
recognised and carries the same legal effects across the Union;

(h) participation in the AI regulatory sandbox is limited to a period that is appropriate to the complexity and scale of the project. This period may be extended by the national competent authority;

(i) the sandboxes shall 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 the society at large.

3. Prospective providers in the 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 & Experimentation Facilities, Digital Hubs and Centres of Excellence.

4. When national competent authorities consider authorising testing in real world conditions supervised within the framework of an AI regulatory sandbox established under this Article, they shall specifically agree with the participants on the terms and conditions of such testing and in particular on the appropriate safeguards with the view to protect fundamental rights, health and safety. Where appropriate, they shall cooperate with other national competent authorities with a view to ensure consistent practices across the Union.

Article 54 - 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 purposes 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 governed by public law or by private law and in one or more of the following areas:

(ii) public safety and public health, including disease detection, diagnosis prevention, control and treatment and improvement of health care systems;

(iii) a high level of protection and improvement of the quality of the environment, protection of biodiversity, pollution as well as green transition, climate change mitigation and adaptation;

(iiia) energy sustainability;

(iiib) safety and resilience of transport systems and mobility, critical infrastructure and networks;

(iiic) 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 Title III, Chapter 2 where those requirements cannot be effectively 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 mechanism 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 that data;

(e) providers can only further share the originally collected data in compliance with EU 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 do not lead to measures or decisions affecting the data subjects nor 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) 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 in Annex IV;

(j) a short summary of the AI project developed in the sandbox, its objectives and expected results 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.

1a. For the purpose of prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and the prevention of 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 Member State or Union law and subject to the same cumulative conditions as referred to in paragraph 1.

2. Paragraph 1 is without prejudice to Union or Member States legislation excluding processing for other purposes than those explicitly mentioned in that legislation, as well as to Union or Member States laws laying down the basis for the processing of personal data which is necessary for the purpose of developing, testing and training of innovative AI systems or any other legal basis, in compliance with Union law on the protection of personal data.

## Article 54a - Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes

1. Testing of 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 the provisions of this Article and the real-world testing plan referred to in this Article, without prejudice to the prohibitions under Article 5.

The detailed elements of the real world testing plan shall be specified in implementing acts adopted by the Commission in accordance with the examination procedure referred to in Article 74(2).

This provision shall be without prejudice to Union or national law for the testing in real world conditions of high-risk AI systems related to products covered by legislation listed in Annex II.

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 putting into service of the AI system on their own or in partnership with one or more prospective deployers.

3. The testing of high-risk AI systems in real world conditions under this Article shall be without prejudice to ethical review that may be required by national or Union 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(s) where the testing in real world conditions is to be conducted;

(b) the market surveillance authority in the Member State(s) 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 in that Member State has not provided with an answer in 30 days, the testing in real world conditions and the real world testing plan shall be understood as approved. In cases where national law does not foresee a tacit approval, the testing in real world conditions shall be subject to an authorisation;

(c) the provider or prospective provider with the exception of high-risk AI systems referred to in Annex III, points 1, 6 and 7 in the areas of law enforcement, migration, asylum and border control management, and high risk AI systems referred to in Annex III point 2, has registered the testing in real world conditions in the non-public
part of the EU database referred to in Article 60(3) with a Union-wide unique single
identification number and the information specified in Annex VIIIa;

(d) the provider or prospective provider conducting the testing in real world conditions is established in the Union or it 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 only be transferred to third countries outside the Union provided 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 6 months, which may be extended for an additional amount of 6 months, subject to prior notification by the provider to the market surveillance authority, accompanied by an explanation on the need for such time extension;

(g) persons belonging to vulnerable groups due to their age, physical or mental disability are appropriately protected;

(h) where a provider or prospective provider organises the testing in real world conditions in cooperation with one or more 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 on how to use the AI system referred to in Article 13; the provider or prospective provider and the deployer(s) 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 other applicable Union and Member States legislation;

(i) the subjects of the testing in real world conditions have given informed consent in accordance with Article 54b, 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 subject and his or her 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 and deployer(s) with 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 subject of the testing in real world conditions, or his or her 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 his or her informed consent and request the immediate and permanent deletion of their personal data. The withdrawal of the informed consent shall not affect the activities already carried out.

5a. In accordance with Article 63a, Member States shall confer their market surveillance authorities the powers of requiring providers and prospective providers information, of carrying out unannounced remote or on-site inspections and on performing checks on the development of the testing in real world conditions and the related products. Market surveillance authorities shall use these powers to ensure a safe development of these tests.

6. 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 62 of this Regulation. The provider or prospective provider shall adopt immediate mitigation measures or, failing that, 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.

7. Providers or prospective providers shall notify the national market surveillance authority in the Member State(s) where the testing in real world conditions is to be conducted of the suspension or termination of the testing in real world conditions and the final outcomes.

8. The provider and prospective provider shall be liable under applicable Union and Member States liability legislation for any damage caused in the course of their participation in the testing in real world conditions.
## Article 54b - 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 54a, informed consent shall be freely given by the subject of testing prior to his or her participation in such testing and after having been duly informed with concise, clear, relevant, and understandable information regarding:

(i) the nature and objectives of the testing in real world conditions and the possible inconvenience that may be linked to his or her participation;

(ii) the conditions under which the testing in real world conditions is to be conducted, including the expected duration of the subject's participation;

(iii) the subject's rights and guarantees regarding participation, in particular his or her 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;

(iv) the modalities for requesting the reversal or the disregard of the predictions, recommendations or decisions of the AI system;

(v) the Union-wide unique single identification number of the testing in real world conditions in accordance with Article 54a(4c) 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 subject or his or her legal representative.

## Article 55 - 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 the first
subparagraph to access to the AI regulatory sandbox, provided that they 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, users and, as appropriate, local public authorities;

(c) utilise existing dedicated channels and where appropriate, establish new ones for communication with SMEs including start-ups, users, 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;

(ca) 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.

2a. The AI Office shall undertake the following actions:

(a) upon request of the AI Board, provide standardised templates for the areas covered by this Regulation;

(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.
2b. Microenterprises as defined in Article 2(3) of the Annex to the Commission Recommendation 2003/361/EC concerning the definition of micro, small and medium-sized enterprises, provided those enterprises do not have partner enterprises or linked enterprises as defined in Article 3 of the same Annex may fulfil certain elements of the quality management system required by Article 17 of this Regulation in a simplified manner. For this purpose, the Commission shall develop guidelines on the elements of the quality management system which may be fulfilled in a simplified manner considering the needs of micro enterprises without affecting the level of protection and the need for compliance with the requirements for high-risk AI systems.

2c. Paragraph 1 shall not be interpreted as exempting those operators from fulfilling any other requirements and obligations laid down in this Regulation, including those established in Articles 9, 10, 11, 12, 13, 14, 15, 61 and 62.

# TITLE VI GOVERNANCE

Article 55b - Governance at Union level

1. The Commission shall develop Union expertise and capabilities in the field of artificial intelligence. For this purpose, the Commission has established the European AI Office by Decision [...].

2. Member States shall facilitate the tasks entrusted to the AI Office, as reflected in this Regulation.
Article 56 - Establishment and structure of the European Artificial Intelligence Board

1. A 'European Artificial Intelligence Board' (the 'Board') is 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.

2a. Each representative shall be designated by their Member State for a period of 3 years, renewable once.

2b. Member States shall ensure that their representatives in 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 58;

(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.

3. 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, duration of mandate and specifications of the tasks of
the Chair, the voting modalities, and the organisation of the Board's activities and its sub-groups.

3a. The Board shall establish two standing sub-groups to provide a platform for cooperation and exchange among market surveillance authorities and notifying authorities on 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 in 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 as referred to in Article 58a may be invited to such sub-groups or to specific meetings of those subgroups in the capacity of observers.

3b. The Board shall be organised and operated so as to safeguard the objectivity and impartiality of its activities.

4. The Board shall be chaired by one of the representatives of the Member States. The European 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 58 - 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. For this purpose the Board may in particular:

(a) contribute to the coordination among national competent authorities responsible for the application of this Regulation and, in cooperation and subject to agreement of the concerned market surveillance authorities, support joint activities of market surveillance authorities referred to in Article 63(7a);
(b) collect and share technical and regulatory expertise and best practices among Member States;

(c) provide advice in 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 47, the functioning of regulatory sandboxes and testing in real world conditions referred to in Articles 53, 54 and 54a;

(e) upon 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 code of practice pursuant to this Regulation as well as the Commission's guidelines;

(ii) the evaluation and review of this Regulation pursuant to Article 84, including as regards the serious incident reports referred to in Article 62 and the functioning of the database referred to in Article 60, the preparation of the delegated or implementing acts, and possible alignments of this Regulation with the legal acts listed in Annex II;

(iii) on technical specifications or existing standards regarding the requirements set out in Title III, Chapter 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 artificial intelligence, the uptake of artificial intelligence in the Union and the development of digital skills;

(via) trends on the evolving typology of AI value chains, in particular on the resulting implications in terms of accountability;

(vi) on the potential need for amendment of Annex III in accordance with Article 7 and on the potential need for possible revision of Article 5 pursuant to Article
84, 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 the 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;

(j1) assist the AI Office in supporting national competent authorities in the establishment and development of regulatory sandboxes and facilitate cooperation and information-sharing among regulatory sandboxes;

(k) contribute and provide relevant advice in the development of guidance documents;

(l) advise the Commission in relation to international matters on artificial intelligence;

(m) provide opinions to the Commission on the qualified alerts regarding general purpose AI models;

(n) receive opinions by the Member states on the qualified alerts regarding general purpose AI models and on national experiences and practices on the monitoring and enforcement of the AI systems, in particular systems integrating the general purpose AI models.
1. An advisory forum shall be established to advise and provide technical expertise to the Board and the Commission 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 regards to SMEs and other undertakings.

3. The Commission shall appoint the members of the advisory forum, in accordance with the criteria set out in the previous paragraph, among 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, European Union Agency for Cybersecurity, 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 two times a year. The advisory forum may invite experts and other stakeholders to its meetings.

8. In fulfilling its role as set out in paragraph 1, the advisory forum may prepare opinions, recommendations and written contributions upon request of the Board or the Commission.

9. The advisory forum may establish standing or temporary subgroups 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 of its activities. That report shall be made publicly available.
Article 58b - 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. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 74(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 artificial intelligence necessary for the tasks set out in paragraph 3, and shall be able to demonstrate meeting all of the following conditions:

(a) particular expertise and competence and scientific or technical expertise in the field of artificial intelligence;

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

(c) ability to carry out activities diligently, accurately and objectively.

The Commission, in consultation with the AI Board, shall determine the number of experts in 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 European AI Office, in particular with regard to the following tasks:

(a) support 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 68h [Alerts of systemic risks by the scientific panel];

(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 different general purpose AI models and systems;

(iv) contributing to the development of tools and templates;

(b) support the work of market surveillance authorities, at their request;

(c) support cross-border market surveillance activities as referred to in Article 63(7a), without prejudice of the powers of market surveillance authorities;

(d) support the AI Office when carrying out its duties in the context of the safeguard clause pursuant to Article 66.

4. The experts shall perform their tasks with impartiality, objectivity and 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, procedure and modalities for the scientific panel and its members to issue alerts and request the assistance of the AI Office to the performance of its tasks.
Article 58c - 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 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 58b(1), taking into account the objectives of the adequate implementation of this Regulation, cost-effectiveness and the necessity to ensure an effective access to experts by 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 EU AI testing support pursuant to Article 68a and experts pursuant to this Article is efficiently organised and provides the best possible added value.

Chapter 2 - NATIONAL COMPETENT AUTHORITIES

Article 59 - Designation of national competent authorities and single point of contact

2. Each Member State shall establish or designate at least one notifying authority and at least one market surveillance authority for the purpose of this Regulation as national competent authorities. These national competent authorities shall exercise their powers independently, impartially and without bias so as to safeguard the principles of objectivity of their activities and tasks and to ensure the application and implementation of this Regulation. The members of these authorities shall refrain from any action incompatible with their duties. Provided that those principles are respected, such activities and tasks may be performed by one or several designated authorities, in accordance with the organisational needs of the Member State.
3. Member States shall communicate to the Commission the identity of the notifying authorities and the market surveillance authorities and the tasks of those authorities and as well as any subsequent changes thereto. Member States shall make publicly available information on how competent authorities and single point of contact can be contacted, through electronic communication means by... [12 months after the date of entry into force of this Regulation]. Member States shall designate a market surveillance authority to act as single point of contact for this Regulation and 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.

4. Member States shall ensure that the national competent authority is provided with adequate technical, financial and human resources, and infrastructure to fulfil their tasks effectively under this Regulation. In particular, the national competent authority shall have a sufficient number of personnel permanently available whose competences and expertise shall include an in-depth understanding of artificial intelligence 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 deemed necessary, update competence and resource requirements referred to in this paragraph on an annual basis.

4a. National competent authorities shall satisfy an adequate level of cybersecurity measures.

4c. When performing their tasks, the national competent authorities shall act in compliance with the confidentiality obligations set out in Article 70.

5. By one year after 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.

6. The Commission shall facilitate the exchange of experience between national competent authorities.

7. 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 Board's and the Commission's guidance and advice, as appropriate. Whenever national competent authorities intend to provide guidance and advice with regard to an AI system in areas
covered by other Union legislation, the competent national authorities under that Union legislation shall be consulted, as appropriate.

8. When Union institutions, agencies and bodies fall within the scope of this Regulation, the European Data Protection Supervisor shall act as the competent authority for their supervision.

# TITLE VII - EU DATABASE FOR HIGH-RISK AI SYSTEMS LISTED IN ANNEX III

## Article 60 - 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 a EU database containing information referred to in paragraphs 2 and 2a concerning high-risk AI systems referred to in Article 6(2) which are registered in accordance with Articles 51 and 54a. 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 AI Board.

2. The data listed in Annex VIII, Section A, shall be entered into the EU database by the provider or where applicable the authorised representative.

2a. The data listed in Annex VIII, Section B, shall be entered into the EU database by the deployer who is or who acts on behalf of public authorities, agencies or bodies, according to articles 51(1a) and (1b).

3. With the exception of the section referred to in Article 51(1c) and Article 54a(5), the information contained in the EU database registered in accordance with Article 51 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 54a shall be accessible only to market surveillance authorities and the Commission, unless the prospective provider or provider has given consent for making this information also accessible the public.
4. The EU database shall contain personal data only insofar 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.

5. 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 database shall comply with the applicable accessibility requirements.

# TITLE VIII - POST-MARKET MONITORING, INFORMATION SHARING, MARKET SURVEILLANCE

## Chapter 1 - POST-MARKET MONITORING

### Article 61 - 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 artificial intelligence 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 allow the provider to evaluate the continuous compliance of AI systems with the requirements set out in Title III, Chapter 2. Where relevant, post-market monitoring shall include an analysis of the interaction with other AI systems. This obligation shall not cover sensitive operational data of deployers which are law enforcement authorities.
3. The post-market monitoring system shall be based on a post-market monitoring plan. The post-market monitoring plan shall be part of the technical documentation referred to in Annex IV. The Commission shall adopt an implementing act laying down detailed provisions establishing a template for the post-market monitoring plan and the list of elements to be included in the plan by six months before the entry into application of this Regulation.

4. For high-risk AI systems covered by the legal acts referred to in Annex II, Section A, where a post-market monitoring system and plan is already established under that legislation, in order to ensure consistency, avoid duplications and minimise additional burdens, providers shall have a choice to integrate, as appropriate, the necessary elements described in paragraphs 1, 2 and 3 using the template referred in paragraph 3 into already existing system and plan under the Union harmonisation legislation listed in Annex II, Section A, provided it achieves an equivalent level of protection.

The first subparagraph shall also apply 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 regarding their internal governance, arrangements or processes under Union financial services legislation.

## Chapter 2 - SHARING OF INFORMATION ON SERIOUS INCIDENTS

### Article 62 - 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.

1a. As a general rule, the period for the reporting referred to in paragraph 1 shall take account of the severity of the serious incident.
1b. The notification 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.

1c. Notwithstanding paragraph 1b, in the event of a widespread infringement or a serious incident as defined in Article 3(44) point (b) the report referred to in paragraph 1 shall be provided immediately, and not later than 2 days after the provider or, where applicable, the deployer becomes aware of that incident.

1d. Notwithstanding paragraph 1b, in the event of 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.

1e. Where necessary to ensure timely reporting, the provider or, where applicable, the deployer, may submit an initial report that is incomplete followed up by a complete report.

1a. Following the reporting of a serious incident pursuant to the first subparagraph, 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 co-operate 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.

2. Upon receiving a notification related to a serious incident referred to in Article 3(44)(c), the relevant market surveillance authority shall inform the national public authorities or bodies referred to in Article 64(3). The Commission shall develop dedicated guidance to facilitate compliance with the obligations set out in paragraph 1. That guidance shall be issued 12 months after the entry into force of this Regulation, at the latest, and shall be assessed regularly.

2a. The market surveillance authority shall take appropriate measures, as provided in Article 19 of the Regulation 2019/1020, within 7 days from the date it received the notification
referred to in paragraph 1 and follow the notification procedures as provided in the Regulation 2019/1020.

3. 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(44)(c).

3a. For high-risk AI systems which are safety components of devices, or are themselves devices, covered by Regulation (EU) 2017/745 and Regulation (EU) 2017/746 the notification of serious incidents shall be limited to those referred to in Article 3(44)(c) and be made to the national competent authority chosen for this purpose by the Member States where that incident occurred.

3a. National competent authorities shall immediately notify the Commission of any serious incident, whether or not it has taken action on it, in accordance with Article 20 of Regulation 2019/1020.

## Chapter 3 - ENFORCEMENT

### Article 63 - 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. However, for the purpose 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 to which legal acts listed in Annex II, section A apply, 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 previous paragraph in justified circumstances, Member States may designate another relevant authority to act as a market surveillance authority provided that coordination is ensured with the relevant sectoral market surveillance authorities responsible for the enforcement of the legal acts listed in Annex II.

3a. The procedures referred to in Articles 65, 66, 67 and 68 of this Regulation shall not apply to AI systems related to products, to which legal acts listed in Annex II, section A apply, when such legal acts already provide for procedures ensuring an equivalent level of protection and having the same objective. In such a case, these sectoral procedures shall apply instead.

3b. Without prejudice to the powers of market surveillance authorities under Article 14 of Regulation 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)(d) and (j) of Regulation 2019/1020 remotely as appropriate.

4. For high-risk AI systems placed on the market, put into service or used by financial institutions regulated by Union legislation on financial services, 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 placement on the market, putting into service or the use of the AI system is in direct connection with the provision of those financial services.

4a. By way of a derogation from the previous subparagraph, in justified 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 (SSM) established by Council Regulation No 1204/2013, 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 European Central Bank's prudential supervisory tasks as specified in that Regulation.

5. For high-risk AI systems listed in point 1 in so far as the systems are used for law enforcement purposes and for purposes listed in points 6, 7 and 8 of Annex III, Member States shall designate as market surveillance authorities for the purposes of this Regulation either the competent data protection supervisory authorities under Regulation 2016/679, or Directive (EU) 2016/680 or any other authority designated pursuant to the same conditions laid down in Articles 1 to 44 of Directive or 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.

6. Where Union institutions, agencies and bodies 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 acting in its judicial capacity.

7. Member States shall facilitate the 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 II or other Union legislation that might be relevant for the high-risk AI systems referred to in Annex III.

7a. 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 and 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 several Member States in accordance with Article 9 of the 2019/1020. The AI Office shall provide coordination support for joint investigations.

7a. Without prejudice to powers provided 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 the provider to the documentation as well as the training, validation and testing datasets used for the development of the high-risk AI system, including, where appropriate and subject to security safeguards, through
application programming interfaces ('API') or other relevant technical means and tools
enabling remote access.

7b. Market surveillance authorities shall be granted access to the source code of the high-risk AI system upon a reasoned request and only when the following cumulative 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 Title III, Chapter 2; and

(b) testing/auditing procedures and verifications based on the data and documentation provided by the provider have been exhausted or proved insufficient.

7c. Any information and documentation obtained by market surveillance authorities shall be treated in compliance with the confidentiality obligations set out in Article 70.

Article 63a - 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 this AI system with the obligations of this Regulation. To carry monitoring and supervision tasks the AI Office shall have all the powers of a market surveillance authority within the meaning of the Regulation 2019/1020.

2. Where the relevant market surveillance authorities have sufficient reasons to consider that 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, is non-compliant with the requirements laid down in this Regulation, it shall cooperate with the AI Office to carry out evaluation of compliance and inform the Board and other market surveillance authorities accordingly.

3. When a national market surveillance authority is unable to conclude its investigation on 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 where access to this
information can be enforced. In this 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. National market authorities shall safeguard the confidentiality of the
information they obtain in accordance with the Article 70. The procedure provided in
Chapter VI of the Regulation (EU) 1020/2019 shall apply by analogy.

Article 63b _ Supervision of testing in real world conditions by market surveillance authorities

1. Market surveillance authorities shall have the competence 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 54, the market surveillance authorities shall verify the compliance with the provisions of Article 54a 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 to the conditions set out in Article 54a(4) (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 54a and 54b are not met, it may take any of the following decisions on its territory, as appropriate:

(a) suspend or terminate the testing in real world conditions;

(b) require the provider or prospective provider and user(s) 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 54a(4)(b), the decision or the objection shall indicate the grounds thereof and the modalities and conditions for the provider or prospective provider to challenge the decision or objection.

5. Where applicable, where a market surveillance authority has taken a decision referred to in paragraph 3 of this Article, it shall communicate the grounds therefor to the market
surveillance authorities of the other Member States in which the AI system has been tested
in accordance with the testing plan.

Article 64 - Powers of authorities protecting fundamental rights

3. 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 mandate 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.

4. By three months after the entering into force of this Regulation, each Member State shall identify the public authorities or bodies referred to in paragraph 3 and make a list publicly available. Member States shall notify the list to the Commission and all other Member States and keep the list up to date.

5. Where the documentation referred to in paragraph 3 is insufficient to ascertain whether a breach of obligations under Union law intended to protect fundamental rights has occurred, the public authority or body referred to in paragraph 3 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 reasonable time following the request.

6. Any information and documentation obtained by the national public authorities or bodies referred to in paragraph 3 pursuant to the provisions of this Article shall be treated in compliance with the confidentiality obligations set out in Article 70.
1. AI systems presenting a risk shall be understood as a product presenting a risk defined in Article 3, point 19 of Regulation (EU) 2019/1020 insofar as risks to the health or safety or to fundamental rights of persons are concerned.

2. Where the market surveillance authority of a Member State has sufficient reasons to consider that an AI system presents a risk as referred to in paragraph 1, 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 (referred to in Article 5). When 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 64(3). The relevant operators shall cooperate as necessary with the market surveillance authority and the other national public authorities or bodies referred to in Article 64(3).

Where, in the course of that evaluation, the market surveillance authority and where applicable in cooperation with the national public authority referred to in Article 64(3) 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 it may prescribe and in any event no later than fifteen working days or as provided for in the relevant Union harmonisation law as applicable

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.

3. Where the market surveillance authority considers that 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 market throughout the Union.

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 artificial intelligence practices referred to in Article 5;

(a) a failure of a high-risk AI system to meet requirements set out in Title III, Chapter 2;

(b) shortcomings in the harmonised standards or common specifications referred to in Articles 40 and 41 conferring a presumption of conformity;

(ba) non-compliance with provisions set out in Article 52.

7. The market surveillance authorities of the Member States 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, no objection has been raised by either a market surveillance authority of a Member State or 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 is without prejudice to the procedural rights of the concerned operator in accordance with Article 18
of Regulation (EU) 2019/1020. The period referred to in the first sentence of this
paragraph shall be reduced to thirty days in the event of non-compliance with the
prohibition of the artificial intelligence practices referred to in Article 5.

9. The market surveillance authorities of all Member States 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 65a - Procedure for dealing with AI systems classified by the provider as a not high-risk inapplication of Annex III

1. Where a market surveillance authority has sufficient reasons to consider that an AI system classified by the provider as non-high-risk in application of Annex III is high-risk, they 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 Annex III 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 it 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 the requirements and obligations of this Regulation within the period referred to in paragraph 2, the provider shall be subject to fines in accordance with Article 71.

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 market throughout the Union.
6. Where the provider of the AI system concerned does not take adequate corrective action within the period referred to in paragraph 2, then the provisions of Article 65 paragraphs 5 to 9 apply.

7. Where, in the course of that evaluation pursuant to paragraph 1, the market surveillance authority establishes that the AI system was misclassified by the provider as not high-risk to circumvent the application of requirements in Title III, Chapter 2, the provider shall be subject to fines in accordance with Article 71.

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 60.

## Article 66 - Union safeguard procedure

1. Where, within three months of receipt of the notification referred to in Article 65(5), or 30 days in the case of non-compliance with the prohibition of the artificial intelligence practices referred to in Article 5, objections are raised by the market surveillance authority of a Member State against 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 operator or operators and shall evaluate the national measure. On the basis of the results of that evaluation, the Commission shall decide whether the national measure is justified or not within six months, or 60 days in the case of non-compliance with the prohibition of the artificial intelligence practices referred to in Article 5, starting from the notification referred to in Article 65(5) and notify such decision to the market surveillance authority of the Member State concerned. The Commission shall also inform all other market surveillance authorities of such decision.

2. If the measure taken by the relevant Member States is considered justified by the Commission, all Member States shall ensure that appropriate restrictive measures are taken in respect of the AI system concerned, such as withdrawal of the AI system from their market without undue delay, and shall inform the Commission accordingly. If the national
measure is considered unjustified by the Commission, the Member State concerned shall
withdraw the measure and 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 67 - Compliant AI systems which present a risk

1. Where, having performed an evaluation under Article 65, after consulting the relevant national public authority referred to in Article 64(3), the market surveillance authority of a Member State finds that although a high-risk AI system is in compliance with this Regulation, it presents a risk to the health or safety of persons, 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 operators shall ensure that corrective action is taken in respect of all the AI systems concerned that they have made available on the market throughout the Union 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. 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 operator 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 or not and, where necessary, propose appropriate measures.
5. The Commission shall immediately communicate its decision to the Member States concerned and to the relevant operators. It shall also inform of the decision all other Member States.

### Article 68 - 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 49;

(b) the CE marking has not been affixed;

(c) the EU declaration of conformity has not been drawn up;

(d) the EU declaration of conformity has not been drawn up correctly;

(ea) the registration in the EU database has not been carried out;

(eb) where applicable, the authorised representative has not been appointed;

(ec) the 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 ensure that it is recalled or withdrawn from the market without delay.

### Article 68a - EU AI testing support structures in the area of artificial intelligence

1. The Commission shall designate one or more EU AI testing support structures to perform the tasks listed under Article 21(6) of Regulation (EU) 1020/2019 in the area of artificial intelligence.
2. Without prejudice to the tasks referred to in paragraph 1, EU AI testing support structure shall also provide independent technical or scientific advice at the request of the Board, the Commission, or market surveillance authorities.

## Chapter 3b - REMEDIES

### Article 68a - Right to lodge a complaint with a market surveillance authority

1. Without prejudice to other administrative or judicial remedies, complaints to the relevant market surveillance authority may be submitted by any natural or legal person having grounds to consider that there has been an infringement of the provisions of this Regulation.

2. In accordance with Regulation (EU) 2019/1020, complaints shall be taken into account for the purpose of conducting the market surveillance activities and be handled in line with the dedicated procedures established therefore by the market surveillance authorities

### Article 68 c - A 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 an high-risk AI system listed in Annex III, with the exception of systems listed under point 2, and which produces legal effects or similarly significantly affects him or her in a way that they consider to adversely impact their health, safety and fundamental rights shall have the right to request from the deployer clear and meaningful explanations on 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 paragraph 1 follow from Union or national law in compliance with Union law.

3. This Article shall only apply to the extent that the right referred to in paragraph 1 is not already provided for under Union legislation.
Article 68d - Amendment to Directive (EU) 2020/1828

In Annex I to Directive (EU) 2020/1828 of the European Parliament and of the Council<fnref n="30" />,
the following point is added: “(67a) Regulation xxxx/xxxx of the European Parliament and
of the Council [laying down harmonised rules on artificial intelligence (Artificial
Intelligence Act) and amending certain Union legislative acts (OJ L ...)]”.

Article 68 e - Reporting of breaches and protection of reporting persons

Directive (EU) 2019/1937 of the European Parliament and of the Council shall apply to the reporting of breaches of this Regulation and the protection of persons reporting such breaches.

Chapter 3c - SUPERVISION, INVESTIGATION, ENFORCEMENT AND MONITORING IN RESPECT OF PROVIDERS OF GENERAL PURPOSE AI MODELS

Article 68f - Enforcement of obligations on providers of general purpose AI models

1. The Commission shall have exclusive powers to supervise and enforce Chapter/Title [general purpose AI models] taking into account the procedural guarantees by virtue of Article 68m. The Commission shall entrust the implementation of these tasks to the European AI Office, without prejudice to the powers of organisation of the Commission

<footnote n="30">³⁰ 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>
and the division of competences between Member States and the Union based on the Treaties.

2. Without prejudice to Article 63a paragraph 3, market surveillance authorities may request to the Commission to exercise the powers laid down in this Chapter, where this is necessary and proportionate to assist with the fulfilment of their tasks under this Regulation.

### Article 68g - Monitoring actions

1. For the purposes of carrying out the tasks assigned to it under this Chapter, 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 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 at least indicate:

(a) the point of contact of the provider of the general purpose AI model concerned;

(b) 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 68h - 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 requirements referred to in Article 52a
[Classification of general purpose AI models with systemic risk].

2. Upon such qualified alert, the Commission, through the AI Office and after having informed the AI Board, may exercise the powers laid down in this Chapter for the purpose of assessing the matter. The AI Office shall inform the Board of any measure according to Articles 68i-68m.

3. A qualified alert shall be duly reasoned and at least indicate:

(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 reasons for the suspicion of the scientific panel;

(c) any other information that the scientific panel considers relevant, including, where appropriate, information gathered on its own initiative.

## Article 68i - 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 according to Article 52c [Obligations for providers of general purpose AI models] and 52d [Obligations on providers of general purpose AI models with systemic risk] or any additional information that is necessary for the purpose of assessing compliance of the provider with this Regulation.

2. Before the request for information is sent, 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 according to Article 58b [Scientific panel](2).

4. The request for information shall state the legal basis and the purpose of the request, specifying what information is required and set the period within which the information is
to be provided, and the fines provided for in Article 72a [fines] for supplying incorrect, incomplete or misleading information.

5. The provider of the general purpose AI model concerned or their representatives and, in the case of legal persons, companies or firms, or where they have no legal personality, the persons authorised to represent them by law or by their constitution shall supply the information requested on behalf of the provider of the general purpose AI model concerned. Lawyers duly authorised to act may supply the information on behalf of their clients. The latter shall remain fully responsible if the information supplied is incomplete, incorrect or misleading.

## Article 68j - 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 the obligations under this Regulation, where the information gathered pursuant to Article 68i [Power to request information] is insufficient; or

(b) to investigate systemic risks at Union level of general purpose AI models with systemic risk, in particular following a qualified report from the scientific panel in accordance with point (c) of Article 68f [Enforcement of obligations on providers of general purpose AI models and general purpose AI models with systemic risk](3).

2. The Commission may decide to appoint independent experts to carry out evaluations on its behalf, including from the scientific panel pursuant to Article [scientific panel of independent experts]. All independent experts appointed for this task shall meet the criteria outlined in Article 58b, paragraph 2.

3. For the purpose of paragraph 1, the Commission may request access to the general purpose AI model concerned through application programming interfaces ('API') or further appropriate technical means and tools, including through 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 72a [fines] for failure to provide access.

5. The providers of the general purpose AI model concerned and, in the case of legal persons, companies or firms, or where they have no legal personality, the persons authorised to represent them by law or by their constitution shall provide the access requested on behalf of the provider of the general purpose AI model concerned.

6. The modalities and the conditions of the evaluations, including the modalities for involving independent experts and the procedure for the selection of the latter, shall be set out in implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 74(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 68k - 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 Title VIIIa, Chapter 2 [Obligations for provider of general purpose AI models];

(b) require a provider to implement mitigation measures, where the evaluation carried out in accordance with Article 68j [*Power to conduct evaluations*] 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 under 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 these commitments binding and declare that there are no further grounds for action.

## Article 68m - Procedural rights of economic operators of the general purpose AI model

Article 18 of the Regulation (EU) 2019/1020 apply by analogy to the providers of the general purpose AI model without prejudice to more specific procedural rights provided for in this Regulation.

# TITLE IX CODES OF CONDUCT

## Article 69 - 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 Title III, Chapter 2 of this Regulation 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 foreseen in European ethic guidelines for trustworthy AI;
(b) assessing and minimizing the impact of AI systems on environmental sustainability, including as regards energy-efficient programming and techniques for efficient design, training and use of AI;

(c) promoting AI literacy, in particular 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 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 deployers and 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.

# TITLE X - CONFIDENTIALITY AND PENALTIES

## Article 70 - 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) intellectual property rights, and confidential business information or trade secrets of a natural or legal person, including source code, except the cases referred to in Article 5 of Directive 2016/943 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure apply;

(b) the effective implementation of this Regulation, in particular for the purpose of inspections, investigations or audits;

(ba) public and national security interests;

(c) integrity of criminal or administrative proceedings;

(da) the integrity of information classified in accordance with Union or national law.

1a. The authorities involved in the application of this Regulation pursuant to paragraph 1 shall only request data that is strictly necessary for the assessment of the risk posed by the AI system and for the exercise of their powers in compliance with this Regulation and Regulation 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 it was requested for, in accordance with applicable national or European legislation.

2. Without prejudice to paragraph 1 and 1a, information exchanged on a confidential basis between the national competent authorities and between national competent authorities and the Commission shall not be disclosed without the prior consultation of the originating national competent authority and the deployer when high-risk AI systems referred to in points 1, 6 and 7 of Annex III are used by law enforcement, border control, immigration or asylum authorities, 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 points 1, 6 and 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 63(5) and (6), 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.

3. Paragraphs 1, [1a] and 2 shall not affect the rights and obligations of the Commission, Member States and their relevant authorities, as well as notified bodies, with regard to the exchange of information and the dissemination of warnings, including in the context of cross-border cooperation, nor the obligations of the parties concerned to provide information under criminal law of the Member States.

4. 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 71 - Penalties

1. In compliance 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 and taking into account the guidelines issued by the Commission pursuant to Article 82b. 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 notify the Commission and at the latest by the date of entry into application of those respective rules and of those respective measures and shall notify them, without delay, of any subsequent amendment affecting them.

3. Non-compliance with the prohibition of the artificial intelligence practices referred to in Article 5 shall be subject to administrative fines of up to 35 000 000 EUR or, if the offender is a company, up to 7 % of its total worldwide annual turnover for the preceding financial year, whichever is higher.

4. Non-compliance of an AI system 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 a company, up to 3% of
its total worldwide annual turnover for the preceding financial year, whichever is higher:

(b) obligations of providers pursuant to Article 16;

(d) obligations of authorised representatives pursuant to Article 25;

(e) obligations of importers pursuant to Article 26;

(f) obligations of distributors pursuant to Article 27;

(g) obligations of deployers pursuant to Article 29, paragraphs 1 to 6a;

(h) requirements and obligations of notified bodies pursuant to Article 33, 34(1), 34(3), 34(4), 34a;

(i) transparency obligations for providers and users pursuant to Article 52.

5. The supply of incorrect, incomplete or misleading information to notified bodies and 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 a company, up to 1 % of its total worldwide annual turnover for the preceding financial year, whichever is higher.

5a. In case of SMEs, including start-ups, each fine referred to in this Article shall be up to the percentages or amount referred to paragraphs 3, 4 and 5, whichever of the two is lower.

6. When deciding whether to impose an administrative fine and 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 been already applied by other market surveillance authorities of one or more Member States to the same operator for the same infringement;

(ba) whether administrative fines have been already 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 Act;

(c) the size, the annual turnover and market share of the operator committing the infringement;

(ca) 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;

(ca) the degree of cooperation with the national competent authorities, in order to remedy the infringement and mitigate the possible adverse effects of the infringement;

(cb) the degree of responsibility of the operator taking into account the technical and organisational measures implemented by them;

(ce) 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;

(cf) the intentional or negligent character of the infringement;

(cg) any action taken by the operator to mitigate the harm of damage suffered by the affected persons.

7. 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.

8. 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 other bodies as applicable in those Member States. The application of such rules in those Member States shall have an equivalent effect.

8a. The exercise by the market surveillance authority of its powers under this Article shall be subject to appropriate procedural safeguards in accordance with Union and Member State law, including effective judicial remedy and due process.

8b. 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 any related litigation or judicial proceedings;
1. The European Data Protection Supervisor may impose administrative fines on Union institutions, agencies and bodies falling within the scope of this Regulation. When deciding whether to impose an administrative fine and 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 the number of affected persons and the level of damage suffered by them, and any relevant previous infringement;

(aa) the degree of responsibility of the Union institution, agency or body, taking into account technical and organisational measures implemented by them;

(ab) any action taken by the Union institution, agency or body to mitigate the damage suffered by affected persons;

(b) 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 or agency or body concerned with regard to the same subject matter;

(c) any similar previous infringements by the Union institution, agency or body;

(ca) 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 or body notified the infringement;

(cb) the annual budget of the body.

2. Non-compliance with the prohibition of the artificial intelligence practices referred to in Article 5 shall be subject to administrative fines of up to EUR 1 500 000.
3. 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, agency or body 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 or agency fined.

6a. 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 any litigation or judicial proceedings.

### Article 72a - 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 its total worldwide turnover in the preceding financial year or 15 million EUR whichever is higher. Fines should be imposed one year after the entry into application of the relevant provisions in this Regulation in order to allow providers sufficient time to adapt when the Commission finds that the provider intentionally or negligently:

(a) infringes the relevant provisions of this Regulation;

(b) fails to comply with a request for document or information pursuant to Article 68i [Power to request documentation and information], or supply
of incorrect, incomplete or misleading information;

(b) fails to comply with a measure requested under Article 68k [Power to request measures];

(c) fails 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 conduct an evaluation pursuant to Article 68j [Power to conduct evaluations].

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 68k(3) or in relevant codes of practice in accordance with Article 52e [Codes of practice].

2. Before adopting the decision pursuant to paragraph 1 of this Article, the Commission shall communicate its preliminary findings to the provider of the general purpose AI model or general purpose AI model with systemic risk and give opportunity to be heard.

2a. Fines imposed in accordance with this article shall be proportionate, dissuasive and effective.

2b. The information on the fines shall be also communicated to the Board as appropriate.

3. The Court of Justice of the European Union shall have unlimited jurisdiction to review decisions whereby the Commission has fixed a fine. It may cancel, reduce or increase the fine imposed.

4. The Commission shall adopt implementing acts concerning the modalities and practical arrangements for the proceedings in view of possible adoptions of decisions pursuant to paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 74(2).
# TITLE XI - DELEGATION OF POWER AND COMMITTEE PROCEDURE

## Article 73 - 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 4, Article 7(1), Article 11(3), Article 43(5) and (6) and Article 48(5)] shall be conferred on the Commission for a period of five years from ... [the date of entry into force of the Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than 9 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 7(1), Article 7(3), Article 11(3), Article 43(5) and (6) and Article 48(5)] 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. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

5. Any delegated act adopted pursuant to [Article 4], Article 7(1), Article 11(3), Article 43(5) and (6) and Article 48(5) 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 74 - 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.

TITLE XII - FINAL PROVISIONS

Article 75 - 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 in the meaning of Regulation (EU) YYY/XX [on Artificial Intelligence] of the European Parliament and of the Council*, the requirements set out in Chapter 2, Title III of that Regulation shall be taken into account.”

* Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ ...).”

Article 76 - 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 in the meaning of Regulation (EU) YYY/XX [on Artificial Intelligence] of the European Parliament and of the
Council*, the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into account.

Article 77 - 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 in the meaning of Regulation (EU) YYY/XX on [Artificial Intelligence] of the European Parliament and of the Council*, the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into account.

Article 78 - Amendment to Directive 2014/90/EU

In Article 8 of Directive 2014/90/EU, the following paragraph is added:

“4.

“For Artificial Intelligence systems which are safety components in the meaning of Regulation (EU) YYY/XX [on Artificial Intelligence] 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 Title III, Chapter 2 of that Regulation.

<footnote>* Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ ...).”</footnote>

<footnote>* Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ ...).”</footnote>

<footnote>* Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ ...).”.</footnote>
## Article 79 - 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 in the meaning of Regulation (EU) YYY/XX [on Artificial Intelligence] of the European Parliament and of the Council*, the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into account.

* Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ ...).".

## Article 80 - 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 in the meaning of Regulation (EU) YYY/XX [on Artificial Intelligence] of the European Parliament and of the Council *, the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into account.

* Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ ...).".
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 in the meaning of Regulation (EU) YYY/XX [on Artificial Intelligence] of the European Parliament and of the Council*, the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into account.

* Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ ...).”

_________”

(2) In Article 19, the following paragraph is added:

“4. When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence systems which are safety components in the meaning of Regulation (EU) YYY/XX [on Artificial Intelligence], the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into account.”

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

“4. When adopting implementing acts pursuant to paragraph 1 concerning Artificial Intelligence systems which are safety components in the meaning of Regulation (EU) YYY/XX [on Artificial Intelligence], the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into account.”

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

“3. When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence systems which are safety components in the meaning of Regulation (EU) YYY/XX [on Artificial Intelligence], the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into account.”
(5) In Article 57, the following paragraph is added:

“ When adopting those implementing acts concerning Artificial Intelligence systems which are safety components in the meaning of Regulation (EU) YYY/XX [on Artificial Intelligence], the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into account.”

(6) In Article 58, the following paragraph is added:

“3. When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence systems which are safety components in the meaning of Regulation (EU) YYY/XX [on Artificial Intelligence], the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into account..”

### Article 82 - 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 in the meaning of Regulation (EU) YYY/XX [on Artificial Intelligence] of the European Parliament and of the Council*, the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into account.

* Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ ...).

“

### Article 82a - 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 - 15 and Article 28;
(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 52;

(e) detailed information on the relationship of this Regulation with the legislation referred to in Annex II of this Regulation as well as 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(1).

When issuing such guidelines, the Commission shall pay particular attention to the needs of SMEs including start-ups, local public authorities and sectors most likely to be affected by this Regulation.

The guidelines referred to in the first subparagraph 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. Upon request of the Member States or the AI Office, or on its own initiative, the Commission shall update already adopted guidelines when deemed necessary.

*Article 83 - AI systems already placed on the market or put into service*

1. Without prejudice to the application of Article 5 as referred in Article 85 (3) (-aa) AI systems which are components of the large-scale IT systems established by the legal acts listed in Annex IX that have been placed on the market or put into service before 12 months after the date of application of this Regulation referred to in Article 85(2) shall be brought into compliance with this Regulation by end of 2030.

The requirements laid down in this Regulation shall be taken into account in the evaluation of each large-scale IT systems established by the legal acts listed in Annex IX to be undertaken as provided for in those respective acts and whenever those legal acts are replaced or amended.
2. Without prejudice to the application of Article 5 as referred in Article 85 (3) (-aa) this Regulation shall apply to operators of high-risk AI systems, other than the ones referred to in paragraph 1, that have been placed on the market or put into service before [date of application of this Regulation referred to in Article 85(2)], only if, from that date, those systems are subject to significant changes in their designs. In the case of high-risk AI systems intended to be used by public authorities, providers and deployers of such systems shall take the necessary steps to comply with the requirements of the present Regulation four years after the date of entry into application of this Regulation.

3. Providers of general purpose AI models that have been placed on the market before [date of application of this Regulation referred to in point a) Article 85(3)] shall take the necessary steps in order to comply with the obligations laid down in this Regulation by [2 years after the date of entry into application of this Regulation referred to in point a) of 85(3)].

### Article 84 - Evaluation and review

1. The Commission shall assess the need for amendment of the list in Annex III, the list of prohibited AI practices 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. The Commission shall submit the findings of that assessment to the European Parliament and the Council.

2. By two years after the date of application of this Regulation referred to in Article 85(2) and every four years thereafter, the Commission shall evaluate and report to the European Parliament and to the Council on the need for amendment of the following:

- the need for extension of existing area headings or addition of new area headings in Annex III;

- the list of AI systems requiring additional transparency measures in Article 52;

- the effectiveness of the supervision and governance system.

2a. By three years after the date of application of this Regulation referred to in Article 85(3) 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. This report shall
include an assessment with regard to the structure of enforcement and the possible need for
an 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.

3. The reports referred to in paragraph 2 shall devote 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, and notably administrative fines as referred to in Article 71(1), applied by Member States to infringements of the provisions of this Regulation;

(ba) adopted harmonised standards and common specifications developed to support this Regulation;

(bb) the number of companies that enter the market after the enter into application of the regulation and how many of them are SMEs.

3a. By ... [two years after the date of entry into application of this Regulation referred to in Article 85(2)] the Commission shall evaluate the functioning of the AI office, whether the 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 Office and its enforcement competences and to increase its resources. The Commission shall submit this evaluation report to the European Parliament and to the Council.

3a. By two years [after the date of application of this Regulation referred to in Article 85(2)] and every four years thereafter, the Commission shall submit a report on the review of the progress on the development of standardization deliverables on energy efficient development of general-purpose 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.

4. Within ... [two years after the date of application of this Regulation referred to in Article 85(2)] 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 Title III, Chapter 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.

5. For the purpose of paragraphs 1 to 4 the Board, the Member States and national competent authorities shall provide the Commission with information on its request, without undue delay.

6. In carrying out the evaluations and reviews referred to in paragraphs 1 to 4 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.

7. 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, fundamental rights and in the light of the state of progress in the information society.

7a. To guide the evaluations and reviews referred to in paragraphs 1 to 4 of this Article, the Office shall undertake to develop an objective and participative methodology for the evaluation of risk level based on the criteria outlined in the relevant articles and inclusion of new systems in: the list in Annex III, including the extension of existing area headings or addition of new area headings in that Annex; the list of prohibited practices laid down in Article 5; and the list of AI systems requiring additional transparency measures pursuant to Article 52.

7b. Any amendment to this Regulation pursuant to paragraph 7 of this Article, or relevant future delegated or implementing acts, which concern sectoral legislation listed in Annex II Section B, shall take into account the regulatory specificities of each sector, and existing governance, conformity assessment and enforcement mechanisms and authorities established therein.

7c. By ... [five years from the date of application of this Regulation], the Commission shall carry out an assessment of the enforcement of this Regulation and shall report it to the European Parliament, the Council and the European Economic and Social Committee, taking into account the first years of application of the 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 an Union agency to resolve any identified shortcomings.
1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

2. This Regulation shall apply from [24 months following the entering into force of the Regulation]. With regard to the obligation referred to in Article 53(1), this obligation shall include either that at least one regulatory sandbox per Member State shall be operational on this day or that the Member State participates in the sandbox of another Member State *

3. By way of derogation from paragraph 2:

(-a) Title I and II [Prohibitions] shall apply from [six months following the entry into force of this Regulation];

(a) Title III Chapter 4, Title VI, Title VIIIa [GPAI], Title X [Penalties] shall apply from [twelve months following the entry into force of this Regulation];

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

Codes of practices shall be ready at the latest nine months after the entry into force of this Regulation. The AI Office shall take the necessary steps, including inviting providers pursuant to Article 52e paragraph 5.

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

Done at Brussels,

For the European Parliament

The President

For the Council

The President
ANNEX II - List of Union harmonisation legislation

Part I - 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).

## Part II - 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);

18a. 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);

19. 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 points (a) and (b) of Article 2(1) thereof, where it concerns unmanned aircraft and their engines, propellers, parts and equipment to control them remotely, are concerned.
ANNEX IIa - List of criminal offences referred to in Article 5 (1)(iii)

- terrorism;

- trafficking in human beings;

- sexual exploitation of children and child pornography;

- illicit trafficking in narcotic drugs and psychotropic substances;

- illicit trafficking in weapons, munitions and explosives;

- murder, grievous bodily injury;

- illicit trade in human organs and tissue;

- illicit trafficking in nuclear or radioactive materials;

- kidnapping, illegal restraint and hostage-taking;

- crimes within the jurisdiction of the International Criminal Court;

- unlawful seizure of aircraft/ships;

- rape;

- environmental crime;

- organised or armed robbery;

- sabotage;

- participation in a criminal organisation involved in one or more 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, insofar 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 whose sole purpose is to confirm that a specific natural person is the person he or she claims to be;

(aa) 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;

(ab) AI systems intended to be used for emotion recognition.

2. Critical infrastructure:

(a) AI systems intended to be used as safety components in the management and operation of critical digital infrastructure, road traffic and the supply of water, gas, heating and 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;

(ba) AI systems intended to be used for the purpose of assessing the appropriate level of education that individual will receive or will be able to access, in the context of/within education and vocational training institution;
(bb) AI systems intended to be used for monitoring and detecting prohibited behaviour of students during tests in the context of/within education and vocational training institutions.

4. Employment, workers management and access to self-employment:

(a) AI systems intended to be used for recruitment or selection of natural persons, notably to place targeted job advertisements, to analyse and filter job applications, and to evaluate candidates;

(b) AI intended to be used to make decisions affecting terms of the work related relationships, promotion and termination of work-related contractual relationships, to allocate tasks based on individual behaviour or personal traits or characteristics and to monitor and evaluate 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 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;

(ca) AI systems intended to be used for risk assessment and pricing in relation to natural persons in the case of life and health insurance.

6. Law enforcement, insofar 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, agencies, offices or bodies in support of law enforcement
authorities or on their behalf to assess the risk of a natural person to become a victim
of criminal offences;

(b) AI systems intended to be used by or on behalf of law enforcement authorities or by Union institutions, bodies and agencies in support of Law enforcement authorities as polygraphs and similar tools;

(d) AI systems intended to be used by or on behalf of law enforcement authorities, or by Union institutions, agencies, offices or bodies in support of law enforcement authorities to evaluate the reliability of evidence in the course of investigation or prosecution of criminal offences;

(e) AI systems intended to be used by law enforcement authorities or on their behalf or by Union institutions, agencies, offices or bodies in support of law enforcement authorities for assessing the risk of a natural person of offending or re-offending not solely based on 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;

(f) AI systems intended to be used by or on behalf of law enforcement authorities or by Union agencies institutions, agencies, offices or bodies in support of law enforcement authorities for profiling of natural persons as referred to in Article 3(4) of Directive (EU) 2016/680 in the course of detection, investigation or prosecution of criminal offences.

7. Migration, asylum and border control management, insofar as their use is permitted under relevant Union or national law:

(a) AI systems intended to be used by competent public authorities as polygraphs and similar tools;

(b) AI systems intended to be used by or on behalf of competent public authorities or by Union agencies, offices or bodies 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 has entered into the territory of a Member State;

(d) AI systems intended to be used by or on behalf of competent public authorities or by Union agencies, offices or bodies to assist competent public authorities for the
examination of applications for asylum, visa and residence permits and associated
complaints with regard to the eligibility of the natural persons applying for a status,
including related assessment of the reliability of evidence;

(da) AI systems intended to be used by or on behalf of competent public authorities, including Union agencies, offices or bodies, in the context of migration, asylum and border control management, for the purpose of detecting, recognising or identifying natural persons with the exception of 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 used in a similar way in alternative dispute resolution;

(aa) 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 whose output natural
persons are not directly exposed to, such as tools used to organise, optimise and
structure political campaigns from an administrative and logistic 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 or can be used to interact with hardware or software, including other AI systems, that are not part of the AI system itself, where applicable;

(c) the versions of relevant software or firmware and any requirement related to version update;

(d) the description of all forms in which the AI system is placed on the market or put into service (e.g. software package embedded into hardware, downloadable, API etc.);

(e) the description of 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, marking and internal layout of those products;

(fa) a basic description of the user-interface provided to the deployer;

(g) instructions of 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 these have been 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, also with regard to persons or groups of persons on which 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 Title III, Chapter 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 Articles 13(3)(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 Title III, Chapter 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 Title III, Chapter 2 as well as potentially discriminatory impacts; test logs and all test reports dated and signed by the responsible persons, including with regard to pre-determined changes as referred to under point (f);

(ga) 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;

3. A description of the appropriateness of the performance metrics for the specific AI system;

4. A detailed description of the risk management system in accordance with Article 9;

5. A description of relevant changes made by the provider to the system through its lifecycle;

6. 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 Title III, Chapter 2, including a list of other relevant standards and technical specifications applied;

7. A copy of the EU declaration of conformity;

8. A detailed description of the system in place to evaluate the AI system performance in the post-market phase in accordance with Article 61, including the post-market monitoring plan referred to in Article 61(3).
## ANNEX V - EU declaration of conformity

The EU declaration of conformity referred to in Article 48, shall contain all of the following information:

1. AI system name and type and any additional unambiguous reference allowing identification and traceability of the AI system;

2. Name and address of the provider or, where applicable, their authorised representative;

3. A statement that the EU declaration of conformity is issued under the sole responsibility of the provider;

4. A statement that the AI system in question is in conformity with this Regulation and, if applicable, with any other relevant Union legislation that provides for the issuing of an EU declaration of conformity;

4a. 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;

5. References to any relevant harmonised standards used or any other common specification in relation to which conformity is declared;

6. 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;

7. Place and date of issue of the declaration, name and function of the person who signed it as well as an indication for, and on behalf of whom, that person signed, 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 to 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 Title III, Chapter 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 61 is consistent with the technical documentation.
# ANNEX VII - Conformity based on assessment of quality management system and assessment of technical documentation

## 1. Introduction

Conformity based on assessment of quality management system and 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 the authorised representative, their name and address as well;

(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 their tasks, the notified body shall be granted full access to the training, validation, and testing datasets used, including, where appropriate and subject to security safeguards, through application programming interfaces (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 supplies further evidence or carries out further tests so as to enable a proper assessment of conformity of the AI system with the requirements set out in Title III, Chapter 2. Whenever the notified body is not satisfied with the tests carried out by the provider, the notified body shall 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 Title III, Chapter 2, after all other reasonable ways 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 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 Title III, Chapter 2, an EU technical documentation assessment certificate shall be issued by the notified body. 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 Title III, Chapter 2, the notified body shall refuse to issue an EU technical documentation assessment certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.

Where the AI system does not meet the requirement relating to the data used to train it, re-training of the AI system will be needed prior to the application for a new conformity assessment. In this case, the reasoned assessment decision of the notified body refusing to issue the EU technical documentation assessment certificate shall contain specific
considerations on the quality data used to train the AI system, notably 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 approved by the notified body which issued the EU technical documentation assessment certificate. The provider shall inform such notified body of its intention to introduce any of the above-mentioned changes or if it becomes otherwise 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 EU 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 EU 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 fulfils 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 an EU technical documentation assessment certificate was issued.
# ANNEX VIII - Information to be submitted upon the registration of high-risk AI systems in accordance with Article 51

## SECTION A - Information to be submitted by providers of high-risk AI systems in accordance with Article 51(1)

The following information shall be provided and thereafter kept up to date with regard to high-risk AI systems to be registered in accordance with Article 51(1):

1. Name, address and contact details of the provider;

2. Where submission of information is carried out by another person on behalf of the provider, the name, address and contact details of that person;

3. Name, address and contact details of the authorised representative, where applicable;

4. AI system trade name and any additional unambiguous reference allowing identification and traceability of the AI system;

5. Description of the intended purpose of the AI system and of the components and functions supported through this AI system;

5a. A basic and concise description of the information used by the system (data, inputs) and its operating logic;

6. Status of the AI system (on the market, or in service; no longer placed on the market/in service, recalled);

7. Type, number and expiry date of the certificate issued by the notified body and the name or identification number of that notified body, when applicable;

8. A scanned copy of the certificate referred to in point 7, when applicable;

9. Member States in which the AI system is or has been placed on the market, put into service or made available in the Union;

10. A copy of the EU declaration of conformity referred to in Article 48;
11. Electronic instructions for use; this information shall not be provided for high-risk AI systems in the areas of law enforcement and migration, asylum and border control management referred to in Annex III, points 1, 6 and 7.

12. URL for additional information (optional).

## SECTION B - Information to be submitted by deployers of high-risk AI systems in accordance with Article 51(1b)

The following information shall be provided and thereafter kept up to date with regard to high-risk AI systems to be registered in accordance with Article 51:

1. The name, address and contact details of the deployer;

2. The name, address and contact details of the person submitting information on behalf of the deployer;

5. A summary of the findings of the fundamental rights impact assessment conducted in accordance with Article 29a;

6. The URL of the entry of the AI system in the EU database by its provider;

7. A summary of the data protection impact assessment carried out in accordance with Article 35 of Regulation (EU) 2016/679 or Article 27 of Directive (EU) 2016/680 as specified in paragraph 6 of Article 29 of this Regulation, where applicable.

## SECTION C - Information to be submitted by providers of high-risk AI systems in accordance with Article 51(1a)

The following information shall be provided and thereafter kept up to date with regard to AI systems to be registered in accordance with Article 51(1a).

1. Name, address and contact details of the provider;

1. Where submission of information is carried out by another person on behalf of the provider, the name, address and contact details of that person;
2. Name, address and contact details of the authorised representative, where applicable;

3. AI system trade name and any additional unambiguous reference allowing identification and traceability of the AI system;

4. Description of the intended purpose of the AI system;

5. Based on which criterion or criteria provided in Article 6(2a) the AI system is considered as not high-risk;

6. Short summary of the grounds for considering the AI system as not high-risk in application of the procedure under Article 6(2a);

7. Status of the AI system (on the market, or in service; no longer placed on the market/in service, recalled); Member States in which the AI system is or has been placed on the market, put into service or made available in the Union.
ANNEX VIIIa - Information to be submitted upon the registration of high-risk ai systems
listed in annex iii in relation to testing in real world conditions in accordance with Article 54a

The following information shall be provided and thereafter kept up to date with regard to
testing in real world conditions to be registered in accordance with Article 54a:

1. Union-wide unique single identification number of the testing in real world conditions;

2. Name and contact details of the provider or prospective provider and users involved in the testing in real world conditions;

3. A brief description of the AI system, its intended purpose and other information necessary for the identification of the system;

4. A summary of the main characteristics of the plan for testing in real world conditions;

5. Information on the suspension or termination of the testing in real world conditions.
ANNEX IX - Union legislation on large-scale IT systems in the area of Freedom, Security and Justice

1. Schengen Information System

(a) Regulation (EU) 2018/1860 of the European Parliament and of the Council of 28 November 2018 on the use of the Schengen Information System for the return of illegally staying third-country nationals (OJ L 312, 7.12.2018, p. 1).

(b) Regulation (EU) 2018/1861 of the European Parliament and of the Council of 28 November 2018 on the establishment, operation and use of the Schengen Information System (SIS) in the field of border checks, and amending the Convention implementing the Schengen Agreement, and amending and repealing Regulation (EC) No 1987/2006 (OJ L 312, 7.12.2018, p. 14).

(c) Regulation (EU) 2018/1862 of the European Parliament and of the Council of 28 November 2018 on the establishment, operation and use of the Schengen Information System (SIS) in the field of police cooperation and judicial cooperation in criminal matters, amending and repealing Council Decision 2007/533/JHA, and repealing Regulation (EC) No 1986/2006 of the European Parliament and of the Council and Commission Decision 2010/261/EU (OJ L 312, 7.12.2018, p. 56).

2. Visa Information System

(a) Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EC) No 767/2008, Regulation (EC) No 810/2009, Regulation (EU) 2017/2226, Regulation (EU) 2016/399, Regulation XX/2018 [Interoperability Regulation], and Decision 2004/512/EC and repealing Council Decision 2008/633/JHA - COM(2018) 302 final. To be updated once the Regulation is adopted (April/May 2021) by the co-legislators.

3. Eurodac

(a) Amended proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the establishment of 'Eurodac' for the comparison of biometric data for the effective application of Regulation (EU) XXX/XXX [Regulation on Asylum and Migration Management] and of Regulation (EU]
XXX/XXX [Resettlement Regulation], for identifying an illegally staying third-country national or stateless person and on requests for the comparison with Eurodac data by Member States' law enforcement authorities and Europol for law enforcement purposes and amending Regulations (EU) 2018/1240 and (EU) 2019/818 – COM(2020) 614 final.

4. Entry/Exit System

(a) Regulation (EU) 2017/2226 of the European Parliament and of the Council of 30 November 2017 establishing an Entry/Exit System (EES) to register entry and exit data and refusal of entry data of third-country nationals crossing the external borders of the Member States and determining the conditions for access to the EES for law enforcement purposes, and amending the Convention implementing the Schengen Agreement and Regulations (EC) No 767/2008 and (EU) No 1077/2011 (OJ L 327, 9.12.2017, p. 20).

5. European Travel Information and Authorisation System

(a) Regulation (EU) 2018/1240 of the European Parliament and of the Council of 12 September 2018 establishing a European Travel Information and Authorisation System (ETIAS) and amending Regulations (EU) No 1077/2011, (EU) No 515/2014, (EU) 2016/399, (EU) 2016/1624 and (EU) 2017/2226 (OJ L 236, 19.9.2018, p. 1).

(b) Regulation (EU) 2018/1241 of the European Parliament and of the Council of 12 September 2018 amending Regulation (EU) 2016/794 for the purpose of establishing a European Travel Information and Authorisation System (ETIAS) (OJ L 236, 19.9.2018, p. 72).

6. European Criminal Records Information System on third-country nationals and stateless persons

(a) Regulation (EU) 2019/816 of the European Parliament and of the Council of 17 April 2019 establishing a centralised system for the identification of Member States holding conviction information on third-country nationals and stateless persons (ECRIS-TCN) to supplement the European Criminal Records Information System and amending Regulation (EU) 2018/1726 (OJ L 135, 22.5.2019, p. 1).

7. Interoperability
(a) Regulation (EU) 2019/817 of the European Parliament and of the Council of 20 May 2019 on establishing a framework for interoperability between EU information systems in the field of borders and visa (OJ L 135, 22.5.2019, p. 27).

(b) Regulation (EU) 2019/818 of the European Parliament and of the Council of 20 May 2019 on establishing a framework for interoperability between EU information systems in the field of police and judicial cooperation, asylum and migration (OJ L 135, 22.5.2019, p. 85).
ANNEX IXa - Technical documentation referred to in Article 52c(1a): technical documentation for providers of general purpose AI models:

Section 1 - Information to be provided by all providers of general-purpose AI models

The technical documentation referred to in Article X (b) shall contain at least the following information as appropriate to the size and risk profile of the model:

1. A general description of the general purpose AI model including:

(a) the tasks that the model is intended to perform and the type and nature of AI systems in which it can be integrated;

(b) acceptable use policies applicable;

(c) the date of release and methods of distribution;

(d) the architecture and number of parameters;

(e) modality (e.g. text, image) and format of inputs and outputs;

(f) the license.

2. A detailed description of the elements of the model referred to in paragraph 1, and relevant information of the process for the development, including the following elements:

(a) the technical means (e.g. instructions of use, infrastructure, tools) required for the general-purpose AI model to be integrated in AI systems;

(b) the design specifications of the model and training process, including training methodologies and techniques, the key design choices including the rationale and assumptions made; what the model is designed to optimise for and the relevance of the different parameters, as applicable;
(c) information on the data used for training, testing and validation, where applicable, including type and provenance of data and curation methodologies (e.g. cleaning, filtering etc), the number of data points, their scope and main characteristics; how the data was obtained and selected as well as all other measures to detect the unsuitability of data sources and methods to detect identifiable biases, where applicable;

(d) the computational resources used to train the model (e.g. number of floating point operations – FLOPs), training time, and other relevant details related to the training;

(e) known or estimated energy consumption of the model; in case not known, this could be based on information about computational resources used;

**Section 2 - Additional information to be provided by providers of general purpose AI model with systemic risk**

3. Detailed description of the evaluation strategies, including evaluation results, on the basis of available public evaluation protocols and tools or otherwise of other evaluation methodologies. Evaluation strategies shall include evaluation criteria, metrics and the methodology on the identification of limitations.

4. Where applicable, detailed description of the measures put in place for the purpose of conducting internal and/or external adversarial testing (e.g. red teaming), model adaptations, including alignment and fine-tuning.

5. Where applicable, detailed description of the system architecture explaining how software components build or feed into each other and integrate into the overall processing.
# ANNEX IXb - Transparency information referred to in Article 52c(1b): technical documentation for providers of general purpose AI models to downstream providers that integrate the model into their AI system

The information referred to in Article 52c shall contain at least the following:

1. A general description of the general purpose AI model including:

(a) the tasks that the model is intended to perform and the type and nature of AI systems in which it can be integrated;

(b) acceptable use policies applicable;

(c) the date of release and methods of distribution;

(d) how the model interacts or can be used to interact with hardware or software that is not part of the model itself, where applicable;

(e) the versions of relevant software related to the use of the general purpose AI model, where applicable;

(f) architecture and number of parameters,

(g) modality (e.g., text, image) and format of inputs and outputs;

(h) the license for the model.

2. A description of the elements of the model and of the process for its development, including:

(a) the technical means (e.g. instructions of use, infrastructure, tools) required for the general-purpose AI model to be integrated in AI systems;

(b) modality (e.g., text, image, etc.) and format of the inputs and outputs and their maximum size (e.g., context window length, etc.);

(c) information on the data used for training, testing and validation, where applicable, including, type and provenance of data and curation methodologies.