Changes from plenary report to adopted text

Article 55 – paragraph 1 – point c a (new): (ca) foster the participation of SMEs and other relevant stakeholders in the standardisation development process.

Article 55 – paragraph 2: 2. The specific interests and needs of the SMEs, start-ups and users shall be taken into account when setting the fees for conformity assessment under Article 43, reducing those fees proportionately to development stage, their size, market size and market demand. The Commission shall regularly assess the certification and compliance costs for SMEs and start-ups, including through transparent consultations with SMEs, start-ups and users and shall work with Member States to lower such costs where possible. The Commission shall report on these findings to the European Parliament and to the Council as part of the report on the evaluation and review of this Regulation provided for in Article 84(2).

Article 56 – SECTION 1 – Title: Title / SECTION 1: General provisions on the European Artificial Intelligence Office

Article 56 – title: Establishment of the European Artificial Intelligence Office

Article 56 – paragraph 1: 1. The ‘European Artificial Intelligence Office’ (the ‘AI Office’) is hereby established. The AI Office shall be an independent body of the Union. It shall have legal personality.

Article 56 – paragraph 2 – introductory part: 2. The AI Office shall have a secretariat, and shall be adequately funded and staffed for the purpose of performing its tasks pursuant to this Regulation.

Article 56 – paragraph 2 a (new): 2 a. The seat of the AI Office shall be in Brussels.

Article 56 a (new): Article 56 a / Structure / The administrative and management structure of the AI Office shall comprise: / (a) a management board, including a chair / (b) a secretariat managed by an executive director; / (c) an advisory forum.

Article 56 b (new): Article 56 b / Tasks of the AI Office / The AI Office shall carry out the following tasks: / a) support, advise, and cooperate with Member States, national supervisory authorities, the Commission and other Union institutions, bodies, offices and agencies with regard to the implementation of this Regulation; / b) monitor and ensure the effective and consistent application of this Regulation, without prejudice to the tasks of national supervisory authorities; / c) contribute to the coordination among national supervisory authorities responsible for the application of this Regulation, / d) serve as a mediator in discussions about serious disagreements that may arise between competent authorities regarding the application of the Regulation / e) coordinate joint investigations, pursuant to Article 66a; / f) contribute to the effective cooperation with the competent authorities of third countries and with international organisations, / g) collect and share Member States’ expertise and best practices and to assist Member States national supervisory authorities and the Commission in developing the organizational and technical expertise required for the implementation of this Regulation, including by means of facilitating the creation and maintenance of a Union pool of experts / h) examine, on its own initiative or upon the request of its management board or the Commission, questions relating to the implementation of this Regulation and to issue opinions, recommendations or written co…

Article 56 c (new): Article 56 c / Accountability, independence, and transparency / 1. The AI Office shall: / a. be accountable to the European Parliament and to the Council in accordance with this Regulation; / b. act independently when carrying out its tasks or exercising its powers; and / c. ensure a high level of transparency concerning its activities and develop good administrative practices in that regard. / Regulation (EC) No 1049/2001 shall apply to documents held by the AI Office.

Article - 57 a (new) – SECTION 2 – title: Title / SECTION 2: Management Board

Article - 57 a (new): Article - 57 a / Composition of the management board / 1. The management board shall be composed of the following members: / (a) one representative of each Member State’s national supervisory authority; / (b) one representative from the Commission; / (c) one representative from the European Data Protection Supervisor (EDPS); / (d) one representative from the European Union Agency for Cybersecurity (ENISA); / (e) one representative from the Fundamental Rights Agency (FRA) / Each representative of a national supervisory authority shall have one vote. The representatives of the Commission, the EDPS, the ENISA and the FRA shall not have voting rights. Each member shall have a substitute. The appointment of members and substitute members of the management board shall take into account the need to gender balance. The members of the management board and their substitute members shall be made public. / 2. The members and substitutes members of the management board shall not hold conflicting positions or commercial interests with regard to any topic related to the application of this Regulation. / 3. The rules for the meetings and voting of the management board and the appointment and removal of the Executive Director shall be laid down in the rules of procedure referred to in Article – 57 b, point (a).

Article - 57 b (new): Article - 57 b / Functions of the management board / 1. The management board shall have the following tasks: / (a) to make strategic decisions on the activities of the AI Office and to adopt its rules of procedure by a two-thirds majority of its members; / (b) to implement its rules of procedure; / (c) to adopt the AI Office’s single programming document as well as it annual public report and transmit both to the European Parliament, to the Council, to the Commission, and to the Court of Auditors; / (d) to adopt the AI Office’s budget; / (e) to appoint the executive director and, where relevant, to extend or curtail the executive director’s term of office or remove him or her from office; / (f) to decide on the establishment of the AI Office’s internal structures and, where necessary, the modification of those internal structures necessary for the fulfilment of the AI Office tasks;

Article - 57 c (new): Article - 57 c / Chair of the management board / 1. The management board shall elect a Chair and two deputy Chairs from among its voting members, by simple majority. / 2. The term of office of the Chair and of the deputy Chairs shall be four years. The terms of the Chair and of the deputy Chairs renewable once.

Article 57 – SECTION 3 – title: Secretariat

Article 57 – paragraph 1: 1. The activities of the secretariat shall be managed by an executive director. The executive director shall be accountable to the management board. Without prejudice to the respective powers of the management board and the Union institutions, the executive director shall neither seek nor take instructions from any government or from any other body

Article 57 – paragraph 2: 2. The executive director shall attend hearings on any matter linked to the AI Office's activities and shall report on the performance of the executive director’s duties when invited to do so by the European Parliament or the Council.

Article 57 – paragraph 3: 3. The executive director shall represent the AI Office, including in international fora for cooperation with regard to artificial intelligence;

Article 57 – paragraph 4: 4. The secretariat shall provide the management board and the advisory forum with the analytical, administrative and logistical support necessary to fulfil the tasks of the AI Office, including by: / (a) Implementing the decisions, programmes and activities adopted by the management board; / (b) preparing each year the draft single programming document, the draft budget, the annual activity report on the AI Office, the draft opinions and the draft positions of the AI Office, and submit them to the management board / (c) Coordinating with international fora for cooperation on artificial intelligence;

Article 58 – SECTION 4 – title: Advisory Forum

Article 58 – paragraph 1 – introductory part: The advisory forum shall provide the AI Office with stakeholder input in matters relating to this Regulation, in particular with regard to the tasks set out in Article 56b point (l).

Article 58 – paragraph 2 (new): The membership of the advisory forum shall represent a balanced selection of stakeholders, including industry, start-ups, SMEs, civil society, the social partners 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.

Article 58 – paragraph 3 (new): The management board shall appoint the members of the advisory forum in accordance with the selection procedure established in the AI Office’s rules of procedure and taking into account the need for transparency and in accordance with the criteria set out in paragraph 2;

Article 58 – paragraph 4 (new): 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.

Article 58 – paragraph 5 (new): 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. The Joint Research Centre shall be permanent member, without voting rights.

Article 58 – paragraph 6 (new): 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.

Article 58 – paragraph 7 (new): The advisory forum shall hold meetings at least four times a year. The advisory forum may invite experts and other stakeholders to its meetings. The executive director may attend, ex officio, the meetings of the advisory forum.

Article 58 – paragraph 8 (new): In fulfilling its role as set out in paragraph 1, the advisory forum may prepare opinions, recommendations and written contributions.

Article 58 – paragraph 9 (new): 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.

Article 58 – paragraph 10 (new): The advisory forum shall prepare an annual report of its activities. That report shall be made publicly available.

Article 58 a – SECTION 5 – title: European Authorities on benchmarking

Article 58 a (new): Article 58 a / Benchmarking / The European authorities on benchmarking referred to in Article 15 (1a) and the AI Office shall, in close cooperation with international partners, jointly develop cost-effective guidance and capabilities to measure and benchmark aspects of AI systems and AI components, and in particular of foundation models relevant to the compliance and enforcement of this Regulation based on the generally acknowledged state of the art, including as reflected in relevant harmonized standards.

Article 59 – title: Designation of national supervisory authorities

Article 59 – paragraph 1: 1. Each Member State shall designate one national supervisory authority, which shall be organised so as to safeguard the objectivity and impartiality of its activities and tasks by ...[three months after the date of entry into force of this Regulation].

Article 59 – paragraph 2: 2. The national supervisory authority shall ensure the application and implementation of this Regulation. With regard to high-risk AI systems, related to products to which legal acts listed in Annex II apply, the competent authorities designated under those legal acts shall continue to lead the administrative procedures. However, to the extent a case involves aspects exclusively covered by this Regulation, those competent authorities shall be bound by the measures related to those aspects issued by the national supervisory authority designated under this Regulation. The national supervisory authority shall act as market surveillance authority.

Article 59 – paragraph 3: 3. Member States shall make publicly available and communicate to the AI Office and the Commission the national supervisory authority and information on how it can be contacted, by… [three months after the date of entry into force of this Regulation]. The national supervisory authority shall act as single point of contact for this Regulation and should be contactable though electronic communications means.

Article 59 – paragraph 4: 4. Member States shall ensure that the national supervisory authority is provided with adequate technical, financial and human resources, and infrastructure to fulfil their tasks effectively under this Regulation. In particular, the national supervisory 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, competition law, 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.

Article 59 – paragraph 4 a (new): 4 a. Each national supervisory authority shall exercise their powers and carry out their duties independently, impartially and without bias. The members of each national supervisory authority, in the performance of their tasks and exercise of their powers under this Regulation, shall neither seek nor take instructions from any body and shall refrain from any action incompatible with their duties.

Article 59 – paragraph 4 b (new): 4 b. National supervisory authorities shall satisfy the minimum cybersecurity requirements set out for public administration entities identified as operators of essential services pursuant to Directive (EU) 2022/2555.

Article 59 – paragraph 4 c (new): 4 c. When performing their tasks, the national supervisory authority shall act in compliance with the confidentiality obligations set out in Article 70.

Article 59 – paragraph 5: 5. Member States shall report to the Commission on an annual basis on the status of the financial and human resources of the national supervisory authority with an assessment of their adequacy. The Commission shall transmit that information to the AI Office for discussion and possible recommendations.

Article 59 – paragraph 6: deleted

Article 59 – paragraph 7: 7. National supervisory authorities may provide guidance and advice on the implementation of this Regulation, including to SMEs and start-ups, taking into account the AI Office or the Commission’s guidance and advice. Whenever the national supervisory authority intend to provide guidance and advice with regard to an AI system in areas covered by other Union law, the guidance shall be drafted in consultation with the competent national authorities under that Union law, as appropriate.

Article 59 – paragraph 8: 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 and coordination.

Article 59 a (new): Article 59 a / Cooperation mechanism between national supervisory authorities in cases involving two or more Member States / 1. Each national supervisory authority shall perform its tasks and powers conferred on in accordance with this Regulation on the territory of its own Member State. / 2. In the event of a case involving two or more national supervisory authorities, the national supervisory authority of the Member State where the infringement took place shall be considered the lead supervisory authority. / 3. In the cases referred to in paragraph 2, the relevant supervisory authorities shall cooperate and exchange all relevant information in due time. National supervisory authorities shall cooperate in order to reach a consensus.

Title VII: EU DATABASE FOR HIGH-RISK AI SYSTEMS

Article 60 – title: EU database for high-risk AI systems

Article 60 – paragraph 1: 1. The Commission shall, in collaboration with the Member States, set up and maintain a public 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 Article 51.

Article 60 – paragraph 2: 2. The data listed in Annex VIII, Section A, shall be entered into the EU database by the providers.

Article 60 – paragraph 2 a (new): 2 a. The data listed in Annex VIII, Section B, shall be entered into the EU database by the deployers who are or who act on behalf of public authorities or Union institutions, bodies, offices or agencies and by deployers who are undertakings referred to in Article 51(1a) and (1b).

Article 60 – paragraph 3: 3. Information contained in the EU database shall be freely available to the public, user-friendly and accessible, easily navigable and machine-readable containing structured digital data based on a standardised protocol.

Article 60 – paragraph 4: 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 which is a public authority or Union institution, body, office or agency or a deployer acting on their behalf or a deployer which is an undertaking referred to in Article 51(1a)(b) and (1b).

Article 60 – paragraph 5: 5. The Commission shall be the controller of the EU database. It shall also ensure to providers and deployers adequate technical and administrative support. / The database shall comply with the accessibility requirements of Annex I to Directive (EU) 2019/882.

Article 61 – paragraph 2: 2. The post-market monitoring system shall actively and systematically collect, document and analyse relevant data provided by deployers or 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 environment, including other devices and software taking into account the rules applicable from areas such as data protection, intellectual property rights and competition law.

Article 61 – paragraph 3: 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 [twelve months after the date of entry into force of this Regulation].

Article 62 – title: Reporting of serious incidents

Article 62 – paragraph 1 – introductory part: 1. Providers and, where deployers have identified a serious incident, deployers of high-risk AI systems placed on the Union market shall report any serious incident of those systems which constitutes a breach of obligations under Union law intended to protect fundamental rights to the national supervisory authority of the Member States where that incident or breach occurred.

Article 62 – paragraph 1 – subparagraph 1: Such notification shall be made without undue delay after the provider, or, where applicable the deployer, has established a causal link between the AI system and the incident or the reasonable likelihood of such a link, and, in any event, not later than 72 hours after the provider or, where applicable, the deployer becomes aware of the serious incident.

Article 62 – paragraph 1 a (new): 1 a. Upon establishing a causal link between the AI system and the serious incident or the reasonable likelihood of such a link, providers shall take appropriate corrective actions pursuant to Article 21.

Article 62 – paragraph 2: 2. Upon receiving a notification related to a breach of obligations under Union law intended to protect fundamental rights, the national supervisory 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 by [the entry into force of this Regulation] and shall be assessed regularly.