Author: AI Act

1. The Commission may request the provider of the general-purpose AI model concerned to provide the documentation drawn up by the provider in accordance with Articles 53 and 55, or any additional information that is necessary for the purpose of assessing compliance of the provider with this Regulation.

2. Before sending the request for information, the AI Office may initiate a structured dialogue with the provider of the general-purpose AI model.

3. Upon a duly substantiated request from the scientific panel, the Commission may issue a request for information to a provider of a general-purpose AI model, where the access to information is necessary and proportionate for the fulfilment of the tasks of the scientific panel under Article 68(2).

4. The request for information shall state the legal basis and the purpose of the request, specify what information is required, set a period within which the information is to be provided, and indicate the fines provided for in Article 101 for supplying incorrect, incomplete or misleading information.

5. The provider of the general-purpose AI model concerned, or its representative shall supply the information requested. In the case of legal persons, companies or firms, or where the provider has no legal personality, the persons authorised to represent them by law or by their statutes, shall supply the information requested on behalf of the provider of the general-purpose AI model concerned. Lawyers duly authorised to act may supply information on behalf of their clients. The clients shall nevertheless remain fully responsible if the information supplied is incomplete, incorrect or misleading.

1. The AI Office, after consulting the Board, may conduct evaluations of the general-purpose AI model concerned:

(a) to assess compliance of the provider with obligations under this Regulation, where the information gathered pursuant to Article 91 is insufficient; or,

(b) to investigate systemic risks at Union level of general-purpose AI models with systemic risk, in particular following a qualified alert from the scientific panel in accordance with Article 90(1), point (a).

2. The Commission may decide to appoint independent experts to carry out evaluations on its behalf, including from the scientific panel established pursuant to Article 68. Independent experts appointed for this task shall meet the criteria outlined in Article 68(2).

3. For the purposes of paragraph 1, the Commission may request access to the general-purpose AI model concerned through APIs or further appropriate technical means and tools, including source code.

4. The request for access shall state the legal basis, the purpose and reasons of the request and set the period within which the access is to be provided, and the fines provided for in Article 101 for failure to provide access.

5. The providers of the general-purpose AI model concerned or its representative shall supply the information requested. In the case of legal persons, companies or firms, or where the provider has no legal personality, the persons authorised to represent them by law or by their statutes, shall provide the access requested on behalf of the provider of the general-purpose AI model concerned.

6. The Commission shall adopt implementing acts setting out the detailed arrangements and the conditions for the evaluations, including the detailed arrangements for involving independent experts, and the procedure for the selection thereof. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).

7. Prior to requesting access to the general-purpose AI model concerned, the AI Office may initiate a structured dialogue with the provider of the general-purpose AI model to gather more information on the internal testing of the model, internal safeguards for preventing systemic risks, and other internal procedures and measures the provider has taken to mitigate such risks.

1. Where necessary and appropriate, the Commission may request providers to:

(a) take appropriate measures to comply with the obligations set out in Articles 53 and 54;

(b) implement mitigation measures, where the evaluation carried out in accordance with Article 92 has given rise to serious and substantiated concern of a systemic risk at Union level;

(c) restrict the making available on the market, withdraw or recall the model.

2. Before a measure is requested, the AI Office may initiate a structured dialogue with the provider of the general-purpose AI model.

3. If, during the structured dialogue referred to in paragraph 2, the provider of the general-purpose AI model with systemic risk offers commitments to implement mitigation measures to address a systemic risk at Union level, the Commission may, by decision, make those commitments binding and declare that there are no further grounds for action.

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

1. The Commission shall develop guidelines on the practical implementation of this Regulation, and in particular on:

(a) the application of the requirements and obligations referred to in Articles 8 to 15 and in Article 25;

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

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

(d) the practical implementation of transparency obligations laid down in Article 50;

(e) detailed information on the relationship of this Regulation with the Union harmonisation legislation listed in Annex I, as well as with other relevant Union law, including as regards consistency in their enforcement;

(f) the application of the definition of an AI system as set out in Article 3, point (1). When issuing such guidelines, the Commission shall pay particular attention to the needs of SMEs including start-ups, of local public authorities and of the sectors most likely to be affected by this Regulation. The guidelines referred to in the first subparagraph of this paragraph shall take due account of the generally acknowledged state of the art on AI, as well as of relevant harmonised standards and common specifications that are referred to in Articles 40 and 41, or of those harmonised standards or technical specifications that are set out pursuant to Union harmonisation law.

2. At the request of the Member States or the AI Office, or on its own initiative, the Commission shall update guidelines previously adopted when deemed necessary.

1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2. The power to adopt delegated acts referred to in Article 6(6) and (7), Article 7(1) and (3), Article 11(3), Article 43(5) and (6), Article 47(5), Article 51(3), Article 52(4) and Article 53(5) and (6) shall be conferred on the Commission for a period of five years from 1 August 2024. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

3. The delegation of power referred to in Article 6(6) and (7), Article 7(1) and (3), Article 11(3), Article 43(5) and (6), Article 47(5), Article 51(3), Article 52(4) and Article 53(5) and (6) may be revoked at any time by the European Parliament or by the Council. A decision of revocation shall put an end to the delegation of power specified in that decision. It shall take effect the day following that of its publication in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.

5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6. Any delegated act adopted pursuant to Article 6(6) or (7), Article 7(1) or (3), Article 11(3), Article 43(5) or (6), Article 47(5), Article 51(3), Article 52(4) or Article 53(5) or (6) shall enter into force only if no objection has been expressed by either the European Parliament or the Council within a period of three months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by three months at the initiative of the European Parliament or of the Council.

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.

1. In accordance with the terms and conditions laid down in this Regulation, Member States shall lay down the rules on penalties and other enforcement measures, which may also include warnings and non-monetary measures, applicable to infringements of this Regulation by operators, and shall take all measures necessary to ensure that they are properly and effectively implemented, thereby taking into account the guidelines issued by the Commission pursuant to Article 96. The penalties provided for shall be effective, proportionate and dissuasive. They shall take into account the interests of SMEs, including start-ups, and their economic viability.

2. The Member States shall, without delay and at the latest by the date of entry into application, notify the Commission of the rules on penalties and of other enforcement measures referred to in paragraph 1, and shall notify it, without delay, of any subsequent amendment to them.

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

4. Non-compliance with any of the following provisions related to operators or notified bodies, other than those laid down in Articles 5, shall be subject to administrative fines of up to 15 000 000 EUR or, if the offender is an undertaking, up to 3 % of its total worldwide annual turnover for the preceding financial year, whichever is higher:

(a) obligations of providers pursuant to Article 16;

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

(c) obligations of importers pursuant to Article 23;

(d) obligations of distributors pursuant to Article 24;

(e) obligations of deployers pursuant to Article 26;

(f) requirements and obligations of notified bodies pursuant to Article 31, Article 33(1), (3) and (4) or Article 34;

(g) transparency obligations for providers and deployers pursuant to Article 50.

5. The supply of incorrect, incomplete or misleading information to notified bodies or national competent authorities in reply to a request shall be subject to administrative fines of up to 7 500 000 EUR or, if the offender is an undertaking, up to 1 % of its total worldwide annual turnover for the preceding financial year, whichever is higher.

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

7. When deciding whether to impose an administrative fine and when deciding on the amount of the administrative fine in each individual case, all relevant circumstances of the specific situation shall be taken into account and, as appropriate, regard shall be given to the following:

(a) the nature, gravity and duration of the infringement and of its consequences, taking into account the purpose of the AI system, as well as, where appropriate, the number of affected persons and the level of damage suffered by them;

(b) whether administrative fines have already been applied by other market surveillance authorities to the same operator for the same infringement;

(c) whether administrative fines have already been applied by other authorities to the same operator for infringements of other Union or national law, when such infringements result from the same activity or omission constituting a relevant infringement of this Regulation;

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

(e) any other aggravating or mitigating factor applicable to the circumstances of the case, such as financial benefits gained, or losses avoided, directly or indirectly, from the infringement;

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

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

(h) the manner in which the infringement became known to the national competent authorities, in particular whether, and if so to what extent, the operator notified the infringement;

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

(j) any action taken by the operator to mitigate the harm suffered by the affected persons.

8. Each Member State shall lay down rules on to what extent administrative fines may be imposed on public authorities and bodies established in that Member State.

9. Depending on the legal system of the Member States, the rules on administrative fines may be applied in such a manner that the fines are imposed by competent national courts or by other bodies, as applicable in those Member States. The application of such rules in those Member States shall have an equivalent effect.

10. The exercise of powers under this Article shall be subject to appropriate procedural safeguards in accordance with Union and national law, including effective judicial remedies and due process.

11. Member States shall, on an annual basis, report to the Commission about the administrative fines they have issued during that year, in accordance with this Article, and about any related litigation or judicial proceedings.

1. The European Data Protection Supervisor may impose administrative fines on Union institutions, bodies, offices and agencies falling within the scope of this Regulation. When deciding whether to impose an administrative fine and when deciding on the amount of the administrative fine in each individual case, all relevant circumstances of the specific situation shall be taken into account and due regard shall be given to the following:

(a) the nature, gravity and duration of the infringement and of its consequences, taking into account the purpose of the AI system concerned, as well as, where appropriate, the number of affected persons and the level of damage suffered by them;

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

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

(d) the degree of cooperation with the European Data Protection Supervisor in order to remedy the infringement and mitigate the possible adverse effects of the infringement, including compliance with any of the measures previously ordered by the European Data Protection Supervisor against the Union institution, body, office or agency concerned with regard to the same subject matter;

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

(f) the manner in which the infringement became known to the European Data Protection Supervisor, in particular whether, and if so to what extent, the Union institution, body, office or agency notified the infringement;

(g) the annual budget of the Union institution, body, office or agency.

2. Non-compliance with the prohibition of the AI practices referred to in Article 5 shall be subject to administrative fines of up to EUR 1 500 000.

3. The non-compliance of the AI system with any requirements or obligations under this Regulation, other than those laid down in Articles 5, shall be subject to administrative fines of up to EUR 750 000.

4. Before taking decisions pursuant to this Article, the European Data Protection Supervisor shall give the Union institution, body, office or agency which is the subject of the proceedings conducted by the European Data Protection Supervisor the opportunity of being heard on the matter regarding the possible infringement. The European Data Protection Supervisor shall base his or her decisions only on elements and circumstances on which the parties concerned have been able to comment. Complainants, if any, shall be associated closely with the proceedings.

5. The rights of defence of the parties concerned shall be fully respected in the proceedings. They shall be entitled to have access to the European Data Protection Supervisor’s file, subject to the legitimate interest of individuals or undertakings in the protection of their personal data or business secrets.

6. Funds collected by imposition of fines in this Article shall contribute to the general budget of the Union. The fines shall not affect the effective operation of the Union institution, body, office or agency fined.

7. The European Data Protection Supervisor shall, on an annual basis, notify the Commission of the administrative fines it has imposed pursuant to this Article and of any litigation or judicial proceedings it has initiated.