Changes from plenary report to adopted text

Article 1 – paragraph 1 – point 25 – point c, Article 75 – paragraph – 1c: 1c. The Commission shall, subject to Article 28(8), ensure that pre-market conformity assessments and tests of AI systems referred to in paragraph 1 that are classified as high-risk and subject to third-party conformity assessment under Article 43 are carried out before such AI systems are placed on the market or put into service. These tests and assessments shall verify that the systems comply with the relevant requirements of this Regulation and may be placed on the market or put into service in the Union in accordance with this Regulation. The Commission shall entrust the performance of these tests or assessments to notified bodies designated under this Regulation, in which case the notified body shall act on behalf of the Commission. Article 34(1) and (2) shall apply mutatis mutandis to the Commission when exercising its powers under this paragraph.

Regulation (EU) 2024/1689

Article 1 – paragraph 1 – point 26 – point b, Article 77 – paragraph 1 – point b: 1. National public authorities or bodies which supervise or enforce the respect of obligations under Union law protecting fundamental rights, including the right to non-discrimination, shall have the power to make a request and access any information or documentation created or maintained from the relevant market surveillance authority under this Regulation in accessible language and machine-readable format by electronic means where access to that information or documentation is necessary for effectively fulfilling their mandates within the limits of their jurisdiction. This paragraph is without prejudice to the tasks, powers and independence of the relevant national public authorities or bodies under their mandates in accordance with Union and national law;

Regulation (EU) 2024/1689

Article 1 – paragraph 1 – point 26 – point c – introductory part, Article 77 – paragraph 1a (new): (c) the following paragraph 1a, 1b and 1ba are inserted:

Regulation (EU) 2024/1689

Article 1 – paragraph 1 – point 26 – point c, Article 77 – paragraph 1a (new): 1a. Subject to the conditions specified in this Article, the market surveillance authority shall grant the relevant public authority or body referred to in paragraph 1 access to such information or documentation, including by requesting such information or documentation from the provider or the deployer, where necessary and without undue delay.

Regulation (EU) 2024/1689

Article 1 – paragraph 1 – point 26 – point c, Article 77 – paragraph 1b (new): 1b. Market surveillance authorities and public authorities or bodies referred to in paragraph 1 shall cooperate closely and provide each other with mutual assistance necessary for fulfilling their respective mandates, with a view to ensuring coherent application of this Regulation and Union law protecting fundamental rights and streamlining procedures while respecting their respective competences, tasks, powers and independence. This shall include, in particular, exchange of information where necessary for the effective supervision or enforcement of this Regulation and the respective other Union legislation.;

Regulation (EU) 2024/1689

Article 1 – paragraph 1 – point 26 – point c, Article 77 – paragraph 1b a (new): 1ba. Requests for assistance shall contain all the necessary information, including the purpose of and reasons for the request.

Regulation (EU) 2024/1689

Article 1 – paragraph 1 – point 28 – introductory part, Article 96 – paragraph 1: (28) in Article 96(1), point (a) and the second subparagraph are replaced by the following:

Regulation (EU) 2024/1689

Regulation (EU) 2024/1689

Article 1 – paragraph 1 – point 28, Article 96 – paragraph 1 – subparagraph 1: -1a. in Article 96, paragraph 1, subparagraph 1, the following point is inserted: / ‘(fa) the application of the obligations referred to in Article 27, including the possibility to reference or include relevant sections or parts of the data protection impact assessment into the fundamental rights impact assessment pursuant to Article 27(4) of this Regulation, using, where relevant, standardised templates. ’

Regulation (EU) 2024/1689

Article 1 – paragraph 1 – point 29 – point a a (new), Article 99 – paragraph 4 – point da (new): (aa) in paragraph 4 the following point (da) is inserted: / ‘(da) obligations of providers and third parties, including providers of general purpose AI models, pursuant to Article 25(2), (3) and (4); ’

Regulation (EU) 2024/1689

Article 1 – paragraph 1 – point 29 – point b, Article 99 – paragraph 6: 6. In the case of and 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.;

Regulation (EU) 2024/1689

Article 1 – paragraph 1 – point 29 – point b, Article 99 – paragraph 6 a (new): 6a. In Article 99, paragraph 6a is inserted: / ‘In the case of SMCs, with the exception of providers of general-purpose AI models with systemic risk, each fine referred to in this Article shall be up to the percentages or amount referred to in paragraphs 4 and 5, whichever is lower.’

Regulation (EU) 2024/1689

Regulation (EU) 2024/1689

Article 1 – paragraph 1 – point 30 – point b, Article 111 – paragraph 4 (new): 4. Providers of AI systems, including general-purpose AI systems, generating synthetic audio, image, video or text content, that have been placed on the market before 2 August 2026 shall take the necessary steps in order to comply with Article 50(2) by 2 November 2026.;

Regulation (EU) 2024/1689

Article 1 – paragraph 1 – point 31 – point a, Article 113 – paragraph 3 – point d (new): Chapter III, Sections 1, 2, and 3, with the exception of Article 6(5), shall apply;

Regulation (EU) 2024/1689

Article 1 – paragraph 1 – point 31 – point a, Article 113 – paragraph 3 – point d – point i (new): deleted

Regulation (EU) 2024/1689

Article 1 – paragraph 1 – point 31 – point a, Article 113 – paragraph 3 – point d – point ii (new): deleted

Regulation (EU) 2024/1689

Article 1 – paragraph 1 – point 31 – point a, Article 113 – paragraph 3 – point d – subparagraph 1 – introductory part: deleted

Regulation (EU) 2024/1689

Article 1 – paragraph 1 – point 31 a (new), Annex I – Section A: (31 a) In Annex I, Section A is deleted

Regulation (EU) 2024/1689

Article 1 – paragraph 1 – point 31 b (new), Annex I – Section B – point 20 a (new): (31b) In Annex I, Section B, the following points are added: / ‘20a. 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); / 20b. 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); / 20c. 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); / 20d. 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); / 20e. 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); / 20f. 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); / 20g. 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 relati…

Regulation (EU) 2024/1689

Article 1 – paragraph 1 – point 32, Annex VIII – section B: (32) in Annex VIII, section B, points 7 and 9 are deleted;