(1)

in Article 8, the following paragraphs are added: ‘The Commission shall adopt delegated acts in accordance with Article 47 of this Regulation to amend Annex III to this Regulation by adding health and safety requirements in respect of Artificial Intelligence (AI) systems that are classified as high-risk pursuant to Article 6(1) of Regulation (EU) 2024/1689 of the European Parliament and of the Council (*3) due to the fact that they are a safety component in a product covered by this Regulation, or they are themselves a product covered by this Regulation. Those requirements shall ensure that the relevant requirements set out in Chapter III, Section 2, and Articles 17, 19, 72 and 73 of Regulation (EU) 2024/1689 are reflected. When adopting the delegated acts referred to in the third paragraph, the Commission shall take into account the objectives of Regulation (EU) 2024/1689 and ensure a level of protection consistent with that Regulation. Those delegated acts shall apply by 2 August 2028. (*3) Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj).’;"

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Source: EUR-Lex (Cellar) · retrieved 2026-10-14 · Text as adopted (Official Journal); later amendments are not incorporated in this text.