Amendments to Regulation (EU) 2023/1230
Article 3
Regulation (EU) 2023/1230 is amended as follows: (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 ).’;" (2) in Article 20, the following paragraph is added: ‘10. Until harmonised standards or common specifications are referenced or adopted pursuant to this Article as regards high-risk AI systems, high-risk AI systems within the scope of this Regulation which comply with the relevant harmonised standards referenced, or common specifications adopted pursuant to Articles 40 and, respectively, 41 of Regulation (EU) 2024/1689 shall be presumed to be in conformity with the essential health and safety requirements set out in Annex III to this Regulation as regards high-risk AI systems.’ ; (3) Article 47 is amended as follows: (a) paragraphs 2 and 3 are replaced by the following: ‘2. The power to adopt delegated acts referred to in Article 6(2) and (11) and Article 7(2), shall be conferred on the Commission for a period of five years from 19 July 2023. The power to adopt delegated acts referred to in Article 8, third paragraph, shall be conferred on the Commission for a period of five years from 27 July 2026. 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 no later than three months before the end of each period. 3. The delegation of power referred to in Article 6(2) and (11), Article 7(2) and Article 8, third paragraph, may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision 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.’ ; (b) paragraph 6 is replaced by the following: ‘6. A delegated act adopted pursuant to Article 6(2) and (11), Article 7(2) or Article 8, third paragraph, shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two 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 two months at the initiative of the European Parliament or of the Council.’.