in force 2026-07-27 MODIFIED+1,386 −0§
Amended by Digital Omnibus on AI 32026R1744
applies from: unknown (the text changed beyond its dates, so no date that moved can be read as the application date)
dates added to the text: 2024-06-13, 2028-08-02
The provision adds two new paragraphs empowering the Commission to adopt delegated acts amending Annex III to add health and safety requirements for Artificial Intelligence systems classified as high-risk under Article 6(1) of Regulation (EU) 2024/1689, where those systems are safety components or products covered by this Regulation, with those requirements to reflect specified provisions of that Regulation.
A further new paragraph requires the Commission, when adopting those delegated acts, to take into account the objectives of Regulation (EU) 2024/1689 and to ensure a consistent level of protection, and states that the delegated acts shall apply by 2 August 2028.
The first two paragraphs on essential health and safety requirements for machinery, related products, and partly completed machinery remain unchanged between the two versions.
Cited: Art. 8, v2 · Art. 8, v1
text before / after
texts differ too much for an inline diff; shown separately
before (02023R1230-20260529)
Article 8 Essential health and safety requirements for products within the scope of this Regulation Machinery or related products shall only be made available on the market or put into service if, where properly installed and maintained and used for their intended use or under conditions which can reasonably be foreseen, they meet the essential health and safety requirements set out in Annex III. Partly completed machinery shall only be made available on the market if it meets the relevant essential health and safety requirements set out in Annex III.
after (02023R1230-20260727)
Article 8 Essential health and safety requirements for products within the scope of this Regulation Machinery or related products shall only be made available on the market or put into service if, where properly installed and maintained and used for their intended use or under conditions which can reasonably be foreseen, they meet the essential health and safety requirements set out in Annex III. Partly completed machinery shall only be made available on the market if it meets the relevant essential health and safety requirements set out in Annex III. 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 CouncilRegulation (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). 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.