in force 2026-05-29 INSERTED+2,438 −0§
Amended by Regulation (EU) 2024/2748 32024R2748
applies from: unknown (an inserted provision states its own application date only in prose)
Sources disagree — the text comparison and the amending act's instructions found this change; the EU's own amendment metadata does not list it. All are shown; none is overruled.
A new Article 8b establishes that, alongside the presumption of conformity under Article 7, conformity with the general safety requirement in Article 5 may also be presumed where severe internal market disruptions considered when activating the internal market emergency mode significantly restrict manufacturers' ability to use published European standards, provided the product conforms to national health and safety requirements compliant with Union law.
The new provision also directs Member States to ensure their competent authorities treat compliance with certain other European, international, or national standards as presumption of conformity with the general safety requirement for the risks those standards cover, unless the standards are inadequate under the other elements of Articles 6 and 8.
It further states that Article 7(3) applies to the presumption of conformity established under this new Article 8b.
Cited: Art. 8b, v2
text before / after
inserted text (02023R0988-20260529)
Article 8b Presumption of conformity with the general safety requirement in the context of an internal market emergency 1. In addition to the presumption of conformity laid down in Article 7 of this Regulation, where severe disruptions to the functioning of the internal market, which were taken into consideration when the internal market emergency mode was activated in accordance with Article 18 of Regulation (EU) 2024/2747, significantly restrict the possibilities for manufacturers to make use of relevant European standards the references of which have already been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012, the presumption of conformity with the general safety requirement laid down in Article 5 may also be established for the purpose of placing products on the market if the product conforms to national requirements as regards the risks and risk categories covered by health and safety requirements laid down in the national law of the Member State in which the product is made available on the market, provided that such law is in compliance with Union law. 2. In addition to the cases where the presumption of conformity with the general safety requirement laid down in Article 5 of this Regulation applies under paragraph 1 of this Article and Article 7(1) of this Regulation, Member States shall take all appropriate measures to ensure that, for the purpose of placing or making available of products on the market, their competent authorities consider that products which comply with relevant European standards other than those the references of which have been published in the Official Journal of the European Union in accordance with Article 10(7) of Regulation (EU) No 1025/2012, with relevant international standards developed by a recognised international standardisation body as defined in Article 2(9) of Regulation (EU) No 1025/2012, or with relevant national standards developed by a national standardisation body as defined in Article 2(10) of Regulation (EU) No 1025/2012, are presumed to meet the general safety requirement laid down in this Regulation as far as the risks and risk categories covered by those standards are concerned, unless such standards are not adequate in view of the other elements of Articles 6 and 8 of this Regulation. 3. Article 7(3) applies to the presumption of conformity established in accordance with this Article.