in force 2026-05-29 INSERTED+4,575 −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 43d has been inserted, empowering the Commission to adopt implementing acts listing standards or establishing common specifications for subsystems and safety components designated as crisis-relevant goods, applicable where harmonised standards are unpublished or unavailable within a reasonable time, or where severe internal market disruptions restrict manufacturers' use of already-published harmonised standards.
The new article sets out how such implementing acts are adopted, how long they apply, the consultation steps preceding their preparation, the resulting presumption of conformity and its cessation after the internal market emergency mode ends, a derogation concerning goods already placed on the market, and a procedure for Member States to flag inadequacies in a listed standard or common specification.
Cited: Art. 43d, v2
text before / after
inserted text (02016R0424-20260529)
Article 43d Presumption of conformity based on standards and common specifications 1. Where subsystems and safety components have been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts, listing appropriate standards or establishing common specifications for such subsystems and safety components to cover the applicable essential requirements set out in Annex II to this Regulation in the following cases: (a) where a reference to harmonised standards covering the applicable essential requirements set out in Annex II to this Regulation has not been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable period; or (b) where severe disruptions to the functioning of the internal market, which led to the activation of the internal market emergency mode in accordance with Article 18 of Regulation (EU) 2024/2747, significantly restrict the possibilities of manufacturers to make use of the harmonised standards that cover the applicable essential requirements set out in Annex II to this Regulation and the references of which have already been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012. 2. The implementing acts referred to in paragraph 1 shall set out the most appropriate alternative technical solution for the purposes of providing a presumption of conformity in accordance with paragraph 5. To that end, references of European standards or references of relevant applicable national or international standards may be published in those implementing acts or, if there is no European standard or relevant applicable national or international standard, common specifications may be established by those implementing acts. 3. The implementing acts referred to in paragraph 1 of this Article shall be adopted in accordance with the examination procedure referred to in Article 44(3) and shall apply until the last day of the period during which the internal market emergency mode is activated, unless such implementing acts are amended or repealed in accordance with paragraph 7 of this Article. 4. Before preparing the draft implementing act referred to in paragraph 1 of this Article, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers that the conditions in paragraph 1 of this Article have been fulfilled. When preparing that draft implementing act, the Commission shall take into account the views of relevant bodies or expert groups established under this Regulation and shall duly consult all relevant stakeholders. 5. Without prejudice to Article 17, subsystems and safety components that are in conformity with the standards or common specifications referred to in paragraph 1 of this Article, or parts thereof, shall be presumed to be in conformity with the applicable essential requirements set out in Annex II that are covered by those standards, common specifications or parts thereof. From the day following the expiry or deactivation of the internal market emergency mode, it shall no longer be possible for manufacturers to rely on the presumption of conformity provided by the standards or the common specifications referred to in the implementing acts referred to in paragraph 1 of this Article. 6. By way of derogation from Article 43a(3), first subparagraph, unless there is sufficient reason to believe that the subsystems or safety components, covered by the standards or common specifications referred to in paragraph 1 of this Article, present a risk to the health or safety of persons, the subsystems or safety components that are in conformity with those standards or common specifications and which have been placed on the market, shall be deemed to be in conformity with the applicable essential requirements set out in Annex II after the expiry or repeal of an implementing act adopted pursuant to paragraph 3 of this Article and after the expiry or deactivation of the internal market emergency mode. 7. When a Member State considers that a standard or common specification referred to in paragraph 1 does not entirely satisfy the applicable essential requirements set out in Annex II, it shall inform the Commission thereof by submitting a detailed explanation. The Commission shall assess that detailed explanation and may, if appropriate, amend or repeal the implementing act listing the standard or establishing the common specification in question.