Regulation (EU) 2023/988 ／ 第IIa章 — 緊急時手続
第8b条 域内市場緊急事態における一般安全要件への適合の推定
Article 8B — Presumption of conformity with the general safety requirement in the context of an internal market emergency
1. 本規則第7条に定める適合の推定に加えて、規則（EU）2024/2747第18条に従い域内市場緊急モードが発動された際に考慮された域内市場の機能の深刻な混乱により、規則（EU）No 1025/2012に従いすでに欧州連合官報にその参照が公表されている関連する欧州規格を製造業者が利用する可能性が著しく制限される場合には、製品の上市の目的で、製品が市場で提供される加盟国の国内法に定める安全衛生要件の対象となるリスク及びリスクの区分に関する国内要件に当該製品が適合するときは、当該国内法が連合法に適合していることを条件として、第5条に定める一般安全要件への適合の推定を確立することもできる。
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. 本条第1項及び本規則第7条第1項に基づき本規則第5条に定める一般安全要件への適合の推定が適用される場合に加えて、加盟国は、製品の上市又は市場での提供の目的で、規則（EU）No 1025/2012第10条第7項に従い欧州連合官報にその参照が公表されたもの以外の関連する欧州規格、規則（EU）No 1025/2012第2条第9号に定義する承認された国際標準化機関が作成した関連する国際規格、又は規則（EU）No 1025/2012第2条第10号に定義する国家標準化機関が作成した関連する国内規格に適合する製品は、当該規格が対象とするリスク及びリスクの区分に関する限り、本規則に定める一般安全要件を満たすものと推定されると権限ある当局がみなすことを確保するため、すべての適切な措置を講じなければならない。ただし、当該規格が本規則第6条及び第8条のその他の要素に照らして適切でない場合を除く。
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.