Regulation (EU) 2023/988 ／ 第III章 — 経済事業者の義務
第13条 製造業者の義務が他の者に適用される場合
Article 13 — Cases in which obligations of manufacturers apply to other persons
1. A natural or legal person shall be deemed to be a manufacturer for the purposes of this Regulation and shall be subject to the obligations of the manufacturer set out in Article 9 where that natural or legal person places a product on the market under the natural or legal person’s name or trademark.
2. 製品に大幅な変更を加える製造業者以外の自然人又は法人は、この規則の適用上製造業者とみなされ、変更の影響を受ける製品の部分について、又は大幅な変更が製品の安全性に影響を及ぼす場合には製品全体について、第9条に定める製造業者の義務に服する。
2. A natural or legal person, other than the manufacturer, that substantially modifies the product, shall be deemed to be a manufacturer for the purposes of this Regulation and shall be subject to the obligations of the manufacturer set out in Article 9 for the part of the product affected by the modification or for the entire product if the substantial modification has an impact on its safety.
3. 物理的又はデジタル的な手段による製品の変更は、製品の安全性に影響を及ぼし、かつ次の基準を満たす場合には、大幅なものとみなす。
3. A modification of a product, by physical or digital means, shall be deemed to be substantial where it has an impact on the safety of the product and the following criteria are met:
(a)変更が、製品の当初のリスクアセスメントにおいて予見されていなかった方法で製品を変化させること。
(a)the modification changes the product in a manner which was not foreseen in the initial risk assessment of the product;
(b)変更により、危害の性質が変化し、新たな危害が生じ、又はリスクの水準が上昇したこと。及び
(b)the nature of the hazard has changed, a new hazard has been created or the level of risk has increased because of the modification; and
(c)変更が、消費者自身により又は消費者の代理として消費者自身の使用のために行われたものでないこと。
(c)the modifications have not been made by the consumers themselves or on their behalf for their own use.