Regulation (EU) 2023/1230 / 第II章 — 経済事業者の義務
第16条 半完成機械の販売業者の義務
Article 16 — Obligations of distributors of partly completed machinery
この法令は規則(EU)2026/1744(AIデジタルオムニバス)により一部改正されています(2026年7月27日発効)。本文は改正前のものです。
1. When making partly completed machinery available on the market, distributors shall act with due care in relation to the requirements of this Regulation.
2. 半完成機械を市場で提供する前に、販売業者は、次のことを確認しなければならない。
2. Before making partly completed machinery available on the market, distributors shall verify that:
(a)半完成機械に第11条第8項に規定するEU組込宣言書が添付されていること。
(a)the partly completed machinery is accompanied by the EU declaration of incorporation referred to in Article 11(8);
(b)半完成機械に第11条第7項に規定する組立説明書が添付されており、それが、当該半完成機械が市場で提供される加盟国が定める、半完成機械を組み込む者が容易に理解できる言語で記載されていること。
(b)the partly completed machinery is accompanied by the assembly instructions referred to in Article 11(7), and that they are in a language which can be easily understood by the person who incorporates the partly completed machinery as determined by the Member State in which the partly completed machinery is to be made available on the market;
3. 販売業者は、半完成機械が本規則に適合していないと認め、又はそう信じる理由を有する場合には、それが適合させられるまで、当該半完成機械を市場で提供してはならない。さらに、当該半完成機械が関連する必須安全衛生要件に関するリスクをもたらす場合には、販売業者は、製造業者又は輸入業者及び市場監視当局にその旨を通知しなければならない。
3. Where a distributor considers or has reason to believe that partly completed machinery is not in conformity with this Regulation, the distributor shall not make the partly completed machinery available on the market until it has been brought into conformity. Furthermore, where the partly completed machinery presents a risk as regards relevant essential health and safety requirements, the distributor shall inform the manufacturer or the importer as well as the market surveillance authorities to that effect.
4. 販売業者は、半完成機械が自らの責任の下にある間、保管又は輸送の条件が附属書IIIに定める関連する必須安全衛生要件への適合を損なわないことを確保しなければならない。
4. Distributors shall ensure that, while a partly completed machinery is under their responsibility, the storage or transport conditions do not jeopardise conformity with the relevant essential health and safety requirements set out in Annex III.
5. 自らが市場で提供した半完成機械が本規則に適合していないと認め、又はそう信じる理由を有する販売業者は、適宜、当該半完成機械を適合させ、撤去し、又はリコールするために必要な是正措置がとられることを確実にしなければならない。さらに、当該半完成機械が関連する必須安全衛生要件に関するリスクをもたらす場合には、販売業者は、当該半完成機械を市場で提供した加盟国の権限ある国の当局に直ちにその旨を通知し、特に不適合の内容及びとった是正措置の詳細を示さなければならない。
5. Distributors who consider or have reason to believe that partly completed machinery which they have made available on the market is not in conformity with this Regulation shall make sure that the corrective actions necessary to bring that partly completed machinery into conformity, to withdraw it or recall it, as appropriate, are taken. Furthermore, where the partly completed machinery presents a risk as regards the relevant essential health and safety requirements distributors shall immediately inform the competent national authorities of the Member States in which they have made the partly completed machinery available on the market to that effect, giving details, in particular, of the non-conformity and of any corrective actions taken.
6. 販売業者は、権限ある国の当局から理由を付した要請があった場合には、紙又はデジタル形式により、半完成機械の本規則への適合を証明するために必要なすべての情報及び文書を当該当局に提供しなければならない。販売業者は、当該当局の要請に応じ、自らが市場で提供した半完成機械がもたらす必須安全衛生要件に関するリスクを除去するためにとられる措置について、当該当局に協力しなければならない。
6. Distributors shall, further to a reasoned request from a competent national authority, provide that authority with all the information and documentation, in paper or digital format, necessary to demonstrate the conformity of the partly completed machinery with this Regulation. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks as regards the essential health and safety requirements presented by partly completed machinery which they have made available on the market.