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答案(中文)
欧洲法院(ECJ)在2015年9月10日C-106/14案判决中对“物品”一词的解释是,该术语既适用于附件XVII中的限制,也适用于REACH法规的其他方面。该判决可在此处查阅:http://curia.europa.eu/juris/liste.jsf?language=en&td=ALL&num=C-106/14。就REACH法规而言,“物品”一词具有REACH法规第3(3)条规定的特定含义。第3(3)条将物品定义为“在生产过程中被赋予特殊形状、表面或设计的物体,其功能比化学成分更受决定”。 “复杂物体”由多个符合 REACH 第 3(3) 条规定的标准的物品组成,例如,自行车是由多个物品组成的复杂物体,例如车把、电缆、螺丝等。欧洲化学品管理局 (ECHA) 关于物品中物质要求的指南对复杂物体进行了解释。请注意,“复杂物体”一词对应于上述欧洲法院判决中使用的“复杂产品”(参见上述指南的脚注 12)。欧洲法院在其判决中指出,REACH 法规不包含任何专门管理复杂产品的条款,因此,在没有具体规定的情况下,无需区分单独的物品(例如螺丝)或作为复杂产品组件的物品(例如自行车中的螺丝)。因此,当被纳入复杂产品时,“物品”只要保留其特殊的形状、表面或设计(这些比其化学成分更能决定其功能),就仍然是 REACH 定义下的物品。附件 XVII 中限制“物品”的条目涵盖任何符合 REACH 法规第 3(3) 条标准的物品。因此,如果某个条目限制含有/释放物质 X 的物品投放市场,且该限制影响到复杂物品,则应检查每件物品中物质 X 的存在/释放情况。如果限制条目提及“物品的部件”,则应理解为物品的组成部分。请注意,附件 XVII 中某些条目已制定问答 (Q&A) 和指南,可提供更多信息。问答和指南可在 ECHA 网站上找到:https://echa.europa.eu/information-restricted-substances。
Answer (EN)
The term ‘article’, as interpreted by the European Court of Justice (ECJ) in its judgement of 10 September 2015 in case C-106/14 applies in the same way to restrictions in Annex XVII as to the other aspects of the REACH Regulation. The judgement is available here: http://curia.europa.eu/juris/liste.jsf?language=en&td=ALL&num=C-106/14.
For the purposes of REACH, the term 'article' has the specific meaning set out in Article 3(3) of the REACH Regulation. Article 3(3) defines an article as ‘an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition’.
'Complex objects' are made up of more than one article which meet the criteria laid down in Article 3(3) of REACH, e.g. a bicycle is a complex object made up of several articles, such as handlebar grips, cables, screws etc. Complex objects are explained in the ECHA Guidance on requirements for substances in articles. Please note the term ‘complex object’ corresponds to ‘complex product’ that is used in the ECJ Judgement referred to above (see footnote 12 of the above guidance).
The ECJ, in its judgment, observed that the REACH Regulation does not contain any provisions specifically governing complex products and that consequently, in the absence of specific provisions, there is no need to draw a distinction between articles of their own (e.g. screw) or when incorporated as components of a complex product (e.g. a screw in a bike). Therefore, when incorporated into a complex product, an 'article' remains an article within the meaning of REACH, as long as the article retains its special shape, surface or design, which is more decisive for its function than its chemical composition.
Entries in Annex XVII restricting 'articles' cover any object meeting the criteria in Article 3(3) of the REACH Regulation. Therefore, if an entry restricts the placing on the market of articles containing/releasing substance X and the restriction affects complex objects, the presence/release of substance X in each of the individual articles should be checked.
If a restriction entry refers to ‘parts of articles’, this should be understood as referring to an integral part of an article. Please note questions and answers (Q&As) and guidelines for some entries in Annex XVII have been developed which provide further information. The Q&As and guidelines are available on the ECHA website here: https://echa.europa.eu/information-restricted-substances.