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根据第 56(1)(e) 条,分销商是否可以被视为直接下游用户 (DU) 并申请授权?
问题(中文)
根据第 56(1)(e) 条,分销商是否可以被视为直接下游用户 (DU) 并申请授权?
Question (EN)
Can a distributor be considered as the immediate Downstream User (DU) in the context of article 56(1) (e) and apply for an authorisation?
中文内容由 Google Cloud Translation 自动生成,仅供参考;请以英文原文为准。问答资料来自欧盟化学品管理局(ECHA)官方网站。
答案(中文)
不可以。根据 REACH 法规第 56(1)(e) 条,仅存储附件 XIV 物质的分销商不能被视为下游用户(参见 REACH 法规第 3(14) 条)。但是,如果参与者自己使用这些物质(例如重新包装),则不再被视为分销商。届时,他们将被视为下游用户,因此应申请授权(并可能涵盖其下游用户的用途),除非已获得授权。如果分销商(即仅存储该物质的实体)不“使用”该物质,则他们在供应链中是“透明的”。因此,授予下游用户的申请应理解为涵盖该物质的制造商/进口商以及其间的所有分销商。但是,这仅适用于下游用户申请人和制造商/进口商之间没有使用该物质的参与者(例如配方商、重新包装公司等)的情况。此外,分销商必须将相关信息(例如安全数据表、授权号)传达给其下游用户。
Answer (EN)
No. A distributor who only stores the Annex XIV substance before placing it on the market cannot be considered as Downstream Users in the context of Article 56(1)(e) (see Article 3(14) of the REACH Regulation). However, actors can no longer be considered as distributors if they use the substances themselves (e.g. repackaging). Then they are considered as downstream users and, as such, shall apply for authorisation (and may cover uses of their downstream users), unless already covered by an authorisation.
Distributors (i.e. entities who only store the substance) are "transparent" in the supply chain if they do not "use" the substance. Therefore an application granted to a downstream user should be understood as covering the manufacturer/importer of that substance and all the distributors in between. However, this only applies in cases where there are no actors using the substance (e.g. formulators, repackaging companies, etc.) between the downstream user applicant and the manufacturer/importer. Also, distributors have to communicate the relevant information (e.g. safety data sheets, authorisation numbers) to their downstream users.