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)
对于注册档案中信息要求的每一次调整,您都需要在 IUCLID 档案的每个相关端点中添加理由。目前主要有两种情况:当物质通过化妆品进口到 EEA,且未在 EEA 进行进一步加工时:除了遵循 ECHA 提供的说明(见下文)外,您还应在 IUCLID 中的相应端点添加一条解释性说明,说明该物质仅用于化妆品,以成品状态进口,且未在 EEA 内进行进一步加工或重新包装;如果物质/化妆品在欧洲经济区 (EEA) 进一步加工,但可以证明没有工人接触:您可以根据 REACH 附件 XI 第 3.1 节的规定,利用常规调整可能性,免除 REACH 附件 VIII 第 8.6 和 8.7 节(分别为重复剂量毒性和生殖毒性)规定的测试要求以及附件 IX 和 X 中的测试。基于化妆品的豁免场景说明 [PDF] 在应用这些调整时,为了根据附件 XI 第 3.2 节的要求进行论证,您无需考虑与成品化妆品使用相关的生命周期阶段,因为这些阶段在化妆品法规下是单独监管的。虽然根据附件 XI 第 3.2 节,对于仅涵盖化妆品用途的注册档案,通常不能豁免急性毒性测试,但包含附件 XI 第 3.2 节要素的类似豁免可用于此终点。有关如何利用此适应性可能性的更多详细信息,请参阅《信息要求和化学品安全评估指南》第 5.1 节 R.5 章“信息要求的适应性”。此外,ECHA 还提供了以下具体建议,供您在创建或更新注册档案时遵循。
Answer (EN)
As for every adaptation of an information requirement in a registration dossier, you need to insert a justification in each of the relevant endpoints of the IUCLID dossier.
Two main types of scenarios have been identified:
Where the substance is imported into the EEA in a cosmetic product that is not further processed in the EEA: in addition to following the instructions provided by ECHA (see below), you shall add, to the respective endpoint(s) in IUCLID, an explanatory note stating that the substance is solely used in cosmetics, imported in the finished state and not further processed nor repackaged inside the EEA;
Where the substance/cosmetic product is further processed in the EEA, but where absence of worker exposure can be demonstrated: you may avail yourself of the regular adaptation possibilities, pursuant to Annex XI, section 3.1 of REACH, to waive the testing requirements addressed by sections 8.6 and 8.7 (repeated dose toxicity and reproductive toxicity respectively) of Annex VIII to REACH and the test in Annex IX and X.
Illustration of cosmetics-based waiving scenarios [PDF]
When applying these adaptations, for the purpose of the justification required according to Annex XI, section 3.2, you do not need to consider the life-cycle stages related to the use of the finished cosmetic product, as these are regulated separately under the Cosmetics Regulation.
While testing for acute toxicity cannot normally be waived under Annex XI, section 3.2, for the purpose of registrations dossiers that cover only cosmetic uses, a similar waiver containing the elements of Annex XI, section 3.2 may be used for this endpoint.
See section 5.1 of the Guidance on information requirements and chemical safety assessment, Chapter R.5: Adaptation of information requirements for further details on how to make use of this adaptation possibility.
Furthermore, ECHA provides further specific recommendations to follow below when you create or update your registration dossier.