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REACH法规第56(3)条规定,物质在科学研究与开发(SRD)中的使用不受授权要求的约束。此项豁免是否也涵盖SRD最终使用之前的生命周期步骤(例如配方)?

问题(中文)
REACH法规第56(3)条规定,物质在科学研究与开发(SRD)中的使用不受授权要求的约束。此项豁免是否也涵盖SRD最终使用之前的生命周期步骤(例如配方)?
Question (EN)
Article 56 (3) of REACH exempts from the authorisation requirement the use of a substance in scientific research and development (SRD). Does this exemption also cover the life-cycle steps (such as formulation) preceding the end-use in SRD?
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)
是的,在SRD中豁免最终用途之前的上游物质使用,其最终进入SRD的物质数量(即每位用户低于1吨/年)也不受限制,但须遵守下文所述。第3(23)条将SRD定义为“在受控条件下”和“每年少于1吨”进行的任何科学实验、分析或化学研究。因此,第56(3)条中的豁免涵盖了受一定风险控制水平限制的活动,即在受控条件下使用,且每年使用量少于1吨。该豁免也适用于物质在SRD最终用途之前的上游生命周期阶段,适用于最终进入该最终用途的物质数量,以及在上游生命周期中在受控条件下处理和/或使用的物质数量,即使在上游生命周期阶段处理和/或使用的物质数量超过每年1吨。如果本问答中所表达的立场与欧洲化学品管理局(ECHA)此前在2011年12月20日的RCOM中所表达的立场有任何冲突,则应以本问答中所表达的立场为当前对该法律的理解。本问答中所表达的立场优先于ECHA此前就此问题所表达的任何其他观点。
Answer (EN)
Yes, the uses of a substance upstream preceding an exempted end-use in SRD are also exempted in quantities of the substance ending up in SRD (i.e. under 1 t/y per user) subject to what is set out below.   Article 3(23) defines SRD as any scientific experimentation, analysis or chemical research to be carried out "under controlled conditions" and "in a volume less than one tonne per year". Therefore, the exemption in Article 56 (3) covers an activity which is delimited by a certain level of control of risks– i.e., use under controlled conditions and in a volume less than 1 tonne per year. It also applies to the upstream life-cycle stages of the substance preceding its end-use in SRD, for the volumes ending up in that end-use and which, during the upstream life-cycle, are handled and/or used under controlled conditions, even if the volume handled and/or used during the upstream life-cycle stages exceeds 1 tonne per year. In case of any contradictions between the position expressed in this Q&A and the positions expressed previously by ECHA in the RCOM of 20 December 2011, the position expressed in this Q&A should be considered as the current understanding of the law. It takes precedence over any other views communicated previously by ECHA on this issue.