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产品和流程导向研究与开发 (PPORD) 中的用途是否免于授权要求?
问题(中文)
产品和流程导向研究与开发 (PPORD) 中的用途是否免于授权要求?
Question (EN)
Are uses in Product and Process Orientated Research and Development (PPORD) exempted from the authorisation requirement?
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)
PPORD 中的用途并非普遍免于授权要求。但是:授权清单中的特定条目可能包含低于规定最大数量的 PPORD 用途豁免;如果产品和工艺开发活动是在受控条件下进行的,且每年的用量少于一吨,则可能属于科学研究与开发 (SRD) 的定义。在这种情况下,这些活动无需授权。更多信息,另请参阅欧洲化学品管理局 (ECHA) 的“科学研究与开发 (SR&D) 和产品与工艺导向研究与开发 (PPORD) 指南”,网址:https://echa.europa.eu/guidance-documents/guidance-on-reach。
Answer (EN)
Uses in PPORD are not generically exempted from the authorisation requirement.
However:
Specific entries in the Authorisation List may include an exemption for uses in PPORD below a specified maximum quantity;
Activities to develop products and processes may fall under the definition of Scientific Research & Development (SRD) if they are carried out under controlled conditions in a volume less than one tonne per year. In this case, they are exempted from authorisation.
For more information, see also ECHA’s “Guidance on Scientific Research and Development (SR&D) and Product and Process Orientated Research and Development (PPORD)”, available at: https://echa.europa.eu/guidance-documents/guidance-on-reach.