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)
根据 REACH 法规第 3 条第 22 款,PPORD 的定义是“任何与产品开发或进一步开发物质(无论是单独、制剂还是物品)相关的科学开发,其过程中会通过中试工厂或生产试验来开发生产工艺和/或测试该物质的应用领域”。任何物质的科学开发,例如在中试工厂或大规模生产中进行的扩大生产规模、改进生产工艺,或对该物质的应用领域进行调查,均属于 PPORD 的定义,无论涉及的吨位大小。为了促进创新,REACH 法规第 9 条规定,单独生产或进口的物质或以混合物形式生产的物质,以及为 PPORD 目的而掺入或进口到物品中的物质,均可免于注册义务,有效期为 5 年。如需获得豁免,公司需要向欧洲化学品管理局 (ECHA) 提交 PPORD 通知。根据申请,欧洲化学品管理局 (ECHA) 可将此豁免期限进一步延长最多 5 年,对于药品(人用或兽用)的开发以及尚未上市的物质,则可延长最多 10 年。更多信息,请参阅具体的科学研究与开发 (SR&D) 指南以及面向产品和工艺的研究与开发 (PPORD) 指南:http://echa.europa.eu/guidance-documents/guidance-on-reach。
Answer (EN)
According to Article 3 (22) of the REACH Regulation PPORD is defined as "any scientific development related to product development or the further development of a substance, on its own, in preparations or in articles in the course of which pilot plant or production trials are used to develop the production process and/or to test the fields of application of the substance".Any scientific development of a substance consisting of, for example, campaign(s) for the scaling-up, improvement of a production process in a pilot plant or in the full-scale production, or the investigation of the fields of applications for that substance, falls under the definition of PPORD irrespective of the tonnage involved.
In order to promote innovation, Article 9 of the REACH Regulation specifies that substances manufactured or imported on their own or in mixtures, as well as substances incorporated in articles or imported in articles for the purpose of PPORD can be exempted from the duty to register for a period of 5 years. To be exempted a company needs to submit a PPORD notification to the ECHA. Upon request, ECHA may further extend this exemption for up to another 5 years, or 10 years for the development of medicinal products (for human or veterinary use) as well as for substances that are not placed on the market. Further information is provided by the specific Guidance on Scientific Research and Development (SR&D) and Product and Process Oriented Research and Development (PPORD): http://echa.europa.eu/guidance-documents/guidance-on-reach.