Question (EN)
What is regarded as scientific research and development, which is exempted for restrictions? For example, does research by students at universities fall under this?
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）
REACH 法规第 3(23) 条将科学研究与开发定义为“在受控条件下进行的任何科学实验、分析或化学研究，其数量每年少于一吨”。为了进一步阐明豁免（根据 REACH 法规第 67(1) 条，制造、投放市场或将物质用于科学研究与开发 (SRD) 可获得限制豁免），请注意，在授权流程下提供了以下问答（关于第 56 条中关于在科学研究与开发中使用附件 XIV 物质的豁免）。同样的方法可以广泛地被认为适用于限制。问答 1153 指出，为进一步分析而进行的取样不属于豁免范围，因此不被视为科学研究与开发。但是，“被视为在进行分析活动中使用样品的一部分的活动”属于豁免范围。问答 1030 解释说，在科学研究和开发中，在豁免的最终用途之前的上游使用某种物质，在特定条件下，其最终进入 SRD 的数量（即每个用户每年低于 1 吨）也可获得豁免。问答 585 解释说，在特定条件下，授权豁免也适用于在监测和质量控制等分析活动中使用某种物质。无论分析在何处进行，即现场或场外设施，此豁免均适用，但不包括采样活动。如果大学和中学的学生在受控条件下进行科学实验、分析或化学研究，且每年用量少于 1 吨，则可能属于豁免范围。换句话说，如果用于科学实验、分析或化学研究的物质的量少于每年 1 吨，并且在受控条件下使用，则该用途不受限制。
Answer (EN)
Article 3(23) of the REACH Regulation defines scientific research and development as “any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume less than one tonne per year”.
To further clarify the exemption (within Article 67(1) of the REACH Regulation, manufacture, placing on the market or use of a substance in scientific research and development (SRD) is exempted for restrictions), note that under the authorisation process the following Q&As (concerning the exemption in Article 56 for the use of Annex XIV substances in scientific research and development) has been provided. The same approach can be broadly considered as applicable to restrictions.
Q&A 1153 states that sampling for further analysis is not exempted and thus not regarded as scientific research and development. However, “activities considered to form part of the use of the sample in performing analytical activities” fall within the exemption.
Q&A 1030 explains that the uses of a substance upstream preceding an exempted end-use in scientific research and development are also exempted in quantities of the substance ending up in SRD (i.e. under 1 t/y per user) subject to certain conditions.
Q&A 585 explains that the exemption from authorisation also applies to the use of a substance in analytical activities such as monitoring and quality control under certain conditions. This exemption applies irrespective of where the analysis is performed i.e. on-site or off-site facilities, but does not cover sampling activities.
Scientific experimentation, analysis or chemical research in universities and secondary schools, conducted by students, may fall within the exemption, if they are carried out under controlled conditions, in a volume less than one tonne per year. In other words, if the volume of a substance used in scientific experimentation, analysis or chemical research is less than one tonne per year and it is used under controlled conditions, restrictions do not apply to that use.