我需要遵守哪个版本的测试指南？

我需要遵守哪个版本的测试指南？

Which version of the test guideline am I required to comply with?

为了满足 REACH 法规中规定的信息要求，您提供的数据必须至少满足您注册物质或更新注册吨位范围时适用的测试指南的条件，根据该指南需要提供相关信息。任何新测试都必须按照最新更新的 OECD 测试指南版本进行，即使欧盟测试方法法规（法规 440/2008）尚未更新以反映最新更新的适用 OECD 测试指南版本。2008 年 6 月 1 日之后进行的生态毒理学和毒理学测试和分析需要按照良好实验室规范 (GLP) 的原则进行。对于物理化学测试，GLP 是可取的，但不是强制性的。如果满足附件 XI 第 1.1 节中规定的标准，ECHA 可能会接受未按照 GLP 或在注册/吨位范围更新时适用的标准测试方法进行的实验的现有数据（即 2008 年之前进行的研究）。此外，如果研究是按照2008年之后的标准测试方法进行的，但并非按照注册或吨位更新时适用的测试方法版本进行的，且符合适用测试指南的要求，ECHA也可能接受这些研究。请特别注意记录测试材料是否代表您注册的物质。您还需要提供有效的理由，证明这些数据足以用于分类和标签以及/或风险评估。

In order to fulfil an information requirement set out in the REACH Regulation, the data provided by you must at least fulfil the conditions of the test guideline which was applicable at the time when you registered the substance, or updated your registration tonnage band under which the information requirement in question is required.Any new testing must be conducted according to the most recently updated OECD test guideline version, also if the EU Test Methods Regulation (Regulation 440/2008) has not yet been updated to reflect that latest updated applicable OECD test guideline version. Eco-toxicological and toxicological tests and analyses performed after 1 June 2008 need to be carried out in compliance with the principles of good laboratory practice (GLP). For physicochemical testing, GLP is desirable but not mandatory.   Existing data (i.e. studies conducted before 2008) from experiments not conducted according to GLP or standard test methods applicable at the time of registration/ tonnage band update may be accepted by ECHA if the criteria set out in Annex XI, Section 1.1 are met. Also, studies conducted in accordance with standard test methods after 2008 but not according to the version of the test method applicable at the time of registration or tonnage update may be accepted by ECHA if those studies meet the requirements of that applicable test guideline. Take special care in documenting that the test material is representative for your registered substance. You also need to provide a valid justification that the data are adequate for the purpose of classification and labelling and/or risk assessment.