REACH 是否要求对安全数据表进行任何更改？

REACH 是否要求对安全数据表进行任何更改？

Does REACH require any changes in Safety Data Sheets?

是的，根据 REACH 法规第 31 和 32 条，安全数据表 (SDS) 需要进行一些更改。但是，安全数据表 (SDS) 的职责和责任基本保持不变。REACH 法规附件 II 提供了安全数据表的编制指南。以下列表总结了主要变化：第 8 节（和第 7 节）将总结与人类健康和环境有关的已确定用途的风险管理措施。这包括传达给生产消费者制剂或物品的下游用户的消费者相关措施。此外，相关的衍生无影响水平 (DNEL) 和预测无影响浓度 (PNEC) 也应在此处提供。SDS 中的物理化学性质、毒理学和生态毒理学信息将根据 REACH 法规附件 VI 至 XI 的信息要求进行更新。 PBT 和 vPvB 评估的结果将在第 12 部分中呈现。根据制造商的化学品安全评估 (CSA) 结果，可能需要更新 SDS 第 16 部分中关于不建议使用的资料。如果根据 REACH 法规第 14 条进行化学品安全评估后制定了暴露场景 (ES)，则必须将其作为附件附加到 SDS 中，从而适当地传递到供应链中。SDS 第 1.2 部分中有关物质用途的信息必须与附件中 ES 的简称一致，表明 ES 涵盖哪些用途。由于 REACH 要求将废物处置考虑因素纳入制造商的化学品安全评估，因此可能需要根据 ES 中包含的具体物质的废物管理建议更新 SDS 第 13 部分。值得注意的是，现在对于被评估为PBT（持久性、生物累积性和毒性）或vPvB（高持久性和高生物累积性）的物质、列入REACH法规附件XIV候选清单的物质以及含有这些物质的混合物，还需要提供安全数据表 (SDS)。更多信息，请参阅欧洲化学品管理局 (ECHA) 网站上的安全数据表编制指南：http://echa.europa.eu/guidance-documents/guidance-on-reach。您也可以查阅注册指南及其第6.1.1节“向客户提供安全数据表 (SDS)”：http://echa.europa.eu/guidance-documents/guidance-mainly-for-industry-use。

Yes, according to Articles 31 and 32 of the REACH Regulation some changes in the Safety Data Sheet (SDS) are required. However, the duties and responsibilities for Safety Data Sheets (SDSs) remain largely the same. Guidance for the compilation of Safety Data Sheets is given in Annex II of the REACH Regulation.   The following list summarises the main changes: The risk management measures for the identified uses with regard to human health and the environment are to be summarised in section 8 (and 7). This includes consumer related measures communicated to a downstream user producing consumer preparation or articles. Also the relevant Derived No-Effect Levels (DNELs) and Predicted No-Effect Concentrations (PNECs) should be presented here. The information on physicochemical properties, toxicology and eco-toxicology in the SDS is to be updated in line with the information requirements of Annex VI to XI of the REACH Regulation. The results of the PBT and vPvB assessment are to be presented in section 12. The information on uses advised against in section 16 of the SDS may need to be updated depending on the outcome of the manufacturer's Chemicals Safety Assessment (CSA). Where Exposure Scenarios (ES) are developed as a result of conducting a chemical safety assessment in accordance with Article 14 of the REACH Regulation they must be annexed to the SDS and thereby be appropriately passed down the supply chain. The information on uses of the substance in section 1.2 of the SDS must be consistent with the short titles of the ES in the annex, indicating which uses are covered by the ES. Since REACH includes a requirement to include the waste disposal considerations into the manufacturer's chemicals safety assessment, section 13 of the SDS may need to be updated with substance specific waste management advice as contained in the ES.   It is important to note that now SDSs are additionally required for substances assessed to be PBTs (Persistent, Bioaccumulative and Toxic) or vPvBs (very Persistent and very Bioaccumulative), for substances included in the candidate list for potential inclusion in Annex XIV of the REACH Regulation, as well as for mixtures containing any of these substances.   Further information can be found in the Guidance on the compilation of safety data sheets available on ECHA's website at: http://echa.europa.eu/guidance-documents/guidance-on-reach    You may also consult the Guidance on registration and its section 6.1.1-'Provide a Safety Data Sheet (SDS) to customers' at: http://echa.europa.eu/guidance-documents/guidance-mainly-for-industry-use.