我在注册单体时是否需要进行化学安全评估（CSA）？

我在注册单体时是否需要进行化学安全评估（CSA）？

Do I need to perform a chemical safety assessment (CSA) in my registration for the monomer?

视情况而定。作为单体的注册人（无论您是单体的制造商、进口商还是聚合物的进口商），当满足 REACH 第 14 条规定的条件时，您都需要进行 CSA。CSR 应记录您进行的化学安全评估 (CSA)。CSA 包含危害评估。如果物质符合第 14(4) 条列出的危害标准或被评估为 PBT/vPvB，您还需要进行暴露评估和风险表征。在 CSA 中，您必须报告和评估该单体在欧盟的所有用途，包括聚合反应。您无需考虑因使用聚合物而产生的暴露（包括暴露于剩余未反应的单体或因聚合物降解而产生的单体）。但是，如果您依赖附件 XI 第 3.2 节下的基于暴露的调整 (EBA) 来满足 REACH 附件 VII 至 X 中规定的标准 REACH 信息要求，则您也需要提供聚合后单体的暴露信息。此类调整必须基于全面而严格的暴露评估，涵盖单体整个生命周期内的所有相关暴露，包括作为聚合物中未反应单体或聚合物降解产物的潜在单体暴露（参见欧洲化学品管理局 (ECHA) 上诉委员会在 A-001-2020 案中的裁决）。请参阅《单体和聚合物指南》第 3.2.1.5 节。

It depends. As a registrant of a monomer (regardless of whether you are a manufacturer or importer of the monomer or an importer of a polymer), you are required to perform a CSA when the conditions set out in Article 14 of REACH are fulfilled. The CSR should document the chemical safety assessment (CSA) performed by you.The CSA includes the hazard assessment. If the substance fulfils the hazard criteria listed in Article 14(4) or is assessed to be a PBT/vPvB, you also need to perform an exposure assessment and risk characterisation.In the CSA, you must report and assess all the uses of the monomer in the EU up to and including polymerisation. You do not have to consider the exposure arising from use(s) of the polymer (including the exposure to remaining unreacted monomer(s) or to the monomer(s) resulting from the degradation of the polymer). However, if you rely on an exposure-based adaptation (EBA) under Annex XI section 3.2 for fulfilling the standard REACH information requirements set out in Annexes VII to X of REACH, you are required to provide information on the exposure to the monomer also after polymerisation. Such an adaptation must be based on a thorough and rigorous exposure assessment covering all relevant exposures throughout the life-cycle of the monomer, including the potential exposure to the monomer as an unreacted monomer in the polymer, or as a degradation product of the polymer (see ECHA’s Board of Appeal decision in Case A-001-2020).See section 3.2.1.5 of the Guidance for monomers and polymers.