不含水（无水）的物质和该物质的水合物必须被视为同一种物质吗？

不含水（无水）的物质和该物质的水合物必须被视为同一种物质吗？

Must the water-free (anhydrous) substance and the hydrates of this substance be regarded as the same substance?

就注册而言，物质的水合物和无水物质被视为相同。如果无水物质已由制造商/进口商注册，并且某公司使用该物质生产水合物质，则该公司被视为下游用户。因此，相应的注册档案必须包含供应链中出现的无水物质和水合物质的必要信息，即化学品安全评估，其中包含水合物质和无水物质的暴露评估和风险表征。这些信息需要通过安全数据表 (SDS) 在整个供应链中传达，安全数据表应包含所有必要的事实，例如，供应链中出现的无水物质和水合物质的暴露场景和已确定的用途。已注册无水物质的注册编号必须在安全数据表 (SDS) 第 1 部分中注明。第 37 条和第 38 条为下游用户规定的规定适用于物质的水合物和无水物质。注册人需要在其 CSA 中考虑物质的特定形式对下游用途的潜在影响，特别是在下游使用过程中形式发生变化时。

For the purpose of registration, hydrates of a substance and the anhydrous substance are regarded as the same. If the anhydrous substance is registered by the manufacturer/ importer, and if a company uses that substance to manufacture the hydrated substance, this company is regarded as a downstream user. Therefore, the respective registration dossier must include the necessary information for the anhydrous and the hydrated substance occurring within the supply chain, i.e. the chemical safety assessment with exposure assessments and risk characterisations of hydrated substances and the water-free substance. This information needs to be communicated along the supply chain in safety data sheets which should include all the necessary facts, e.g. exposure scenarios and identified uses for the water-free as well as the hydrated substance which occur within the supply chain. The registration number of the registered anhydrous substance must be specified in section 1 of the SDS. The provisions foreseen for downstream users according to Articles 37 and 38 can be implemented for both the hydrates of a substance and the anhydrous substance. Registrants need to take into account in their CSA the potential implications of specific forms of the substance on downstream uses, in particular when the form is changed during downstream use.