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安全数据表上需要哪些有关限制的信息,以及何时需要由于限制而更新安全数据表?

问题(中文)
安全数据表上需要哪些有关限制的信息,以及何时需要由于限制而更新安全数据表?
Question (EN)
What information on restrictions is needed on the safety data sheet and when does the safety data sheet need to be updated due to restrictions?
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31(6)条规定,安全数据表(SDS)应包含第15节“监管信息”。REACH附件II规定了SDS的编制要求。第15(1)节特别指出,如果SDS涵盖的物质或混合物属于欧盟层面与保护人类健康或环境相关的特定条款(例如,第VIII章下的限制),则必须提及这些条款,除非SDS的其他部分已提及此信息。因此,所有适用于SDS涵盖的特定物质或混合物的限制条目都需要在其中注明。例如,包含REACH附录1至6中列出的致癌、致突变或生殖毒性物质(其本身或混合物)的SDS需要参考附件XVII的条目28、29或30。如果这些物质存在其他特定限制,则也需要在SDS中提及。此外,REACH法规第31(9)条要求供应商在限制措施实施后立即更新安全数据表。在第16条(其他信息)中,需要明确说明与先前版本相比哪些地方发生了变更,除非安全数据表的其他部分已提供此类说明,并附有变更说明。
Answer (EN)
Article 31(6) of the REACH Regulation provides that the safety data sheet (SDS) shall contain a Section 15 entitled ‘regulatory information’. Annex II to REACH provides requirements for the compilation of the SDS. Section 15(1) specifically mentions that, if the substance or mixture covered by the SDS is the subject of specific provisions in relation to the protection of human health or the environment at Union level (e.g. restrictions under Title VIII), these provisions must be mentioned, unless this information is already mentioned in other parts of the SDS. Thus, all restriction entries applicable to the specific substance or mixture covered by the SDS need to be indicated therein. As an example, SDSs including carcinogenic, mutagenic or toxic to reproduction substances (as such or in a mixture) listed in appendices 1 to 6 to REACH, need to refer to entries 28, 29 or 30 of Annex XVII. If another specific restriction exists for these substances, this needs to be mentioned as well in the SDS. Moreover, Article 31(9) of the REACH Regulation requires suppliers to update the SDS without delay once a restriction has been imposed. In Section 16 (other information), a clear indication of where changes to the previous version have been made needs to be included, unless such indication is given elsewhere in the safety data sheet, with an explanation of the changes.