附件 XVII 第 46 条是否涵盖化妆品中的痕量物质？

附件 XVII 第 46 条是否涵盖化妆品中的痕量物质？

Does the entry 46 of Annex XVII cover traces in cosmetic products?

化妆品法规 1223/2009 废除了指令 76/768/EEC，禁止销售含有壬基酚（CAS：25154-52-3）和 4-壬基酚支链（CAS：84852-15-3）的化妆品。根据化妆品法规第 17 条，允许在化妆品中存在痕量壬基酚，前提是这种存在在良好生产规范下在技术上是不可避免的，并且产品不会对人体健康造成损害。REACH 附件 XVII 第 46 条禁止在浓度高于 0.1%（重量）的多种应用（包括化妆品）中将壬基酚和壬基酚聚氧乙烯醚作为一种物质或混合物投放市场。第 46 条的目的是为了保护环境。因此，REACH 第 67（2）条不适用。第46条涵盖化妆品中存在对环境构成风险的痕量物质。REACH附件XVII第46条的应用与(EC) 1223/2009号法规相辅相成，且不冲突。

Regulation 1223/2009 on cosmetic products, that repealed Directive 76/768/EEC, introduces a ban on the marketing of cosmetic products containing nonylphenol (CAS: 25154-52-3) and 4-nonylphenol, branched (CAS: 84852-15-3). Pursuant to Article 17 of the cosmetics Regulation, the presence of traces in cosmetic products is allowed, provided that such presence is technically unavoidable in good manufacturing practice and that the product does not cause damage to human health.   Entry 46 of Annex XVII to REACH bans the placing on the market of nonylphenol and nonylphenol ethoxylates as a substance or in mixtures in a number of applications including cosmetic products, when the concentration is higher than 0.1% by weight. The objective of entry 46 is the protection of the environment. Therefore Article 67 (2) of REACH does not apply. Entry 46 covers traces in cosmetic products to the extent that their presence presents a risk to the environment. The application of entry 46 of Annex XVII to REACH is complementary to, and does not conflict with, Regulation (EC) No 1223/2009.