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答案(中文)
该授权法规引入了四个新的危害类别。一个针对人类健康,三个针对环境:内分泌干扰人类健康:ED HH1、ED HH2;内分泌干扰环境:ED ENV1、ED ENV2;持久性、生物累积性和毒性,或高持久性和高生物累积性:PBT、vPvB;持久性、迁移性和毒性,或高持久性和高迁移性:PMT、vPvM。对于每个危害类别,法律文本都包含其定义、物质分类标准、混合物浓度限值以及危害通报。相应的危险类别和类别代码也包含在附件六第1部分表1.1中。经修订的附件三第1部分中的新危险说明如下:o EUH380:可能导致人类内分泌紊乱。o EUH381:怀疑导致人类内分泌紊乱。o EUH430:可能导致环境中的内分泌紊乱。o EUH431:怀疑导致环境中的内分泌紊乱。o EUH440:在环境和生物体(包括人类)中积累。o EUH441:在环境和生物体(包括人类)中强烈积累。o EUH450:可能导致水资源的长期和弥漫性污染。o EUH451:可能导致水资源的非常持久和弥漫性污染。此外,该法规对新的危险类别引入了新的标签要求:在附件一第3.11.3和4.2.3部分中,现在它规定,如果混合物中内分泌干扰物第 2 类的含量达到或超过 0.1% 且不供公众使用,则包装上的标签应带有 EUH210 声明“可根据要求提供安全数据表”。附件 III 第 1 部分中的优先规则:o 如果指定了危险说明 EUH441,则可以省略声明 EUH440。o 如果指定了危险说明 EUH451,则可以省略声明 EUH450。
Answer (EN)
The Delegated Regulation has introduced four new hazard classes. One for human health and three for the environment:Endocrine disruption for human health: ED HH1, ED HH2.Endocrine disruption for the environment: ED ENV1, ED ENV2.Persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative properties: PBT, vPvB.Persistent mobile and toxic, or very persistent and very mobile properties: PMT, vPvM.For each hazard class, the legal text includes their definitions, classification criteria for substances, concentration limits for mixtures, and hazard communication. The corresponding hazard class and category codes are also included in Table 1.1 of Part 1 of Annex VI.The new hazard statements in Part 1 of Annex III, as amended, are:o EUH380: May cause endocrine disruption in humans.o EUH381: Suspected of causing endocrine disruption in humans.o EUH430: May cause endocrine disruption in the environment.o EUH431: Suspected of causing endocrine disruption in the environment.o EUH440: Accumulates in the environment and living organisms including in humans.o EUH441: Strongly accumulates in the environment and living organisms including in humans.o EUH450: Can cause long-lasting and diffuse contamination of water resources.o EUH451: Can cause very long-lasting and diffuse contamination of water resources.Further, the regulation introduces new labelling requirements on the new hazard classes:In Parts 3.11.3 and 4.2.3 of Annex I, now it states that the label on the packaging should bear the statement EUH210 “Safety data sheet available on request” if the mixture contains endocrine disruptors Category 2 at or above 0.1% and it is not intended for the use of the general public.Rules of precedence in Part 1 of Annex III:o If the hazard statement EUH441 is assigned, the statement EUH440 may be omitted.o If the hazard statement EUH451 is assigned, the statement EUH450 may be omitted.