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答案(中文)
一旦授权法规 2023/707 生效(2023 年 4 月 20 日),制造商、进口商、下游用户和分销商应考虑以下任务以履行其义务。具体顺序和时间将取决于每个运营商的具体情况:他们是否将物质或混合物投放市场;他们是否是联合提交的成员;他们的物质或混合物是否已经投放市场等。此列表并非详尽无遗,但列出了新法律文本触发的主要任务。根据新的危险类别标准,审查其产品组合中物质和混合物的分类和标签。他们应利用所有可用信息进行自我分类。注意适用于他们的物质和混合物的过渡期,并确保他们最迟在这些日期之前履行其义务。过渡期允许他们提前履行义务,并避免最后一刻的困难。如果他们是 REACH 联合提交的成员,则应启动讨论,就其物质的分类和标签达成一致。按照实施条例 2020/1435 的规定,立即更新注册档案。如果申报者是制造商/进口商团体的成员,则应启动讨论,就其物质的分类和标签达成一致。并相应地更新清单申报。联系同一物质的其他申报者,就新的分类和标签达成一致。联合申报的负责人或制造商/进口商团体的负责人(如果经营者是其中任何一方的成员)可以协助进行此类沟通。修改物质和混合物的标签。在相关情况下,使用新的危害信息更新其已向毒物中心提交的任何申报。考虑是否需要重新向毒物中心提交申报。自2026年5月1日起,先前未归类为人类健康或物理危害的混合物可能必须根据新的人类健康危害进行分类。请更新其安全数据表 (SDS),使其符合新的分类和标签要求,并包含所有反映新危害所需的相关信息。他们可能需要为先前未分类的物质或混合物编制安全数据表。如果他们的混合物未分类,但含有0.1%或以上的第2类内分泌干扰物,且不面向公众使用,则应准备编制并根据要求提供安全数据表。
Answer (EN)
Once the Delegated Regulation 2023/707 enters into force (20 April 2023), manufacturers, importers, downstream users and distributors should consider the following tasks in order to comply with their duties. The exact order and timing will depend on the specific scenario of each operator: if they place on the market substances or mixtures; if they are members of a joint submission or not; if their substance or mixture is already placed on the market or not, etc. The list is not exhaustive but lists the main tasks triggered by the new legal text. Review the classification and labelling of the substances and mixtures in their portfolio against the criteria of the new hazard classes. They should use all available information for self-classification.Take note of the transitional periods for substances and mixtures that apply to them and make sure they have fulfilled their duties at the latest by those dates. Transitional periods allow to comply earlier and avoid last-minute difficulties.If they are part of a joint submission under REACH, initiate the discussion to agree on the classification and labelling of their substances. Update the registration dossier without undue delay, as outlined in the Implementing Regulation 2020/1435.If they are part of a group of manufacturers/importers for the purpose of C&L notification, initiate the discussion to agree on the classification and labelling of their substances. Update the notification to the inventory accordingly.Contact the other notifiers for the same substance to agree on the new classification and labelling. The leader of the joint submission, or the leader of the group of manufacturers/importers, if the operator is a member of either, can help in such communication.Revise their labels, for both substances and mixtures.Update, when relevant, any poison centre notification they have already made, with the new hazard information.Consider whether a new poison centre notification is needed. Mixtures previously not classified for human health nor physical hazards may have to be classified for the new human health hazards from 1 May 2026.Update their safety data sheets (SDS) with the new classification and labelling, and all relevant new information that is needed to reflect the new hazards. They may need to compile an SDS for substances or mixtures which were previously not classified. Prepare to compile and provide an SDS upon request if their mixtures are not classified but contain a substance in 0,1% or more of an endocrine disruptor Category 2 and is not intended for the general public.