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为什么某种物质会被列入 CoRAP 清单?清单采用了哪些标准?

问题(中文)
为什么某种物质会被列入 CoRAP 清单?清单采用了哪些标准?
Question (EN)
Why is a substance on the CoRAP list? Which criteria have been used?
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44(1)条规定了选择物质进行物质评估的通用标准。该法规文本规定,优先排序应基于风险。根据第44(1)条:“(...) 标准应考虑:危害信息,例如,物质与已知关注物质或持久性且易于生物累积的物质的结构相似性,表明该物质或其一种或多种转化产物具有关注特性或持久性且易于生物累积的特性;暴露信息;吨位,包括多个注册人提交的注册的总吨位”。欧洲化学品管理局 (ECHA) 与成员国合作完善了这些标准,并发布在其网站上:物质评估优先排序物质的选择标准(2011 CoRAP 选择标准)http://echa.europa.eu/documents/10162/13628/background_doc_criteria_ed_32_2011_en.pdf。这些标准应用于识别潜在关注物质的初始阶段。进一步的筛选和选择过程将考虑这些物质是否已受到监管措施的约束,以及物质评估的有效性,并通过索取有关该物质的更多信息来澄清关注点。因此,仅仅满足基于风险的标准并不意味着该物质会自动被纳入CoRAP。根据REACH法规第45(5)条,只要成员国掌握的信息表明某种物质属于评估重点,成员国就可以向欧洲化学品管理局(ECHA)通报该物质。因此,CoRAP也可能包含根据成员国通报而纳入的物质。在确定物质的优先顺序时,会同时考虑危害和暴露信息(或缺乏这些信息)。在包含多种物质的第一个CoRAP中,最初的关注点通常与潜在的PBT特性、疑似内分泌干扰、致癌、致突变和生殖毒性以及广泛的分散用途或消费者用途和/或高吨位有关。总体而言,这些物质的用途涵盖各个领域,并不侧重于任何特定的工业、专业或消费用途。最终发布的 CoRAP 还会概括说明该物质被优先考虑和选择进行物质评估的原因(关注理由)。在纳入 CoRAP 之前,这些物质尚未接受评估,因此,所指出的关注理由仅是基于选择标准对可能存在风险领域的指示。初始关注理由不应被视为对已知风险的声明,也不应被视为对评估范围的声明。在评估过程中,可能会识别其他关注领域并进行进一步调查。只有在物质评估完成后,才能定义和通报风险。成员国已同意,从 2013 年 CoRAP 首次更新开始,将编制并发布关于每种物质选择的更详细的论证文件。
Answer (EN)
The REACH Regulation Article 44(1) provides the general criteria for substances to be selected for substance evaluation. The legal text defines that prioritisation shall be on a risk-based approach. According to Article 44(1): "(...) the criteria shall consider: hazard information, for instance structural similarity of the substance with known substances of concern or with substances which are persistent and liable to bio-accumulate, suggesting that the substance or one or more of its transformation products has properties of concern or is persistent and liable to bio-accumulate; exposure information; tonnage, including aggregated tonnage from the registrations submitted by several registrants". The criteria have been refined by ECHA in cooperation with the Member States and are published on ECHA's website: Selection criteria to prioritise substances for Substance Evaluation (2011 CoRAP selection criteria) http://echa.europa.eu/documents/10162/13628/background_doc_criteria_ed_32_2011_en.pdf. These criteria are applied in the initial step of the identification of substances with potential concerns. A further screening and selection process takes into consideration whether the substances are already subject to regulatory measures and the effectiveness of the substance evaluation to clarify the concern by requesting further information on the substance. Thus, meeting the risk-based criteria alone does not automatically mean an inclusion of the substance in the CoRAP. According to Article 45(5) of the REACH Regulation, a Member State may notify ECHA of a substance, whenever it is in possession of information suggesting that the substance is a priority for evaluation. Thus, the CoRAP may also contain substances that have been included based on notifications from Member States. Both hazard and exposure information (or a lack of it) is taken into consideration upon prioritising the substances. In the first CoRAP with many substances, the initial concerns are generally related to potential PBT-properties, suspected endocrine disruption, or carcinogenic, mutagenic and reprotoxic properties in combination with wide dispersive or consumer use(s) and/or high tonnages. In general, the uses of these substances cover various areas and do not focus on any particular industrial, professional or consumer uses. The final published CoRAP also contains a general indication of the reasons why the substance was prioritised and selected for substance evaluation (grounds for concern). Before inclusion in the CoRAP, the substances have not been evaluated and thus the indicated grounds for concern are just an indication of the possible areas of risk, based on the selection criteria. The initial grounds for concern should not be taken as a statement on a known risk or as a statement on what the evaluation will cover. During the evaluation, other areas of concern may be identified and investigated further. Only after the substance evaluation is completed, risks can be defined and communicated. The Member States have agreed that from the first update of the CoRAP in 2013, more detailed justification documents regarding selection of each substance will be prepared and published.