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答案(中文)
REACH 既适用于 REACH 第 3(39) 条定义的自然界中存在的物质,也适用于它们的合成类似物。但是,REACH 附件 V 规定,如果自然界中存在的以下物质未经化学改性,则可免于注册:矿物、矿石、矿石精矿、原始和加工天然气、原油和煤炭。这些物质只能通过特定方式进行处理(例如,溶于水、浮选),这些方式在 REACH 第 3(39) 条中有规定,并且不包括化学改性(第 3(40) 条)。如果自然界中存在的其他物质未经化学改性,则也可免于注册,除非:它们符合 CLP 法规(第 1272/2008 号法规)的危险分类标准,或者根据附件 XIII 中规定的标准,它们具有持久性、生物累积性和毒性,或者具有高持久性和高生物累积性,或者至少在两年前根据第 59(1) 条被确定为引起第 57(f) 条规定的同等关注程度的物质。有关附件 V 中不同豁免的进一步解释和背景信息,请参阅注册指南第 2.2.3.4 节 - “REACH 法规附件 V 涵盖的物质”。REACH 注册问答提供了通过提取工艺获得的自然界中存在的物质。有关自然界中存在的聚合物物质的具体指导,请参阅单体和聚合物指南第 3.2.1.3 节“天然聚合物或化学改性天然聚合物的情况”。由于天然物质的合成类似物不符合 REACH 第 3(39) 条中定义的自然界中存在的物质的标准,因此任何每年生产或进口一吨或一吨以上此类物质的制造商或进口商都必须对其进行注册。
Answer (EN)
REACH applies both to substances occurring in nature, as defined by Article 3(39) of REACH, and to their synthetic analogues.However, Annex V to REACH states that the following substances occurring in nature are exempted from registration if they are not chemically modified: minerals, ores, ore concentrates, raw and processed natural gas, crude oil and coal. These substances can only be processed by certain means (e.g. dissolution in water, flotation), which are specified in Article 3(39) of REACH and do not include chemical modification (Article 3(40)).Other substances occurring in nature are also exempted from registration if they are not chemically modified, unless:they meet the criteria for classification as dangerous according to the CLP Regulation (Regulation 1272/2008), orthey are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII, orthey were identified in accordance with Article 59(1) at least two years previously as substances giving rise to an equivalent level of concern as set out in Article 57(f).Further explanations and background information on the different exemptions in Annex V are included in section 2.2.3.4 - 'Substances covered by Annex V of the REACH Regulation' of the Guidance on registration.The REACH Registration Q&As provide guidance on substances occurring in nature that are obtained by extraction processes.For particular guidance on polymer substances occurring in nature, see section 3.2.1.3 - 'Case of a natural polymer or a chemically modified natural polymer' of the Guidance for monomers and polymers.Since the synthetic analogues of naturally occurring substances do not meet the criteria for substances occurring in nature as defined in Article 3(39) of REACH, any manufacturer or importer of these substances in quantities of one tonne or more per year is required to register them.