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答案(中文)
受授权约束的物质(包含在 REACH 附件 XIV 中)也可能出现在限制清单(REACH 附件 XVII)中。需要注意的是,REACH 下的授权适用于物质生命周期中的某些步骤,例如物质的“使用”(单独或以混合物形式)以及物质的“投放市场”以供进一步使用(单独或以混合物形式)。授权不适用于物质的生产、物质作为物品的投放市场以及物质的某些用途(例如中间体)。限制可能涵盖物质的单独或以混合物形式生产、物质的使用以及物质作为其他物质的成分、混合物或物品的投放市场。因此,对于也包含在 REACH 附件 XIV 中的物质,REACH 附件 XVII 中可能存在限制,涵盖物质生命周期中未获授权的步骤。可以考虑以下情况:1.物质列入附件 XIV 之前的限制在某些情况下,当某种物质被列入附件 XIV 时,附件 XVII 中已经存在一项涵盖该物质的制造、使用和/或投放市场的限制,因此,两项限制同时适用。如果限制涵盖该物质的“用途”,则该用途受其中规定的限制和条件的约束。限制未涵盖的物质用途仍受授权条款的约束。例如,邻苯二甲酸二(2-乙基己基)酯 (DEHP) 同时列入 REACH 附件 XIV 和附件 XVII(限制条目 51)。附件 XVII 的条目 51(1) 禁止在玩具和儿童护理用品中使用浓度等于或大于增塑材料重量 0.1% 的 DEHP。这意味着实际上 DEHP 在物品中的使用浓度不能超过该值,而单独使用(以及投放市场)DEHP 或其混合物则需获得授权。2. 物质列入附件 XIV 后的限制:对物品中物质的生产或投放市场采取限制措施没有任何限制。事实上,REACH 第 69(2) 条要求 ECHA 考虑在日落日期(注:从日落日期起,除非获得授权,否则禁止将物质投放市场和使用)之后,是否对物品中使用附件 XIV 中所列物质的风险进行了充分控制,或者该用途是否已过授权豁免期。如果 ECHA 得出结论认为物品中该物质的使用可能对人类健康和/或环境构成风险,ECHA 将准备限制提案,向欧盟委员会提出限制建议。有关此流程的信息可访问欧洲化学品管理局 (ECHA) 网站。值得注意的是,只有因其危险特性而被认定为高度关注物质 (SVHC) 的物质(注意:SVHC 是指被归类为 CMR 类别 1A 或 1B、PBT 和 vPvB 物质以及同等关注程度的物质(例如内分泌干扰物))才可列入授权清单(REACH 附件 XIV)。对于附件 XIV 中先前列出的物质,可以对其“使用”进行限制,以涵盖因该物质固有特性(而非 SVHC 特性)而导致的“使用”对人类健康或环境造成的风险(REACH 第 58(5) 条)。
Answer (EN)
Substances subject to authorisation (included in Annex XIV of REACH) might be also present in the restriction list (Annex XVII to REACH). It has to be noted that authorisation under REACH applies to certain steps in the life cycle of a substance, such as the ‘use’ of a substance, on its own or in mixtures, and the ‘placing on the market, for further use, of a substance, on its own or in mixtures. Authorisation does not apply to the manufacture of substances or to the placing on the market of substances in articles and to certain uses of substances (e.g., intermediates). Restriction may cover the manufacture of substances, on their own or in mixtures, uses of substances and their placing on the market, on their own, as constituents of other substances, in mixtures or in articles. Therefore, there can be restrictions in Annex XVII of REACH for substances that are also included into Annex XIV to REACH covering those steps in the life cycle of substances that are not covered by authorisation. The following cases may be considered:1. Restrictions preceding the listing of a substance in Annex XIVThere may be cases where, when a substance is included in Annex XIV, a restriction already exists in Annex XVII covering the manufacture, use and/or placing on the market of that substance and thus, both apply in parallel. If the restriction covers the ‘use’ of the substance, that use is governed by the restriction and conditions set therein. Uses of the substance not covered by the restriction are still subject to authorisation provisions. This is the case, for example of Bis(2-ethylhexyl) phthalate (DEHP) which is included in both Annex XIV of REACH and in Annex XVII (Restriction entry 51). Entry 51(1) of Annex XVII prohibit the use of DEHP in toys and childcare articles in a concentration equal to or greater than 0,1% by weight of the plasticised material. This means in practice that DEHP cannot be used in such articles above that concentration, while uses (and the placing on the market) of DEHP on its own or in mixtures for further use are subject to authorisation. 2. Restrictions posterior to the listing of a substance in Annex XIV:There is no limitation in adopting restrictions on the manufacture or placing on the market of a substance in articles. Indeed, Article 69(2) of REACH requires ECHA to consider if the risks arising from the use of a substance included into Annex XIV in articles is adequately controlled after the sunset date (NB: Sunset date from which the placing on the market and the use of a substance is prohibited, unless an authorisation is granted), or the use is exempt from authorisation has passed. If ECHA concludes that the use of that substance in articles may pose a risk for the human health and/or the environment, ECHA will propose a restriction to the European Commission by preparing a restriction proposal. Information on this process is available on ECHA’s website.It is worth considering that, only substances that are identified as Substance of Very High Concern (SVHC) (NB: SVHC are substances classified as CMR category 1A or 1B, PBT and vPvB substances and substances of equivalent level of concern (e.g. Endocrine Disruptors)) for their hazardous properties can be included in the authorisation list (Annex XIV of REACH). A restriction on the ‘use’ of a substance previously listed in Annex XIV can be adopted to cover risks to human health or the environment from the ‘use’ of the substance arising from intrinsic properties other than SVHC properties (Article 58(5) REACH).