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实施一项新限制措施需要经历哪些阶段?这个过程持续多久?

问题(中文)
实施一项新限制措施需要经历哪些阶段?这个过程持续多久?
Question (EN)
What are the phases of adopting a new restriction? What is the duration of this process?
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 67(1) 条规定,附件 XVII 中限制的物质,无论是在其混合物中还是在物品中,除非符合该限制条件,否则不得生产、投放市场或使用。根据 REACH 法规第 69(1) 条,当委员会担心某种物质的生产、投放市场或使用对人类健康或环境构成风险,而这种风险尚未得到充分控制并需要解决时,委员会可以要求欧洲化学品管理局启动限制程序。成员国(或一组成员国)也可以根据 REACH 法规第 69(4) 条启动限制程序。根据第 69(2) 条,当附件 XIV 或 REACH(授权清单)中某种物质的日落日期过后,欧洲化学品管理局将核实该物质在物品中的使用是否会对人类健康或环境构成风险。如果欧洲化学品管理局 (ECHA) 认定风险未得到充分控制,则必须向委员会提交限制提案(附件 XV 档案)。适用于此类情况的限制程序受 REACH 法规第 69-73 条的约束,并在 ECHA 网站的限制程序页面上进行了说明。请注意,为了提前告知即将提出的提案,在提案文件准备之前,应在意向登记处公开准备限制提案的意向。此限制流程的阶段(及其持续时间)如下:1)准备和提交限制提案(12 个月)- 第 1 阶段 2)就限制报告和 SEAC 意见草案进行公众咨询(6 个月)- 第 2a 阶段 3)ECHA 风险评估委员会(RAC)和社会经济分析委员会(SEAC)的意见形成(提案公布后 12 个月)- 第 3.1 阶段 4)如果委员会认为限制条件得到满足,则将准备对 REACH 附件 XVII 中限制清单的修正草案(收到 SEAC 意见后 3 个月内)。委员会通过委员会程序作出决定(持续时间不定)。最后,遵守并执行限制规定——第三阶段。委员会还可以针对符合致癌性、致胚芽突变性或生殖毒性1A类或1B类分类标准且可供消费者使用的物质(REACH法规第68(2)条),就其本身、混合物或物品中的物质提出消费者使用限制建议。此流程采用简化流程,无需咨询RAC和SEAC。
Answer (EN)
Article 67(1) of the REACH Regulation states that a substance in its on, in a mixture or in an article, for which Annex XVII contains a restriction, cannot be manufactured, placed on the market or used unless it complies with the conditions of that restriction. On the basis of Article 69(1) of REACH the Commission may request, ECHA, to start a restriction procedure when they are concerned that the manufacture, placing on the market or use of a certain substance poses a risk to human health or the environment that is not adequately controlled and needs to be addressed. A Member State (or a group of Member States) can also start a restriction procedure on the basis of Article 69(4) of REACH.  On the Basis of Article 69(2), when the sunset date of a substance included into Annex XIV or REACH (Authorisation List) has passed, ECHA verifies if the use of that substance in articles may pose a risk to human health or the environment. If ECHA concludes that the risk is not adequately controlled, they have to submit a restriction proposal (Annex XV dossier) to the Commission. The restriction procedure applicable to these cases is regulated in Articles 69-73 of REACH and explained on the ECHA website in the Restriction procedure page. Note that to communicate about the upcoming proposal in advance, the intention to prepare a restriction proposal is made public in the registry of intentions before the proposal file itself is prepared. The phases (and their duration) of this restriction process are: 1) Preparation and submission of a restriction proposal (12 months) – Phase 1 2) Public consultations on the restriction report and the SEAC’s draft opinion (6 months) – Phase 2a 3) Opinion development of ECHA’s Committee for Risk Assessment (RAC) and Committee for Socio-economic Analysis (SEAC) (12 months since publication of  the proposal) – Phase 3.1 4) If the Commission considers that the conditions for a restriction are fulfilled, it prepares a draft amendment to the list of restrictions in Annex XVII to REACH (within 3 months of receipt of the SEAC opinion). Commission decision in a comitology procedure (duration varies). And finally, complying with and enforcing the restriction – Phase 3 The Commission can also propose restrictions for consumer use as regards substances on their own, in mixtures or in articles, which meet the criteria for classification as carcinogenic, germ mutagenic or toxic for reproduction category 1A or 1B and could be used by consumers (Art. 68(2) REACH). This process follows a simplified path which does not require consultations by RAC and SEAC.