新闻动态
NEWS
REACH绿色合规----限制程序
来源:上海沐睿 | 作者:沐睿环境-莉哥 | 发布时间: 2021-09-03 | 422 次浏览 | 分享到:

REACH制定了一套限制流程,针对可对健康或环境构成不可接受风险的特定物质,用于规范其制造、投放市场或使用。限制是管理其他 REACH流程未能解决的风险的“安全网”。 

应委员会要求,可由成员国或欧洲化学品管理局编制限制建议书。第VIII篇规定了限制流程。REACH附录XVII列出了所有受限物质及其限制条件。 

限制过程的主要步骤(REACH第69-73条)、 时间轴和行为人的概览(来自ECHA网站)。

REACH foresees a restriction process to regulate the  manufacture, placing on the market or use of certain  substances if they pose an unacceptable risk to health  or the environment. The restriction is designed as a  “safety net” to manage risks that are not addressed by  the other REACH processes.  

Proposals for restrictions can be prepared by Member  States or by ECHA on request of the Commission. The  Restriction process is described in Title VIII. Annex  XVII of REACH lists all restricted substances and the  conditions of their restrictions.  

Overview on main steps of the Restriction process  (Art. 69 to 73 REACH), timeline and actors (source ECHA  website)

为了便于开放式探讨和交流,欧洲化学品管理局组织有关被提议的限制的公众咨询。公共咨询自REACH附录XV限制报告在欧洲化学品管理局网页上发布开始启动,咨询期将持续六个月。

To facilitate open discussion and dialogue, ECHA  organises public consultation on proposed restrictions.  The consultation starts when the REACH Annex XV  restriction report is published on the ECHA web page  and is open for six months. Interested parties may  comment on the proposed restriction and the Annex XV  REACH restriction report.


利益相关方可对被提议的限制及REACH 附录XV限制报告提出建议。 利益相关方将被邀请就附录XV卷宗提出建议。强烈建议在咨询期的前三个月内提出建议,以确保你的观点和要求被考虑到。更重要的是要关注限制过程并参与限制咨询步骤, 因为目标物质,因为限制措辞的解释(例 如,“part thereof”),或者因为欧洲化学品管理局为了更好确定限制范围的具体指导, 限制咨询步骤会对汽车行业产生重大影响。 

Stakeholders are invited to comment on the Annex XV  dossier. It is highly recommended to provide comments  within the first three months of the consultation period in order to ensure your opinions and requests are  considered by others. It is all the more important to pay  attention to this restriction process and be involved in  the consultation step for restrictions that could impact  significantly the automotive industry because of the  substances targeted, because of the interpretation of  the restriction wording (e.g. “part thereof”), or because  of specific ECHA guidance aiming at better defining the  scope of the restriction.


按照REACH第68.2条规定,满足1A类或1B 类致癌、致突变或生殖毒性(CMR)分类标准,可能被消费者使用且欧委会建议限制消费者使用的单独物质、配制品中的物质或物品中的物质,REACH附录XVII不需遵循上述 图5.11.1的完整程序(REACH第69至73条将 不适用)进行修订,尤其是无需咨询所有的利益相关方(按照REACH第133(4)条规定的程序)。这可能导致限制过程的时间线缩短,从而减少行业合规行动的时间。 

According to Art. 68.2 REACH, for a substance on its own,  in a mixture or in an article which meets the criteria for  classification as CMR 1A or 1B, and could be used by  consumers and for which restrictions to consumer use  are proposed by the Commission, Annex XVII REACH will  be amended without following the complete procedure  described in Picture 5.11.1 above (Art. 69 to 73 REACH  does not apply), and particularly without consulting all  interested parties (in accordance with the procedure  referred to in Art. 133.4 REACH). This may result in a  shorter timeline for the restriction process and thus  also reduce the time available to industry for any compliance actions.


注::限制流程和授权流程的差异 

» 根据授权,如果没有明确允许,禁止物质的任何使用 

» 根据限制,如果没有明确禁止,允许物质的所有用途

限制和授权过程是相关的,并且在实践中对用途有类似的影响。然而它们的范围不同,参与者角色不同,程序也有不同的起因。授权只能按照REACH第57.a-f 条的规定处理候选清单中的SVHCs,而限制可以施加给任何在制造、使用或投放市场过程中对人类健康或环境产生不可接受风险的的物质。这可以在整个欧盟范围内管理(REACH第68.1条)。 二者的主要不同之处是,进口至欧洲经济区的物品无需履行授权义务(进口至欧洲经济区且含有REACH附录XIV中的物质无需履行授权义务),而限制流程则适用进口物品。 根据限制程序和其他欧盟法规规定,被禁止所有用途的物质可能并未纳入REACH附录 XIV或从REACH附录XIV中删除(REACH第 58.7条) 

通常,如果因会对人体或环境造成不可接受 风险而禁止物质的所有用途或部分(众所周知)用途时,应优先采用限制流程。

NOTE Difference between Restriction and Authorisation  Process:  

» Under Authorisation, every use of a substance is  prohibited if not explicitly allowed 

» Under Restriction every use of a substance is allowed if not explicitly prohibited 

The restriction and authorisation processes are  related and can in practice have similar effect on the  uses. However, they have different scope, the roles of  actors differ and the procedures may have different  cause. Authorisation can only address SVHCs on the CL as specified by Art. 57.a-f REACH whereas  restrictions may be imposed on any substance  where there is an unacceptable risk to human health  or the environment arising from the manufacture,use or placing on the market. This can be addressed  on a Community-wide basis (Art. 68.1 REACH).  One main difference is that the import into the EEA of  articles is not covered by the authorisation obligation  (an article imported in EEA, containing a substance in  Annex XIV REACH, is not concerned by authorisation obligation) whereas the restriction process can cover  import of articles.  Substances for which all uses are prohibited under restriction procedure or under other Community  legislation may not be included in Annex XIV REACH or  must be removed from it (Art. 58.7 REACH). Generally, the restriction process is the preferred  option in cases where it is justified to prohibit all uses  of a substance or to ban some (well known) uses  because of unacceptable risks for human health or  the environment.


建议 

• 与汽车行业的授权流程相似,汽车行业也针对限制流程采用了影响评估流程,为了能够从总体上了解可能的限制对汽车企业的影响。因此,建议在过程中提供意见,以获得具有代表性的总体信息。 

• 为了了解限制对您的业务的影响,您可参考 REACH工作组编制的附录XVII的所有条目表,该表评估了它们对汽车行业(物品,生 产)的影响,见附录K。

Recommendation 

• Similar to the Automotive Industry processes for  authorisation, the automotive industry also uses for  restriction the Impact Assessment Process in order  to generate an overview of the impact of possible  restrictions on automotive business. It is thus recommended to give input to that process in order to  provide a representative overview. 

• To understand the impact of a restriction on your  business you may refer to the table developed by the  REACH TF of all entries of Annex XVII which assesses their impact on the automotive industry (articles,  production), see Annex K.



上海沐睿环境有限公司是国内专业从事汽车法规合规的第三方咨询公司,多年来,为上汽,长城,宇通,大通,爱驰,蔚来等OEM提供汽车环保法规合规服务,团队跟踪与研究全球的环保合规,期待为更多的企业提供服务。www.automds.cn    

详情咨询info@murqa.com