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REACH绿色合规----个人或联合申请
来源:上海沐睿 | 作者:沐睿环境-莉哥 | 发布时间: 2021-09-02 | 340 次浏览 | 分享到:

申请可以有一个申请人或者一组申请人提交, 例如 

• 下游用户 

• 上游行为人 

• 通过涉及上游行为人(级别1)和下游用户 (级别2)的两级申请策略。 

An application can be submitted by one applicant or a  group of applicants, such as: 

• By downstream user(s) 

• By upstream actor(s) 

• Or through a two-level application strategy involving  both upstream actors (level 1) and downstream users (level 2)


由于联合申请可能存在复杂性和技术问题,欧洲化学品管理局建议您在以下情况下制定并提交联合申请: 

• 所有共同申请人申请联合申请中所有用途的授权,

• 找到一种可接受的方式来共享申请中提供的所有信息。 

Due to the possible complexity and technical issues of  joint applications, ECHA recommends that you develop  and submit a joint application when: 

• all co-applicants of the group apply for all uses in the  joint application for authorisation, 

• they have found an acceptable way to share all information provided in the application.


在复杂情况下,每个共同申请人最好分别提交自己的申请。 

根据供应链的复杂性,强烈建议与所有参与者 (供应商,客户等)进行讨论,并确定您的情况适合的最佳方法。一旦确定,确保申请人拥有所有涵盖你和你的下游用户的用途的必要信息。 

In complex cases, it may be preferable for each coapplicant to submit their own application separately. 

Depending on the complexity of the supply chain,  it is highly recommended to enter into discussions  with all actors involved (suppliers, customers, etc.)  and to determine the best approach for your case.  Once decided, ensure that the applicant has all the  information needed to cover your use and those of your  DUs.


授权申请的准备申请使用附录XIV中物质的授权有两种途径: 

1.充分控制途径:通过证明使用该物质的风险可以得到充分控制,即暴露低于衍生无影响水平(DNEL)。

2.社会经济分析途径:通过证明使用该物质的社会经济效益大于风险,并且没有合适的替代物质或技术。 

申请中需要的信息(评估报告)取决于您是否能够充分控制风险,以及针对您申请的用途是否有合适的替代物质或技术。

AfA preparation There are two possible routes to apply for an  authorisation to use an Annex XIV substance:

1.Adequate control route: by demonstrating that  the risk from using the substance is adequately  controlled, i.e. that the exposure is below the derived  no-effect level (DNEL). 

2.Socio-economic analysis route: by demonstrating  that the socio-economic benefits of using the  substance outweigh the risks and that there are no suitable alternative substances or technologies.

The information (assessment reports) required in an  application will depend on whether you can demonstrate  adequate control of the risks and whether there  are suitable alternative substances or technologies  available for the use you are applying for.


授权申请的基本信息包括: 

• 识别申请中所涵盖的物质 

• 申请人的姓名和联系方式 

• 要求特定用途的授权 

• 化学品安全报告 

• 对替代选择的分析 

• 替代计划

根据为授权申请选择的路线,可能包括其他信息:社会经济分析(SEA),不考虑对人类健康或环境的风险的理由(参见关于授权申请准备的ECHA指南) 

The basic information in the AfA includes: 

• Identity of substance or substances covered by the  application, 

• Name and contact details of the person or persons  making the application, 

• Request for authorisation(s) for specific use(s), 

• Chemical Safety Report(s), 

• An analysis of the alternatives, 

• Substitution plan.

Depending on the route chosen for the AfA, other  information may be included: A socio-economic  analysis (SEA), a justification for not considering  the risks to human health or environment (see ECHA  Guidance on the preparation of an application for authorisation).


授权申请的提交和评估 

ECHA风险评定委员会(RAC)和社会经济分析委员会(SEAC)对授权申请中包括的每种用途提出意见。该意见概述了RAC和SEAC对申请人评估报告的评估,并包括了对可能包含在授权决定中的任何条件或监察安排的建议, 以及关于用途授权被授予的限时审查期限的建议。  

AfA submission and evaluation 

ECHA’s Committees for Risk Assessment (RAC) and  Socio-Economic Analysis (SEAC) develop an opinion on  each use included in an application for authorisation.  This opinion outlines the RAC and SEAC evaluation  of an applicant’s assessment reports and includes  recommendations for any conditions or monitoring  arrangements that could be included in an authorisation  decision as well as a recommendation on the length of  the time-limited review period, should an authorisation  be granted for the use.


RAC和SEAC的建议基于申请以及在可能的 替代选择的公众咨询阶段中收到的任何信息。RAC和SEAC可以向申请人索取的其他信息也需要考虑在内。 

The RAC and SEAC opinion is based on the application,  as well as any information received in the public  consultation on possible alternatives. RAC and SEAC can request additional information from an applicant, which  is also taken into account.


已经提交有关公众咨询中潜在替代选择信息的申请人、委员会和第三方之间也可以组织“三方会议”。 

委员会将在与REACH委员会中成员国讨论后,最终决定授权或不授权。决策过程至少需要6个月。

A ‘trialogue meeting’ may also be organised between the  applicant, the Committees and third parties who have  submitted information about potential alternatives in the public consultation.  

The final decision to grant or not grant an authorisation  is taken by the Commission after discussion with  Member States in the REACH Committee. The decisionmaking process takes at least six months.



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