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REACH绿色合规----授权程序
来源:上海沐睿 | 作者:沐睿环境-莉哥 | 发布时间: 2021-09-02 | 316 次浏览 | 分享到:

REACH法规设立了授权程序,以便更好地管理与SVHCs相关的环境和健康风险,并逐步使用在经济和技术上都是可行的合适的替代物质或技术取代这些SVHC。 

符合REACH第57条规定标准且在候选清单中的物质将很可能被加入到REACH附录XIV中。 

欧盟委员会可根据向ECHA提交的授权申请 (AfA)授予特定用途授权。如果委员会授权,则在修改或撤销之前有效,但需要进行受时间限制的审查,这意味着授权持有人需提交审查报告。 授权过程包括4个主要步骤:

  1. SVHC的确认

  2. 列入授权清单的建议

  3. 授权申请

  4. 评估和决定(授权或拒绝授权) 

The REACH Regulation sets up the authorisation  procedure to permit a better management of the  environmental and health risks associated with SVHCs  and progressively replace those SVHCs with suitable  alternative substances or technologies where these are economically and technically viable.

Substances fulfilling the criteria of Art. 57 REACH and on  the CL will most likely be added to Annex XIV REACH. 

Authorisation can be granted for specific uses by the  European Commission on the basis of an Application  for Authorisation (AfA) made to ECHA. When an  authorisation is granted by the Commission, it is valid  until amended or withdrawn, but it is subject to timelimited review, meaning authorisation holders are  required to submit a review report. 

The authorisation process involves 4 main steps:

  1. Identification of SVHCs

  2. Recommendation for inclusion  in the Authorisation List

  3. Application for Authorisation

  4. Evaluation and Decision  (Authorisation granted or refused)


授权范围 

授权适用于物质的“使用”(REACH第3.24 条,见第2.1节),这意味着当附录XIV中的物质满足以下条件时授权适用: 

• 处理的 

• 调配的或者混合的 

• 消耗的 

• 储存或者保存(单独或者在配制品中) 

• 被处理 

• 装入容器或者从一个容器转移到另一个容器 

• 被用于物品中 

• 其他使用 

Authorisation scope 

Authorisation applies to the“use”of a substance (Art.  3.24 REACH, see Chapter 2.1), which means that  authorisation applies to the Annex XIV substance when  it is: 

• Processed; 

• Formulated or mixed; 

• Consumed; 

• Stored or kept (on its own or in a mixture); 

• Treated; 

• Filled into containers or transferred from one container to another; 

• Incorporated into an article; 

• Otherwise utilised.


如果附录XIV物质已经被用于物品中,则授权不适用,即如果该物质已经用于生产物品,这种情况下该物质不再“被使用”且不需要使用该物质的授权(见下文“授权对物品的影响” )。

Authorisation does not apply if the Annex XIV substance  has already been incorporated into an article, i.e. if  the substance has been used to produce articles,  the substance as such is no longer“used”and no  authorisation of use of the substance is required (see “Effect of authorisation on articles” below).


授权免除 

据现行的欧盟法规规定的使用该物质后人类康和环境保护有关的最低要求,如果风险能够得到适当的控制,则物质的用途和用途类别可豁免授权(REACH第58.2条)。 

附录XIV中用于科学研究和开发(PPORD)的物质,不需要申请授权。这类用于科学研究与发展的物质及最大豁免数量必须在附录XIV中详细说明(REACH第56.3条)。 

Exemptions to authorisation  

Uses and categories of uses may be exempted from  authorisation if, on the basis of existing community  legislation imposing minimum requirements related to  the protection of human health and the environment for  the use of the substance, the risk is properly controlled  (Art. 58.2 REACH).  No application for an authorisation is required for a  substance listed in Annex XIV REACH that is used in  scientific research and development (PPORD). Such  substances used for PPORD must be specified in Annex  XIV REACH as well as maximum quantity exempted (Art.  56.3 REACH).


以下用途豁免授权(REACH第56.4条): 

• 用于指令91/414/EEC范围内的植物保护产品。 

• 用于指令98/8/EC范围内的生物消毒产品。 

• 用作指令98/70/EC所涵盖的汽油和柴油燃料质量相关的汽车燃料。 

• 用作矿物油产品的移动或固定燃烧设备的燃料及用作封闭系统的燃料。 

• 现场分离中间体和运输分离中间体(REACH 第2.8.b条)。

The following uses are exempted (Art. 56.4 REACH):  

• Uses in plant protection products within the scope of  Directive 91/414/EEC. 

• Uses in biocidal products within the scope of Directive 98/8/EC. 

• Use as motor fuels covered by Directive 98/70/EC relating to the quality of petrol and diesel fuels. 

• Uses as fuel in mobile or fixed combustion plants of  mineral oil products and use as fuels in closed systems. 

• On-site isolated intermediates and transported isolated intermediates (Art. 2.8.b REACH).


在特定条件下,以下用途豁免授权(REACH 第56.5条): 

• 用于指令76/768/EEC范围内的化妆品。 

• 用于法规(EC)1935/2004范围内的食品接触材料。 

Under specific conditions, the following uses are  exempted (Art. 56.5 REACH): 

• Uses in cosmetic products within the scope of Directive 76/768/EEC. 

• Uses in food contact materials within the scope of  Regulation (EC) No1935/2004.


其他授权豁免还包括配制品中物质的使用 (REACH第56.6条): 

• 对于持久性、生物累积性和毒性物质(PBT) 、高持久性和高生物积聚性物质(vPvB)或内分泌干扰物质(REACH第57.d-f条),低于重量百分比为0.1%的浓度限值。 

• 对于其他所有物质,低于CLP法规规定的特 定浓度限值(CLP第11.3条)

Further exemptions include the use of substances when  they are present in mixtures (Art. 56.6 REACH): 

• For PBT, vPvB or endocrine disrupting substances  (Art. 57.d-f REACH), below a concentration limit of  0.1 % weight by weight. 

• For all other substances, below the specific concentration limits according to the CLP Regulation  (Art. 11.3 CLP). 


更多豁免另见第5.2节。 

See also further exemptions in Chapter 5.2.


向授权清单添加物质的程序 (附录XIV) 以下是向候选清单添加物质的程序及其在附录 XIV中的优先次序、建议和包含的说明。 

Process for adding substances to Authorisation List (Annex XIV) Below is a description of the process to add substances  to the CL and their prioritisation, recommendation and  inclusion in Annex XIV.


» 授权程序独立于注册程序 

» 物质的授权无吨位阈值规定。因此授权程序独立于任何吨位范围。这意味着有些物质需要授权但不需要注册。

NOTE 

» The authorisation procedure is independent of  the registration procedure. 

» There is no tonnage threshold for a substance to  be subject to authorisation. Authorisation procedures therefore apply independently of any tonnage bands. This means that there are substances that require authorisation but do not require  registration.



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