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REACH绿色合规----物品中物质的注册
来源:上海沐睿 | 作者:沐睿环境-莉哥 | 发布时间: 2021-08-30 | 353 次浏览 | 分享到:

按照REACH第7.1条规定,欧洲经济区的生产商和从欧洲经济区以外进口汽车产品的进口商或非欧洲经济区物品制造商的“唯一代表”对同时符合以下所有条件的物品中的物质需履行注册义务: 

• 在正常或合理可预测使用条件下,物品存在有意释放物质。 

• 每个生产商或进口商每年总制造或进口(有意释放)物质的量超过1吨。 

• 尚未进行使用注册的物质(REACH第7.6 条:注册豁免)。 

A registration according to Art. 7.1 REACH is obligatory for EEA producers and importers of automotive articles  from outside the EEA or the“OR of non EEA manufacturer” of articles for those substances in articles meeting all  of the following conditions: 

• The substance is intended to be released from the  article during normal or reasonably foreseeable conditions of use. 

• The total amount of the substance present in all articles exceeds 1 tonne per year per producer or importer. 

• The substance has not yet been registered for the  use (Art. 7.6 REACH exemption).


根据一般规则,术语“有意释放”指物品的某一(附带的)功能或品质配制品的释放有关。 

As a general rule, the term‘intended to be released’ implies that a certain (accessory) function or quality of  an article is connected to the release of a substance or mixture.


如果物质的释放是物品运行不可避免的副效应,但对物品发挥功能没有帮助作用,则不能视为有意释放。例如:高度摩擦条件下材料的磨损和损耗,如:受损的衬片、轮胎;用于减少两活动部件之间摩擦的润滑剂泄漏(参见欧洲化学品管理局网站上物品中物质的要求指南)。这种物质释放符合REACH第7.5条的规定,如果符合以下的所有条件,欧洲化学品管理局可作出决定,要求物品生产商或进口商申请注册: 

A release of substances is not considered to be an  intended release if it is an unavoidable side effect of  the functioning of the article, but the release does not contribute to the functioning of the article. Examples:  wear and tear of materials under conditions of high  friction, e.g. brake linings, tyres; leakage of lubricant  used to reduce the friction between two moving parts  (see “Guidance on requirements for substances in  articles” on the ECHA website). This substance release  could be subject to Art. 7.5 REACH where the ECHA could  take decisions to require producers or importers of  articles to submit a registration if all of the following conditions apply:


1.每位生产商或进口商每年制造或进口的物品中的此类物质的量高于1吨;

2.欧洲化学品管理局有理由怀疑: 

a)物质从物品中释放,且

b)物品中释放的物质对人类健康和环境带来风险

1.the substance is present in those articles in  quantities totalling over one tonne per producer or  importer per year;

2.ECHA has grounds for suspecting that: 

a)the substance is released from the articles, and 

b)the release of the substance from the articles presents a risk to human health or the environment.


REACH第7.6条规定的注册豁免:注册义务不适用于已经进行该用途注册的物质或其他豁免的物质,例如水(请参考本指南第5.2节)。 因此,欧洲经济区生产商应确认其供应商是否已对有意释放物质进行了注册。 

Exemption according to Art. 7.6 REACH: This registration  obligation does not apply for substances already  registered for that use or substances otherwise  exempted, e.g. water (please refer to Chapter 5.2 of  this Guideline). Therefore EEA producers should check  if their suppliers have already registered the substance  intended to be released.


全球汽车行业已确定下列物品组装到汽车上后为在正常使用条件下有意释放物质的物品: 

1.香水分配器

2.消防系统(不包括手持移动灭火器),

3.挡风玻璃清洗器的流体储层,

4.释放压缩气体的点火装置。 

请注意,虽然利用压缩气体的点火装置被视为在起动车辆时预期释放物质的物品,但我们已了解其有害和风险物质的基本组成( 氢、氧、惰性气体、氮),根据REACH法规附录V(9)规定,这些物质免于注册。其他未列出的物质或配制品可能需要注册。 

The global automotive industry has identified the  following list of examples of articles that intentionally release substances after being assembled onto a  vehicle, when normal use conditions apply:  

1.Fragrance dispensers,

2.Fire extinguisher systems (excluding a hand held  mobile fire extinguisher).

3.Windshield-washer fluid reservoirs,  

4.Pyrotechnic devices that release compressed gases.  

Please note that although a pyrotechnic device with  compressed gas is considered as an article with substances that intentionally release when activated in a vehicle, basic elemental substances for which hazards and risks are already well known (hydrogen, oxygen, noble gases, nitrogen) are exempt from registration, per Annex V (9) of the REACH Regulation.  Registration may be required if other substances or  mixtures are utilised.


注:汽车行业支持烟火行业协会(VPI)及汽车烟火产品制造商的立场,即烟火反应的化学产品在部署后豁免附件V(3)的REACH注册要求,因为化学品是在反应中消耗。 见附件 L2“汽车工业烟火立场文件”。 

NOTE:

The automotive industry supports the position  of the Association of the Pyrotechnics Industry  (VPI) and the manufacturers of automotive  pyrotechnic products that the chemical products  of the pyrotechnic reaction are exempt from REACH  registration requirements under Annex V (3) upon  deployment, since the chemicals are consumed in  the reaction. See Annex L2 “Automotive Industry  Pyrotechnic Position Paper”.


除了例 4“释放压缩气体的点火装置”,上述例子1-3,如果上述物品为单独进口(即未与汽车装配),则其将被视为装在容器中的配制品,因此需履行与容器中配制品相关的注册义务。除手持式灭火器外,在进口非有意释放的容器中的配制品中,最典型的例子就是轮胎修理包: 

Beside example 4 “Pyrotechnic devices that release  compressed gases”, the above mentioned examples  1-3, if imported on their own (i.e. not assembled onto the vehicle) would be considered mixtures in containers,  and would therefore be subject to the registration  obligations associated with mixtures in containers.  Beside portable fire extinguishers, the most prominent  example for imported mixtures in containers without  intentional release are tyre repair kits:


轮胎修理包不是车辆的组成部分。因此,按照 REACH第7.1条规定,无需履行注册义务。但是,如果你进口这种修理包(即使在进口车辆内),你将被视为物质/配制品的进口商。 

The kit is not part of the vehicle. Thus, there are no  registration obligations acc. to Art. 7.1 REACH. However,  if you are importing it (even if in an imported vehicle) you are considered as an importer of a substance/ mixture.


在这种情况下,你应该检查进口密封剂配制品所含物质的数量,如果超过了1吨每年的限值,除非上游供应商已经对其进行注册,否则唯一代表或相关公司必须按照REACH第6条的规定进行注册。 

In such cases one should check the amount of imported  substances in the sealant mixture. If the 1 tpa threshold  is exceeded, either the OR or the company concerned  will need to undertake a registration under Art. 6 REACH,  unless already done so by the upstream supplier.


配制品包括但不限于:制动器、变速器、蓄电池及转向装置所用的液体介质、润滑脂及润滑剂,上述物质在汽车物品中或汽车物品上,是实现物品功能的组成部分,因此被视为物品不可分割的一部分。因此,如果这些配制品包含在进口物品中,则其无需进行预注册和注册。 但是,配制品中的这类物质如果是单独进口, 则其需要进行预注册和注册。

Mixtures such as, but not limited to brake, transmission,  battery, and steering fluids, greases, and lubricants  that are in or on automotive articles are integral to the function of those articles and are therefore considered  to be an integral part of the article. They would therefore  not require pre-registration and registration if contained  in or on imported articles. These same substances in  mixtures can however, require pre-registration and  registration if imported on their own.


物品中有意释放的物质应按照与单独物质或配制品中的物质相同的注册时间表进行注册 (REACH第23条,AIG第3章)。 

A substance intended to be released from an article  should be registered according to the same timelines  as those that apply to substances on their own or in mixtures (Art. 23 REACH, AIG Chapter 3).


注册费物品中物质注册所需的费用在法规(EC)864/2015(修订法规 (EC)340/2008中有明确规定。 

Fees Fees required for the registration of substances  in articles are specified in the Regulation (EC) No  864/2015 (amending Regulation (EC) 340/2008).


注:如果需要注册的物质被视为在容器中运输的物质,则此物质应按照REACH第6条进行注册。请注意,根据REACH第3.3条,容器本身可视为物品。 

NOTE:If the substance that requires registration is  considered as a substance delivered in a container,  the substance has to be registered according to Art.  6 REACH. Please note that the container itself may be  considered an article according to Art. 3.3 REACH.


更多详细信息,请参见REACH第6、7、23 、28条与欧洲化学品管理局关于物品中物质的要求指南。

For more details, please refer to Art. 6, 7, 23, 28 REACH  and ECHA Guidance on Requirements for Substances in  Articles.



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