本章解释了汽车行业需要REACH指南的原因，但并不全面概述“REACH是什么？”。

This Introduction explains why the automotive industry needs such guidelines but will not give a complete overview of“What is REACH?”.

REACH法规3于2006年12月被纳入欧盟(EU) 法律，并于2007年6月1日生效。作为一部欧委会法规，REACH法规将自动成为欧盟成员国的法律，因此无需按照与欧盟或欧委会指令相同的方式进行转换。但是，各成员国执行REACH时，必须考虑本国的法规体系。

The REACH Regulation3 was adopted into European Community (EC) law in December 2006 and came into force on 1 June 2007. As an EC regulation, it automatically becomes law in each Member State, so it does not need transposition in the same way as an EU or EC directive. However, each Member State is obliged to enforce REACH under consideration of the individual national legislation scheme.

REACH的实际影响 

REACH Realities

REACH不只是化工行业的问题，它影响所有物品的生产商或进口商。

REACH不只是欧盟内部公司的问题。

REACH不只是环境、健康与安全专业人士的问题。

不符合REACH要求的公司将没有市场。REACH将对所有在欧洲经济区开展业务的公司（及客户或子公司在欧洲经济区开展业务的公司）造成威胁。

REACH可能会对业务的连续性产生负面影响，可能会破坏供应链。

了解REACH对业务的影响并制定战略性行动计划的公司相比其他公司将获得竞争优势。

替代物应遵循ACEA可持续替代标准（见附件O），并且需在产品开发计划中逐渐采用 替代物质以降低成本。

REACH is not just a chemical industry issue as it impacts producers or importers of articles.

REACH is not only an EU-based company issue.

REACH is not only an issue for environmental, health and safety specialists.

Companies that do not comply with REACH will have no market. REACH poses a threat to any company doing business in the EEA (and businesses with customers or suppliers who do business in the EEA).

Business continuity can be adversely impacted by REACH and supply chains can be disrupted.

Companies that understand the business implications and impacts of REACH and develop strategic action plans will gain competitive edge over those that do not.

Substitutions should follow the ACEA sustainable substitution criteria (see Annex O) and need to be phased in with product development programmes to  minimise cost.

REACH的目标

Aims of REACH

REACH旨在确保“人体健康与环境的高度保护，包括提高物质危害性评估的替代方法，以及在提升竞争力与创新的同时，促进物质在内部市场的自由流通”（REACH第1.1条）。

REACH aims to ensure a “high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards of substances, as well as the free circulation of substances within the internal market while enhancing competitiveness and innovation” (Art. 1.1 REACH).

因此，REACH的主要目标是：

降低化学品对人体及环境的风险，减少动物实验。

鼓励采用REACH附录XIV与XVII所列的特定危险物质的替代物。

要求对附录XIV和XVII中规定的物质进行授权使用或限制。

为了应对REACH的实际影响并实现REACH的目标，REACH要求汽车原始设备制造商及供应商马上或在不久将来采取行动。

To accomplish these realities and to fulfil the aims and objectives, REACH requires action from the automotive OEMs and their suppliers immediately and in the future.

需要进行注册时，必须保证供应商对所有业务相关的单独物质或配制品中的物质进行具体用途注册。对于非欧洲经济区供应商，强烈建议在欧洲经济区指定一名唯一代表，承担进口商的职责。在这种情况下，非欧洲经济区的供应商可继续向欧洲经济区输入产品，而无需将每位客户都变为REACH规定的进口商。

When registration is considered, one has to be assured that all business relevant substances on their own or in mixtures are or will be registered for your specific use by a supplier. For non-EEA suppliers it is highly recommended to appoint an OR in the EEA to take on the responsibilities of an importer. In this case, non-EEA suppliers can continue to deliver into the EEA without each of their customers becoming importers under REACH.

除注册外，REACH还包括其他很多义务，这些义务要求汽车行业采用现有的工艺及工具， 并实践新的做法。

As well as registration, REACH includes a number of other obligations that require the automotive industry to adapt processes and tools already in existence as well as the implementation of new practices.

义务

Obligations

义务REACH规定由汽车行业负责提供物质的安全信息并有效控制物质使用所导致的风险。根据以前的管理制度，由政府承担证明物质不安全并限制其使用的举证责任。REACH涵盖所有的单独物质、配制品中的物质及物品中的物质，但放射性物质、不可分离中间体、运输过程中所用的物质以及废物（REACH第2条）将免于注册。这些物质在其他现行法规中另有规定。欧盟成员国可以对国防用物质给予免除权。

REACH puts the responsibility on industry to provide safety information for substances and to properly manage the risks arising from their use. Under the previous regime, the burden of proof was on  governments to prove substances were unsafe and  to restrict their use. REACH covers all substances on  their own, in mixtures and in articles, but there are exemptions for radioactive substances, non-isolated intermediates, substances used during transportation,  and waste (Art. 2 REACH). These are covered by other existing regulations. Member States may also grant  exemptions for substances used in the interest of defence.  

根据REACH规定，对于年生产量或年进口量超过1吨（单个法人实体）的单独物质或配制品中的物质，制造商及进口商必须为法人实体办理注册，按规定免于注册的物质除外。注册要求还适用于在特定条件下，物品中有意释放的物质，在这种情况下，物品生产商/进口商必须确保物质的注册。为了履行这些义务，整个供应链需要信息传递（数据、用途、数量、 安全使用措施等）。根据REACH，下游用户具有一系列特定的义务和责任，因此必须与其供应商紧密合作，对确定用途进行注册。

Under REACH, manufacturers and importers have a duty to register substances on their own, or in mixtures that they produce or import in quantities over 1 tonne per year (per legal entity), unless the substance is exempt from registration. Registration requirements also apply to substances intended to be released from articles under certain conditions, in which case the article  producer/importer is responsible for ensuring that the substances are registered. To fulfil these obligations,  the entire supply chain needs to communicate (data,  uses, quantities, control measures for safe use, etc.).  Downstream users have a specific set of duties and  obligations under REACH and will have to work closely with their suppliers to have their identified uses  registered.

供应链中的所有行为人都应制定战略行动计划 （参见第6章）以确保遵循REACH规定，并最大限度降低REACH带来的业务风险。

Each player in the supply chain should develop a strategic action plan (see Chapter 6) to ensure compliance and minimise the business risks posed by  REACH.

汽车行业包括物品（螺丝钉、扣件）或复杂物件（如：汽车、发动机、保险杠）的生产商和进口商、配制品（如：美国的发动机油）的进口商及物质 （如澳大利亚的元素镁）的进口商。物品生产商与物品进口商需履行REAHC 规定中的特定义务，尤其是物品中有意释放的物质的注册以及对于在特定条件下物品中存在的候选清单物质，向下游用户及欧洲化学品管理局进行的信息传递/通报。根据REACH规定，如果物品中的物质已经进行了此用途的注册，则无需注册或向欧洲化学品管理局通报。 但在这种情况下，对于候选清单物质的存在， 必须向下游用户进行信息传递。 

The automotive industry includes producers and  importers of articles (e.g. screw, fastener) or complex objects (e.g. car, engine, bumper), importers of mixtures (e.g. engine oil from USA) and importers of substances (e.g. elemental magnesium from Australia). Article producers and article importers have specific obligations under REACH, in particular the registration of substances intended to be released from articles and the communication/notification to downstream users and ECHA of CL substances present in the article under certain conditions. Under REACH it is not required to register or to notify ECHA of substances in articles if they are already registered for that use. However, the  presence of CL substances must be communicated to downstream users in this case.

注» 自欧洲经济区以外进口物质或配制品的公司不再视为下游用户，而是视为进口商，必须履行REACH规定的进口商义务。

 » 生产有意释放物质的物品的公司不属于下游用户，如果此用途尚未注册，则还要履行注册的义务。

 » 原先在欧洲经济区生产（且已完成注 册）的物质或配制品再进口至欧洲经济区视为已注册。

NOTE » Companies that import substances or mixtures from outside the EEA are no longer considered  to be downstream users but importers and have to comply with the importer’sobligations under  REACH.

» Companies that produce articles that intentionally release substances are not acting as downstream users and may have registration obligations if this use has not been already registered. 

» Substances or mixtures that were originally produced (and for which the registration has been  completed) in the EEA and which have been  re-imported to the EEA are considered as being  registered.

对于被确定为高度关注并列入REACH附录 XIV（需授权物质清单）的物质必须通过授权流程。该授权程序可能会限制物质在市场上的销售。应该注意的是，如果下游用户在供应链中的上游行为人已经获得了与其相同用途的授权，则此下游用户无需再申请授权。

Substances have to undergo an authorisation process if they have been identified as being of very  high concern (SVHCs) and have then been included in REACH Annex XIV (list of substances subject to authorisation). This authorisation procedure may limit the availability of a substance to the market. It should  be noted that downstream users do not need to apply for an authorisation if the authorisation for their use has  already been granted to an actor further up their supply  chain.

除这些注册与通报义务外，REACH还把2008年修订的危险物质的限制、分类及标签法规作为基础。分类、标签与包装法规（CLP法规 (EC)1272/20084）是联合国化学品全球统 一分类与标签系统(GHS)在欧洲的实施法规。 此法规将导致REACH的进一步改编，这也会影响汽车行业，如：增加通报或安全数据表有关的义务，以及符合定义了高关注度物质 （SVHC）的REACH第57条标准的统一物质分 类。

In addition to these registration and notification obligations, REACH builds on the legislation regarding  restriction, classification and labelling of dangerous substances that was amended in 2008. The Classification, Labelling and Packaging Regulation (CLP Regulation (EC) No 1272/20084 ) as the European implementation of the United Nations (UN) Globally Harmonised System for Classification and Labelling of  Chemicals (GHS) is leading to further adaptations of  REACH that are also impacting the automotive industry,  e.g. with additional obligations in regard to notification and safety data sheets as well as to harmonised substance classifications fulfilling the criteria of Art. 57 REACH which defines a Substance of Very High Concern  (SVHC).

REACH审查

REACH Review Art

第138条REACH要求委员会进行不同的评审以评估是否修订REACH的适用范围，例如关于第33条，化学品安全评估的范围，聚合物的注册责任的范围，PBT/vPvB标准的范围等。根据类似审查，委员会可酌情提出立法建议。

138 REACH calls on the Commission to carry out  different reviews to assess whether or not to amend the  scope of REACH e.g. with regard to the scope of Art. 33,  of Chemical Safety Assessments, of registration duties  for polymers, of the PBT/vPvB Criteria, etc. On the basis  of such a review, the Commission may, if appropriate,  present a legislative proposal.

来源：https://www.automds.cn/page148?article_id=333

上海沐睿科技服务有限公司，是一家专注前瞻技术研发与工业级工程研发验证转型的科技服务企业。国内专业从事汽车法规合规的服务机构，多年来为上汽，长城，宇通，大通，爱驰，特斯拉，蔚来等OEM提供汽车环保法规合规服务，并为国内第一辆新能源出口欧盟提供全套REACH服务方案，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

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