《欧洲绿色协议》为实现零污染的无毒害环境设定了远大的目标。2020年10月14日通过的《化学品可持续战略》是零污染的第一批成果的野心。《化学品可持续战略》的目标是更好地保护公民和社会保护环境，防止危险化学品，鼓励创新，以安全和可持续的发展替代方案。为此目的，《战略》概述了旨在增加知识基础和增加知识的若干行动化学物质的控制。
化学物质在我们的日常生活中无处不在。它们对我们的幸福和高生活水平至关重要是应对未来挑战的关键技术的重要组成部分。REACH规例化学品的注册，评估，授权和限制，以及CLP的相关法规化学品的分类、标签和包装是欧盟评估和包装的主要立法化学品的管理。REACH法规最后一次评估是在2018年(被称为“最新REACH”审查”)。它的结论是，REACH是有效的，但还有进一步改进的机会，简化和减轻负担。评估之后，一些非立法行动已经开始启动(其中一些已经完成，另一些仍在进行中)以改进REACH的实施。此外，履行《化学品可持续发展策略》，CLP及其其他化学品法规也会针对性的修订。
The European Green Deal sets a high ambition for a toxic-free environment leading to zero pollution. The Chemicals Strategy for Sustainability adopted on 14 October 2020 is the first delivery of the zero-pollution ambition. The objectives of the Chemicals Strategy for Sustainability are to better protect citizens and the environment against hazardous chemicals and encourage innovation for the development of safe and sustainable alternatives. To this end the Strategy outlined a number of actions intended to increase the knowledge base and control of chemicals.
Chemicals are everywhere in our daily lives. They are fundamental for our well-being and high living standard and are important building blocks of key technologies to address future challenges. The REACH Regulation on Registration, Evaluation, Authorisation and Restriction of chemicals, together with the CLP Regulation on Classification, Labelling and Packaging of chemicals, are the key Union legislation for the assessment and management of chemicals. The REACH Regulation was last evaluated in 2018 (referred to as “latest REACH Review” below). It concluded that REACH is effective but that there are opportunities for further improvement, simplification and burden reduction. Following the evaluation, a number of non-legislative actions have been launched (some of them finalised, others still ongoing) to improve the implementation of REACH.
In addition, to deliver on the commitments made in the Chemicals Strategy for Sustainability, the CLP Regulation will also be subject to a targeted revision, along other sectoral chemical legislation.
该倡议旨在解决的问题
Problem the initiative aims to tackle
化学品可持续性战略认识到有必要对REACH进行有针对性的修订，以实现其目标通过解决已确定的下列问题来实现目标:
The Chemicals Strategy for Sustainability recognises the need for a targeted revision of REACH to achieve its objectives by addressing the following problems that have been identified:
1.REACH是全球最先进的知识基础但许多人的知识仍存在差距物质
关于关键危险类别所需的信息不允许充分彻底的危险评估，包括致癌性、神经毒性、免疫毒性和内分泌紊乱。相同的适用于中间体、聚合物和最低吨位范围的物质，不进行风险评估非阈值物质的要求。
REACH is the most advanced knowledge base globally but there are still gaps in knowledge of many substances. The information required on critical hazard classes does not allow a sufficiently thorough hazard assessment, including for carcinogenicity, neurotoxicity, immunotoxicity and endocrine disruption. The same applies to intermediates, polymers, and substances in the lowest tonnage range, and no assessment of risks is required for non-threshold substances.
2.注册人的安全评估没有考虑化学品的组合效应
个人注册人只对自己的物质负责，而没有考虑到，在现实中人类和环境暴露在来自不同来源的大量不同物质中。因此确保一种物质的安全使用本身不足以保护人类和环境免受综合影响。
The registrants’ safety assessments do not take combination effects of chemicals into account. Individual registrants are only responsible for their own substances and do not take into account that, in reality, humans and the environment are exposed to a plethora of different substances from different sources. Thus, securing safe use of one substance is in itself not sufficient for protecting humans and the environment against combination effects.
3.供应链中的沟通效率低下
在最新的REACH Review中发现并报告，供应链上下层关于使用和必要的风险管理措施的沟通缺乏准确性和清晰度，对风险控制产生了显著的负面影响。
The communication in the supply chains is inefficient. As identified and reported in the latest REACH Review, the communication up and down the supply chain on uses and necessary risk management measures lacks accuracy and clarity, which has a significant negative impact on the control of risks.
4.注册档案和物质的评估过于复杂和不足
评估注册档案和物质的程序很复杂，存在若干瓶颈，延误了向注册人索取资料和就可能的危害和风险得出结论的时间。此外这些程序不足以确保所有注册档案的合规性。
The evaluation of registration dossiers and substances is too complex and insufficient. The procedures for evaluation of registration dossiers and substances are complex, with several bottlenecks delaying the request for information from registrants and the conclusions on possible hazards and risks. In addition, the procedures are insufficient to ensure compliance of all registration dossiers.
5.授权程序过于繁重和不灵活 授权程序给公司和当局都带来了沉重的负担
大量的小剂量物质使用申请、不明确的授权标准和信息空白(特别是在竞争对手已经实施替代方案的情况下)，以及申请中不明确的信息(特别是来自供应链上游的申请人和仅来自代表的信息)导致了冗长的讨论和决策的延误。在许多情况下，这使得总部位于欧盟的公司与非欧盟的竞争对手相比处于竞争劣势。
The authorisation procedure is too heavy and inflexible. The authorisation process has imposed a heavy burden on both companies and authorities. A multitude of applications for the use of small quantities of substances, unclear criteria for authorisation and information gaps (in particular for uses where competitors have already implemented alternatives), as well as unclear information in applications (in particular from applicants up the supply chain and from only representatives) have led to prolonged discussions and delays in decision making. In many cases, this has placed EU-based companies at a competitive disadvantage compared to their non-EU competitors.
6.目前的限制过程太慢 不足以充分保护消费者和专业用户免受最危险物质的危害
正常的限制程序，通过具体的风险评估，给当局带来了沉重的负担，要记录对健康或环境不可接受的风险。尽管REACH已经规定使用通用方法(即假设该使用构成风险)来限制消费品中的某些致癌、诱变或反毒(CMR)物质，但该程序不能用于其他关键危害类别，包括内分泌干扰物、持久性、生物累积性和毒性/非常持久性和生物累积性(PBT/vPvB)物质、免疫毒物、神经毒物、呼吸敏感剂或影响特定器官的物质。此外，专业用户经常使用与普通消费者相同的产品，但使用频率更高，使用时间更长。然而，它们不太可能像在工业环境中那样受益于同样的风险管理。因此，他们至少应该得到消费者层面的保护。
The current restriction process is too slow to sufficiently protect consumers and professional users against risks from the most hazardous substances. The normal restriction procedure, through specific risk assessment, puts a high burden on authorities to document unacceptable risk for health or the environment. Although REACH already enshrines the use of a generic approach (i.e. assuming that the use constitutes a risk) for restricting certain carcinogenic, mutagenic or reprotoxic (CMR) substances in consumer products, this procedure cannot be used for other critical hazard classes including endocrine disruptors, persistent, bioaccumulative and toxic/very persistent and very bioaccumulative (PBT/vPvB) substances, immunotoxicants, neurotoxicants, respiratory sensitisers or substances that affect specific organs. Moreover, professional users are often using the same products as consumers, but much more frequently and during longer periods of time. Yet, they are unlikely to benefit from the same risk management as in industrial settings. Hence, they should get a level of protection at least at the level of consumers.
7.管制和执行在所有会员国中并非同等有效
会员国之间存在着很大的差异，这取决于现有资源和不同的政策，导致管制的效力不一致。从欧盟以外国家进口的产品越来越多，包括消费者通过在线门户网站直接购买的产品，允许进口不受必要控制的产品，以确保符合欧盟法律。这些差异对消费者和环境构成了风险，并对合规的欧洲工业的竞争力产生了负面影响。
The control and enforcement is not equally effective in all Member States. Considerable differences exist between Member States depending on available resources and different policies leading to inconsistent effectiveness of controls. The increasing import of products from countries outside the EU, including by consumers’ direct purchases through online portals, allows for import of goods that are not subject to the necessary controls to ensure compliance with EU law. These differences represent a risk for consumers and the environment and they negatively affect the competitiveness of compliant European industry.
欧盟干预的依据(法律依据和辅助性检查)
Basis for EU intervention (legal basis and subsidiarity check)
该倡议涉及对现有欧盟法规进行有针对性的修订，该法规基于《欧盟运行条约》第114条，在欧盟层面协调化学品条款，以保持内部市场的良好运行。根据即将修订的法规，由于其规模和影响，这一倡议的目标不能仅由成员国充分实现，因此可以在欧盟层面更好地实现。因此，辅助性原则得到了尊重。
The initiative concerns a targeted revision of an existing EU Regulation, which is based on Article 114 of the Treaty on the Functioning of the European Union that is harmonising provisions on chemicals at EU level in order to preserve the good functioning of the internal market. In line with the Regulation to be revised, the objectives of this initiative cannot be sufficiently achieved by the Member States alone, by reason of its scale and effects, and can therefore be better achieved at EU level. Therefore, the subsidiarity principle is respected.
目标和政策选择
Objectives and Policy options
这一举措的总体目标是确保REACH法规的条款反映了委员会在创新以及对健康和环境的高水平保护方面的雄心，同时按照《化学品可持续战略》的规定保留内部市场。为解决已查明的问题，将考虑采取一系列可能的措施。基线情况包括对截至2021年4月的该条例现行条款的延续。已确定了修订REACH法规以填补空白并简化和加强法律条款的初步可能选项清单。对于每个选项，还可以考虑各种子选项，包括可能的豁免。选项和子选项不是互斥的，但是可以(而且很可能会)结合在一起。这些选择是初步的，并可能随着分析而发展。
The overall objective of the initiative is to ensure that the provisions of the REACH Regulation reflect the ambitions of the Commission on innovation and a high level of protection of health and the environment, while preserving the internal market, as provided for in the Chemicals Strategy for Sustainability. To address the problems identified, a range of possible measures will be considered. The baseline situation consists of a continuation of the current provisions of the Regulation as of April 2021. An initial list of possible options to revise the REACH Regulation to fill gaps and to simplify and strengthen the legal provisions has been identified. For each option, various sub-options, including possible exemptions, may also be considered. The options and sub-options are not mutually exclusive, but can (and most likely will) be combined with each other. The options are preliminary and may evolve with the analysis.
1.修订注册要求
将分析修订制造商和进口商注册要求的各种方案，包括增加有关危险的信息、安全使用文件、某些聚合物的注册和环境足迹信息。
Revision of the registration requirements: Various options for revising the registration requirements for manufacturers and importers will be analysed, including increased information on hazards of concern, documentation of safe use, registration of certain polymers, and information on the environmental footprint.
2.引入混合物评估因子(MAF)
将分析通过引入附件一中的多种MAFs中的一种来解决接触几种物质(组合效应)风险的选项。
Introduction of a Mixtures Assessment Factor (MAF): Options for addressing the risks of exposure to several substances (combination effects) by introducing one of more MAFs in Annex I will be analysed.
3.简化供应链中的沟通
将评估改善安全数据表(下游公司和工人关于化学品风险和防护措施的信息)的方案，特别是协调的电子格式。
Simplifying communication in the supply chains: Options for improving safety data sheets (information for downstream companies and workers on chemical risks and protective measures) will be assessed, including in particular harmonised electronic formats.
4.修订关于档案和物质评价的规定
将考虑各种备选办法，以确保注册档案符合规定，并确保有足够的资料就所关注的问题作出结论。这包括可能撤销不符合规定的登记号码，并允许当局委托进行测试以获取危害信息。
Revision of the provisions for dossier and substance evaluation: Various options will be considered for ensuring that registration dossiers are in compliance and that sufficient information for concluding on concerns is available. These include the possibility to revoke registration numbers for non-compliant registrations and to allow authorities to commission tests to obtain hazard information.
5.改革授权程序
可选方案包括澄清和简化现行规定，对较小规模的应用进行国家授权，从REACH中移除授权标题，将REACH授权和限制系统整合为一个系统，并改进与其他立法的接口(补充《化学品战略》下的一种物质一种评估行动)
Reforming the authorisation process: Options include clarifications and simplifications of the current provisions, national authorisation for smaller applications, removing the authorisation title from REACH, integrating the REACH authorisation and restriction systems into one and improving the interface with other pieces of legislation (complementing actions under the one-substance one-assessment action under the Chemicals Strategy)
6.改革限制程序
备选方案包括将通用风险方法扩展到限制内分泌干扰物、PBT/vPvB物质、免疫毒物、神经毒物、呼吸敏感物质和影响特定器官的物质;将通用风险方法扩展到专业使用的产品;以及在限制中实施必要使用的概念，包括准予减损的标准。
Reforming the restriction process: Options include extending the generic risk approach to restrictions to endocrine disruptors, PBT/vPvB substances, immunotoxicants, neurotoxicants, respiratory sensitisers and substances that affect specific organs; extending the generic risk approach to products marketed for professional use; and operationalising the concept of essential use in restrictions, including the criteria for granting derogations.
7.修订管制和执法规定
备选办法包括确定国家管制和执法的最低要求，包括更严格的边境管制;建立欧洲审计能力来审计成员国的执行情况。
Revision of provisions for control and enforcement: Options include establishing minimum requirements for national controls and enforcement, including stricter border controls; and establishing a European Audit Capacity to audit Member States enforcement.
预期影响的初步评估
Preliminary Assessment of Expected Impacts
1.可能对经济影响
Likely economic impacts
预计REACH法规的一些变化将导致包括中小企业在内的整个供应链的成本增加。这将是由于注册某些聚合物的义务、物质注册信息要求的增加、新的风险管理措施的引入以及公司产品组合的变化(遵循新的限制或逐步停止使用需要授权的高度关注物质)的结果。根据运营商在供应链中的位置和规模的不同，成本很可能会有所不同。然而，所有经营者都将受益于简化、透明和可预测的规定。
预计这些变化将进一步激励创新和替代，欧洲工业作为一个整体将通过绿色产业走向更安全和可持续的产品和增加消费者信心而反弹。在这方面，有关化学品的更多信息可用于创新目的以及生产安全和可持续的化学品和出口产品，这可能有利于创新产业投资于安全和可持续的解决方案。此外，对进口产品实施与国内产品相同的要求将确保一个公平的竞争环境，从而减轻欧盟工业目前的劣势。
REACH法规的修订和改革预计将影响欧洲化学品管理局未来的授权，以及税收持有人从向该机构支付的费用中获得的收入。
It is expected that some changes to the REACH Regulation will lead to increased costs for industry, including for SMEs, throughout the supply chains. This would be a result of the obligation to register certain polymers and the increased information requirements for the registration of substances, the introduction of new risk management measures and the changes to the companies’ product portfolios following new restrictions or the phasing out of the use of Substances of Very High Concern subject to authorisation. The costs will most likely vary among operators depending on their position in the supply chain and their size. However, all operators will benefit of simplified, transparent and predictable provisions.
It is expected that changes will further incentivise innovation and substitution and that the European industry as a whole will rebound through the greening of the industry towards more safe and sustainable products and increased consumer confidence. In this respect, more information on the chemicals can be used for innovation purposes and the production of safe and sustainable chemicals and products for export, which might benefit the innovative industry investing in safe and sustainable solutions. Furthermore, imposing the same requirements for imported products as for domestic products would ensure a level playing field, thus alleviating the current disadvantage for EU industry.
The revisions and the reforms of the REACH Regulation are expected to impact the future mandate of the European Chemicals Agency and the income deriving from the fees payable to the Agency by duty holders.
2.可能对社会影响
Likely social impacts
该倡议将通过减少对普通公民、工人和自营职业者的危险化学品接触，包括通过环境，来加强对人类健康的保护。此外，在工作场所更好地控制和更安全地使用化学品将减少职业病和工人过早退休的风险，并为社会带来相关的医疗费用。短期内由于新的法律要求或使用危险化学品的产品成本增加，可能会造成失业;然而，从长期来看，使用最危险化学品替代品的产品的生产增长预计将弥补这一损失。
The initiative will increase the protection of human health by reducing the exposure to hazardous chemicals, for citizens in general, and for workers and self-employed, including via the environment. Furthermore, better control and safer use of chemicals at workplaces will reduce the risk of occupational diseases and premature retirement of workers, as well as related health costs for society. In the short term, there may be job losses resulting from new legal requirements or increased costs for products using hazardous chemicals; however, in the long term this is expected to be compensated by growth in production of products using alternatives to the most hazardous chemicals.
3.可能对环境影响
Likely environmental impacts
改善物质监管，包括产生更多数据，将支持创新举措，以替代最具问题的物质。此外，更有效地限制消费者使用和专业使用的产品中除社会必需用途外最具毒性、持久性、流动性和/或生物累积性的物质，将进一步减少这些物质的排放，从而改善环境保护。更安全地使用化学品将减少向环境释放危险物质，从而降低不采取行动所需要的环境补救成本。
An improved regulation of substances, including by generating more data, will support innovation initiatives towards substituting the most problematic substances. Moreover, more efficient restrictions of the most toxic, persistent, mobile and/or bioaccumulative substances in products for consumer use and professional use, except for uses essential for society, will further reduce the emissions of these substances, thus improving the environmental protection. Safer use of chemicals will result in reduced releases of hazardous substances to the environment, thus reducing the costs of environmental remediation that not acting would entail.
4.可能对基本权利产生的影响
Likely impacts on fundamental rights
这项倡议将改善《欧洲联盟基本权利宪章》所载的对消费者和环境的保护。
The initiative will improve the protection of consumers and the environment as enshrined in the Charter of Fundamental Rights of the European Union.
5.可能对简化和/或管理负担的影响
Likely impacts on simplification and/or administrative burden
将分析简化REACH法规和减少行政负担的方案，特别是对中小企业。
对工业而言，预计更严格的注册要求，特别是对低吨位物质和某些聚合物的注册要求，将增加行政负担和相关的合规成本。这在一定程度上可以通过增加使用替代的非动物试验方法来缓解。预计供应链沟通工具的改进将减少行政负担。简化授权和限制程序将使这些程序更加透明和可预测，从而减轻行政负担，尽管遵守限制和授权条件可能在短期内导致额外成本。
对于欧盟以及成员国一级的主管当局来说，评估条款可能会得到澄清，从而减少行政负担。预计还将通过精简和简化限制和授权程序来减轻当局的行政负担。
Options for simplification of the REACH Regulation and reducing administrative burdens, especially for SMEs, will be analysed.
For industry, it is anticipated that stricter registration requirements, in particular for substances at lower tonnages and for certain polymers, will increase the administrative burden and related compliance costs. This may to some extent be alleviated by increased use of alternative non-animal test methods. It is expected that improvement of tools for communication in the supply chains will reduce the administrative burdens. Simplifying the authorisations and restrictions processes will make these more transparent and predictable and, thus, reduce the administrative burden, although compliance with restrictions and authorisation conditions might lead to additional costs in the short term.
For authorities, at EU as well as at Member State levels, the evaluation provisions may be clarified, thus reducing the administrative burden. Reduced administrative burden for authorities is also expected through streamlining and simplifying the restriction and authorisation processes.
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