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The EU has some of the world’s strictest chemical controls but dangerous substances are still creeping into the market, threatening the health of workers, consumers and the environment. Dolores Romano and Andreea Anca look at the flaws in the Authorisation and Restriction procedures of EU’s main chemicals regulation.

This article follows the Walking the EU’s talk on a toxic free environment – PART ONE, focusing on REACH’s Registration and Evaluation procedures. 

The European Commission requires that chemicals identified as substances of very high concern (SVHCs) need to be authorised if used in consumer products and for industrial purposes. The EU Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) system is among the strictest in the world, yet in practice the mechanism still permits the industry to use SVHCs substances that are hazardous for people and nature. The upcoming revision of REACH is an opportunity for the Commission to address the weaknesses in the implementation of these processes.  

Authorisation

Through the Authorisation phase, REACH bears the huge responsibility of eliminating or substituting the chemicals of highest concern for people and the environment. The procedure helps authorities identify substances of very high concern, such as carcinogens, mutagens, reprotoxicants, endocrine disrupters that remain in the environment for a long time and bioaccumulate in the food chain. The Authorisation step is also an incentive for substitution, helping create a new market for safer alternatives. Moreover, the written text places the burden of proof on the industry, which needs to demonstrate that the risks posed by SVHCs are controlled or minimized, and that no alternatives are available. 

Lobby pressure 

When REACH was approved, businesses fiercely attacked the Authorisation leg of the regulation. The powerful industry lobby managed to interfere in the end with the application of this procedure and the EU authorities granted authorisation to almost all the companies’ applications, regardless of their compliance with the requirements of the Application for Authorisation (AfAs). So far, these problematic approvals have resulted in the protection of companies that continue manufacturing and using toxic chemicals, at the expense of innovative business models that use safer alternatives.  

The procedures to develop opinions on AfAs and the decision-making process of the Commission and Member States could take as long as six years. The authorities also lack resources, relevant criteria and the consideration of alternative providers. The attempt to fix and complete applications late (decision-making) in the process is burdensome and controversial, resulting sometimes in objections from the European Parliament, and court cases against the Commission. 

Restriction 

The Restriction in REACH is a straightforward process, largely accepted by stakeholders. It can impose specific use conditions, limit or ban the manufacture, import, sale, or use of a substance. A restriction may apply to any substance on its own, in a mixture, or in an article and can include certain polymers. Proposals for restrictions can be made by EU Member States, the European Commission or the European Chemicals Agency (ECHA), and involve scientific risk assessment and socio-economic considerations. As with an AfA, the European Commission makes the final decision on a restriction, which has to be supported by EU member states.  

But this crucial REACH process has also suffered from long delays, as restricting chemicals in the EU takes eight years on average. The delays are caused by a combination of factors, such as the lack of compliance by the industry with the obligations to provide information on the hazards, uses and exposure of chemicals, or the high level of evidence required for authorities to demonstrate that the hazardous chemicals are causing an unacceptable risk. The wide exemptions, the long transitional periods (the extra time granted to businesses to continue using, hence releasing into the environment the hazardous chemicals despite the ban) and the exclusion of risks from end-of-life phase (e.g., reuse, recycling, landfilling, incineration) further undermines the Restriction of chemicals under REACH. 

EEB recommendations 

The European Environmental Bureau (EEB)’s chemicals policy working group highlighed several actions that could speed up the regulation of hazardous chemicals, such as extending the fast-track restriction route (Art 68.2) to additional hazard categories and professional uses, opening this option to competent authorities in Member States, adding additional SVHCs categories under authorisation, incentivising the restriction of chemicals groups (instead of individual chemicals) and establishing strict deadlines to each process. 

Substitution should be promoted at the early stage by asking SVHCs’ downstream users to perform substitution plans and to notify their uses, by introducing fees for using SVHC’s and restricted chemicals, by improving the available information on alternatives through a substitution support network, and by supporting industry frontrunners.

The EEB further recommends a swift ban of toxic chemicals in consumer articles. 

EEB links relevant to the REACH revision:

EEB comments to CARACAL regarding REACH Authorisation and Restriction reform

Joint comments to CARACAL on Registration and Evaluation under REACH Revision

EEB comments to CARACAL on use and exposure information under REACH Revision

EEB comments to the Commission’s study developing an essential use concept under REACH Revision (March 2022)

Joint comments to CARACAL to regulate the combination effects of chemicals under REACH (August 2020)

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