EU chemicals policy has been one of the most ambitious and detailed areas of the EU regulatory polity. In part five of RENFORCE Blog’s special series on the enforcement of EU law, Leander Stähler addresses a concrete challenge to enforcing these rules – the registration of chemicals – and highlights the potential of the Commission’s new strategy.
Chemicals are a significant raw material for a variety of products and processes. In 2018 alone, the EU’s chemical industry booked sales of €565 billion, with the global industry revenue above $ 4 trillion in that same year. In light of the risks certain chemicals pose to workers, the environment and human health, it comes as no surprise that chemicals require diligent regulation. The EU’s paramount regulatory instrument (REACH, promulgated in 2006) is one of the world’s most extensive and detailed forms of chemicals regulation, yet certain aspects of enforcing it remain lacking.
The Structure of REACH and the Enforcement Challenge of Mandatory Registration of Chemicals
So, how is REACH enforced? Akin to other EU policy areas, a corresponding EU agency (the European Chemicals Agency or ECHA) plays a coordinating role, whilst enforcement competences are carried by corresponding national authorities. These national enforcers in turn are mandated to coordinate best practices and other cooperative activities via an enforcement forum. In spite of these distinguishing features of EU law enforcement, i.e. an EU-level agency and a cooperative network enforcing harmonised rules, REACH is widely considered to suffer from an implementation problem.
REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. The first of which, registration, is epitomised by the “no data, no market” principle. This principle entails that registration dossiers are submitted to ECHA outlining technical details on chemicals placed on the European market, their risk to human health and the environment and how these risks are managed by the registrant. Ergo, this data must be submitted or there is no access to the market. In spite of this apparent bright-line rule, a 2018 review of REACH by the European Commission concluded that a lack of compliance of registration dossiers was a key factor hampering the success of the Regulation.
In order to address this issue, it is important to understand how dossier non-compliance can be addressed. After receiving registration dossiers, ECHA can evaluate them and upon finding them non-compliant, submit a draft decision to require a registrant to submit additional information to ECHA’s Member State committee. This same committee makes the final decision on the compliance of the dossiers. Newly submitted information will then be re-checked by ECHA. Following this procedure and if the submitted information remain non-compliant, subsequent substance evaluation decisions are executed by national enforcement authorities.
As of 2019 this process has been streamlined; a decreasing proportion of draft decisions now require the involvement of the Member State committee and ECHA is planning to increase the use of a combined approach to ECHA-level dossier evaluation and Member State-level substance evaluation (COMBO). Further integration of evaluation procedures between ECHA and the Member State authorities can be expected, especially via the enforcement forum.
Importantly, these improvements such as COMBO and greater cooperation between ECHA and the Member States are necessarily within the current legal dimensions of REACH. Although the European Commission is empowered to make changes to the Annexes to REACH, meaning that information that needs to be submitted in a dossier or the list of substances that must be registered can be expediently amended, it cannot amend the powers of ECHA and national enforcers. In order to change this, the complete EU legislature would have to amend REACH. Some have argued that the structure of REACH, which shifts the burden of proof from registrants to the authorities after the submission of dossiers, is a structural issue of REACH as companies are likely to be reluctant to state that their chemicals pose a risk. Non-governmental organisations have also highlighted the fact that sanctions for non-compliance across the Member States are not harmonised, which can make full compliance in certain Member States a non-incentive for registrants and can fracture the level of compliance along national boundaries.
Overall, it is clear that this issue challenges the success of the precautionary principle as the keystone of EU environmental policy. The idea behind this principle is that risks to the environment, such as those posed by chemicals, should be pro-actively prevented. Although the principle had “defined the contours” of REACH, non-compliance demonstrates that many registrants are not taking adequate precautions.
The Way Forward for REACH: Adjusting the Regulatory Design for Registration
Judging by the European Commission’s new strategy published in October 2020, a re-framing of REACH appears imminent and enforcement of REACH will be one particularly crucial aspect of this re-framing. This is evident from the urgency with which the Commission heralds a new “zero tolerance” approach to non-compliance in section 2.3.2 of the strategy. It is clear that the Commission seeks to tackle key factors contributing to non-compliance such as the difference in capacity of national enforcers, as well as the dominant role of imports as non-compliant substances and the role of substances sold online.
Enforcement will play a key role in the Commission’s initiative to revitalise REACH. It is clear that the Commission seeks to integrate its fresh chemicals strategy with priorities set in the Green Deal, the forthcoming Customs Union strategy and the implementation of the new Market Surveillance regulation. At the European level, the Commission is proposing a power to audit Member States in regard to their implementation of REACH and new powers for OLAF to investigate chemical trade. At the national level, the Commission is seeking greater integrated enforcement via inter-EU coordination tools and information exchange and proposes increasing Member State enforcement capacity to better exploit integration. Generally, the Commission is calling for an expansion of enforcement tools, particularly digital enforcement tools and the use of EU-level IT systems for ensuring compliance. Beyond the public law sphere, it is especially noteworthy that the Commission is calling upon greater involvement of the representative action procedure as a private dimension to enforcement.
Arguably, it remains to be seen whether these envisaged changes will directly ensure a stronger level of compliance of registration dossiers, yet an extended catalogue of tools may allow enforcers to respond more effectively and deter non-compliant registrants. Markedly absent from this preliminary strategy is the role of ECHA vis-à-vis registration dossiers, i.e. the authority responsible for these dossiers. In whichever way this strategy may be concretised in the future, the Commission has reached the conclusion that “[l]egal proposals, including a revision of the REACH Regulation in the most targeted way possible” are the way forward.