The ECHA: any chemistry between the agency and enforcement? DRAFT

By Daan, Giulio, Henrik and Majed

Section I – ECHA: There’s more than meets the eye

Chemicals are of fundamental importance for the well-functioning of modern society. Think of chemicals such as hydrogen and bromine. However, dangerous chemicals, such as asbestos, have led to the loss of many lives. Therefore, the European Chemicals Agency (ECHA) is concerned with the safe use of chemicals within the internal market. However, officially it is not an enforcement agency. Paradoxically, a closer examination of this ‘non-enforcement’ agency reveals that it has powers that can be classified as enforcement powers. The arguments for and against the ECHA possessing direct and indirect enforcement capacities are carefully weighed in this blog post.

As this post shows, some arguments point to the ECHA’s lacking enforcement capacities, such as its reliance on national authorities and its lack of direct involvement with citizens in the various stages under REACH. However, various other arguments can be presented that point in the direction of it, in reality, possessing different variations of enforcement powers. Not only can it take binding decisions in the registration phase, but also by delivering its scientific opinions, it is in the driver’s seat of an enforcement network which is built upon the National Competent Authorities’ (NCAs) powers. With that said, in the end, it is up to you to decide how to view ECHA’s enforcement powers.

Direct and indirect enforcement

Enforcement can be understood as the capacity to prevent potential violations of the law while ensuring compliance with its obligations. Direct enforcement can be understood as monitoring, investigating, and sanctioning individuals and businesses who are subject to the rules and regulations of substantive law. On the other hand, indirect enforcement concerns those instances where public authorities coordinate and influence the application of the law by national or European authorities, but not directly against citizens.

The iceberg: a schematic overview of ECHA’s enforcement capacities

Section II – The ECHA lacking enforcement capacities The ball is in the Member States’ court

Looking at the ECHA’s operations shows that the Agency lacks enforcement powers. Be it the checking for completeness of the dossiers filed by companies or the evaluations of the compliance of the information with the required standards, ECHA’s decisions are effectively made by its Member State Committee. Take, for instance, the evaluation of chemicals. What the Agency does is draw up a ‘Community Rolling Action Plan’ which is a list of chemicals the Member States’ authorities can discretionally choose from to later assess the chemical in complete autonomy.

Next, is that the national authority prepares a draft decision, which in most cases is the final decision in respect of the chemical at issue that will be made by the ECHA itself. Therefore, the impression is that of an Agency that limits itself to rubber-stamping what in reality is the working of the competent authorities of the individual Member States. After all, Article 45(1) of the REACH Regulation unequivocally states that “the Agency shall rely on the competent authorities of Member States” with regard to the role they play in the proper evaluation of chemicals.

Direct enforcement or bureaucratic pen-pushing?

Secondly, the REACH Regulation sets out the ECHA’s functions in respect of the registration, evaluation, authorisation, and restriction of chemicals. With regards to authorisation and restriction, the role of the Agency is purely advisory, whereas, in the registration and evaluation processes, its decisions are technically binding. Yet is it really the case that the faculty to make binding decisions provides the Agency with direct enforcement powers? A mere glance over the Agency’s tasks suggests that it is not. It is true that the Agency may accept (unconditionally or conditionally) or reject a company’s application for placing a chemical on the market, but that is virtually all its direct enforcement ability. During that phase, the Agency enforces the standards of information required by REACH directly in relation to the applicant. All the while, this direct enforcement is little more than a formal check to verify whether the information included in the applicant’s dossier is complete. Past this bureaucracy-dictated check, there is little in the Agency’s activities that may amount to direct enforcement. As said, in the authorisation and restriction stages, its role is purely advisory and, with regards to the evaluation stage, the Member States’ authorities are the ones in charge of verifying the substantial compliance of the information with the legal standards.

Section III – The ECHA possessing enforcement capacities The EU’s chemistry expert

The ECHA is a pre-decision-making agency. Even though the ECHA does not make a certain decision by itself, it influences the outcome to a great extent. The ECHA can have such influence over decisions through the drafting of decisions, opinions and recommendations. Since the ECHA is considered the leading expert on the EU’s chemicals policy, other parties require good arguments in order to diverge from the ECHA’s stance. Thus, while formally the decision might be made by the Commission, factually, it is the agency that stipulates what will happen. The rationale behind this phenomenon is that the Commission does not possess the expertise required in order to assess the ECHA’s recommendations and thus it will usually adopt the ECHA’s stance. Thus, although the ECHA legally lacks direct enforcement powers in most fields, through indirect enforcement the ECHA factually enforce rules in the field of EU chemical policy. This makes sense because EU agencies are usually set up to be the experts in their field and it would be inefficient not to provide these experts with the tools to materialize their knowledge.

A closer look: direct and indirect enforcement in practice through the ECHA

While the ECHA does not legally possess enforcement capacities, it does play a central role in the enforcement of the EU’s chemicals policy. In terms of direct enforcement, the ECHA is capable of taking binding and consequential decisions directly on individuals and businesses during the dossier submission stage, where it undertakes a ‘completeness check’ of the content of applications. At this stage and during the registration phase, the ECHA can solely decide whether to accept or reject the application of the chemical in question. A negative decision by the ECHA can have significant consequences on the applicants, who will need to either appeal the decision or submit a revised registration application. This can delay or prevent registration altogether and, consequently, the subsequent circulation of a chemical substance into the Union. The ECHA is therefore capable through this capacity of independently preventing potential violations of REACH while achieving compliance with its obligations.

Following the registration phase, the ECHA continues to play an important role in the evaluation and authorization stages. Here, the agency harmonizes and supervises cooperation with NCAs in a manner akin to that of an enforcement network, inducing a high level of collaboration between the different NCAs. In addition, decisions adopted by those NCAs often rely on the scientific opinions of the ECHA, demonstrating how the agency contributes to the indirect enforcement of the obligations under REACH.