The Board of Appeal (“BoA”) of the European Chemicals Agency (“ECHA”) has annulled a decision by ECHA which was issued in the substance evaluation of carbon tetrachloride and which requested the submission of further information by registrants, namely the submission of an extended one-generation reproductive toxicity study (“EOGRTS”).

The contested decision was annulled by the BoA because it was deemed disproportionate as an EOGRTS was not deemed necessary to clarify a potential risk to human health and the environment. Moreover, the decision did not provide sufficient justification why ECHA requested information that only was standard for one registrant for registration from all registrants of the substance during substance evaluation. The case was remitted to ECHA for further re-evaluation and further action.

1. Principle of proportionality

Firstly, the BoA drew attention to the principle of proportionality. The principle of proportionality requires that European Union measures do not exceed the limits of what is appropriate and necessary in order to achieve the objectives legitimately pursued by the measure in question. When there is a choice between several appropriate measures, recourse must be had to the least onerous, and the disadvantages caused must not be disproportionate to the aims pursued.

Whereas European Union Courts frequently give broad discretion to European Union institutions when they assess compliance with the principle of proportionality and in particular only examine if a measure taken, e. g. by ECHA, is manifestly inappropriate, the BoA does not limit its assessment. Instead, the BoA has made clear that it will assess compliance with the principle of proportionality in more detail than European Union Courts. It justifies this with the technical and scientific expertise of the members of the BoA and Art. 93 para. 3 REACH according to which the BoA may exercise any power which lies within the competence of ECHA.

2. Three-tier test for information request in substance evaluation

The BoA established a three-tier test for information requests by ECHA in substance evaluation proceedings.

Firstly, the BoA highlighted that ECHA must be able to demonstrate the presence of a potential risk to human health and the environment if it requests additional information in the substance evaluation proceedings. Secondly, the potential risk must be identified clearly by ECHA and must satisfy real information needs and hazard concerns, but must not address purely theoretical risks. Thirdly, the requested information must have a realistic possibility of leading to improved risk management measures. None of these conditions was fulfilled in the contested decision by ECHA. In particular, the substance in question was very highly regulated; in particular restricted under Annex XVIII and no consumer and widespread exposure occurred. Exposure to workers was managed on the basis of the lowest DNEL for liver carcinogenicity. Moreover, ECHA´s evidence supporting a concern was weak. The already existing risk measurements were therefore deemed sufficient by the BoA.

3. Substance evaluation and dossier evaluation

In addition, the BoA clearly distinguishes between substance evaluation on the one hand and dossier evaluation on the other hand. A gap in the registration dossier of a single registrant cannot per se justify an information request to all registrants in substance evaluation.  

The BoA highlights that the normal course of action should be for ECHA to carry out a compliance check of the registration dossier prior to the performance of a substance evaluation. In this way, the substance evaluation can be based on a more complete set of (standard) data. In addition, the BoA highlights the importance of the legislative decision to establish thresholds for registration purposes and their corresponding data requirements which took into account the cost of generating data and the requirement for data and cost-sharing. Information requests in substance evaluation could in particular adversely affect low tonnage and intermediate registrants if they are not responsible for providing this information in their own substance registration.

The basic rule established by the BoA is that a compliance check pursuant to Art. 41 REACH must be used to fill data gaps relating to the “standard” information which is to be provided pursuant to Annexes VI to XI REACH.

The BoA accepts, however, that there might be exceptional circumstances in which such standard information can be requested by ECHA by way of asubstance evaluation. However, ECHA must clearly justify if it extends standard information requests in the substance evaluation procedure. Such a justification may be an immediate, relevant and real concern for human health or the environment from the use of the substance. In particular, ECHA must state reasons why it demands information in substance evaluation instead of during dossier evaluation and why it demands information from all registrants of a substance instead of only registrants with high tonnage bands. In this case, ECHA had not given sufficient justification for choosing substance evaluation and for choosing all registrants as addresses of its decision.

4. Impact of the Decision

The case is likely to have significant impact on future decisions by ECHA and pending appeals in substance evaluation. ECHA will need to adapt its current administrative practice and will need to give more detailed and fully substantiated reasons in its substance evaluation decisions. Furthermore, the BoA has clarified the relationship between substance and dossier evaluation and clearly determined that a dossier evaluation should generally  precede a substance evaluation.

Since the BoA has made it clear that it will examine compliance of ECHA with the principle of proportionality in more detail than European Union Courts in subsequent judicial proceedings, any future or pending appeal against decisions of ECHA should already present all potential arguments why the principle of proportionality may have been infringed by ECHA. Arguments which may be dismissed at a later stage before the European Union Courts may be successfully claimed before the BoA. 

In summary, this decision of the BoA is certainly to be regarded as a landmark case which helps a great deal in paving the way to a better structured, more predictable administrative practice of ECHA as it lays down some very fundamental guidelines to be followed by ECHA.