Little-Known Step - More than six years after the REACH regulation went into force, perhaps the least-known part of the regulation is the Board of Appeal (BoA) of the European Chemicals Agency (ECHA) and the appeals process.

In one way this is easy to understand, as the number of appeals has been less than anticipated by the European Commission, ECHA and the Board of Appeal itself. However, each BoA decision could have a significant effect on the interpretation and implementation of REACH, the Biocidal Products Regulation (BPR) that took effect Sept. 1, and the working practices of ECHA generally.
The BoA was established by REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) to allow recipients of, and those affected by, certain ECHA decisions made under REACH to have those decisions reviewed by an independent and impartial body.

The BPR has now extended the remit of the BoA to also consider appeals against certain ECHA decisions made under the BPR. One of the keys to the successful operation of the BoA is for it to be - and to be perceived as - independent and impartial.

To this end, a number of measures have been taken. First, all the full-time members of the BoA, and its external alternates and additional members (AAMs), are appointed by the ECHA Management Board rather than by ECHA and its executive director. Second, the members of the BoA may not perform any other duties in the agency. Third, while there are benefits to the BoA from being co-located with ECHA in terms of understanding the processes followed, both the BoA and ECHA are extremely vigilant in ensuring that the members of the BoA are never exposed to case-specific material or discussions that might be perceived to potentially influence the BoA's decision-making. Members of the BoA also attend stakeholder events to help ensure that they are in touch with the wider stakeholder environment, and they actively encourage invitations to attend events outside ECHA. And fourth, perhaps most importantly, all BoA final decisions and most of its procedural decisions are published.

As mentioned above, only certain ECHA decisions can be appealed to the BoA. In short, under REACH these are ECHA decisions related to two fundamental REACH processes: registration (rejection of registrations; certain conditions for product and process orientated research and development [PPORD] exceptions; and data-sharing decisions) and evaluation (dossier evaluation, testing proposals and compliance checks, and substance evaluation). Under the BPR, appealable decisions are related to data-sharing, technical equivalence, and the rejection of applications because of nonpayment of fees.

The BoA comprises three full-time members, one technically qualified and two legally qualified, appointed for a term of five years per member. One of the legally qualified members serves as chairman for the duration of the five-year tenure. Three BoA members consider each appeal. These will usually be the three full-time members, but AAMs may be used in certain circumstances. Each full-time member has alternates who may be appointed to work on a case if there is a potential conflict of interest or if a member of the BoA is not available. Additional members may also be called to work on particular cases for resource reasons, i.e., the number of cases is such that they can be processed at a reasonable rate only by calling upon additional resources.

The appeals process itself is in principle quite straightforward. But while lawyers do not need to be involved in an appeal, the appellant should be aware that the appeals process bears certain similarities to judicial proceedings. The appellant makes an appeal by submitting a notice of appeal (NoA) within three months of the date of notification of the decision being contested. Certain mandatory elements of a NoA must be supplied for the appeal to be admissible, and these are specified in the Rules of Procedure of the BoA (for example, proof that the appeal fee has been paid, and the pleas in law and the arguments of fact and law being relied on by the appellant).

An announcement of each appeal received will be published on the BoA section of the ECHA website so that interested parties are aware of the subject matter of appeals and also so that potential interveners in a case have sufficient information on which to base an application to intervene. Again, the BoA Rules of Procedure lay down the requirements for an application to intervene, and the BoA will make a decision on whether such applications shall be accepted.

The decision-making process for the BoA includes a written procedure and, in some cases, an oral hearing. The written procedure involves ECHA providing a defense of its decision, in response to the NoA, and potentially further submissions from the appellant and ECHA and responding to specific questions from the BoA or requests for information. Once the written procedure is closed, if either the appellant or ECHA requests an oral hearing then one shall be held; an oral hearing can also be held if required by the BoA. Once the written procedure and the oral hearing are completed, the BoA will consider and prepare its decision, which, if necessary, will be adopted by a vote of the BoA. All final decisions and certain procedural decisions (e.g., decisions on applications to intervene and requests for confidentiality) are published, minus any information accepted as being confidential by the chair of the BoA.

The BoA can, in broad terms, take any decision that would have been open to ECHA when they made the initial decision. In practice, most BoA decisions are likely to be to: reject the appeal and uphold the contested decision; annul the contested decision and remit the contested decision back to ECHA for further consideration with ECHA being bound by the reasoning in the BoA decision; or annul the contested decision and substitute the contested decision with another as directed in the BoA decision.

It should be borne in mind that the review performed by the BoA is a legality review, which implies that the appeals process should not be regarded as a second chance for registrants but as a means to correct decisions that are legally incorrect. If a company is considering utilizing the appeals system, it is advised to read carefully the relevant legislation as well as the guidance and supporting material prepared by the BoA.

Over time the BoA's decisions will help to clarify certain grey areas in REACH and the BPR. They also will help to ensure that ECHA's processes are fully in line with the requirements in both of these regulations as well as with EU law more generally. While most stakeholders will not need to use the appeals system, the decisions made by the BoA may nevertheless be relevant to all stakeholders.

While the appeals process and the work of the Board of Appeal may not be the best-known aspect of REACH, it is nonetheless an integral part of the systems established by REACH and the BPR. It plays a vital role in ensuring the smooth and effective operation of these regulations in the interests of all stakeholders. Andrew Fasey, technically qualified member of the ECHA Board of Appeal Mercedes Ortuño, chairman of the ECHA Board of Appeal.

Note: The views expressed in this article are those of the authors alone and do not necessarily represent the views of the European Chemicals Agency or its Board of Appeal. Furthermore, this article has been written in a relatively informal style to make it accessible to as wide an audience as possible. This article should therefore not be used as the basis for either preparing an appeal or during the appeals procedure itself. The REACH regulation, BoA's Rules of Procedure, BoA's Practice Directions, the Biocidal Products Regulation, and other resources made available on the Board of Appeal's section of the ECHA website should be carefully consulted by anyone who needs to understand the legal provisions concerning the Board of Appeal and the appeals process (http://echa.europa.eu/regulations/appeals).