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March 18, 2010

ECHA Board of Appeals Issues Guidance for Appealing ECHA Decisions

Bergeson & Campbell, P.C.

On March 10, 2010, the European Chemicals Agency (ECHA) Board of Appeals (Board) issued a document, Practice Directions to Parties to Appeal Proceedings Before the Board of Appeal of the European Chemicals Agency (Practice Directions), to provide guidance on various aspects of the appeals proceedings, including communications with the Board, procedures for lodging a notice of appeal and other pleading documents, the rights of parties to confidentiality, and procedures for parties seeking to intervene in a pending case. The Practice Directions are available online. The Board states that these Practice Directions are intended to “ensure the smooth, reliable and cost effective running of proceedings,” and are meant to complement the Rules of Procedure already in place that set forth the Board’s rules applicable to appeal proceedings (available online). Below is a discussion of the ECHA decisions that are subject to appeal and the guidance provided by the Board in its Practice Directions.

ECHA Decisions Subject to Appeal

ECHA decisions that can be appealed before the ECHA Board of Appeals are specified in Article 91 of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. These decisions are:

  • Article 9(4) and (7) — Exemptions from the General Obligation to Register for Product and Process Orientated Research and Development (PPORD): With regard to PPORD:
    • A decision to “impose conditions with the aim of ensuring that the substance or the preparation or article in which the substance is incorporated will be handled only by staff of listed customers as referred to in paragraph 2(e) in reasonably controlled conditions, in accordance with the requirements of legislation for the protection of workers and the environment, and will not be made available to the general public at any time either on its own or in a preparation or article and that remaining quantities will be re-collected for disposal after the exemption period”; or
    • A decision “to extend the five-year exemption period by a further maximum of five years, or in the case of substances to be used exclusively in the development of medical products for human or veterinary use, or for substances that are not placed on the market, for a further maximum of ten years, upon request if the manufacturer or importer or producer of articles can demonstrate that such an extension is justified by the research and development programme.”
  • Article 20(2) — Duties of the Agency: With regard to duties of ECHA, decisions regarding the completeness of a registration (not including an assessment of the quality or the adequacy of any data or justification submitted) or the rejection of a registration if the registrant fails to complete the registration with the deadline set.
  • Article 27(6) — Sharing of Existing Data in the Case of Registered Substances: With regard to the sharing of existing data in the case of registered substances, a decision by ECHA to give a “potential registrant permission to refer to the information requested by [the registrant] in [its] registration dossier, subject to the potential registrant providing, upon request by the Agency, proof that [it] has paid the previous registrant(s) for that information a share of cost incurred.”
  • Article 30(2) and (3) — Sharing of Data Involving Tests: With regard to the sharing of data involving tests:
    • In cases where a relevant study involving tests is not available within the Substance Information Exchange Forum (SIEF) and a decision has not been reached among SIEF participants as to who is to carry out the test within a deadline set by ECHA, a decision by ECHA specifying which registrant or downstream user shall perform the test.
    • In cases where an owner of a relevant study involving testing on vertebrate animals refuses to provide either proof of the cost of that study or the study itself to another participant, a decision by ECHA made within 12 months of the other participants’ registration submissions that such other participants should repeat the study
    • In cases where an owner of a relevant study involving testing on vertebrate animals refuses to provide either proof of the cost of that study or the study itself to another participant but a registration containing such information has already been submitted by another registrant, a decision by ECHA to give the other participants permission to refer to the information in their registration dossiers.
  • Article 51(3) and (6) — Adoption of Decisions under Dossier Evaluation: With regard to the adoption of decisions under dossier evaluation:
    • When ECHA does not receive any proposals, a decision to “take the decision in the version notified under paragraph 1” (its draft decision in accordance with Articles 40 or 41, together with the comments of the registrant, to the competent authorities of the Member States).
    • Within 60 days of referral, when the Member State Committee reaches a unanimous agreement on the draft decision, an ECHA decision to “take the decision accordingly.”

Practice Directions

ECHA states that the Practice Directions are intended to help appellants and their representatives prepare appeals in the most effective way. The Practice Directions cover the main elements of proceedings before the Board. Of particular interest, we note the following:

  • Communication with the Board: In its Practice Directions, the Board provides practical advice for communicating with the Board, including addresses where information should be sent, special requirements for communicating with the Board via e-mails and facsimiles, and the number of copies of a document to be submitted to the Board.
  • Appeal Fees: A Fee Regulation was issued on April 16, 2008, EC No. 340/2008, that sets forth the rules applicable to the payment of the appeal fee (available online). In its Practice Directions, the Board states that all payments must be made in Euros by bank transfer to the bank account held by ECHA and identified on its website. The Board provides additional guidance on how to make the payments, including referencing the identity of the appellant on the payment, ensuring that bank charges are paid by the appellant, and ensuring that proof of payment is attached to the notice of appeal. The Board also provides guidance on how companies can seek a reduction or refund of the appeal fee.
  • Time Limits: The rules for calculating time limits are set forth in Article 23 of the Rules of Procedure. In the Practice Directions, the Board clarifies that an appeal must be made within three months of the notification of the decision to the person concerned, or in the absence of such notification, of the day it became known. In addition, although Article 24 of the Rules of Procedure describes how time limits can be extended “by whoever prescribed” the time limit, the Board states in the Practice Directions that the time limit for lodging a notice of appeal cannot be extended.
  • Templates: Article 6 of the Rules of Procedure describes the contents of the notice of appeal. In the Practice Directions, the Board provides further guidance on the content and form of the pleadings, including the initial notice of appeal. The Board also has created four templates to assist submitters in preparing their appeals. Templates for a cover letter, a table for annexes, an evidence sheet, and a checklist of documents to support the filing of an appeal can be found online.
  • Summary and Publication of the Notice of Appeal: Article 6(6) of the Rules of Procedure states that an announcement of a notice of appeal shall be published on ECHA’s website, indicating the date of registration of an appeal initiating proceedings, the names and addresses of the parties, the subject mater of the proceedings, the remedy sought by the appellant, and a summary of the pleas in law and of the main supporting arguments. In the Practice Directions, the Board states that to facilitate the preparation of the announcement, the appellant should attach to its notice of appeal the summary of the dispute, which should not exceed one page. No confidential information should be included in the summary document.
  • Confidentiality Requests: The Rules of Procedure at Articles 6(1)(g), 7(2)(d), and 8(4)(g) provide that a notice of appeal, Agency defense, and any intervention must indicate, where appropriate, what information is to be regarded as confidential. In the Practice Directions, the Board clarifies that requests for confidentiality must be made in writing at the time the document is lodged, “under a separate heading of the procedural document in question or by a separate application lodged together with the principal document(s).” The request “shall indicate the relevant words, figures or passages for which confidentiality is claimed, together with the reasons for that request.” The Board also states that determinations as to whether particular information will be regarded as confidential will be made by the Chairman of the Board based on all the circumstances of each individual case. Moreover, the Board states: “Since the Board cannot rely on any matters which have not been the subject of disclosure between the principal parties to the proceedings, confidential treatment cannot be accorded to an appellant vis-á-vis ECHA or vice versa.” The Board also provides guidance on how to prepare non-confidential, sanitized versions of the document(s) at issue and how to prepare “marked confidential” versions of the document(s) where the confidential information is left between square brackets.
  • Intervention Procedures: Article 8 of the Rules of Procedure set forth the circumstances under which a person establishing an interest in a case submitted to the Board can intervene in those proceedings. The Board states in the Practice Directions applications to intervene must contain the information set forth in Article 8(4) of the Rules of Procedure, and states that the application should “contain a concise statement of the matters at issue in the proceedings which affect the person introducing the application.” Intervenors are urged to take into account the guidance provided in the Practice Directions for lodging notices of appeals and other pleadings. Applications for leave to intervene will be provided to the other parties to the case, who will be afforded an opportunity to comment on the application.
  • Oral Procedures: Article 13 of the Rules of Procedure sets forth the procedures for when the Board can hold hearings. In the Practice Directions, the Board provides some additional guidance on the language to be used in oral proceedings, the summons to a hearing, requests by a party for a closed hearing, the location of the hearing, and the attendance of the parties at the hearing.