Article

New Board of Appeal Decisions Published Concerning Testing Requirements

Posted on: August 27, 2020

by Dr. Martina Schneider

man in laboratory looking at test tubes - New Board of Appeal Decisions Published Concerning Testing RequirementsSince 2010, the Board of Appeal provides a means for companies to request an independent review of certain decisions taken by ECHA under the REACH and Biocidal Product regulations.

The Board of Appeal is part of ECHA; however, it forms its decisions independently and is comprised of a chairman and two members: a technically qualified member and a legally qualified member.

Appeal Procedure

The decisions that can be appealed are identified in Article 91 of REACH and Article 77 of the Biocidal Product regulation. The appeal must be received by the Board of Appeal within three months of the date of the contested decision. An appeal is subject to a fee in the range of 1794 – 7175 Euro (depending on the decision type and company size).

ECHA provides the documentation needed for the appeal on their webpage and more guidance on the procedure can be found here.

Recent published decisions

On August 18, 2020, two new decisions were adopted which concern vertebrate animal testing under REACH for substances that are used exclusively as cosmetic ingredients.

As part of a compliance check, ECHA requested additional testing for two substances solely used in cosmetic products which the registrant appealed against. The registrants stated that these substances would not require vertebrate animal testing since this would conflict with the provisions of the Cosmetic regulation.

These final decisions by the Board of Appeal underlined the fact that REACH does not automatically exempt substances used in cosmetics from certain information requirements. Only if the conditions for an adaptation (e.g., a waiver for the studies) are included in the registration can certain testing be exempted.

The conflict between REACH and the Cosmetic regulation have, in many cases, previously been subject to discussion. ECHA has already published a factsheet, a Q&A and a clarity statement on this topic. The decisions by the Board of Appeal will hopefully serve as an additional resource to have more clarity on this topic for the future.

Actions:

  • In case you receive a decision from ECHA that you wish to appeal, familiarise yourself with the previous cases handled by the Board of Appeal
  • If you consider submission of an appeal, be aware of the deadline for the submission which is three months of the date of the contested decision

References:

Regulation (EC) No 1907/2006 (REACH): https://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX:32006R1907

Regulation (EC) No 1223/2009 (Cosmetics regulation):  https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32009R1223

Keywords:

  • REACH
  • Cosmetic regulation
  • Board of Appeal
  • European Union

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