On 19 November 2024, the Board of Appeal of the European Chemicals Agency (ECHA) dismissed the appeal filed by Coloured Chemicals BV, a Dutch company, over the rejection of its registration for ethyl methyl carbonate. The Board upheld ECHA's decision, citing the appellant's failure to meet data adequacy standards as required under Article 20(2) of the REACH Regulation.
Background of the Case
Coloured Chemicals BV submitted its initial registration for ethyl methyl carbonate (EC 433-480-9, CAS 623-53-0) on 8 June 2023, opting to provide partial data under the provisions of Article 11(3) of the REACH Regulation. Specifically, the company asserted that a long-term toxicity study for sediment organisms under Section 9.5.1 of Annex X was unnecessary due to low soil exposure risks. ECHA deemed this justification insufficient and requested further data.
Despite updating its dossier on 12 June 2023, the company’s adaptation was again rejected, prompting ECHA to consider the registration incomplete and retain the registration fee. Coloured Chemicals BV then submitted a second registration, which was accepted on 13 July 2023. However, the company appealed to have the original fee refunded.
Legal Arguments and Rulings
The appellant argued that ECHA had exceeded its mandate under Article 20(2) by assessing the adequacy of the submitted data, a process reserved for compliance checks under Article 41. Furthermore, it claimed ECHA had inconsistently applied its standards, accepting similar data from other registrants.
The Board, however, clarified that ECHA’s completeness checks must ensure the submitted information is meaningful, requiring registrants to justify adaptations with clear scientific reasoning. Coloured Chemicals BV’s submission failed to meet these criteria. Additionally, the Board found no evidence supporting claims of inconsistent application by ECHA.
Implications of the Decision
The Board of Appeal's dismissal confirms ECHA’s authority to reject incomplete registrations under Article 20(2) and retain associated fees. The ruling reinforces the requirement for registrants to provide robust scientific justifications for adaptations under REACH's technical dossier framework.
