Chambre de recours

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28 July 2020
New ECHA Board of Appeal decisions on data and cost-sharing

The Board of Appeal today published two decisions, covering nine appeals (A-013-2018 and Joined Cases A-014 to A-021-2018), concerning data and cost-sharing.

The nine appeals were filed by a potential registrant of nine substances. The Appellant had applied to ECHA for permission to refer to vertebrate animal studies from registrations of the substances. ECHA refused permission to refer on the grounds that the Appellant’s behaviour during the data and cost-sharing negotiations did not show a real intention to find an agreement. The Appellant argued before the Board of Appeal that ECHA should have granted it permission to refer because the previous registrants for the nine substances proposed terms for data and cost-sharing which were not fair, transparent and non-discriminatory.

The Board of Appeal held that the previous registrants had failed to comply with the requirements of transparency (the itemisation of data and costs), and the requirement for the terms to be non-discriminatory (the exemption of registrants’ affiliates from paying for data). The Board of Appeal therefore annulled ECHA’s nine decisions and granted the Appellant permission to refer to the requested vertebrate animal studies.

Andrew Fasey, Member of the Board of Appeal and Rapporteur for the nine cases, said: “The two decisions published today provide further clarification, in addition to that in the recent decision A-010-2017, of the Board of Appeal’s interpretation of the rules in the REACH Regulation and the Commission Implementing Regulation 2016/9 for data and cost-sharing and how these rules should be implemented by ECHA. The law requires ECHA to apply clear and objective criteria in the assessment of applications for permission to refer and these decisions further identify what these criteria should be”.

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