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ECHA Board of Appeal | 23 August 2022 | Dragon Chemical Europe GmbH, Germany

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Subject matter: A decision taken by the European Chemicals Agency pursuant to Article 46(1) of the REACH Regulation2

Contested Decision: Decision of 24 May 2022 on the substance evaluation of 5-amino-o-cresol (EC number 220-618-6; CAS number 2835-95-2)

Background and remedy sought by the Appellant: On 24 May 2022, the Agency adopted the Contested Decision requesting the Appellant to submit, by 29 August 2023, information on an in vivo mammalian alkaline comet assay test (OECD test guideline 489) in liver, gastro-intestinal tract (glandular stomach and duodenum) and urinary bladder performed in rats via the oral route. The study was requested to clarify a potential risk related to mutagenicity.

The Appellant requests the Board of Appeal to annul the Contested Decision, order the refund of the appeal fee, and take such other measures as justice may require.


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