Board of Appeal decision on an appeal against a compliance check for Pigment Red 112

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The Board of Appeal today published its decision in case A-011-2018. The case concerned an appeal against an ECHA compliance check decision on the substance Pigment Red 112. The contested ECHA decision found that there were a number of data-gaps in the registration dossier subject to the compliance check. The ECHA decision consistently required the registrant (now the appellant) to provide information on pre-natal developmental toxicity (PNDT) studies in a first and second species, an extended one generation reproductive toxicity study (EOGRTS), tests on algae and invertebrates, and a fish early-life stage (FELS) test.

The appellant argued, first, that it would be disproportionate to carry out these studies because they will not provide relevant information for managing the risks posed by Pigment Red 112. Second, that the appellant's registration dossier already contains the relevant studies on algae and invertebrates so there were no data gaps. And third, that a FELS test (Annex IX of the REACH Regulation) is not standard information for the registration of Pigment Red 112 because the chemical safety assessment (CSA) included in the registration dossier does not show that it is necessary.



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