In case A-006-2022, the Appellants challenged a compliance check decision requiring an extended one-generation reproductive toxicity study (EOGRTS) under REACH Annex IX. The Appellants argued that the time limit set out in the decision prevented them from investigating the effects of their substance on the gut microbiome before starting the EOGRTS.
The Board of Appeal held that the Agency was not required to extend the time limit, as the investigation of the effects of the substance on the gut microbiome is not a legal prerequisite for conducting the EOGRTS nor is scientifically necessary based on the existing information.