Division 1 An application for inclusion of an active substance in category A of the Simplified Active Substance List under Regulation (EU) No 528/2012 shall specify the relevant category, the identity of the substance and the intended uses of the products for which authorisation will be sought, and contain conclusive evidence to demonstrate the following:F1F2

1. (a)

   that the substance complies with the description of the relevant category; and

2. (b)

   that there is a robust consensus of expert opinion that the substance does not give rise to concern in accordance with Article 28(2) of that Regulation.

The evidence referred to in point (b) shall include all relevant published literature data regarding the substance in question and all relevant data on the substance generated by the applicant. It may also include read-across from chemical analogues/homologues, (Q)SAR predictions, data from existing studies, in vitro studies, historical human data, or conclusions from other regulatory authorities or frameworks.