EU proposes data requirements for generic biocides
The European Commission has proposed changes to the information required for applications for approval of biocide products, including non-crop pesticides, under the new EU biocidal products Regulation (528/2012). Product authorisation requires prior approval of the relevant active ingredient and the latest proposals cover applications for products containing the same ai, but from a different source. They add a requirement for proof of technical equivalence of the ai with the one already approved. The latest proposals are among many adjustments being made to Regulation 528/2012 before it is implemented in September (Agrow No 666, p 9). The proposals would amend Annex III, which stipulates the information requirements for product approvals. The changes apply to products with ais that have different manufacturing locations, processes or starting materials compared with the approved "reference" ai. Applicants would have to prove that the ai from the alternative source does not have significantly more hazardous properties than the reference ai.