EU Biocides Regulation 528/2012 (EU BPR) – ECHA’s open invitations following redefinition of active substances in the biocides active substance review program

Where the evaluation of an active substance demonstrates that it does not exactly match the identity of the substance as originally included in the Review Program (Part 1 of Annex II of the biocides Review Regulation), the substance identity will be redefined by the evaluating competent authority (after consultation with the participant). It will be the redefined substance that will then go forward for Approval under the EU BPR, whilst for the ‘original’ substance an opportunity will be made for industry to come forward and take over the role of participant, and so support that ‘original’ substance through the review program. The following active substance/product type combinations originally included in the review program have been so redefined and are therefore no longer considered to be supported in the biocides active substance review program: Bacillus subtilis for product type 3 (this does not cover does not cover Bacillus amyloquefaciens); Bacillus sphaericus for product type 18 (this does not cover Bacillus sphaericus 2362, strain ABTS-1743); and Bacillus thuringiensis subsp. israelensis, Serotype H14 for product type 18 (this does not cover Bacillus thuringiensis subsp. israelensis, strain SA3A). The European Chemicals Agency (ECHA) has published an open invitation, which allows interested companies to take over the role of participant for the above active substance/product type combinations. Interested companies should complete the notification procedure in Article 17 / of the Review Regulation by the 30 September 2016. Notifications should be submitted to the European Chemicals Agency (ECHA), via R4BP /. If no-one takes over the role of participant, these active substance/product type combinations will be subject to a non-approval decision and products containing them for the affected product types will have to be removed from the market.

HSE Biocides e-bulletin, 16 November 2015 ; ;