Understanding Article 54 of Biocidal Products Regulation EU No 528/2012 (BPR)
The intention of the provision of Article 54 of the Biocidal Products Regulation EU No 528/2012 BPR . Is to enable the European Chemicals Agency ECHA to determine the similarity of the chemical composition. And hazard profile of active substances that may differ from the one that was evaluated for the purpose of approval (reference source).
The assessment of technical equivalence (TE) is required when the active substance to be used in a biocidal pro
duct (BP) differs from the reference source of the approved active substance by having . A different manufacturing process, a different manufacturing location or a different manufacturer.
A positive decision on the Technical equivalence of the active substance issued by ECHA is a required element in the application for a BP authorisation (Commission Delegated Regulation (EU) No 837/2013 amending Annex III to the BPR).