A biocidal product authorisation is a regulated process. Active substances are approved at European level and products are authorized at the level of the Member States (or of the European Union).
Since the enforcement of Regulation (EU) N° 528/2012 on 01/09/2013, the dossiers are prepared in the IUCLID software and submitted via the R4BP platform. They must contain all studies and data allowing the characterization of the active substance and / or the product, to evaluate the efficacy and the risk assessments on Humans, consumers and the environment.
During the transitional period, as long as biocidal active substances are not approved, national regulations still apply with their country-specific requirements.
For several years, the Staphyt Regulatory team has successfully prepared and submitted numerous authorisation dossiers in various European countries.