Biocides Regulation 528/2012/EU

The areas in which we can make a difference include:

  • Compiling the technical documentations: The physical-chemical properties, efficacy trials, toxicological, ecotoxicological &the environmental fate studies under GLP

  •  Preparation of the risk assessments according to applicable European models for biocidal products

  •  Writing study summaries via IUCLID software, for all parts of a dossier

  •  Identifying efficacy trial providers and GLP laboratories

  •  Preparation and submission of applications for the inclusion in the “Article 95” list of authorized suppliers of active substances

  • Preparation of technical equivalence dossiers for new sources of active substances

  • Submission of the dossiers via the R4BP platform

  • Preparation of the PAR (Product Assessment Report & the Summary of Product Characteristics with SP Editor

  •  Preparation and updating of SDS according to the CLP requirements

  •  Calculation of PEC / PNEC for the exposure of non-target organisms to a product

If you would like help with any of the above, or would like further information, please contact us at +45 26 70 96 48 and send questions to info@toxregulatoryaffairs.com