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