regulatory services offer1

With 15 years of experience in the field of regulatory chemistry and thanks to its multi-disciplinary team of scientists, A.S.C. Biocides can offer you a broad range of services:

  • Define whether Regulation (EU) No.528/2012 applies to your active substance or biocidal product
  • Register your biocidal product in various European countries during the transitional period while national regulations still prevail
  • Estimate costs and timelines for preparing your active substance or biocidal product dossier in accordance with Regulation (EU) No.528/2012; plan all necessary actions accordingly
  • Prepare the entire or part of your active substance or biocidal product dossier according to the Technical Notes for Guidance Viel Arbeit - Akten und Laptop(TNsG)
  • Prepare a technical equivalence dossier
  • Evaluate if your biocidal products are eligible for the simplified authorisation procedure or if they meet the definition of a Biocidal Product Family
  • Verify the reliability of existing studies and identify which studies are missing from your dossiers
  • Monitor studies under Good Laboratory Practice (GLP), and/or efficacy trials
  • Perform Human and Environmental risk assessments, Consumer (residues) risk assessments
  • Prepare a compensation dossier to replace, if necessary, protected studies
  • Organise your data in the IUCLID format and submit your applications through the Register for Biocidal Products (R4BP)
  • Submit applications for Mutual Recognitions in sequence or in parallel to extend the national authorisation of your biocidal product to other European countries
  • Manage all requests from the Authorities during the evaluation period until your active substance is approved or your biocidal product is authorised

In addition, A.S.C. Biocides can upon request:Nuevos pictogramas de peligrosidad 2011

  • Write or review the labelling, classification and Safety Data Sheet (SDS) of your product
  • Manage the mandatory declarations of your biocidal product in France to INRS (French National Research and Safety Institute) and MEDDE (French Ministry of Ecology, Sustainable Development and Energy)


For additional information : Contact us