Registration dossiers for substances and products: biocides

Registration dossiers for active substances and products biocides logo

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.

You need to

  • Define a national or European approval strategy,
  • Define and monitor your study program (physico-chemistry, analysis, toxicology, ecotoxicology, environmental fate and efficacy),
  • Obtain approval for your active substance,
  • Obtain authorisation for your biocidal product or biocidal product family, a Union authorisation or an authorisation through the simplified authorisation procedure when appropriate,
  • Obtain authorisation by “Mutual Recognition” or “same product” procedures,
  • Modify your biocidal product authorisation (new use, new packaging, …).

Our expertise

  • Validate the status of your active substances, biocidal products and the related regulatory constraints (type of dossier, regulatory deadlines, etc.),
  • Register your biocidal products during the transitional period in the different European countries,
  • Prepare the compulsory declarations of your biocidal products to the poison centers,
  • Analyze the existing studies and identify the missing data for the preparation of your dossier (data gap analysis),
  • Accompany you to meet the competent authorities and present your biocidal dossiers,
  • Identify reliable efficacy trial providers and GLP laboratories to obtain complete, high-standard and on-time test reports,
  • Monitor physico-chemical, toxicological, environmental fate and ecotoxicological studies under Good Laboratory Practice (GLP) or efficacy trials,
  • Write study summaries via IUCLID software, for all parts of a dossier,
  • Prepare bridging documents, expert statements for chemical risk, arguments, and bibliographic summaries,
  • Prepare risk assessments for Human (professional and general public), animals, environment and consumers (primary and secondary exposure) according to available European or national models and propose refinements where necessary,
  • Identify the CLP classification of your products and prepare / revise labels and SDS for the concerned Member States,
  • Write the PAR (Product Assessment Report),
  • Prepare the Summary of Product Characteristics (SPC) with SPC Editor,
  • Compile additional documents (letters of access, attestations, SDS, supporting document, etc.),
  • Submit dossiers via the R4BP platform, and maintain contact with the competent authorities,
  • Follow-up on procedures and answer to any additional requests,
  • Carry out Mutual Recognition dossiers (in sequence or in parallel), modification of authorisations (administrative, minor, major) according to Regulation (EU) No 354/2013, “same product” requests according to Regulation (EU) No 414/2013 and 2016/1082,
  • Preparation and submission of applications for inclusion in the “Article 95” list of authorized suppliers of active substances,
  • Prepare technical equivalence dossiers for new sources of active substance.

You want to build your registration dossier in another business area?