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Staphyt Regulatory team can advise and support you in all the regulatory procedures required to obtain approval of a biocidal active substance and/or authorization for a biocidal product, in Europe as per Regulation (EU) No.528/2012 and/or at national level as per local regulations.

Our team has prepared several approval dossiers of biocidal active substances in Europe, and submitted numerous transitional authorization, national or EU authorization and mutual recognitions (MR) dossiers for biocidal products and/or product families.

Thanks to this experience, our team has assisted many customers in regulatory strategy, in particular enabling them to optimize their approval costs.

You need to

  • Understand and follow EU and national regulations in this field,
  • Place your biocidal products on the market,
  • Analyse the available data, identify the missing data,
  • Set up laboratory studies (GLP) or field studies,
  • Assess the risks of your products for humans, animals and the environment,
  • Prepare and submit the approval application dossiers for your biocidal active substances or products,
  • Submit the Anti-Poison Centre declarations for the hazardous products placed on the European market,
  • Communicate with the French and European authorities,
  • Find partners to share the costs of the biocide dossiers.

Our expertise

  • Keep track of changes to the regulations and provide biocide watch tailored to your needs,
  • Assist you with any regulatory issue,
  • Assess your product portfolio, estimate the resources required, and create a strategic plan according to your constraints, your markets and the regulatory deadlines,
  • Analyse the data already available on your active substance or your product, to put together your dossier (data gap analysis),
  • Monitor physico-chemical, toxicology, environmental fate and ecotoxicology GLP studies, or efficacy tests,
  • Prepare risk assessments for humans, animals, the environment and for the consumer (residues),
  • Put together and submit the approval dossier for an active substance and/or authorisation dossier for a product, as per European requirements,
  • Liaise with the French and European authorities,
  • Declare your biocidal products on Simmbad and Synapse, and equivalent portals in other European countries (electronic notifications),
  • Declare your products to Anti-Poison Centres (Art. 45 CLP) of European Member States,
  • Prepare and, if necessary, submit the transitional period dossiers in France and various European countries (Belgium, Netherlands, etc.),
  • Determine, check or adapt the CLP classification and the labelling of your products, and prepare safety data sheets (including extended SDS) for your substances and products, according to European regulations and specific national provisions,
  • Conduct tailored training (technical or  regulatory),
  • Translate all types of document.

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