Plant protection

Plant protection logo

Staphyt Regulatory team can advise and support you in all regulatory procedures required to obtain approval of active substance and/or product authorisation for Plant Protection Products in Europe, as per Regulation (EC) No. 1107/2009 and at national level as per local regulations.

Our team has facilitated the approval of several active substances and successfully submitted a host of dossiers for formulated products in Europe and in the world (North Africa, Middle East, Asia).

Thanks to this experience, our team has supported numerous customers in regulatory strategy, in particular enabling them to optimise their registration costs.

You need to

  • Understand and keep track of  EU and national regulations,
  • Place your conventional / biocontrol products  or adjuvants on the market,
  • Analyse the available data, identify the missing data,
  • Set up laboratory studies  (GLP) or field studies (GEP),
  • Assess the risks to humans and environment for your products,
  • Prepare and submit the approval application dossiers for your active substances, or registration application dossiers for your products,
  • Communicate with French and European authorities,
  • Submit the Anti-Poison Centre declarations for the hazardous products placed on the European market.

Our expertise

  • Keep track of changes to the regulations, and provide a regulatory watch tailored to your needs,
  • Assist you with any regulatory issue,
  • Define the optimum strategy (costs and lead times) to obtain Product Authorisation,
  • Perform the data gap analysis for your dossier,
  • Manage and coordinate the development of your conventional / biopesticide products or adjuvants,
  • Coordinate your pan-European projects,
  • Monitor your GLP and GEP studies and obtain high-quality test reports within the allotted time frame,
  • Produce your European and national Biological Assessment Dossiers (BADs),
  • Prepare and submit the dossiers for PPPs as per Regulation (EC) No.1107/2009 (covering all sections under dRR format), and for biocontrol products,
  • Assess the toxicological, ecotoxicological and environmental risks,
  • Tailor the approval dossiers to the requirements of Member States,
  • Liaise with the French and European authorities,
  • Prepare the experimental use permit dossiers,
  • 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,
  • Declare your products to Anti-Poison Centres (Art. 45 CLP) of European Member States (including France via SYNAPSE/INRS),
  • Conduct tailored training (technical or regulatory),
  • Translate all types of document.

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