Registration dossiers for substances and products: plant protection

Registration dossiers for active substances and products plant protection logo

Registration of a plant protection product in Europe is a regulated process:

  • Approval of active substances and inclusion to the Annex of Regulation (EC) No 540/2011 [European Regulations (EC) No 1107/2009 and (EC) No.283/2013, MCA / MCP format].
  • Submission of a dRR (draft Registration Report) for formulations [European Regulations (EC) No.1107/2009 and (EC) No.284/2013]. This dossier is the summary of several studies and tests used to prepare a risk assessment for human health, environment and ecotoxicology, but also to evaluate the biological efficacy of the product.

Since European Regulation (EC) No.1107/2009 came into force, dossiers are prepared according to a zonal approach (core dossier) and national specificities must be compiled in a national addenda.

For several years, Staphyt Regulatory has allowed the registration / approval of many active substances in Europe. We have also successfully prepared and submitted numerous product dossiers (conventional and biopesticides) in the 3 regulatory areas of Europe (South zone, Center zone and North zone) and in the rest of the world (North Africa, Middle East, Asia).

Our range of services covers the area of both conventional and biopesticide products.

You need to

  • Define a European or national registration strategy,
  • Notify regarding a new active substance or apply for an authorisation dossier for a new preparation containing this new active substance,
  • Prepare a post-approval renewal registration dossier,
  • Prepare any other type of dossier: extension of use, change of composition, generic product, parallel importation, mutual recognition, experimental use permit etc.,
  • Submit the Anti-Poison Center declarations (Article 45 CLP Regulation) in the Member States (including France via SYNAPSE / INRS).

Our expertise

  • Evaluate existing studies and identify missing or critical data for compiling your dossier,
  • Prepare bridging documents, expert statements for chemical risk, arguments, and bibliographic summaries,
  • Write a technical equivalence dossier for a new source of active substance,
  • Define endpoints and prepare risk assessments according to European or national models: risk to the operator, workers and bystanders, the consumer, fate and behaviour in the environment (surface water, groundwater) impact on non-target organisms,
  • Identify the CLP classification of your product and prepare the label and SDS,
  • Identify the PPE (Personal Protective Equipment) required for product users,
  • Write each section of the dossier and the complementary documents (confidential information, study summaries, etc.),
  • Write any other types of dossier: mutual recognition, extension of use, change of composition, experimental use permit etc.,
  • Declaring products to the Anti-Poison Center (Article 45 CLP Regulation) in the Member States (including France via SYNAPSE / INRS),
  • Reformat existing dossiers according to national requirements,
  • Submit the dossier to the competent authorities and keep in contact for a smooth procedure,
  • Respond to new requirements, prepare a statement or request for exemption, until approval is obtained.

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