Regulatory Efficacy Team
Eurofins Agroscience Services provides a full range of services leading to the compilation of draft registration reports (dRR) for agrochemicals and biopesticides. The submission of efficacy and crop safety data to support an application for approval of any product is a requirement for member states in Europe and many other parts of the world. The data should be summarized to complete the objective of supporting all label claims corresponding with the GAP and recommended use pattern.
At EAS Group we have over 20 years experience of regulatory requirements regarding efficacy and crop safety, including preparation of all necessary documents for submission.
We have a team of 12 experienced personnel based across France, Germany, the UK, Italy, Spain, Poland and Belgium totally dedicated to dealing with these requirements and preparing dossiers for zonal and national submissions.
This team is further supported by members of our field network who have established contacts in national regulatory authorities in other EU countries.
The size and capability of our team enables us to prepare high quality dossiers in time to meet your submission deadlines.
Across the team we have wide ranging experience of preparing dossiers to support applications for first approvals or re-registrations of all types of conventional and natural plant protection products, including herbicides, fungicides, insecticide, plant growth regulators, post-harvest treatments and also biostimulants and fertilizers.
For the complete service that we offer, where EAS provides management of a whole project to support the approval or re-registration of an active substance and/or products, the Regulatory Efficacy team work very closely with all colleagues involved in the project, including study and trials managers and team of experts covering all other areas of regulatory, to ensure an effective and successful outcome for the client
- Advice and proposals on trials programs and studies needed to meet all Sections 3 requirements to support applications for the approval of Plant Protections Products and Biopesticides in the EU.
- Main Sections 3 requirements include those for demonstrating the efficacy and crop safety, resistance risk, effects on quality and processing, impact on succeeding and adjacent crops,
- Completeness checks and Data Gap Analysis on existing data packages
- Preparation of Biological Assessment Dossiers, National Addenda and Section 3 dRR Part B summaries to support EU zonal submissions
- National Comparative Assessments for products containing candidates for substitution
- Preparation of documents and cases to support applications for Mutual Recognition between countries
- Dealing with the national regulators on technical issues and submissions on behalf of the client
- Advice on requirements for Experimental Use Permit
For more information, please contact Cecile Monnier, Head of Regulatory Efficacy team