Procedures for the Authorisation of Plant Protection Products in France
Procedures for the Authorisation of Plant Protection Products in France
Kerona Scientific held their third PPP Symposium dealing with key regulatory aspects relevant to the registration of products and active substances under the Plant Protection Products Regulation (EC) No. 1107/2009. The second day of the symposium included presentations on CLH processes for active substances, plant biostimulants and fertilisers, and updates from regulatory zones.
Amélie Grimaldi, Senior Regulatory Manager at Staphyt, presented slides detailing the authorisation procedures of PPPs (Plant Protection Products) in France. The presentation described regulatory processes in France and also specific French national requirements for risk assessment and risk management.
Amélie started the presentation with a brief description of the roles of the Ministry of Agriculture and ANSES (French Agency for Food, Environmental and Occupational Health & Safety) in the context of plant protection regulation, followed by a summary of the pre-notification, pre-submission and evaluation procedures in France. The two main departments involved in these processes are DAMM (Authorisation Department) and DEPR (Regulated Products Assessment Department).
Amélie outlined the specificities associated with the French evaluation of biopesticide products including lower fees and fast tracked applications. She also gave a synopsis of French specificities in the context of efficacy, physio-chemistry and analytical, residues, toxicology, environmental fate and ecotoxicology. This included methods to refine the various risk assessments, information on EPPO and residue zones, and information on the trials required for major and minor crops. Amélie proceeded to discuss in more detail the risk assessment tiers of environmental fate surface water and groundwater, including the risk assessment tools FROGS (French Refinement of Groundwater Scenarios), PEARL and PELMO. She also provided a list of guidance documents produced by ANSES.
Finally, Amélie summarised the data packages required for the risk assessment of bees and bumble bees at the various tiers and also gives a brief synopsis of the data matching and compensation dossier submission process.
If you missed the PPP Symposium, a copy of all the presentations is available on the publications section here: https://kerona.ie/product/dublin-ppp-symposium-2022-speakers-presentations/
If you need assistance with registration of plant protection products in France, please do not hesitate to contact the experts of the plant protection team at Kerona Scientific at info@kerona.ie and for Southern Europe info@kerona.es