EU guidance on post-approval formulation changes
The European Commission has issued guidance on the permitted changes to agrochemical formulations that can be made after a product has been approved. The guidance distinguishes between “significant” and “non-significant” changes to the co-formulants in approved products. The Commission notes several reasons that might necessitate such changes, such as new scientific and technical knowledge, economic demands, unavailability of supply, improved performance, or classification or concerns regarding certain critical co-formulants. The aim of the guidance is to harmonise the approach and provide a timeframe for procedures.