The Applicant Guide: Formulation chemistry and toxicology?
Which applications will require an assessment of formulation chemistry?
Formulation physico-chemical properties and storage stability are dependent upon the formulation constituents and the packaging of the product. This aspect should be addressed for the following applications:
- new product with a formulation never previously authorised.
- changes to the formulation of an authorised product.
- changes to the packaging for an authorised product.
- any other changes that may affect the physico-chemical properties of the formulation.
For details on how to support applications for the changes listed above see Physical and Chemical Properties.
How do I generate data on the toxicology of the active substance?
The toxicology evaluation will be performed in accordance with uniform principles. Data on formulated products should be provided in accordance with Commission Regulation (EC) 284/2013. Further information is available on the pesticide toxicology webpages.