PP 1/307 (1) Efficacy considerations and data generation when making changes to the chemical composition or formulation type of plant protection products

Specific scope This Standard considers the possible impacts of biologically significant changes in chemical composition of plant protection products and the requirements to support such changes[Note 8. Other areas of the risk assessment will have different ...]. A change in chemical composition is defined within this Standard as a change in the chemical composition but where the content of active substance is comparable and the formulation type remains unchanged[Note 9. Definition is broadly in accordance with EU Guidance document ...]. The Standard also covers the circumstances in which a change in formulation type (automatically defined as a new product) may be supported by a more limited data package. Also discussed within the Standard is the development of a new product which is to be based on the principle of comparing with, and ‘bridging’ to, an existing formulation. The existing authorized formulation should have a full underlying supporting data package[Note 10. In this circumstance, the guidance provided within this Standard ...]. Specific approval and amendment First approved in 2018‐09.