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PP 1/307 (1) Efficacy considerations and data generation when making changes to the chemical composition or formulation type of plant protection products
Publication year - 2019
Publication title -
eppo bulletin
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.327
H-Index - 36
eISSN - 1365-2338
pISSN - 0250-8052
DOI - 10.1111/epp.12486
Subject(s) - scope (computer science) , chemical composition , biochemical engineering , composition (language) , computer science , risk analysis (engineering) , chemistry , business , engineering , linguistics , philosophy , organic chemistry , programming language
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.