EUROPE-EFSA: Guidance on active substance applications for approbation and renewal
8 April 2019
EUROPE – COM: Guidances update on active substance applications for approbation and renewal
30 April 2019
EFSA published a technical report on the outcome of expert’s discussions in the area of physical and chemical properties and analytical methods that took place during a Pesticide Peer Review Meeting in November 2018.
The main issues identified are related to (i) the quality and level of details of the renewal assessment reports and (ii) the adherence to the new data requirements, in particular regarding analytical methods and general issues regarding the assessment of the impurity profiles and specifications of the technical material. Discussions which focused mainly on national authorisation of Plant Protection Products (PPP) were not included in this EFSA technical report.
The main topics addressed are:
- CRD guidance on physical and chemical properties
- Physical-chemical properties of active substances and PPP
- Revision of some guidance documents
- Methods used for the generation of pre-approval data
- Monitoring methods for body fluids and tissues
- Evaluation of extraction efficiency in residue analytical methods
- Guidance of isomers
- Impurities
- Five representative batches
- Confirmation of analyte identification (active substance, relevant and significant impurities)
- LOQ for relevant and significant impurities (5 batch analysis)
- Detected but not quantified impurities (5 batch analysis)
- Specifications
- Microorganisms
- Equivalence assessment issues for PPP authorisation at MS level
For each issue addressed in the document, a background is presented followed by the outcome of discussions reflecting the opinion of the majority of the participating experts and the associated EFSA proposals.
To download:
Outcome of the pesticides peer review meeting on general recurring issues in physical and chemical properties and analytical methods – EFSA Supporting publication 2019:EN-1623
See also our previous articles:
EFSA: Issues in physical-chemical properties and analytical methods
Lynxee consulting’s team is at your disposal to answer your questions.
Contact us! https://lynxee.consulting/en/contact/
