Methods of Analysis
This page provides guidance on the requirements for methods of analysis for authorisation of plant protection products. This includes methods for determining the active substances and impurities in technical materials, plant protection products, food, feed and environmental matrices as regulated by Regulation (EC) No 1107/2009 (there are data requirements under the regulation).
The guidance and resources below are provided to assist applicants when preparing submissions.
Prior to submission applicants should also check that applications are complete using the Chemistry section of the common omissions checklist.
Methods of analysis are required to support both the pre-authorisation (data generation) studies for all sections and for post-authorisation control (monitoring) in plant protection products, foods, feeds and environmental matrices.
Methods should be fully described and validated according to the appropriate guidance. Submissions should include:
- principle of method
- full details of reagents and apparatus
- general sample preparation techniques
- analytical procedure
- details of fortifications and calibrations
- representative chromatograms
- calculations and references
- validation data in line with the appropriate guidance
- details on extraction efficiency for residues methods
Care should be taken to ensure the methods available match the residue definitions in the relevant matrices. Guidance on method details and validation data can be found in the following documents: