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:
Methods of Analysis for Technical Materials and Formulations
Methods of Analysis Supporting Data Generation for Registration (all sections)
- Residues: Guidance for generating and reporting methods of analysis in support of pre-registration data requirements for Annex II (part A, Section 4) and Annex III (part A, Section 5) of Directive 91/414 (SANCO/3029/99 rev. 4)
- Technical Guideline on the Evaluation of Extraction Efficiency of Residue Analytical Methods (SANTE 2017/10632 Rev. 3)
Methods of Analysis for Post-Registration Control and Monitoring for Residues in Food, Feed and Environmental Matrices
- Guidance document on pesticide residue analytical methods (SANCO/825/00 rev. 8.1)
- OECD guidance (documents listed below are available at this link)
- OECD (2007). Guidance document on Pesticide Residue Analytical Methods. Series on Testing and Assessment No. 72 and Series on Pesticides No. 39
- OECD (2014). Guidance document for single laboratory validation of quantitative analytical methods – Guidance used in support of pre-and-post-registration data requirements for plant protection and biocidal products. Series on Testing and Assessment No. 204 and Series on Pesticides No. 9