The UK has left the EU, new rules from January 2021
The transition period after Brexit comes to an end this year.
The following page is intended to provide guidance to applicants on the requirements for methods of analysis for the active substances and impurities in technical materials, formulations, food, feed and environmental matrices as regulated by Regulation (EC) No 1107/2009. In addition to consulting the below guidance and resources, applicants should check that their applications are complete using the Chemistry section of the common omissions checklist.
Methods of analysis are required both to support the pre-registration data for all sections and for monitoring in formulations, foods, feeds and environmental matrices. Care should be taken to ensure the methods available match the residue definitions in the relevant matrices. Guidance on the pertinent method details and appropriate validation data can be found in the following documents (n.b. All link from the following EC index page: Guidelines on Active Substances and Plant Protection Products) :
Methods of Analysis Supporting Data Generation for Registration
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 ).
Methods of Analysis for Post-Registration Control and Monitoring
Methods of analysis for technical materials and formulations
Technical Material and Preparations: Guidance for generating and reporting methods of analysis in support of pre- and post-registration data requirements for Annex II (part A, Section 4) and Annex III (part A, Section 5) of Directive 91/414. (SANCO/3030/99 rev.4 )
- EFSA working document for the PRAPeR meeting of experts
- EU Guidance on completion of Part B5 (Analytical Methods) of the draft registration report (see Procedural Guidance on the EC webpage).
- Guidance document on pesticide residue analytical methods (SANCO/825/00 rev. 8.1)