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) :
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 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 )