SANCO/3030/99 rev.5
"Technical Active Substance and Plant protection products: Guidance for generating and reporting methods of analysis in support of pre- and post-registration data requirements for Annex (Section 4) of Regulation (EU) No 283/2013 and Annex (Section 5) of Regulation (EU) No 284/2013".
New version of the guidance (rev.5) published on 22 March 2019
Implementation as of October 1, 2019
The amendments compared to the previous version (rev.4) concern a general update of the guidance in accordance with the documentary evolution of Regulation (EU) No. 283/2013 and 284/2013. These regulations establish the data requirements for active substances and plant protection products.
- The Background
The SANCO guidance provides guidance on requirements for analytical methods for chemicals and plant protection products that are associated with applications for registration and pre-registration of active substances or technical active substances. These requests are governed by Regulation (EC) No 1107/2009.
- Summary of SANCO/3030/99 (rev.5)
The SANCO guidance contains information on the scope and applicability of analytical methods associated with registration applications (pre-, post- and monitoring). It provides a framework for the use of chemical derivation, when the properties of the target analyte are not compatible with the analytical procedure. This framework includes a set of analytical requirements and elements to be demonstrated, including the specificity of the derived species for the analyte of interest. In the particular case of a non-specific derivative species (i.e. when the derivative formed is common to two active substances/impurities/co-formulants), the method is considered non-specific and its use is strongly discouraged.
The guidance also specifies the criteria for the validation of methods for the analysis of technical active substances or plant protection products. In both cases, this includes the determination of the active substance, impurities or additives/co-formulants. For technical active substances, confirmation of the identity of the analyte is required for a pre-registration application. This confirmation can be part of the method validation. In the case of plant protection products, confirmation of the identity of impurities is required as part of the method validation. This can be treated using a very specific method or a confirmation method (example: use of two transitions or one transition with several fragments representative of the substance in LC or GC-MS/MS).
- Impact on the GLP framework
The compliance requirements in the GLP framework for the validation of analytical methods in support of applications for registration are carried out within the framework of Regulation (EC) N-1107/2009, detailed in Directive 2004/10/EC and reported in Regulation (EC) 1107/2009, Art 3 point 19. The development and validation of a method is not part of GLP. However, when a method is used to generate data for safety purposes, for example when the active substance degrades into (eco)toxicologically active products, these studies should be carried out within the GLP framework.
