Definition of minimum performance requirements for analytical methods of GMO testing : European Network of GMO Laboratories (ENGL)

As laid down in the Annex of Commission Regulation (EC) No. 1829/2003 as amended by Commission Regulation (EC) No 1981/2006, and Annex 1 of Commission Regulation (EC) N. 641/2004, the Community Reference Laboratory for GM Food and Feed (CRL-GMFF) is responsible for the evaluation and validation of methods of analysis in the context of GMO authorisation under Commission Regulation (EC) No 1829/2003. The CRL-GMFF is assisted by the ENGL (European Network of GMO Laboratories). The ENGL recommends that the assessment, by the CRL-GMFF, of methods submitted by the applicants as part of the GMO authorisation process is undertaken in two distinct phases: Phase 1 - evaluation of the method performance data submitted by the applicant as part of the official dossier; and Phase 2 - evaluation of method performance data following a full validation study by collaborative trial. At present this document refers to polymerase chain reaction (PCR) based analytical methods for the determination and quantification of GMOs. However, if novel methods (e.g. those using technologies other than PCR) are subsequently developed that fulfil legal requirements then this document will be amended accordingly.