The validation verifies that the method is "fit-for-purpose", i.e.
• For un-authorised GMOs the purpose of the method is to correctly and reliably detect and if possible identify GM material, without the need to quantify.
• For authorised GMOs, or GMOs authorised elsewhere and already undergoing the EU authorisation process, the purpose of the method includes quantification.
The EURL GMFF declares methods to be valid for the detection, identification and quantification only if they meet pre-defined method performance criteria which are established in close collaboration with the European Network of GMO Laboratories (ENGL).
It is the responsibility of the applicant to develop and include such a method in the application dossier and it is the responsibility of the JRC, through the EURL GMFF, to confirm that the method is valid, i.e. fit-for-purpose.
The validation of GMO methods is carried out by the EURL GMFF according to a five step procedure:
1. Completeness check: is the information provided by the GMO developer complete?
2. Dossier assessment: has the applicant correctly tested the method and are the test results OK?
3. In house verification: Does the method work well in the laboratory of the EURL GMFF on control samples provided by the GMO developer?
4. International validation trial: Does the method function adequately in 12 qualified laboratories, all receiving the same test samples?
5. Reporting: The results of the validation steps are summarised in a report that then is provided to EFSA, as part of its overall opinion on the GMO, published on the EURL GMFF website, and included into the GMO Methods database.
So far, the EURL GMFF has validated more than 80 GMO analysis methods that can detect, identify, and in most cases also quantify specific GM versions of soybean, cotton, maize, oilseed rape, potato, rice and sugar beet.
Many current GMOs include in their inserts so called "elements", shorter strings of DNA that are typical indicator for GMOs. If one or several of these elements are found in a food or feed product where they do not belong, a GMO is present. Methods targeting these elements are also validated by the EURL GMFF and can be found in the GMOmethods database. They are used by control laboratories for an initial screening of food or feed samples for the presence of any GMO and allow detecting unauthorised, i.e. illegal GMOs for which no specific method is available.