European Union Reference Laboratory for Genetically Modified Food and Feed (EURL GMFF)
Guidance documents
The EURL GMFF, in line with its dual mandate under Regulation (EC) No 1829/2003 and Regulation (EU) 2017/625, issues guidance documents meant to provide support to GMO testing laboratories and to applicants for GM food and feed authorisation. The guidance documents below are organised into sections on:
data and control samples submission for applicants under Regulation (EC) No 1829/2003 or other relevant EU GMO legislation,
criteria for acceptance of the methods, their verification and validation,
parameters for verifying the appropriateness of GMO certified reference materials (CRMs) and conversion factors.
Applications for method validation under Regulation (EC) No 1829/2003
Applicants must consult this section's guidance documents when preparing and submitting files for GM food and feed validation under Reg. (EC) No 1829/2003.
By submitting the application, you agree to adhere to the Method validation and verification process and guidance documents published on EURL GMFF website (https://gmo-crl.jrc.ec.europa.eu/guidance-documents). You understand that the published Validation Report (https://gmo-crl.jrc.ec.europa.eu/method-validations) will include a summary of the method performances obtained by your organization during its in-house validation or verification processes.
Description of the EURL GMFF validation process (modified 14/10/2024)
Definition of minimum performance requirements for analytical methods of GMO testing - Part 1 (inserted / modified 20/04/2015), document valid from 20/10/2015
Technical guidance document from the European Union Reference Laboratory for Genetically Modified Food and Feed on the implementation of Commission Regulation (EU) No 619/2011
Guideline for the submission of DNA sequences derived from genetically modified organisms and associated annotations within the framework of Directive 2001/18/EC and Regulation (EC) No 1829/2003 (inserted / modified 24/04/2017)
Form for the submission of DNA sequences and associated annotations to the European Union Reference Laboratory for GM Food and Feed or EFSA, according to appropriate existing EU legislation (Annex 01) (inserted / modified 24/04/2017)
Instructions to organise the sequencing information and data submitted in accordance to the 'Guideline' - Annex 02 supporting info (inserted / modified 24/04/2017)
Verification of analytical methods for GMO testing when implementing interlaboratory validated methods - version 2 - Supplementary information (inserted / modified 13/02/2018)
Workflow for CRM sample and certificate check by the EURL GMFF in the frame of the authorisation to place GMFF on the market - Version 2 (inserted/modified 13/12/2021)
Application note 1: Use of the harmonised conversion factors to transform PCR results from the DNA copy number ratio domain into the mass fraction domain (modified 27/10/2021)
