Skip to main content

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

Definition of minimum performance requirements for analytical methods of GMO testing (inserted / modified 20/04/2015), document valid from 20/10/2015
English
(748 kB - PDF)
Download 

 

Format to provide information on GM detection methods and related samples (inserted / modified 24/04/2017)
English
(86 kB - DOC)
Download 

 

Template protocol format for submission of a GMO specific real-time PCR system (inserted / modified 10/02/2015)
English
(94 kB - DOC)
Download 

 

Explanatory notes to applicants (Reg (EU) No 120/2014) (inserted / modified 03/03/2017)
English
(220 kB - PDF)
Download 

 

Explanatory notes to applicants (Reg. EU No. 503/2013) (inserted / modified 24/04/2017)
English
(479 kB - PDF)
Download 

 

Note to the applicants on the type and nature of control samples according to Reg. (EC) No 1829/2003 (inserted / modified 30/01/2008)
English
(31 kB - PDF)
Download 

 

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
English
(97 kB - PDF)
Download 

 

Explanatory notes to applicants (Reg. EC No. 641/2004)
English
(118 kB - PDF)
Download 

 

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)
English
(441 kB - PDF)
Download 

 

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)
English
(1,4 MB - PDF)
Download 

 

Instructions to organise the sequencing information and data submitted in accordance to the 'Guideline' - Annex 02 (inserted / modified 24/04/2017)
English
(64 kB - PDF)
Download 

 

Instructions to organise the sequencing information and data submitted in accordance to the 'Guideline' - Annex 02 supporting info (inserted / modified 24/04/2017)
English
(8 kB - ZIP)
Download 

 

Method validation and verification

Description of the EURL GMFF validation process (inserted / modified 24/04/2017)
English
(593 kB - PDF)
Download 

 

Verification of analytical methods for GMO testing when implementing interlaboratory validated methods - version 2 (inserted / modified 13/02/2018)
English
(1,7 MB - PDF)
Download 

 

Verification of analytical methods for GMO testing when implementing interlaboratory validated methods - version 2 - Supplementary information (inserted / modified 13/02/2018)
English
(751 kB - ZIP)
Download 

 

Overview on the detection, interpretation and reporting on the presence of unauthorised genetically modified materials
English
(2,74 MB - PDF)
Download 

 

Guidance document on Measurement Uncertainty for GMO Testing Laboratories - 3rd Edition
English
(2,13 MB - PDF)
Download 

 

CRMs and conversion factors

Workflow for CRM sample and certificate check by the EURL GMFF in the frame of the authorisation to place GMFF on the market (inserted / modified 19/09/2019)
English
(69 kB - PDF)
Download 

 

Parameters and acceptance criteria to verify the appropriateness of GMO certified reference materials - Version 2 (inserted / modified 02/12/2019)
English
(85 kB - PDF)
Download 

 

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)
English
(546 kB - PDF)
Download 

 

Conversion factors (CF) for certified references materials (CRM) (version 6 - 20/09/2021)
English
(78 kB - PDF)
Download