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European Union Reference Laboratory for Genetically Modified Food and Feed (EURL GMFF)

Legal basis

"The Joint Research Centre (JRC) of the European Commission has been designated as European Union Reference Laboratory for Genetically Modified Food and Feed (EURL GMFF) 1 under Regulation (EC) No 1829/2003. Under its provisions, the JRC is assisted by a consortium of official enforcement laboratories referred to as the “European Network of GMO Laboratories” (ENGL).

Under Regulation (EU) 2017/625 the JRC is also designated as EURL GMFF 2 for official controls and other official activities performed to ensure additional verification of plant health and plant protection products rules.

The tasks and duties of the EURL GMFF under these two Regulations are summarised below."

Legal mandates

Under Regulation (EC) No 1829/2003 with the support of the ENGL

"Duties of the EURL GMFF under Regulation (EC) No 1829/2003 are detailed in its Annex and further expanded under Regulation (EC) No 1981/2006. Accordingly, the EURL GMFF is responsible for:"

  • Reception, preparation, storage, maintenance, and distribution to NRLs of the appropriate positive and negative control samples;
  • Testing and validation of the method for detection, including sampling and identification of the transformation event and, where applicable, for the detection and identification of the transformation event in the food/feed;
  • Evaluating the data provided in the application for authorisation of the GM food/feed to verify its suitability to ring-trial validation;
  • Submitting full evaluation reports to European Food Safety Authority (EFSA);
  • Settling the disputes between MS concerning the results of the tasks outlined above.
Read more on validation

Under Regulation (EU) 2017/625 repealing Regulation (EC) No 882/2004 on official controls

Under Article 94 of Regulation (EU) 2017/625, the EURL GMFF is responsible for contributing to the improvement and harmonisation of analytical methods used for official control. In this context, it fulfils the following tasks:

  • Providing NRLs with details and guidance on analytical methods, including reference methods;
  • Coordinating the application by the NRLs of these methods by organising proficiency tests and by ensuring appropriate follow-up and informing the Commission and the Member States of the results and follow-up;
  • Coordinate practical arrangements to apply new analytical methods and informing NRLs of advances in this field;
  • Providing information to NRLs on relevant national, Union and international research activities;
  • Conducting training courses for staff from NRLs, and, if needed, from other official laboratories as well as of experts from third countries;
  • Providing reference material to NRLs;
  • Publish the list of NRLs designated by the Member States.
  • Cooperate to develop methods of analysis and testing of high standards;
  • Providing scientific and technical assistance to the Commission;
  • Collaborating with EFSA and laboratories responsible for analysing feed and food in third countries;

EU relevant legal acts

Legal act

Regulation (EC) No 1829/2003 on genetically modified food and feed.

It establishes a single harmonised, time-limited and transparent EU procedure for authorisation of GM food/feed requiring a positive risk assessment opinion by EFSA. The Regulation further provides for mandatory labelling of GM food/feed at a threshold of 0.9% at the single ingredient level and the submission and validation of methods for GMOs detection in the EU authorisation procedure. It officially designates the Commission's Joint Research Centre (JRC) as the Community Reference Laboratory (CRL) 1 and defines its tasks.

Legal act

Regulation (EU) No 2017/625 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health, and plant protection products.

It harmonises the EU framework for verifying compliance to food and feed law, animal health and welfare rules, and extends the official control activities to plant health and plant protection products. It establishes the European Union Reference Laboratories (EURL) and designates the JRC as EURL for GM food and feed (EURL GMFF) for harmonising GMO-control activities throughout the Member States.

Legal act

Commission  Implementing Regulation (EU) No 120/2014 amending Regulation (EC) No 1981/2006 on detailed rules for the implementation of Article 32 of Regulation (EC) No 1829/2003 as regards the Community reference laboratory for genetically modified organisms.

It updates the list of designated National Reference Laboratories (NRLs) supporting the EURL GMFF for method validation and the rules of financial contributions paid by the applicant to the EURL GMFF.

Other relevant legal act

Regulation (EU) No 619/2011 laying down the methods of sampling and analysis for the official control of feed as regards the presence of genetically modified material for which an authorisation procedure is pending or the authorisation of which has expired.

It regards GM material authorised for commercialisation in a third country for which the authorisation procedure in EU is pending or has expired. The Regulation lays down specific requirements for the methods of sampling and analysis for the official control of GM feed. It also makes a validated detection method, the availability of CRMs and a favourable EFSA opinion a pre-condition for the low-level presence of elsewhere authorised GMO in feed. The lowest amount or concentration of analyte allowed in a sample is set at the level of 0.1% (related to mass fraction of GM material).

Other relevant legal act

Regulation (EU) No 503/2013 on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 and amending Commission Regulations (EC) No 641/2004 and (EC) No 1981/2006.

It replaces certain provisions of Regulation (EC) No 641/2004 and specifies the information to be included in applications for authorisation of GM plants for food and feed uses. It details the information to be provided and the requirements for methods of detection, sampling and reference material.

Other relevant legal act

Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC.

It provides a harmonised procedures and criteria for authorisation of deliberate release (experimental (Part B) or commercial (Part C)) of GMOs into the environment. It provides an official definition of GMO and a list of technologies exempted from the application of the EU GMO legislation. The Directive limits the authorisation to a period of ten years (renewable) and introduces compulsory monitoring after the GMOs have been released or placed on the market. Traceability and labelling obligations are enforced for any authorised GMO.

 

 

1  The official version of Regulation (EC) No 1829/2003 designates as the Community Reference Laboratory (CRL) the Commission's Joint Research Centre (JRC). The CRL name was changed in European Union Reference Laboratory (EURL) after entry into force of the Treaty of Lisbon in 2009.

2  The official version of Regulation (EC) No 882/2004 indicates as Community reference laboratory for genetically modified organisms (GMOs) the laboratory referred to in the Annex to Regulation (EC) No 1829/2003. This Regulation designates as Community Reference Laboratory (CRL) the Commission's Joint Research Centre (JRC). The CRL name was later changed in European Union Reference Laboratory (EURL) after entry into force of the Treaty of Lisbon in 2009.