Institute for Health and Consumer Protection
Acronym: TP: GMOs
The GMOs Thematic Programme coordinates the work of a number of individual JRC Actions in the area of genetically-modified organisms.
The GMO Thematic Programme for 2009 will be structured in three Packages
Package 1 (comprising objectives 1 and 2): Support to the EU framework of authorization, labeling and monitoring of GMOs
Package 2 (comprising objectives 3 and 4): Support to the EU framework for cultivation of GMOs in coexistence with conventional crops
Package 3 (comprising objectives 5 and 6): New policy issues and strategic development of JRC GMO workprogramme
Package 1: Support to the EU framework of authorization, labeling and monitoring of GMOs
The process for authorization for placing GMOs and derived products in the market is strictly controlled by EU legislation. The EU regulatory framework includes the following components:
- Deliberate release into the environment and the marketing of GMOs (including GM seeds) - Directive (EC) N° 2001/18.
- Authorisation for the placing of GM food and feed into the market - Regulation (EC) N° 1829/2003.
- Traceability and labelling of GM products - Regulation (EC) N° 1830/2003/EC
- Transboundary movements of GMOs - Regulation (EC) N° 1946/2003/EC (which partly implements the international Cartagena Protocol on Biosafety)
- Food and feed safety control (not exclusively for GMOs but including them) - Regulation (EC) N° 882/2004 (the Regulation also addresses Community Reference Laboratories - CRLs)
In support of this legislation, the JRC (IHCP) houses the Community Reference Laboratory for Genetically Modified Food and Feed (CRL-GMFF).
In conformity to Regulation 1829/2003/EC, the CRL is assisted by the European Network of GMO Laboratories (ENGL) to which the JRC was assigned the Chair in 2002. The ENGL has a membership of over 100 laboratories nominated by EU Member States' Competent Authorities.
Some background infomation concerning the Packages:
A major part of Package 1 is concerned with the managing/operation of the CRL and the ENGL. Yet there is also has a strong scientific-technological component of research needed to underpin this work.
The project covers the tasks and responsibilities of the Community Reference Laboratory for Genetically Modified Food and Feed (CRL-GMFF). The CRL operates under two main legal mandates. The first is defined by two Regulations: Regulation (EC) No 1829/2003 and Regulation (EC) No 641/2004 on "Detailed rules for the implementation of Regulation (EC) No 1829/2003". The second is defined by Regulation (EC) No 882/2004 on official controls applied to ensure the verification of compliance with feed and food law, animal health and animal welfare. The tasks of the CRL include:
- the validation of methods for GMO detection submitted by applicants to EFSA, including the production and distribution of control samples and organization of ring-trials
- settlement of disputes between Member States
- emergency situations arising from the release of unauthorized GMOs in to the European market: support to DG SANCO in drafting emergency measures and validating methods ad hoc
Obligations of the CRL also include performing additional molecular characterization (DNA analysis, sequencing) of GMOs for verification of information provided in the GMO dossiers submitted to EFSA. The CRL also manages the fees provided by notifying companies and manages payment to the national control laboratories that participate in the validation ring-trials.
Deliverables of the CRL-GMFF include publication of validation studies of GMO detection methods, reports to EFSA on validated methods, provision of plasmid control samples to the national laboratories for validated methods of the CRL-GMFF, and the preparation and delivery of the annual report of the CRL-GMFF activities of 2008 to the European Commission
The CRL has a second mandate (CRL-GMO), under Regulation (EC) No 882/2004 for official food and feed control. It has to assist the National Reference Laboratories in their tasks of monitoring the European market in a context of health and consumer protection. Its tasks are to provide harmonisation and communication of scientific data amongst laboratories; to monitor quality levels of the GMO control laboratories and to level their capacities through training and workshops.
In conformity to Regulation (EC) No 1829/2003/EC, the CRL is assisted by the European Network of GMO Laboratories (ENGL) to which the JRC was assigned the Chair in 2002. The ENGL has a membership of over 100 laboratories nominated by EU Member States' Competent Authorities and operates under a consortium agreement. Its tasks are to contribute to the European harmonisation and standardisation of methods for sampling, detection, identification and quantification of GMOs and derived products. Deliverables in 2009 include the organization of Plenary and Steering Committee meetings of ENGL and managing ENGL public website and Intranet.
Once GM crops are authorised for cultivation in the EU, there are rules and technical measures for GM crop cultivation in coexistence with conventional crops which are not fully harmonized at EU level. Co-existence refers to the ability of farmers to choose between the cultivation of genetically modified (GM) or non-GM crops, in compliance with the relevant legislation on labelling rules for GM organisms (GMOs), food and feed and/or purity standards. Yet, since agriculture is an open process, perfect segregation of different production types is not possible in practice.
In 2003, the European Commission established its policy on co-existence based on the subsidiarity principle, leaving Member States to develop their own strategies to ensure co-existence in agriculture.
In 2006, the Agriculture Council requested the Commission to prepare Community guidelines for the development of practical crop-specific co-existence measures. Such guidelines should take into account the economic costs of co-existence measures, as well as their technical effectiveness.
The Commission's response to the 2006 Council request lead to the establishment of the European Co-existence Bureau, a joint initiative between JRC and DG AGRI. The Bureau is hosted and managed by JRC (IPTS) and acts as a platform for scientific and technical co-operation with Member States and stakeholders to define best agricultural management practices for segregation of GM crops from conventional crops. The site of the Bureau was established in Seville in 2007.
The JRC is now well known for its research on the process of adoption of GM crops by EU farmers and the socio-economic impacts of GM crops cultivation in Europe and world-wide. The quantification of socio-economic impact of GMOs is relevant for EU policy makers both considering the EU as importer and producer of agricultural commodities.
A number of specific policy developments in the GMO field will take place during 2009. The TP-GMO Action will act as contact point when customers request a JRC contribution that involves complementary work currently done in various institutes. A coordinated response will be given by TP-GMO. Also, 2009 is the first operational year of the new Thematic Programme GMOs. By the end of the year, the JRC needs to produce, after consultation with main customers, a strategy on how to enlarge/re-structure its GMO activity portfolio to respond to new customer demands.