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S/T support for the implementation of GMO legislation

Objective

Specific Objectives:
1. To organise the complete work programme related to the European Network of GMO Laboratories (ENGL), including the organization, chairing and reporting of plenary and WG sessions. To establish an adequate operational mechanism for (ENGL). To provide a bulletin board over the Extranet to allow ENGL Members and their colleagues in national MS to have access to discussion documents and to have access to a discussion forum. To organise WG sessions to deal with sampling, method validation, reference materials, bio-terrorism in the context of the agro-food chain;
2. To establish the necessary provisions for the duties connected to the proposed GMO Food and Feed legislation in which the JRC, together with the ENGL is appointed as Community Reference Laboratory;
3. To negotiate with the major biotech industries GM-materials and methods transfer required by ENGL for enforcement purposes;
4. To ensure that suitable methods for GMO detection, identification and quantification become available to support EU policy;
5. To organize and co-ordinate ring trials for the implementation of the novel foods, feeds and seeds legislation to assure that suitable methods for GMO detection, identification and quantification become available to support EU policy;
6. To perform research into statistical models for the evaluation of validation results and to select the best methods;
7. To identify and promote the use of appropriate sampling methods to support. EU legislation for the detection/quantification of GMO's in raw materials, ingredients and final food products;
8. To perform R&D on sampling methods for the detection/quantification of GM material;
9. To achieve harmonization between various proposals for sampling plans (ISO, CEN, USDA, ISTA, etc.) by collaborating with international committees;
10. To report and disseminate through publication and discussion, proposals and rationales for the enforcement and implementation of the GMO legislative programme. To disseminate results to international standardisation bodies such as CEN;
11. To maintain an Internet-based system for exchange of notifications under part B of Directive 90/220 (environmental deliberate release of GMO's) and weekly update of the relevant Internet site on behalf of DG ENV. To implement a system providing access to the 2001/18/EC directive part C dossiers for commercialisation of GMO's;
12. To represent the EC as invited expert in the Biosafety Clearing House;
13. To provide a molecular register for storing the data and providing access; to bioinformatics tools, to be used for the detection, identification, monitoring and risk assessment analysis of GMO's as required for the implementation of the EU-directives;
14. To put a mechanism in place to have quick assess to nucleic acid sequences of authorised and non-authorised GMO's and to communicate the data to relevant Commission services;
15. To host a database of internationally validated methods in support to Codex Alimentarius;
16. To develop and optimise existing molecular methods for the qualitative detection of GMO's;
17. To develop and comparatively analyse different strategies for the quantitative detection of GMO's;
18. To improve protocols for quantitative detection of GMO's and for immunological assays;
19. To critically compare different approaches for GMO quantification (competitive PCR/Real-Time PCR);
20. To develop appropriate strategies for the detection of non-authorised GMO lines;
21. To help the implementation of appropriate facilities for the detection of GMO's and the use of suitable analytical methods, in particular by facilitating capacity building and technology transfer to control authorities of Member States, to National Reference Laboratories, to Accession Countries and/or National/International bodies;
22. To organise and conduct training courses and ad-hoc training periods according to specific MS needs/requests.

To make available a compiled training manual, to update it and disseminate it. To organise training outside of the JRC, particularly in Candidate Countries. Anticipated milestones and schedule Complete work programme related to the European Network of GMO aboratories (ENGL) Operational mechanism for ENGL and bulletin board over the Extranet for ENGL Members WG sessions on sampling, method validation, reference materials and bio- terrorism Provisions for the Community Reference Laboratory duties connected to the proposed GMO Food and Feed legislation Acquired GM-materials and methods required by ENGL for enforcement purposes Methods for GMO detection, identification and quantification and associated ring trials Statistical models for the evaluation of validation results Sampling methods for the detection and quantification of GM material Harmonized proposal for sampling plans Reports on methods for the detection, identification and quantification of GMO's as well as on sampling procedures Publications on method optmisation, method validation and on sampling strategies Internet-based system for exchange of notifications under part B of Directive 90/220 (environmental deliberate release of GMO's) and weekly update of the relevant Internet site on behalf of DG ENV Internet-based system providing access to the 2001/18/EC directive part C dossiers for commercialisation of GMOs Molecular register to be used for the detection, identification, monitoring and risk assessment analysis of GMOs Mechanism for quick assess to nucleic acid sequences of authorised and non- authorised GMOs Database of internationally validated methods for Codex Alimentarius.

Optimised existing molecular methods for the qualitative detection of GMO's Comparison of strategies for the quantitative detection of GMO's Improved protocols for quantitative detection of GMO's and for immunological assays Comparison of approaches for GMO quantification (competitive PCR/Real-Time PCR) Strategy for the detection of non-authorised GMO lines Training courses and compiled training manual.
Planned Deliverables:
Complete work programme related to the European Network of GMO aboratories (ENGL) Operational mechanism for ENGL and bulletin board over the Extranet for ENGL Members WG sessions on sampling, method validation, reference materials and bio- terrorism Provisions for the Community Reference Laboratory duties connected to the proposed GMO Food and Feed legislation Acquired GM-materials and methods required by ENGL for enforcement purposes Methods for GMO detection, identification and quantification and associated ring trials Statistical models for the evaluation of validation results Sampling methods for the detection and quantification of GM material Harmonized proposal for sampling plans Reports on methods for the detection, identification and quantification of GMO's as well as on sampling procedures Publications on method optmisation, method validation and on sampling strategies Internet-based system for exchange of notifications under part B of Directive 90/220 (environmental deliberate release of GMO's) and weekly update of the relevant Internet site on behalf of DG ENV Internet-based system providing access to the 2001/18/EC directive part C dossiers for commercialisation of GMOs Molecular register to be used for the detection, identification, monitoring and risk assessment analysis of GMOs Mechanism for quick assess to nucleic acid sequences of authorised and non- authorised GMOs Database of internationally validated methods for Codex Alimentarius.

Optimised existing molecular methods for the qualitative detection of GMO's Comparison of strategies for the quantitative detection of GMO's Improved protocols for quantitative detection of GMO's and for immunological assays Comparison of approaches for GMO quantification (competitive PCR/Real-Time PCR) Strategy for the detection of non-authorised GMO lines Training courses and compiled training manual.
Summary of the Action:

This action deals with all Commission requests (from DG SANCO, DG ENV, DG TRADE and DG AGRI) to provide S/T support in the area of biotechnology for the implementation of current and future EU legislation. The action aims at: Setting up the European Community Reference Laboratory on GMO as requested by the Council when adopting the GMO food and feed proposal; Testing and validation of proposed methods for sampling, detection, identifications and quantification of GMO's; Managing the exchange of information on field trials for experimental release and on notifications for marketing of GMO products; Providing a series of electronic instruments to facilitate data access, data exchange and information exchange; Providing assistance with international issues (e.g. in the context of the EU-US negotiations, of OECD, of Codex Alimentarius and of the Cartagena Protocol on Biodiversity).. Rationale The marketing and release of GMOs into the environment is regulated within the EU by strict procedures and Regulations.

The Directive 2001/18/EC, is in force to regulate the deliberate release of GMOs into the environment for research purposes and for marketing of products containing GMOs and genetically modified organisms (GMOs) cannot be marketed within the European Union (EU) as food or food ingredients without following the requirements of the Novel Foods Regulation (EC No 258/97). Specific labelling requirements apply to foodstuffs in order to ensure that the final consumer is informed about the eventual GMO content. The so-called "threshold regulation" (49/2000) stipulates that foodstuffs shall not be subject to the additional specific labelling requirements when material derived from the genetically modified organisms is present in food ingredients in a proportion no higher than 1% of the food ingredients individually considered. It is important to note that threshold regulation applies to authorised GMOs only and that GMOs that have not received a consent under the novel foods Directive cannot be tolerated at all ('tolerance zero'). The need to monitor and verify the presence and the amount of GMOs in agricultural crops and in products derived thereof has generated a demand for analytical methods capable of detecting, identifying and quantifying either the DNA introduced or the protein(s) expressed.

The availability of validated methods for the detection, identification and quantification of genetically modified organisms (GMOs) in food samples is therefore a key component for the implementation of the European Unions Regulations. In addition adequate methods for sampling of seeds, grains and foodstuffs are required as it is essential that a number of molecular databases as well as the tools to interrogate them are established. All these issues trigger the content of this project. One of the most visible items is the management of the European Network of GMO Laboratories.

Funding Scheme

JRC - Joint Research Centre research

Coordinator

Institute for Health and Consumer Protection
Address
Via E. Fermi 1
21020 Ispra
Italy