Integration of Co-Extra results in EU tools for coexistence & traceability. Guy Van den Eede

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1 Integration of Co-Extra results in EU tools for coexistence & traceability Guy Van den Eede IHCP - Institute for Health and Consumer Protection Ispra - Italy

2 Labelling for GMOs: an historical perspective Between 1992 and 1998, 18 GMOs have been approved under the environmental Directive. Labelling was required but validated detection methods were not required or foreseen and no thresholds existed. In 1997 Commission Regulation (EC) no. 258/97 (Novel Foods) sets the labelling provisions for GM Food in order to ensure that the necessary information is available to the consumer. Various mandatory labelling schemes for GMOs in at least 20 countries had different thresholds and/or product-tracing standards. No sequence information deposited No reference material existing No networking established

3 2003: Full traceability and labelling provisions During the summer of 2000, traces of StarLink maize were detected in some food products, such as taco shells. StarLink was approved for use in animal feed, but had not received approval for human consumption. In 2003, the EC issued: (1) a new regulation covering GM Food and Feed and (2) strict provisions for traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms. Methods validated and sequence information deposited; Control samples and reference material available.

4 1999: The Conception of ENGL

5 The ENGL Today Covers all EU GMO regulatory frameworks; Covers the needs of both CRL mandates; Covers all MS + EEA, EFTA member states and Candidate Countries and Potential Candidate Countries; International dimension; Currently > 100 national laboratories.

6 ENGL Activities To initiate and maintain a dialogue on sampling, detection, identification and quantification, and screening for enforcement purposes; To explore possibilities for technical and financial co-operation for developing research projects of mutual interest (role in setting-up and running Co-Extra); To design and execute validation studies; The exchange of information and data.

7 Definition of minimum performance requirements for analytical methods of GMO testing

8 ENGL explanatory document on unit of measurement

9 Guidance document on measurement uncertainty for GMO testing laboratories

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12 Pending technical questions that require scientific input How to deal with unapproved GMOs at low concentrations? UGMs; Novel detection approaches (e.g. matrix-based methods, differential Q-PCR); Decision support systems; Detection versus quantification;

13 Need to establish a scientific sound, comprehensive control scheme, dealing with sampling, testing, data interpretation and reporting Cost-effective sampling and sub-sampling strategies; Method database including protocols; Novel efficient detection methods (including non-pcr); Modular approach to method validation; New reference materials; Decision Support System; Pending technical questions that require scientific input

14 Pending technical questions that require scientific input What is the most appropriate Unit of measurement? ENGL: Considers the haploid genome unit as the most coherent and unambiguous way of expressing a measured content of GMOs throughout the agricultural and food/feed production chain. Suitable calibrants and reference materials; Reliable reference PCR assays; Commutability studies (e.g. pjanus);

15 Pending technical questions that require scientific input Today we see a change of practice moving forward from validation of methods for notification purposes towards validation of approaches for control purposes (e.g. role of NRLs). Innovative approaches for method validation (e.g. qualitative, multiplex); High-throughput and multiplexing; Matrix-based methods; Decision support systems; Reference methods.

16 Some reflections The EU regulations have inscribed the obligation for notifiers to provide detailed information as well control samples and reference materials. Major impact on testing. Ten years ago it was unforeseeable that all information about event-specific methods are published on the Internet even before the GMOs are approved. ENGL members must continue to be part of science projects of excellence. Control authorities must demonstrate to the consumers and stakeholders that the EC is capable to implement a stringent regulation in a very complex technical area. ENGL has been already well represented in FP5 (QPCRGMFOOD) and has been a privileged partner in Co-Extra (Co-Extra presentations in all ENGL plenaries).

17 European Research leads towards standardisation : 1st EU Research Project: "Development of methods to identify foods produced by means of genetic engineering" : "Development of qualitative as well as quantitative detection methods to identify a genetic modification in soybean and maize products" : "Reliable, standardised, specific, quantitative detection of genetically modified food QPCRGMOFOOD" : "New technology in food sciences facing the multiplicity of new released GMO" GMOCHIPS : Sustainable introduction off GM crops into European Agriculture - Sigmea : "GM and non-gm supply chains: their co-existence and traceability" CoExtra (more than 200 scientists in 52 organisations in 18 countries)

18 Conclusion Congratulations to Co-Extra and all its participants and partners. We BADLY NEED follow-up research to Co-Extra!!!

19 Thank you!