Editorial: The future of plant biotechnology
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What regulation is in place? The Deliberate Release Directive 90/220/EC was revised in April 2002 (now named 2001/18/EC). In addition, several other regulations covering the labelling of products are in place. The Novel Food Regulation (258/97/EC) agreed on in 1997 is due for revision very shortly and a discussion paper on its implementation and options for change is expected from the Commission imminently. In addition two new regulations are under discussion in the EU: please see Geraldine Schofield’s paper in this issue covering the authorisation of GM food and feed and the other on traceability and labelling. The Commission’s proposal has addressed key issues
& HENRY STEWART PUBLICATIONS 1478-565X. J O U R N A L O F C O M M E R C I A L B I O T E C H N O L O G Y . VOL 9. NO 1. 5–7. SEPTEMBER 2002
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that are necessary to provide a clear regulatory framework guaranteeing safety for consumers and practicability for the industry. The Commission has proposed: • legal recognition of accidental traces of genetically modified organisms (GMOs) in non-GM or other crops, also called adventitious presence (AP); • establishment of a more comprehensive, centralised and transparent regulatory procedure for the safety assessment and approval for commercialisation of GMOs. Both issues are of key importance to make a safe and practical GMO regime possible. Nonetheless, companies are seriously concerned about specific requirements on labelling in the proposed regulations that cannot be supported through scientifically verifiable testing methodologies. Whereas the former Novel Food Regulation foresaw labelling only in the cases where the application of genetic engineering could be detected by analytical methods, the new labelling provisions will cover all food ingredients, including sugar or plant oil where neither DNA nor protein can be detected. Not only are these proposals impractical, because they cannot be verified by the authorities responsible for implementation, but they also place all operators in a legally uncertain position. At the same time the existing simplified procedures for the authorisation of food (the only procedures that have made an authorisation possible in the last five years!) will be withdrawn, monitoring will become obligatory, and approval will be time limited.
De facto moratorium The increasing gap between GM products (not) authorised in Europe and authorised for the market in other parts of the world, especially the USA, increases the uncertainties in the market. More than 50,000,000 ha of transgenic plants have been used worldwide this year. In comparison, in Europe farmers had less than 15,000 ha of plants. In total we now have had experience of more than 170,000,000 ha worldwide over the last six years. But although the Novel Food Regulation has existed since 1997, not a single GM product besides those accepted as substantially equivalent has been authorised under this regulation. And no product was authorised under the Deliberate Release Directive since 1998 due to political opposition
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