Sep 9, 2004

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Variety approval

GM maize varieties in the EU catalogue of varieties

(08 Sept.2004) The first genetically modified plant varieties have been inscribed in the Common EU Catalogue of Varieties of Agricultural Plant Species. The European Commission approved this decision at its regular meeting on 8 September without discussion. As a result, seventeen maize varieties derived from the insect-resistant maize MON810 can now be marketed and grown in all member states.

Several varieties of MON810 maize are being used in the trial currently underway. The Federal Office of Plant Varieties had released seven of these varieties in limited quantities.

MON810 maize was authorised as far back as 1998, under the Deliberate Release Directive (90/220) which prevailed at the time. Various breeding companies used this event to develop numerous varieties. As with all new varieties, these cannot be put on the market until varietal approval has been granted

First the GMO, then the variety.

Varietal approval is granted by the individual member states, in Germany by the Bundessortenamt (Federal Office of Plant Varieties). Here tests are carried out to see if a new variety meets the requirements of the German Seed Trade Act. Environmental and product safety issues are immaterial at this stage. These matters are dealt with exclusively through the GM authorisation procedure.

Once approved, the variety is inscribed in the national catalogue of varieties. The new variety can then be listed in the Common Catalogue of varieties. Only then is the seed of that variety approved in all member states.

MON810 maize: Variety approval overdue.

If the legal requirements are met, the European Commission is required to convert national variety approvals in to EU-wide approvals. In the case of the MON810 varieties, David Byrne, Commissioner for Consumer Protection, described this step as “logical”. He referred to the fact that this maize has been GM authorised in the EU since 1998 and grown in Spain for years. Approximately 30,000 hectares of BT maize is grown annually in Spain “without any known problems”. In Byrne’s view, if the Commission had refused entry in the Common Catalogue, legal disputes were likely to have ensued.

Seventeen varieties of MON810 maize had previously been authorised at national level, six in Spain and eleven in France. Now the Commission has given its approval, the inscription of these varieties in the Common Catalogue will published in the Official Journal of the EU. Then in principle these varieties can be marketed throughout the EU. In reality, however, the special conditions of cultivation (coexistence) for GM plants have yet to be fully regulated in the majority of EU countries. MON810 maize produces a substance to combat the European corn borer.

Complying with the new rules.

The Commission pointed out that Monsanto, the authorisation holder of MON810, had submitted a monitoring plan as required by Deliberate Release Directive 2001/18/EC, which is now in force. This was positively evaluated by the Scientific Committee on Plants and approved by the member states in the Regulatory Committee. MON810 varieties and the food and feed products derived from them are subject to the new labelling and traceability requirements that came into effect in April 2004.