Oct 24, 2003

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Timetable for GMO authorisations

European Commisssion backs down over seed

(24 October) In the row over thresholds for genetically modified seed, the European Commission announced this week that Member States would be given more say in this matter after all. At the same time, the Commission disclosed its timetable for the first authorisations of GMOs within the European Union since 1998.

At the centre of the seed row is the Commission’s proposal for a staggered system of labelling thresholds for adventitious presence of GMOs in conventional or organic seed. The proposed thresholds are 0.3% for rapeseed, 0.5% for sugar beet, maize and potato and 0.7% for soya beans. Any products with GMO content below these thresholds would not need to be labelled as containing GMOs.

Originally, the Commission had been planning to introduce these thresholds via a so-called management committee procedure. In this case, the Member State representatives in the EU Committee on Seeds would have needed a qualified majority to be able to block the Commission’s proposal. The Italian and German governments and Members of the European Parliament, amongst others, had objected to this approach and demanded lower thresholds. The German Federal Minister for Consumer Protection, Renate Künast, for instance, is calling for a threshold at the detection limit of 0.1 per cent.

After some initial hesitation, the Commission has now changed tack: The proposed thresholds are now to be discussed in a “Regulatory Committee procedure”. The Commission will now need a qualified majority from the Member States to implement its proposal. Failing that, the document will be passed to the next level, to be debated in the Council of Ministers. Insiders in Brussels believe that the Commission may well have to reduce the thresholds to secure the necessary support from the Member States.

Timetable for authorisations

The Commission also presented the governments of the Member States with a working paper setting out its detailed timetable for resuming GMO authorisations. Eight genetically modified products are still pending authorisation under the Novel Food Regulation (EC) No. 258/97. For two of these old notifications the scientific assessment will have been completed by the time the new Regulation on Genetically Modified Food and Feed comes into force on 7 November. This means that those two applications will still be processed according to the Novel Food Regulation. The two products in question are Syngenta’s Bt11 sweet maize and Monsanto’s GA21 maize.

For Syngenta’s Bt11 variety the Commission plans to put forward a decision proposal recommending authorisation on 10 November or 12 December, and for GA21 in the first half of 2004. The other authorisations applied for under the Novel Food Regulation are still at an earlier stage in the process, and the Commission is therefore reluctant to make any predictions.

Under the new Deliberate Release Directive (2001/18/EC), which has been in force since October 2002, the EU has so far received 21 applications for authorisation for the placing on the market of GMOs. Eleven of those are limited to import and processing of GM crops, the remaining applications are for cultivation within the EU as well.

The herbicide-tolerant GM maize NK603 from Monsanto is the furthest along in the authorisation process. The European Commission expects the European Food Safety Authority’s expert panel on GMOs to deliver a statement on this in December. NK603 is intended for import and processing, but not for cultivation within the EU. The scientific statement will provide the basis for a decision on the authorisation of the maize at the Regulatory Committee meeting in early February 2004. Furthermore, a statement will soon be sought from EFSA’s GMO expert panel on Monsanto’s GT73 oilseed rape.

On the agenda

In a Regulatory Committee procedure on 4 December, the Member States will vote on the Commission’s proposal for the introduction of a standardised identification code for GMOs. These codes will ensure traceability of genetically modified food and feed. Also in December, the Standing Committee on the Food Chain and Animal Health is due to discuss implementation provisions for the preparation of applications for authorisation, the handling of existing GMO products and for interim provisions in the event of adventitious contamination with unauthorised GMOs.

Sending a signal

The Commission’s timetable for the further processing of the applications already received is anything but set in stone, as this week’s sudden U-turn on the seed thresholds issue has shown. However, it sends a signal to Member States, EU trading partners and the World Trade Organisation (WTO) that the EU is intent on progressing with the assessment and authorisation of GMOs according to its new legislative framework.