4 December 1998

Europe takes hard line on GMcrop approvals

By Philip Clarke

EUROPE is at a crossroads in terms of sanctioning the wider use of genetically modified organisms.

It already lags way behind the US, Canada and Japan which, between them, have almost 100 products on general release. By contrast Brussels has so far approved just 16 GMOs.

Novartis took over two years to win regulatory approval for its insect resistant Bt-maize. That compared with just six months in the US and 10 months in Canada and Japan.

The basic regulation controlling the release of GMOs is Directive 90/220, covering both trials and marketing releases.

To get 90/220 approval, a company must persuade a national government to sponsor its variety, taking on the role of "rapporteur".

The application and all supporting evidence is then submitted to Brussels for a scientific assessment, as well as a review of the environmental, human and animal health implications.

Assuming the opinion is eventually favourable, the commission then instructs the member state to issue a consent.

But that is only part of the process. Four other hurdles must be cleared before GM seeds can go on commercial release, explains Monsanto technical manager Colin Merritt.

The product must gain approval under the separate Novel Foods regulation, controlling new products entering the human food chain. Separate legislation deals with animal feeds.

Then there is the change of use under the control of pesticides regulations, dealing with the registration of agrochemicals to be used with the GM crop.

Finally, each variety must be entered for national list trials to gain sales authorisation in each member state.

So far no GM varieties have received full approval in the UK.

With increasing complaints about approval delays and over 1000 GMOs now on trial throughout the EU, Brussels has embarked on a review of 90/220.

Its main aim is to simplify and speed the process. But parts of the proposal could have the opposite effect. In particular it says:

&#8226 The commission may consider ethical issues.

&#8226 It should also consult the public on all GM applications.

&#8226 GM crops must be compulsorily monitored after their release.

&#8226 Consents by national authorities must be reviewed after seven years.

Scandinavian countries, in particular, favour a more cautious approach to GM crops, and have been keen to see ethical considerations brought into the regulatory process.

Austria and Luxembourg also have a history of resistance to GM crops. They are at loggerheads with the commission over their decisions to block imports of the Novartis Bt-maize.

The most radical turnaround, however, has occurred in France. A change of government last year, and the appointment of a new "green" environment minister, led to the announcement of a two year moratorium on GM crops last summer.

That moratorium threatens the licensing of two oilseed rape varieties which have already been cleared by Brussels and which, ironically, were originally sponsored by the French.

Brussels has launched legal proceedings against the Paris government for failing to pass on new GMO applications – something it is obliged to do within 90 days under EU law.

The UK has also changed tack on GM crops. The government plans to limit the area of commercial releases and has agreed with industry that no insect resistant varieties will be introduced for three years.

It remains to be seen which way the EU will turn. The environment council is due to discuss GMO approvals just before Christmas, and the European Parliament will issue its report on the regulations in February.

With public opinion apparently hardening, and supermarkets reflecting that view, breeder hopes that approvals are set to get easier may be misplaced.