European Battleground for Genetically-Modified Organisms (GMOs) – Further News

It has been a busy day for the European Court of Justice, as no less than three cases relating to the marketing/use of GMOs are reported today.

Failure to implement Directive on the contained use of genetically modified micro-organisms

In Cases C-333/01 and C-436/01, the European Court has ruled that the failure by Spain and Belgium, respectively, to adopt laws to implement Directive 98/91/EC on the contained use of genetically-modified micro-organisms is a breach of Community law. The Commission brought enforcement action under Article 226 EC for a declaration that each Member State had failed to fulfil its obligations under the Directive. This may open up the potential for possible claims for damages by private persons against these respective Member States.

This is an interesting development to the moratorium maintained by a number of Member States (including these two) against the commercialisation/approval of GMOs. It indicates that the Commission is prepared to take a firm line with Member States blatantly flouting Community law. It remains to be seen whether the Commission would consider taking enforcement action against Member States holding off from approving new GMOs, until the proposed directive on the traceability and labelling of products containing GMOs is approved. However, it may yet do so. This is especially interesting at present, given that the US remains keen to take WTO enforcement proceedings against the EU for not lifting the moratorium against GMOs.

The legality of provisional measures to restrict the marketing/use of GM products

In another case pending before the European Court (C-236/01), the Italian courts have sought guidance on issues concerning the simplified approach for approval of GMOs, after a challenge in the Italian courts by Monsanto, Syngenta and Pioneer to the legality of an Italian Decree suspending the marketing/use of products derived from various GM maize lines.

In 1997 and 1998 the biotech companies placed on the market under the "simplified procedure" foods (flour), derived from GM maize. The competent United Kingdom food authority had previously certified that the products in question were substantially equivalent to traditional foods. The Italian Republic, however, had doubts as to the absolute safety of the products and imposed a provisional prohibition on the marketing/use of products derived from the maize lines. Monsanto and the others challenged the relevant Italian Decree, on the ground that it infringed Community law.

Foods which are produced from GMOs but no longer contain them may, under Regulation (EC) No. 258/97 concerning novel foods and novel food ingredients, be placed on the Community market under a simplified procedure, without prior authorisation by the Commission. A further condition for the use of the simplified procedure is that the novel food be substantially equivalent to comparable traditional food, which can be demonstrated by means of an authorisation from a national food assessment body.

In the present case, genes were inserted into maize, which render it resistant to certain herbicides and pests. The GM DNA is destroyed during the processing of the cornmeal, giving rise to a food which is derived from GMOs but no longer contains them, since no organism capable of growth any longer exists in the flour. Nevertheless, the cornmeal still contains a very small amount of transgenic protein (a product of the inserted gene) which, as far as it is known, poses no risk to human health.

The first question referred by the Italian court was to know whether substantial equivalence can exist even when foods continue to contain traces of transgenic protein. Advocate General Alber concludes that novel foods are to be considered substantially equivalent to traditional foods and may accordingly be placed on the market using a simplified procedure, even where they continue to contain traces of transgenic protein, provided it has been demonstrated that those substances do not pose any risk to the consumer.

Second, the Italian court also wished to know to what extent a Member State is entitled to take protective measures of its own, where doubts exist as to the substantial equivalence of novel foods with conventional foods. The Advocate General concluded that the Italian Government was entitled to adopt provisional measures, provided that it had detailed grounds for considering, as a result of new information or a reassessment of existing information, that the use of the food in question endangers human health or the environment. Those measures may be maintained until the Commission or the Council adopts a decision as regards the validity of the grounds put forward, which has not yet occurred.

It is worth noting that the Commission and the Member States agreed, in the light of concerns and criticism, no longer to use the simplified procedure, with effect from January 1998 for products derived from GMOs. The new proposal for a regulation on GM food and feed no longer provides for a simplified procedure.

This Opinion may form a useful basis for analysing the various "precautionary" measures taken by Member States under Article 16 of Directive 90/220/EEC (now under Article 23 of Directive No. 2001/18/EC) to restrict the marketing of authorised GMOs on grounds of alleged risks to human health or the environment. The test would seem to be whether the Member State had detailed grounds (and evidence) for considering, as a result of new information or a reassessment of existing information, that the use of the food in question endangers human health or the environment. Further, this would only justify a temporary measure, pending evaluation of the material by the Commission and a decision by the Council. However, it remains to be seen whether the European Court itself will follow this Opinion, when it gives judgment.

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