BioWorld International Correspondent

BRUSSELS, Belgium - Monsanto Co. won a victory in the European Union's Court of Justice over Italian obstacles to marketing products containing transgenic protein. The court ruled last week that under EU law "the mere presence of residues of transgenic protein in novel foods does not prevent their being placed on the market under a simplified procedure provided there is no risk to human health."

Monsanto Europe was confronted with an Italian ban on corn flour produced from modified maize. The company had already obtained authorizations from France and the United Kingdom to market genetically modified maize grain resistant to certain insects and herbicides, and had launched the corn flour across the EU, under a simplified procedure provided under EU law. But Italy objected, after reports of residues in the flour of transgenic protein expressed by the inserted gene. So Monsanto challenged Italy in the EU court.

The court has confirmed that Italy was acting illegally. EU rules allow for simplified marketing procedures for foods that are produced from genetically modified organisms but no longer contain them. If they are substantially equivalent to comparable traditional foods, the manufacturer merely has to notify the European Commission. The only way an EU member state can legally act is when it has detailed grounds to suspect such a risk, the court said. And then it may only temporarily restrict or suspend the trade in and use of the food in question in its territory. In this case, no scientific justification on health or environmental safety grounds was provided by Italy to justify the ban, according to the ruling.

The case was welcomed by the European biotechnology association, EuropaBio. It was important that the court should throw out a claim that challenged the safety of GM products already approved as safe, it said. "EU laws should be consistently implemented by the EU member states," EuropaBio said. "Otherwise there is no point in having EU legislation."

European Union Welcomes Cartagena Protocol

The Cartagena Protocol on Biosafety - the United Nations agreement on management of GMOs - came into effect Sept. 11, and received a warm welcome from the European Union.

European Environment Commissioner Margot Wallström said the new rules should give a much-needed boost to the trade in biotechnology products. These basic international rules for dealing with GMOs are "a fundamental step toward better global governance in the GMO field," she said. "This is badly needed to maximize the benefits deriving from biotechnology and minimize the risks for the environment and human health. It will contribute to increasing public confidence in the safe management of GMOs."

The protocol is designed to protect biological diversity and human health from the potential risks arising from genetically modified organisms, by providing a clear legal framework for transboundary movement. Shipments of GMO commodities will have to fulfill specific documentation requirements.

"This protocol will particularly help developing countries, which often lack the resources to assess the risks of biotechnology and make informed choices about it," Wallström said. So far 103 countries have signed the protocol, and 57 have ratified it, including the EU itself and seven of its 15 member states: Spain, the Netherlands, Austria, Denmark, Sweden, Luxembourg and France. Wallström urged other EU member states to complete ratification rapidly.

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