BioWorld International Correspondent

BRUSSELS, Belgium - The European Parliament will vote today on new European Union rules concerning labeling and traceability of GMO foods and animal feeds, at the end of a debate that has sharply divided opinion in the EU.

The Parliament's environment committee insisted in June that the proposals should be made even tougher, but industry claimed the draft is already excessively constraining on business operations.

EuropaBio, one of the principal European biotech industry lobby groups, said before the vote: "If the majority of members of the Parliament vote with the hard-line Greens, the new rules could eliminate consumer choice, reduce options for sustainable agriculture in Europe, and disrupt trade with third countries. These are the issues at stake."

But Geert Ritsema, of Friends of the Earth Europe, which has been lobbying the Parliament energetically for tougher rules, said, "Consumers across Europe want full information on all products derived from GMOs."

The way the Parliament as a whole votes on the package is being seen by all sides as a crucial test of the future direction of EU legislation on biotechnology.

A proposal calls for full traceability and labeling of foods derived from GMO crops, instead of the current requirements affecting only products in which GM DNA or protein is detectable. But the European biotech industry and the U.S. government have been arguing that such a system would be unworkable and open to fraud. The proposals also require labeling of animal feed and food products derived from animals raised on GM feed, and the Parliament's environment committee is calling for labeling of food products such as eggs, meat and milk derived from animals fed with GM feed. But EuropaBio has been sending a message to members of Parliament that additional and incremental traceability requirements imposed only on GM foods or feed have no basis in protection of health or the environment and add nothing to the safety of the final product that is not already covered by existing European food law.

The Parliament also is being asked by its environment committee to strengthen the proposals on admitting to the food-chain GMOs that have not been yet approved in the EU. The EU is proposing that they should be allowed into human and animal food up to a level of 1 percent, but the Parliament's environment committee voted in June for zero tolerance. EuropaBio is arguing that legislation should permit the presence of trace amounts of GM products from the EU's trading partners, as long as the health and environmental safety of the GM has been approved by the exporting country using a regulatory system that meets EU standards. Similarly, the committee is urging that the threshold of permitted GMO contamination of foods or feeds should be cut from 1 percent to 0.5 percent, and Friends of the Earth is still arguing for even lower thresholds. But EuropaBio said "guaranteeing 100 percent purity of agricultural commodities is practically impossible." It said there must be "realistic allowances" for traces of adventitious GM in crops.

Since the EU rules governing biotechnology products came into force in October 1991, the commercial release of 18 GMOs has been authorized, but in two cases EU member states have not applied the authorization decision. There have been no authorizations since October 1998, because of a moratorium imposed by some member states, so there are 12 applications stuck in the pipeline. And some member states (Austria, Luxembourg, France, Greece, Germany and the UK) also have banned the marketing of genetically modified maize and oilseed rape products in their territories under a safeguard clause in the existing legislation, although EU experts have concluded that the justifications offered for these bans are inadequate.

British Biotech Boss Leads Lobbying Group

Elliot Goldstein, CEO of British Biotech, has been elected president of the Emerging Biopharmaceutical Enterprises group, the European lobby group within the European Federation of Pharmaceutical Industries and Associations. He takes over from Serono SA CEO Ernesto Bertarelli, who remains on the EBE board as vice president, along with Peter Heinrich, CEO of MediGene AG. Other board members are Ahmed Bouzidi, CEO of Sedac Therapeutics; Antoine Beret, CEO of Trophos; Jean-Luc Belingard, CEO of Beaufour-Ipsen; and Carlo Incerti, CEO of Scientific Development of Genzyme Europe.

The aim of EBE, which now has 34 member companies, is to improve the European business environment for biopharmaceutical technologies. "Biopharmaceutical companies are at the forefront of innovation and they have a key role to play to help achieve the strategic EU goals of fostering competition and creating a dynamic knowledge-based economy," Goldstein said in a statement upon his election.

Investment Bank Prepared To Help Biotech

The European Union regulatory environment for the biopharmaceutical industry is still incoherent, according to Jean-Jacques Mertens, a senior official of the European Investment Bank. The national variations on intellectual property protection and pricing policies, as well as a less-than-enthusiastic public perception of the industry, present challenges for the sector, he said in a statement issued at the end of June.

The consequences include leaving Europe lagging behind the U.S., and creating a net transfer of knowledge from the EU to the U.S. EIB already has provided the sector investment funding of €65 million (US$65 million) and loans of nearly €1 billion since 1997. But the pharmaceutical and biotechnology industries in Europe need and deserve more political and investment support, said Mertens, promising EIB readiness to complement the sector's own funding efforts.

A new study from the EIB says European biotechnology has some particularities that "must be addressed for Europe to secure its place as a leading developer, producer and user of biotechnology products and processes" - including the ethical debate, the "relatively complex regulation" in the EU, and the resulting long development times for new products. As a consequence, funding is difficult to obtain, and smaller start-up firms are particularly hard-hit, according to the EIB.

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