BioWorld International Correspondent

BRUSSELS, Belgium - European Union agriculture ministers reviewed key proposals for new biotechnology regulation when they met in Luxembourg Monday and Tuesday, but without reaching a decision on some of the most contentious issues.

On the planned new EU rules on genetically modified food and feed, which the European Parliament said needed some toughening up when it voted on the proposal in July, ministers got no further than a policy debate.

Three major questions remain outstanding, and Denmark, holding the current EU presidency, has presented compromise solutions that have still to win approval from all 15 EU member states. In particular, because national opinions differ on whether authorizations to place genetically modified food and feed on the market in Europe should require a unanimous decision, or merely a majority, Denmark has suggested replacing the EU's centralized procedure of authorization by a decentralized procedure at the member-state level. But most member states continued to support the idea of a centralized authorization.

There is still no agreement on the thresholds to be established for permissible traces in food and feed of adventitious genetically modified organisms that have not been unauthorized but have nevertheless been assessed as risk-free. The European Parliament voted in July against allowing any unauthorized GMOs into the food chain, and some member states also insist on "zero tolerance." But the legislative proposal, in line with the wishes of the biotechnology industry, urges thresholds to ensure that the new rule is feasible. So the EU presidency is trying to steer a middle course, and buy off by introducing a time limit on tolerance, and a lower level of threshold, at 1 percent.

The other unresolved question is how to label food containing GMO material. But some member states are refusing to allow a threshold even as low as 1 percent, below which no labeling requirement would be applied. They want a label saying "This product contains GMOs" on any product containing or consisting of GMOs, irrespective of the proportion.

The presidency will now decide what final compromise solution can be put forward at a later meeting.

Officials Compromise On EU Stem Cell Research

A compromise agreement has at last been reached on European Union backing for stem cell research. The dispute - a complex spat between Italy and other EU member states over the substance, and between the EU Council of Ministers and the European Parliament over the procedures - had been blocking finalization of the EU's €17 billion research program for 2002-06.

The compromise in effect puts off any immediate answer to the question, but does allow the research program - which covers numerous other fields, ranging from gene therapy to aeronautics - to go ahead. Instead of resolving the question, it provides for guidelines to be drawn up for EU funding for research on embryonic stem cells and on supernumerary embryos.

In early 2003, the European Commission will present a report on human embryonic stem cell research to initiate a wide discussion on bioethics, and will organize a special international seminar. In light of the seminar findings, the Commission will propose guidelines on principles for deciding on EU funding for research projects using human embryos and human embryonic stem cells, which should be agreed to by December 2003.

Scientists, Companies Respond To Research Call

There has been a massive response to the European Union's call earlier this year for expressions of interest in the upcoming research program. European scientists and companies were invited to put forward their ideas on the most promising topics for research, and some 12,000 answers have been received so far, including nearly 2,000 related to life sciences, genomics and biotechnology.

The first formal calls for proposals will be published later this year, and the first concrete projects will be launched in 2003. "This clearly demonstrates the commitment of the EU research community to fully participating in European-level research wherever the opportunity arises," said EU Research Commissioner Philippe Busquin.

Nearly two-thirds of the organizations that submitted expressions of interest in the biotechnology field were academic institutions, and a quarter were research organizations. Industry made up only one-tenth of submitters, and the EU is interpreting that as an indication that industry prefers to hold back its ideas until the calls later in the year.

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