BioWorld International Correspondent

BRUSSELS, Belgium - Despite many of them being under fire for failing to sufficiently implement the current European Union legislation on genetically modified microorganisms (see story page 1), senior representatives of the EU member states last week brought in new modifications to the rules governing research.

Member state ambassadors meeting in Brussels agreed to refine the controls in the EU's basic 1990 rules on biotechnology, by updating one of the technical annexes listing what are considered to be safe genetically modified microorganisms.

The effect will be to tighten up the criteria for defining "safer" products, and at the same time to extend the list of products so designated, and are therefore subject to a lower level of control. The technical amendments are due to be officially adopted this week, when EU ministers will examine the ambassadors' draft text.

Under the amended rules, GMMs can to be added to the list of "safer" organisms on a case-by-case basis if they are clearly identified and if they meet a new set of requirements. The identity of the strain has to be specified. The modification has to be one that is recognized and has been verified. The organism's safety has to be confirmed by documentary evidence. When risks of instability could affect safety, the organism's stability will have to be proved. The GMM should not create any pathogenic or toxic risk for human beings, plants or animals in good health, with pathogenicity covering genetoxic and allergenic aspects.

The GMM should not contain any known incident pathogenic agents, such as other active or dormant microorganisms, near or inside the GMM, which are likely to harm human health and the environment. The modified genetic material must not cause any damage in the event of a transfer and it should not be self-transmissible or transferable to a higher extent that other genes of the receptor or parental microorganism. And GMMs should not have any immediate or delayed harmful effects on the environment in the event of an incident leading to an unintentional release on a wide scale.

Funding Promised For Biotechnology Research

The European Commission has proposed its budget breakdown for the new EU research framework program, which is scheduled to run from 2002 to 2006. Within the EUR17.5 billion (US$16.5 billion) program, genomics and biotechnology will be directly allocated EUR2 billion.

Biotechnology will also benefit from funding under other headings, including nanotechnologies, new production methods, food safety and health risks, sustainable development and global change, anticipation of scientific and technological needs, emerging technologies, research and innovation, human resources, infrastructures and research installations, coordination of work on science and society and development of coherent policies, together worth more than EUR10 billion.

U.S. Warns EU Rules Still Vague

In a new update to its advice to U.S. biotechnology firms, the Office of Agricultural Affairs at the U.S. Mission to the European Union in Brussels has warned that EU biotechnology rules are still far from clear. As it points out, despite the recent agreement on the update of the basic 1990 EU rules on approvals for release and commercialization of genetically modified organisms, a blocking minority of member states continues to maintain an ad hoc moratorium on new product approvals, which has effectively blocked bulk shipments of U.S. corn to Europe.

Meanwhile, European Commission proposals on traceability and labeling, and on labeling of novel feeds, are still awaited. Regulations on labeling of novel foods "lack implementing detail, so it is up to each member state to determine thresholds, testing methods, and what products to test."

No genetically modified product has yet emerged from a full authorization process under the novel foods legislation, the U.S. said. And it added that "none of these regulations make clear with any precision which products processed from GMOs must be labeled, what testing methods apply, or even how a product can be determined 'GMO-free.'"