BRUSSELS, Belgium - Two of the missing links in European Union rules on authorization for biotechnology products came close to being filled in on Dec. 20 when an agreement was at last reached on traceability and labeling of genetically modified organisms (GMOs).
A long-running debate on an update to the EU's 1990 rules had been held up for over a year while a compromise was hammered out on these requirements. Now a revised directive could be finally adopted by mid-February.
Following intensive discussions between EU member state governments, the European Parliament and the European Commission, the revised directive will contain specific provisions for labeling and traceability of live GMOs. It also will contain harmonized risk assessment, time-limited consents and mandatory consultations of EU scientific committees. Broad support has been secured for a two-phase establishment regulatory framework for the authorization and control of GMOs. The framework also will allow for citizens to make an informed choice as to whether they purchase and consume GMO products.
The first phase, to be concluded in the first quarter of 2001, will include specific requirements for traceability of GMOs and derived products, as well as labeling provisions for live GMOs, and a new law on genetically modified seeds. The second phase, to be completed by mid-2001, includes preparation of a new law on genetically modified food labeling. A revision of the existing EU rules on novel foods also is to be proposed by mid-2001.
The agreed-upon text foresees increased accessibility of the public to information. To ensure traceability and monitoring, it provides for registers recording the location of all GMOs grown to be made public as appropriate by the competent authorities and in compliance with national provisions. Deadlines were agreed on for the phasing out of antibiotic resistance markers in GMOs (by the end of 2004 in the case of GMOs placed on the market and by the end of 2008 in the case of GMOs released for other purposes such as research and development). But the pharmaceutical industry has won an important victory: The new directive will not cover GMOs in medicinal substances or compounds for human use when released for other purposes than placing on the market, provided that EU pharmaceutical rules ensure equivalent authorization procedures. A new time limitation was introduced for the renewal of the consent - generally, for 10 years.
Liability will be covered by a separate new law on environmental liability, due to be proposed before the end of 2001. It also would cover damage from GMOs. And enhanced mechanisms are foreseen for environmental risk assessment.
While the details are put into place, the EU's de facto - but technically illegal - moratorium on new authorizations of biotechnology products will continue, as a result of member state caution. But European Environment Commissioner Margot Wallstrvm sees this agreement as the breakthrough that will undo the logjam. She said on Thursday: "When we have the proposals and revised directives on the table, then we will have to decide on the next steps to take. The commission hopes that we then can tackle the issue of the moratorium and pending approval of products."