At its second reading Parliament had wanted to exclude GM pharmaceutical products for human use from the scope of the new directive (which repeals and replaces Directive 90/220). The compromise now agreed states that the directive will not apply to GM medicinal substances and compounds, provided that their voluntary release is not carried out for the purposes of placing them on the market. However, if these GM products are released for research purposes, the directive will apply and certain conditions will be required, including a risk assessment, consent prior to release, a surveillance plan and the provision of information.
The Cartagena Protocol on Biosafety has an important bearing on the new directive. Thus, Parliament wanted not only to mention the protocol, but to call on the Commission to bring forward a legislative proposal for implementing it. Council did not want to concede any ground here at first but under the compromise now reached the Commission is asked to bring forward a legislative proposal by July 2001. The key issue is the export of GMOs to third countries, as the protocol states that the importing country should be notified of any imports and provided with accurate information about them and that its consent should be obtained.
At second reading, the House had asked for public registers of GMOs released for both research and commercial purposes. This point remained difficult to resolve within both Parliament and Council. British experience showed the potential for conflicts with such registers. It was finally agreed that GMOs released in the trial period should be registered and details made available to the public. As regards the release of GMOs for commercial purposes, their locations will have to be notified to the competent authorities and made known to the public in a manner deemed appropriate by the authorities.
In GMO research, antibiotic resistance markers are used to make the organisms easier to handle. When such GMOs are released, there is a risk that the resistance gene will cross over into other species and that the resistance will spread. The Parliament delegation successfully demanded that antibiotic resistance markers should be phased out by 31 December 2004 for GMOs placed on the market as products; GMOs released experimentally are now due to be phased out by 31 December 2008.
Labelling and traceability of GMOs
The Commission is expected to commit itself in a written declaration to bring forward a proposal on labelling and traceability, which are essential for consumers as they can only take decisions on what they know. The Commission is likely to say that the proposal will be presented in the course of 2001 and will provide appropriate traceability for products derived from GMOs, as well as supplementing the labelling regime in accordance with the White Paper on Food Safety.