Current EU legislation on GMOs is regarded as the strictest in the world. It deals with a plethora of issues, including rules relating to the release of GMOs into the environment, the traceability and labelling of GMOs and GMOs in food and animal feed. The co-existence of GM and conventional crops is currently under discussion at EU level.
Directive 2001/18/EC on the deliberate release of GMOs into the environmentIn 1990, Directive 90/220/EEC relating to experimental releases and marketing of GMOs entered into force. However, due to considerable advances in genetic modification in the 1990s, Member States decided to revise the legislation. During the ensuing debate, five Member States in 1998 evoked the 'safeguard clause' of the existing directive, which allowed for a temporary ban of a GM product on a state's territory if there were substantial evidence that it imposed risks to human health or the environment. This resulted in a de facto moratorium on the approval of new GM products, sparking a trade war with the US (which claimed that the ban violates WTO agreements).
The new Directive 2001/18/EC was adopted in October 2001, introducing new rules to ensure that all GM food and crops are subject to strict risk assessments before they can be sold, marketed or planted in the EU.
Regulation 1830/2003/EC on Traceability and Labelling This Regulation, which was adopted by the Council in July 2003 and amends Directive 2001/18, requires the labelling of all foods produced from GMOs. However, food does not need to be labelled if it contains less than 0.9 per cent of genetically modified material or if GMOs are 'adventitious' [accidental] and technically unavoidable. The threshold for the presence of GMOs which have not yet been authorised in the EU (but have received a favourable scientific risk assessment) was set at 0.5 per cent. The regulation also stipulates that GMOs must be traceable throughout the entire production and distribution process, thus making it compulsory to the producers of GM seeds and crops to inform any purchaser of the presence of GMOs and to record to whom and from whom GM products are made available.
Regulation 1829/2003/EC on GM Food and Feed This regulation was also adopted by the Council in July 2003, introducing a centralised authorisation procedure for GMOs used as food or animal feed. If a company wants to market a GM crop in the EU, it does not need to request separate authorisation for the use of the crop as food or feed. The use of GMOs in animal feed did not previously require a specific authorisation. The 'simplified procedure' for putting on the market GM-foods which are considered to be substantially equivalent to existing foods will be abandoned.
Commission Guidelines on Co-existence The issue of the co-existence of GM and conventional crops is currently being debated at EU-level. To ensure that the thresholds stipulated by the Regulation on Traceability and Labelling can be complied w ith, additional rules are necessary concerning the purity and labelling of the seeds that food products are derived from. The most controversial issues in the debate on co-existence concern:
GMO thresholds in organic produce;
thresholds for GMO in seeds;
the possibility of setting up GM-free zones.
The Commission on 23 July 2003 published guidelines suggesting a tolerance level of 0.3 and 0.7 per cent of the 'adventitious' or technically unavoidable presence of GMOs in crops, depending on the variety. However, according to the Commission, the responsibility for setting conditions for the co-existence of crops should lie with the individual Member States.