Genetically Modified Organisms

In response to public fears about genetically modified organisms (GMOs) in food, the European Union adopted in July 2003 two regulations establishing an EU-wide system to trace and label GMOs and to regulate the commercialisation and labelling of food derived from GMOs. These new laws came into force in April 2004. On 18 May, the Commission put an end to the 'de facto' moratorium on approving new GM products for the European market, which had been in place since 1998.

The public debate on genetically modified organisms (GMOs) in seeds, crops and food continues to be highly polarised.

A sizeable agro-biotechnological industrial sector is thriving on the production of GMOs. Genetic engineering of crops contributes to more profitable farming by extracting genes bearing a specific, hereditary trait from one organism and artificially inserting them into another organism. The aim of genetic modification is to make crops resistant to insects, herbicides, drought etc. In food, GMOs can make products more nutritious, improve their taste and increase their shelf live.

However, consumer and environmental NGOs are trying to limit the production of what they call "Frankenstein food" and "GMO pollution", pointing to the unknown risks for human health and the environment. Surveys have shown that a large proportion of EU citizens are opposed to GM food.

The scientific community is not yet in a position to give a definitive answer as to the dangers of GMOs due to a lack of long-term experience. At the moment, the only known health risks that may be caused by GM food are food allergies and increased resistance to antibiotics. Moreover, studies have shown that wildlife can be harmed by GM crops and that GMOs can cross-pollinate with other plants.

Most GMOs are grown in the US, where pre-market safety reviews of GM products are voluntary. EU Member States insist on more thorough checks and several European countries re ject GMOs outright. Policy-makers find themselves in the difficult position of legislating in a highly contentious area with a lack of definitive scientific data.

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;
  • civil responsibility;
  • 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.

The European Parliament on 18 December 2003 called for more effective and stricter protection for organic and conventional farmers against accidental contamination of their products. Opposing the Commission's approach to leave the final decision up to the Member States, MEPs think that there is an urgent need for EU-wide regulations on co-existence. Moreover, the report says that GMO producers should have civil liability for any cross-contamination of non-GMO products. Member States wishing to restrict GMO cultivation in certain geographical areas should have the right to do so. 

The EP also considered that the thresholds of 0.3 and 0.7 per cent for the 'adventitious' presence of GMOs in seeds was set too high, saying that a limit value for the labelling of GM impurities in seeds should be set "at the technically measurable and reliable detection threshold".

In its debate on 29 September 2002, the Agriculture Council revealed the wide range of attitudes on co-existence in the various Member States. Opinions ranged from Austria's call for a solid EU-wide framework on co-existence to a more liberal French and British position demanding maximum flexibility.

Greenpeace, Friends of the Earth Europe and the European Environmental Bureau have condemned the Commission's recommendations, criticising its advice to allow genetic contamination of organic products by applying the same labelling threshold to conventional and organic farming. However, environmental pressure groups welcomed the Commission's recommendation that measures of a regional dimension could be considered to prevent GM contamination, as they felt this would open the door to regional bans of GM crops.

EuroCommerce, the European trade representation of the Retail, Wholesale and International Trade, has also attacked the draft directive, stating that it would lead to growing GMO contamination of the whole food and animal feed supply chain and reduce the consumers' freedom of choice between GM and non-GM food.

EuropaBio, representing the biotech industry, has welcomed the Commission's initiative, saying that the guidelines would help widen the choice of farmers, processors and consumers. However, the industry maintains that no special legislation for civil liability is needed, as existing national laws provide sufficient possibilities to seek compensation for economic loss.

The Council is currently awaiting a new proposal by the Commission after the executive had decided to change the legal basis for the proposal on labelling thresholds for GMOs in conventional seeds. However, due to differences within the Commission, this decision has been postponed (see EURACTIV 9 September 2004).

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