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MEMO/06/61

Brussels, 7 February 2006

Europe’s rules on GMOs and the WTO

There is a need for strong regulatory oversight of GM technology

There is a general consensus between scientists that GMOs are not inherently unsafe, but that their safety for the environment, human health and animal health needs to be assessed on a case by case basis before marketing. This approach is supported by international organisations such as the World Health Organisation, the Codex Alimentarius, the FAO or the OECD. The EU legislation follows strictly the internationally recommended approach and reflects the requirements of the Cartagena Protocol on Biosafety, to which the EU is a signatory.

The EU regulatory framework also provides for strict monitoring of GM products after their initial release to market through the implementation of mandatory labelling and traceability rules. The EU believes that such regulatory oversight is of utmost importance to address any potential failure of the regulatory system, such as those that have been experienced in the US in the recent past when non-approved GMOs such as Starlink GM maize, or Bt 10 GM maize entered the US food chain.

The EU has no ban on safe GM products

In the EU, GMOs can only be placed on the market after having undergone a stringent science-based risk assessment on a case by case basis. This approach is fully in line with international standards, in particular with the Cartagena Protocol on Biosafety as well as with the relevant Guidelines adopted by the Codex Alimentarius Commission in 2003 and by the International Conventional on Plant Protection.

So far, more than 30 GMOs or derived food and feed products have been approved for marketing in the EU. As an example, in early January 2006, the EU granted approvals to three new GM maize products after a rigorous safety assessment.

Contrary to US claims, the EU is one of the largest importers of GMOs and derived food and feed. The EU is the largest soybean and soy meal importer and the fact is that soy imports consist largely of Monsanto “Round-Up Ready” soybean, which is cultivated in all the main soybean global producers, i.e. the US, Brazil and Argentina. The claim that the there is a moratorium on approval of GM products in Europe is self-evidently untrue.

The EU approval process may appear to be lengthy for some countries which adopt a more lenient approach towards food and environmental safety issues. The longer times to assess the safety of GMOs in the EU are due to the complexity of the science involved as well as to delays incurred by biotech companies to provide suitable data demonstrating the safety of the products.

The WTO challenge on GMOs is unhelpful and unfounded

In May 2003, the US, supported by Canada and Argentina, launched a WTO case against the EU concerning the EU authorisation regime for GMOs. Whilst the three complainants publicly argue that the WTO case is straightforward and clear, the panel has taken a number of years to reach final conclusions on the dispute. This shows that the matters at stake are far more complex than claimed by the US, Argentina and Canada.

Indeed, against the arguments of all three complainants, the WTO panel agreed with the EU that it would be unwise to rule on such a complex topic without hearing the views of scientists. The panel eventually decided to gather the views of independent and highly reputable scientists from different parts of the world, including Europe and America. That consultation process confirmed the legitimacy of the health and environmental issues addressed in EU regulations and procedures. The US has explicitly said that it does not challenge the EU’s legal framework for clearing GMOs for import and distribution.

10 years after the first commercial release, 90% of GMOs remain cultivated in 4 countries : USA (55%), Argentina (19%), Brazil (10%), Canada (6%).

The EU remains confident that its regulatory regime over GMOs and GM food and feed is fully compatible with its international commitments including those under the WTO. The US has not at any stage challenged the EU’s legal framework.

What are the US’s real concerns with the EU system?

The US appears not to like the EU authorisation regime, which it considers to be too stringent, simply because it takes longer to approve a GMO in Europe than in the US. The US appears to believe that GMOs that are considered to be safe in the US should be de facto deemed to be safe for the rest of the world. The EU has argued that a sovereign body like the EU and its Member States, or indeed any country in the world, has the right to enact its own regulations on the food that its citizens would eat, providing that the measures are compatible with existing international rules and based on clear scientific evidence.

The US also opposes GMO traceability rules because it considers that they constitute an obstacle to US commodity exports, despite the fact that US traders can in fact meet those requirements without difficulties.

The US is also adamantly opposed to labelling rules for food products produced from GMOs, even though these rules are designed to help ensure that customers are well-informed about what they are buying.

US soybean and soy meal exports have steadily declined over the last ten years because of a decline of competitiveness of US agriculture on the global market. The trends in EU maize imports further confirm that US farmers are no longer low-cost producers and are less and less able to compete with emerging countries such as Brazil or Argentina on global commodity markets. EU trade data show clearly that EU rules on GM are not affecting the imports of more competitive GMO exporters.

Getting the rules on GMOs right.

The EU has always acknowledged that biotechnology offers promising avenues to develop agricultural production, in particular for developing countries, and it can contribute to the fight against food insecurity.

The EU has always made it clear that every country has the sovereign right to make its own decisions on GMOs in accordance with the values prevailing in its society. This principle obviously applies to both developed and developing countries. It is the legitimate right of developing countries’ governments to fix their own level of protection and to take the decisions they deem appropriate to prevent unintentional dissemination of GM seeds. This right is fully recognised in international agreements such as the Cartagena Protocol on Biosafety which the EU considers to be the key international agreement governing the transboundary movements of GMOs.

The Cartagena Protocol on Biosafety provides an international forum for the international governance of GMOs. So far more than 130 countries actively participate to it. However, the US, Canada and Argentina have refused to ratify it.

The EU considers that major GMO producers such as the US should adopt a co-operative approach to the development of a sound international legal framework for these products, instead of taking hostile steps at the WTO.

For more information on the EU regulatory framework covering GMOs, GM food and feed is available at http://ec.europa.eu/food/food/biotechnology/index_en.htm


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