16/5/2003
Current EU legislation in the EU on GMOs

Community legislation on GMOs has been in place since the early 1990s and throughout the decade, this regulatory framework has been further extended and refined. The EU introduced specific legislation designed to protect its citizens' health and the environment while simultaneously creating a unified market for biotechnology.

GMOs for deliberate release in the environment

Directive 2001/18/EC sets out the rules governing the release of GMOs into the environment. It entered into force in October 2002. It puts in place astep-by-step approval process, based on a case by case assessment of the risks to human health and the environment before any GMO or product consisting of or containing GMOs, such as maize, tomatoes, or microorganisms can be released into the environment or placed on the market.

Under Directive 2001/18/EC, a company intending to market a GMO must first submit an application to the competent national authority of the Member State where the product is to be first placed on the market. The application must include a full environmental risk assessment. If the national authority gives a favourable opinion on the placing on the market of the GMO concerned, this Member State informs the other Member States via the Commission. If there are no objections, the competent authority that carried out the original evaluation grants the consent for the placing on the market of the product. The product may then be placed on the market throughout the European Union in conformity with any conditions required in that consent.

If objections are raised and maintained, a decision has to be taken at Community level. The Commission first asks for the opinion of its Scientific Committees, composed of independent scientists, highly qualified in the fields associated with medicine, nutrition, toxicology, biology, chemistry, or other similar disciplines. If the scientific opinion is favourable, the Commission then proposes a draft Decision to the Regulatory Committee composed of representatives of Member States for opinion. If the Regulatory Committee gives a favourable opinion, the Commission adopts the Decision.

If not, the draft Decision is submitted to the Council of Ministers for adoption by qualified majority or rejection. If the Council does not act within 3 months, the Commission can adopt the decision.

During the notification process, the public is also informed and has access to the publicly available data on the internet: http://gmoinfo.jrc.it/

Three complete dossiers have been submitted to the Commission (GM maize NK 603, GM oil seed rape GT 73 GM maize NK 603 x MON 810 all from Monsanto) . The 3 applications are for import and processing only (not for cultivation).

GM foods

Regulation (EC) 258/97 on Novel Foods and Novel Food Ingredients sets out rules for authorisation and labelling of novel foods including food products containing, consisting or produced from GMOs.

The first step of an authorisation procedure is an assessment of an application to market a GM food product by the Member State where the food is to be first placed on the market. In case of a favourable opinion, this Member State informs the other Member States via the Commission. If there are no objections against the application, this Member State can authorise the product for marketing in the entire EU.

If there are objections by other Member States, a decision at Community level is required. The Commission consults the Scientific Committees on matters relating to public health and adopts a decision after receiving a favourable opinion from the Regulatory Committee composed of Member State representatives.

As a derogation from the full authorisation procedure, the Novel Foods Regulation provides for a simplified procedure for foods derived from GMOs but no longer containing GMOs, which are "substantially equivalent" to existing foods with respect to composition, nutritional value, metabolism, intended use and the level of undesirable substances. In such cases, the companies only have to notify the Commission when placing a product on the market together with either scientific justification that the product is substantially equivalent or an opinion to the same effect, delivered by the competent authorities of a Member State.

Under the Novel Food Regulation, there are two applications at an advanced stage of the approval process, (one for Monsanto GA 21 maize, and one for Syngenta Bt 11 sweet maize) that are almost ready for a decision. The European Commission is working with both companies with a view to clarifying a number of pending issues.

Last December, the Commission informed MS that cottonseed oil from two Monsanto GM cottonseeds have been placed on the market under the simplified procedure of the Novel Food Regulation (the Regulation provides that when substantial equivalence is established, applicants have only to notify the placing on the market to the Commission). The two cottonseed oils are not distinguishable from their conventional counterparts.

Another new application under Novel Food (for Monsanto GM Maize NK 603) is currently being examined by the EU.

EU Rules on traceability and labelling

The EU recognises the consumers' right for information and labelling as a tool to make an informed choice. Since 1997 labelling to indicate the presence of GMOs as such or in a product is mandatory. From 17 October 2002 onwards Directive 2001/18/EC foresees that Member States shall take all necessary measures to ensure a labelling of GMOs as or in products at all stages of the placing on the market.

The Novel Foods Regulation provides for the mandatory labelling of foods and food ingredients which contain or consist of a GMO without prejudice to the other labelling requirements of Community law. The labelling requirements for foods produced from GMOs, but no longer containing GMO are based on the concept of equivalence.

Council Regulation (EC) 1139/98 lays down provisions for the labelling of foods and food ingredients derived from one maize and one soya variety based on the presence of DNA or protein resulting from genetic modification. This criterion serves as a model providing the rules applicable to labelling of all foods and food ingredients derived from GMO.

In January 2000, the Commission adopted Regulation (EC) 50/2000 ensuring that also additives and flavourings have to be labelled if DNA or protein of GMO origin is present in the final product.

The Commission has recently adopted two common positions (1) on GM food and feed and (2) on Traceability and Labelling of GMOs. These common positions are in the process of being examined by the European Parliament and the Council and expected to be adopted by the end of the year. Indeed, second readings are planned for July.

International regulatory framework for GMOS

All international agreements such as the WTO Sanitary and Phytosanitary Measures (SPS) Agreement, the WTO Technical Barriers to Trade (TBT) Agreement) and the Cartagena Protocol on Biosafety to the Convention on Biological Diversity recognise the right to their members to take the measures at the levels they consider appropriate, for example to protect human or animal health or the environment.

The Cartagena Protocol to the Biodiversity Convention regulates the transboundary movements of GMOs. It has been signed by 102 countries including the European Union. The US is not a party to the Biodiversity Convention and therefore has not signed the Biosafety Protocol. The Protocol will come into force after ratification by 50 countries (41 countries have ratified it at the end of January 2003), including the European Community). It will be legally binding for the countries that will ratify it and countries that have signed it are expected, under international law, to act in good faith and not to take measures which could contradict its objectives.

The Protocol establishes an Advanced Informed Agreement (AIA) procedure for ensuring that countries are provided with the information necessary to make informed decisions before agreeing to the import into their territory of GMOs intended for deliberate release into the environment (this includes all vegetative parts that are meant for planting such as seeds). However, the AIA procedure does not apply to GMOs which are for human consumption (food), for animal feeds or for processing. For these, relevant information has to be provided to the Parties through the Biosafety Clearing House (a mechanism set up by the Protocol to facilitate the exchange of information on GMOs, including national regulation pertaining to them, and to assist countries in the implementation of the Protocol). Moreover, these commodities, when exported, must be accompanied by documentation specifying that they "may contain" GMOs and that they are not intended for intentional introduction into the environment. The Parties shall decide on the detailed requirements for this purpose, including specification of the identity of the GMOs and any unique identification.

The US is the largest agricultural commodity exporter but also the largest GM crops producer. In 2002, the US has grown more than 35 million hectares out of the 58 million hectares of GM crops cultivated world wide. The US opposes the biosafety protocol because the enforcement of the protocol will interfere with the main US agriculture commodity exports, i.e. maize and soybeans. However, if the US were to follow the Biosafety Protocol, they would have to specify that food aid might contain GMOs if that was the case, for example.

Several countries have adopted a case by case authorisation process for GMOs but authorisations are not always synchronous with US approvals. Others, such as Sri Lanka, which have not yet adopted a regulatory framework, have banned the import of GMOs. Even China, which has one of the largest biotech industry is now taking a cautious approach with the authorisation of GM food.

Because US traders refuse to segregate, the US maize and soybean face difficulties on the international market because of the possible presence in shipments of GMOs that are not authorised in the importing countries. In addition, due to consumers' concerns over the safety of GMOs, the food and feed industry is increasingly looking for supply of non GM maize and non GM soybean. For those reasons, the US has a vested interest in an international deregulation of GMOs trade and in a non labelling policy of GM food and feed.

The EU has developed a comprehensive regulatory framework for GMOs and for GM food and feed including traceability and labelling provisions. Many countries are now looking at the EU policy to develop their own policy. The US fears that several countries will adopt a similar approach as the EU to regulate GMOs and GM food and feed products.

GMOs and food aid

A number of developing countries, especially in Africa face a humanitarian crisis as a result of adverse weather conditions.

The US has committed to supply 499 000 tonnes of maize grain as food aid between September 2002 and March 2003. In the US, 35% of the maize is produced from GMOs. However, only 1 to 2% of the harvest is segregated (due to the cost of segregation, such maize is more expensive than non-segregated maize). Therefore, US maize is likely to contain GMOs.

Some African countries in the region have initially refused to take the maize for a combination of reasons, namely human health concerns, environmental consideration, the risk of spread of transgenes into their own maize production, and the repercussion such a spread could have on regional and international trade and Intellectual Property Rights concerns.

Following the Zambian ban on GMOs, the US has sponsored a study trip for Zambian scientists in the US and in a number of European capitals. The Zambian scientists have met the European Commission services and have been provided with copies of all scientific assessments from the EU scientific committees (all opinions are favourable).

In their report, the Zambian scientists still argued against the introduction of GM maize in Southern Africa. The Zambian government has confirmed its decision to ban GM maize in the light of the report of the Zambian scientists.

Other countries (Zimbabwe, Mozambique, Malawi) eventually accepted US maize provided that it is milled, which is a process preventing he release of GMs into the environment (their initial ban relates to environmental concerns). But the US has refused to fund the milling.

The US is blaming the EU for the African refusal of the US maize. However, the Commission has repeatedly said that there is no reason to believe that GM food is inherently unsafe to human health. However, developing country governments have the legitimate right to fix their level of protection and to take the decision they deem appropriate to safeguard their territory from unintentional dissemination of GM crops.

With respect to food aid, the Commission policy is to source food for emergency situation as much as possible in the region as this contributes to the development of local markets, provides additional incentives for producers and ensures that products distribute closely match local consumption habits. The US policy is to provide food aid in kind and use surplus production.

For practical reasons and to respect the choice of beneficiary countries, the Commission has requested the World Food Programme to purchase only conventional (non GM) maize for distribution as food aid. This avoids food aid being rejected, the cost of milling (in the case of Zimbabwe, Malawi and Mozambique) and difficulties during the transit of countries like Mozambique that have taken action against the transit of GMOs in their territory.

Food aid is being distributed. In Zambia, the Commission has allocated € 20 Million to the WFP for regional purchase of maize. By mid January 174,000 tonnes out of the 277,000 committed by the EU has been purchased - 99% has been procured in the region (70% South Africa, 23% Malawi, 7% Tanzania and less than 1% in the EU).