State of play on GMO authorisations under EU law

Brussels, 28 January 2004

Existing approvals

Under the rules on the deliberate release of GMOs into the environment (Directive 2001/18/EC and previously Directive 90/220/EC ) so far 18 GMOs have been approved for different uses, some for cultivation, some for import and processing, some as feed, some as food (see annex 1). In terms of crops species, these GMOs include maize, oil seed rape, soybean and chicory.

Under the regulation on GM food and Feed which cover novel food and novel feed ingredients, (Regulation (EC) No 1829/2003 ) products from 15 GMOs can legally be marketed in the EU (see Annex 4).

These are:

• One GM soy and one GM maize approved under Directive 90/220/EEC prior to the entering into force of the Novel Food Regulation;

• Processed foods derived from inter alia 7 GM oilseed rape, 4 GM maize and oil from 2 GM cottonseeds. These products have all been notified as substantially equivalent in accordance with the Novel Food Regulation.

Approval of new GMO products for environmental release and placing on the market

Twenty two applications for the placing on the market of GMOs have been submitted into the authorisation procedure under Directive 2001/18/EC (Annex 2), e.g. maize, oil seed rape, sugar beet, soy beans, cotton, rice, fodder beet. Eleven of these applications have a scope which is restricted to import and processing, while the remaining ones also include cultivation as a requested use.

The most advanced of the above 22 applications in the procedure is the Monsanto NK603 GM maize, on which the European Food Safety Authority (EFSA) has delivered a favourable opinion. This application is for import and processing. It does not include cultivation as a requested use. Directive 2001/18/EC requires the Commission to adopt a Decision following consultation of the Member States in a Regulatory Committee. Taking account of the above the favourable opinion from EFSA and the necessary administrative procedures, the Commission has called a meeting of the Regulatory Committee for 18 February.

Two further applications (Monsanto GT73 oilseed rape) and (hybrid maize MON 863 x 810) have been formally submitted to the EFSA for evaluation and opinions are expected soon. The scope of this application is also limited to import and processing. The remaining applications are currently being appraised by national authorities.

Approval of new GMO products as food

Article 46(1) of the Regulation 1829/2003 on GM Food and Feed provides that applications for the authorisation of a GM food made under the Novel Foods Regulation which have received a final scientific assessment before the coming into application of the new Regulation are still to be processed under the Novel Foods Regulation. Authorisation for a GM food will include labelling and traceability provisions as required by the new law.

There are currently nine GM products pending authorisation under the Novel Food Regulation (for details see the list attached in Annex 3) e.g. maize, soybean and sugar beet.

The scientific risk assessment has been completed for three of the applications, a GM sweet maize from Syngenta (Bt11), a GM field corn from Monsanto (GA21) and a GM maize from Monsanto (NK603). An opinion with regard to the draft decision to authorise BT11 under the conditions as specified was submitted to the Standing Committee on the Food Chain and Animal Health on December 8, 2003. As no qualified majority was reached by the Committee, the Commission has decided today to submit the proposal to the Council. The Council has three months to act and to adopt or reject the proposed decision with qualified majority. The Council could also decide not to act. In this case it will be upon the Commission to take a decision.

The Commission has referred two other maize lines from Monsanto (MON 863 and MON 810 X MON863) to EFSA for advice. In both cases, the Commission has to await the advice from the EFSA before proceeding with these applications.

The four remaining applications are currently in the first stage of the authorisation process and are still undergoing risk assessment by a competent authority in a Member State.

National safeguard measures on GMOs

Under environmental legislation

Directive 90/220/EEC under its Article 16 (known as the safeguard clause) provided that where a Member State has justifiable reasons to consider that a GMO, which has received written consent for placing on the market, constitutes a risk to human health or the environment, it may provisionally restrict or prohibit the use and/or sale of that product on its territory.

Article 16 has been invoked by Member States on nine separate occasions, three times by Austria, twice by France, and once each by Germany, Luxembourg, Greece and the United Kingdom (Annex 5). The scientific evidence provided by these Member States as justification for their measures, was submitted to the Scientific Committee(s) for opinion. In all of these cases, the Committee deemed that there was no new evidence which would justify overturning the original authorisation decision. National measures notified under Article 16 of Directive 90/220/EEC have now to be dealt with under the safeguard clause provision of Directive 2001/18/EEC (Article 23). In view of the new regulatory framework, the Commission has informed Member States that they should now withdraw their measures under Directive 90/220/EEC and lift the prohibitions.

On GM foods

Only one Member State has invoked the safeguard clause (Article 12) under the Novel Food Regulation. This took place in August 2000, when Italy suspended the trade in and use of products derived from four GM maize varieties (MON 810 from Monsanto; T25 from Bayer Crop Science; Bt11 from Syngenta and MON 809 from Pioneer) which had been notified under the simplified procedure for products considered as "substantially equivalent".

The Commission immediately sought an opinion from the Scientific Committee for Food which concluded, in September 2000, that the information provided by the Italian Authorities did not provide detailed scientific grounds for considering that the use of the GM foods in question endangered human health.

Co-existence

The cultivation of GM crops will logically have implications for the organisation of agricultural productions. Pollen flow between adjacent fields is a natural phenomenon and there will be some pollen flow from GM crops to conventional crops and vice versa. Because of the labelling requirements for GM food and feed, this may have economic implications for farmers who want to produce non-labelled food or feed products. Coexistence is about giving farmers the practical choice between conventional, organic and GM crop production in compliance with the legal obligations for labelling and purity standards.

On 5 March 2003, the Commission agreed that it should be up to the Member States to develop and implement management measures concerning co-existence, in accordance with the subsidiarity principle (see IP/03/314 ).

On July 2003 the Commission has also adopted a Commission recommendation ( 2003/556/EC ) on co-existence setting out guidelines for the development of national strategies and best practices to ensure co-existence (see IP/03/1096 ).

More information on EU policies and legislation on GMOs can be found at:

http://europa.eu.int/comm/food/food/biotechnology/gmfood/index_en.htm

ANNEX 1

GMO PRODUCTS

ProductNotifierDate of Commission Decision (1) / Member State Consent (2) [Table and further information]

DN: MEMO/04/17 Date: 28/01/2004