Commission Press Release (IP/04/663), 19 May 2004
The European Commission authorised today the placing on the market of sweet corn from genetically modified maize line Bt11. This decision is valid for 10 years and addressed to the company Syngenta. Any imports of the canned vegetable will have to show clearly on the labelling that the corn has been harvested from a genetically modified plant. Grain from the GM maize line Bt11 has been authorised for import into Europe since 1998 and is widely used in the EU in feed (Authorisation granted on 22 April 1998 in accordance with Council Directive 90/220/EC) and in derived food products (Notification of 6 February 1998 pursuant to Article 5 (substantial equivalence) of Regulation (EC) 258/97), e.g. maize oil, maize flour, sugar and syrup, snack foods, baked foods, fried foods, confectionary and soft drinks. The authorisation today covers the specific use for imports of canned or fresh sweet corn (maize). The labelling will have to show clearly that the corn is a GMO in line with the new EU legislation. An authorisation for cultivation for Bt11 maize is pending and has not yet been granted.
David Byrne, Commissioner for Health and Consumer Protection, said: "GM sweet corn has been subject to the most rigorous pre-marketing assessment in the world. It has been scientifically assessed as being as safe as any conventional maize. Food safety is therefore not an issue, it is a question of consumer choice. The new EU rules on GMOs require clear labelling and traceability. Labelling provides consumers with the information they need to make up their own mind. They are therefore free to choose what they want to buy. The Commission is acting responsibly based on stringent and clear legislation."
The sweet corn from the GM maize Bt11 will be labelled in accordance with new laws agreed by Council and European Parliament over the past years and in force since 18 April 2004 (Regulation (EC) No 1829/2003 on GM food and feed). Bt 11 sweet corn has undergone thorough safety assessment for any adverse impact on public health on the basis of international guidelines. It has been assigned a unique identifier to allow traceability and will be entered in the Community Register of genetically modified food and feed. The authorisation is valid for 10 years. The Commission took the decision as required in cases where the Council has neither adopted the Commission proposal, nor indicated its opposition to it.
The EU has put in place a clear, transparent and stringent system to regulate genetically modified food, feed and plants over the past four years. The legislation ensures that GMOs authorised in the EU are safe for human consumption and for release into the environment. Clear labelling rules allow farmers to choose what to plant and consumers to choose what to buy. It is therefore only logical that this safe system is applied in practice. Each authorisation is granted on its own merits and requests for authorisations which do not fulfil all criteria were and will be rejected. The decision enters into force the day when it is notified to the applicant. The decision enters into force the day when it is notified to the applicant.
For further information, see http://europa.eu.int/comm/food/food/biotechnology/index_en.htm and MEMO/04/102 (Questions and Answers on the regulation of GMOs in the EU)
Additional Notes:
On 11 February 1999, Novartis (in the meantime: Syngenta), submitted a request to the competent authorities of the Netherlands for placing sweet maize from genetically modified maize line Bt11 on the market as a novel food or as a novel food ingredient. The corn has been harvested from a plant genetically modified to produce Bt toxin, which is similar to that produced by bacteria and widely used as a natural insecticide for many years.
The Netherlands' competent food assessment body came to the conclusion that Bt11 sweet maize is as safe as conventional sweet maize as did the EU Scientific Committee on Food. The EU scientific opinion focused on the issues raised by Member States' authorities (e.g molecular characterisation and as well as toxicity studies as raised in the opinion of the "Agence française de sécurité sanitaire des aliments" (AFSSA).
The methodology used for the safety assessment of Bt11 was also in line with the recent guidelines prepared by the EU Scientific Steering Committee concerning the assessment of GMOs, GM food and GM feed and with the Codex Principles and Guidelines on Foods Derived from Biotechnology.
The Joint Research Centre (JRC) of the European Commission, in collaboration with the European Network of GMO Laboratories (ENGL), has carried out a full validation study (ring-trial) following internationally accepted guidelines to test the performance of a quantitative event-specific method to detect and quantify the Bt11 transformation event in sweet maize. The method validated had been developed by the National Veterinary Institute of Norway and INRA, France. Both the method and the results of the validation have been made publicly available.
Sweet maize from genetically modified maize line Bt11 and food containing sweet maize from genetically modified maize line Bt11 as an ingredient shall be labelled in accordance with the provisions of Regulation (EC) No 1829/2003 and shall be subject to the traceability requirements laid down in Regulation (EC) No 1830/2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC.
Information on the identification of sweet maize from genetically modified maize line Bt11, including the validated detection method and the reference material, contained in the annex, shall be retrievable from the Register to be established by the Commission in accordance with Article 28 of Regulation (EC) No 1829/2003.
Genetically modified maize Bt11 has been notified to the Biosafety Clearing-House, pursuant to Articles 11(1) and 20(3)(c) of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity.
The Standing Committee on the Food Chain and Animal Health has not given an opinion. The Commission has therefore submitted a proposal to the Council on 4 February 2004 pursuant to Article 13, paragraph 4 b) of Regulation (EC) No 258/97 and in accordance with Article 5, paragraph 4 of the Council Decision 1999/468/EC, the Council being required to act within 3 months.
The proposal was considered by the Agriculture Council on 26 April 2004. At that meeting Ireland, Italy, the Netherlands, Finland, Sweden and the UK voted in favour. Denmark, Greece, France, Luxembourg, Austria and Portugal voted against. Belgium, Germany and Spain abstained. Since the Council had not acted within the required time limit, the Decision must now to be adopted by the Commission.
Under the rules of Regulation 1830/2003 on labelling and traceability, business operators must transmit and retain information about products that contain or are produced from GMOs at each stage of the placing on the market. Traceability provides the means to trace products containing or produced from GMOs through the production and distribution chains.
Regulation 1829/2003 on GM food and feed provides for comprehensive information by labelling all food and feed containing, consisting of or produced from a GMO. All food, including soya or maize oil produced from GM soya and maize, and food ingredients, such as biscuits with maize oil produced from GM maize must be labelled. The label has to indicate "This product contains genetically modified organisms" or "produced from genetically modified (name of organism)".