EFSA Press Statement, 12 April 2005
The European Food Safety Authority (EFSA) was informed on 23 March 2005 of the inadvertent release in the United States of a non-authorised genetically modified (GM) maize line called Bt10, and its unintended export as Bt11 for research purposes to Spain and France. According to Syngenta, the biotechnology company that has developed Bt10 and Bt11 maize, the two new proteins (Cry1Ab and PAT) expressed in Bt10 and Bt11 are identical. Bt11 maize is authorized in the European Union (EU) for use in food and feed following advice from the former EU Scientific Committees (SCP 2000 [see footnote 1 below], SCF 2002 [see footnote 2 below]). However, contrary to Bt11, Bt10 contains a gene (blaTEM) conferring resistance to the antibiotic ampicillin.
EFSA's Panel on Genetically Modified Foods (GMO Panel) is currently undertaking an assessment of an application [see footnote 3 below] for the use of Bt11 in cultivation. Upon being made aware of the inadvertent release of Bt10 maize, the GMO Panel immediately sought information from the applicant to confirm that the risk assessment of Bt11 maize would not be compromised by the unintended presence of Bt10 maize.
EFSA is working in close collaboration with the European Commission on issues related to the safety of Bt10 maize. In this respect, EFSA would like to underline the following points:
1. Opinion of the Scientific Committee on Plants on the submission for placing on the market of genetically modified insect resistant and glufosinate ammonium tolerant (Bt-11) maize for cultivation. Notified by Novartis Seeds SA Company (notification C/F/96/05-10). 30 November 2000. http://europe.eu.int/comm/food/fs/sc/scp/out86_gmo_en.html
2. Opinion of the Scientific Committee on Food on a request to place genetically modified sweet maize line Bt11 on the market (expressed on 17 April 2002 ). http://europe.eu.int/comm/food/fs/sc/scf/out129_en.pdf
3. EFSA-Q-2004-012, application under Directive 2001/18/EC
4. Opinion of the Scientific Panel on Genetically Modified Organisms on the use of antibiotic resistance genes as marker genes in genetically modified plants, The EFSA Journal (2004) 48, 1-18 http://www.efsa.eu.int/science/gmo/gmo_opinions/384_en.html
5. Opinion of the Scientific Panel on Genetically Modified Organisms on a request from the Commission related to the Austrian invoke of Article 23 of Directive 2001/18/EC, The EFSA Journal (2004) 78, 1-13. http://www.efsa.eu.int/science/gmo/gmo_opinions/507/opinion_gmo_safeguard_clauses_austria_en1.pdf