EFSA issues opinion on Genetically Modified Bt11 Maize

The European Food Safety Authority’s (EFSA) Scientific Panel on Genetically Modified Organisms (GMO Panel) has published today an opinion on Bt11 maize relating to its placing on the market for the purpose of cultivation, import, processing and use as any other maize. BT11 maize has already been authorized for food and feed use following evaluations carried out by the former Scientific Committees of the European Commission. The Panel concluded that the placing of Bt11 maize on the market will not cause an adverse effect on human or animal health or the environment in the context of its proposed use. No data have emerged to indicate that Bt11 maize is less safe than its conventional counterpart. Following the inadvertent release of the non-authorised genetically modified (GM) Bt10 maize line and its unintended export for research purposes to Spain and France as Bt11, the GMO Panel requested that the applicant confirm that the Bt11 maize used for the safety studies was not contaminated with Bt10. Only after having received that confirmation from the applicant did the GMO Panel continue its risk assessment and adopt the opinion.

Bt11 maize has been genetically modified to provide protection against specific lepidopteran pests, such as the European corn borer. It also contains a gene providing tolerance to the herbicide glufosinate.

According to the procedure laid down in legislation, the initial evaluation was carried out by the Competent Authorities of a Member State, in this case France, and was subsequently reviewed by all other Member States. As questions were raised by several Member States, the European Commission (EC) asked EFSA for an international evaluation and to deliver an opinion.

The GMO Panel considered the application as well as additional information provided by the applicant and comments provided by Member States. The scientific assessment also included the examination of the genetic material (ie DNA) inserted into Bt11 maize and of the newly expressed proteins produced by the GM plant relative both to allergenicity and safety.

In the context of the import from the United States of maize contaminated with a non-authorised GM maize line Bt10 (Commission Decision 2005/317/EC of 18 April 2005 and the related EFSA statement), EFSA asked the applicant for additional information. The Panel explicitly wanted to know if the Bt11 maize which was used for the safety studies had been contaminated with Bt10 maize materials. As the applicant confirmed that only Bt 11 maize – not contaminated by Bt 10 maize – has been used for these studies; the Panel could finalise its assessment on Bt11 and adopt the opinion.

The Panel concluded that Bt11 maize will have a similar impact on the environment compared to the non-GM line. The only possible adverse effect identified by the Panel might be a resistance to the newly introduced protein in the corn borer exposed to Bt11 maize following cultivation for several years. The Panel’s experts evaluated and agreed on the monitoring plan provided by the applicant. In order to minimise the exposure of non-target insects and to delay the development of resistance to the newly inserted protein in target insects, the Panel recommended that the cultivation should be accompanied by an appropriate risk management.

Finally, the GMO Panel concluded that there is no evidence to indicate that the placing of Bt11 maize and its derived products on the market is likely to cause adverse effects on human or animal health or on the environment in the context of its proposed use.

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