Food/feed and environmental risk assessment of insect-resistant and herbicide-tolerant genetically modified maize Bt11 x GA21 in the European Union under Regulation (EC) No 1829/2003 (EFSA/GMO/UK/2007/49). Opinion of the Panel on Genetically Modified Organisms of the Norwegian Scientific Committee for Food Safety

In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Environment Agency (former Norwegian Directorate for Nature Management) has requested the Norwegian Food Safety Authority (NFSA) to give final opinions on all genetically modified organisms (GMOs) and products containing or consisting of GMOs that are authorized in the European Union under Directive 2001/18/EC or Regulation 1829/2003/EC within the Authority’s sectoral responsibility. The Norwegian Food Safety Authority has therefore, by letter dated 13 February 2013 (ref. 2012/150202), requested the Norwegian Scientific Committee for Food Safety (VKM) to carry out scientific risk assessments of 39 GMOs and products containing or consisting of GMOs that are authorized in the European Union. The request covers scope(s) relevant to the Gene Technology Act. The request does not cover GMOs that VKM already has conducted its final risk assessments on. However, the Agency requests VKM to consider whether updates or other changes to earlier submitted assessments are necessary. The insect-resistant and herbicide-tolerant genetically modified maize Bt11 x GA21 (Unique Identifier SYN-BTØ11-1 x MON ØØØ21-9 ) from Syngenta Seeds is approved under Regulation (EC) No 1829/2003 for food and feed uses, import and processing since 28 July 2010 (Commission Decision 2010/4263/EC). Genetically modified maize Bt11 x GA21 has previously been risk assessed by the VKM Panel on Genetically Modified Organisms (GMO), commissioned by the Norwegian Food Safety Authority and the Norwegian Environment Agency related to the EFSAs public hearing of the application EFSA/GMO/UK/2007/49 in 2008 (VKM 2009a). In addition, Bt11 and GA21 has been evaluated by the VKM GMO Panel as single events and as a component of several stacked GM maize events (VKM 2005a,b, 2007, 2008, 2009b,c,d, 2010, 2012a,b).