Food, Feed and Environmental Risk Assessment of Glufosinatetolerant Genetically Modified Oilseed Rape T45 for Food and Feed Uses, Import and Processing Under Regulation (EC) No 1829/2003 (Application EFSA/GMO/UK/2005/25)

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 assignment includes a scientific risk assessment of oilseed rape T45 from Bayer Crop Science (Unique Identfier ACS-BNØØ8-2) for food and feed uses, import and processing. Food additives produced from T45 oilseed rape were notified in the EU as existing food additives within the meaning of Article 8 (1) (b) of Regulation 1829/2003, authorized under Directive 89/10/EEC (Community Register 2005). Feed materials produced from T45 were also notified as existing feed products containing, consisting of or produced from T45 according to Articles 8 and 20 of Regulation (EC) No 1829/2003 in 2003. A notification for placing on the market of T45 according to the Directive 2001/18/EC was submitted in March 2004 (C/GB/04/M5/4), covering import and processing of T45 into food and feed. The application was further transferred into Regulation (EC) No 1829/2003 in November 2005 (EFSA/GMO/UK/2005/25). An application for renewal of authorisation for continued marketing of food additives and feed materials produced from T45 oilseed rape was submitted under Regulation (EC) No 1829/2003 in 2007 (EFSA/GMO/RX/T45). The EFSA GMO Panel performed one single comprehensive risk assessment for all intended uses of genetically modified oilseed rape T45 and issued a comprehensive scientific opinion for both applications submitted under Regulation (EC) No 1829/2003. The scientific opinion was published in January 30 2008 (EFSA 2008