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In June 2013 the European Commission launched a call for proposals on a two-year carcinogenicity rat feeding study with maize NK603 (KBBE.2013.3.5-03). In this call the Commission referred to:

-  The EU legal framework on GMOs ensures that genetically modified (GM) food and feed are when placed on the market safe as regards human and animal health and the environment. The European Commission has very recently adopted a Regulation concerning applications for the authorisation of GM food and feed, requesting applicants to carry out an obligatory 90-day feeding study with whole food/feed for each submitted GMO dossier (Implementing Regulation No 503/213). Depending on the outcome of previous studies, a two-year carcinogenicity study with rats may also be requested by the European Food Safety Authority (EFSA) on a case-by-case basis.

-  A request to EFSA to assist the Commission to provide supplementary guidance on key elements to consider for a 2 year carcinogenicity trial in rats with whole food/feed.

 

In this context, and to address possible concerns, including those raised recently by a study on "Long-term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize" the European Commisson asked the following issues related to two-year feeding trials need to be addressed in a stepwise approach:
1. Execution of at least one rat feeding trial(s) with GM maize NK 603 (and additional GMOs where scientifically justified) applying the EFSA protocol. Participating institutions should strictly comply with all applicable international standards and norms concerning feeding trials in close collaboration with EFSA.
2. Analysing, reporting and providing recommendations, in particular as to the scientific justification and added value of such long-term feeding trials with regard to GMO risk assessment.

 

The proposals under this topic were required to:

-  Strictly adhere to the principles of scientific excellence, independence and transparency.
-  Feeding stuff used in the trials should be produced following the principles of good agricultural practice.

-  Dedicated communication programmes, targeting scientists, policy makers and the general public will be developed as part of the project. These programmes should also consider taking into account the concerns and opinions of the wider stakeholder community, e.g. relevant risk assessment and regulatory bodies.

 

The European Coimmission expects that the results of the project will enable risk managers drawing conclusions with regard to framework of the currently applicable GM food/feed risk assessment requirements and procedures in the EU.