The European Food Safety Authority has issued a guidance document outlining specific data requirements and the methodology to be followed for risk assessment should applications for food or animal feed derived from genetically modified animals be submitted for market authorization in the European Union.

The guidance provides a risk assessment approach that compares GM animals and derived food and animal feed with their respective conventional counterparts. Important components of the risk assessment include molecular characterization, compositional analysis and assessment of toxicity, nutritional aspects and potential allergenicity.


The draft guidance document also suggests recommendations for post-market monitoring and surveillance of GM animals and derived food and feed. EFSA says the recommendations seek to identify potential unintended effects related to genetic modification that may arise after the product has been authorized for placement on the market, including the recommendation that PMM be required to determine possible long-term unexpected effects with low incidence. 

EFSA invites stakeholders and all interested parties to comment on its draft guidance through a public consultation available on EFSA's website until September 30. Following the public consultation, EFSA will incorporated suggestions into a revised guidance document to be adopted by EFSA panels at the end of 2011.