Call for comments on GM animal guidelines

The European Food Safety Authority (EFSA) has published guidelines for the risk assessment to be carried before marketing approval is granted for any food or feed products derived from genetically engineered animals, and launched a public consultation on its proposals.

As yet, no applications for approval of food and feed derived from GM animals have been submitted in the EU, but the technology has advanced rapidly in recent years and regulators outside the EU are currently evaluating the safety of GM animal products. For example, in the US the Food and Drug Administration (FDA) is currently considering an application to market a GM salmon.

EFSA began to develop its guidelines, which integrate the risk assessment of food and feed from GM animals with related aspects of animal health and welfare, in 2007. A separate EFSA guidance document, due to be launched for public consultation in 2012, will address the environmental risk assessment of GM animals.

The risk assessment of GM animals proposed in the draft guidance follows a comparative approach that is similar to that required by EFSA for the risk assessment of GM crop plants.  Components of the assessment include molecular characterisation, analysis of food composition - to test if food and feed from GM animals is nutritionally equivalent to conventional products - , toxicity testing, and potential allergenicity.

The draft guidance also highlights the need for extensive comparative analysis of the characteristics and traits of GM animals, including physiological parameters, with those of their conventional counterparts. It also proposes that health and welfare should be assessed at all stages of development of a GM animal.

In addition, there are recommendations for post-market monitoring and surveillance of GM animals, food and feed, to identify any potential unintended effects of the genetic modification arising after the product has been authorised for placement on the market.

Comments are invited via the EFSA website until 30 September 2011, with a final version of the guidelines due to be published before the end of the year.

http://www.efsa.europa.eu