The document, which focuses on GM fish, insects, mammals and birds, outlines the specific data requirements and methodology for the environmental risk assessment of GM animals should applications be submitted for market authorisation in the European Union in the future. 
The risk assessment is based on a comparative approach between GM and non-GM animals. The document includes the interactions of the GM animal with target and non-target organisms; environmental impacts of the techniques used to rear or keep the GM animal; and the impact of the GM animal on human and animal health, for example to assess potential risks to farmers, other workers or the general public that may come into contact with GM animals. The draft guidance requires that these and other potential risks are assessed using a systematic, step-by-step approach. Recommendations are also made for the post-market environmental monitoring of GM animals.
According to the Guidance, at present, no applications for market approval of GM animals have been submitted in the EU. However, some non-EU countries regulators are already evaluating GM animals, both in terms of food/feed and environmental safety. The European Commission aims to be prepared for future applications for introduction on the EU market of food and feed derived from GM animals 
All stakeholders and interested parties are invited to provide their comments on the guidance through an online public consultation that runs until 31 August 2012.
The proposed Guidance, a loophole for the introduction of animal GM food?
GM animals reared as food are not welcome by the consumer. The European Union should maintain the GM veto instead of preparing for an approval of such food and feed. The recent Guidance is a loophole for the introduction of animal GM food in the EU.
 Draft guidance on environmental risk assessment of GM animals: EFSA launches public consultation. European Food Safety Authority. 21 Jun 2012.
 Guidance on the environmental risk assessment of genetically modified animals