This guidance document addresses the assessment of the safety of GM
animal-derived food and feed for humans and animals, placed on the
market within the framework of Regulation (EC) No 1829/20035. It
also addresses the health and welfare assessment of the GM animals.
Animals that were taken into consideration include all husbandry
animals, and fish, as well as crustaceans and molluscs. Insects and
other invertebrates were not taken into account, with the exception
of honey bees that are used in agricultural practice. This guidance
does not address issues related to risk management (traceability,
labelling, coexistence). Ethical and socio-economic issues are also
outside the scope of the document.