Abstract: Biotechnology-derived (BD) foods are those foods produced from gene modified organisms,which are developedby those processes whereby genes that are not endogenous to the organism are transferred to microorganisms,plants,oranimals employed in food production,or where the expression of existing genes is permanently modified,using the techniquesof eexisting genes is permanently modified,using the techniques of genetic engineering.It was briefly introduced the conceptof substantial equivalence for the assessment of safety for BD foods.Two key issues for the safety of BD foods,i.e.theinherent toxicity of the transgenes and their products,and unintended effects resulting from the insertion of the new geneticmaterial into host genome,were analyzed and discussed from the perspectives of both theoretic conjecture and reviews oftrial results.The status and challenges of current safety assessment methodologies for Bd foods were also smmarized.

Key words: biotechnology-derived foods, safety, transgene, evaluation