When substantial equivalence apart from certain defined differences is established, further safety assessment should focus on those defined differences. When substantial equivalence cannot be established, it does not necessarily mean that the food product is unsafe. Not all such products will necessarily require extensive safety testing. The objectives should be clear and care should be taken in experimental design. Human nutritional studies may be required, especially when the new food is intended to replace a significant part of the diet.
Food allergies afflict a small percentage, but significant number, of consumers.
Some of these consumers will experience life-threatening reactions upon exposure to foods to which they are allergic. Thus, a rational scientific approach to the assessment of the allergenicity of genetically modified organisms can and should be undertaken. The Consultation considered the possibility of horizontal gene transfer from genetically modified plants to be vanishingly small. Thus, data on gene transfer is only necessary when the nature of the marker gene is such that, if transfer were to occur, it would give rise to a human health concern. In assessing any such health concerns, the human and animal use of the antibiotic and the prevalence of resistance to the same antibiotic in the gastrointestinal microflora should be considered.