1. The Consultation agreed that the safety assessment of foods derived from biotechnology requires an integrated and stepwise, case-by-case approach, and that this method also be applied to the evaluation of the allergenicity of food derived from biotechnology.
2. The Consultation emphasized that all foods derived from biotechnology must be assessed for allergenic potential.
3. The original decision tree from the FAO/WHO 2000 Consultation served as a basis for this consultation. The Consultation concurred that this decision tree be modified as a consequence of more recent research and which is reflected in the FAO/WHO 2001 decision tree.
4. When the expressed protein is derived from a source with known allergenicity, the FAO/WHO 2001 decision tree proposes that the initial investigation be analysis of sequence homology to known allergens in the source. If this is negative, the next step will be investigations on possible IgE binding using immunoassays and may also include investigations in vivo in patients allergic to the source food.
5. When the expressed protein is derived from a source with no known allergenicity, the FAO/WHO 2001 decision tree proposes that the initial investigation would also be analysis of sequence homology to known allergens from food and environmental sources. If positive matches are found with known allergens, then the protein is considered likely allergenic. If no significant sequence homology is identified, then targeted serum screening is conducted with serum samples that contain high levels of IgE antibodies with a specificity that is broadly related to the gene source. If the targeted serum screening is positive, then the protein is considered likely allergenic. If the targeted serum screening is negative, then pepsin resistance of the expressed protein and the immunogenicity of the expressed protein in suitable animal models are to be assessed to determine the likelihood that the protein will be allergenic.
6. The Consultation agreed that the FAO/WHO 2001 decision tree is not applicable to the evaluation of foods where hypo-allergenicity has been induced by down-regulation of genes.
7. The Consultation was of the opinion that an evaluation of proteins for sequence homology with sufficient sensitivity and specificity to detect potential cross-reactivity is an important part of the process for the assessment of the allergenicity of the expressed protein.
8. The Consultation agreed that further studies would be required to determine the amount of allergen that sensitises and elicits allergic events.
9. The Consultation recognized the need to constantly update allergen databases.
10. The Consultation concluded that animal models have not been evaluated for all food allergens but there is sufficient scientific evidence that using these models will contribute valuable information regarding the allergenicity of foods derived from biotechnology.
11. The Consultation agreed that pepsin susceptibility is a relevant parameter for the identification of potential allergens and that the protocol described is not intended to mimic the physiologic conditions of gastric digestion.
12. The use of human in vivo methods to evaluate the allergenicity of foods derived from biotechnology may in many circumstances raise ethical issues and their use will have to be considered on a case-by- case basis.
13. Post-market surveillance is a valuable tool in the monitoring of adverse effects and long-term sequelae of foods derived from biotechnology and the Consultation recognized that the feasibility of certain aspects of its implementation would need further investigation.
14. The Consultation accepted that the FAO/WHO 2001 decision tree and its accompanying clarifying text will require modification in the future as a result of the rapidly expanding scientific base in the allergy and biotechnology fields but that this decision tree is appropriate based on our present knowledge.