Annotated Bibliography Entry

 

Reference: FAO/WHO 2001a.
Title: Evaluation of Allergenicity of Genetically Modified Foods 
Authors: Report of a Joint FAO/WHO Expert Consultation on Allergenicity of Foods Derived from Biotechnology, 22 –25 January 2001
Publisher: Food and Agriculture Organization of the United Nations (FAO), Rome, Italy
Publication details: 2001. 27p.

Summary
          Conclusions
          Recommendations
Table of Contents

 

Back to FAO/WHO page

 

Summary

A Joint FAO/WHO Expert Consultation on Foods Derived from Biotechnology was held at the Food and Agriculture Organization of the United Nations (FAO) in Rome from 22 to 25 January 2001. The purpose of the consultation was to establish a reliable methodology to assess the allergenicity of new foods produced by the recombinant DNA technique. Applying appropriate risk management measures could reduce the risk of allergenicity of genetically modified foods.

Conclusions

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

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.

Back to top

 

Recommendations

1. The Consultation recommends that the FAO/WHO 2001 decision tree be used for determining allergenicity of foods derived from biotechnology.

2. The Consultation recommends that FAO and WHO should endeavour to update the decision tree as and when required.

3. The identification of food allergens and the characteristics of these allergens that define their immunogenicity are encouraged.

4. Protein and gene databases required for the assessment of allergenicity of foods derived from biotechnology should be frequently updated and maintained.

5. Further research is needed on the development and validation of suitable animal models and procedures for the assessment of allergenicity of foods derived from biotechnology.

6. The Consultation recommends that the possibility of implementing post-marketing surveillance should be further studied.

7. The Consultation recommends that FAO and WHO provide technical support to member countries to strengthen their capacity and infrastructure to enable those countries to undertake the evaluation of the allergenicity of foods derived from biotechnology.

8. The Consultation recommends to FAO and WHO the establishment of a coordination network to promote and strengthen the interaction between experts to improve standard operating procedures, good laboratory practices and good clinical practice to facilitate the evaluation of the allergenicity of foods derived from biotechnology.

Back to top

FAO/WHO 2001a. Evaluation of Allergenicity of Genetically Modified Foods

Contents

1. Introduction 1

2. Background 1

3. Scope 2

4. Overview of Food Allergies 3

5. Decision Tree Approach to the Evaluation of the Allergenicity of Genetically Modified Foods 5
5.1. Introduction 5
5.2. The FAO/WHO 2001 decision tree 6
5.3. Food containing a gene derived from a source known to be allergenic 7
5.4. Food containing a gene derived from a source not known to be allergenic 8
5.5. Post marketing surveillance 9
5.6. Other criteria that were considered 9

6. Standardization of Methodologies 10
6.1. Sequence homology as derived from allergen databases 10
6.2. Specific serum screening 11
6.3. Targeted serum screening 12
6.4. Pepsin resistance 12
6.5. Animal models 13

7. Conclusions 14

8. Recommendations 16

9. List of Abbreviations 17

10. References 18

Annex 1: List of Participants 20
Experts 20
Authors of working papers 21
Observers from international organizations 22
Chairman of the Codex ad hoc Task Force on Foods Derived from Biotechnology 22
Chairperson of the Codex Committee on Food Labelling 23
FAO/WHO Secreta 23

Annex 2: List of Documents 24

Annex 3: FAO/WHO 2000 Decision Tree 25

Annex 4: FAO/WHO 2001 Decision Tree 26          

Back to top

Web site: http://www.who.int/fsf/Gmfood/index.htm