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Draft Recommendations for the Labelling of Foods that can cause Hypersensitivity (Draft Amendment to the General Standard for the Labelling of Prepackaged Foods) (Agenda Item 6)[5]

22. The Committee recalled that the Commission had adopted at Step 5 the Draft Amendment to the General Standard, including a list of foods and ingredients that can cause hypersensitivity, based on the recommendations of the FAO Technical Consultation on Food Allergies. The Commission also considered the request of the Committee concerning the need for further scientific advice on the inclusion on substances in the list and noted that the WHO Secretary of JECFA had agreed in principle that it would be possible to address this issue in the framework of JECFA.

23. Dr. Steve Taylor (University of Nebraska, USA), FAO Consultant, presented a paper which had been prepared in order to facilitate the discussion of the Committee on hypersensitivity and the identification of the issues requiring further work. Dr. Taylor recalled that a clear distinction should be established between allergies, which affected the immune system, and food intolerances, that the establishment of levels of tolerance was a difficult question and still the subject of controversy. He pointed out that as the information available on the prevalence of allergies was still incomplete, it was necessary to collect more information and ensure the participation of specialists and institutions working in this area. He recalled that the Consultation had relied essentially on the criteria of comparative prevalence and evidence of severe reactions to establish the current list of "common" foods that can cause hypersensitivity. The Committee expressed its appreciation to Dr. Taylor for this interesting document, which also included an analysis of each substance included in the list.

24. The Representative of WHO informed the Committee that JECFA was prepared to evaluate the potential hypersensitivity of specific substances at the request of the Committee and that for the development of more generic advice consideration might be given to the possibility of convening a consultation. He also asked for clarification of the request made at the last session of the Committee "to determine the foods to be included in the list and the criteria to do so", especially whether reference should be made to food groups or individual foods, and if consideration should be given only to allergic reactions or also to intolerance.

25. The Committee confirmed that the title of the amendment referred to hypersensitivity in order to include both food allergies and intolerances, in view of their importance from a public health point of view. It was also recalled that the list included both food groups and individual foods, on the basis of the recommendations of the Consultation.

26. The Secretariat indicated that JECFA was prepared to consider the question of hypersensitivity at its 53rd Session (June 1999), provided the Committee clearly identified the issues requiring scientific advice and prioritized them. The Committee was informed that JECFA was in the process of identifying individuals with the required expertise in order to consider scientific evidence on hypersensitivity in the framework of JECFA.

27. The Committee expressed its appreciation for the offer of JECFA to consider further evidence on foods that may cause hypersensitivity and therefore providing a scientific basis and criteria for the inclusion of foods on the list. The Committee noted that this would not delay the finalization of the current amendment under consideration and that the list could be further considered in the framework of JECFA if needed.

28. Several delegations stressed that the current list had been established on the basis of the recommendations of the Consultation, which had also defined criteria. The Committee should therefore finalize the list as currently drafted, as it was necessary to address an important public health issue. The Delegation of Norway pointed out that there was a link between the list and the amendment of the "25% rule" as if many exemptions existed to full ingredient listing, it would be necessary to include more substances in the list.

29. While there was consensus on the necessity to finalize the list, the Committee noted that it would need to be updated and some of its entries might need to be clarified, as follows. Some delegations pointed out that certain current classes of food, such as "milk and milk products" or "fish and fish products" might be too broad and include products which were not actually causing hypersensitivity. For example, in the case of "soybean, peanuts and their products" the protein fraction was allergenic but there was no evidence that refined or heat treated oil caused such reactions; the definition of foods or food groups would therefore need to be reviewed in this perspective. It was also proposed by some delegations that JECFA consider the limit levels of substances causing hypersensitivity, the question of carry-over in composite ingredients and the question of criteria for the inclusion of substances in the list.

30. The Committee had an exchange of views on the proposal to amend the "25% rule" under which the individual ingredients of compound ingredients present at less than 25% in any food did not need to be labelled, in relation to consumer information on hypersensitivity. Some delegations expressed the view that the reduction to 5% would offer an improvement for affected consumers, although it did not completely solve their problems.

31. Several delegations and the Observer from the EC however stressed that there was no scientific basis for this reduction as reactions might be caused by smaller amounts of allergenic substances. Moreover, the issue of the 25% rule should not be linked to hypersensitivity and required a larger debate in the overall perspective of consumer information through adequate labelling. The Committee, recognizing that there was no consensus at this stage and that further discussion was needed on this important issue, agreed to return this section to Step 6 for further comments and consideration at its next session.

Status of the Draft Recommendations for the Labelling of Foods that can Cause Hypersensitivity (Draft Amendment to the General Standard for the Labelling of Prepackaged Foods)

32. The Committee agreed to forward the Draft Amendment on the list of ingredients which should always be declared to Step 8 for adoption by the 23rd Session of the Commission (see Appendix III- section 4.2.1.4), and to return Section 4.2.1.3 (on the 25% rule) to Step 6 for additional comments (see Appendix VI).


[5] CX/FL 98/5 (comments from Australia, Denmark, Singapore, ), CX/FL 98/5-Add.1 (Association of European Coeliac Societies-AOECS), CRD 2 (Canada, France, Germany, Norway, Confederation of the Food and Drink industries of the EU-CIAA, European Dairy Association-EDA, International Dairy Federation-IDF), CRD 20 (India), CRD 16 (Discussion paper by Dr. S. Taylor)

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