31. The Committee recalled that the Twenty-second Session of the CAC adopted the Proposed Draft Standard for Gluten-Free Foods at Step 5 while recommending that comments on methods of analysis and on amounts of gluten in gluten free foods should be taken into account when finalizing the standard. The Committee noted that without an appropriate method of analysis it was not scientifically justified to advance the Draft further.
32. The Delegation of Sweden introduced its recent study on gluten determination in foods by an enzyme immunoassay using a monoclonal antibody against omega-gliadin (CRD 33), noting that the detection limit of the method (AOAC 991.19) was about 20-40 ppm and the repeatability was acceptable. Some Delegations pointed out that the method presented, raised some technical concerns: it was performed only on wheat and due to this uncertainty exists as regards its applicability to other cereals. It measured only omega-gliadin and other gliadins should also be taken into account. There were also concerns about variability of results using this method. The need of further improvement was raised. The Spanish Delegation, referring to its written comments (CRD 21), expressed concerns about establishing limits without having a method to detect all prolamins.
33. The Committee noted that in some cases a proprietary method was the most specific way to detect an analyte, such as in the case of gluten detection. Since Codex had not endorsed these techniques as methods of analysis of Codex, the CCMAS should consider this problem.
34. Several delegations suggested that the Committee should ask FAO and WHO to convene an Expert Consultation to address the issue of the level and the method of analysis. Other delegations proposed to consult the CCMAS on this issue. The Secretariat informed the Committee that on the request of the CCFL, JECFA was prepared to consider the question of hypersensitivity at its 53rd Session (June 1999) and the intolerance to gluten might be discussed in this context. The Secretariat recalled that the role of the CCMAS was to endorse methods of analysis proposed by specialized Committees and the CCNFSDU needed to specify the method.
35. Spain presented its position about fixing a level at 200 ppm indicating that in the interest of protecting health, consumers’ safety and their legitimate economic concerns is unwarranted to classify foods with a gluten content of 200 ppm as gluten free. Several delegations and the Observer from the AAC proposed that the discussion of this draft should be adjourned until a reliable method of analysis became available. Other delegations were in favour of continuing work on it in order to meet the urgent need of patients suffering from coeliac disease and proposed to advance a proposal for a single level at 200 ppm to Step 8. A new preamble would suggest revision of a standard when improved analytical methodology become available. Taking into account the absence of an appropriate and accurate method of analysis, it was proposed to maintain the gluten free level at 200 ppm for all foods and to include a new preamble suggesting the future amendment of the standard when new scientific evidence became available.
36. Several delegations pointed out that the current definition proposing two levels of “gluten-free” foods was confusing and misleading for the consumer and that the single level should be set. However, other delegations and the Observer from AOECS stressed the need for two levels with regard to the naturally gluten free foods and the products which had been rendered gluten free. The Committee noted that the proposed term “gluten-free” might mislead the consumer and recognized that the term “low or reduced in gluten” should be considered.
37. The Observer from AOECS, supported by some delegations, expressed the view that the level of 200 ppm for all gluten-free foods was too high to protect coeliacs and the gluten level should refer only to the end product for better consumer protection.
38. The Delegation of Finland proposed to remove oats from the list as recent clinical scientific research showed that oats could be tolerated by coeliac disease patients as it allows to provide dietary fibres for coeliacs. The Observer from AOECS, supported by some delegations, stressed that the square bracket on oats should be removed as oats might have negative impact on the health of coeliacs and that the medical experts had not reached consensus on this issue.
39. The Committee recognized that the development of reliable method of analysis for gluten was the key point in this discussion and that the development of the method should be encouraged by all means.
STATUS OF THE DRAFT REVISED STANDARD FOR GLUTEN-FREE FOODS
40. The Committee agreed to leave the text of the draft as it was in CX/NFSDU 98/4 and to return it to Step 6 for further consideration. The Committee also agreed that the question regarding the proprietary techniques should be raised to the CCMAS as a general matter.
