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This article comes to us from Frederik Willem Janssen, Zutphen, The Netherlands, e-mail: teizjanz@PI.NET. If you have specific questions about it, please contact him directly. The Codex Alimentarius provides the gluten-free standard for European food manufacturers. This article will deal with foods that are officially labeled as gluten free. In the European Union there is a directive on foods for special dietary uses (89/398/EEG), and this directive is the basis for all national legislation in the countries of the European Union. Though the directive deals with gluten-free foods there is no assigned limiting level of gluten for gluten-free food yet, so it is up to the national regulatory bodies of the member states to set their own level. There is however, an international body handling these matters: Codex Alimentarius. Codex Alimentarius is a Geneva-based International organization jointly run by the World Health Organization and FAO , and its aim is to establish worldwide standards for foods in the broadest sense. Food legislation in many countries is based on Codex Standards, although it is not mandatory to implement them in all cases. There is a Codex committee producing standards on food labeling, on hygiene, on composition etc., etc. There is a committee on Foods for Special Dietary Uses (FSDU) and ... there is a Standard on gluten-free Food! The oldest Standard dates from 1981, and it says that foods may be labeled as gluten-free only if the nitrogen content of the protein derived from wheat is less than 50 mg N/100 gm on dry matter, which may be equivalent to about 20-30 mg gliadin in wheat starch. The calculation is quite complicated by the fact that most of the protein in wheat starch is starch granule protein and not gluten. There is a new Codex Standard in preparation, and a proposal to set the limiting level of gluten to 200-mg gluten/kg (20-mg/100 g) gluten-free food on dry matter. If we assume that half of the gluten is gliadin, this equals 10-mg gliadin/100 g o.d.m., so the level has gone down by a factor two in comparison to the old standard. If accepted, the new standard will be valid for end products and not for raw materials. In my previous posting I already mentioned that there are comments on the proposal from Sweden ( One of the reasons why the level in the Standard has not yet been effected (the proposal has been dealt with already two years ago) is that there is no validated analytical method (ring-tested) available to check compliance to this level. Though it might look rather simple to analyze gluten, it is generally done with an Enzyme Linked Immuno Sorbent Assay - ELISA, it is in fact very tricky, and especially as the term gluten is very imprecise. Gluten is a mixture of gliadin and glutenin - each composed of several sub-fractions - and its composition with respect to sub-fractions is cultivar dependent. There is also an effect on the recovery caused by the heat processing of the food, and although excellent work has been done by Dr Skerrit of CSIRO in Australia to circumvent this problem (he designed a method based on omega gliadin, which is the most heat stable gliadin fraction), there is still a feeling that this method still needs to be improved. Remember that agencies charged with enforcement of food laws must be able to bring suits against producers of non-complying gluten-free foods. So analytical methods need to be robust and accurate. Codex Alimentarius bases its standard on scientific facts, and thats why there is no zero tolerance. There is simply no scientific evidence that this is required (at least there is no concordant view among scientists about the maximum tolerable gluten intake), and it is reasoned that any unduly reduction in the permissive level will reduce the number of gluten-free food available unnecessary. Though Codex Alimentarius has been criticized in the past for being a food-producer driven body it is still the only world-wide forum for food standards, and its role within the framework of the GATT and WTO makes its work of sterling importance in settling trade disputes. In 1993 the National Food Alliance (UK NGO) produced a report titled Cracking the Codex. This report stated that even though the voting in Codex is nationwide, and quite often by consensus, there is a large impact of the producer lobby, especially in the preliminary stages of decision making. Even though there is no implemented standard in national legislation many countries will stick to the Codex Standard. The conclusion is that in many countries food labeled as gluten free will almost definitely contain gluten. As the regulatory agencies of most countries will not press charges against producers of gluten-free foods if the level is below the Codex Standard limit (though, as said, some countries may have lower regulatory levels). Codex Standards still do not have the status of national laws.

This 11/29/98 update comes to us from Frederik Willem Janssen, The Netherlands: fwjanssen@WXS.NL About a week ago I promised to post info about agenda item 4 (Gluten Free Food) as dealt with at the meeting of Codex Alimentarius NFSDU (Nutrition and Food for Special Dietary Uses) which was held in September in Berlin Germany. As usual this meeting starts on Monday and continues till Wednesday, Thursday is a day off (time for the secretariat to draw resolutions) and on Friday these draft resolutions are discussed. Unfortunately I wasnt able to stay till Friday. However, the resolutions as discussed on Friday were handed to me afterwards however and I pass them with some corrective changes accepted during that day. For those of you who have no interest in reading this clerical stuff I summarize: The proposed limits (20) for food gluten-free by nature and 200 for food rendered gluten-free will stay between square brackets (so no decision has been made). The same holds for oats, awaiting further toxicological data about its celiac-toxicity it should be considered as toxic. The main obstacle for finalizing the standard is the lack of an appropriate method of analysis. Progress has been made but still not to that extent that enforcing agencies can be satisfied. Maybe we will see some progress in the next 2 years! Proposed Revisions: Alinorm 99/26, Draft Revised Standards for Gluten-Free Foods (Agenda Item 4): 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 their 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 (ref. 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. There were also concerns about the reproducibility of the method. It measured only omega-gliadin and other gliadins should also be taken into account. The need of further improvement was raised. Spain expressed concern about setting units where no method of analysis is available and not all the different types of gliadins can be detected. 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 (Codex committee on Methods of Analysis and Sampling) 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 (Codex committee on Food Labeling), JECFA (Joint expert committee on Food Additives) 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. Several delegations and the Observer from the AAC (Association des Amidonneries Cooperative) proposed that the discussion of this draft should be adjourned until a reliable method of analysis became available. Other delegations were in favor of continuing work on it in order to meet the urgent need of the patients suffering from coeliac disease and proposed to advance the proposed draft for a single level of 200 ppm to step 8. 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 a revision of the standard when a method of analysis or new scientific evidence became available. 36. While concerning the proposed definition of gluten-free foods, several delegations wanted to point out that the current approach was confusing and misleading the consumer and that the level should be uniform for all foods. 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 the oats from the list as scientific studies showed that oats can be tolerated by celiacs and allows to provide dietary fibers for coeliacs. The Observer from AOECS, supported by some delegations, stressed that the square brackets 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 of gluten was the key point of 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. The following documents were discussed during the meeting: CX/NFSDU 98/4 - Add 1 (Comments from Australia, Spain, UK, AAC, ISDI); CX/NFSDU 98/4 - Add 2 (AOECS); CRD 3 (Uruguay, ISDI); CRD 13 (USA); CRD 21 (Spain); CRD 33 = CRD 42 (Sweden); CRD 44 (India); CRD 51 (Norway).