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  • Jefferson Adams
    Jefferson Adams

    FDA Set to Adopt New Gluten-Free Labeling Standards In-Line with New Codex Alimentarius Standards

    Celiac.com 07/23/2008 - Folks who follow a gluten-free diet can take comfort that the Codex Alimantarius, the international body responsible for setting food safety standards, has moved a step closer to adopting the gluten-free standards they drafted in November 2007, and their new standards are, for the most part, in-line with the proposed FDA regulations. However, those hoping for speedy adoption of similar standards by the FDA will just have to wait until the FDA takes one last round of public comment and evaluates safety standards used in developing the standards. Certainly, anticipation has been running high, as several blogs and otheronline sources have wrongly claimed that the new FDA standards will go intoeffect in August 2008.

    From June 30 to July 5, 2008, the Codex Alimentarius Commissionrecently held their 31st session, where they accepted without changethe 2007 Draft Revised Codex Standard for Foods for Special Dietary Usefor Persons Intolerant to Gluten. According to the latest CodexAlimentarius standard, any product labeled “gluten-free,” includingthose made from de-glutened wheat starch will contain no more than 20parts gluten per million. This last part is especially important, astheir earlier standards for the use of “gluten-free” on labels allowedup to 200 parts gluten per million if the product contained ingredients that normally contained gluten. The 2007 standard still includes a special category for foods that are not naturallygluten-free, but have been rendered gluten-free through processing, such as wheat starch that has had its gluten removed. Thiscategory is called “foods specially processed to reduce gluten to alevel above 20 up to 100 milligrams per kilogram.” The Codex Alimentarius Committee has yet to post the new standard on the their website.

    The adoption of a less than 20 ppm standard on foods labeled "gluten-free" by both the Codex Alimentarius and the FDA would mean that consumers across Europe and North America could count on a single, uniform standard for food that is labeled "gluten-free." This new standard has been driven primarily by the efforts of celiac disease support groups, people diagnosed with celiac disease, and gluten-free diet followers, whose influence also led to the creation and passage of the Food Allergen Labeling and Consumer Protection Act in 2004.

    The FDA will not issue their final ruling until they make the draft available for public review and consider one more round of commentary, along with previous public comments, as well as publishing a notice on the safety assessment made in developing the final rule. The FDA will likely publish the notice on the safety assessment soon, but there is no indication as to just when they will issue the final rule.

    A large part of the celiac community has been eagerly anticipating the announcement of the final rule. Until that great day, all of you gluten-free folks will just have to be content knowing that solid, reliable standards for the use of the term "gluten-free" on food labels are just around the corner.

    The next session of the Codex Alimentarius Commission will be held from 29 June to 4 July 2009 in Rome.

    Here are the new Codex Alimentarious Standards for Gluten-Free foods, which will appear on their Web site soon:

    2.1.1 Gluten-free foods

    Gluten-free foods are dietary foods

    a) consisting of or made only from one or more ingredients which do not contain wheat (i.e., all Triticum species, such as durum wheat, spelt, and kamut), rye, barley, oats1 or their crossbred varieties, and the gluten level does not exceed 20 mg/kg in total, based on the food as sold or distributed to the consumer,and/or

    B)
    consisting of one or more ingredients from wheat (i.e., all Triticum species, such as durum wheat, spelt, and kamut), rye, barley, oats1 or their crossbred varieties, which have been specially processed to remove gluten, and the gluten level does not exceed 20 mg/kg in total, based on the food as sold or distributed to the consumer.

    2.1.2 Foods specially processed to reduce gluten content to a level above 20 up to 100 mg/kg

    These foods consist of one or more ingredients from wheat (i.e., all Triticum species, such as durum wheat,spelt, and kamut), rye, barley, oats1 or their crossbred varieties, which have been specially processed to reduce the gluten content to a level above 20 up to 100 mg/kg in total, based on the food as sold or distributed to the consumer.

    Decisions on the marketing of products described in this section may be determined at the national level.



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    Thank you for this update. Please keep the Celiac community informed when the FDA opens the comment period so we can weigh in.

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    This new standard would enable sensitive celiacs to stick to the critical 100% gluten-free diet in order to maintain good health and aim for longevity. In the Netherlands it is so tempting to buy a product that is labeled gluten free whilst containing wheat starch up to the 200ppm and then live to regret it... Likewise, you can hardly blame your hosts who have gone through the trouble of buying these so called gluten free products for you and yet you suffer the consequences...We are already fortunate to have gluten free labels. Yet new step is the last vital step to an easier life for celiacs. So thank you and I hope many celiacs will express their support where it is needed and make this new standard operative asap.

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    Food News For Filipinos! The Philippine Government is adopting the

    New Codex Alimentarius Standards for Gluten Free Labeling!

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    That's great news about new labeling standards on the horizon.

    Please tell us what we can do as individuals to support or move this process along. How can we lend our voice - who do we call or write to?

    thanks,

    T

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    This is all fine and good for people who can tolerate some gluten, but what about us who cannot tolerate any? Gluten free should be gluten free period!!!!!

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    Wow, it's nice that they lowered it..but for myself..that's still not low enough. I or should I say my body knows that if there's the little trace...it tells me...I feel that the guidelines should be out there to be a part of our diet not make our diet worst...if a child has a peanut allergy, well there can't be any trace at all for that reason why is it not so for us with celiac? we might not die right away but due to the type of disease this is, we can die from all types of cancer due to getting the little traces the FDA says we can handle..but correct me if I am wrong..when I got told I had celiac I wasn't told that I could have a little trace of gluten, I was told I could not have anything with gluten and no cross contamination either was on that list...so till this gets to where its not so much about money but about having a better way of life this is still unacceptable.

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    My family every time say that I am killing my time here at web, except I know I am getting experience every day by reading such pleasant articles or reviews.

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  • About Me

    Jefferson Adams earned his B.A. and M.F.A. at Arizona State University, and has authored more than 2,000 articles on celiac disease. His coursework includes studies in biology, anatomy, medicine, science, and advanced research, and scientific methods. He previously served as Health News Examiner for Examiner.com, and devised health and medical content for Sharecare.com. Jefferson has spoken about celiac disease to the media, including an appearance on the KQED radio show Forum, and is the editor of the book "Cereal Killers" by Scott Adams and Ron Hoggan, Ed.D.

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    Scott Adams
    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 WHO and the 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.


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