In 1994 I was diagnosed with celiac disease, which led me to create Celiac.com in 1995. I created this site for a single purpose: To help as many people as possible with celiac disease get diagnosed so they can begin to live happy, healthy gluten-free lives. Celiac.com was the first site on the Internet dedicated solely to celiac disease. In 1998 I created The Gluten-Free Mall, Your Special Diet Superstore!, and I am the co-author of the book Cereal Killers, and founder and publisher of Journal of Gluten Sensitivity.
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 (<20 PPM "GF" and <200 PPM for "gluten reduced"), and from the European celiac societies <40 PPM for "GF". Another proposition was to change the units again to mg/100 g rather than PPM (mg/kg).
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.