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 Open Original Shared Linkfor 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.

Celiac.com Sponsor (A12):
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:

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.