FDA Set to Adopt New Gluten-Free Labeling Standards In-Line with New Codex Alimentarius Standards
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From June 30 to July 5, 2008, the Codex Alimentarius Commission recently held their 31st session, where they accepted without change the 2007 Draft Revised Codex Standard for Foods for Special Dietary Use for Persons Intolerant to Gluten. According to the latest Codex Alimentarius standard, any product labeled “gluten-free,” including those made from de-glutened wheat starch will contain no more than 20 parts gluten per million. This last part is especially important, as their earlier standards for the use of “gluten-free” on labels allowed up 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 naturally gluten-free, but have been rendered gluten-free through processing, such as wheat starch that has had its gluten removed. This category is called “foods specially processed to reduce gluten to a level 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:
As always, Celiac.com welcomes your comments (see below).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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