Requirements for a Gluten-Free Food Label

Do you know about the regulatory requirements for food labeling, specifically when it comes to gluten free products?

03 April 2014

Are you currently trying a gluten-free diet? If so, you are joining approximately 1 in 3 Americans or 1 in 8 Canadians who have eliminated the cereal protein from their diet. Gluten-free foods have come to the forefront of consumer trends for 2014.

Although there is clear evidence that individuals with celiac disease are intolerant to gluten, there is no robust scientific data to suggest that consuming a gluten-free diet is beneficial to those not suffering from celiac disease. Despite this, consumers are flocking to gluten-free foods, citing benefits in weight loss, blood cholesterol, and inflammation. "Gluten-free" foods currently represent an estimated $10.5 billion industry in the United States, and a $90-million industry in Canada.

With a huge shift in the market towards "gluten-free" foods, we ask the question: what are the labelling requirements for gluten?

In the United States, the U.S. Food and Drug Administration requires that foods containing a "Gluten-Free" claim contain less than 20 ppm of gluten, the lowest concentration that appears to be safe for those afflicted with celiac disease. There are no regulatory requirements to declare the presence of gluten on the labels of foods; however, wheat is considered a major food allergen and is subject to the Food Allergen Labeling and Consumer Protection Act of 2004.

Conversely, in Canada, pre-packaged foods containing a potential source of gluten (i.e., barley, oats, rye, triticale, or wheat, kamut or spelt, or modified gluten products derived thereof) must be labelled on the list of ingredients, or with a "Contains" statement with the source of gluten. Foods in which gluten may be present as a result of cross-contamination need not be labelled. "Gluten-Free" foods are regulated as "food for special dietary use" and are subject to the regulations established under Section B.24 of the Food and Drug Regulations. Section B.24.018 of the Food and Drug Regulations currently prohibit the use of gluten-free claims on any foods containing gluten protein or modified gluten protein; however, a specific concentration limit is not established in the Regulations. It is noted, however, that Health Canada considers foods containing gluten not exceeding 20 ppm to meet the health and safety intent of Section B.24.018.

In the European Union, Food Information for Consumers Regulation (EU) No. 1169/2011 establishes that ingredients causing allergies or intolerances, including gluten, that are still present in the finished product must be labelled, subject to the content and formatting requirements laid out in Article 21. As per Commission Regulation 41/2009, a "Gluten-free" label can be made for foods containing gluten at 20 ppm or less. A "Very Low Gluten" claim can be made at 100 ppm or less only in foods containing cereal ingredients that have been specially processed to remove the gluten content.

Does your food product meet the requirements for gluten-free labelling?

For questions regarding regulatory requirements for food labelling, please leave us a comment below, and a member of our team will get back to you.

*Supporting references available upon request

Today's expert blogger, Annette Lau, is a scientific and regulatory associate with broad experience in preparing safety evaluations for food ingredients/additives, dietary supplement ingredients, consumer products, cosmetic ingredients, and drug excipients. She has compiled application dossiers for submission to various departments of the United States Food and Drug Administration, Health Canada, the European Food Safety Authority, and authoritative bodies in Europe. Her familiarity with the regulatory requirements for substantiating safety in each product category makes her an asset to the Intertek Scientific & Regulatory Consultancy team.