June 13, 2016 Canadian Food Inspection Agency updates the Industry Labelling Tool on Allergen-Free, Gluten-Free and Precautionary Statements.
With the rising popularity of Gluten-Free foods and the proposed increase in food allergies, it is has become mandatory that pre-packaged food labels declare food allergens or gluten sources when present. Allergen statements appearing on food labels and promotional materials contribute to a consumer’s overall impression of a product. As such, these claims are subject to a number of requirements. In May 2016, the Canadian Inspection Food Agency updated their Industry Labeling Tool to provide supplementary information on Allergen-Free, Gluten-Free and Precautionary Statements requirements for food product labels.
In order for a food to be represented as “Gluten-Free”, it must comply with section B.24.018 of the Food and Drug Regulations (FDR). Health Canada and the Canadian Food Inspection Agency (CFIA) consider gluten protein below 20 ppm to generally not represent health risks to consumers with celiac disease. The CFIA also takes into consideration whether any present gluten is due to intentional addition or to cross-contamination. Provided appropriate methods of analysis are used, quantitative claims related to the amount of gluten in foods are permitted. “Low gluten” or “reduced gluten” claims are not permitted in Canada, as they are considered to be misleading. A “wheat-free” claim cannot be used interchangeably with a “Gluten-Free” claim, as gluten can be present in sources other than wheat.
Gluten-Free foods fortified to achieve levels of enrichment equivalent to those required in flour, according to section D.03.003 of the FDR and under specific conditions, are allowed. These foods however cannot be advertised to the general public. Over-fortification posing health risks may be subject to enforcement action by the CFIA.
Gluten-Free Oats, Canary Seeds and Beer
Health Canada has created a Marketing Authorization to permit Gluten-Free oats and foods made using Gluten-Free oats as ingredients, to be labelled as ‘Gluten-Free’. This claim however is not permitted for use on regular oats or products containing these oats. Health Canada has published a guidance document on the requirements applicable to “Gluten-Free oat” label claims.
Canary seeds do not contain gluten and under certain conditions may be represented as Gluten-Free. Canary seeds do however contain other proteins similar to proteins associated with wheat allergies. As such, Health Canada has deemed it inappropriate for canary seed, or food containing canary seed, to be labelled as “wheat-free claim”. Health Canada also requires canary seed and foods containing canary seed to be labelled with a statement to the effect that the product “may not be suitable for people with wheat allergy”, provided the food does not also contain wheat as an ingredient.
Health Canada and the CFIA object to the use of Gluten-Free claims in beer products made from gluten containing grains. They do however, permit the use of the statement “This product is fermented from grains containing gluten and [processed or treated or crafted] to remove gluten. The gluten content of this product cannot be verified, and this product may contain gluten”. Beer-like products made from non-gluten grains are permitted to make Gluten-Free claims.
Food allergen Precautionary Statements can be made on a voluntary basis when the presence of allergens in food is unavoidable. Mandatory food allergen and gluten declarations are required when an allergen or allergen-containing ingredients are deliberately added to a food.
As an industry best practice, Health Canada and the CFIA recommend use of only the following Precautionary Statement on food labels: “may contain [X]” (where X is the name by which the allergen is commonly known). It is also best practice for these Precautionary Statements be placed after any allergen “contains” statement or immediately after the list of ingredients.
The principles outlined in the information for Canadians with mustard allergy published by Health Canada, may be also be used to assess whether other Precautionary Statements be carried over to the end food product.
Due to the large number of food proteins with potential to cause adverse reactions in certain individuals, general “Allergen-Free” and “No Allergens” claims are not permitted. Allergen-Free claims such as “(naming the food allergen)-free” and “contains no (naming the food allergen)”, are permitted only in foods that have been specially formulated or are processed under special conditions. The CFIA requires that production systems or process controls be put in place to ensure consumers are not mislead as to the safety of the food. These claim may not be used in conjunction with a “may contain (naming the same allergen)”, except under specific conditions. (Naming the food allergen source)-free symbols and representations fall privy to the same requirements as Allergen-Free claims. It is recommended that clarifying text accompany these symbols to avoid misinterpretations.
Regulated parties are responsible for the safety of their products, including addressing potential risks associated with the presence of allergens. When making Gluten-Free, Allergen-Free and Precautionary Statements on food labels, manufacturers may be requested to provide evidence to substantiate these claims. During inspections, CFIA inspectors may ask how potential health risks to allergic consumers are being addressed.
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