SAFEGUARDS | Food NO. 109/16

On May 3, 2016 the Canadian Food Inspection Agency (CFIA) expanded the allergen section of its labeling tool, specifically gluten-free and wheat-free claims, precautionary labeling and allergen-free claims in conjunction with precautionary statements. Additionally, the CFIA is notifying the industry of Health Canada’s position on gluten-free and wheat-free claims for products that contain canary seed. [1]

Gluten-Free Claims

Gluten-free food is defined as a food not containing any gluten protein or modified gluten protein, including gluten fraction, from wheat, oats, barley, rye, triticale or their hybrids as per compliance to B.24.018 of the Food and Drug Regulations (FDR). Any unintentional contamination must be below 20 mg/kg (ppm) and processing must be designed to assure this compliance level. A gluten-free claim cannot be used interchangeably with a wheat-free claim, as gluten can be present in products that do not include wheat. A gluten-free claim can be placed on oat products, provided that the oats have been specially produced to contain no more than 20 mg/kg of gluten from wheat, rye, barley or their hybridized strains. If there is no specific processing in place to assure that level then this claim cannot be made.

Health Canada now permits the sale of glabrous (hull) varieties of brown and yellow colored canary seed (Phalaris canariensis L.). If the product packaging lists a gluten-free claim on it, then the CFIA requires a precautionary statement of “may not be suitable for people with wheat allergy”. Of course a wheat-free claim on this product would be inappropriate, since it contains proteins that are similar to those responsible for wheat allergies.

The CFIA does not prohibit the labeling of quantitative statements in regards to gluten, such as “contains less than x gluten”, provided they are truthful, not misleading and that the product does not exceed the amount declared. Testing to verify the amount declared must be performed by an appropriate method. This would be the R5 ELISA method for any product, except for those that are hydrolyzed, fermented or enzymatic processed. However, the CFIA does prohibit low and reduced gluten claims. 

Gluten-Free claims can be made for a beer that is made from non-gluten grains, provided there is no cross contamination with gluten containing ingredients. Similarly, Health Canada and the CFIA would not object to a statement of “this product is fermented from grains containing gluten and [processed or treated or crafted] to remove gluten” provided the statement is truthful and can be substantiated.

Allergen Free Claims

Canada has ten priority allergens; peanuts, tree nuts (almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine nuts, pistachios and walnuts), sesame seeds, milk, eggs, seafood (fish, crustaceans and shellfish), soy, wheat, sulphites and mustard. If a declaration states that a product does not contain or is free of a specific allergen, such as “egg-free”, then this is acceptable provided there is none of the allergen in the product, including any allergens from production cross-contamination. Utilizing a specific allergen free symbol is acceptable but the CFIA recommends adding the text so there is no misunderstanding of the symbol. For products that contain coconut, the statement “does not contain tree nuts and peanuts” is acceptable if truthful because unlike the US Food and Drug Administration, Health Canada and the CFIA do not consider coconut to be a tree nut. Use of the statements “allergen free” and “no allergens” without reference to a specific allergen is unacceptable, as there over 200 food proteins that can cause an allergic reaction and these statements would be considered misleading.

Precautionary Statements

A precautionary statement, as with all label statements, must be truthful and not misleading, as per subsection (5(1) of the Food and Drugs Act. While there is no regulation requirement on the wording and location, the CFIA recommends “may contain x”, where x is the common name of the allergen and the statement is located either after the “Contains” statement, or after the ingredients if there is no “Contains” statement. Health Canada has developed a procedure to determine whether a precautionary statement on an ingredient should be carried over to the finished product, and the CFIA offers four options:

  • Putting production system or process controls in place
  • Performing sampling of end product for allergen presence
  • Working with suppliers on ingredient specifications
  • Carrying over precautionary labeling to final products intended to be sold at retail

Additionally, the CFIA recommends not combining the precautionary statement of “may contain wheat” with gluten-free and suggests using “may contain less than 20 ppm wheat” instead, if the product does meet the gluten-free requirements.

It is always recommended that label reviews be performed as well as allergen testing to help verify any allergen claim or precautionary statement. There are multiple methodologies for allergen testing, such as ELISA, PCR and Next-Generation DNA Sequencing.

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