Undeclared Allergens and Gluten in Bakery Products with Gluten-free claims – June 1, 2020 to March 31, 2021

Approximately 7% of Canadians have self-reported as having at least 1 food allergy, but the actual number of medically confirmed food allergies is expected to be slightly lower^Footnote 1. It is believed that the rate of food allergies is increasing, particularly among children. Food allergies are estimated to affect up to 5% of adults and up to 8% of children in developed countries^Footnote 2. Food allergens are food proteins that can cause a reaction of the body's immune system, and can represent a serious or life threatening health risk for allergic individuals, or contribute to chronic health issues for those with pre-existing health conditions like celiac disease. Celiac disease is a chronic reaction where the body reacts to a component of gluten which can damage or destroy certain intestinal cells. Approximately 1% of the total population are affected with celiac disease^Footnote 3.

The priority food allergens are the 10 most common food allergens that are associated with severe allergic or allergy-like reactions in Canada. These allergens consist of peanuts, tree nuts, sesame, seafood (fish, shellfish and crustaceans), eggs, milk, soy, mustard, sulphites, and wheat^Footnote 4. Gluten, while not a true allergen, is a family of proteins found in certain grains like wheat, rye, barley, kamut, and spelt and is included in this list^Footnote 5. Gluten can cause digestive problems and other issues for people with certain health conditions such as celiac disease and gluten sensitivity. This makes proper identification and labelling of allergens in food by the manufacturer essential.

Undeclared allergens can be found in foods due to their presence in the raw ingredients, or can be accidentally introduced along the food production chain through cross contamination. Regardless of the source of the allergens, industry must ensure that the food they produce is safe for human consumption. This can be achieved by complying with specific Canadian regulations where applicable, or by keeping the levels as low as reasonably possible.

This was the first survey conducted by the agency for undeclared allergens and gluten in bakery products with gluten-free claims. The main objective of this survey was to obtain baseline information regarding the presence and levels of undeclared allergens and gluten in bakery products with gluten-free claims.

All products were tested "as sold," meaning that they were not prepared as per the manufacturer's instructions or as they would typically be consumed.

All products were sampled between June 2020 and March 2021. Samples were collected from local and regional grocery stores located in 6 major cities across Canada. These cities encompassed 4 geographical areas: Atlantic (Halifax), Quebec (Montreal), Ontario (Toronto, Ottawa) and the West (Vancouver, Calgary). The number of samples collected from these cities was in proportion to the relative population of the respective areas.

The following products were not included in the survey:

• products with all of the following allergens in the list of ingredients – almond, hazelnut, peanut, sesame, soy/soybean, egg, milk, and wheat, barley, oats, rye, triticale, or gluten
• products with a precautionary statement for all priority allergens
• non pre-packaged products/bulk bin products
• products with no list of ingredients
• products past the best before date

Samples were analyzed by an ISO/IEC 17025 accredited food testing laboratory under contract with the Government of Canada. The samples were tested as sold, meaning that the product was tested as-is and not as prepared according to package instructions.

In Canada, food allergens and gluten must be declared in the list of ingredients if they are present in the prepackaged product in order to comply with the requirements of the Food and Drug Regulations Section B.01.010.1. A prepackaged product will be deemed non-compliant if any level of undeclared allergens and gluten is detected.

Health Canada considers that gluten-free foods, prepared under good manufacturing practices, which contain levels of gluten not exceeding 20 parts per million (ppm) (due to cross contamination) meet the intent of the Food and Drug Regulations Section B.24.018 for a gluten-free claim.

Almost 91% of all bakery products with gluten-free claims in this survey did not contain any detectable levels of allergens and gluten. The results for 26 samples found positive are shown in table 2.

Of the 287 samples tested in this survey, almost 91% did not contain any detectable levels of allergens or gluten, while 26 samples were found to contain varying levels of undeclared gluten, BLG, casein, soy, sesame and egg.

The best currently available scientific evidence indicates that levels of gluten below 20 ppm in gluten-free foods would be protective of health of the vast majority of people with celiac disease^Footnote 5. Accordingly, 4 positive results for gluten with levels of 20 ppm or greater, 1 positive result for both BLG and casein, 1 positive result for egg, 3 positive results for sesame as well as 16 positive results for soy were forwarded to the CFIA's OFSR for follow-up.

The extent of the follow-up actions taken by the CFIA is based on the level of contamination and the resulting health concern as determined by a health risk assessment. Appropriate follow-up actions include additional sample testing, facility inspection, and product recall. The health risk assessment is based on exposure to the allergens and gluten through consumption. The exposure is calculated by using the typical serving sizes for each food. Assessment based on serving size means not all detectable levels of undeclared allergens and gluten in food will cause a reaction in an allergic individual.

Milk

Both undeclared BLG and casein were detected in 1 dessert product. BLG (a whey protein) and casein are major milk proteins. Casein derivatives such as sodium caseinate are often used as emulsifier and thickening agents in processed food including chocolate products^Footnote 6. Whey proteins also have excellent emulsifying and foaming properties, so they are widely used in producing desserts, yogurts, etc^Footnote 7, ^Footnote 8, ^Footnote 9. Low levels of BLG and casein could be introduced into products due to cross contamination on the production line^Footnote 10. This dessert product was deemed to pose a health risk to consumers, and was recalled^Footnote 11.

Egg

A single product in this survey tested positive for undeclared egg. Low levels of egg in the product could be a result of cross-contact of mislabeled or contaminated raw ingredient^Footnote 12. Inadequate cleaning of shared processing and/or packaging equipment between each run could introduce low level allergens in products^Footnote 13. This product was deemed not to present a risk to consumers.

Sesame

Undeclared sesame was found in 3 bread products. Sesame seeds have long been used in the food industry to produce sesame oils, salad dressing, bakery products, etc. Cross-contamination from processing and handling on the shared production line may be the reason of the low level of sesame in the tested bread product^Footnote 13. All 3 samples were assessed as being of no risk to consumers.

Gluten

5 dessert products were found to contain varying level of undeclared gluten (5.2, 65, 69, 160 and 9200 ppm). Lower detected levels of gluten have been known to be present due to cross-contamination as a result of manufacturing or distribution practices, as grains containing gluten are widely used in the production of many pre-packaged foods^Footnote 14. Further investigation performed by OFSR on the dessert product containing high level of undeclared gluten (9200 ppm) indicated that this product was put in the wrong packaging sleeve, and none of such product was left on the market, so this sample wasn't deemed to be a health risk. Therefore, only 1 positive sample was deemed to pose a health risk to consumers, and was recalled^Footnote 15.

Soy

Undeclared soy was found in 16 products. The presence of low level of soy in cereal grains product may be due to cross contamination during normal agricultural activities, such as the growth, the harvest, the transport and the storage of grains^Footnote 16. The levels found were low and deemed not to pose a risk to consumers.

Summary

A single dessert product containing BLG and casein, and 1 other bakery product containing gluten were deemed to represent a health risk and were recalled. No published literature could be found on the similar topic for results comparison.

This survey generated baseline information on the background level of undeclared allergens and gluten in bakery products with gluten-free claims collected from 6 cities across Canada. Information gathered in this survey, in conjunction with other data including the Canadian Total Diet Study and Statistics Canada's Canadian Health Measures Survey food consumption data, are critical in assessing the health risk that our food supply poses to Canadian consumers. The results of the CFIA's surveillance activities are also used to inform the Canadian public and stakeholders by raising consumer awareness and help build public confidence in their food supply by removing non-compliant products.