Undeclared Allergens and Gluten in Meal Replacements and Nutritional Supplements - April 1, 2016 to March 31, 2017
Food allergen - Targeted surveys
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Targeted surveys provide information on potential food hazards and enhance the Canadian Food Inspection Agency's (CFIA's) routine monitoring programs. These surveys provide evidence regarding the safety of the food supply, identify potential emerging hazards, and contribute new information and data to food categories where it may be limited or non-existent. We use them to focus surveillance on potential areas of higher risk. Surveys can also help identify trends and provide information about how industry complies with Canadian regulations.
Food allergies can affect people of all ages but are particularly common in children. Food allergens can represent a serious or life threatening health risk for allergic individuals. Additionally, although it is not considered an allergen, undeclared gluten may contribute to chronic health issues for those individuals with celiac disease or gluten sensitivity. Allergens and gluten can be found in food due to their presence in the raw ingredients or they can be accidentally introduced along the food production chain due to cross contamination. Regardless of the source of the allergens, industry must ensure that the food produced is safe for human consumption, either by complying with specific Canadian regulations where applicable or by keeping the levels as low as reasonably possible.
The main objective of this survey was to obtain baseline information regarding the presence and levels of undeclared allergens and gluten in meal replacements and nutritional supplements. 300 were tested and 0.7% (2) of the samples were found to contain undeclared allergens including the milk protein beta-lactoglobulin (BLG), as well as egg. 1 positive result for undeclared BLG was found in a cereal product, while the other positive result was for undeclared egg allergen in a meal replacement product.
All positive results were forwarded to the CFIA's Office of Food Safety and Recall (OFSR) to determine if the levels found would pose a health concern to allergic individuals. The extent of the follow-up actions taken by the agency is based on the seriousness of the contamination and the resulting health concern as determined by a health risk assessment. 1 meal replacement product sampled was found to present a health risk and was recalled.
What are targeted surveys
Targeted surveys are used by the CFIA to focus its surveillance activities on areas of higher health risk. The information gained from these surveys provides support for the allocation and prioritization of the agency's activities to areas of greater concern. Targeted surveys are a valuable tool for generating information on certain hazards in foods, identifying and characterizing new and emerging hazards, informing trend analysis, prompting and refining health risk assessments, highlighting potential contamination issues, as well as assessing and promoting compliance with Canadian regulations.
Food safety is a shared responsibility. The agency works with federal, provincial, territorial and municipal governments and provides regulatory oversight of the food industry to promote safe handling of foods throughout the food production chain. The food industry and retail sectors in Canada are responsible for the food they produce and sell, while individual consumers are responsible for the safe handling of the food they have in their possession.
Why did we conduct this survey
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 lowerFootnote 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 countriesFootnote 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 diseaseFootnote 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 wheatFootnote 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 listFootnote 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 labeling 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 meal replacements and nutritional supplements, as there is growing demand for these productsFootnote 6, Footnote 7. The main objective of this survey was to obtain baseline information regarding the presence and levels of undeclared allergens including milk (BLG and casein), gluten, almond, hazelnut, peanut, egg, sesame, and soy in meal replacements and nutritional supplements.
All products were tested "as sold," meaning that they were not prepared as per manufacturer's instructions or as they would typically be consumed.
What did we sample
All products were sampled from April 2016 to March 2017. 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 (1 of or more in the list of ingredients was fine for testing) – almond, hazelnut, milk/dairy, peanut, soy, egg, sesame, wheat, barley, oats, rye, triticale, kamut, spelt, or gluten
- products with no list of ingredients for which it is required
- products with a precautionary statement for all priority allergens
- non-prepackaged products
- products past the "use by" or "best before" date
- Natural Health Products (NHP) bearing an 8-digit Natural Product Number (NPN), Drug Identification Number (DIN), Exemption Number (EN), or Homeopathic Medicine Number (DIN-HM)
- regular granola bars
|Product type||Number of domestic samples||Number of imported samples||Number of samples with unspecified origin Table Note a||Number of total samples|
- Table Note a
Unspecified refers to those samples for which a country of origin could not be determined from the product label or available sample information.
How were samples analyzed and assessed
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 ingredient 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.
What were the survey results
Over 99% of meal replacements and nutritional supplements sampled in this survey did not contain any detectable levels of undeclared allergens. There were 2 imported products founded positive for undeclared allergens. A cereal product was found to contain 0.1ppm of BLG, while 66.9ppm of Egg was found in a meal replacement product.
What do the survey results mean
Only 2 of the 300 samples tested positive for undeclared allergens. These included a cereal sample for BLG and a meal replacement sample for undeclared egg.
The milk protein BLG was present in 1 (0.3%) of the samples tested. The level found was low and below what is expected to be of any functional value as an additive. This possibly indicates it was present as a result of cross contamination in an ingredient or the final product. It was deemed not to pose a risk to consumers.
1 product (0.3%) in this survey tested positive for undeclared egg, and the detected level was determined to pose a risk to consumers by Health Canada and was recalled. Egg can be effective in the food breading process as egg white solids can be used as an emulsifier which aids in adding integrity and adhesion to grain-based coatingsFootnote 8. It is also possible that the levels of egg present were a result of cross-contamination.
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.
All positive results were forwarded to the OFSR for follow-up and the meal replacement product containing undeclared egg was deemed to represent a health risk and was recalledFootnote 9.
This survey generated new information on the background level of undeclared allergens and gluten in meal replacements and nutritional supplements 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 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.
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