It has now been one year since amendments to the Food and Drug Regulations enhanced the labelling of food allergens in Canada. Although reports don’t reveal a dramatic increase in the frequency of allergen-related recalls, surprisingly the most common category of recalls since the new requirements came into force was undeclared mustard.
As discussed in Ron Doering’s recent article in Food in Canada, “Can’t cut the mustard – it’s everywhere” this result is due to the addition of “mustard” to the list of 10 priority food allergens. The revised Regulations require manufacturers to clearly identify food allergens, gluten sources, and sulphites either in the list of ingredients or at the end of the list of ingredients with the following statement "Contains: ...". Manufacturers must also now list components of ingredients if they contain food allergens, gluten sources, or sulphites. As Ron notes, this “corrects past situations in which manufacturers didn’t need to disclose the presence of an allergen if it were contained within what they listed as spices, flavourings or seasonings.” The new requirements have, in practice, presented quite a challenge for food manufacturers since frequently suppliers do not disclose the various components within the these ingredients. As a result, the new requirements will require more information sharing between manufacturers and suppliers.
A review of the recalls in the past year also indicates that manufactures and importers should be wary of the potential for cross-contamination as the CFIA may increase the class assigned to a recall and require a recall to the retail level if the presence of an undeclared allergen has resulted in an adverse reaction. It is important to note that with the exception of gluten, where CFIA has indicated that enforcement action on products containing less than 20 ppm gluten from cross-contamination will not include a recall of the product (see Compliance and Enforcement of Gluten-Free Claims), there are no threshold levels for allergens.
While Lowest Observed Adverse Effect Levels (LOAELs) for food allergens can give us an idea of what levels have been associated with adverse reactions in the past, (see pg. 54 of FDA’s Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food) these values should not be considered absolute threshold levels as there are too many uncertainties regarding the levels that people can react to, and the amounts being detected and quantified by testing.
As a result, manufacturers and importers will want to keep up to date on available guidance (see The Use Of Food Allergen Precautionary Statements On Prepackaged Foods and the new Highly Refined Oils Derived from Food Allergen Sources) and ensure that contractual arrangements with suppliers and contract manufacturers are drafted to include appropriate remedies if mislabelling or cross-contamination leads to a costly recall.