Allergen-Free, Gluten-Free and Precautionary Statements
Food Allergen Precautionary Statements
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A food allergen precautionary statement is a declaration on the label of a prepackaged food of the possible inadvertent presence of an allergen in the food. Precautionary statements are made by food manufacturers and importers on a voluntary basis and are appropriate when, despite all reasonable measures, the inadvertent presence of allergens in food is unavoidable. Precautionary statements are not a substitute for Good Manufacturing Practices.
Precautionary labelling must not be used when an allergen or allergen-containing ingredient is deliberately added to a food – in such cases, mandatory food allergen and gluten declaration is required.
Like all labelling statements, precautionary statements are subject to subsection 5(1) of the Food and Drugs Act (FDA) and must be truthful and not misleading.
There are no regulations stipulating the wording and location of precautionary statements. However, for consistency in interpretation and understanding, Health Canada and the CFIA recommend that food manufacturers and importers use only the following precautionary statement on food labels:
"may contain [X]"
where X is the name by which the allergen is commonly known. This is a recommendation and industry best practice.
Additionally, it is a best practice to place precautionary statements in the location on the label where the affected consumers will be looking for allergen information. Therefore, precautionary statements are best placed after any allergen "contains" statement, or if there isn't one, immediately after the list of ingredients.
For more information on precautionary statements please see Health Canada's Use of Food Allergen Precautionary Statements on Prepackaged Foods.
Precautionary Labelling of Food Ingredients
Health Canada has published information for Canadians with mustard allergy that clarifies that it is not a requirement to carry over precautionary labelling on ingredient labels to the label of end food products made with those ingredients. This is a manufacturer or importer's decision, made in consideration of whether the end product poses a potential health risk to an allergic consumer. While the Health Canada information above was developed for mustard which may be inadvertently present in cereal grain flours, the same principles may be used to assess whether other precautionary allergen statements should be carried over to the end food product.
Regulated parties are responsible for the safety of their products, including addressing potential risks associated with the presence of allergens. Options to achieve this may include (but are not limited to);
- Putting production system or process controls in place,
- Performing sampling of end product for allergen presence,
- Working with suppliers on ingredient specifications, and
- Carrying over precautionary labelling to final products intended to be sold at retail.
During inspections, CFIA inspectors may request information from manufacturers or importers to demonstrate how potential health risks to allergic consumers are being addressed.
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