Allergen-free, gluten-free and cross contamination statements
Food allergen cross contamination (or precautionary) statements
A cross contamination statement is a declaration on the label of a prepackaged product that alerts consumers of the possible presence of an allergen in the food.
Cross contamination statements may be declared by food manufacturers and importers when, despite all reasonable measures there is the unintended presence of food allergens in the food. Cross contamination statements are not a substitute for Good Manufacturing Practices.
Note: The words "precautionary statements" and "cross contamination statements" have the same meaning and can be used interchangeably to refer to prepackaged products that may contain a food allergen source.
Cross contamination statements 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, cross contamination statements are subject to subsection 5(1) of the Food and Drugs Act (FDA) and must be truthful and not misleading.
If the label of a prepackaged product declares that due to the risk of cross-contamination, the product may contain a food allergen or gluten, the cross contamination statement:
- must be declared immediately after the "food allergen source, gluten source and added sulphites" statement or, if there is none, the list of ingredients, and must appear within the same background colour and/or within the same solid borders as the statement or list of ingredients [B.01.010.4(1)(a)(i)-(ii), FDR]
- must appear without any intervening written, printed or graphic material between it and the "food allergen source, gluten source and added sulphites" statement or, if there is none, the list of ingredients [B.01.010.4(1)(b), FDR]
- must appear in bold, if the cross contamination statement is not introduced by a title and if the cross contamination statement begins on the same line immediately after the list of ingredients or the food allergen source statement that precedes it [B.01.010.4(1)(c), FDR], and
- if the cross contamination statement is introduced by a title, that title must appear in bold if the statement begins on the same line immediately after the list of ingredients or the food allergen source statement that precedes it [B.01.010.4(1)(d), FDR].
Health Canada and the CFIA recommend that food manufacturers and importers use only the title below to introduce precautionary/cross contamination statement on food labels:
"May contain: [X]" or "May contain: [X]" (if it begins on a separate line)
where X is the name of the allergen prescribed source name.
Note: If the cross contamination statement begins on a separate line, the "May contain" title does not have to be bolded (see Option 1 below).
The following examples illustrate the two acceptable ways to show cross contamination or precautionary statements after the list of ingredients and the "food allergen source, gluten source and added sulphites" statement.
Option 1:
- Ingredients: White beans, Water, Sugars, Pork, Salt, Modified cornstarch, Onion powder, Mustard, Spices.
- Contains: Mustard
- May contain (or May contain): Sesame, Soybeans
The "May contain" statement may be shown in bold type or in regular type when it begins on a new line.
Option 2:
- Ingredients: White beans, Water, Sugars, Pork, Salt, Modified cornstarch, Onion powder, Mustard, Spices.
- Contains: Mustard. May contain: Sesame, Soybeans.
In this example, the "May contain" statement must be in bold when it does not begin on a new line.
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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