Questions and Answers Regarding the Labelling of Food Allergens and the use of Precautionary Statements

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What are precautionary statements?

A precautionary statement is a declaration on the label of a prepackaged food warning consumers of the possible inadvertent presence of a food allergen in a food.

For more information on precautionary labelling, please see our Information Letter.

Do the new regulations cover the precautionary labelling?

The new regulations cover food allergens, gluten sources and sulphites that have been deliberately added to food products. They do not cover the inadvertent presence of these substances as a result of cross contamination.

Is there any prescribed wording for precautionary statements?

Currently, there is no prescribed text for precautionary statements.

Precautionary statements can be an appropriate risk management tool to assist consumers with food allergies or sulphite sensitivity in making  safe food choices and to prevent the inadvertent consumption of undeclared allergens by these consumers. As with all food labelling statements, allergen precautionary statements must be truthful, clear and unambiguous.

In order to provide consumers with consistent messaging, the CFIA and Health Canada (HC) are asking the industry to limit allergen precautionary statements to the wording "may contain X" or "not suitable for consumption by persons allergic to "X", where "X" is the name of the priority food allergen.

HC and CFIA are jointly developing policy options for precautionary labelling. In consultation with the food industry and consumer associations, HC and CFIA will work towards  and allergen-free claims. In consultation with the food industry and consumer associations, Health Canada and CFIA will work towards developing further guidance on the use of precautionary labelling to better protect the allergic consumer.

When are precautionary statements ("may contain") appropriate to warn consumers that the food might contain a food allergen?

Precautionary statements should only be used in situations where the food preparation or manufacturing conditions have an identified risk of potentially introducing the allergenic ingredient and/or its derivatives that could not have been avoided through good manufacturing practices. The over-use of precautionary statements on food labels may only serve to decrease consumer confidence in the validity of these statements.

Precautionary statements are appropriate when a food may have inadvertently come into contact with a food allergen or there is potential for cross-contamination or carryover that could not have been avoided by using good manufacturing practices. It is not to be used in lieu of good manufacturing practices or adherence to legal requirements. This type of labelling is not appropriate when the food allergen is present in the food as an ingredient or as a component.

For instance, it would be acceptable to use a "may contain milk" statement on a candy, not formulated with milk ingredients, where the food is processed on the same manufacturing equipment and where there may be a possible transfer of milk to the final product. Precautionary labelling would also be acceptable in the case of a package of mixed tree nuts that may have come into contact with peanuts.

It would not be acceptable to have a "may contain soy" statement on a ham and cheese sandwich if the ham contains soy ingredients. The list of ingredients would have to indicate that the product does contain soy.

Under section B.01.011, FDR, 'may contain' statements are permissible if the product sometimes contains the ingredient and sometimes does not. Is this still permissible if the ingredient is a priority food allergen?

No, it is not permissible to use a "may contain" statement under section B.01.011 for priority food allergens. If the priority food allergen is added as an ingredient, it must be declared.

Do precautionary statements from ingredient packages or suppliers have to be reflected in the final product label?

The CFIA recommends that precautionary statements on ingredients be transferred to the finished product if the finished product does not already list the priority food allergen in the list of ingredients. Manufacturers should have controls in place to ensure the safety of incoming raw materials.

However, the manufacturer should fully investigate the validity of the precautionary statement on the incoming ingredient. For example, it would not be appropriate to use a 'may contain fish' statement for an ingredient that did not come into contact with fish products and where there are no traces of fish transferred to the finished product.

Are group names such as tree nuts, fish, crustaceans and shellfish permitted to be used in a precautionary statement?

Yes, group names are permitted in precautionary statements in cases where there may be a possibility of inadvertent carryover with many different types of foods from these groups.

May peanuts be grouped under the group name "tree nuts"?

No, they may not be grouped under the name "tree nuts" because peanuts are not a tree nut and, therefore, must be declared separately.

Is "seafood" acceptable as a declaration to name the allergen source in a precautionary statement for fish, crustacean and shellfish?

The group names are to be identified as fish, crustacean and shellfish to ensure clear information for individuals with specific allergies.

Can an allergen-free claim co-exist on the label with a precautionary statement?

For example:

• "Nut free" with "Allergy Alert - manufactured on equipment that processes tree nuts"
• "Non Dairy" with "may contain milk derivative"
• "No Peanuts added" with "manufactured in a facility that processes peanuts"

No, statements, such as these, that contradict each other cannot be used as they are considered misleading. Any label statements made must be factual and not misleading.

Is a voluntary precautionary statement required to be declared in English and French?

When used, the precautionary statement must be shown in both official languages. If the product meets the criteria for a "local product" set out in section B.01.012, FDR and is permitted to be labelled in one of the official languages, the precautionary statement may be labelled in the same official language.

Additional information

Precautionary Labelling for Allergens in Pre-packaged Foods

Gazette II - Proposed amendments to the Food and Drug Regulations Enhanced Labelling for Food Allergen and Gluten Sources and Added Sulphites

Health Canada - Questions and Answers about the New Regulations to Enhance the Labelling of Food Allergens, Gluten and Added Sulphites