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

Precautionary Labelling for Allergens in Pre-packaged Foods

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

---

I. Applicable Products

Q1. Which priority food allergens are required to be declared on food products?

In Canada, the priority food allergens are peanuts; the following tree nuts (almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine nuts, pistachios, walnuts), sesame seeds; milk; eggs; fish (including crustaceans (e.g. crab, crayfish, lobster, shrimp) and shellfish (e.g. clams, mussels, oysters, scallops), soy; wheat; and sulphites. These priority allergens have been shown to account for more than 90% of severe adverse reactions related to food allergens.

Priority Food Allergens in Canada

• Peanuts
• Almonds, Brazil nuts, cashew nuts, hazelnuts, macadamia nuts, pecans, pine nuts, pistachios, walnuts
• Sesame Seeds
• Milk
• Eggs
• Fish, Crustaceans, Shellfish
• Soy
• Wheat
• Sulphites

Q2. When are priority food allergens required to be declared?

Priority food allergens must be declared on all pre-packaged foods labelled with a list of ingredients so that consumers with food allergies are alerted to avoid the product.

Except in the case of the following foods when they do not declare a list of ingredients:

• prepackaged foods packaged from bulk and sold at the same retail store;
• prepackaged meat, poultry and their by-products that are barbecued, roasted or broiled on the retail premises;
• prepackaged individual servings of foods, such as sandwiches, made at a commissary and sold through automatic vending machines or mobile canteens;
• prepackaged individual portions of foods served by restaurant or other commercial enterprise with meals or snacks, such as condiments, crackers;
• prepackaged alcoholic beverages with composition standards set out in Division 2, FDR;
• prepackaged vinegars with composition standards set out in Division 19, FDR;
• prepackaged one bite confections sold individually; and
• prepackaged fruit and vegetables that are packaged in a wrapper or confining band of less than ½ inch in width.

Q3. When must sulphites be declared?

Although sulphites are not considered to be a true allergen, they are included as a priority food allergen since they can cause severe adverse reactions in people with sulphite sensitivities. If sulphites are added directly as an ingredient to a pre-packaged food with a list of ingredients or where sulphites are present as components of ingredients not exempt under B.01.009 of the Food and Drug Regulations (FDR), then their presence, at any level, must be declared in accordance with B.01.008 of the FDR.

Where an ingredient containing sulphites is added to a food and is normally exempt from declaring its components under B.01.009 FDR, the sulphites must be declared if the amount of sulphites in the final food is greater than 10 p.p.m. For example, wine, a standardized alcoholic beverage, is exempt from displaying a list of ingredients under B.01.008 and from declaring its components when used as an ingredient in another food under B.01.009; however, many wines contain sulphiting agents. Therefore, despite these exemptions, when wine is used as an ingredient in a food and the final food contains more than 10 p.p.m. sulphites from the wine (or originating from other ingredients), the sulphites must be declared.

Q4. How do the requirements for declaring added priority food allergens relate to the exemptions under section B.01.009 of the Food and Drug Regulations (FDR)?

Section B.01.009 FDR exempts certain foods from declaring their components when these foods are used as ingredients in another food. As failure to declare food allergens may be contrary to subsection 5.(1) of the Food and Drugs Act, the exemptions in section B.01.009 FDR do not apply to priority food allergens. Added priority food allergens must be declared on all pre-packaged foods with a list of ingredients in a manner that alerts the consumer with food allergies to the presence of the food allergen.

Health Canada has advised that the declaration of all priority food allergens, gluten sources and sulphites will be required under the proposed enhanced allergen labelling regulations. It is expected that these amendments will require the use of plain language, such as milk, in addition to sodium caseinate, to describe the presence of the priority food allergens.

Q5. If an ingredient exempt from component declaration under B.01.009 FDR is used as an added ingredient in a prepackaged product, are the priority food allergenic components of this ingredient required to be declared on the prepackaged product?

Yes, if  the final prepackaged food is labelled with a list of ingredients. A prepackaged food product, labelled with a list of ingredients, is unsafe for people with food allergies if some of those ingredients or components are priority allergens and are not declared on the label.

For example: If margarine that contains milk ingredients is used as an ingredient in prepackaged cookies, the presence of any milk ingredients must be shown on the label of the prepackaged cookies, even though margarine is exempt from component declaration when added as an ingredient under section B.01.009, FDR.

Q6. When an ingredient is exempt from component declaration under subsection B.01.009 (1) of the Food and Drug Regulations, must all the components be declared if any priority food allergens are declared?

No, only the priority food allergens are required to be declared.

Q7. When a list of ingredients is voluntarily declared on a display sign for foods sold from bulk, do the priority food allergens have to be declared?

Yes, if a company provides a list of ingredients, all priority food allergens present must be declared. This also applies to display signs on foods sold from bulk.

Q8. Is coconut, as a tree nut, considered a priority food allergen?

No, coconut is not considered a priority food allergen at this time. The allergenic tree nuts that are required to be declared are: almonds, Brazil nuts, cashew nuts, hazelnuts, macadamia nuts, pecans, pine nuts, pistachios and walnuts.

Q9. How must priority food allergens be declared when they are present in a food?

When a prepackaged food contains a priority allergen or a protein-containing derivative of a priority food allergen, the name of the food allergen must be declared. For example, if milk protein is present (casein or B-lactoglobulin), milk must be declared on the label. In addition, the specific species of fish, crustacean or shellfish must also be declared (e.g. tuna, oysters, shrimp).

There are three options for the format for declaring priority allergens:

Option 1
Declare all of the components in each ingredient in brackets after the ingredient name.

For example:
List of ingredients: haddock, batter (water, modified cornstarch, wheat flour, salt, soy oil, sodium bicarbonate, milk ingredients, guar gum), toasted wheat crumbs (wheat flour, palm oil shortening, salt, yeast), seasoning (herbs, spices, wheat flour, sesame seeds), lemon juice with sulphites. Fried in hydrogenated soy oil.

Explanation:
The batter and lemon juice do not have any regulatory exemption from declaring their components. All their components must be declared.
Toasted wheat crumbs and seasoning are exempt from declaring non-allergenic components by subsections B.01.009 (1) and (2), FDR respectively. The option chosen here is to declare all the components when the allergenic components are present in the food ingredients.

Option 2
Declare the name of the priority food allergens in plain language in brackets after the ingredients. The allergen is required to be declared only once in the list of ingredients. The other components that are not included in the priority allergen list are not required to be declared if the ingredient is exempted from component declaration under subsection B.01.009 (1), FDR.

For example:
List of ingredients: haddock, batter (water, modified cornstarch, wheat flour, salt, sodium bicarbonate, milk ingredients, guar gum), toasted wheat crumbs, seasoning (sesame seeds), lemon juice with sulphites, Fried in hydrogenated soy oil.

Explanation:
The batter and lemon juice ingredients do not have any regulatory exemption from declaring their components. All their components must be declared. For the toasted wheat crumbs, "wheat" does not have to be declared as it is in the name of the ingredient. "Wheat" does not have to be declared in the seasoning as it is already declared in the batter and the toasted wheat crumbs, however, the sesame seed must be declared.

Option 3
Use a "Contains" statement to list all the priority food allergens present in the food product. If this statement is used, it must declare all the food allergens present in the food. The statement must be shown at the end of the list of ingredients.

For example:
List of ingredients: haddock, batter (water, modified cornstarch, wheat flour, salt, sodium bicarbonate, milk ingredients, guar gum), toasted wheat crumbs, seasoning, lemon juice with sulphites, Fried in hydrogenated soy oil.
Contains: haddock, wheat, milk, sesame seeds, soy, sulphites.

Explanation:
The option chosen here is to use a "contains" statement to list all of the food allergens in the food. If proof can be provided that the soy oil does not contain any soy proteins, it will not be required to be listed with the allergen names in the "contains" statement.

Q10. Is the "contains" statement required to be declared in English and French?

Yes, since it is used to indicate the presence of priority allergens in a food product, it is considered to be mandatory information. If the product meets the criteria for a "local product" set out in subsection B.01.012 (1), FDR, and is permitted to be labelled in one of the official languages, the "contains" statement may be shown in the same official language.

Q11. When soy oil is used as an ingredient in another food, must the allergen source "soy" be declared?

When a pre-packaged food contains a priority food allergen or a protein-containing derivative of a priority food allergen, the name of the food allergen must be declared. If refined soy oil does not contain protein residue, it is not considered to be a risk to consumers with soy allergies. Therefore, the name of the allergen source is not required to be declared

Q12. Ingredients, such as lecithin, mono and diglycerides, starches etc., can be derived from food allergens. Is the allergen source for these ingredients required to be declared?

If the ingredient contains any protein from the allergen source, the food allergen source must be declared e.g. soy lecithin, wheat starch, egg lecithin etc.

It is expected that the future food allergen labelling amendments to the FDR will require the declaration of the sources of lecithin, hydrolyzed protein, starch and modified starch, regardless of the source or the presence or absence of protein residue.

II. Precautionary Statements

Q13. 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.

Q14. 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.

Q15. 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.

Q16. 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.

Q17. 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.

Q18. 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.

Q19. 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.

Q20. 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.

Q21. 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.

Q22. 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.