Questions and Answers About the New Regulations to Enhance the Labelling of Food Allergens, Gluten and Added Sulphites

General

Q1. What are the foods that will need to be declared under the new allergen labelling regulations?

A1. The following foods, or any of their protein-containing derivatives, are the allergens that will need to be declared under the new regulations:

1. almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine nuts, pistachios or walnuts;
2. peanuts;
3. sesame seeds;
4. wheat, kamut, spelt or triticale;
5. eggs;
6. milk;
7. soybeans;
8. crustaceans;
9. shellfish; or
10. fish.

Also,

The gluten source will need to be declared when a food contains gluten protein or modified gluten protein from barley, oats, rye, triticale or wheat, including kamut or spelt;

Added sulphites will have to be declared when directly added to a food, when they are components of an ingredient not exempted from component declaration or when the total amount of sulphites contained within the food is 10 parts per million or more.

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Q2. How was it determined which foods should be declared under the new regulations?

A2. A working group consisting of representatives from Health Canada, the Canadian Food Inspection Agency (CFIA), and practicing pediatric allergists, working in consultation with various consumer groups¹, developed a scientifically-based list of foods known to cause severe adverse reactions in sensitive individuals. This working group published its conclusions in 1999, providing the scientific foundation for the identification of priority allergens in Canada². The list of foods that must be declared under the new regulations is based on the working group's conclusions. This list is expected to be consistent with the list of foods and ingredients known to cause hypersensitivity which are required to be declared in the list of ingredients by the Codex Alimentarius General Standard for Labelling of Prepackaged Foods.

1. The Canadian Society of Allergy and Clinical Immunology, the Allergy/Asthma Information Association, the Canadian Celiac Association and other experts in food allergies and sensitivities in Canada and the United States.
2. Zarkadas, M., Scott, F.W., Salminen, J., Ham Pong, A. (1999). Common Allergenic Foods and Their Labelling in Canada - A Review. Can. J. All. & Clin. Immunol., 4(3): 118-141.

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Q3. Coconut is a "tree nut". Will all tree nuts, including coconut, need to be declared on food labels?

A3. No, only the tree nuts identified in the new regulations will have to be declared. However, coconut will have to be declared in the same manner as any other ingredient that is not a food allergen.

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Q4. What should I look for on a food label to find out if the food product has had a food allergen or gluten source added to it?

A4. You should always read the list of ingredients first. Under the new regulations manufacturers will have the option of declaring an added food allergen or gluten source either in the list of ingredients or in a statement immediately after the list of ingredients called "Allergy and Intolerance Information - Contains:''. If you don't see the allergen or gluten source in the list of ingredients, look for the statement.

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Q5. I have Celiac Disease, how will the new regulations better help me to identify safe food choices?

A5. The consumption of cereal grains containing "gluten" causes the immune system of a celiac to react negatively to its presence, causing damage to the inner lining of the small bowel, reducing the person's ability to absorb essential nutrients. These grains include: wheat (e.g., durum, spelt, kamut), barley, rye, and their cross-bred hybrids (e.g., triticale, which is a cross between wheat and rye). Currently the only treatment for celiac disease is to continually maintain a strict gluten-free diet. This disease affects nearly 1% of the population. The new regulations require that food containing gluten or gluten protein will have to include the common name of the gluten source in the list of ingredients.

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Q6. Will some food products be exempt from the requirement to declare food allergens, gluten sources or added sulphites?

A6. The new regulations will cover all prepackaged foods that have a list of ingredients.
Some foods that are not required to have a list of ingredients will continue to be exempt from ingredient declaration. They are:

(a) prepackaged products packaged from bulk on retail premises, except prepackaged products that are a mixture of nuts;

(b) prepackaged individual portions of food that are served by a restaurant or other commercial enterprise with meals or snacks;

(c) prepackaged individual servings of food that are prepared by a commissary and sold by automatic vending machines or mobile canteens;

(d) prepackaged meat and meat by-products that are barbecued, roasted or broiled on the retail premises;

(e) prepackaged poultry, poultry meat or poultry meat by-products that are barbecued, roasted or broiled on the retail premises;

Prepackaged fresh fruit and vegetables that have had a wax coating applied to them as a covering will also be exempt.

If a manufacturer chooses to provide a list of ingredients for any of these foods, then the allergen labelling requirements defined by the regulations will apply.

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Q7. What is the difference between a food, an ingredient, and a component?

A7. The legal definition of "food" is in the Food and Drugs Act, and the definitions for "ingredient" and "component" are in the Food and Drug Regulations. Essentially, a food is anything that is manufactured, sold or represented for use as food or drink for humans. Ingredients are individual foods that are combined to make prepackaged food products. Components can be thought of as ingredients of ingredients.

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Q8. What is a "prepackaged food" or a "prepackaged product"?

A8. In practice, the terms are used interchangeably. According to the Food and Drug Regulations, "prepackaged product" means any food that is contained in a package in the manner in which it is ordinarily sold to or used or purchased by a person;

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Q9. What about hydrolysed plant protein, starch, and lecithin? Will the new regulations require that the sources of these ingredients be identified?

A9. Yes, the regulations will require that a list of ingredients identify the specific sources of hydrolysed plant proteins, starches and modified starches, and lecithins. These plant or animal sources may or may not be food allergens themselves, but this will allow allergic individuals to make informed choices when purchasing foods containing these.

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Q10. I have noticed statements such as "May contain milk ingredients" or "Manufactured in a facility that also processes nuts" on many food product labels. Does this kind of labelling have something to do with the new regulations?

A10. No, these are examples of "allergen precautionary labelling", used to notify consumers that a food allergen may be unintentionally present in a food. The new regulations cover food allergens, gluten sources and sulphites that have been deliberately added to foods as part of food manufacture.

For more information on precautionary labelling, please visit Health Canada’s website.

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Q11. Once the new regulations are in place, how much time do manufacturers and importers have before their food products must comply with the new labelling requirements?

A11. Manufacturers and importers will have one year to adopt the new labelling changes once they have been published in the Canada Gazette Part II; however, any manufacturer or importer who chooses to use the "Allergy and Intolerance Information - Contains:'' statement before that year expires will need to comply immediately with all the new labeling changes as applicable.

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Q12. Since manufacturers and importers have one year to change their food labels, how will consumers who are food allergic, or gluten intolerant or sulphite-sensitive be protected in the meantime?

A12. Right now both Health Canada and the Canadian Food Inspection Agency (CFIA) are strongly urging manufacturers and importers to follow Health Canada's directions for the labelling of prepackaged foods containing priority allergens, gluten sources and added sulphites. Individuals who need to avoid certain foods should carefully read food product labels. Should Health Canada identify a significant health risk regarding undeclared food allergens, gluten sources, or added sulphites in a prepackaged food, the CFIA may take enforcement action as needed to protect the health of Canadians.

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Q13. Are Canada's new requirements for labelling food allergens the same as those of other countries?

A13. Every effort has been made to harmonize with other countries which have developed similar food labelling laws, i.e.: the European Union, Australia/ New Zealand, and the United States. However, each authority must balance between regulating the priority food allergens that form a significant health risk within their country, adapting the particularities of their own national and federal statutes. For example, both the U.S. and Canada require food allergens to be declared either in the list of ingredients or in a statement that indicates the food product contains the allergen. Canada requires that the statement be entitled "Allergy and Intolerance Information - Contains" to clearly indicate that the information in the statement is in addition to the information in the list of ingredients.

For more information on allergen labelling requirements in the United States, please visit the
Food and Drug Administration's website.

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Q14.Is there a website for the Canadian Food Inspection Agency where I can find more information about food allergen labelling in Canada?

A14. Yes. Please visit the CFIA's Food Allergens website.

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Sulphites

Q15. Don't the current Food and Drug Regulations already require that sulphites be labelled in the list of ingredients?

A15. The current Regulations require that sulphites, like any other food additive, be declared in the list of ingredients of food labels when they are added directly to a prepackaged food or when it is a component of an ingredient not exempt from component declaration. However, the Regulations currently exempt certain ingredients from component declaration. If sulphites are a component of one of these ingredients they would not have to be declared. Under the new regulations, when present in the finished food at a level of 10 parts per million or more, added sulphites will have to be declared on the label using the statement "Allergy and Intolerance Information - Contains". Documented reactions to sulphites occurred at levels of 10 parts per million or above. There will be no changes to the requirements of sulphites declaration when used as a food additive.

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Q16. Under the new regulations, will sulphites that are added directly to a prepackaged food only need to be declared if they are present at a level of 10 parts per million or more?

A16. No, any sulphites that are added directly to a prepackaged food or are a component of an ingredient not exempt from component declaration, must be declared in accordance with the existing requirements of declaration of food additives in the list of ingredients at any level. It is only when the inherent level of sulphites present in a food go beyond 10ppm that most documented allergic reactions occur; hence, beyond this level sulphites should be included in the specific statement "Allergy and Intolerance Information - Contains:" alerting the sensitive consumer of the potential for risk.

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Q17. If sulphites are added to a prepackaged food, how does it have to be declared?

A17.

1. If any amount of sulphites are added (food additive ingredient), this must be declared in the list of ingredients as outlined in the current regulation. This is the case for any addition of a food additive.
2. Sulphites added directly as an ingredient at a level of 10ppm or higher, will have to be listed in a statement immediately following the list of ingredients "Allergy and Intolerance Information - Contains:", as well as being included in the list of ingredients as required in the existent regulation pertaining to food additives (see 1 above).
3. Added sulphites, which are components of ingredients exempt from component declaration present in a concentration less than 10ppm, do not require declaration.
4. Added sulphites, which are components of ingredients which are not exempt from component declaration, must be declared at any level.
5. Added sulphites, which are components of ingredients present in a concentration of 10ppm or greater will have to be listed in a statement following the list of ingredients "Allergy and Intolerance Information - Contains:".
6. Sulphites naturally present in a product at any level are exempt from declaration.

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Q18. What should I look for on a food label to find out if a food has had sulphites added to it?

A18. Check the list of ingredients first and also look for a statement immediately after the list of ingredients called "Allergy and Intolerance Information - Contains:". The manufacturer must declare sulphites in this statement if sulphites have been: directly added to the food, added indirectly as components of an ingredient not exempt from component declaration or, are exempt ingredient components present in the food at a level of 10 parts per million or more. This statement is mandatory when sulphites are added at a level of 10 ppm or more, unlike the optional use of this statement for food allergens or gluten (See Q11).

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Standardized Foods

Q19. What is a "standardized food"?

A19. The Food and Drug Regulations contain descriptions of certain foods that specify, for example, what is allowed in those foods as ingredients. These descriptions are standards of identity and composition that have to be met for a food to be legally called by the name in the standard. The foods are referred to as "standardized foods". Examples of standardized foods include bread, milk, cheese, orange juice, sausage, jam, wine, beer, vinegar and salt. Foods that do not have a standard of identity are referred to as "unstandardized foods". Snack foods like potato chips, various bakery items such as rolls, donuts and cakes, yogurt, and pizza are examples of unstandardized foods.

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Q20. Will the new regulations require food allergens to be declared for beer, wine, and other standardized alcoholic beverages that do not need a list of ingredients?

A20. Although standardized alcoholic beverages such as beer and wine are not required to have a list of ingredients, if they contain a food allergen then the food allergen will need to be declared somewhere on the label in the statement called "Allergy and Intolerance Information - Contains:''. However, milk, egg and fish will not have to be declared when fining agents derived from these allergens are used in the manufacture of standardized alcoholic beverages or bourbon whiskey. Health Canada may reconsider this position should there be available scientific evidence suggesting that residues of these fining agents remain in the final beverage products that could cause a health risk to susceptible individuals.

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Q21. I have never noticed an ingredients list on vinegar. How will I know if vinegar contains a food allergen?

A21. Under the new regulations vinegar and various standardized vinegar products will be required to declare food allergens, gluten sources and added sulphites somewhere on the label in the statement called "Allergy and Intolerance Information - Contains:''.