ARCHIVED - Health Canada's Proposal to Update the Canadian List of Food Allergens Requiring Enhanced Labelling

Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch

August 2009

Purpose

As a result of public comments received upon publication of Health Canada's proposed regulatory amendments entitled 'Project 1220 – Enhanced Labelling for Food Allergen and Gluten Sources and Added Sulphites', Health Canada considered the inclusion of mustard, garlic and onions in the definition of food allergens.

Health Canada scientists have subsequently conducted a systematic literature review of the available information on the potential allergenicity of mustard, garlic and onions, to determine the scientific validity of adding these foods to the Canadian list of allergens requiring enhanced labelling in Canada.

As a result of their assessment, Health Canada scientists have concluded that mustard fulfils the Canadian criteria of a priority food allergen and are now proposing its addition to the list of allergens requiring enhanced labelling; also, as a result of similar scientific investigation, it has been determined that there is insufficient evidence to include garlic or onions in this list. Therefore, the Department will be adding mustard seeds, and not adding garlic or onions to the Canadian list of allergens requiring enhanced labelling, as part of the same regulatory amendments.

Background

Food allergies are sensitivities caused by a reaction of the body's immune system to specific proteins in a food. Current estimates are that food allergies affect as many as 6% of young children and 3% to 4% of adults.

In allergic individuals, a food protein is mistakenly identified by the immune system as being harmful. The first time an allergic individual is exposed to such a protein, the body's immune system responds by creating antibodies called immunoglobulin E (IgE). When the allergic individual is exposed again to the same food protein, IgE antibodies and chemicals such as histamine are released. Histamine is a powerful chemical that can cause a reaction in the respiratory system, gastrointestinal tract, skin or cardiovascular system. In the most extreme cases, food allergies can be fatal. Although any food can provoke an immune response in allergic individuals, a few foods are responsible for the majority of food allergies.

In Canada, 'food allergens requiring enhanced labelling' are those which are most frequently associated with food allergies and allergy-type reactions and require enhanced labelling. These Canadian 'priority food allergens' are currently defined as: peanuts; tree nuts (almonds, Brazil nuts, cashews, hazelnuts (filberts), macadamia nuts, pecans, pine nuts (pignolias), pistachio nuts and walnuts); sesame seeds; milk; eggs; fish; crustaceans; shellfish; soy and wheat. Sulfites are considered a food additive, but are treated with the same degree of concern as a food allergens requiring enhanced labelling since they can also cause anaphylaxis-type reactions in sensitive individuals.

Current Situation

In Canada, the Food and Drug Regulations require that most prepackaged foods carry a label and that their ingredients appear on these labels in decreasing order of proportion. However, some ingredients used in food products are currently exempt from declaration in the list of ingredients (i.e.: components of margarine, seasoning and flour).

On July 26, 2008, Health Canada published proposed amendments to the Food and Drug Regulations (1220 – Enhanced Labelling for Food Allergen and Gluten Sources and Added Sulphites) in Canada Gazette, Part I (CGI). The overall objectives of the proposed regulatory amendments are:

• To minimize risks associated with inadvertent consumption of undeclared food allergens, gluten sources and added sulphites; and
• To maximize choice of safe and nutritious foods for consumers with food allergies and celiac disease.

The proposed regulatory amendments would require that the presence of any food allergen requiring enhanced labelling, gluten source or added sulfites be declared on food labels whenever they, or their derivatives, are added to prepackaged foods having a list of ingredients, whether they are added as ingredients or as components of ingredients.

Just over 140 comments were received from the general public, patient groups, health professionals, consumer organizations, and governmental agencies during the public comment period which followed publication of these proposed regulatory amendments in Canada Gazette, Part I.

Of the responses, many of which came from individual families and health professionals, a significant number requested that mustard be added to the list of food allergens requiring enhanced labelling based on observing/witnessing, or experiencing adverse reactions associated with the consumption of mustard or food products containing mustard. A smaller, yet significant number of correspondents requested that garlic and/or onions be added to the list of food allergens requiring enhanced labelling.

In order to establish a new food allergen requiring enhanced labelling in Canada, scientific information obtained through the systematic review of available scientific literature must be assessed using pre-established criteria. In Canada these criteria include following the recommendations required to amend the Codex Alimentarius Commission's ^{Footnote 1} list of priority allergenic foods by individual countries. Examples of these recommended criteria are as follows:

• A scientifically proven cause-effect relationship between exposure to the food in question, and the symptoms of severe allergic reactions should exist.
• Reports of systemic-type reactions following exposure to the food must be identified.
• A scientific assessment of all available information on reactions from the food should be carried out (i.e.: prevalence data in children and adults, clinical studies).

Additional consideration is given to the possibility that the food or food ingredient may become a hidden source of food allergens in pre-packaged food products for sale in Canada, as a result of the Canadian labelling regulatory context (i.e.: exemption from ingredient labelling, etc...).

Review of Mustard as a Priority Food Allergen

Health Canada scientists conducted a systematic review of the available information on the allergenicity of mustard in order to determine the scientific validity of its inclusion on the list of priority food allergens in Canada.

A total of 42 publications from the scientific literature were considered relevant to the assessment of mustard as a food allergen.

Consideration of the following scientific evidence has resulted in Health Canada's decision to propose the addition mustard to the list of priority food allergens:

• There are Canadian case reports supporting the occurrence of mustard food allergies in children and adults in Canada ;
• European data indicate mustard is the 3^rd or 4^th most common food allergen in France and mustard is recognized as an allergen by the International Union of Immunological Societies (IUIS, 2009);
• A credible cause-effect relationship is supported by positive double-blind, placebo-controlled, food challenge studies designed to assess the allergenicity of mustard;
• Reports describe severe systemic reactions following exposure to small amounts of mustard within foodstuff;
• Results from characterization studies of allergenic proteins indicate that proteins in mustard are resistant to degradation by heat and digestive enzymes which makes these proteins more likely to withstand food processing; and
• The thermostable allergenic proteins in mustard have the potential to be hidden within certain ingredients, preparations and mixtures in processed and pre-packaged foods, with exemptions from individual component declaration.

The currently available scientific evidence fulfills all Canadian criteria for the addition of mustard to the list of priority food allergens in Canada. As a result, Health Canada has recommended that mustard be added to the list of food allergens requiring enhanced labelling, and that the proposed amendments to the Food and Drug Regulations relating to the labelling of food allergens should reflect this decision accordingly.

Review of Garlic and/or Onion as a Priority Food Allergen

Health Canada scientists conducted a systematic review of the available information on the allergenicity of both garlic and onions in order to determine the scientific validity of including garlic and/or onions to the list of food allergens requiring enhanced labelling in Canada.

A total of 36 publications from the scientific literature were considered relevant to the assessment of garlic and/or onions as a food allergen. The review of the scientific information currently available does not provide sufficient evidence to fulfill the Canadian criteria required to add new allergens to the list of priority allergens. Although there is scientific evidence suggesting that some individuals experience severe reactions with the consumption of garlic and/or onion, neither is considered to be a common food allergen in children and adults; furthermore, there are insufficient clinical data to establish a credible cause-effect relationship for the oral allergenicity of garlic and/or onions.

In addition, based on the currently available scientific information, the potential for severe allergic reactions to occur as a result of hidden sources of garlic and/or onion in pre-packaged foods is considered minimal.

Recommendations

After its completion of detailed scientific assessments, Health Canada scientists have concluded that mustard fulfils the Canadian criteria to be added to the list of food allergens requiring enhanced labelling, but that there is insufficient evidence to include garlic or onions to this list. The Department is therefore proposing to add mustard to the Canadian list of food allergens requiring enhanced labelling, to ensure that the proposed food allergen labelling regulatory amendments reflect this decision.

Additional Information

For more information on this proposal, please contact the Bureau of Chemical Safety, at: 613-957-0973 or bcs-bipc@hc-sc.gc.ca.