CANADIAN FOOD LABELLING LAWS: WHEN IS A LABEL NOT A LABEL?

Food labelling is currently regulated by the Canadian Food and Drugs Act and Regulations, which was passed in 1954 when the effects of undeclared trace amounts of food allergens were not fully appreciated. Efforts are presently underway to make all food labelling safer for food-allergic individuals.

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By Antony J. Ham Pong, MB, BS, FRCPC, and Marion Zarkadas, MSc

Dr. Ham-Pong is lecturer, department of pediatrics, University of Ottawa, consultant, Children's Hospital of Eastern Ontario, and committee member, Regulatory Review Project 19 (labelling of food causing severe adverse reactions in Canadians), joint Agriculture & Agri-Food and Health Canada Committee, Ottawa, Ontario.
Ms. Zarkadas is a food specialist, Agriculture & Agri-Food Canada, and project leader, Regulatory Review Project 19, Ottawa, Ontario.

CASE REPORT #1
A 3-1/2-year-old boy with eczema has a milk allergy that has caused vomiting, sneezing and hives. The father purchased a bag of tortilla chips after verifying that the labelled ingredients did not include milk. The ingredients listed were corn, vegetable oil, color and seasoning (salt, monosodium glutamate [MSG]). The boy ate three tortilla chips and immediately experienced a burning sensation in the mouth and facial swelling. He was treated with epinephrine in the emergency department of a nearby hospital.
The manufacturer was contacted and revealed that, in addition to salt and MSG, the seasoning contained milk products, cheese, onion powder, garlic powder, tomato powder, imitation parsley, and may also contain caramel and annato.

CASE REPORT #2
A 17-month-old boy had a history of milk allergy, eczema and asthma. Thirty-five minutes after eating chicken with teriyaki sauce at a Japanese restaurant, he began to experience wheezing and hives that required treatment in the emergency department. The boy has had chicken at the same restaurant previously without any difficulties. The manufacturer of the teriyaki sauce was contacted regarding the components, but the child was not known to be allergic to any of them. On the allergist's advice, the father obtained the ingredient list of the chicken served at the restaurant, which was located on the bulk shipping carton. The list indicated the presence of milk solids in the chicken.

These case histories illustrate some of the difficulties experienced by individuals with food allergies under the current Canadian Food and Drugs Act and Regulations (FDR). The FDR came into force in 1954 and is a consumer-protection statute dealing with health, safety and economic-fraud aspects of food, drugs, cosmetics and medical devices.' Health Canada and Agriculture & Agri-Food Canada (HC/AAFC) currently are reviewing regulation that would affect the labelling of food that is known to cause adverse reactions. Unfortunately, at the time the FDR was passed, food allergies and the possible impact of undeclared trace amounts of allergens in food were not fully appreciated. This has led to serious consequences for food-allergic individuals.

The Canadian FDR, which apply to prepackaged food at all levels of trade in Canada, require a complete list of ingredients on the labels of almost all food. Within these regulations, however, certain food ingredients are exempt from declaration of some or all components (ingredients of ingredients). In addition, common names for some forms of hydrolysed plant proteins and starch do not identify the plant source. As a result, it is possible for food that causes adverse reactions in hypersensitive individuals to be present in a prepackaged food in Canada without being identified on the food label.
 

The patient in the first case report ran afoul of the exemptions listed in Table 1. If a seasoning constitutes less than 2% of a total food product, the ingredients of the seasoning do not necessarily have to be declared. The tortilla chip seasoning contained milk proteins and other components that were not declared, but were present in sufficient quantities to cause an acute allergic reaction. Salt and MSG were declared as required by regulation (Table 2). The food ingredients listed in Table 1 contain common allergenic components that do not have to be declared and, thus, may lead to unexpected allergic reactions.

TABLE 1

SOME "INGREDIENTS" THAT ARE EXEMPT FROM DECLARATION OF THEIR COMPONENTS WHEN ADDED TO OTHER FOOD    Margarine  Starches  Standardized bread  Glucose and corn syrup  Prepared or preserved meat, fish, poultry or their byproducts, if they constitute less than 10% of another food     product  Hydrolyzed plant protein  Flavoring preparations  Spice mixtures  Seasoning and herb mixtures  Taken from: Canadian Food and Drug Regulations, section B.01.009, division 1, part B.

The following are examples of food that contain allergenic components that are declared on the label when sold separately. When that food is added as an ingredient of another food, however, some of the components do not have to be declared.
Most types of margarine contain milk proteins, and starches and modified starches may not always be identified by plant source. Standard bread contains wheat, but may also contain milk, egg and other flours (such as chickpea flour), up to 5% of the total weight. If bread is added as an ingredient to another food, such as bread crumbs, these components do not have to be declared. Glucose and corn syrup may contain sulfites.

The greatest source of confusion regarding allergic reactions appears to be with flavoring preparations, seasonings and spice mixtures. "Natural flavours" can’t include milk, egg, fish, beef extract and other components. Food that has a higher risk of containing undeclared milk proteins includes seasoned chips (such as potato and tortilla chips), batter, coated or seasoned french fries, hot dogs and processed meats. Fish may be found as flavoring ingredients in cheese spreads, salad dressings, flavoured croutons and Worcestershire sauce. Other examples of products regarded as 'seasonings" include ketchup, soya sauce, prepared mustard, Worcestershire sauce and cheese powders. Seasonings may also include carriers and binders that may contain salt, sugar, lactose, whey powder and other milk powders, cereal flours and starches.

TABLE 2

SOME FOOD ADDITIVES THAT MUST BE LISTED  Flavoring enhancers: e.g., monosodium glutamate  Salt  A food additive in excess of the amount required for normal effect  pH-adjusting agents such as citric acid, lactic acid or sulfites added directly to the food

Table 3 lists typical ingredients of Worcestershire sauce that must be declared on the label of the sauce as sold, and compares this list to the components that must be declared when the sauce is less than 2% of the total product and is labelled as "seasoning." As can be seen, several allergens, including fish and walnut, may be present but do not have to be labelled when Worcestershire sauce is identified as seasoning in a food product.

The second patient developed an allergic reaction because of the presence of an unexpected allergen--milk protein--in retail chicken. Certain foods sold at the retail level (Table 4) are exempt from ingredient listings, and this includes food served in eating establishments. The original shipping container containing bulk food, however, should have an ingredient list that identifies the offending component, as determined subsequently in this case. In practice, it may be difficult to obtain that ingredient list quickly, since the original bulk packaging may have been discarded.

TABLE 3
WORCESTERSHIRE SAUCE: AN EXAMPLE OF COMPONENT EXEMPTION

Possible ingredients Malt vinegar  Molasses  Sugar  Salt  Shallots  Tamarinds  Walnuts  Anchovies  Onion powder  Chilies  Cloves  Garlic powder  Chili essence  Pepper  Lemon oil

Components declared when Worcestershire  sauce is < 2% of product  Seasoning Salt

PRECAUTIONARY LABELLING
Precautionary labelling of food was allowed by Field Operations Directorate, Health Protection Branch of Health and Welfare Canada in March, 1994. This recognized that, due to cross-contamination, certain food products may inadvertently contain compounds that can cause severe reactions, allergic or otherwise. Canadian food manufacturers, therefore, have been allowed to use the words "may contain" to indicate the potential presence of these products, usually allergens that can cause severe reactions. This was intended as a nonregulatory initiative to allow consumers to make informed choices about potential allergens in food.

Manufacturers were informed that this type of labelling must be used judiciously and should only be temporary until adequate steps can be taken to ensure the absence of the identified food. There have been some concerns expressed by allergic individuals that such precautionary labelling may be used in place of good manufacturing practices as a type of reverse disclaimer, to protect manufacturers from legal liability. While most manufacturers adhere to good manufacturing practises and use precautionary labelling to protect and inform the consumer, the extent of indiscriminate use of precautionary labelling is unknown.

TABLE 4

SOME PREPACKAGED PRODUCTS EXEMPT FROM INGREDIENT LISTING  Bulk food packaged at retail  Individual food portions served with meals or snacks  Single servings of crackers, sugar, ketchup, mustard, etc.  Individual food sold in automatic vending machines or mobile canteens  Poultry and meat cooked at retail  Standardized alcoholic beverages and vinegar  Taken from: Canadian Food and Drug Regulations, section B.01.008, division 1, part B.

TABLE 5

PROPOSED CANADIAN LIST OF FOOD THAT SHOULD ALWAYS BE DECLARED ON FOOD LABELS (HC/AAFC) Wheat, rye, barley, oats and hybridized strains Peanuts, tree nuts, soy Sesame Milk Eggs Fish and Shellfish Sulfites greater than/equal to 10 ppm

FUTURE DIRECTIONS
A review of the FDR was initiated in 1993 and is still ongoing. Of interest to allergists and allergic consumers is a joint consultation on "Labelling of food causing severe adverse reactions in Canadians" by Agriculture & Agri-Food Canada and Health Canada. This committee is currently attempting to identify food that can cause anaphylactic, life-threatening or seriously debilitating medical conditions, to clarify the impact of the regulations on the labelling of this food and to propose changes to those regulations so that this food can be more accurately identified on food labels. This consultation group will also make recommendations on precautionary labelling. The proposed Canadian list of food (Table 5) is similar to that of the draft list prepared by the Codex Committee on Food labelling (Food and Agriculture/World Health Organization, 1996).

Currently, a food-allergic individual must be knowledgeable and careful to avoid ingesting prepackaged food containing undeclared allergens. At present, that person needs to be aware that certain food may have a higher risk of carrying certain allergens, even if that risk is not stated as such on the label. He or she must also know that cross-contamination with allergenic food can occur both at the manufacturing and retail level.

These proposed regulatory changes, if enacted, will allow the vast majority of food-allergic individuals to recognize when traces of allergenic food is present in a food product simply by reading the label.

REFERENCES
1 . A strategic direction for change: A review of the regulations under the Food and Drugs Act. Health Protection Branch, August 1993, 1:9.
2. Canadian Food and Drug Regulations, section B.01.009, division 1, part B.
3. Canadian Food and Drug Regulations, section B.01.008, division 1, part 8.

Appeared in ALLERGY in September 1996. Used by permission of the author.  

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