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Allergy and Intolerance

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The presence of an undeclared allergen or gluten source in a food is not a concern for the majority of Canadians. However, undeclared allergens and gluten sources may represent a serious or life threatening health risk for allergic or sensitive individuals. As well, undeclared gluten may contribute to chronic health issues for those individuals with Celiac disease or gluten sensitivity.

Health Canada and the Canadian Food Inspection Agency (CFIA) have jointly identified priority foods and their derivatives which are estimated to be responsible more than 90 percent of adverse food reactions within the Canadian population.

Please visit Health Canada's Food Allergies and Intolerances and Allergy and Intolerance for a list of the priority allergens and further information regarding food allergies and intolerances.

Food allergies and intolerances have become a major issue for many food manufacturers, importers, and distributors. Increased consumer awareness, improvements in allergen detection methods, recognition of the serious consequences of undeclared allergens, and the financial impact of food recalls have all served to raise the visibility of this issue. It is important that food companies take steps to prevent the presence of undeclared ingredients in their products that may cause allergic reactions in sensitive individuals.

Hazard Analysis Critical Control Point (HACCP) systems, Good Manufacturing Practices (GMPs) and Good Importing Practices (GIPs) are food safety controls with respect to preventing allergen contamination. Many food companies have developed successful allergen prevention plans which include allergy awareness of all staff and company commitment.

Labelling Regulations for Food Allergens, Gluten Sources and Sulphites

For information on labelling regulations of food allergens please continue to Food Allergen Labelling on Health Canada's website.

Allergens that are intentionally added to a product as an ingredient or component must be included in the list of ingredients or in a contains statement on the product label. Further information regarding the Canadian Labelling Requirements can be found on Food Labelling for Industry page. The CFIA has also published A Tool For Managing Allergen Risks In Food Products that can assist users in managing allergen risks in food products.

Other Information

Causes and Sources of Undeclared Allergens

The CFIA has divided the various causes of undeclared allergens in foods sold in Canada into 8 groups.

  • Cross-Contamination or Carry Over
  • Inapropriate Use of Rework
  • Ingredient Changes, Substitutions or Additions
  • Incorrect Labels
  • Incorrect or Incomplete List of Ingredients
  • Unknown Ingredients
  • Misrepresentation of Common Names and Hidden Allergens
  • Labelling Exemptions

Hazard Analysis Critical Control Point (HACCP) Systems, Good Manufacturing Practices (GMPs), Good Importing Practices (GIPs) and other food safety controls

Information regarding food safety controls that can be used by companies to mitigate the risks associated with food allergens please visit the following sites:

Controlling food allergens in the food industry is an essential part of GMPs. The following CFIA guidance documents are designed to help manufacturers and importers create their own controls to improve food safety and meet regulatory requirements by providing a foundation for the development of a system for ensuring food safety. They are written based on the Codex Recommended International Code of Practice - General Principles of Food Hygiene.

Allergen Prevention Plan (APP)

Whether or not systems such as GMPs and HACCP are employed, an allergen prevention plan (APP) should be implemented for any operation in which potential allergen hazards exist in order to effectively manage food allergy risks. In development of an effective APP, which is often led by an allergy-prevention team, consideration is given to risk evaluation, allergen mapping, ingredient control, engineering and system design, traffic patterns, work-in-progress, rework, maintenance, packaging and labelling and training. All processing steps need to be undertaken thoroughly to ensure that even the small amounts of common allergens are addressed.

Annex 1 is a reference/example that can assist users in developing an allergen prevention plan.

Annex 1 - Developing Your Allergen Prevention Plan

Food allergies have become a major issue for many food manufacturers, packers, importers, and distributors. Increased consumer awareness, improvements in allergen detection methods, recognition of the serious consequences of undeclared allergens, and the financial impact of food recalls have all served to raise the visibility of this issue. It is important that food companies take steps to prevent the presence of undeclared ingredients in their products that may cause allergic reactions in sensitive individuals.

Hazard Analysis Critical Control Point (HACCP) systems, Good Manufacturing Practices (GMPs) and Good Importing Practices (GIPs) are food safety controls with respect to preventing allergen contamination. Many food companies have developed successful allergen prevention plans which include allergy awareness of all staff and company commitment. Effective steps can include the following:

1. Establish an allergy control team: In a large manufacturing plant this could include staff from quality assurance, purchasing, manufacturing, engineering, food safety, etc. In a small plant it is advisable to have at least one person who has the responsibility for assessing and maintaining an allergy prevention plan. The HACCP Team/Coordinator may choose to develop this prevention plan.

2. Identify the key allergens or food causing sensitivities and intolerances in your operation:

Most adverse food reactions are caused by the protein, modified protein and protein fractions of the following foods and their derivatives:

  • peanuts
  • tree nuts (almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine nuts, pistachios, walnuts)
  • sesame seeds
  • milk
  • mustard seed
  • eggs
  • seafood (fish, crustaceans and shellfish)
  • soy
  • wheat
  • gluten sources
  • sulphites

Sulphites are not true allergens. Therefore, sulphites do not cause true allergic reactions. Allergic reactions are severe adverse reactions that occur when the body's immune system overreacts to a particular protein. However, sulphites may cause severe adverse reactions (Sulphite sensitivity reactions) similar to those with food allergies. They are grouped with the priority allergens and gluten sources for convenience.

A company may wish to identify other allergens of specific concern to its products.

Conduct a hazard analysis on the incoming materials and processing steps to determine areas of greatest concern. Each product, process and possible allergen should be assessed. This can be done by preparing a master list of all ingredients, raw materials and products, identifying those that contain allergens, and indicating any special handling and storage instructions for each of them.

3.1 Review Prerequisite Programs/GMP's/GIP's:

  • Storage and Handling: Store and handle allergenic foods and ingredients in a manner that will avoid cross-contamination with other food products. This may require dedicated storage areas for the various allergen-containing ingredients handled in the plant. If it is not possible to store allergenic foods and ingredients in separate areas, it is suggested they be stored below non-allergenic foods and ingredients, e.g., in bottom shelf/rack, to prevent allergens falling on other foods and ingredients. Ensure that allergenic foods and ingredients are clearly identified by signs or colour codes.
  • Equipment and System Design: Determine which products and production lines present the highest risk. Consider dedicated lines for certain allergen-containing foods. Minimize the amount of equipment that comes into contact with allergenic ingredients by isolating allergen addition points and adding allergenic ingredients near the end of the process. Reduce cross-over of lines and design equipment to allow for complete cleaning and inspection.
  • Cleaning and Maintenance of Equipment: Ensure that your sanitation program addresses the need to remove allergenic foods. Disassemble equipment and manually clean where necessary. With equipment that is very difficult to clean, you may consider dedicating it to specific allergen-containing foods.
  • Employee Training: Incorporate allergy awareness and controls into the training for all employees, using a variety of approaches and educational materials to reinforce awareness and commitment.

3.2 Review process controls (HACCP programs where applicable):

  • Incoming Ingredients: Obtain accurate ingredient information from all suppliers to identify all allergens, including allergens present as components (ingredients of ingredients). This can be done by obtaining ingredient specification sheets, letter of guarantees, certificate of analysis or a complete list of ingredients. Ensure that they meet your company's specifications and are completely labelled. You may also consider adjusting formulations to avoid allergenic ingredients.
  • Product Formulation: Provide current written formula to production employees. Establish process controls to ensure that multi-component products are produced in accordance with the formula, to ensure a consistent product and prevent the addition of allergen-containing ingredients not listed on the label.
  • Allergen Mapping of the Plant: Using flow diagrams of the processes for multiple production lines, identify equipment that is used for both allergenic and non-allergenic products. The identified equipment may have greater potential for allergen cross-contamination. Control measures such as cleaning and production scheduling can be used to reduce the carry-over potential.
  • Production Scheduling: If dedicated lines are not available, products containing allergens should be scheduled at the end of production runs so equipment can be thoroughly cleaned, before the next run of products. The same precautions should be in place to avoid cross-contamination between products containing different allergens.
  • Use of Rework: Ensure that rework containing allergens is redirected to the originally intended product, or to a product with the same ingredients.
  • Labelling and Packaging: Ensure that the labelling and packaging is accurate and matches the right product. Ensure that ingredient substitutions are reflected on the label. Dispose of outdated labels.

4. Communicate food allergy and sensitivity awareness regularly to employees and suppliers.

5. Regularly assess the allergy prevention plan: This is to ensure continual effectiveness. Reassess after any changes are made to products or processes, e.g., ingredient suppliers, formulations, equipment, process flows, production schedules, etc.


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Date modified:
2013-07-02