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Allergen control under HACCP

Allergen control under HACCP

In the last few years, industry has increased its food safety efforts towards better identification and control of allergens. Food allergy is an abnormal immune response to dietary components, usually proteins. It is reported that 4% of the Canadian population is affected with approximately 150-200 deaths per year due to anaphylaxis in North America. According to a 2011-2012 review of food recalls and withdrawals in the US, 35% of all incidents were due to mislabelling or non-labeling of allergenic ingredients.  For the consumer suffering from allergies, avoidance of food allergens by carefully reading food labels is the most effective prevention.

On August 4, 2012, new Enhanced Labelling for Food Allergen Regulations came into force in Canada.  These regulations increased the labelling requirements for prepackaged foods containing specific types of priority allergens, gluten sources and added sulphites. The food sector was given 18 months to comply with the new requirements which included the declaration of “priority allergens.” The 11 food allergens of interest are peanuts, tree nuts (almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine nuts, pistachio nuts and walnuts), sesame seeds, milk, eggs, fish, crustaceans and shellfish, soy, wheat, sulphites and mustard. In order to provide guidance to the food sector, the Canadian Food Inspection Agency (CFIA) has made available a “tool for managing allergen risks in food products”. As a side note, sulfites, one of the 11 priority allergens, are chemical compounds that are used as anti-oxidants and preservatives in food and beverages. Although not technically allergens, they may cause food sensitivity and intolerances in some people.

Canadian businesses that export food to the United States must abide by the allergen labeling requirements set in the Food Allergen Labeling and Consumer Protection Act (FALCPA). The US “major food allergens” list or “big 8” is slightly different from that of Canada and comprises: milk, eggs, fish, wheat, tree nuts, peanuts, soy, crustaceans and mollusks. Unlike in Canada, sulfites, mustard and sesame seeds are not considered priority allergens in the US. However, The Food and Drug Administration (FDA) require that sulfites that are purposely added to a food preparation or beverage be declared on food labels when concentration in the finished product is greater or equal to 10 ppm (expressed as total SO2). A further distinction between Canadian and American labelling regulations is that coconut is considered a tree nut allergen under American law while it is not a priority allergen in Canada.

The alcoholic beverage industry is also impacted by the Canadian allergen labelling regulations. Except for a few exempted products, alcoholic products with detectable food allergens, gluten sources or added sulphites (present in the product at 10 ppm or more) will require labelling. Wine, for instance, may be clarified using allergen- or gluten-based fining agents. Typical protein-based fining agents include ovalbumin (egg), casein (milk) and sometimes isinglass (fish). According to Health Canada, good wine filtration practices generally result in a product free of detectable allergens. On the other hand, a wine that is unfiltered could contain detectable allergens and would need to be evaluated by the winery and labelled accordingly.

It is important for food producers to identify and control the flow of food allergens in the processing environment in order to accurately label prepackaged foods. Companies are now developing Allergen Control Programs (ACP) to meet these requirements. Controlling allergens is an integral part of the HACCP program, and like other food safety hazards, must be tackled following a systematic risk-based approach. Under HACCP, allergens are categorised as chemical hazards. When conducting a hazard analysis on a given product, food manufacturers should focus on risks associated with process steps but also consider other plant activities such as material sourcing, formulation of new products and management of plant trials. Potential hazards identified during these activities may be controlled as part of pre-requisite programs. In order to facilitate this process, the Canadian Food inspection agency (CFIA), published in 2012 a revision to the Food Safety Enhancement program (FSEP) manual adding a seventh pre-requisite (PRP) program under the title, Operational Pre-requisite Requirements.

When developing a food allergen program, processors should review existing product formulations and ingredient documentation from suppliers for the presence of allergens and their derivatives. For example, sesame oil or sesame salt may be listed on a bill of materials and are likely to contain allergens if unrefined. The facility’s allergen list should be routinely cross-checked against a physical inventory of ingredients present in the plant. In addition, the review should also cover non-food chemicals such as lubricants that have been shown to potentially contain allergenic materials. These materials should be tagged and handled as allergens.

According to a 2003 study conducted by the Food Allergy Research and Resource Center (University of Nebraska–Lincoln), the top reasons for involuntary allergen contamination in food were inadequate management of ingredient changes, poor management of food contact sanitation during product changeovers (switching from lots containing allergens to non-allergenic product), mis-handling of rework and failure to review the HACCP plan at regular intervals.  Possible strategies for controlling these situations include the addition of a rework step on the process flow diagram so that a full hazard analysis may be conducted on this process step and controls applied. The use of colour-coded utensils and labels may be used to visually identify allergens and matching production records in the plant. The HACCP plan review should take place a minimum of annually (unless changes to the product or process require more frequent re-validation) and follow a clear and detailed agenda. It’s also important that supplier and new product approval programs be in place to identify the introduction of new allergens into the process flow.

When allergens and their derivatives are purposely added to food, they must be declared either in the ingredients list or as a “contains” statement under Canadian law. As for the declaration of traces of allergens resulting from possible cross-contamination, the label declaration is voluntary. As of recently, “May contain” statements on food labels have increased but fail to provide consumers with accurate information. The CFIA stresses that “May contain” statements must be “truthful, clear and non-ambiguous, and that they not be a substitute for Good Manufacturing Practices.”

Therefore, due diligence must be exercised through proper inspection and testing to validate the likelihood of traces of allergens being present in the finished product. This process is documented and forms part of the HACCP plan. As FARRP experts have advised, food safety documentation should first identify the food allergens that are present in the facility, their physical forms and concentrations. Once this information is known, an assessment of food contact surfaces and finished product is carried out to determine the allergen load resulting from cross-contact and carry-over product. If product or food contact equipment test positive for allergens, adequate sanitation activities must be developed and validated to show their effectiveness at reducing the allergen load to a non-detectable level. General or specific protein swabs may be employed to verify the absence or presence of detectable allergens.  Based on some industry reports, adenosine triphosphate (ATP) swabs can be a successful alternative to protein testing as part of an allergen control program.  Alternatively, products or swabs may be sent out to specialised laboratories for quantitative analysis.

When risks of allergen cross-contamination are identified, validation of sanitation activities should be completed at least annually or whenever changes are made to the product or process. Between validation checks, verification of sanitation activities must show that procedures are followed consistently. While allergen or ATP swabbing may be used for verification of sanitation activities, food allergy experts agree that “visually clean” is still a good standard to verify the effectiveness of sanitation practices. This standard applies to food and non-food contact surfaces and may require equipment disassembly and full removal of allergenic food waste to ensure the standard is met.

For more detailed information on allergen control and labelling, refer to the references below.


Purdue University, Food Allergy Statistics.

Health Canada, Food Allergies and Intolerances

Health Canada, Vintage Wine and Application of Enhanced Allergen Regulations

Canadian Food Inspection Agency, List of Ingredients and Allergens.

U.S. Food and Drug Administration, Guidance for Industry: A Food Labeling Guide (6. Ingredient Lists)

Food Safety Magazine (2013). Best Practices with Allergen Swabbing. 

Food Safety Magazine (December 2008/January 2009). Building a World-class Allergen Control Program, Part 2

FoodDrink Europe (2003). Guidance on Food Allergen Management for Food Manufacturers. 

Health Canada (2012).The Use Of Food Allergen Precautionary Statements On Prepackaged Foods.

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