Health Canada Guidelines for Software As A Medical Device

Food allergies are a public health concern in many countries. In Canada alone, it is estimated that over 3 million Canadians are affected by food allergies, with two thirds of those afflicted being young children. Presently, there are no known therapies to cure allergies, so current options include strict avoidance, through education such as recognizing when a reaction is taking place and taking steps for immediate medical attention, and understanding how to properly read food product labels. As a food manufacturer ensuring strict avoidance is generally out your control, it is vital for you however to do your part to keep consumers safe by making sure your product labels clearly and accurately declare allergens and gluten sources when present as ingredients or components of ingredients.

What is food allergy?

Our immune system normally protects us by helping fight off bacteria, viruses, fungi, and other organisms that can make us sick.

An allergy is when an immune system reacts to a normally harmless substance, most often a protein, as something that is harmful and triggering a series of immunological reactions.

In many cases these reactions lead to hives, swelling or a severe anaphylaxis reaction which can be potentially fatal.  Peanuts are the most common food allergen and is closely associated anaphylaxis.

Food Allergen Labeling

Accurate and consistent allergen labeling is a legal requirement under Safe Food for Canadian Regulations (SFCR).  They will appear in the ingredient list or in a “Contains” statement located immediately after the ingredient list. Health Canada requires food manufacturers to clearly label products if any of the “Priority Allergens” are present or potentially present among the ingredients. The Priority Allergens are:

  • Peanuts
  • Tree nuts (almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine nuts, pistachios, and walnuts)
  • Soy
  • Wheat and Triticale (hybrid of wheat and rye grains)
  • Eggs
  • Milk
  • Seafood (Collectively as shellfish, fish, crustaceans and Molluscs)
  • Sesame
  • Sulphites (as a food additive)
  • Mustard

Having accurate information on your food product label is crucial. However, allergen labeling is not always cut and dry as some ingredients may not always neatly fit into the list of Priority Allergens. This is where having a food safety expert can help navigate regulations and requirements.  For example, products containing sodium caseinate must be labeled as a “milk” allergen and not “casein”. In other cases, cross-contamination may be an issue within your manufacturing so food allergen(s) or gluten source(s) may be unintentionally present in the food despite following Good Manufacturing Practices. In such a case precautionary statements such as “may contain”, ”processed in a facility…” are sometimes used.

Can we help? Our Food Safety Experts are available to assist you in interpreting allergen labeling requirements in Canada.

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