Notice to industry: Undeclared milk allergens in chocolate products
January 30, 2024
In 2022 and 2023, there were multiple non-compliances due to undeclared milk in dark chocolate samples tested by the Canadian Food Inspection Agency (CFIA), many of which resulted in recalls.
Undeclared allergens can pose serious health problems for consumers who are allergic to them, sometimes even causing death. It is your responsibility to ensure that the food you import or manufacture is safe and meets Canadian requirements.
Your obligations
Manufacturers and importers must ensure chocolate products do not contain undeclared milk allergens.
Preventive control plans
You must develop and implement a preventive control plan to prevent ingredients that contain milk allergens from contaminating chocolate in which these allergens are not intended to be present. This includes providing evidence that control measures in place to address cross-contamination are effective.
Your preventive control plan must also include a description of the measures that you take to make sure that the food is packaged and labelled in a manner that is not false, misleading or deceptive, or that creates an erroneous impression.
Declaring milk allergen hazards
You must ensure that milk allergen hazards are appropriately declared on the food label. Milk cannot be added to the list of ingredients if it has not intentionally been added to the product as an ingredient. This is a contravention of the Food and Drugs Act and the Food and Drug Regulations.
Cross-contamination statements
Cross-contamination statements may be declared by food manufacturers and importers when, despite all reasonable measures, there is a risk of an unintended food allergen in the food.
Cross-contamination statements are not a substitute for good manufacturing practices. Like all statements, they are subject to subsection 5(1) of the Food and Drugs Act and must be truthful and not misleading.
If you use chocolate from a supplier as an ingredient in your product(s) and that chocolate has a cross contamination statement like "may contain: milk," you should carry that statement forward to your finished product label unless you are able to demonstrate that the product does not represent any risk to milk allergic consumers.
Allergen-free claims
Manufacturers making a claim about the absence of food allergens such as "milk-free" or "contains no milk" must ensure there is absolutely no amount of the milk allergen present in the product, whether intentionally or inadvertently. Consult the allergen-free claims page for more information.
Negative claims
Additionally, a "non-dairy" or similar statement can only be used on a product which does not contain any milk ingredient or derivative. The word "dairy" when used as an adjective generally means "made from milk." Please consult the page on negative claims pertaining to the absence or non-addition of a substance for more information on claims such as dairy-free and lactose-free.
Compliance and enforcement
Failure to comply with regulatory requirements may result in your products being recalled, seized or detained. In addition, your Safe Food for Canadians licence could be suspended or cancelled. The CFIA continues to monitor the situation and will take enforcement action where appropriate.
Guidance
To help you comply with the regulations, the CFIA has created the Supplier Food Safety Assurance Program (SFSAP).
- Select suppliers who implement food safety programs based on Hazard Analysis Critical Control Point (HACCP) and/or internationally recognized voluntary third-party assurance programs for the control of allergens
- Select suppliers who regularly sample and test their products and process environment, have the samples analyzed by an accredited lab, and provide certificates of analysis
- Establish a formal agreement with your supplier to help ensure that their products meet Canadian requirements for safe food
- Review and update labels as needed whenever formulations and/or suppliers change
To help you develop, implement and maintain your Preventive Control Plan, the CFIA has developed the following guidance:
- Regulatory requirements: Preventive control plan (domestic and importers)
- Preventive controls for the preparation of chocolate
- Guidance on preventive controls for food allergens, gluten and added sulphites
- Guidance on preventing cross-contamination
To help you ensure that the products you prepare or import comply with allergen labelling requirements, the CFIA has developed the following guidance in its industry labelling tool:
You may use other guidance documents developed by provincial governments, industry associations, international partners or academic bodies, as long as they achieve the same outcome.
If you still have questions
For more information, visit our updated toolkit for food businesses and use our new virtual assistant tool.
If you are unable to find answers to your questions, you can contact CFIA online.
Stay connected to the latest news and updates about food recalls, food safety, animal health and plant health.
- Date modified: