Health Canada
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Food and Nutrition

Melamine

The Government of Canada Responds to Reports of Melamine
in Food Products

Background:

Recently, there have been reports from several countries of the possible contamination of a variety of food products with the chemical melamine, including products containing milk and milk-derived ingredients from China.

Melamine is a synthetic chemical used in a variety of industrial applications including the production of resins and foams, cleaning products, fertilizers and pesticides. It is not naturally occurring and is not allowed to be added to food.

To date, no melamine related illnesses have been reported in Canada and no melamine-contaminated infant formulas have been discovered in this country. The Canadian Food Inspection Agency (CFIA) has taken a number of actions including product sampling, testing, food recalls and advisories related to products that may be contaminated with melamine. The CFIA is also working with the Canadian Border Services Agency to ensure that border restrictions remain in place and are updated as new information becomes available. For the latest information, see the Next link will take you to another website CFIA website.

As a precaution, Health Canada, the CFIA and the Public Health Agency of Canada are working with their partners in the provinces and territories and the World Health Organization (WHO) and other international food regulatory bodies to respond to this emerging issue. We have alerted the public health community and health professionals in Canada about this issue and the need to be watchful of possible illness among Canadians.

Health Canada's Risk Assessment for Melamine in Foods Containing Milk and Milk-Derived Ingredients:

To determine how much melamine could be consumed without experiencing any adverse health effects, Health Canada scientists reviewed all the available data about the health effects of melamine and evaluated the health risks.

Health effects from exposure to melamine vary depending on the amount and duration of exposure. Scientific research indicates that effects to the bladder and kidneys, such as bladder stones and chronic kidney inflammation, can be seen if exposed to high enough levels of melamine. Exposure to low levels would not carry great risk, but significant exposure can lead to bladder stones, which, in turn, may result in kidney failure and, in some rare cases, death.

HC has adopted the ‘tolerable daily intake’ (TDI) recommended by the World Health Organization's (WHO) scientific experts on melamine and has adjusted its standard for melamine in infant formula.

In reviewing the available scientific information about the health effects of melamine, a World Health Organization (WHO) expert committee established a tolerable daily intake (TDI) for melamine of 0.2 mg/kg body weight per day. This TDI for melamine was developed using a 200-fold safety factor to account for uncertainties and to ensure that all age groups are protected. This means that a person could ingest up to 0.2 mg of melamine each day for each kilogram of their bodyweight with the assurance that there would be no adverse health effects.

To support the development of interim standards for melamine in products containing milk and milk-derived ingredients, Health Canada is adopting this new TDI recommended by the WHO expert consultation, and will be taking the additional measure of lowering its allowable level for melamine in infant formula from 1ppm to 0.5 ppm in order to ensure that exposures remain below this new TDI. The new 0.5 ppm standard for melamine will apply to all infant formula products.

While basing their assessment on the latest scientific evidence available, Health Canada scientists will continue to investigate health effects of melamine and structurally related chemicals such as Cyanuric acid and will update this assessment accordingly.

Health Canada scientists will also continue to work in close consultation with a network of scientists from other international jurisdictions, including the US Food and Drug Administration (US FDA), the European Food Safety Authority, the European Commission, Food Standards Australia New-Zealand, the New-Zealand Food Safety Authority, the UK Food Standards Agency, the Agence Française de Sécurité Sanitaire des Aliments (AFSSA) and the Japanese Food Safety Commission.

Health Canada Standards for Melamine

Health Canada and the CFIA work together to protect Canada's food supply. Health Canada is responsible for setting standards and regulations and the CFIA is responsible for enforcing those standards. Based on its recent risk assessment, Health Canada has set interim standards to differentiate between normal background levels and intentional contamination of melamine in products containing milk and milk-derived ingredients.

Since melamine is used for various industrial applications, low levels are present in the environment and trace amounts may occur in certain food commodities. The presence of such low levels in food does not pose a health risk. Nevertheless, for the purpose of differentiating between the presence of low background levels of melamine in food and the problem of intentional adulteration, Health Canada has set the following interim standards for melamine in products containing milk and milk-derived ingredients:

  • Infant formula and sole source nutrition products, including meal replacement products
  • Other food products containing milk and milk-derived ingredients
    • Maximum of 2.5 ppm*

It remains Health Canada's policy that levels of potential contaminants in infant foods should be kept as low as reasonably achievable.

Health Canada's interim standards for melamine in products containing milk and milk-derived ingredients are set to ensure that all age groups and segments of the population are protected and were developed using a consistent approach adopted by other food regulatory agencies in Europe, Australia, New Zealand and the United States.

Should new scientific evidence become available, Health Canada's risk assessment will be reviewed and the interim standards will be re-examined.

Testing results that are above interim standards will be assessed to determine what action is appropriate. Based on the assessment, product action will be initiated ranging from investigating the source of contamination within the manufacturing process and removing packages from retail (when there is very little or no risk to human health) to a recall with public notification for a product that represents a higher risk.

If you or someone you know have consumed products on Next link will take you to another website CFIA's recall list and are feeling unwell, consult your physician.

The Government of Canada will continue to update Canadians as this investigation continues.

For more information on melamine, go to: Melamine - Questions and Answers


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World Health Organization(WHO) Expert Meeting to Review Toxicological Aspects of Melamine and Cyanuric Acid

The WHO Collaborating Centre for Food Contamination Monitoring within Health Canada's Food Directorate is supporting the organization of the expert meeting announced by the World Health Organization to review toxicological aspects of melamine and cyanuric Acid. This meeting is held in collaboration with the Food and Agriculture Organization of the United Nations (FAO) and took place December 1-4, 2008 in Ottawa, Ontario, Canada.


Meeting Objectives and Expected Outcome

To review current knowledge on:

  • Chemistry of melamine alone and in combination with its analogues (e.g. cyanuric acid)
    Analytical methods relative to detection of these chemical substances in various foods
  • Occurrence of melamine in foods as a result of normal food production and processing (e.g. from migration of food contact material, pesticide or fertilizer use) as opposed to adulteration
  • Toxicity of melamine alone and in combination with its analogues (e.g. cyanuric acid)
  • Human health risk assessment, including species sensitivities and sensitive sub-populations
  • Knowledge gaps

The outcome of the expert meeting is expected to provide a description and analysis of, at least, the following areas:

  • Current state of knowledge on toxicology, exposure and analytical methodology
  • Risk assessment, including attendant uncertainties
  • Knowledge gaps
  • Conclusions and recommendations

More information on the Next link will take you to another website WHO Expert Meeting.

Related Resources

*These levels will apply to a combined concentration of melamine and cyanuric acid (a chemical generally found together with melamine).