Questions and Answers - Melamine
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- Question 1: What is melamine?
- Question 2: Is melamine approved for direct / deliberate addition to food in Canada?
- Question 3: Is infant formula from China available for sale in Canada?
- Question 4: What is the situation with infant formula in China?
- Question 5: Has the Government of Canada been in contact with Chinese officials regarding contaminated infant formula originating from China?
- Question 6: How do we know other infant formula for sale in Canada is safe?
- Question 7: What are the possible impacts of melamine on human health? Are certain groups more vulnerable to negative health impacts than others?
- Question 8: How much melamine is considered safe? Explain the levels of melamine that make a product safe or unsafe?
- Question 9: What does Health Canada's interim maximum level of 0.5 ppm in infant formula mean?
- Question 10: Why has Canada lowered its established maximum level for melamine in infant formula products to 0.5 ppm from the original 1.0 ppm?
- Question 11: How will the Government of Canada enforce these maximum levels?
- Question 12: How does melamine get into a product?
- Question 13: Do we know if melamine accumulates or is easily eliminated from the body?
- Question 14: What is the Government of Canada advising the public to do with Chinese infant formula or other products that have been recalled?
- Question 15: What is the Government of Canada doing about melamine in food?
- Question 16: Is the Canadian Government communicating with regulatory authorities in other countries?
- Question 17: Where can I get more information on this issue?
- Question 18: Why do the interim maximum levels apply to the combination of melamine and cyanuric acid, when the recent international assessment only covered melamine?
Answer 1: 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.
Melamine is the same chemical that was implicated in the pet food recall in 2007. The issue of melamine presence in Chinese dairy products is considered a new and separate issue from the pet food recall.
Answer 2: No. Canada does not allow melamine to be used as a food ingredient.
However, very low levels of melamine could be found in food due to its industrial uses, such as from pesticides and fertilizers. The levels of melamine from these sources would not represent a human Health Risk.
Answer 3: No infant formula produced in China is approved for sale in Canada. The Government of Canada also confirmed that no infant formula approved in Canada uses milk ingredients sourced from China. In addition a national retail survey of stores in Canada found no evidence of infant formula produced in China. If consumers are in possession of infant formula from China, they are advised not to use the product and to notify the CFIA at 1-800-442-2342.
The Government of Canada is cautioning Canadians against purchasing infant formula manufactured in China from Internet sites or from other sources
Answer 4: The Chinese government has initiated extensive testing programs and has reported that melamine has been found in numerous infant formulas from several companies.
Answer 5: Yes. A Canadian Food Inspection Agency (CFIA) representative in Beijing is in contact with the general Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) in China. The CFIA is aware of the situation in China and is working with the appropriate authorities in that country, as well as in other countries, to investigate products containing milk and milk-derived ingredients from China that are available for sale in Canada.
Answer 6: All infant formulas must be approved by Health Canada before they are allowed for sale in Canada. No formulas produced in China have been approved for sale. As a precaution, the Canadian Food Inspection Agency is working with retailers to make sure that no unapproved products from China have made their way to stores in Canada.
Health Canada has contacted the major manufacturers and importers of infant formula sold in Canada. The companies have confirmed that they do not use any milk ingredients sourced from China.
Answer 7: Health effects from exposure to melamine vary depending on the amount and duration of exposure. Significant exposure to melamine may result in bladder and kidney stones, which, in turn, may result in acute or chronic renal failure and, in some rare cases, death.
While there is limited evidence to suggest any group might be more susceptible to melamine, based on their developmental status, it might be expected that newborns and infants could be more sensitive.
Reports from China have verified numerous cases whereby infants consuming milk-based formula which contained high levels of melamine have suffered from mild to severe effects mainly related to kidney function.
Answer 8: 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 maximum levels for melamine in products containing milk and milk-derived ingredients:
Infant formula and sole source nutrition products, including meal replacement products
- Maximum level of 0.5 part per million (ppm)
Other food products containing milk and milk-derived ingredients
- Maximum level of 2.5 ppm
These interim maximum levels were developed following a rigorous health risk assessment using a consistent approach adopted by other jurisdictions, such as the United States, Europe, Australia, and New Zealand. Health Canada's interim maximum levels 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 will be re-examined as new data become available.
In December 2008, the World Health Organization (WHO) in collaboration with the Food and Agriculture Organization of the United Nations (FAO) held an expert consultation to review the risks of melamine present in foods. This expert consultation recommended a tolerable daily intake for melamine of 0.2 mg/kg bw/day. Health Canada has adopted this recommendation, resulting in the re-evaluation and update of its maximum level for melamine in infant formula from 1.0 ppm to 0.5ppm. Overall, the result of this updated position will provide an even greater protection to Canadian infants.
Answer 9: Using the Health Canada new standard of 0.5 ppm in concentrated infant formula, hypothetically, a 5 kg baby could consume up to 2 kg of infant formula on a continuing daily basis with the assurance that there would be no adverse health effects. This further demonstrates the safety margins built into Health Canada's interim maximum levels for melamine in products containing milk and milk-derived ingredients. It is important to note that no infant formula product allowed for sale in Canada has tested positive for levels of melamine above even this new interim maximum level.
- Health Canada has decided to adopt the new tolerable daily intake (TDI) of 0.2 mg/kg bw/day recommended by the World Health Organization. Due to specific factors in the Canadian market whereby ready-to-eat infant formula is readily available (products that do not require dilution prior to consumption), Health Canada has lowered its maximum level for melamine in infant formula from 1.0 ppm to 0.5 ppm to ensure that exposure to melamine remains below the new TDI.
- It is of significant importance to note that no infant formula products allowed for sale in Canada have tested positive for levels of melamine above 0.5 ppm.
Answer 11: Testing results that are above interim maximum levels 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.
Shipments of imported products are assessed at the border to determine next steps that will continue to protect the safety of the Canadian food supply.
Answer 12: High levels of melamine in any food product are thought to be due to contamination in an attempt to artificially increase the protein content. Low or background levels of melamine that might be found in foods may result from various sources related to the presence of melamine in the environment resulting from its industrial uses.
Answer 13: Low or background levels of melamine ingested through the diet are not expected to accumulate and would be rapidly removed from the body, even over long term or chronic exposure. Adverse health effects would occur as the body attempts to eliminate high levels of melamine such as those associated with contamination.
Answer 14: Consumers are advised to not consume product that has been recalled. The product should be disposed of or returned to the place of purchase for further action.
For additional recall information related to a specific product, consumers should consult the CFIA's web site.
Answer 15: With the use of a validated method based on sound scientific principles, both Health Canada and the Canadian Food Inspection Agency (CFIA) are currently in the process of analyzing infant formula sold in Canada. In addition, a variety of other dairy-based foods are also being tested for possible melamine presence or contamination. Specifically, products made from milk or milk-derived ingredients that could contain contaminated product are being examined. Milk-derived ingredients include whole milk powder, non-fat milk powder, whey powder, lactose powder, and casein.
The Public Health Agency of Canada continues to monitor disease trends in case they indicate exposure to melamine.
The CFIA has taken a number of measures including product sampling and testing and food recalls and advisories related to products that may contain melamine or are found to contain melamine. The CFIA is also working with CBSA to implement various border activities. For the latest information see the CFIA website.
If any risk is identified from melamine exposure in foods available in Canada, the Government of Canada will take appropriate action, to ensure that Canadian consumers are protected.
Answer 16: Health Canada and The Canadian Food Inspection Agency are working closely with the United States Food and Drug Administration (FDA) and will continue to work closely with other foreign food regulators to share information throughout the investigation. The Public Health Agency of Canada (PHAC) continues to collaborate with the World Health Organization and other international medical and public health partners to share information regularly on this issue.
Answer 17: For more information consumers and industry can call the Canadian Food Inspection Agency at 1-800-442-2342 / TTY 1-800-465-7735 (8:00 a.m. to 8:00 p.m. Eastern time, Monday to Friday).
Answer 18: The interim maximum levels apply to the combination of melamine and cyanuric acid (a compound that may be found in conjunction with melamine) in order to ensure that foods available for sale in Canada that contain milk and milk-derived ingredients have not been contaminated or adulterated with either compound. In the absence of data on the combined toxicity of melamine and cyanuric acid, Health Canada was only able to consider the toxicological data for melamine alone and for cyanuric acid alone. The Tolerable Daily Intake (TDI) for melamine recently adopted by the WHO Expert Consultation on Melamine (0.2 mg/kg body weight per day for melamine alone) is lower than the TDI for cyanuric acid (1.5 mg/kg body weight per day alone). Therefore, the melamine TDI was used as the basis for the interim maximum levels for melamine and cyanuric acid in foods containing milk and milk-derived ingredients. As a result of the recent adoption by Health Canada of the WHO TDI for melamine, Health Canada's interim maximum level for infant formula was updated to 0.5 ppm of melamine and cyanuric acid combined. The interim standard for other foods containing milk and milk-derived ingredients remains at 2.5 ppm of melamine and cyanuric acid combined. Consideration will be given to revising the interim maximum levels accordingly should any new information on the combined toxicity of melamine and cyanuric acid becomes available. It is important to note that background levels of melamine and/or cyanuric acid in foods appear to be well below these interim maximum levels.
These maximum levels will apply to a combined concentration of melamine and cyanuric acid (a chemical generally found together with melamine).
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