Ochratoxin A in foods: Health risk assessment and risk management approach

Health Canada’s Food and Nutrition Directorate has completed an updated human health risk assessment of ochratoxin A (OTA) in foods.

OTA is a natural toxin produced by fungi of the Penicillium and Aspergillus genera. It mainly develops on foods during storage, under conditions that favour fungal activity (such as increased moisture and temperature). It can also develop in agricultural commodities in the field.

In 2025, Health Canada published an updated health risk assessment (HRA) for dietary exposure to OTA. This assessment considered more recent Canadian data on:

• the occurrence of OTA in retail foods
• food consumption patterns of Canadians
• scientific information on the hazards posed by OTA

Health Canada found that Canadians were exposed to somewhat lower levels of OTA through the diet than previous estimates in 2009: Health risk assessment of ochratoxin A for all age-sex strata in a market economy (2009).

Most exposure to OTA in people living in Canada came from:

• grain-based foods, including:
  • infant and breakfast cereals
  • bread
  • pasta
  • cookies
  • crackers
• food ingredients such as flour

This is expected given the common occurrence of OTA in cereal grains and that grain-based foods are common dietary staples.

The HRA concludes that based on the current knowledge of the effects of OTA on human health, the level of dietary exposure is of low concern. As such, implementing regulatory maximum levels as a risk management measure is not deemed necessary at this time.

Since the early 2000s, Health Canada has been managing dietary exposure to OTA through:

• monitoring and surveillance
• risk assessment
• research
• international engagement

This is done in collaboration with the Canadian Food Inspection Agency and the Canadian Grain Commission. Continuing this approach is suitable given:

• the conclusions of Health Canada’s recent HRA
• levels have remained relatively stable, based on occurrence data for OTA in domestically-grown cereal crops and foods sold in Canada between 2009 to 2023

Overall, Health Canada considers current dietary exposures to OTA for people living in Canada to be of low concern to human health. If new information emerges that would lead to a notably different outcome of the HRA, Health Canada will take appropriate steps to help ensure that dietary exposures to OTA remain within safe levels, including revisiting the need for maximum levels.

To obtain a copy of the Food and Nutrition Directorate’s Health Risk Assessment for Dietary Exposure to Ochratoxin A, please send an email to BCS-BIPC@HC-SC.GC.CA with subject line OTA_HHRA_BCS_2025_EN.