Summary of Comments Received on Health Canada's Proposed Maximum Limits for Ochratoxin A in Certain Foods - August 2008 to June 2009

August 2010


Ochratoxin A (OTA) is a toxic fungal metabolite that causes nephrotoxic, teratogenic, immunosuppressive and carcinogenic effects in a number of animal species. It has also been implicated in the development of a chronic kidney disease in humans known as Balkan Endemic Nephropathy. OTA occurs naturally in low concentrations in many foods, such as cereal-derived staples as well as other food commodities including grapes, raisins, wine, coffee and beer.

On August 29st, 2008 Health Canada's Bureau of Chemical Safety (BCS), Food Directorate, sent pre-consultation letters to targeted stakeholder groups requesting input on Health Canada's proposed maximum limits for ochratoxin A (OTA) in foods. On March 2, 2009, BCS webposted it's Information Document on Health Canada's proposed Maximum Limits (Standards) for the Presence of the Mycotoxin Ochratoxin A in Foods on the Health Canada website requesting further comments on this proposal from the larger stakeholder community. Comments were accepted until 12:00 a.m. EDT on June 1st, 2009.

On December 9, 2009, the Bureau of Chemical Safety's 'Health risk assessment of ochratoxin A for all age-sex strata in a market economy' was published in the on-line journal Food Additives and Contaminants (Volume 27, Issue 2, February 2010, pages 212-240) and is publicly available through the link on the following webpage:

Summary of Comments

Health Canada received input from various stakeholders representing the food industry and professional organizations, including:

  • Canadian Council of Grocery Distributors
  • Canada Grains CouncilFootnote 1
  • Canadian Grain Commission
  • Canadian National Millers Association
  • Canadian Vintners Association
  • Canadian Wheat Board
  • Coffee Association of Canada
  • Eastern Cereals and Oilseeds Research Centre
  • Food Safety Network
  • Nestlé Nutrition Canada
  • PBM Nutritionals, LLC.
  • SHS International
  • Western Grain Elevator Association

With the exception of the proposed Maximum Limits (MLs) for raw cereal grains, stakeholders generally supported the proposed MLs for OTA in foods, and noted that OTA concentrations are generally below the proposed levels and that Canada's proposed MLs are aligned with those of other international jurisdictions. Stakeholders from the grain industry were opposed to the proposed MLs for raw cereal grains. In addition, several respondents have requested that the proposed MLs in raw cereal grains be adopted as voluntary guidelines for a period of at least two years.

Key issues that were identified by stakeholders during the comment period are highlighted below.

1) OTA Standards in Cereal Grains
Questions/Comments Health Canada's Response
1A) OTA standards in cereal grains are not urgently needed because levels in Canadian grains are already very low; regulations will not provide additional protection to consumers; and buyers of raw and processed grains have already incorporated maximum mycotoxin limits within their product purchasing specifications. 1A) On the basis of its risk assessment, Health Canada has identified the need to reduce exposure to OTA. As OTA is widely, but unevenly, distributed in the food chain, maximum limits will ensure that exposure to high levels is reduced.
1B) OTA standards in raw grain, specifically wheat, should not be implemented because the sampling and analytical requirements of compliance testing are not practical, affordable, and in some cases, available, to industry. Testing raw cereal grain for OTA would also delay grain flow through the supply chain, increasing the potential for OTA levels to proliferate. 1B) Codex has developed, and the EU has implemented, an OTA standard for raw cereal grains, suggesting that the implementation of the proposed OTA levels should be achievable.

Nonetheless, Health Canada's focus is to set OTA standards in cereal commodities that are not only protective of human health but are also achievable by Canadian industries.

In consideration of the comments received by industry, Health Canada will review its proposed risk management approach for raw cereal grains, including the consideration of the development of reference values for raw cereal grains, while imposing enforceable standards for finished food products. Health Canada will communicate with the Canadian Food Inspection Agency (CFIA) to help ensure that their associated enforcement strategy reflects any proposed risk management decision.

2) HACCP-Based Code of Practice
Questions/Comments Health Canada's Response
A new HACCP-based code of practice is not required by the grain industry. Canadian grain producers already employ effective measures to manage OTA and are well aware of the key factors in preventing the growth of OTA-producing organisms. Best practices and HACCP-based programs in agricultural production, harvest, storage, handling, and processing are already employed by most organizations within the production and supply chain and no additional control points could be added that have not already been considered. Health Canada is in favour of all types of OTA risk mitigation measures that are implemented throughout the food supply chain, be they HACCP-based or other types of best practices. The results of ongoing research on, for example, how grain storage conditions affect OTA formation, may aid in improving practices that reduce the likelihood of OTA production.

Existing HACCP-based programs and codes of practice, such as the CAC / RCP 51-2003 - Code of Practice for the Prevention and Reduction of Mycotoxin Contamination in Cereals, including annexes on Ochratoxin A, Zearlenone, Fumonisins and Tricothecenes, provide excellent guidance on best practices. Health Canada is prepared to work with all stakeholders to ensure that appropriate risk mitigation strategies are put into place and will continue to engage them in the further development and implementation of these evolving programs and related documents.

Will there be HACCP specifications for imported foods? Imported foods will have to meet the OTA standards that are in place in Canada, however, the country of origin is responsible for establishing best practices that are suitable to that country. Importers will be responsible for ensuring that the OTA standards are met for imported products coming into Canada.
3) Trial Period for the Proposed MLs
Questions/Comments Health Canada's Response
A 2-year trial period for the proposed MLs, in particular those for raw grain, will permit additional research and evaluation of the potential efficacy of the MLs in reducing OTA exposure as a component of the proposed risk management strategy. This voluntary period will also enable industry to determine what measures they will need to put in place in order to meet the proposed standards. Health Canada is considering alternative options for managing raw cereal grains other than imposing a standard that will be actively enforced (see 1B). As well, a considerable period of time will have passed between these MLs being proposed and coming into force. Therefore an additional 2-year trial period should not be necessary.
4) Confirmation of Jurisdiction and Enforcement Roles
Questions/Comments Health Canada's Response
A discussion between Health Canada, the Canadian Food Inspection Agency, and the Canadian Grain Commission is necessary to clarify jurisdictions and enforcement roles to ensure the uniform national enforcement of new standards. Health Canada agrees that it is important that respective roles be clearly understood and that any jurisdictional uncertainties should be clarified.
5) Additional Research is Required before MLs are Implemented
Questions/Comments Health Canada's Response
Footnote 1

Statistics Canada. 2004. Canadian Community Health Survey--Nutrition (CCHS). Detailed information for 2004 (Cycle 2.2). Ottawa (ON): Statistics Canada. Available from:

Return to footnote 1 referrer

It would be premature to move forward with the proposed MLs before the completion of the present study on grain storage conditions and OTA formation that is being completed through the joint efforts of the University of Manitoba, the Canadian Wheat Board, and the Canadian Grain Commission. New storage guidelines for farmers and industry may be the result of this research which should be considered in the overall risk management plan for OTA. Health Canada is committed to reducing identified human health risks in the food supply. The data on which the  health risk assessment was based illustrated that OTA concentrations are generally below the proposed levels. Any new scientific information regarding OTA will help focus risk mitigation measures in order to further reduce OTA levels in cereal grains and cereal-derived foods.
An independent peer review process should be conducted to estimate the risks associated with OTA exposure and propose appropriate risk management strategies. Any independent party is welcome to review and provide comments on the Health Canada risk assessment (available as described in the Background section of this document) at any time.

Health Canada is confident that through the peer review process undertaken in publishing its risk assessment in the journal Food Additives and Contaminants, scientifically sound information regarding the risks associated with OTA exposure, as well as the need for appropriate risk management strategies, have been considered.

More research is needed regarding OTA development, how it can be identified at the source, and how to improve farm management practices. Health Canada is supportive of additional research being conducted in these areas. However, Health Canada recognizes that to date there is research which supports efforts to mitigate OTA formation. Also, MLs for OTA could be revisited when new information becomes available.

Health Canada continues to support the development and implementation of additional safe and efficacious tools that will prevent the contamination of grains with OTA.

Research is needed to ensure that regulatory proposals are based on current consumer dietary behaviour. Recent Canadian consumption data collected by Statistics Canada through the Canadian Community Health Survey (CCHS) Cycle 2.2 in 2004Footnote 1 are becoming more widely available to Health Canada's Food Directorate. Prior to the availability of these data, older Canadian data or United States Department of Agriculture (USDA) food consumption data were employed. The USDA data is comparable to Canadian consumption data and includes a large sample size for children. Health Canada intends to compare the exposure estimates for deoxynivalenol (DON) generated using both American and Canadian food consumption data as another means to verify that the US data employed in the publication "Health risk assessment of ochratoxin A for all age-sex strata in a market economy" was a suitable Canadian surrogate.
6) OTA Standards in Additional Foods
Questions/Comments Health Canada's Response
OTA standards were not proposed for several foods that have the potential to be contaminated with OTA and for which standards exist in some other countries (e.g., roasted coffee, soluble coffee, wine, meat, cocoa, soy products, spices, and cheese). Canada could become a dumping ground for foods that do not meet the OTA standards in other countries. Health Canada assessed the contributions of many of these commodities to the total OTA exposure for the general Canadian population, however available information did not necessitate the need for developing MLs in those commodities.

Health Canada will continue to evaluate the need for establishing OTA standards in other foods as new information becomes available. Establishing MLs for OTA in some foods does not preclude the development of additional MLs for OTA in other foods in the future.

7) Development of Other Mycotoxin Standards
Questions/Comments Health Canada's Response
If standards for deoxynivalenol (DON) in foods are going to be proposed by Health Canada, could these be considered in tandem with those of OTA? Health Canada considers OTA, a post-harvest toxin, and DON, a pre-harvest toxin, to be distinctly different issues.

Health Canada intends to implement the proposed MLs for OTA independently of any MLs for DON that may be proposed in the future.

8) Clarification of the Foods that are Included under each of the Proposed MLs
Questions/Comments Health Canada's Response
Which cereal grains are included in the proposed MLs? The guidance value for raw cereal grains (see 1B) applies to wheat, barley, oats, and rice, which are the raw cereal grains included in Health Canada's risk assessment. The ML for directly consumed cereal grains applies to the pertinent types of wheat, barley, oats, and rice. There is currently only an ML for wheat bran, however Health Canada is considering expanding this ML to include brans from other cereal grains. Health Canada will assess OTA levels in less commonly consumed cereal grains and cereal-like products on a case-by-case basis.
Is soy infant formula included in the "dietary foods for special medicinal purposes intended for infants"? If not, should a standard for it be developed? Yes, Health Canada intends to establish a 0.5 ng/g limit for formula destined to infants and young children.

A summary of Health Canada's proposed MLs and guidance values for OTA in foods that take into consideration comments received during the public consultation that closed on June 1, 2009, is provided below.

Proposed Value (ng/g) (under consideration as a guideline)
Raw cereal grains (i.e., wheatFootnote 2, barley, oats, rice) 5
Proposed Maximum Limits (ML) (ng/g)
Wheat branFootnote 3 7
Directly consumed cereal grains (e.g. bulgur wheat, rice, oats, pearled barley) and cereal-derived products (e.g. flour; finished foods such as bread and breakfast cereals) 3
Grape juice 2
Dried vine fruit (e.g. raisins) 10
Infant formulas and cereal-based foods for infants and young children 0.5
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