Modification to the list of contaminants (ethyl carbamate in alcoholic beverages)

Notice of Modification – List of Contaminants and Other Adulterating Substances in Foods
Reference number: MCON-2605
July 24, 2026

Summary

The purpose of this notice is to inform the public and stakeholders that Health Canada has modified Part 2 of the List of Contaminants and Other Adulterating Substances in Foods to establish regulatory maximum levels for ethyl carbamate in certain alcoholic beverages, as shown in Table 1. This notice also provides a summary of the results from the public consultation held on this topic.

This modification comes into force on July 24, 2026.

Background

Food contaminants and other adulterating substances are chemicals that may affect food safety or quality. They can occur naturally, accidentally, or be added intentionally for fraud.

Prohibitions or maximum levels (MLs) can be established to manage risk and reduce exposure to those substances. In Canada:

• Prohibitions and MLs are set out respectively in Part 1 and Part 2 of the List of Contaminants and Other Adulterating Substances in Foods, incorporated by reference in section B.15.001 of the Food and Drug Regulations
• Additional non-regulatory MLs are set out in Health Canada's administrative List of Maximum Levels for Various Chemical Contaminants in Foods

These MLs are established by Health Canada based on scientific evidence and stakeholder consultation, and enforced by the Canadian Food Inspection Agency (CFIA).

As part of the regulatory modernization initiative described in the Path Forward for Contaminants and Other Adulterating Substances in Foods, Health Canada is consolidating all MLs into the List of Contaminants and Other Adulterating Substances in Foods and systematically reviewing and updating them in the process.

Issue

Health Canada reviewed the non-regulatory MLs for ethyl carbamate established in the List of Maximum Levels for Various Chemical Contaminants in Foods for various alcoholic beverages with the intent of transferring these MLs to the regulatory List of Contaminants and Other Adulterating Substances in Foods ^{Footnote 1 Footnote 2}, and conducted a detailed achievability analysis for these products. Health Canada concluded that:

• Existing MLs for ethyl carbamate in alcoholic beverages established in the administrative List of Maximum Levels for Various Chemical Contaminants in Foods remain protective of health and are readily achievable
• The beverage categories (namely, table wines, fortified wines, distilled spirits, fruit brandies, liqueurs, and sake) no longer fully reflect today's market, as these categories and their associated MLs were established in the 1980s

Rationale

The results of Health Canada's assessment support the transfer of the MLs for ethyl carbamate from the List of Maximum Levels for Various Chemical Contaminants in Foods to the regulatory List of Contaminants and Other Adulterating Substances in Foods.

Therefore, Health Canada decided to:

• Maintain the ML values already established
• Update product categories to better reflect today's diverse alcoholic beverage market while preserving the original intent of the MLs

The changes are not expected to significantly impact long-term dietary exposures to ethyl carbamate or pose a concern to human health. Updates to the product categories also help ensure that ethyl carbamate concentrations remain as low as reasonably achievable (ALARA).

Consultation

Health Canada published the Proposal to transfer the maximum levels for ethyl carbamate in alcoholic beverages to the List of Contaminants and Other Adulterating Substances in Foods (reference number: P-CON-25-01) on February 19, 2025, to signify its intent to transfer the existing MLs for ethyl carbamate to its regulatory list while redescribing the corresponding alcoholic beverage categories in the process. The proposal was open for comments for 75 days.

During the consultation phase, Health Canada received comment submissions from alcoholic beverage manufacturers, representatives of the alcoholic beverage industry, a provincial government, and international partners. Health Canada also received one comment submission that was out of scope.

The comments were generally supportive, with some leading to minor changes. Specifically, descriptions of certain alcoholic beverage categories were updated. The changes are summarized below.

Summary of stakeholder comments and Health Canada's response

1. Comments supporting the establishment of regulatory MLs:

Comments expressed support to the transfer the maximum levels (ML) for ethyl carbamate in alcoholic beverages from the administrative List of Maximum Levels for Various Chemical Contaminants to the regulatory List of Contaminants and Other Adulterated Substances in Foods and maintain the current values of the MLs.

Health Canada's response:

Acknowledges the support to transfer the current MLs for ethyl carbamate in alcoholic beverages.

Outcome:

No change to the proposal

2. Comments not supporting the establishment of regulatory MLs:

Comments indicated that it is unnecessary to transfer the MLs to the regulatory list since the Codex Alimentarius does not include MLs for ethyl carbamate in alcoholic beverages and surveillance data show that products are expected to have a high achievability rate with the MLs. It was also noted that the transfer would lead to increased testing costs.

Health Canada's response:

The Government of Canada first established MLs for ethyl carbamate in alcoholic beverages in the mid-1980s and these have been in effect for over 40 years.

Surveillance data have shown that these MLs are readily achievable by products offered for sale in Canada, while minimizing the health risks associated with exposure to ethyl carbamate.

The transfer of the MLs from the administrative list to the regulatory list is not expected to negatively impact current monitoring activities or alter the way surveillance is conducted in Canada. Monitoring products for compliance with the MLs is expected to continue in the same way it has been done for many years.

The transfer of these MLs will align their status with the modernized way the Government of Canada regulates foods, while ensuring that the existing level of safety oversight is maintained.

Outcome:

No change to the proposal

3. Comments on product categories description:

Comments generally supported the proposed amendments to the products categories for each ML as they will add clarity to the types of products to which the MLs apply. The following points were also noted about the proposed descriptions.

1. The proposed format to enumerate exceptions in a paragraph may lead to misinterpretation of what products are excluded from a given ML and an alternative formatting was suggested for enhanced clarity.
2. Fortified wines do not carry a vintage year (they are labelled according to age) and the originally proposed text to describe older products "with a vintage year date earlier than 1995" may not be appropriate. It was suggested to consider "aged 20 years or greater" as an alternative.
3. While many fortified wines are produced through the addition of a distilled spirit to a wine, certain wines are fortified through other winemaking techniques. It was recommended to expand the definition of fortified wines to include those produced through unique ageing (namely, under a yeast veil and/or prolonged fermentation) and heating processes (such as the Solera method).
4. It was recommended that guidance be published to provide clarification on product categories and to support compliance and enforcement activities by the CFIA.

Health Canada's responses:

1. Health Canada agrees that the originally proposed format to listing exceptions within a paragraph could lead to misinterpretation.

   For consistency with best practices in drafting regulations, Health Canada has retained applicable exceptions and indicates any excepted products directly in the paragraph that lists the product. For example, the paragraph for wines was updated to "Wines, except those wines set out in paragraph (d) of this item". This format has also been applied to other paragraphs where exceptions are listed.

2. Health Canada has no concerns with the recommendation to change how older fortified wines are described as it would better align with the current way that these products are labelled and recognized. For consistency, the same description will be used for older wine products.

   The text "aged 20 years or greater" as proposed in the comments expands the range of targeted products from those that are pre-1995 (roughly 30 years old or greater at present) to those that are 20 years old or greater. The surveillance data provided in support of the comments indicate that expanding the exemption for wine and fortified wine products from those aged 30 years or more to those aged 20 years or more would have a negligible impact ethyl carbamate exposures and would not pose a health concern.

   Therefore, the text in paragraphs (c) and (d) were changed from "with a vintage year date earlier than 1995" to "aged 20 years or greater".

3. Health Canada has no concerns with expanding the definition of "fortified wines" to include manufacturing processes that may not involve the addition of a distilled spirit but use other fortification techniques.

   Regardless of how they are manufactured, fortified wines are generally higher in alcohol content than non-fortified wines, and consumed in lower amounts and less frequently given their higher alcohol content.

4. A guidance document intended to support the CFIA in their compliance and enforcement activities will be available by request to the CFIA.

Outcomes:

Minor changes to the proposal:

• Change to the text where exceptions are listed in paragraphs (b), (d) and (e): pointing to the paragraphs where the rule is set out instead of enumerating the alcoholic beverages that are subject to another ML (see Table 1)
• Amendment to the text in paragraphs (c) and (d): replacing "with a vintage year date earlier than 1995" with "aged 20 years or greater" (see Table 1)
• Expanded definition of "fortified wines" in the compliance and enforcement guidance

4. Comments on the maximum levels – Baijiu:

Comments recommended to categorize Chinese Baijiu with fruit-based distilled spirits where an ML of 400 ppb ethyl carbamate would apply, as these products may contain precursors to ethyl carbamate formation. In addition, it was recommended that Health Canada conduct a comprehensive risk assessment of ethyl carbamate on alcoholic beverage products that includes Baijiu.

Health Canada's response:

Ethyl carbamate was assessed by the Government of Canada through the Chemicals Management Plan (CMP) initiative in 2016^{Footnote 1}. The MLs for ethyl carbamate were reviewed by Health Canada's Food and Nutrition Directorate as part of the risk management commitments following the CMP assessment^{Footnote 2}. Although consumption data specific to Baijiu were not available, occurrence data for Baijiu were available and the assessment considered consumption patterns for beverages that are expected to be consumed similarly to Baijiu.

Since Baijiu is a distilled spirit made from fermented cereal grains such as sorghum, under the original proposal, it would have been subject to an ML of 150 ppb ethyl carbamate.

Data in support of the recommendation were not provided with these comments. However, surveillance data for Baijiu products sold in Canada indicate that approximately 89% of Baijiu samples had ethyl carbamate concentrations less than 150 ppb and 94% were below 200 ppb. Studies published in the scientific literature have also shown that ethyl carbamate concentrations in Baijiu can vary from less than 10 ppb to more than 500 ppb, and generally average concentrations of less than 200 ppb.

In light of these results, Health Canada has re-classified Baijiu under the ML of 200 ppb ethyl carbamate. Baijiu represents a very low proportion of the overall distilled spirit market in Canada and does not contribute significantly to ethyl carbamate dietary exposure. The slightly higher ML of 200 ppb from the original 150 ppb is not expected to pose a health concern and would be consistent with levels that are ALARA. At this time, there is insufficient evidence to support an ML of 400 ppb for Baijiu products.

Outcome:

Adding "Baijiu" to paragraph (a) (see Table 1)

5. Comments on the maximum levels – distilled spirits:

Comments indicated that, previously, all liqueurs were subject to the ML of 400 ppb. Under the new proposal, this will only be the case for fruit-based liqueurs, while all other liqueurs will be subject to the ML of 150 ppb (distilled spirits). As such, manufacturers may not have the opportunity to adapt to the change. It was recommended that all liqueurs (not just fruit-based) be subject to an ML of 400 ppb.

Comments also expressed concerns on the ability of some whisky products to meet the applicable ML of 150 ppb for distilled spirits.

Health Canada's response:

The ML of 400 ppb has always applied to liqueurs from fruit, while liqueurs from food materials other than fruit ^{Footnote 3} have always been subject to the ML of 150 ppb (including liqueurs from nuts). Health Canada has not proposed to change this as the available data suggests that distilled spirits made from food materials other than fruit are able to readily meet the ML of 150 ppb.

Results currently available to Health Canada indicate that whisky products are also able to readily meet the 150 ppb ML for distilled spirits.

Health Canada continues to encourage manufacturers to follow best agricultural and manufacturing practices to minimize ethyl carbamate formation.

Outcome:

No change to the proposal

6. Comment on the maximum levels – maple wines:

Comments indicated that alcoholic beverages from the fermentation of maple sap (wines, fortified wines) and from the distillation of fermented maple sap (spirits) may have difficulty in meeting applicable MLs.

Comments included data demonstrating this claim and also showed that longer ageing periods resulted in higher ethyl carbamate concentrations in the products. Most results submitted as evidence showed that ethyl carbamate concentrations in alcoholic beverages from maple sap products are below 200 ppb indicating that this ML would be readily achievable for these products.

Health Canada's response:

The results provided in support of the comments showed that wines, fortified wines and distilled spirits from maple sap could exceed their applicable MLs of 30, 100 and 150 ppb, respectively. Longer fermentation periods may result in higher ethyl carbamate concentrations, as they allow more time for its formation when precursors are present.

Alcoholic beverages from maple sap represent a very low proportion of the overall alcohol beverage market, and therefore represent a negligible proportion of alcoholic beverage consumption in Canada. In addition, wines from maple sap are specialty products and typically consumed like dessert wines and thus in lower quantities and less frequently than dry wines. Therefore, alcoholic beverages from maple sap are not a significant source of exposure to ethyl carbamate and applying an ML of 200 ppb for these products will not pose a health concern.

Outcome:

Adding "alcoholic beverages from maple sap" to paragraph (a) (see Table 1)

7. Comment on the maximum levels – rice wines:

Comments expressed concerns that rice-based wines other than sake may not be able to meet the ML of 30 ppb set out for "wines". Additional data were provided in support of this claim.

Health Canada's response:

Under the original proposal, only rice-based products called sake would be subject to the ML of 200 ppb while other rice-based wines or rice-based distilled spirits would be subject to the MLs of 30 ppb and 150 ppb, respectively. Health Canada revisited the available monitoring results on ethyl carbamate in rice-based alcoholic beverages and considered the additional data provided. Ethyl carbamate concentrations in rice-based alcoholic beverages other than sake follow a similar pattern to those observed in sake. The majority of the market for rice-based alcoholic beverages is sake, and the contribution of other rice-based beverages to ethyl carbamate exposure is expected to be very low. Furthermore, Health Canada has issued advice for consumers to limit their sake consumption to no more than 4 drinks per week (see "Ethyl carbamate in food"). This is based on the fact that the alcohol content in sake can vary substantially and sake products with lower alcohol content (i.e. similar to dry wines) can be consumed in higher amounts.

Therefore, expanding the entry for sake to all rice-based alcoholic beverages is not expected to significantly impact chronic exposures to ethyl carbamate or pose a health concern.

Outcome:

Amendment to paragraph (a): replacing "sake" with "alcoholic beverages from rice" (see Table 1)

Modification to the list

Health Canada has modified Part 2 of the List of Contaminants and Other Adulterating Substances in Foods to set out maximum levels for ethyl carbamate in various alcoholic beverages under the new item E.1 and its corresponding paragraphs. Consequently, the maximum level for ethylene thiourea—previously listed under item E.1—is now set out under the new item E.2, as shown in Table 1.

Additional modifications

Descriptors were added to the titles of the two parts of the List of Contaminants and Other Adulterating Substances in Foods, for clarity and harmonization with other Health Canada's incorporated by reference documents. The previous titles "Part 1" and "Part 2" were updated to "Part 1: Prohibitions" and "Part 2: Maximum Levels", respectively.

The MLs for ethyl carbamate that were established in the administrative List of Maximum Levels for Various Chemical Contaminants in Foods were removed from that list concurrently with the addition of the regulatory MLs for ethyl carbamate to Part 2 of the List of Contaminants and Other Adulterating Substances in Foods. The entries that were removed from the administrative list are shown in Table 2.

Other relevant information

International status

The Codex Alimentarius Commission (CAC) has not established MLs for ethyl carbamate in food and beverages but has published codes of practice to prevent and reduce ethyl carbamate formation in alcoholic beverages. Various risk management measures have been implemented by other health-based organizations, with the majority focusing on non-regulatory or voluntary approaches.

Engagement

Health Canada sought feedback from the National Quality Assurance Committee representing the Canadian Liquor Jurisdictions (NQAC–CLJ) and the Canadian Food Inspection Agency (CFIA) on compliance and enforcement considerations throughout the policy's development, up to its finalization.

Guidance

Health Canada has revised its consumer advice on Ethyl carbamate in food to provide more comprehensive information on potential exposure to this substance from alcoholic beverages.

To help classify alcoholic beverage products to the proper ethyl carbamate ML, the Guidance for Ethyl Carbamate Maximum Levels in Alcoholic Beverages is available through the Canadian Food Inspection Agency. This guidance document does not have regulatory status. Product compliance with the regulatory ML(s) and Part I, Section 4(1) of the Food and Drugs Act may still be determined on case-by-case basis. To obtain a copy of the guidance document please contact the CFIA.

Implementation and enforcement

The modification shown in Table 1 comes into force on July 24, 2026, the day of its publication in Part 2 of the List of Contaminants and Other Adulterating Substances in Foods.

You can consult the Notices of Proposal and Notices of Modification web page to stay informed of modifications to the list. You can also register for Health Canada's Consultation and Stakeholder Information Management System to be automatically notified when these notices are issued.

The Canadian Food Inspection Agency is responsible for the enforcement of the Food and Drugs Act and its associated regulations with respect to foods.

Contact information

If you wish to submit an inquiry or new scientific information about contaminants in foods sold in Canada please contact Health Canada's Bureau of Chemical Safety.

If your communication is specific to this notice, please use the words "ethyl carbamate (MCON-2605)" in the subject line of your message.

Bureau of Chemical Safety
Food and Nutrition Directorate
251 Sir Frederick Banting Driveway
Postal locator 2202C
Tunney's Pasture
Ottawa ON K1A 0K9
Email: bcs-bipc@hc-sc.gc.ca

Useful links

Health Canada:

• Ethyl carbamate in food

Government of Canada's Chemicals management plan (CMP):

• Ethyl carbamate - information sheet