预警信息

Background

Food contaminants and other adulterating substances are chemicals that may be present in foods at levels that could impact the overall safety and/or quality of foods. These substances can either be inadvertently or naturally present in foods or, in some cases, intentionally added for fraudulent purposes. Establishing a prohibition or a maximum level (ML) is a form of risk management that may be employed to eliminate or reduce exposure to a particular chemical contaminant in foods. Canadian prohibitions and MLs for chemical contaminants in food are set out in Part 1 and Part 2, respectively, of the List of Contaminants and Other Adulterating Substances in Foods, which is incorporated by reference into section B.15.001 of Division 15 of the Food and Drug Regulations. Maximum levels for contaminants are also set out in Health Canada's administrative (non-regulatory) List of Maximum Levels for Various Chemical Contaminants in Foods.

All prohibitions and MLs for contaminants in food are established by Health Canada's Food and Nutrition Directorate based on scientific evidence, in consultation with stakeholders and are enforceable by the Canadian Food Inspection Agency (CFIA).

As part of Health Canada's initiative toward regulatory modernization detailed in the Path Forward for Contaminants and Other Adulterating Substances in Foods, the Directorate is consolidating all MLs into the single regulatory List of Contaminants and Other Adulterating Substances in Foods while systematically reviewing and updating these MLs as they are transferred from one list to the other.

Issue

The administrative List of Maximum Levels for Various Chemical Contaminants in Foods includes MLs for ethyl carbamate in table wines (30 parts per billion or ppb), fortified wines (100 ppb), distilled spirits (150 ppb), fruit brandies and liqueurs (400 ppb) and sake (200 ppb). In 2022, as part of the Government of Canada's Chemical Management Plan (CMP) assessment of ethyl carbamate, Health Canada confirmed that the MLs for ethyl carbamate in alcoholic beverages continue to be protective of human health and readily achievable.

Health Canada is proposing to transfer the MLs for ethyl carbamate in alcoholic beverages from the List of Maximum Levels for Various Chemical Contaminants in Foods, to the regulatory List of Contaminants and Other Adulterating Substances in Foods, maintaining the current value of the MLs but amending some of the product categories to better reflect the diverse market of alcoholic beverages.

Rationale

The Food and Nutrition Directorate's evaluation on the risk management commitments for ethyl carbamate published in May 2022 confirmed that the MLs for ethyl carbamate in alcoholic beverages currently included on the administrative List of Maximum Levels for Various Chemical Contaminants continue to be health protective. The results of a detailed achievability analysis also found that for the large majority of the targeted alcoholic beverages, ethyl carbamate concentrations are able to meet (i.e., are below) their applicable ML. For most products, the achievability rate was greater than 94%. Therefore, Health Canada is proposing to transfer the MLs for ethyl carbamate to the regulatory list, without change to the actual values (i.e., maximum concentrations).

However, these MLs were originally established in the 1980s and since then, the alcoholic beverage market has significantly evolved. As such, the alcoholic beverage categories applicable to each ML do not necessarily reflect the current market. Health Canada is proposing changes to some of the descriptions of the alcoholic beverage categories to better represent the contemporary market while still maintain the original intent of the MLs.

Wines

The term table wine presents some ambiguity relative to its use in other jurisdictions, either by representing very unspecific products or in contrast, being very prescriptive in terms of its content. The proposed term "wines" would better express the intent of this category to include any alcoholic beverage produced by the alcoholic fermentation of grapes or other plant (e.g., any fruit other than grapes) or food (e.g., honey).

Wines pre-1995 vintage

Wines, including fortified wines, with a vintage date before 1995 are more likely to have higher ethyl carbamate concentrations, since the development and implementation of best practices to minimize ethyl carbamate formation may not have been fully adopted until after that time. As such, Health Canada proposes to include pre-1995 vintage wines in the 100 ppb ML category and pre-1995 vintage fortified wines in the 400 ppb ML category. Considering the rarity of pre-1995 vintage wines on the market, long-term exposures to ethyl carbamate from such products are not expected and the higher MLs are still considered health protective.

Sweet wines

Available monitoring data for ethyl carbamate show that several types of sweet wines (also known as dessert wines) often exceed the 30 ppb ethyl carbamate ML for wines. Sweet wines generally have a higher sugar content (i.e., ≥ 60 g total residual sugar/L) and their consumption patterns are more comparable to those for fortified wines (i.e., consumed in lower amounts and less frequently than "non-sweet" wines). Considering these consumption patterns, a higher ML for sweet wines of 100 ppb ethyl carbamate, which is the ML currently established for fortified wines, would still be health protective.

Therefore, Health Canada proposes to include wines with greater than 60 g/L residual sugar in the 100 ppb ML category rather than the 30 ppb ML category. The amount of residual sugar would not include sugar added after the fermentation process (e.g., sugar from added juice or high fructose corn syrups would not be considered).

Distilled spirits

An ML of 150 ppb was originally developed for distilled spirits. However, a separate ML of 400 ppb was also established for "fruit brandies and liqueurs" to accommodate distilled products made from the fermentation of certain fruits, such as stone fruit, which may contain precursors to ethyl carbamate formation that could lead to higher concentrations.

Considering today's alcoholic beverage market is extremely varied, the current description of the 400 ppb ML category does not capture all relevant distilled products from fruits intended for this ML. Health Canada proposes to update the description of this category (400 ppb) from "fruit brandies and liqueurs" to "distilled spirits from fruit".

Sake

When the MLs for ethyl carbamate were originally developed in the 1980s, a separate ML of 200 ppb for sake was established because sake products could not consistently meet the 30 ppb ML for wine. More recent monitoring data confirm this and therefore, Health Canada is not proposing any changes to the description for this category. Other rice-based wines not identified as sake will be subject to the ML for wines (30 ppb) and other distilled spirit products from fermented rice will be subject to the ML for distilled spirits (150 ppb).

Proposed modification

Health Canada proposes to modify Part 2 of the List of Contaminants and Other Adulterating Substances in Foods by adding the MLs for ethyl carbamate and re-describing the alcoholic beverage categories for each ML, as outlined below.

Part 2 – List of Contaminants and Other Adulterating Substances in Foods

Other relevant information

International

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.

Guidance

In May 2022, Health Canada issued a consumer advice for sake and fruit brandy in regard to potential ethyl carbamate exposure. Health Canada will update the descriptions of these alcoholic beverages on its webpage using the terms proposed herein.

Implementation and enforcement

The proposed changes will be effective the day on which they are published in Part 2 of the List of Contaminants and Other Adulterating Substances in Foods. This will be announced via a Notice of Modification that will be published on the?Notices of Proposal and Notices of Modification webpage.

You can register for Health Canada's Consultation and Stakeholder Information Management System (CSIMS) to stay informed of such notices as they 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.

Consultation

Anyone wishing to submit comments on the Proposal to transfer the maximum levels for ethyl carbamate in alcoholic beverages to the List of Contaminants and Other Adulterating Substances in Foods may do so by sending an email to the Food and Nutrition Directorate's Food Incorporation by Reference Unit (FIRU) at food.ibr-ipr.aliments@hc-gc.ca by May 5, 2025, 75 days from the date of this posting. Please use the words "ethyl carbamate (P-CON-25-01)" in the subject line of the email.