Ethyl carbamate - information sheet
Carbamic acid, ethyl ester
CAS Registry Number 51-79-6
- Screening Assessment, Internationally Classified Substance Grouping, Carbamic acid, ethyl ester (Ethyl carbamate) (published on May 28, 2016).
- Risk Management Approach for Ethyl Carbamate (published on May 28, 2016 for a 60-day public comment period). Risk management was taken.
- Associated notice: Canada Gazette, Part I: Vol. 150, No. 22 - May 28, 2016
On this page
- About this substance
- Human and ecological exposures
- Key health and ecological effects (hazard)
- Risk assessment outcomes
- Preventive actions and risk reduction
- Related resources
- The Government of Canada conducts risk assessments of substances under the Canadian Environmental Protection Act, 1999 (CEPA 1999) to determine whether they present or may present a risk to human health or to the environment.
- The risks posed by a substance are determined by both its hazardous properties (potential to cause adverse human health or ecological effects) and the amount or extent of exposure to people or the environment.
- When needed, the Government implements risk management measures under CEPA 1999 and other federal acts to help prevent or reduce potential harm.
- The Government concluded that ethyl carbamate is harmful to human health due to potential exposures through the consumption of alcoholic beverages. Ethyl carbamate is associated with the potential to cause cancer.
- Risk management actions were taken to help reduce exposures to ethyl carbamate.
- The Government also concluded that ethyl carbamate is not harmful to the environment.
About this substance
- The screening assessment focused on carbamic acid, ethyl ester, also known as ethyl carbamate, as part of the Chemicals Management Plan (CMP).
- Ethyl carbamate is one of six substances in the Internationally Classified Substance Grouping which were prioritized for screening assessment because they were classified by certain international agencies as potentially of concern for human health.
- Ethyl carbamate is naturally formed during the fermentation process or during storage of fermented foods and has been detected in many types of fermented foods and alcoholic beverages. It is also a constituent of tobacco plants and is present in tobacco smoke.
- In Canada, the current uses of ethyl carbamate are limited to medical research.
Human and ecological exposures
- The screening assessment indicated that Canadians may be exposed to ethyl carbamate through dietary sources, including alcoholic beverages. Dietary exposure to ethyl carbamate in other fermented foods is expected to be lower than alcoholic beverages.
- Canadians are also exposed to ethyl carbamate from its presence in tobacco smoke.
- Releases of ethyl carbamate to the environment due to human activities are expected to be negligible.
Key health and ecological effects (hazard)
- The International Agency for Research on Cancer has classified ethyl carbamate as ''probably carcinogenic to humans''. The National Toxicology Program in the United States evaluated ethyl carbamate and listed it as "reasonably anticipated to be a human carcinogen." The critical effect for characterization of risk to human health associated with exposure to ethyl carbamate is its ability to cause cancer.
- Environmental effects considered in the ecological assessment included data from scientific research as well as modelled data.
Risk assessment outcomes
- Based upon a comparison of exposure levels to ethyl carbamate from the consumption of alcoholic beverages in adults, and levels associated with critical health effects, the Government determined that this substance may pose a risk to human health.
- Environmental exposure of organisms is considered to be negligible, and ethyl carbamate is not expected to pose a risk to organisms or the environment in Canada.
Screening assessment conclusions
- The Government concluded that ethyl carbamate is harmful to human health at levels of exposure considered in the assessment. The Government also concluded that ethyl carbamate is not entering the environment at concentrations that are harmful.
- Ethyl carbamate does not meet the persistence or bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations of CEPA 1999.
Preventive actions and risk reduction
- Ethyl carbamate is on the Non-Statutory List of substances that have been found to meet at least one of the criteria set out in section 64 of CEPA 1999 (that is, the substance is concluded to be toxic), but that have not been added to Schedule 1 of the Act. The Ministers are satisfied that the Food and Drugs Act is a more appropriate Act to manage the potential risks posed by this substance.
- The risk management approach indicated that the Government considered the following actions to address human health concerns:
- Review the existing Canadian Standards (Maximum Levels) for ethyl carbamate in certain alcoholic beverages and consider amending them, if warranted;
- Continue to support the development and implementation of additional techniques or tools available to industry that will minimize ethyl carbamate formation in alcoholic beverages;
- Continue encouraging industry to adopt international ethyl carbamate reduction strategies, such as those described in the Codex Alimentarius Code of Practice for the Prevention and Reduction of Ethyl Carbamate Contamination in Stone Fruit Distillates;
- Consider developing information documents and/or consumption advice for consumers of certain alcoholic beverages that have the potential to contain higher concentrations of ethyl carbamate; and
- Assess the impact of Canada's Low-Risk Alcohol Drinking Guidelines on reducing exposure to ethyl carbamate.
- In May 2022, Health Canada's Food Directorate released an update on the risk management commitments for ethyl carbamate in foods, including alcoholic beverages. For the latest information, please visit the ethyl carbamate in food web page.
Where to find updates on risk management actions
- The timeline for the Internationally Classified Substance Grouping is updated to reflect new or changed activities.
- Additional information on the risk management of substances addressed under the CMP is available.
- Use the Substances Search tool to find substances that are referenced in certain legislative or regulatory instruments or on Government of Canada websites.
- The screening assessment focused on potential risks from exposure of the general population of Canada, rather than occupational exposure. Hazards related to chemicals used in the workplace are defined within the Workplace Hazardous Materials Information System (WHMIS). For information concerning workplace health and safety and what steps to take in the workplace, Canadians should consult their employer or the Occupational Health and Safety Regulator in their jurisdiction.
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