Ethyl carbamate - information sheet

Carbamic acid, ethyl ester

CAS Registry Number 51-79-6

Publications summarized:

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Overview

  • 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:
  • 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

Related resources

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