Carbamic acid, ethyl ester
CAS Registry Number 51-79-6
What is it?
- Carbamic acid, ethyl ester, also known as ethyl carbamate, is an industrial chemical. Ethyl carbamate can also be found naturally in the environment.
- Ethyl carbamate is a by-product of the fermentation process. Therefore, it can be detected in many types of fermented foods and alcoholic beverages. It is also present in tobacco plants and tobacco smoke.
How is it used?
- Use of this substance in Canada and internationally is limited to medical laboratory research.
- Based on the most recent data, ethyl carbamate is not manufactured or imported into Canada in quantities greater than 100 kg per year.
Why did the Government of Canada assess it?
- Ethyl carbamate is recognized as having health effects of concern based on international classification as a substance that causes cancer in animal studies.
- Ethyl carbamate is one of six substances in the Internationally Classified Substance Grouping, which were identified as priorities for assessment as they either met the categorization criteria of the Domestic Substances List and/or were associated with human health concerns.
- The Internationally Classified substances are being considered as part of the Substance Groupings Initiative for screening assessments of their potential risks to the environment and to human health.
How are Canadians exposed to it?
- Ethyl carbamate is a chemical that is naturally formed during the fermentation process or during storage of fermented foods. 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 not expected to be exposed to ethyl carbamate through environmental media.
- Canadians are also exposed to ethyl carbamate from its presence in tobacco smoke.
How is it released into the environment?
- Considering the low quantity of ethyl carbamate in commerce in Canada and its limited uses, environmental releases of this substance are not expected to be significant.
What are the results of the assessment?
- The Government of Canada has conducted a science-based evaluation of ethyl carbamate, called a screening assessment.
- Screening assessments address the potential for harm to the general population of Canada and the environment.
- Results of the final screening assessment indicate that ethyl carbamate is not expected to accumulate in organisms or remain in the environment for a long time.
- Furthermore, the quantity of ethyl carbamate that may be released to the environment is considered negligible such that harm to organisms in the environment is not expected.
- The Government of Canada has therefore concluded that ethyl carbamate is not entering the environment at levels that constitute a danger to the environment.
- However, the Government of Canada has concluded that ethyl carbamate may be harmful to human health.
- Hazards related to chemicals used in the workplace should be classified accordingly under the Workplace Hazardous Materials Information System (WHMIS).
What is the Government of Canada doing?
- The Government of Canada published the Final Screening Assessment on Ethyl Carbamate and the Proposed Risk Management Approach for Ethyl Carbamate on May 28, 2016. The approach will be followed by a 60-day public comment period, ending on July 27, 2016.
- As outlined in the approach, the Government of Canada proposes to take action on ethyl carbamate under the Food and Drugs Act. The proposed risk management actions are to:
- 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 addition, the Government of Canada has amended the List of Permitted Food Enzymes as regulated under the Food and Drugs Act to enable use of the enzyme urease in the manufacture of wine and sake to reduce ethyl carbamate formation.
- 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 the Canadian Environmental Protection Act, 1999, 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.
What can Canadians do?
- The health risks associated with a chemical depend on the hazard (its potential to cause health effects) and the dose (the amount of chemical to which you are exposed).
- Tobacco products are also a source of ethyl carbamate. Canadians are reminded that they should not smoke or chew tobacco and should avoid second-hand smoke. For more information about how to quit smoking and how to protect your family from second-hand smoke, check out the Smoking and tobacco Web site or speak with your doctor.
- The Government of Canada recommends limiting alcohol intake and supports the use of Canada's Low-Risk Alcohol Drinking Guidelines.
- Canadians who may be exposed to ethyl carbamate in the workplace should consult with their employer and occupational health and safety representative about safe handling practices, applicable laws and requirements under OHS legislation and the Workplace Hazardous Materials Information System (WHMIS).
- As a general precaution, Canadians are reminded when using any product to carefully follow any safety warnings and directions, and to dispose of the products appropriately.
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