Sodium cyclamate and cyclohexylamine - information sheet

Sulfamic acid, cyclohexyl-, monosodium salt
(sodium cyclamate)
CAS Registry Number 139-05-9

Cyclohexanamine
(cyclohexylamine)
CAS Registry Number 108-91-8

Publications summarized:

• Final Screening Assessment for Sodium Cyclamate and Cyclohexylamine (published on April 9, 2022). Public comments received on the draft screening assessment were considered and a summary was published.
• Associated notice: Canada Gazette, Part I: Vol. 156, No. 15 – April 9, 2022

On this page

• Overview
• About these substances
• Human and ecological exposures
• Key health and ecological effects (hazard)
• Consideration of vulnerable populations
• Risk assessment outcomes
  • Screening assessment conclusions
• Preventive actions and risk reduction
  • Additional considerations
  • Where to find updates
• Related resources

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 and 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 ecological hazard and exposure potentials of these 2 substances were classified using the Ecological Risk Classification of Organic Substances (ERC) Approach.
• Sodium cyclamate and cyclohexylamine (CHA) are associated with health effects of potential concern; however, at levels of exposure considered in the assessment, the Government concluded that these substances are not harmful to human health or the environment.

About these substances

• The screening assessment focused on sodium cyclamate and CHA. They were assessed under the third phase of the Chemicals Management Plan (CMP).
• These substances are not expected to occur naturally in the environment.
• According to information gathered by the Government, sodium cyclamate is mainly used in Canada as a table-top sweetener, and as a non-medicinal ingredient in drugs including natural health products. CHA is used in water treatment systems to prevent corrosion, and in boiler water systems to remove build up. It may also be used in cosmetics, as a formulant in pesticides, in the manufacture of food packaging materials, in incidental additives which may be used in food processing establishments, and in other products available to consumers.
• CHA is a metabolite of sodium cyclamate in mammals and CHA data informs the human health effects characterization of both substances.

Human and ecological exposures

• The screening assessment indicated that Canadians may be exposed to sodium cyclamate and CHA from environmental sources (for example, drinking water) and through the use of certain products available to consumers, such as mineral and vitamin supplements, mouthwash, chest congestion relief syrup, aerosol hairsprays, and gel fuel canisters for fireplaces and lanterns.
• Canadians may also be exposed to these substances through their diet, from:
  • the use of sodium cyclamate as a table-top sweetener
  • the use of CHA as a boiler water additive in food processing establishments.
• According to the information considered under the ERC Approach, these substances were identified as having low ecological exposure potential.

Key health and ecological effects (hazard)

• To help inform the health effects characterization in the screening assessment, international reports of data on these substances were considered, among other sources of information. This included assessments by the Joint Food and Agriculture Organization of the United Nations/World Health Organization Expert Committee on Food Additives, the International Agency for Research on Cancer and the European Scientific Committee on Food.
• The European Commission has classified CHA as a reproductive toxicant.
• There were limited health effects (hazard) data for sodium cyclamate; therefore, a comparative approach using data for a similar chemical, called read-across, was used for assessing potential health effects.
• For sodium cyclamate and CHA, the critical effects identified for characterizing the risk to human health are potential effects on the testes.
• According to information considered under the ERC Approach, sodium cyclamate and CHA were identified as having low ecological hazard potential.

Consideration of vulnerable populations

• There are groups of individuals within the Canadian population who, due to greater susceptibility or greater exposure, may be more likely to experience adverse health effects from exposure to substances.
• Certain subpopulations are routinely considered throughout the screening assessment process, such as infants, children and people of reproductive age. For instance, age-specific exposure estimates are routinely derived and developmental and reproductive toxicity studies are evaluated for potential adverse health effects. In doing this, subpopulations with potential for higher exposure and those who may be more susceptible are considered when determining risk assessment outcomes.
• For sodium cyclamate, dietary exposures were estimated for people with diabetes to better understand their consumption of table-top sweeteners containing this substance.

Risk assessment outcomes

• Based upon a comparison of levels to which Canadians may be exposed to sodium cyclamate and CHA, and the levels associated with health effects, the risk to human health from these substances is considered to be low.
• Based upon the outcome of the ERC Approach, these 2 substances are considered unlikely to be causing ecological harm.

Screening assessment conclusions

• The Government concluded that sodium cyclamate and CHA are not harmful to human health at levels of exposure considered in the assessment, and that they are not entering the environment at levels that are harmful.

Preventive actions and risk reduction

• Although CHA was not considered to be harmful to human health at levels of exposure considered in the assessment, this substance is considered to have a health effect of concern due to its potential to cause reproductive effects. There may be a concern if exposures were to increase.
• Therefore, the Government published a notice of intent (NOI) to apply the Significant New Activity (SNAc) provisions of CEPA 1999 to CHA. This publication has a 60-day public comment period ending on June 8, 2022.
• The SNAc provisions would require that the Government be notified of certain proposed new activities related to CHA, and that the new activity be assessed for potential risks to human health and the environment before being undertaken.
• The notice outlines the proposed definition of a significant new activity in relation to CHA, as well as the information that would need to be provided to the Government for assessment before the new activity is undertaken.

Additional considerations

• Although sodium cyclamate is not considered to be harmful at levels of exposure considered in the assessment, this substance has health effects of concern based on its potential to cause reproductive effects.
• An analysis of information related to current and potential future uses of sodium cyclamate suggest that it is unlikely that exposure will increase to levels of concern to human health. For this reason, follow-up activities to track changes in exposure and/or commercial use patterns for sodium cyclamate are not being considered at this time.

Where to find updates

• The timeline for the Sodium Cyclamate and Cyclohexylamine Group is updated to reflect new or changed activities. Also, information on SNAc provisions applied to substances, where applicable, is found in the SNAc publications dataset
• Details on information gathering initiatives and information on the risk management of substances addressed under the CMP are also available.
• Use the Substances Search tool to find substances that are referenced in certain legislative or regulatory instruments or on Government of Canada websites.

Related resources

• Sodium cyclamate and CHA are found in products available to consumers. Canadians should follow any safety warnings and directions related to the product and dispose of products responsibly.
• Sodium cyclamate should be used only on the advice of a physician when used as a table-top sweetener.
• Health Canada's Guidelines for Incidental Additive Submissions specifies a concentration limit for using cyclohexylamine as an additive in boiler water systems in food processing facilities.
• 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. For information concerning workplace health and safety and what steps to take in the workplace, Canadians should consult their employer and/or the Occupational Health and Safety Regulator in their jurisdiction.