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 of people and the environment.
When needed, the Government implements risk management measures under CEPA and other federal acts to help prevent or reduce potential harm.
The Government concluded that chlorhexidine and its salts are harmful to the environment, but not to human health at levels of exposure considered in the assessment. The chlorhexidine moiety may cause adverse effects on aquatic organisms. Risk management actions were proposed to help address these ecological concerns.
The screening assessment under the Chemicals Management Plan (CMP) focused on the chlorhexidine moiety. It addressed chlorhexidine and its salts, which includes, but is not limited to, chlorhexidine, chlorhexidine diacetate, chlorhexidine dihydrochloride, and chlorhexidine digluconate.
Chlorhexidine diacetate was initially part of Batch 12 of the Challenge Initiative of the CMP (then referred to as chlorhexidine acetate). However, to consider exposure from all potential sources of the chlorhexidine moiety, a subsequent screening assessment to address a broader group of substances was published, namely the screening assessment for chlorhexidine and its salts.
These substances do not occur naturally in the environment.
According to information gathered by the Government, these substances are used as broad-spectrum antiseptics and antimicrobial preservatives in products, such as cosmetics, natural health products, prescription and non-prescription drugs for human or veterinary uses, and hard-surface disinfectants.
These substances may be used in hand sanitizers.
Human and ecological exposures
The screening assessment indicated that Canadians may be exposed to these substances through the use of products available to consumers, such as cosmetics (for example, body moisturizer, lipstick, and lip balm) and natural health products (for example, sunscreen and mouthwash).
These substances may be released to the environment through discharges from wastewater treatment systems, from the manufacture of chlorhexidine-based products and from consumer use of products containing these substances.
Key health and ecological effects (hazard)
Potential effects on the liver, based on laboratory studies, were considered to be the critical effects identified for characterizing the risk to human health in the screening assessment.
In the environment, the chlorhexidine moiety has the potential to cause adverse effects to aquatic organisms at low concentrations.
Risk assessment outcomes
Based upon a comparison of levels to which Canadians may be exposed to chlorhexidine and its salts, and the levels associated with health effects, the risk to human health from these substances is considered to be low.
Considering all information presented in the screening assessment, it was determined that there is risk of harm to the environment from chlorhexidine and its salts.
Screening assessment conclusions
The Government concluded that chlorhexidine and its salts are not harmful to human health at levels of exposure considered in the assessment.
The Government also concluded that chlorhexidine and its salts are entering or may enter the environment at levels that are harmful to the environment.
Also, the chlorhexidine moiety was found to meet the persistence criteria, but not the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations of CEPA.
Preventive actions and risk reduction
On February 12, 2025, chlorhexidine and its salts were added to Part 2 of Schedule 1 to CEPA. Adding a substance to Schedule 1 does not restrict its use, manufacture or import. Rather, it enables the Government to take enforceable risk management actions under CEPA, using a 2-track approach to manage risks.
Toxic substances that pose the highest risk (that is, meet certain criteria) are added to Part 1 of Schedule 1. These are prioritized for total, partial, or conditional prohibition.
Other toxic substances are added to Part 2 of Schedule 1 and are prioritized for pollution prevention actions, which may include prohibition.
Regulations specifying criteria for the classification of substances that pose the highest risk or that are carcinogenic, mutagenic or toxic to reproduction may be developed. When criteria are available, some substances considered for addition to Part 2 of Schedule 1 may instead be considered for addition to Part 1 of Schedule 1.
Publication of the risk management approach aims to inform stakeholders of proposed risk management actions and continue discussion about their development. The Government proposed the following risk management actions to address ecological concerns:
Implementing an environmental performance agreement and a code of practice under s ection 54 of CEPA to minimize the release of chlorhexidine and its salts to the environment from the industrial use of these substances.
Risk management actions may evolve through the consideration of assessments and risk management options published for other substances. This is to ensure effective, coordinated, and consistent risk management decision-making.
Chlorhexidine and its salts were added to the National Pollutant Release Inventory (NPRI). Further details and updates are found on that program's website.
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
Chlorhexidine and its salts may be found in products available to consumers. Canadians should follow any safety warnings and directions related to the product and dispose of products responsibly.
Health Canada published a summary safety review on the potential link between topical antiseptic non-prescription chlorhexidine products and serious allergic reactions.
Assessments conducted under CEPA focus on risks of exposure of the general population. Hazards related to chemicals used in the workplace are defined within the Workplace Hazardous Materials Information System (WHMIS). If a substance is harmful to the general population, it could also be of concern for individuals in situations where a higher volume of the substance is used or where the substance is used for a longer duration (for example, the workplace). The Government of Canada recognizes that it is the responsibility of the federal, provincial and territorial occupational health and safety organizations to coordinate legislation for the safe use of chemicals in the workplace. We are working to support this role by integrating the information, tools, and technical expertise of the CMP and Health Canada's Workplace Hazardous Products Program.
