Chlorhexidine and its salts – information sheet

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Overview

  • The Government of Canada conducted a science-based evaluation, called a screening assessment, to address the potential for harm to Canadians and to the environment from Chlorhexidine and its salts.
  • Under the Canadian Environmental Protection Act, 1999 (CEPA 1999), the risk posed by a substance is determined by considering both its hazardous properties (its potential to cause adverse human health or ecological effects) and the amount of exposure there is to people and the environment. A substance may have hazardous properties; however, the risk to human health or to the environment may be low depending upon the level of exposure.
  • As a result of the screening assessment, the Government concluded that chlorhexidine and its salts are harmful to the environment, but not to human health at levels of exposure current at the time of the assessment.

About these substances

  • The screening assessment under the Chemicals Management Plan (CMP) focused on the chlorhexidine moiety. It addresses 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.
  • Chlorhexidine salts dissociate (split apart) in water, releasing the chlorhexidine moiety.
  • These substances do not occur naturally in the environment.
  • According to information gathered by the Government, these substances are used as 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.

Human and ecological exposures

  • 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 were considered to be the important or “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, it was determined that there is risk of harm to the environment from chlorhexidine and its salts.
  • The Government of Canada published the Final Screening Assessment for Chlorhexidine and its Salts on June 29, 2019.

Screening assessment conclusions

  • As a result of the screening assessment, the Government concluded that chlorhexidine and its salts are not harmful to human health at current levels of exposure.
  • 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 1999.

Preventive actions and reducing risk

  • The Government of Canada published the Risk Management Approach for Chlorhexidine and its Salts on June 29, 2019. The public is invited to comment on this document during the 60-day public comment period ending on August 28, 2019.
  • The Government will consider adding chlorhexidine and its salts to Schedule 1 of CEPA 1999, also called the List of Toxic Substances.
  • The Government is considering the following risk management actions to address ecological concerns:
    • Implementing a code of practice under Section 54 of CEPA 1999 and an environmental performance agreement (EPA) to minimize the release of chlorhexidine and its salts to the environment from the industrial use of these substances.
  • Information is being sought by the Government to inform risk management decision-making. Details can be found in the risk management approach, including where to send information during the public comment period, ending August 28, 2019.
  • 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.
  • Further information and updates on risk management actions for substances managed under the CMP can be found in the risk management actions table and the two year rolling risk management activities and consultations schedule.

Related information

  • These substances 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 non-prescription topical antiseptic chlorhexidine products and serious allergic reactions.
  • Canadians who may be exposed to these substances in the workplace should consult with their employer and an occupational health and safety (OHS) representative about safe handling practices, applicable laws, and requirements under OHS legislation and the Workplace Hazardous Materials Information System.
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