Formulators of chlorhexidine-based products: Environmental performance agreement overview
This is a 5-year environmental performance agreement and is in effect from November 17, 2022 to November 16, 2027.
Objective
The objective of this agreement is to protect the aquatic environment by minimizing participating companies’ releases of chlorhexidine and its salts, from their facilities that formulate chlorhexidine-based products.
Signatories
The agreement was signed by:
- Environment and Climate Change Canada (ECCC)
- Agrisan Specialty Chemical and Pharmaceutical
- Germiphene Corporation
Key Requirements
As a result of the agreement, participating companies agree to:
- minimize facility releases of chlorhexidine to the aquatic environment (lower than the Predicted No Effect Concentration (PNEC) of 210 ng/L)
- prepare and implement a chlorhexidine and its salts management plan
- must contain best management practices to minimize the release of chlorhexidine
- conduct sampling and analysis 2 times per year for the duration of the agreement
- undergo site verifications conducted by ECCC 2 times throughout the duration of the agreement
- prepare corrective action plans for any required improvements identified during verifications
Deadlines
Chlorhexidine management plan: Within one year after signing the agreement
Chlorhexidine evaluation report (Annex A): November 30 (each year this agreement is in effect, plus one year after)
Performance results
The 2 participating companies submitted their respective 2023 annual evaluation report as well as their chlorhexidine management plan, which is only required once throughout the agreement. However, 1 facility submitted their report and management plan after the reporting deadlines.
Annual evaluation reports focus on the implementation of best management practices and the development of a chlorhexidine management plan to ensure that releases of chlorhexidine from the industrial facilities are not harmful to the aquatic environment. The reports also require the estimation of a facility’s concentration of chlorhexidine moiety to the aquatic environment and sampling results that are representative of the highest expected concentration of chlorhexidine moiety in industrial effluent at its facility’s final discharge point.
Reports were verified by ECCC and indicated that both facilities met the risk management objective and provided the necessary documentation as outlined in the agreement. Results are summarized in Table 1.
Table 1: First year verification results
| Facility | Location | Estimation of chlorhexidine moiety in industrial effluent under the release limit (210 ng/L) | Industrial effluent sampling results under the release limit (210 ng/L) |
|---|---|---|---|
| Agrisan Specialty Chemical and Pharmaceutical | Arthur, ON | Yes | Yes |
| Germiphene Corporation | Brantford, ON | Yes | Yes |
Verification results
ECCC received and verified the 2023 annual evaluation reports, which included information indicating that each facility is meeting the risk management objective and is reporting on their implementation of the recommended best management practices listed in the agreement. ECCC conducted meetings with both facilities to review their submissions, resulting in a submission of revised information.
Agrisan Specialty Corporation and Pharmaceutical indicated that they are no longer releasing chlorhexidine to the aquatic environment. As such, ECCC requested copies of the hazardous waste manifests to demonstrate that the facility is no longer releasing chlorhexidine to the aquatic environment and that 100% of chlorhexidine rinsate is sent for third-party hazardous waste treatment. It was concluded that sampling at the industrial effluent of this facility would no longer be needed as long as copies of the annual hazardous waste manifests are provided for each year that the agreement is in effect.
ECCC also requested additional information from Germiphene Corporation with respect to their chlorhexidine management plan. Germiphene indicated that 2 chlorhexidine products have been discontinued and that plans are underway to further reduce chlorhexidine releases by optimizing the way that products are produced and sold.
Next steps
- Provide assistance to participating companies on any aspect of the agreement during its implementation
- Perform site verifications as defined in the agreement to confirm that the agreement is being fully implemented
- Review annual evaluation reports submitted by participating facilities
Background
Health Canada and ECCC conducted a joint scientific assessment relevant to the evaluation of chlorhexidine and its salts in Canada. On June 29, 2019, a notice summarizing the scientific considerations of the screening assessment for these substances was published in the Canada Gazette, Part I. For further information on the screening assessment for chlorhexidine and its salts, refer to the screening assessment.
On the basis of the information available, the screening assessment concludes that chlorhexidine and its salts are toxic under paragraph 64(a) of CEPA because they are entering or may enter the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity.
To manage this risk, ECCC developed a voluntary control instrument, in the form of an Environmental Performance Agreement, with the 2 formulators of chlorhexidine products. Through this agreement, these facilities agree to minimize releases of chlorhexidine to levels that are protective of the aquatic environment and report on the implementation of best management practices.
Response to comments
The proposed environmental performance agreement was posted online for a 60-day public consultation period from February 14, 2022, to April 15, 2022. Two comments were received from an Indigenous community and are summarized below.
1. Cumulative impacts of chlorhexidine and other chemical substances being released into the Grand River
Concerns were raised with respect to the cumulative impacts of chlorhexidine and other chemical substances released into the Grand River, a body of water from which the Indigenous Community extracts drinking water.
Response:
Under the Chemical Management Plan (CMP) chemical substances are assessed for the risks posed to human health and the environment. If an assessment concludes that a substance poses a risk to the environment and/or human health, risk management actions are taken and may include actions to prevent or reduce the release of the substance.
Consideration of cumulative, synergistic and antagonistic effects among substances may be included in an assessment. However, typically the information available during an assessment only represents the inherent ability of a substance to elicit adverse effects. Sufficient additional information is required for appropriate assessment of cumulative, synergistic and antagonistic effects. The Government of Canada is currently considering how to evolve and better communicate its approach to the identification and assessment of cumulative risk, where warranted.
Regarding chlorhexidine, environmental concentrations were estimated from available information on quantities of chlorhexidine and its salts imported and used in Canada. With this information, it was concluded that there is a risk to the environment and two facilities were identified for risk management using the proposed Environmental Performance Agreement for the Formulation of Chlorhexidine Products. Predicted environmental concentrations in water were also used to estimate potential human exposure from drinking water during the screening assessment, and no human health concerns were identified.
The Government of Canada can review any new information, including information on cumulative impacts, through prioritization processes such as the Identification of Risk Assessment Priorities (IRAP) process to determine if further data collection, risk assessment or no further investigation based on any new data is warranted.
2. Voluntary Approach for managing the risks of chlorhexidine releases to the aquatic environment
Concerns were raised with respect to using a voluntary approach for managing the risks of chlorhexidine releases to the aquatic environment and ECCC was questioned as to why implementing a prohibition on chlorhexidine was not the chosen risk management approach.
Response:
ECCC follows a structured process (the Instrument Choice Framework or ICF) to identify actions to manage the risks posed by chemical substances. There are a number of considerations involved when proposing risk management actions, such as the magnitude of assessed risk, the projected effectiveness of the action or instrument in achieving policy objectives, the number of facilities involved, and economic considerations.
Based on the analysis conducted under an ICF, it was determined that an Environmental Performance Agreement (EPA) was the best action to meet the objectives for the risk management of chlorhexidine and its salts. In this case, risk management is focused on 2 facilities who have been cooperative in engaging with ECCC to develop an EPA.
Chlorhexidine is an effective antiseptic in cleaning products and personal care products used to kill germs and protect human health. The Government of Canada concluded that chlorhexidine and its salts are harmful to the environment, but not to human health at levels of exposure considered in the assessment. For these reasons, a regulated prohibition on the use of chlorhexidine was not considered appropriate.
Related information
Contact us
Chemical Production Division
Environment and Climate Change Canada
Email: pgpc-dppc-cmp-cpd@ec.gc.ca
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