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.
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.
The agreement was signed by:
- Environment and Climate Change Canada (ECCC)
- Agrisan Specialty Chemical and Pharmaceutical
- Germiphene Corporation
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
|Type of reports
|Chlorhexidine management plan
|Within one year after signing the agreement
|Chlorhexidine evaluation report (Annex B)
|November 30 (each year this agreement is in effect, plus one year after)
Results will be summarized and posted after the first annual reports are received.
A team consisting of representatives from ECCC will conduct verifications as per the schedule listed under “Key requirements” above and in the agreement. When the first verifications are completed, a summary of these will be added to this section.
- 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 National Pollutant Release Inventory annually and invite new facilities to participate in the agreement if appropriate
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.
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.
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.
Chemical Production Division
Environment and Climate Change Canada
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