Summary of public comments received on the risk management approach for chlorhexidine and its salts  

Chlorhexidine and its salts were assessed by Environment and Climate Change Canada and Health Canada as part of the Chemicals Management Plan. Comments on the Risk Management Approach and Final Screening Assessment for Chlorhexidine and its Salts were submitted by the Canadian Consumer Specialty Products Association, two companies involved with manufacturing and importing of chlorhexidine-based products, and an individual.

Summarized public comments and responses are provided below, organized by topic.

Proposed risk management actions

Comment: A formulator of chlorhexidine-based products indicated support for the proposed risk management actions.

Response: Noted.

Comment: An industry association indicated that they could provide additional information to inform the development of the risk management instruments, if needed.

Response: Noted.

Information and data updates

Comment: An individual recommended that Health Canada provide more information on occupational exposure sources, post-application exposure, threshold limits and clinical studies for risk characterizations of chlorhexidine in cosmetics and personal care products. The individual also recommended that monitoring of facilities dealing with chlorhexidine and its salt derivatives be done.

Response: The final screening assessment for these substances was published on June 29, 2019 and the public comment period for this risk assessment that took place following publication of the draft is closed. However, through its ongoing prioritization process, the Government of Canada will continue to monitor and review any new scientific evidence available. This information will inform any future prioritization, risk assessment or risk management activities.

Comment: A formulator of chlorhexidine-based products provided information on its annual use and release of chlorhexidine to effluent, and indicated that considering the low releases of the substance to effluent, requiring special recycling or disposal procedures should not be necessary. The stakeholder also provided additional information on how the product is used.

Response: The information submitted was considered in the development of risk management instruments for chlorhexidine and its salts.

Comment: A formulator of chlorhexidine-based products submitted information on:

• uses and releases of chlorhexidine from the wastewater effluent from its facility
• a geographic-based and/or site specific approach to risk management
• best management practices used by the facility, and
• facility specific production and financial data

Response: The information submitted was considered in the development of risk management instruments for chlorhexidine and its salts.

Clarification on risk management terminology

Comment: An industry association requested clarification on what concentration of chlorhexidine would constitute a chlorhexidine-based product.

Response: The proposed risk management objective is to reduce the total concentration of chlorhexidine moiety released from industrial facilities that formulate chlorhexidine-based products. Since the exposure scenario of concern is the release of chlorhexidine moiety from industrial facilities, the quantity of chlorhexidine in a specific product is not as significant as the total quantity of chlorhexidine and its salts used by a facility to make products. Therefore, it is important to know the amount of chlorhexidine and its salts used at any concentration by a facility manufacturing products containing chlorhexidine.

Comment: An industry association requested clarification on what is meant in the Risk Management Approach by “best management practices” for facilities manufacturing or repackaging chlorhexidine-based products.

Response: Industrial releases of chemical substances to the environment can originate from a variety of sources and activities. Best management practices are procedures used in the management and handling of chemical substances to prevent releases of these substances into the environment. Examples of best management practices can include: the recycling, re-use and disposal of water used for equipment and facility cleaning, the design of batch processes/equipment to minimize chemical residues, complete emptying of tanks and piping to minimize waste residue, pre-rinsing and collection of rinsate to be sent to municipal wastewater treatment systems, or burning/disposal of harmful chemical residue in a secure landfill. Best practices should be applied where and when appropriate based on the particular circumstances of each facility.