Chlorhexidine Added to CEPA Schedule 1

Summary#

This item is the Order Adding a Toxic Substance to Part 2 of Schedule 1 to the Canadian Environmental Protection Act, 1999 (SOR/2025-13). It adds the antiseptic chemical 2,4,11,13-Tetraazatetradecanediimidamide, N,N″-bis(4-chlorophenyl)-3,12-diimino-(chlorhexidine) and its salts to Part 2 of Schedule 1 so the government can propose pollution-prevention measures. The Order was registered and came into force on January 31, 2025 and was published in the Canada Gazette, Part II on February 12, 2025.

What it does#

• Adds the substance 2,4,11,13-Tetraazatetradecanediimidamide, N,N″-bis(4-chlorophenyl)-3,12-diimino-(chlorhexidine) and its salts to Part 2 of Schedule 1 of the Canadian Environmental Protection Act, 1999.
• Makes pollution prevention the priority for any future risk management of this substance (Part 2 focuses on pollution prevention; it can still allow bans or limits if needed).
• Does not itself impose new rules or costs. Instead, it gives the government the legal authority to design and consult on future controls or guidance.
• Explains the science behind the addition: a June 2019 screening assessment found an ecological risk to aquatic life but concluded current uses pose low risk to human health. The assessment was published on June 29, 2019.
• Notes past public consultations, including a draft notice on March 6, 2021, and that ministers will consult stakeholders before any specific regulations are made.

Who's affected#

• Businesses that import, formulate or use chlorhexidine-based products (for example manufacturers of antiseptics, disinfectants, some cosmetics, natural health products, and certain drugs).
• Industrial facilities that use chlorhexidine in manufacturing and could release it to wastewater.
• Operators of municipal and industrial wastewater treatment systems, since the substance can pass through treatment and reach water and sediments.
• Regular consumers are not expected to face immediate changes, because the Order itself does not ban products. However, consumers could see changes later if the government proposes restrictions.
• Small businesses: the government’s analysis says the Order itself does not create costs for small businesses.
• The federal departments that led the work are Environment and Climate Change Canada and Health Canada (they recommended the addition).

If it matters to Indigenous communities: the government said this Order does not change treaty obligations and no special Indigenous consultations were carried out, though Indigenous people could comment during public notices.

Why it matters#

• Chlorhexidine can persist in water, sediments and soil and can harm aquatic plants and animals at low concentrations. That is why the substance was added to Schedule 1.
• Adding it to Part 2 lets the government focus on preventing pollution at the source. That could lead to measures such as industrial best practices, limits on releases, or product controls in the future.
• For now, everyday use of products containing chlorhexidine is not identified as a human-health concern at current exposure levels, but environmental risks from industrial releases were identified.
• If you work in industries that make or use chlorhexidine products, or manage wastewater, this change could lead to new rules, reporting, or changes in how products are formulated to reduce environmental releases.