On February 12, 2025, the Canadian government promulgated Order 2025-13 (SOR/2025-13), adding the chemical substance "2,4,11,13-Tetraazatetradecanediimidamide, N,N''-bis(4-chlorophenyl)-3,12-diimino- (Chlorhexidine)" and its salts to Part 2 of Schedule 1 under the Canadian Environmental Protection Act, 1999 (CEPA). The regulation takes effect upon registration, marking a significant step in Canada’s efforts to control toxic substances and safeguard ecological and public health.
Background
Chlorhexidine and its salts are broad-spectrum antimicrobial agents widely used in medical disinfection, personal care products, and industrial applications. However, a 2019 scientific assessment by Environment and Climate Change Canada (ECCC) and Health Canada concluded that the substance meets the ecological toxicity criteria under section 64(a) of CEPA, posing long-term risks to aquatic life and the environment. Based on these findings, the Minister of Environment and Minister of Health jointly recommended stricter controls under CEPA.
Regulatory Process
On March 6, 2021, the proposed amendment was published in Part I of the Canada Gazette, initiating a 60-day public consultation period. After reviewing feedback from industry stakeholders, environmental groups, and the public, the government finalized the decision to list chlorhexidine and its salts in Schedule 1, Part 2, to restrict their use and promote safer alternatives.
The newly regulated substances:
|
CAS RN |
Common Name |
DSL Name/Chemical Name |
|
55-56-1 |
Chlorhexidine |
2,4,11,13-Tetraazatetradecanediimidamide, N,N''-bis(4-chlorophenyl)-3,12-diimino-(chlorhexidine) |
|
56-95-1 |
Chlorhexidine Diacetate |
2,4,11,13-Tetraazatetradecanediimidamide, N,N''-bis(4-chlorophenyl)-3,12-diimino-, diacetate |
|
3697-42-5 |
Chlorhexidine Dihydrochloride |
2,4,11,13-Tetraazatetradecanediimidamide, N,N''-bis(4-chlorophenyl)-3,12-diimino-, dihydrochloride |
|
18472-51-0 |
Chlorhexidine Digluconate |
D-Gluconic acid, compound with N,N''-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-Tetraazatetradecanediimidamide |
Under the regulation, affected industries must comply with CEPA-mandated discharge limits and risk management measures upon its entry into force. Federal, provincial, and territorial authorities will collaborate to ensure compliance through periodic reviews and enforcement actions.
