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The addition of chlorhexidine and its salts to Part 2 of CEPA’s Schedule 1 introduces new compliance considerations for manufacturers and industrial users. While the focus is pollution prevention, industries should anticipate future restrictions and evaluate their supply chains, wastewater management, and regulatory strategies accordingly.The Canadian government has classified chlorhexidine and its salts as toxic under the Canadian Environmental Protection Act (CEPA), 1999. The new regulatory listing, published in the Canada Gazette, Part 2, impacts manufacturers, chemical suppliers, and industrial users across multiple sectors. This decision mandates pollution prevention measures to limit environmental exposure.
Key Insights
Regulatory Update: What You Need to Know
The Order Adding a Toxic Substance to Part 2 of Schedule 1 to CEPA (SOR/2025-13) took effect on 31 January 2025. The ruling, based on a screening assessment by Environment and Climate Change Canada (ECCC) and Health Canada, concluded that chlorhexidine and its salts pose ecological risks, particularly to aquatic ecosystems.
Key Details:
- Affected Substances: Chlorhexidine and its salts, including chlorhexidine digluconate, diacetate, and dihydrochloride.
- Main Uses: Found in antiseptics, disinfectants, cosmetics, pharmaceuticals, and veterinary products.
- Environmental Risk: The substances persist in water and sediment, with potential harm to aquatic species.
- Regulatory Pathway: The listing enables authorities to develop pollution prevention strategies, which may include restrictions or phase-outs in specific applications.
How Will This Affect Manufacturers?
Industries involved in chemical production, healthcare products, and industrial cleaning must assess their use of chlorhexidine. The CEPA listing does not immediately ban the substance but signals potential future restrictions.
Key industry considerations include:
- Supply Chain Adjustments: Companies should evaluate alternative biocides and antimicrobial agents to maintain product compliance.
- Wastewater Treatment Challenges: Facilities using chlorhexidine must consider enhanced filtration to mitigate environmental discharge.
- Regulatory Alignment: Businesses exporting to the EU or US should note that chlorhexidine is already under regulatory scrutiny abroad.
Potential Risk Management Measures
The CEPA amendment grants regulators authority to propose pollution prevention measures, which could include:
- Stricter effluent limits for industrial users.
- Use restrictions in consumer and professional-grade disinfectants.
- Mandatory reporting and monitoring of chlorhexidine discharges.
While no immediate compliance actions are required, businesses should prepare for future regulatory developments and explore proactive substitution strategies.
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