Clean slate: Health Canada opens consultation on proposed biocides regulations
On May 7, 2022, Health Canada opened a consultation on the proposed Biocides Regulations (the “Proposed Regulations”) and related guidance document. The Proposed Regulations would bring disinfectants and surface sanitizers together under a single regulatory framework with a view to establishing a consistent simplified pathway to market authorization.
The consultation period ends July 16, 2022.
The Current Regimes for Disinfectants and Surface Sanitizers
Disinfectants and surface sanitizers are currently regulated by different statutes and regulations. In general, chemical products intended to disinfect hard surfaces and inanimate objects are regulated as disinfectant drugs under the Food and Drugs Act (the “FDA”) and Food and Drug Regulations (the “FDR”), while chemical products intended to sanitize non- food contact hard and porous surfaces and inanimate objects without any disinfectant claims are regulated as sanitizers under the Pest Control Products Act (“PCPA”) and Pest Control Products Regulations (“PCPR”). The functional distinction between a disinfectant and a surface sanitizer is that a disinfectant must be capable of destroying or irreversibly inactivating disease-causing microorganisms, while a surface sanitizer only reduces the population of disease-causing microorganisms. Disinfectant drugs require market authorization from Health Canada to validate their safety, efficacy and quality, and must have a Drug Identification Number (DIN) prior to being sold in Canada. Surface sanitizers require a pre-market assessment by the Pest Management Regulatory Agency (“PMRA”) to evaluate efficacy, safety and quality, and must be registered with the PMRA prior to being sold in Canada.
In the Regulatory Impact Analysis Statement accompanying the Proposed Regulations, Health Canada notes that the two regimes apply different requirements, fees and timelines to disinfectants and surface sanitizers, despite these products having similar risks, benefits, uses and ingredients. The difficulties created by this inconsistency were highlighted by the COVID-19 pandemic, as Health Canada experienced a significant increase in questions from manufacturers regarding appropriate product classification, application pathways, application requirements, and obligations.
The Proposed Biocides Regulations
The Proposed Regulations are made under the FDA and will establish “biocide” as a new classification of health product. A “biocide” is defined as:
“[…] a drug that is sold or represented for use in destroying or inactivating micro-organisms, or in reducing or controlling their number, on a non-living and non-liquid surface. However, it does not include such a drug that is sold or represented for use (a) on the surface of an invasive device as defined in Section 1 of the Medical Devices Regulations; or (b) exclusively on the surface of food.”
In effect, the new biocide product classification will capture products (a) currently classified as disinfectants under the FDA, and (b) products currently classified as surface sanitizers under the PCPA that are intended to prevent the transmission of disease in humans and animals and used on non-liquid surfaces.
The new authorization and regulatory framework would apply safety, efficacy and quality requirements that are based on existing requirements under the FDR, but which are tailored to biocides. The Proposed Regulations would also create a pathway for authorization based on decisions from foreign regulators. Health Canada anticipates that, upon coming into force, only the United States Environmental Protection Agency will be recognized for the purpose of this expedited pathway, but other foreign regulators may be considered in the future.
The following categories of products are outside the scope of the Proposed Regulations:
- sanitizers that do not meet the definition of a drug (algaecides, slimicides, material preservatives, products for odor control);
- sanitizers and disinfectants that meet the definition of a drug, but are for use in air or water (pool and spa disinfectants, water sanitizers, air sanitizers);
- high-level disinfectant and sterilant solutions (contact lens solutions, disinfectants intended for use on medical devices);
- disinfectants and surface sanitizers exclusively used directly on the surface of a food;
- drugs with antimicrobial activity for use on humans or animals; other
Following the consultation period, Health Canada intends to publish communication materials outlining the transition process and host information sessions.
The Biocides Regulations will come into force one year after they are registered in their final form in Part II of the Canada Gazette.
Health Canada is proposing a phased transition approach which would allow already-marketed disinfectants and surface sanitizers to be cleared from current stock. Existing authorization holders of disinfectants and registrants of surface sanitizers would be required to file an abbreviated application and receive a market authorization under the Proposed Regulations within four years of the coming-into-force date.
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