Canada Biocidal Services
In Canada, products making biocidal, antimicrobial or antiviral claims are subject to the Pest Control Products Act (PCPA) and must be registered with the Pest Management Regulatory Agency (PMRA), a division within Health Canada, prior to entering Canadian commerce.
Similar to the US, the manufacturer (or importer) is required to provide information to the PMRA relating to the pesticide ingredients, toxicity, intended usage, labelling, and potential damage to the environment and humans.
Note that anti-pest products intended to be applied to humans (e.g., hand sanitizers) fall out of scope of the PCPA, and are instead regulated under the Natural and Non-prescription Drugs Directorate (NNHPD) as either Natural Health Products or Non-Prescription Drugs, depending on the composition of the product.
If you require further assistance please contact us.
Which services do we offer:
Regulatory scoping assessments and registration roadmaps.
Assistance with end-use product registration under the Biocides Regulations.
Claim substantiation and efficacy testing.
Guidance on packaging, labeling, and post-market requirements
Biocides Regulations (SOR/2024-110)
Biocides Regulations and Transitional Requirements
With the introduction of the Biocides Regulations (SOR/2024-110), a unified regulatory framework has been established. These regulations were registered on May 31, 2024, and will come into force on May 31, 2025.
Scope of the Biocides Regulations
Under the new regulations, a biocide is defined as a drug intended for use in destroying or inactivating micro-organisms, or in reducing or controlling their number, on non-living and non-liquid surfaces. This includes products such as surface disinfectants and sanitizers.
Certain products remain outside the scope of the Biocides Regulations and continue to be regulated under existing frameworks:
Products intended for exclusive use on the surface of food
Products intended for use on the surface of contact lenses or invasive medical devices.
Products for use on humans or animals, which are regulated under the Natural and Non-prescription Health Products Directorate (NNHPD) as either Natural Health Products or Non-Prescription Drugs, depending on their composition.
Transitional Provisions
To facilitate a smooth transition to the new regulatory framework, Health Canada has established a four-year transitional period from the coming-into-force date:
May 31, 2025: Biocides Regulations come into force.
May 31, 2029: End of the transitional period for products with DIN or PMRA Reg No.
MAy 31 2031: for surface sanitizers for use in food premises.
During this period, existing products authorized under the PCPA or the Food and Drug Regulations (FDR) can continue to be sold, provided they comply with the conditions set out in the transitional guidance. Manufacturers are expected to submit applications for market authorization under the Biocides Regulations within this timeframe.
After the transitional period, any remaining products with DINs and PMRA Reg No assigned will be cancelled, and products must have obtained market authorization under the Biocides Regulations to remain on the market.
