The biocides guidance applies to products defined as biocides under regulations, specifically drugs designed to destroy or inactivate microorganisms or control their number on non-living, non-liquid surfaces. To qualify as a biocide and be eligible for market authorization, a product must achieve a minimum efficacy level of 99.9% (3 log10) reduction in microorganisms.
Health Canada affirms that these regulations do not apply to biocides used exclusively on food surfaces, contact lenses, or as high-level disinfectants or sterilants on invasive medical devices, or indirectly invasive devices used to channel or store body fluids.
It’s worth mentioning that the objective of guidance documents is assisting industry and healthcare professionals in complying with statutes and regulations and help Health Canada staff achieve objectives consistently. While these documents are administrative rather than legal and do not have the force of law, compliance may be achieved through alternative methods. It is important for biocide applicants and market authorization holders to review these documents alongside the relevant regulations and other guidance to ensure all legal requirements are met.
Extracted from Health Canada Website “Guidance on Biocides” Written by Susan Gould et al
Published on Health Canada Website June 2024
Source: Health Canada – Guidance on Biocides, June 2024