As 2023 has ended and we reflect on the past year, we also look at the new year for what will happen around the cleaning and disinfection side and possible new diseases. The last few years have had unique challenges for all of us, and COVID-19 is still around and still causing severe sickness in North America again. One of the side effects of that pandemic, which has now transitioned to an endemic, was the increased use of disinfectants and sanitizers, although the main transmission route was not via surfaces but through aerosols. A market report published in 2022 estimates that the disinfectant sector will now grow by 10% annually and reach $10 billion by 2028. Increased spending and the rise of hospital-acquired infections in the healthcare setting will partly drive this projected growth.) as well as new and upcoming regulations and commercial consolidation. (Research and Markets, 2022).
Like many other jurisdictions, Canada had its fair share of challenges, trying to play catchup with the need and demand for COVID-19-approved disinfectants. The system and the regulatory framework were not set up for the pressure caused by the pandemic. In 2020, Canada consolidated the registration of disinfectants and disinfectants-sanitizers that were before registered under two separate regulations, the Food and Drug Act and the Pest Control Act, within the Food and Drugs Act. However, these products, disinfectants and sanitizers are considered “drugs” within the Canadian legislative framework and, before getting market authorization, require the issue of a “Drug Identification Number” (DIN) as a unique identifier. In the US, this would be the EPA registration number. However, Canada still had to scramble during the pandemic, especially with the authorization of products already tested and approved by the EPA in the US. To help, Canada temporarily allowed EPA-approved products to be used in Canada under an “interim exceptional importation and sale order” (Health Canada, 2022; GOC, 2022).
Currently, Canada still has three different regulations dealing with biocides
Currently, Canada still has three different regulations dealing with biocides (surface disinfectants and surface sanitizers). In addition to the Food and Drug Regulations and the Pest Control Products Regulations, there is also the Natural Health Products Regulations. All in all, Canada realizes that a more unified approach is in the best interest of all stakeholders. The proposed regulations were first published in 2022 (Canada Gazette, 2022) and are part of the overall Health and Biosciences Sector Regulatory Review Roadmap updated in 2021 (Health Canada 2021). Health Canada aims to create one comprehensive framework for biocides, applying a more risk-based approach and approval based on foreign decisions. A stakeholder consultation process in 2022 resulted in numerous comments and feedback with an overall positive tone.
Health Canada aims to create one comprehensive framework for biocides
What can be expected from these new regulations? First, once published they will come into effect after one year, so the earliest would be 2025. Secondly, the attempt to include the use of a foreign decisions (UFD) pathway will be very interesting. Although primarily targeted towards the US EPA at this point, it should make it much easier to go through the registration, assessment and approval process in Canada. Thirdly, a more unified and harmonized approach will hopefully improve the Canadian government’s regulatory efficiency. At this point, Health Canada assumes an overall cost of $1.1 million for the industry to bring existing and approved biocides into compliance. At the same time, the estimate is $61.6 million in direct benefit to the industry (Canada Gazette, 2022). Some of the existing processes will stay the same. For example, the DIN designation and identification number will continue, and testing and efficacy requirements will not change. So, what’s in a name? Well, Health Canada defines biocide 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” and how these drugs are regulated in Canada in the future is still to come…
A more detailed review and possible impact analysis will be written once the new regulations are published.
References
Research and Markets. (2022). Global Surface Disinfectant Market Size, Segments, Outlook, and Revenue Forecast 2022-2028 by Composition Type, Form, Application, By End User and Region.https://www.researchandmarkets.com/reports/5680548/global-surface-disinfectant-market-size
Health Canada. (2022). Interim Order to allow exceptional importation and sale to help prevent shortages in relation to COVID-19. https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drug-medical-device-food-shortages.html
Government of Canada. (2022). List of biocides for exceptional importation and sale https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drug-medical-device-food-shortages/biocides-list.html
Canada Gazette. (2022). Part I, Volume 156, Number 19: Biocides Regulations. https://www.gazette.gc.ca/rp-pr/p1/2022/2022-05-07/html/reg2-eng.html
Health Canada. (2021). Health and Biosciences: Targeted Regulatory Review – Regulatory Roadmap. https://www.canada.ca/en/health-canada/corporate/about-health-canada/legislation-guidelines/acts-regulations/targeted-regulatory-reviews/health-biosciences-sector-regulatory-review/roadmap.html
