Proposed New Canadian Biocides Regulation
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Following the experience of Covid-19, the Canadian regulatory authorities plan to consolidate and harmonise the pathway to market for most surface disinfectants and sanitizers. The new legislation aims to provide more consistency, ease the administrative burden of the authorities, and allow for greater alignment between the Canadian and other global regulations of similar substances, which should lead to shorter registration times.
Most surface disinfectants and sanitizers are currently regulated either under the Food and Drugs Act (RSC, 1985, c. F-27) or the Pest Control Products Act (SC 2002, c.28) according to their use. Those used in a multitude of settings need to be registered under both Acts. These will now, with some exceptions, be regulated together under the new Biocidal Regulation (BR), administered by the Food and Drugs Act (FDA) under Health Canada.
The new BR will come into force one year after the registration of the Regulation. Health Canada anticipates that this will likely be in January 2024 for new products. Existing authorisations will continue to be valid for 4 years after the Regulation registration, although authorisation holders must file an abbreviated application within that time period to continue to market the biocide after the transition period.
The following types of products are not in scope of the proposed BR:
Sanitisers that don’t meet the definition of a drug under the FDA rules (for example, algaecides or odour control products). These will continue to be regulated under the PCPA
Sanitisers and disinfectants that meet the definition of a drug, but are for use in air or water (e.g., pool disinfectants). Again, these will continue to be regulated under the PCPA
High-level disinfectant or sterilising solutions, such as contact lens solution, or those that are used on medical devices are considered invasive. These will be regulated under the Medical Device Regulations (SOR /98-282)
Food surface disinfectants and surface sanitisers (such as those that are sprayed on produce). These will continue to be regulated under the Food and Drugs Regulations (FDR CRC, c.870) as food processing aids
Drugs with antimicrobial activity for humans or animals (e.g., hand sanitisers). These will continue to be regulated under the FDR for Natural Health Products
Cleaners will continue to be regulated under the Canadian Consumer Product Safety Act (CCPSA) and the Hazardous Products Act (HPA)
There will be several pathways to registering a new biocide under the BR:
Standard application: Will require general product information (such as manufacturer and importer information, brand name, directions for use), safety information (such as toxicological information), efficacy information to support claims, and quality information.
Applications relying on a comparison with a biocidal product already authorised for use in Canada: Will require that the new product uses the same active ingredient, the formulants are among those permitted in the comparative product, the uses/purposes must fall within the same ones approved for the comparative product, risk information, directions for storage and disposal must be same as in the comparative product and must have the same decontamination procedure (if relevant), must be manufactured with the same master formula.
Applications with the Use of Foreign Decisions (UFDs): A new pathway which will require the use of a decision from ‘a trusted foreign regulatory authority’ when applying in Canada for an identical product. Initially, this pathway will only be open to decisions from the US EPA, but will likely be opened up to others later.
Applications for Multiple Products under one Market Authorisation (MA): This pathway harmonises with other biocidal regulations elsewhere that allow multiple registrations, such as in the US, EU, and UK. The BR will allow one MA for multiple products with minor variations.
Approved biocides will be assigned an 8-digit identification number, similar to the current system (current DIN holders will not change).
There will also be further new obligations for biocides regarding packaging and labelling, including a new initiative that will require manufacturers to avoid packaging that looks like food or beverage packaging to harmonise with similar restrictions in place in other countries.
Significantly, the new BR will seek to take a lifecycle approach with continuous post-market oversight of the risks and benefits associated with a biocide and giving Health Canada the ability to identify, assess and manage new risks and uncertainties to support compliance verification, as well as the authority to suspend or revoke a MA. There will also be new safety monitoring requirements of the MA holder specifically for biocides.
Biocidal product regulations are complex and differ from country to country, despite the Canadian attempt here to harmonise. Do you need help understanding biocidal regulations worldwide? Yordas experts can help demystify the process. We can provide you with regulatory scoping assessments, advise on the quickest routes to market, or help you find sustainable alternatives. Get in touch with our team today to find out how we can help you address your regulatory challenges. You can also visit our website to learn more about our Biocides services.
Get to know our team
Giselle Vincett, Managing Director Yordas Canada
Giselle Vincett leads Yordas’ North American operations. She holds a PhD in Sociology from Lancaster University, UK and worked for over a decade in academic research, teaching and writing. She has extensive experience in designing and leading both large and small publicly and privately funded social research. She has strong experience in research and engagement with a variety of organisations, including government, NGOs, and businesses. Her publication record includes popular and policy-based dissemination, along with academic dissemination in a number of disciplines and across multiple media. At Yordas, Giselle leads business development for North America.
Mike Wolfe, Regulatory Consultant
Mike joined the Yordas Group after completing his PhD at McMaster University in Hamilton, Ontario. Working out of our Canadian office, his expertise is focussed on North American chemical Acts and Regulations such as the Canadian Environmental Protection Act (CEPA) and the U.S. Toxic Substances Control Act (TSCA). This expertise is exemplified through delivery of New Substance Notifications (NSNs) in Canada and assistance with Premanufacturing Notices (PMNs) in the U.S. In addition, Mike has experience working with pesticide registrations through the Pest Control Products Act (PCPA) in Canada.
