In June 2025 the new Biocides Regulations came into force. Under these new regulations, food-contact sanitizers are now regulated as biocides and must undergo a pre-market assessment and have a drug identification number (DIN) issued prior to being sold in Canada. Manufacturers and importers of food contact sanitizers have six years to register their products under the new biocides regulations that came into force on May 31, 2025. A biocide application form must be completed and submitted for all market authorization pathways, and it is essential to follow the official guidance document provided by Health Canada for detailed instructions and requirements. Manufacturers of any food-contact sanitizers that were currently on the market prior to May 31st, 2025, have until May 31, 2029 to submit a biocides transition application to bring their product(s) under the biocides regulations. This new DIN requirement is a significant change for manufacturers as previously marketed food-contact sanitizers only required a Letter of No Objection from Health Canada or a Letter of Guarantee from the manufacturer. Now a biocides DIN application must be filed as a transition application, for products marketed prior to May 31st, 2025, or as a new market authorization for a product being launched after May 31st, 2025. All biocides DIN application pathways require manufacturers to be registered with an Electronic Submission Gateway account to submit the application dossier, or to contract the services of a consultant that holds an ESG account to submit on their behalf. The application for a market authorization for a biocide must be submitted to the Minister and contain specific information about the biocide, and a biocide application must be submitted electronically via the Electronic Submissions Gateway (ESG) and must include both an HTML file and an XML file. When preparing the dossier, applicants must provide detailed information, including CAS registry numbers for all active ingredients and formulants, as well as a master formula outlining the manufacturing process, specifications, and in process controls. The BAF (Biocide Application Form) populates information such as active ingredients and formulant ingredients directly from the Biocides Ingredients Database (BID). There is also the possibility that a novel food-contact sanitizer will require a full review of safety, efficacy, and quality under the biocides regulations if aspects such as active ingredient, combination of active ingredients, use or purpose, physical form or method of application have never been authorized by Health Canada for a biocide. Risk information, shelf life, net quantity, and the same quantities of active ingredients for a given quantity must be included in the application, and the basic formulation and quality requirements must be met. The biocide’s brand names and, if applicable, other biocide’s brand names used for comparison must be included in the application to ensure proper identification and regulatory consistency, and the same information (such as label content, safety data, and shelf life) must be consistent with existing or foreign-approving biocides.
No biocide may be imported, sold, or advertised in Canada without a market authorization issued under the Biocides Regulations, and a biocide submitted for approval must meet all regulatory requirements. It is prohibited to import a biocide unless the name and civic address of the importer of the biocide are published. Biocide market authorization can be authorized based on comparison to another authorized biocide, and this process may involve referencing a third biocide or using the administrative application route. This comparison process is part of the biocide fall, which refers to the regulatory and application process for obtaining market authorization for biocides, including documentation and evidence needed to demonstrate safety and efficacy, and applications can be based on comparisons with other biocides. Exceptional circumstances or uncertainties relating to safety, efficacy, or quality may result in additional terms or conditions being imposed on the market authorization. A monograph application allows for an expedited review if the product fully aligns with the established monograph criteria.
The biocides regulations do have a Use of Foreign Decision (UFD) application pathway that may help a manufacturer with time and cost efficiencies if their food-contact sanitizer is authorized in another jurisdiction by a Health Canada trusted regulatory authority. The use of a foreign biocide or foreign regulatory decision requires compliance with Canadian standards and may involve referencing disinfectants authorized in other jurisdictions. Health Canada has published a list of trusted authorities and currently only the U.S. EPA is listed: List of Foreign Regulatory Authorities for Biocides. Although safety, efficacy and quality data is not required to be submitted under the UFD pathway, Health Canada may request additional information if they are querying the risks, benefits or uncertainties of the product outlined in the application.
Biocide applications have fees associated with each pathway that must be paid to Health Canada typically when the application has passed screening and is accepted into review. Health Canada charges evaluation fees for biocide applications, except for transition applications. Evaluation fees are required for most application types, and detailed information about these fees can be found in the official guidance document. Fees for the application pathways identified below are:
- Biocide transition application – no fee
- Biocide full review – novel biocide – $42,394
- Biocide – use of foreign decision – $3,153
- Biocide – monograph – $1,893
There are other biocide application pathways and the full list of fees can be reviewed here:
Fees for the examination of a biocide application
Service standards (in calendar days) for biocides application pathways are:
Processing 10 days: applies to all application pathways.
- Biocide transition application Screening 1 & Review 1 – 90 days total
- Biocide full review – novel biocide Screening 1 45 days; Review 1 300 days
- Biocide – use of foreign decision Screening 1 45 days; Review 1 90 days
- Biocide – monograph Screening 1 & Review 1 – 60 days total
Surface disinfectants, including those intended for use on non liquid surfaces, are now regulated under the biocides framework, and previously disinfectants authorized under other frameworks must transition by May 31, 2025. Over the past 9 months Dell Tech has been working with the new biocides regulations supporting clients with various application pathways. We have gained excellent experience to help with strategizing to transition your LONO, submit a brand-new Biocides application, work with a lab to test your food contact surface sanitizers for efficacy, safety and quality support, or with developing a new label.
Biocides authorized under the new regulations are subject to post market safety monitoring and post authorization changes, and manufacturers must provide a civic address for all relevant sites involved in manufacturing, labelling, and packaging activities. Reporting side effects of biocides helps in monitoring their safety.
The Minister will issue a market authorization once the requirements of section 11 of the regulations have been met, and the market authorization will include an 8-digit identification number specific to the biocide, which must be included in all marketing materials. The Minister will issue a market authorization if sufficient information is provided to support the safety, efficacy, and quality of the biocide when used according to the label’s recommended conditions of use. The safety and efficacy of a biocide can vary greatly depending on the concentration of the active ingredient, and biocide’s safety assessments are required to ensure human health and environmental protection. Active ingredients in biocides are components that are directly responsible for the biocide’s intended effects.
As existing disinfectants and registered surface sanitizers transition to the biocides framework, they will be listed in the MABD, and the market authorization database is still being developed by Health Canada’s NNHPD. Stakeholders will receive an email from NNHPD providing links to all relevant forms and guidance.
When considering biocide application pathways, the Guidance on Management of Biocide Applications outlines the mechanisms that you can use to request a pre-submission meeting.
If you wish to deviate from the approaches in this guidance, you should contact us.
Dell Tech is dedicated to facilitating your compliance journey. We offer expert consultations to discuss your products and develop an optimal timeline for transitions or registrations. Our team will guide you through the regulatory compliance process, including providing comprehensive details on the associated costs. Please contact us to schedule a meeting and ensure your products meet the new regulatory requirements efficiently.
Need expert support transitioning your food-contact sanitizer under the new Biocides Regulations? Strengthen your regulatory roadmap with targeted training and practical tools from the Dell Tech Academy—designed to help you navigate registration pathways, efficacy testing, compliance timelines, and labeling updates with confidence.
Blog Author
Stephen McCarthy, M.Kin., MBA
Stephen McCarthy is the Director of Regulatory Affairs at Dell Tech, bringing over 25 years of experience in healthcare and regulated therapeutics. He has led global consulting services across cosmetics, drugs, food, and medical devices, and currently serves on the Board of Directors of Cosmetics Alliance Canada.
