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Guidance on the transition of disinfectants and surface sanitizers to the Biocides Regulations: Overview - Canada.ca
18 avr. 2025
legacy-hc-2025-04-21
ID 249935
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Guidance on the transition of disinfectants and surface sanitizers to the Biocides Regulations: Overview - Canada.ca
2 janv. 2026
hc-20260101
ID 428817
updated8 sections changed
8 sections modifiées0 ajoutées0 retirées+36 / -19 lignesVariation: 15%
--- +++ @@ -12,10 +12,12 @@ Compliance and enforcement for transitioning biocides Contact us Purpose-This guidance applies to products that meet the definition of a biocide and will be transitioning to the+This guidance applies to products that meet the definition of a biocide as of May 31, 2025, and will be transitioning to the Biocides Regulations-(the regulations). These biocides include:-surface disinfectants and disinfectant-sanitizers with a Drug Identification Number (DIN) authorized for sale under the+(the regulations) under the+Food and Drugs Act+(FDA). These biocides include:+surface disinfectants and disinfectant-sanitizers with a drug identification number (DIN) authorized for sale under the Food and Drug Regulations (FDR) sanitizers for use on non-living and non-liquid surfaces that are registered as pest control products under the:@@ -27,17 +29,27 @@ Food and Drugs Act (FDA) This guidance includes information for:-applications for a DIN or pest control product registration for a new biocide, but without a final decision before the coming into force date-existing biocides that are authorized or registered under the FDR or PCPA before the coming into force of the regulations-surface sanitizers for use in food premises coming into compliance with the regulations+existing biocides that are authorized or registered under the FDR or PCPA as surface disinfectants or surface sanitizers before the coming into force of the regulations (May 31, 2025)+new applications for biocides regulated under the FDR or PCPA without a final decision before the coming into force date (May 31, 2025)+surface sanitizers for use in food premises coming into compliance with the regulations by the end of the 6-year transition (May 31, 2031) This guidance contains information to help you transition your biocide to come into compliance with the requirements outlined in the regulations, including: compliance and enforcement considerations transition period requirements labelling requirements post-market requirements Definition of a biocide+You should+contact us+if you wish to deviate from the approaches in this guidance. Overview-On May 31, 2024, the governor-in-council registered stand-alone regulations for biocides under the FDA that contain:+The way surface disinfectants and surface sanitizers are regulated in Canada has changed. The+Biocides Regulations+were registered on May 31, 2024, and published in the+Canada Gazette+, Part II on June 19, 2024. The regulations introduce a single regulatory framework in Canada for biocides under the+Food and Drugs Act+and came into force on May 31, 2025.+These stand-alone regulations contain: regulatory requirements tailored to the unique nature of biocides, such as: record retention packaging and labelling@@ -63,7 +75,7 @@ Biocides Regulations for biocides (either a drug or pest control product) with pending applications that do not receive a final decision by this time You can find more details in Table 1 regarding how we will treat applications:-before and after the coming into force of the regulations+after the coming into force of the regulations during and after the transition periods described in the regulations Once a biocide has been issued a market authorization, the regulations require the Minister to maintain and publish: comprehensive information on authorized biocides, except for:@@ -74,24 +86,29 @@ any changes to the status of the authorization how the authorization was granted (application pathway used when based on comparison or the use of foreign decisions) Prior to the coming into force-During the 1-year period between registration and the coming into force of the regulations, applicants can continue to file applications and submissions under the FDA, FDR or PCPR. Health Canada will review any applications or submissions received according to the FDA, FDR or PCPR and issue a decision regarding the product's authorization. For example, a:+During the 1-year period between registration and the coming into force of the regulations, applicants could continue to file applications and submissions under the FDA, FDR or PCPR. Health Canada reviewed any applications or submissions received according to the FDA, FDR or PCPR and issued a decision regarding the product's authorization or conditions of use. For example, a: DIN pest control product registration number-letter of no objection (LONO)+letter of no objection (LONO) for surface sanitizers for use in food premises Coming into force-When the regulations come into force:-we will begin accepting transition applications to transition existing biocides to the regulations-we will continue to review any remaining applications for a biocide submitted under the FDA, FDR or PCPR (as applicable)+When the regulations came into force:+we began accepting transition applications to transition existing biocides to the regulations+we continue to review any remaining applications for a biocide submitted under the FDA, FDR or PCPR (as applicable) applicants for new biocides seeking market authorization must follow the requirements in the regulations instead of the FDR and the PCPA/PCPR post-authorization changes must:-continue to be filed under the FDR and PCPR for products with DINs or pest control product registrations until they are subject to the regulations+continue to be filed under the FDR and PCPR for products with DINs or pest control product registrations until they are subject to the regulations at the end of the 4-year transition period (May 31, 2029) be filed under the regulations for biocides that have transitioned to the regulations Transition period Existing DIN holders or registrants for biocides authorized or registered under the FDR or PCPA may file a transition application or a new application during the transition period to transition their biocides to the regulations. A transition application is an abbreviated application because you do not need to include all of the information required in a new application for a biocide market authorization. Surface sanitizers for use in food premises are not eligible to use a transition application unless they also have disinfectant claims and are authorized with a DIN. Surface sanitizers for use in food premises will need to obtain a market authorization under the regulations using the new application pathways before the end of a 6-year transition period to continue to be sold once the 6 years has elapsed.-To allow us enough time to review and issue a decision for your transition application we recommend you submit your application at least 135 days before the end of the transition period (by January 16, 2029). Since transition applications are only active during the transition period, we will be unable to issue a market authorization through this transition application pathway after the end of the transition period. After the transition period, any transition applications that have not received a decision must re-apply using a new application pathway under the regulations if you are intending to continue to advertise or sell your biocide.+To allow us enough time to review and issue a decision for your transition application we recommend you submit your application at the latest 135 days before the end of the transition period (by January 16, 2029). The+guidance on management of biocide applications+provides guidance on navigating the biocide application process and outlines the mechanisms that we can use to request additional information from you during our assessment of your biocide application. Note that the filing date for your biocide application will only be set once it is considered to be administratively complete following the+processing period+.+Since transition applications are only active during the transition period, we will be unable to issue a market authorization through this transition application pathway after the end of the transition period. After the transition period, any transition applications that have not received a decision must re-apply using a new application pathway under the regulations if you are intending to continue to advertise or sell your biocide. If we receive your transition application after January 16, 2029 , you will receive a letter outlining the risks and consequences if you do not obtain a market authorization for your biocide. These could include:@@ -102,7 +119,6 @@ There are 2 types of transition applications and associated pathways: Transition application for sanitizers registered under the PCPA Transition application for disinfectants and disinfectant-sanitizers authorized under the FDR-<p>You can find information on how to file these applications in the <a href="#">management of biocide applications guidance</a>.</p> Table 1: Transition timeline Timeline Status@@ -165,9 +181,10 @@ ) Pesticides Compliance and Enforcement Policy Contact us-Contact us if you have any questions about the information in this guidance document.+Contact the Natural and Non-prescription Health Products Directorate to:+request pre-submission advice or set up a pre-submission meeting+request consultation if you are unsure what type of application to file Email: nnhpd-dpsnso@hc-sc.gc.ca Page details-Date modified:-2024-06-18+2025-05-29