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Biocides - Canada.ca
Apr 18, 2025
legacy-hc-2025-04-21
ID 173656
updated5 sections changed; 5 added; 3 removed
5 sections changed5 added3 removed+55 / -39 linesChange ratio: 35%
--- +++ @@ -2,13 +2,17 @@ On this page About biocides Using biocides safely-Authorized biocides-How biocides will be regulated in Canada as of May 31, 2025-How we authorize biocides between now and May 31, 2025+How biocides were authorized prior to May 31, 2025+How biocides are regulated as of May 31, 2025+The transition of previously authorized biocides as of May 31, 2025+New biocide authorizations as of May 31, 2025+Food processing aid uses as of May 31, 2025 About biocides As defined in the Biocides Regulations-(regulations), biocides are drugs that are used to destroy or inactivate micro-organisms or reduce or control their number on a non-living and non-liquid surface. They help to prevent micro-organisms from spreading and reduce health risks. In other words, biocides are surface disinfectants and sanitizers.+(regulations) under the+Food and Drugs Act+, biocides are drugs that are used to destroy or inactivate micro-organisms or reduce or control their number on a non-living and non-liquid surface. They help to prevent micro-organisms from spreading and reduce health risks. In other words, biocides are surface disinfectants and sanitizers. Biocides come in formats that can be ready to use or that require mixing with water first. There are biocides for different settings, for example: health care facilities@@ -20,7 +24,7 @@ institutional settings such as in daycares, schools and office buildings household areas-such as for toilet bowls+such as in kitchens and bathrooms Some biocides should only be used by trained professionals. Biocides do not include products that are used: in air or water@@ -39,7 +43,7 @@ Only use approved products. Read and follow all instructions on the product label. Keep biocides and other health or chemical products out of reach of children.-Do not use a biocide at the same time as other chemical products such as cleaners, unless the products are specifically labelled for use together.+Never use a biocide at the same time as other chemical products such as cleaners, unless the products are specifically labelled for use together. Never use these products on human or animal skin or internally as this could cause serious harm. for example, do not swallow or inject these products Learn more:@@ -53,37 +57,30 @@ and remove unsafe products from the Canadian market Report a side effect-Authorized biocides-A biocide may currently be authorized under the+How biocides were authorized prior to May 31, 2025+Prior to May 31, 2025, biocides were authorized separately as surface disinfectants and surface sanitizers under the Food and Drug Regulations (FDR) or the Pest Control Products Act-(PCPA).-Authorized biocides include:-a surface disinfectant or disinfectant-sanitizer with an 8-digit number that follow the letters "DIN" on its label if the Natural and Non-prescription Health Products Directorate (NNHPD) has authorized the product under the FDR-a surface sanitizer with a registration number on its label if the Pest Management Regulatory Agency has registered the product under the PCPA-the number will appear on the label as:-Registration No-. (assigned registration number)-Pest control products act-or-Reg. No.-(assigned registration number) P.C.P. Act-Search these databases:+(PCPA), respectively.+An authorized surface disinfectant has an 8-digit number, a drug identification number (DIN), that follow the letters "DIN" on its label if the Natural and Non-prescription Health Products Directorate (NNHPD) has authorized the product under the FDR.+A surface sanitizer has a registration number on its label if the Pest Management Regulatory Agency has registered the product under the PCPA. The number will appear on the label as:Registration No. (assigned registration number) Pest control products act or+Reg. No. (assigned registration number) P.C.P. Act+Surface disinfectants and surface sanitizers authorized prior to May 31, 2025 are listed in these databases: Pesticide Product Information Database-for registered sanitizers+for sanitizers registered under the PCPA Drug Product Database for disinfectants authorized under the FDR-How biocides will be regulated in Canada as of May 31, 2025-The way biocides are regulated in Canada is changing. The+How biocides are regulated as of May 31, 2025+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 will come into force on May 31, 2025.-Canada Gazette-, Part II publication-Under these regulations, biocides must undergo a pre-market assessment with the NNHPD and be issued a market authorization before they can be imported, sold or advertised in Canada. As part of the pre-market assessment, we require that an application be filed for a market authorization, which includes detailed information on the biocide's safety, efficacy and quality.-Through this pre-market assessment, the Minister must issue a market authorization, in accordance with section 11 of the regulations, if the:+, 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.+Under these regulations, biocides include both surface disinfectants and surface sanitizers. Biocides must undergo a pre-market assessment with the NNHPD and be issued a market authorization before they can be imported, sold or advertised in Canada. As part of the pre-market assessment, we require that an application be filed for a market authorization, which includes detailed information on the biocide's safety, efficacy and quality.+Through this pre-market assessment, the Minister of Health (the Minister) must issue a market authorization, in accordance with section 11 of the regulations, if the: application meets the applicable requirements set out in section 10 or 26 of the regulations, as the case may be applicant has provided the Minister with any additional information and material that's requested under subsection 10(4) or 26(5) of the regulations Minister has sufficient evidence to support the conclusion that the biocide's benefits outweigh its risks, taking into account any uncertainties relating to the benefits and risks@@ -91,8 +88,10 @@ Minister has reasonable grounds to believe that the biocide will be packaged and labelled in accordance with the Food and Drugs Act and the regulations-We will assign an 8-digit identification number to a biocide that has been issued a market authorization. This identification number must appear on the label and indicates it has been authorized for sale.-Inspectors will monitor and enforce the compliance of biocides with the FDA and the regulations through post-market regulatory activities. The Regulatory Operations and Enforcement Branch (ROEB) oversees these activities.+NNHPD will assign an 8-digit identification number to a biocide that has been issued a market authorization. This identification number must appear on the label and indicates it has been authorized for sale.+Inspectors will monitor and enforce the compliance of biocides with the+Food and Drugs Act+and the regulations through post-market regulatory activities. The Regulatory Operations and Enforcement Branch (ROEB) oversees these activities. As well, the Marketed Health Products Directorate (MHPD): monitors and assesses the benefits and risks of marketed health products communicates those risks to health care providers and the public@@ -102,17 +101,35 @@ Marketed Health Products Directorate Regulatory Operations and Enforcement Branch Natural and Non-prescription Health Products Directorate-How we authorize biocides between now and May 31, 2025-We will review all applications for surface disinfectants and sanitizers received-before May 31, 2025,-according to the FDR or PCPA. If approved, we will issue a drug identification number or a pest control product registration number, as appropriate. These biocides must transition to the regulations by the end of a 4-year transition period (by May 31, 2029).+The transition of previously authorized biocides as of May 31, 2025+A surface disinfectant that has been assigned a DIN under the FDR must transition to the biocides framework by the end of a 4-year transition period (by May 31, 2029). This can be achieved by filing a transition application with reduced application requirements and no cost recovery fee. The same 8-digit identification number will be issued as the sequence of numbers used for your DIN under the FDR.+A surface sanitizer registered under the PCPA must also transition to the biocides framework by the end of a 4-year transition period (by May 31, 2029). This can be achieved by filing a transition application with reduced application requirements and no cost recovery fee. A new 8-digit identification number will be issued to replace the pest control product registration number.+For more information on transitioning a disinfectant or surface sanitizer, consult:+Guidance on the transition of disinfectants and surface sanitizers to the Biocides Regulations+New biocide authorizations as of May 31, 2025 Applicants that submit an application for a new market authorization for a biocide as of May 31, 2025,-must meet the requirements in the regulations.-Companies with a registration for a surface sanitizer under the PCPA or an authorization for a disinfectant under the FDR have 4 years from the coming-into-force date to obtain an authorization under the regulations. This can be achieved by filing a transition application.-For more information on transitioning a disinfectant or surface sanitizer, consult:+must meet the requirements in the+Biocides Regulations+.+This includes surface sanitizers for use in food premises, which must obtain a biocide market authorization through a new application pathway by the end of a 6-year transition period (by May 31, 2031) to continue to be sold, advertised, or imported.+For more information on submitting a new application for a surface sanitizer for use in food premises, consult: Guidance on the transition of disinfectants and surface sanitizers to the Biocides Regulations+For more information on obtaining a market authorization for a new biocide, consult:+Guidance on the transition of disinfectants and surface sanitizers to the Biocides Regulations+Food processing aid uses as of May 31, 2025+While food processing aid uses (such as application to the surface of food, for example, fruit and vegetable washes) may be listed on biocide labels, they are not reviewed by NNHPD as part of the premarket assessments required for market authorization.+Biocides with food processing aid uses, like any other substance used in manufacturing or processing food, must comply with+section 4 of the+Food and Drugs Act+,+which in part prohibits the sale of a food that contains a poisonous or harmful substance or is adulterated.+For more information on substances used directly on the surface of food, see the+Food Processing Aids+website from the Food and Nutrition Directorate. Related links+Biocide application form+Biocides Ingredients Database Biocide monograph Biocides Regulations Guidance for industry on biocides@@ -121,5 +138,4 @@ Incorporated by reference List of Foreign Regulatory Authorities for Biocides Incorporated by reference the Labelling Requirements for Pressurized Containers Containing Biocides Page details-Date modified:-2024-06-18+2025-08-13