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Guidance on biocides - Canada.ca
18 avr. 2025
legacy-hc-2025-04-21
ID 249749
Capture suivante
Guidance on biocides - Canada.ca
2 janv. 2026
hc-20260101
ID 428823
updated6 sections changed; 1 added; 1 removed
6 sections modifiées1 ajoutées1 retirées+14 / -18 lignesVariation: 3%
--- +++ @@ -23,18 +23,15 @@ Post-authorization changes Safety monitoring and reporting requirements for marketed biocides Transition of disinfectants and surface sanitizers to the biocides framework-Before the regulations come into force, guidance will be made available on these topics:+Management of biocide applications+Drug, natural health product, and biocide recall guide Evaluation fees for biocides Fees for the right to sell biocides-Management of biocide applications-Drug, natural health product, and biocide recall guide-How to file an application with Health Canada-Steps applicants need to take before filing their application-Notification of first sale, annual notification and permanent discontinuation+Biocide application form user guide Scope and application The biocides guidance applies to products that meet the definition of a biocide under the regulations: a drug that is manufactured, 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-A biocide must have a minimum efficacy level of a sanitizer (99.9% [3 log10]) reduction to meet the definition of a biocide and be eligible to apply for a market authorization under the regulations.+A biocide must have a minimum efficacy level of a sanitizer (99.9% [3 log10] reduction) to meet the definition of a biocide and be eligible to apply for a market authorization under the regulations. The regulations do not apply to biocides that are manufactured, sold or represented for use: exclusively on the surface of food on the surface of a contact lens@@ -50,7 +47,7 @@ Biocides Regulations where indicated.) Active ingredient:-A component of a biocide that is directly responsible for any of the biocide's intended effects. (subsection 1(1) of the regulations)+A biocide that is directly responsible for any of the biocide's intended effects. (subsection 1(1) of the regulations) Alternate formulation: A formulation of a biocide that differs in formulants from the basic formulation but has the same: active ingredients (including their CAS (Chemical Abstracts Service) registry numbers) and quantities@@ -141,7 +138,7 @@ Flashback: The part of a flame projection that extends from the point of ignition back to the designated container when tested in accordance with official method DO-30, Determination of Flame Projection-, dated October 15, 2918 and published by the Government of Canada on its website. (subsection 35(3) of the regulations)+, dated October 15, 1981 and published by the Government of Canada on its website. (subsection 35(3) of the regulations) Food contact surface: A surface that may come into direct contact with food or beverages (for example, eating and drinking utensils, cutting boards, countertops, food processing equipment). Foreign regulatory authority:@@ -203,7 +200,7 @@ Any combination of letters, figures or both by which a biocide can be traced in manufacture and identified in distribution. (subsection 1(1) of the regulations) Major change: A major change, other than a change referred to in section 14, that:-relates to the information or material provided to the Minister in connection with a biocide+relates to the information or material provided to the Minister of Health (the Minister) in connection with a biocide and may reasonably be expected to have a major impact on the quality of the biocide, the benefits or risks associated with the biocide or the uncertainties related to the benefits and risks (subsection 1(1) of the regulations)@@ -355,7 +352,7 @@ Antimicrobial hand washes Food processing aids Food and Drugs Act-Food Directorate+Food and Nutrition Directorate Products exclusively used to: control microbial growth in flume water for fruit or vegetable processing control microbial growth in poultry chiller bath water@@ -420,7 +417,7 @@ Natural Health Product Regulations , depending on the active or medicinal ingredients. Products for use on human skin are not biocides. Food processing aids-Products for exclusive use on the surface of food to reduce microbial contamination or to control microbial growth in water are excluded from the definition of "biocide". They are not subject to the+Products for exclusive use on the surface of food to reduce microbial contamination or in food process water or to control microbial growth in the water are excluded from the definition of "biocide". They are not subject to the Biocides Regulations . Under certain conditions, these products may be considered food processing aids. Learn more about@@ -487,14 +484,14 @@ Health Canada Email: whmis-simdut@hc-sc.gc.ca-Food Directorate-For information on the evaluation requirements and guidance on labelling for food processing aids:+Food and Nutrition Directorate+For questions related to food processing aids: Bureau of Chemical Safety-Food Directorate+Food and Nutrition Directorate Health Products and Food Branch Health Canada Email:-hc.fpmia-meaai.sc@canada.ca+chhad.inquiries-requetes.dedpcs@hc-sc.gc.ca Health Product Compliance Directorate For information on compliance and enforcement activities for biocides and other health products: Health Product Compliance Directorate@@ -503,5 +500,4 @@ Email: hpc.correpondence-correspondance.cps@hc-sc.gc.ca Page details-Date modified:-2024-06-18+2025-08-13