Guidance on biocides

The definitions in this section explain the scientific and regulatory terms used throughout the biocides guidance documents. (Note: Definitions are from the 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)

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
• efficacy to support all label claims
• safety profile, unless improved from the basic formulation

Antimicrobial resistance:

When bacteria, viruses, fungi and parasites change over time and no longer respond to medicines (such as antibiotics, antivirals, antifungals and antiparasitics). This makes infections harder to treat and increases the risk of disease spread, severe illness and death.

Bactericide:

A substance or mixture of substances that is capable of destroying vegetative bacteria, but not necessarily bacterial spores or mycobacteria, on a non-living and non-liquid surface. Biocides with a minimum efficacy against vegetative bacteria may be authorized with claims as a limited disinfectant, general (broad-spectrum) disinfectant or hospital or health care disinfectant.

Bacteriostat:

A substance or mixture of substances that inhibits the growth of vegetative bacteria on a non-living and non-liquid surface.

Basic formulation:

The formulation of a biocide that has been subject to complete efficacy and safety testing, as applicable.

Biocide:

A drug that's 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, but it does not include:

1. such a drug that is manufactured, sold or represented for use exclusively on the surface of food
2. such a drug that is manufactured, sold or represented for use on the surface of a contact lens that is a medical device, as defined in section 1 of the Medical Devices Regulations or
3. such a drug that:
   1. is manufactured, sold or represented for use on the surface of
      1. an invasive device, as defined in section 1 of the Medical Devices Regulations or
      2. a medical device, as defined in section 1 of the Medical Devices Regulations, that is not an invasive device, as defined in that section, but is intended to channel or store gases, liquids, tissues or body fluids, for the purpose of being introduced into the body by infusion or other means of administration and
   2. is capable of destroying or irreversibly inactivating either
      1. all types of pathogenic micro-organisms, but not necessarily large numbers of pathogenic bacterial spores or
      2. all types of micro-organisms

(subsection 1(1) of the regulations)

Biofilm:

A dynamic, self-organized, accumulated mass of bacteria and extracellular polymeric material that:

• adheres tightly to a surface and cannot be easily removed and
• may protect bacteria within from being destroyed by disinfectants

Broad-spectrum virucide:

A substance or mixture of substances that:

• is capable of destroying or irreversibly inactivating, at a minimum, 1 representative hard-to-kill non-enveloped virus and
• is expected to inactivate other enveloped and non-enveloped viruses on a non-living and non-liquid surface

CAS registry number:

The identification number that is assigned to a chemical substance by the Chemical Abstracts Service division of the American Chemical Society. (subsection 1(1) of the regulations)

Change that creates a new biocide:

A change in respect of a biocide that's considered to have created a new biocide that's not authorized to be imported, sold or advertised under the market authorization:

• the substitution, addition or removal of an active ingredient
• a change to the quantity of an active ingredient that's contained in a given quantity of the biocide or
• a change to the physical form of the biocide

Cleaner:

A substance, or mixture of substances, that removes foreign material (for example, soil, inorganic and organic material) from a non-living and non-liquid surface due to the detergent or enzymatic properties of the formulation. It is not intended to have an expressed or implied antimicrobial effect.

Conditions of use:

In respect of a biocide:

• its intended uses or purposes
• the settings in which it is intended to be used
• its risk information
• its directions for use and
• its directions for storage

(subsection 1(1) of the regulations)

Contact time:

The length of time a biocide must be in contact with a target surface or device to achieve the labelled efficacy result.

Designated container:

A disposable metal container that's designed to release pressurized contents by the use of a manually operated valve that forms an integral part of the container. (section 28 of the regulations)

Disinfectant:

A substance or mixture of substances capable of destroying or irreversibly inactivating (a 4 log₁₀ to 6 log₁₀ reduction) pathogenic (disease-causing) and potentially pathogenic (opportunistic) micro-organisms, but not necessarily bacterial spores, on non-living and non-liquid surfaces due to the antimicrobial action of the active ingredient(s).

Disinfectant-sanitizer:

A substance or mixture of substances whose primary use is as a disinfectant and secondary use as a sanitizer on a non-living and non-liquid surface.

Drug:

Includes any substance or mixture of substances manufactured, sold or represented for use in:

• the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals
• restoring, correcting or modifying organic functions in human beings or animals or
• disinfection in premises in which food is manufactured, prepared or kept

(section 2, Food and Drugs Act)

Expiry date:

In respect of a biocide, the year and month in which its shelf life ends. (subsection 1(1) of the regulations)

Flame projection:

The flame resulting from the ignition of a biocide discharged from a designated container when tested in accordance with official method DO-30, Determination of Flame Projection, dated October 15, 1981 and published by the Government of Canada on its website. (subsection 35(3) of the regulations)

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)

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:

A government agency or other entity outside Canada that controls the manufacture, sale or use of biocides within its jurisdiction and that may take enforcement action to ensure that biocides marketed within its jurisdiction comply with the applicable legal requirements. (subsection 1(1) of the regulations)

Formulant:

Any component of a biocide that is not an active ingredient or contaminant. (subsection 1(1) of the regulations)

Fungicide:

A substance or mixture of substances capable of destroying fungi (including yeast) and fungal spores, pathogenic to humans or other animals, on a non-living and non-liquid surface.

Fungistat:

A substance or mixture of substances that inhibits the growth of fungi on a non-living and non-liquid surface (for example, prevents or controls the growth of mould and mildew). Also referred to as mildewstat.

General (broad-spectrum) biocide:

A substance or mixture of substances capable of destroying, inactivating, reducing or controlling both Gram-positive and Gram-negative bacteria on a non-living and non-liquid surface.

Germ:

A term commonly used in public health communications to refer to pathogenic (disease-causing) micro-organisms, such as bacteria, fungi and viruses. Biocides with efficacy at a minimum as a general (broad-spectrum) disinfectant or a hospitals or health care disinfectant can be authorized with "kills germs" claims.

Germicide/microbicide:

A substance or mixture of substances capable of destroying or irreversibly inactivating pathogenic (disease-causing) and potentially pathogenic (opportunistic) micro-organisms, but not necessarily bacterial spores, on a non-living and non-liquid surface. Applicants are encouraged to use the preferred term "disinfectant" on their labelling.

Good laboratory practice (GLP):

The organizational process and conditions under which laboratory studies are planned, performed, monitored, recorded, archived and reported. GLP is intended to promote the quality and validity of test data and improve the international acceptance of data generated in adherence to its principles.

Good manufacturing practices (GMP):

The part of quality management that ensures products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the market authorization or product specification. GMP is concerned with both production and quality control.

High-level disinfectant:

A substance or mixture of substances capable of destroying or irreversibly inactivating all types of pathogenic micro-organisms on a non-living and non-liquid surface, but not necessarily large numbers of pathogenic bacterial spores.

Hospital or health care disinfectant:

A substance or mixture of substances:

• capable of destroying both Gram-positive and Gram-negative bacteria on a non-living and non-liquid surface and
• manufactured, sold or represented for use in hospitals, medical clinics, dental offices or any other health care facility

Household biocide:

Also referred to as "domestic biocide". A biocide that is intended to be distributed only to the general public for personal use. (section 28 of the regulations)

Identification number:

A computer-generated 8-digit number that Health Canada assigns to a biocide when it's issued a market authorization in accordance with the Food and Drugs Act and the regulations. The identification number uniquely identifies the product and must appear on the marketed product label for all biocides authorized for sale in Canada.

Immediate container:

The package that is in direct contact with a biocide. (section 28 of the regulations)

Import:

Import for the purpose of sale. (subsection 1(1) of the regulations)

Inner label:

A label that is on or attached to the immediate container of a biocide. (section 28 of the regulations)

Indirectly invasive device:

A medical device, as defined in section 1 of the Medical Devices Regulations (MDR) that is not an invasive device, as defined in that section, but is intended to channel or store gases, liquids, tissues or body fluids, for the purpose of being introduced into the body by infusion or other means of administration.

Invasive device:

A medical device that is intended to come into contact with the surface of the eye or penetrate the body, either through a body orifice or through the body surface. (section 1, MDR)

Letter of confirmation:

A letter from the market authorization holder of the comparison product (licensor) attesting that they have provided the applicant (licensee) with the master formula and up-to-date label text for the other biocide. The letter mentions the other biocide's brand names and identification number in support of the licensee's application for the same biocide.

Licensing agreement:

An agreement between 2 parties, where 1 party supplies or provides access to the master formula for a previously authorized biocide to another party for sale under the second party's name.

Limited disinfectant:

A substance or mixture of substances capable of destroying Gram-positive or Gram-negative bacteria, but not both, on a non-living and non-liquid surface.

List of Foreign Regulatory Authorities:

The document entitled List of Foreign Regulatory Authorities for Biocides that's published by the Government of Canada on its website, as amended from time to time. (subsection 1(1) of the regulations)

Lot number:

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 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)

Market authorization:

A legal document issued by Health Canada authorizing the sale of a biocide based on the requirements of the Food and Drugs Act and the regulations.

Market authorization holder:

The person who holds the market authorization for a biocide issued under the regulations.

Master formula:

In respect of a biocide, a document that sets out:

1. the ingredients that are used in the manufacture of the biocide and the quantities of those ingredients that are required to manufacture a given quantity of the biocide
2. the specifications for the biocide
3. a detailed description of the procedures required to manufacture, package, label and store the biocide, including safety precautions and in-process controls
4. a detailed description of the methods used to test and examine the packaging material and
5. a statement of tolerances for the properties and qualities of the packaging material

(subsection 1(1) of the regulations)

Minor change:

A minor change that:

• relates to the information or material provided to the Minister in connection with a biocide and
• may reasonably be expected to have a minor 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)

Mycobactericide:

A substance or mixture of substances capable of destroying or irreversibly inactivating mycobacteria on a non-living and non-liquid surface. Applicants are encouraged to use this term on their labelling. Also referred to as a "tuberculocide."

Novel biocide:

A biocide with aspects that have never been authorized for a biocide in Canada, such as a novel:

• physical form
• use or purpose
• active ingredient
• method of application
• combination of active ingredients

One-step cleaner and disinfectant or one-step cleaner and sanitizer:

A substance or mixture of substances that has been tested and found to be effective in the presence of light to moderate amounts of soil (for example, a 5% organic soil load). May be used without a pre-cleaning step for light to moderate amounts of soil (on visibly clean surfaces) in the labelled directions for use.

Outer label:

A label that is on or attached to the outside of a package, other than the immediate container, of a biocide. (section 28 of the regulations)

Package description:

The net quantity of the biocide in the package, the type of package and a statement of the properties and qualities of the packaging material.

Pressurized Containers Labelling Document:

The document entitled Labelling Requirements for Pressurized Containers Containing Biocides, dated December 18, 2021 and published by the Government of Canada on its website. (section 28 of the regulations)

Principal display panel:

The part of the label that:

1. is on or attached to all or part of the surface of the package that is displayed or visible under normal conditions of sale or use or
2. if the package does not have a surface described in paragraph (a), is on or attached to any part of the package except the bottom

(section 28 of the regulations)

Prion:

Proteinaceous infectious particles that are transmissible and pathogenic agents. They cause a variety of progressive neurodegenerative diseases of the central nervous system in humans (Creutzfeldt-Jakob disease) and animals (bovine spongiform encephalopathy in cattle). Collectively, they are called transmissible spongiform encephalopathies (TSEs or prion diseases).

Prions are unlike any other infectious pathogens. This is because they are made up of abnormal folding conformations of a normal, ubiquitous cellular protein, called the "cellular" prion protein (PrP^C). Prions are highly resistant to sterilization processes and disinfectants.

Private label:

Label of an authorized biocide sold under the name or trade dress of a retail store that is not the market authorization holder of the biocide.

Product specifications:

The properties and qualities of the biocide and its ingredients, including the identity, potency and purity and associated tolerances and test methods.

Residual sanitization or disinfection:

A claim that the biocide will have residual sanitizing or disinfection action on treated surfaces.

Sanitizer:

A substance or mixture of substances capable of reducing the microbial population on non-living and non-liquid surfaces by significant numbers (a minimum 3 log₁₀ reduction) due to the antimicrobial action of the active ingredient(s). Does not destroy or eliminate all micro-organisms.

Shelf life:

The period beginning on the day on which a biocide is packaged for sale to consumers, during which, the biocide will, when appropriately stored, retain without any appreciable deterioration its stability and any other qualities claimed for it by the holder of the market authorization for it. (subsection 1(1) of the regulations)

Small package:

A small package of a biocide where the immediate container is not large enough to accommodate an inner label that complies with sections 31 and 32 of the regulations. (section 33 of the regulations)

Specifications:

In respect of a biocide, means:

1. a statement of its properties and qualities, and of the properties and qualities of its active ingredients and formulants, including the identity, potency and purity of the biocide and those ingredients and formulants
2. the net quantity of the biocide in the package, the type of package and a statement of the properties and qualities of the packaging material
3. a detailed description of the methods used to test and examine the biocide and its active ingredients and formulants and
4. a statement of tolerances for the properties and qualities of the biocide and for the properties and qualities of its active ingredients and formulants

(subsection 1(1) of the regulations)

Sporicide:

A substance or mixture of substances capable of destroying or irreversibly inactivating bacterial endospores ("bacterial spores") on a non-living and non-liquid surface.

Sterilant:

A substance or mixture of substances capable of destroying or irreversibly inactivating all types of micro-organisms on a non-living and non-liquid surface, including:

• vegetative bacteria
• bacterial spores
• fungi
• fungal spores
• viruses
• mycobacteria

These are also referred to as "chemical sterilants" or "chemosterilants". They include substances that at the time of use are liquids, gases or vapours (such as ethylene oxide, hydrogen peroxide gas plasma).

Surface sanitizer for use in food premises:

A biocide that is manufactured, sold or represented for use exclusively in premises in which food is manufactured, prepared or kept for sale. (subsection 70(3) of the regulations)

Surrogate microbe:

An alternative microbe species or strain used to represent another, typically due to biosafety concerns, ease of culturing or availability.

Therapeutic product:

A drug or device or any combination of drugs and devices. (section 2, Food and Drugs Act)

Tuberculocide:

A substance or mixture of substances capable of destroying or irreversibly inactivating mycobacteria, specifically tubercle bacilli (Mycobacterium tuberculosis), on a non-living and non-liquid surface. Applicants are encouraged to use "mycobactericide" on their labelling.

Virucide:

A substance or mixture of substances capable of destroying or irreversibly inactivating viruses on a non-living and non-liquid surface. Disinfectants with efficacy against any specific virus may be authorized with a virucide claim.

Volatile:

A substance that evaporates readily at room temperature.

Table 1 lists the legislation and regulatory body responsible for the different product classes. It also gives examples of represented uses.

Medical devices

The following products fall under the Medical Devices Regulations (MDR) and are regulated as medical devices under the FDA and MDR:

• substances or mixtures of substances manufactured, sold or represented for antimicrobial use on the surface of a contact lens that is a medical device
• high-level disinfectants or sterilants manufactured, sold or represented for use on the surface of an invasive or indirectly invasive medical device

Class II to IV medical devices require a medical device licence before they can be sold in Canada. This includes contact lens disinfectants and high-level disinfectants and sterilants.

Refer to the following guidance documents on how to comply with the regulations:

• Guidance for high-level disinfectants and sterilants for use on invasive and indirectly invasive medical devices
• Guidance for safety and effectiveness requirements for contact lens disinfectants

If you sell or import any class of medical devices in Canada, you must apply for and maintain a medical device establishment licence, unless you meet exemption(s) in section 44 of the MDR.

Pest control products

Section 2 of the Pest Control Products Act (PCPA) defines a pest control product as:

1. a product, an organism or a substance, including a product, an organism or a substance derived through biotechnology, that consists of its active ingredient, formulants and contaminants, and that is manufactured, represented, distributed or used as a means for directly or indirectly controlling, destroying, attracting or repelling a pest or for mitigating or preventing its injurious, noxious or troublesome effects
2. an active ingredient that is used to manufacture anything described in paragraph (a) or
3. any other thing that is prescribed to be a pest control product

Learn more about the regulatory requirements for articles treated with a pesticide.

All pest control products manufactured, imported, distributed, sold or used in Canada must be registered or otherwise authorized with the Pest Management Regulatory Agency (PMRA).

Learn more about the registration or authorization requirements for pest control products.

Examples of products that are regulated as pest control products by the PMRA under the PCPA and PCPR include:

• greenhouse, plant and agriculture disinfectants to control plant pathogens
• swimming pool and spa disinfectants or devices, including slimicides and algaecides
• water and air sanitizers
• antimicrobial and bacteriostatic devices
• material preservatives and antimicrobial treated articles, including antimicrobial or bacteriostatic coatings

Most pest control products require a pre-market assessment and a registration number before they can be sold in Canada. As part of the pre-market assessment, we evaluate the health and environmental safety, value and effectiveness of the product.

Consumer cleaning products

A substance or mixture of substances intended for use on a non-living and non- liquid surface may be classified as a consumer product if it:

• does not make an expressed antimicrobial activity claim on the label and
• will be used by an individual for non-commercial purposes

Such products are regulated by the Canada Consumer Product Safety Act (CCPSA) and its associated regulations.

Consumer cleaning products may contain recognized antimicrobial ingredients (such as sodium hypochlorite, quaternary ammonium compounds and hydrochloric acid) as part of their formulation. However, in general, if there's no expressed antimicrobial claim, the product is considered a cleaner and regulated as a consumer product under the CCPSA.

Consumer products are not required to get pre-market approval.

Requirements set out in the Consumer Chemicals and Containers Regulations, 2001 under the CCPSA may apply to products that meet the definition of a chemical product. These include requirements for child-resistant containers and hazard labelling. Suppliers are also required to perform mandatory reporting and record keeping, as specified in the CCPSA.

Workplace cleaning products

Workplace cleaning products that meet the definition of a hazardous product, as set out in section 2 of the HPA, and that are not excluded from the application of the HPA, are regulated under the HPA and the Hazardous Products Regulations (HPR).

Workplace cleaning products may contain recognized antimicrobial ingredients (such as sodium hypochlorite, quaternary ammonium compounds, and hydrochloric acid) as part of their formulation. However, in general, products without an expressed antimicrobial claim are considered to be cleaning products. They are regulated as hazardous when they meet the definition of a hazardous product under the HPA.

Workplace cleaning products, including those that are hazardous products, are not required to have pre-market approval. However, suppliers who sell or import hazardous products that will be used, handled or stored in Canadian workplaces must meet the supplier hazard classification and communication requirements. These are listed in the Workplace Hazardous Materials Information System (WHMIS) and are set out in the HPA and HPR.

We administer compliance activities for workplace cleaning products that are hazardous products. We do this in partnership with the provincial, territorial and federal agencies responsible for occupational health and safety.

Antiseptic skin cleansers

We regulate antiseptic skin cleansers or sanitizers for human use under the FDR or 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 Biocides Regulations. Under certain conditions, these products may be considered food processing aids.

Learn more about food processing aids.

Product classification request

If you are still not sure if a proposed product would be regulated as a biocide, send a product classification request to the Natural and Non-prescription Health Products Directorate.

Include the following information for each product in your request:

• name of the product
• product website (if available)
• physical form (for example, powder, solution)
• setting in which the product is intended to be used
• the product label (if available) or proposed label text
• information on the product placement of sale (if available)
• intended use or purpose associated with the product
• list of active ingredients (with their quantities, if available) and formulants
• directions for use, including method of application and surfaces to which the product may be applied
• risk information such as signal words, precautionary, prevention and first aid statements

For more information on the classification of a therapeutic product, consult:

• Guidance document on managing drug submissions and applications

After reviewing your request, we will advise you on whether the product would be classified as a biocide. Note: A decision on whether a product may be issued a biocide market authorization can only take place after an application is made under the regulations and the requirements have been met.

You may also contact the Pest Management Regulatory Agency to confirm if your product is subject to the PCPA and requires registration.

Natural and Non-prescription Health Products Directorate

For information on the pre-market authorization requirements for biocides:

Natural and Non-prescription Health Products Directorate
Health Products and Food Branch
Health Canada

Email: nnhpd-dpsnso@hc-sc.gc.ca

Medical Devices Directorate

For information on the pre-market authorization requirements for medical devices:

Medical Devices Directorate
Health Products and Food Branch
Health Canada

Email: meddevices-instrumentsmed@hc-sc.gc.ca

Pest Management Regulatory Agency

For information on the pre-market authorization requirements for pest control products:

Pest Management Regulatory Agency
Health Canada

Email:

• pmra.info-arla@hc-sc.gc.ca (general inquiries)
• pmra.subject.to.regulation-sujet.a.la.reglementation.arla@hc-sc.gc.ca (to confirm if your product is subject to the PCPA)

Consumer Product Safety Program

For information on the legislative requirements for consumer cleaning products:

Consumer Product Safety Program
Consumer and Hazardous Products Safety Directorate
Healthy Environments and Consumer Safety Branch
Health Canada

Email: ccpsa-lcspc@hc-sc.gc.ca

Workplace Hazardous Materials Bureau

For information on the legislative requirements for workplace cleaning products that meet the definition of a hazardous product and on WHMIS hazard communication requirements:

Workplace Hazardous Materials Bureau
Consumer and Hazardous Products Safety Directorate
Healthy Environments and Consumer Safety Branch
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:

Bureau of Chemical Safety
Food Directorate
Health Products and Food Branch
Health Canada

Email: hc.fpmia-meaai.sc@canada.ca

Health Product Compliance Directorate

For information on compliance and enforcement activities for biocides and other health products:

Health Product Compliance Directorate
Regulatory Operations and Enforcement Branch
Health Canada

Email: hpc.correpondence-correspondance.cps@hc-sc.gc.ca