Compare to the live page

Archived snapshot

Biocides - Canada.ca

2025-04-18T16:01:50.025Z · legacy-hc-2025-04-21

ID 173656

Original URL ↗

Live page

Live fetch

2026-02-03T23:36:13.401Z

Status: 200 · Type: text/html;charset=utf-8 · Bytes: 33676

Final URL

https://www.canada.ca/en/health-canada/services/drugs-health-products/biocides.html?wbdisable=true

Independent archive · Descriptive changes only; the live page is not archived. Cite the snapshot (/cite).

Fetch live diff again View snapshot

5 sections changed; 5 added; 3 removedMain contentChange ratio: 35%+55 / -39 lines5 sections changed

Word-level highlighting (experimental)High contrast mode

Biocides

On this page

About biocides

Using biocides safely

Authorized biocides

How biocides were authorized prior to May 31, 2025

How biocides will be regulated in Canada as of May 31, 2025

How biocides are regulated as of May 31, 2025

How we authorize biocides between now and 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

such as in patient care areas and on non-invasive medical equipment

food premises

such as on countertops and cutting boards

animal housing areas

such as in veterinary clinics and poultry plants

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

on contact lenses

on invasive or indirectly invasive medical devices

exclusively on the surface of food

Using biocides safely

Heath Canada only authorizes a biocide for sale if its benefits outweigh its risks, taking into account related uncertainties. This does not mean that biocides are free of risk. Risks may include:

unwanted side effects, like allergic reactions

improper storage, leading to unintentional exposure to children

interactions with other chemical products like cleaners

manufacturing problems

like contamination, incorrect ingredients or dosage

Take these steps to minimize your risk:

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:

Protect yourself from poisonings

Advisories, warnings and recalls

You should report any side effects to your health care provider and to Health Canada.

Reporting side effects helps us:

identify rare or serious side effects

make changes in product safety information

issue public warnings and advisories

and

remove unsafe products from the Canadian market

Report a side effect

Authorized biocides

How biocides were authorized prior to May 31, 2025

A biocide may currently be authorized under the

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).

(PCPA), respectively.

Authorized biocides include:

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 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 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

a surface sanitizer with a registration number on its label if the Pest Management Regulatory Agency has registered the product under the PCPA

Reg. No. (assigned registration number) P.C.P. Act

the number will appear on the label as:

Surface disinfectants and surface sanitizers authorized prior to May 31, 2025 are listed in these databases:

Registration No

. (assigned registration number)

Pest control products act

Reg. No.

(assigned registration number) P.C.P. Act

Search 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

How biocides are regulated as of May 31, 2025

The way biocides are regulated in Canada is changing. The

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.

, Part II on June 19, 2024. The regulations introduce a single regulatory framework in Canada for biocides under the

Canada Gazette

Food and Drugs Act

, Part II publication

and came into force on May 31, 2025.

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.

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 must issue a market authorization, in accordance with section 11 of the regulations, if the:

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

and

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.

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 FDA and the regulations through post-market regulatory activities. The Regulatory Operations and Enforcement Branch (ROEB) oversees these activities.

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

reviews and analyses post-market data and information received for biocides to determine if there are any changes to the safety profile of these products

develops risk management strategies to mitigate the identified risks when needed

Learn more about MHPD, ROEB and NNHPD:

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

The transition of previously authorized biocides as of May 31, 2025

We will review all applications for surface disinfectants and sanitizers received

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.

before May 31, 2025,

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.

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).

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.

must meet the requirements in the

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.

Biocides Regulations

For more information on transitioning a disinfectant or surface sanitizer, consult:

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.