Biocides

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.

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

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 or
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 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:

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

A biocide may currently be authorized 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:

Pesticide Product Information Database for registered sanitizers
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 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:

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.

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.

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:

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).

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:

Guidance on the transition of disinfectants and surface sanitizers to the Biocides Regulations

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Date modified:: 2024-06-18

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