Guidance on safety requirements for biocides: Overview

Purpose

You are required to provide safety information in your biocide application so that the Minister of Health (the Minister) can determine if the biocide's benefits outweigh its risks taking into account any uncertainties relating to those benefits and risks. This requirement is set out in both the Food and Drugs Act (act) and Biocides Regulations (regulations).

This guidance document outlines the tools and approaches you can use to meet the safety requirements in the regulations. Using these tools and approaches may reduce the number of times we need to clarify an item in an application. It will also help us make a decision on your biocide more quickly.

You're responsible for ensuring that you:

have scientific evidence to support the safety of your biocide
label and package your biocide to mitigate risks in accordance with the regulations

Your application should include:

sufficient information on the benefits and risks associated with your biocide (including safety information) and any uncertainties relating to those benefits and risks
a summary of this information (including safety information) and any uncertainties relating to those benefits and risks

You should contact us if you wish to deviate from the approaches in this guidance.

Studies that were initiated prior to the publication of this guidance document may have relied on a previous safety guidance document when undertaking studies. For example, you may have referred to the following 2020 guidance:

Safety and efficacy requirements for surface disinfectant drugs

We will assess whether these studies are still acceptable for new biocide applications under the updated data requirements. Contact us if you want to verify the acceptability of your safety data prior to submitting your application.

Currently, we do not have any re-evaluation requirements for authorized biocides. The supporting data approved for a surface disinfectant under the Food and Drug Regulations or a sanitizer under the Pest Control Products Act will be acceptable under the Biocides Regulations for transition applications. If new scientific information becomes available, we may need to confirm that the benefits of your biocide continue to outweigh the risks taking into account any related uncertainties.

General

If the Minister does not have sufficient information to conclude that the benefits outweigh the risks of your biocide, taking into consideration any related uncertainties, we will either:

request additional information to support your biocide or
refuse to issue a market authorization for your biocide

Examples of situations where we may request additional safety information include:

when we are aware of a safety concern related to the biocide
when the proposed risk information on the label text is inconsistent with the hazard profile of your biocide
- for example, your biocide is labelled as an irritant when it's known to be corrosive
when there are known impurities
- for example, carcinogenic impurities
when you have used different hazard classification approaches than those published in Canadian regulations
if you have submitted the minimum application requirements, but there is insufficient information in your application for the Minister to make a decision
when information in your safety summary shows there is a specific concern that should be investigated

Examples of additional safety information that could be requested to better characterize the benefits and risks of your biocide include:

data
literature
safety data sheets (SDS)
written scientific rationale

For guidance on navigating the biocide application process, consult:

Guidance on management of biocide applications
Biocide application form user guide

The guidance on management of biocide applications outlines the mechanisms that we can use to request additional information from you during our assessment of your biocide application.

Good laboratory practice

When testing for safety, you should use good laboratory practice (GLP). This will help to ensure your data is of high quality and is reliable.

Choose a testing laboratory that complies with our GLP compliance requirements. There are many test laboratories in North America that are able to conduct tests that meet these requirements.

Other types of GLP compliance standards include those published by the:

If you rely on non-GLP compliant data (for example, non-GLP studies or GLP studies with outages), you should confirm that the standard you used to assess compliance is equivalent to GLP certification. For example, certain International Organization for Standardization (ISO) certification standards are equivalent. This scenario is more common for testing done by European laboratories

Include rationales to demonstrate:

how the alternate standards differ from GLP standards
how they meet alternative standards
your use of non-GLP compliant testing

We will assess whether the deviations from GLP or alternative standards are acceptable. While we will consider all rationales, we cannot guarantee that we will accept the submitted data.

Application requirements

Information to support the risks and any related uncertainties of your biocide includes:

safety information (when applicable)
a safety summary (when applicable)

Certain applications must contain safety information and/or a summary of the information included in your application about the risks and any related uncertainties of your biocide. Find information below and in the guidance on biocide application pathways and general requirements on when safety data and/or a summary are required, and the specific requirements for each application pathway.

As indicated in the summary of information on benefits, risk and related uncertainties section of the guidance on biocide application pathways and general requirements, the summary helps us screen and review your application. It may also reduce the number of clarification requests we issue, a mechanism outlined in the guidance on management of biocide applications.

Your summary should explain your biocide's safety when used in accordance with the proposed conditions of use. It should include a summary of your safety data and other related information (such as rationales) for your proposed biocide.

If possible, you should put the safety summary in a table:

a sample safety summary template is available

Full review and full review - novel biocide applications

You must provide in your application:

safety information
a safety summary

Find information on what to include in your safety summary for a full review biocide application.

Applications based on comparison and use of foreign decisions

You do not need to provide safety information or a safety summary in your application if you're relying on identical safety information from an application of another biocide that received authorization.
This applies to applications filed through the following pathways:

use of foreign decisions (UFD)
comparison - labelling only
comparison - administrative

However, we recommend that you include a summary of any differences between the foreign biocide or comparison product and your biocide (for example, packaging). This will reduce the need for clarification requests for applications filed through these pathways.

Find information on what to include in your safety summary for comparison and UFD applications.

Monograph applications

Safety information for monograph applications is required, as the monograph specifies only efficacy parameters.

To help the Minister determine that the benefits of your biocide outweigh the risks taking into account any related uncertainties, you should submit the following safety information for a monograph application:

a copy of the SDS, if available
- for example, products with commercial uses
an explanation of the biocide's hazard profile
safety rationales to support the proposed risk information and directions for use

The SDS, if available, should include:

endpoint toxicities and how they relate to the Hazardous Products Regulations (HPR) classification
information on the biocide's safety profile

You must also provide a safety summary, though it can be abbreviated when using the monograph application pathway. The Minister may request additional safety information in order to assess the biocide's benefits, risks and uncertainties.

Find information on what to include in an abbreviated safety summary for a monograph application.

Alternate safety test methods

The safety test methods outlined in this guidance are examples only.

If you want to use an alternate method, you may contact us to request pre-submission advice or a pre-submission meeting to verify if the alternate method is acceptable to demonstrate the safety considerations for your biocide.

We recommend that acute toxicity testing using animal models be reduced or eliminated for your biocide if the testing will not provide new safety information. For example, in situations where a data endpoint is not relevant to the chemical, such as an eye irritation study when the product is determined to be corrosive to skin.

You should contact us if you are choosing to use new approach methods (NAMs) in order to reduce the use of testing on animals. These include any technology, methodology, or approach that can be used to provide information on chemical hazard and risk assessment that avoids the use of live animals. Examples of NAMs include in vitro studies, which are experiments that use human or animal cells to assess a chemical's potential to cause acute toxicity, such as eye irritation and dermal sensitization.

Reasons for pre-submission meetings or consultations

Pre-submission meetings or consultations are an opportunity to advise you on the appropriate safety information you may need to support your biocide application.

You should contact us or schedule a meeting before you submit an application for market authorization for certain biocides, including those:

with an unconventional method of application
with uncommon or novel claims
- long-term residual efficacy claims, for example
with unconventional or novel ingredients
- nanomaterials, for example
that are to be used with other products or activators

For instructions on pre-submission meetings or consultations, consult:

Contact us

Contact the Natural and Non-prescription Health Products Directorate to:

request pre-submission advice or set up a pre-submission meeting
discuss the appropriate safety information you may need to support your biocide
- for example, the additional safety information for a novel biocide
- for example, using different hazard classification approaches than those published in Canadian regulations
- for example, information to support the residue analysis for your biocide
- for example, information to support the chronic exposure potential for your biocide
discuss alternative test methods or modifications for your biocide
- for example, using new approach methods (NAMs) in order to reduce the use of testing on animals
discuss the use of toxicity testing waivers

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

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2025-08-13

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