Guidance on safety requirements for biocides: Safety information

About safety information

You must provide us with relevant safety information so the Minister can determine your biocide's safety. Your safety information must be based on your biocide’s formulation or a substantially similar formulation.

As indicated in the hazard classification criteria and precautions section of the guidance on labelling requirements for biocides, the Food and Drugs Act and the Biocides Regulations do not generally specify hazard classification criteria or precautionary statements for biocides.

In preparing your safety information for your biocide application, the following Canadian hazard classification criteria for chemical products may be appropriate for evaluating the hazards of your biocide:

Consumer Chemicals and Containers Regulations, 2001
- for biocides intended only for use in household settings
Hazardous Products Regulations
- for hazardous biocides intended for use, handling or storage in workplaces and commercial settings
  - such as hospitals, institutions, industrial settings, food processing facilities, animal housing areas

Contact us if you wish to use different hazard classification approaches for your biocide than those published in Canadian regulations.

Safety information submitted for your biocide can be in the form of test data or comprehensive scientific rationales with literature search results, such as:

acute health effects information (tested acute endpoint toxicities) for humans and animals
- biocides intended for use in animal housing areas or where household pets may be exposed
physical and chemical hazard classification rationales
surface compatibility information
hazard information
- for example, endpoint toxicities, pH, acid reserve, exposure limits
rationales for safety labelling (risk information) differences for similar biocides

In some cases, a relevant toxicity data waiver may be acceptable in lieu of mammalian acute toxicity tests.
For guidance on waiving acute toxicity tests, consult:

Residues

Many biocide ingredients remain on surfaces after their contact time. These biocides can create a potential for chemicals to build up or stay on surfaces for long periods of time and may lead to:

chronic toxicities
antimicrobial resistance
the contamination of food and animal feed

A potable water rinse statement may be required on your biocide label. This statement would tell users to remove residual amounts of the biocide once the contact time has passed.

Use on food contact surfaces

Some biocides for use on surfaces or objects may come into direct contact with food or drinks and become unintentional residues in foods (such as incidental additives). These biocides include those for use:

in domestic or commercial settings
in areas where food or drink is manufactured, prepared or stored
on surfaces such as:
- eating and drinking utensils, cutting boards, and countertops
- piping of food or drink dispensers
- any other food processing equipment

Food processing aid uses

A biocide that may become an unintentional residue in foods is different from a product that's indicated for use directly on the surface of a food (for example, fruit and vegetable washes). While food processing aid uses (such as application to the surface of food) may be listed on biocide labels, they are not reviewed by NNHPD as part of the premarket assessments required for biocide market authorization.

Learn more about food processing aid uses.

Other uses with potential for residues

Residues are also a concern for biocides that are intended for use on surfaces or objects that come in contact with:

young children
animal feed or drinking water
skin for prolonged periods
- for example, for use on clothing or shoes

Residue analysis

If you do not wish to include a statement on the label to rinse with potable water after using the biocide, you should explain why in your application. To support your decision, you should include a scientific rationale based on its conditions and formulation (for example, referencing a maximum food tolerance limit or exemption).This could include:

an incidental additive "letter of no objection", if the Food and Nutrition Directorate had previously issued one for the biocide's formulation
information addressing the potential hazards from incidental contact with, which may include residue analysis safety studies:
- skin
- food
- drink
- animal feed
- young children
quantitative data (analytical or theoretical estimates) on the worst-case estimated dietary intake from use of the biocide
- for example, residual amount that may be transferred to food or drink

To help you determine if your biocide requires a potable water rinse statement, we recommend you consult the following resources:

US Code of Federal Regulation (21 CFR)
US FDA Food Contact Premarket Notification
US EPA's Safer Chemical Ingredients List
US EPA’s Inert Finder database
National Sanitation Foundation (NSF) International standards
European Union Regulations on Registration, Evaluation Authorization and Restriction of Chemicals (REACH) limits
other applicable certification bodies or standards setting organizations

Maximum in-use concentrations not requiring rinse in food premises

Table 1 gives the maximum in-use concentrations permitted in food premises without a potable water rinse statement for biocides containing 1 of the single active ingredient categories. These limits have been established by the Food and Nutrition Directorate.

A potable water rinse is not required as use of your biocide if the the concentrations are at or below the maximum in-use concentrations. A rinse statement is required for biocides that exceed these in-use concentrations, unless sufficient information has been included in the application to support its omission.

Table 1: Maximum in-use concentrations permitted without a potable water rinse statement
Chemical substance	Maximum in-use concentrations permitted without a potable water rinse
Chlorine releasing compounds (for example, hypochlorites)	200 ppm of available chlorine
Quaternary ammonium compounds	400 ppm of available active quaternary ammonium compounds
Iodophors	25 ppm, expressed as titratable iodine
Hydrogen peroxide, peracetic acid	1,100 ppm of hydrogen peroxide or peracetic acid
ppm: parts per million

Health effects

Exposure to biocides in both household and commercial settings is associated with health hazards to humans and animals. Your application should include acute toxicity information for all relevant exposure routes and should address any physical or chemical hazards. This information helps us assess potential health risks and determine strategies that need to be taken to reduce those risks.

You should conduct a comprehensive assessment to determine how much of your biocide humans or animals will be exposed to based on the most probable route or use multiple routes of exposure and associated effects. Safety information submitted for your biocide can be in the form of test data or comprehensive scientific rationales.

Acceptable test methods

In general, Health Canada recognizes biocide test methods and protocols published by international standards organizations or other regulators. You should use the current official version of the test method and you should follow all prescribed information outlined for the test method you use.

In general, we recognize safety test methods published by:

We recommend the following OECD short-term exposure endpoints test protocols:

Acute oral toxicity (LD50): 420, 423 or 425
Acute dermal toxicity (LD50): 402
Acute inhalation toxicity (LC50): 403
Acute dermal irritation and corrosion: 404
Acute eye irritation and corrosion: 405

You may also submit alternate studies, but you should explain why you used these alternate tests or data. For example, 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.

Chronic exposure potential

Whether your biocide is for use in a household or commercial setting, we may ask for additional information related to the biocide’s chronic exposure potential, to help us determine the benefits and risks associated with your biocide.

For example, a novel characteristic for a biocide could include innovative technologies that impact the establishment of the benefits and risks of the biocide due to an increase in the exposure profile to the user (such as extended residual claims).

Additional information may be required for your biocide so that the Minister has sufficient evidence to conclude that the benefits associated with the biocide outweigh the risks associated with it, taking into account any uncertainties relating to the benefits and risks. These include, for example, safety studies on:

genotoxicity
carcinogenicity
reproductive and developmental toxicity
metabolism (metabolic impacts) and pharmacokinetics

Contact us to discuss testing requirements for biocides with chronic exposure potentials or for biocides that have significant uncertainties relating to the benefits or risks associated with the biocides (especially for novel biocides). In exceptional circumstances we may impose terms and conditions on the market authorization to manage the uncertainties associated with the biocide.

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Date modified:: 2025-06-18

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