Guidance on safety requirements for biocides: Safety data

On this page

• About safety information
• Residues
• Health effects

About safety information

You must provide us with relevant safety information so the Minister can determine your biocide's safety.

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

• acute health effects information (tested acute end point toxicities) for humans and animals
  • biocides intended for use in animal housing areas or where household pets may be exposed
• physical and chemical hazards
• surface compatibility information
• hazard information
  • for example, end-point toxicities, pH, acid reserve, exposure limits
• rationales for safety labelling (risk information) differences for similar biocides
• chronic health effects for biocides with non-volatile ingredients or use on food contact surfaces (when applicable)
• toxicity testing waivers (when applicable)

In some cases, an appropriate scientific rationale or a relevant toxicity data waiver may be acceptable in lieu of mammalian acute toxicity tests.

For guidance on waiving acute toxicity tests, consult:

• PMRA's Guidance for waiving or bridging of mammalian acute toxicity tests for pesticides
• US EPA's Bridging or waiving data requirements
• US EPA's Guidance for waiving or bridging of mammalian acute toxicity tests for pesticides and pesticide products

If you're not sure if you should use a data waiver, you may email us to ask for clarification at nnhpd-dpsnso@hc-sc.gc.ca before filing your application.

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.

Some biocides may become unintentional residues in foods. These biocides include those for use:

• in domestic or commercial settings
• in areas where food or drink is manufactured, prepared or stored
• on surfaces that may come into direct contact with food or drink, such as:
  • counters or cutlery
  • piping of food or drink dispensers
  • any other food processing equipment

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.

Learn more about substances for use directly on the surface of food.

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

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. To support your decision, include:

• an incidental additive "letter of no objection", if the Food Directorate had previously issued one for the biocide's formulation
• a scientific rationale based on its conditions of use and formulation
• information (if applicable) addressing the potential hazards (identified using safety studies) from incidental contact with:
  • 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

Learn more about safety studies.

To help you determine if your biocide requires a potable water rinse statement, consult:

• US Code of Federal Regulation
• Canada's Domestic Substances List
• Food Contact Premarket Notification
• US EPA's Safer Chemical Ingredients List
• National Sanitation Foundation International
• European Union Regulations on Registration, Evaluation Authorization and Restriction of Chemicals

Table 1 gives the maximum in-use concentrations permitted without a potable water rinse statement for biocides containing 1 of the single active ingredient categories.

A potable water rinse statement is not required if the biocide's use is 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.

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 testing for all relevant exposure routes. These tests help us assess potential health risks and determine strategies that need to be taken to reduce those risks.

You may 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.

Consult the Organisation for Economic Co-operation and Development's 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 (including in vitro methods), but you should explain why you used these alternate tests or data.

Whether your biocide is for use in a household or commercial setting, we may ask for additional information, to help us determine the benefits and risks associated with your biocide. Additional information may include, for example, safety studies on:

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