Guidance on safety requirements for biocides: Biocides requiring additional information
On this page
Additional safety information
Some biocides may require additional safety information in their application for a market authorization to determine if the benefits outweigh the risks while considering any related uncertainties.
This includes novel biocides and non-novel biocides, such as those that:
- have a direction for use on some soft surfaces, such as:
- items that are laundered
- household carpets
- contain unusual ingredients or impurities that pose concerns
- use relatively new application methods that increase the uncertainties associated with their safety
Safety studies that may be requested for these biocides, on a case-by-case basis, include:
- genotoxicity
- carcinogenicity
- residue analysis
- reproductive and developmental toxicity
- sub-chronic and chronic toxicity
- metabolism (metabolic impacts) and pharmacokinetics
- post-market safety data, if available
- for example, foreign post-market safety data
Contact us to discuss the additional safety information you may need to support your biocide.
Food processing aid uses
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 biocide 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.
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. Examples of these surfaces or objects include eating and drinking utensils, cutting boards, countertops and food processing equipment.
For information you require to support the safety of the biocide for these uses, visit the section on residues.
Contact us to discuss the residue analysis you may need to conduct to support your biocide.
Novel biocides
We need to understand the safety profile of your novel biocide. Learn more about the application requirements for novel biocides.
The safety information that may be requested for a novel biocide depends on the specific characteristics of the biocide. Contact us to discuss the additional data you may need to support your novel biocide.
To help us determine if the benefits of your biocide outweigh the risks, while considering any associated uncertainties, you should provide information on testing for:
- acute oral toxicity
- dermal sensitization
- acute dermal toxicity
- primary eye irritation
- acute inhalation toxicity
- primary dermal irritation
For biocides that are confirmed to be novel through a biocide classification request, we strongly recommend that you request pre-submission consultation to:
- determine the unique requirements that may apply to establish the benefits and risks of your biocide
- understand how to satisfy specific safety, efficacy, labelling and quality requirements that would apply to your biocide
For more information on pre-submission meeting requests, consult: