Guidance on biocide application pathways and general requirements: One application for one market authorization

On this page

• Overview
• Formulation variations under one market authorization
• Kits
• Cross promotion and co-packaging

Overview

You can file 1 application to obtain 1 market authorization to sell a biocide under:

• 1 brand name with only 1 formulation
• multiple brand names (a primary brand name and alternate brand names) with only 1 formulation
• 1 brand name with formulation variations (a basic formulation and alternate formulations)
• multiple brand names (a primary brand name and alternate brand names) with formulation variations (a basic formulation and alternate formulations)
• 1 package containing multiple products (a kit)

Formulation variations under one market authorization

We will permit formulation variations under a single market authorization if the only elements that differ are:

• formulants
• brand names

Everything else must stay the same in your application, which includes the:

• shelf-life
• physical form
• label text
• product specifications
• market authorization holder name and contact information
• active ingredients (including Chemical Abstract Service (CAS) registry numbers) and their quantities

When marketing the biocide, you can design a label that only contains a subset of your label text to reflect its:

• authorized uses
• settings
• methods of application
• associated directions for use

However, the marketed label must include all required labelling elements as outlined in the market authorization. The risk information (safety labelling) for the biocide must also be the same on all marketed labels for the biocide.

Acceptable formulation variations include the replacement of a formulant by another:

• of the same class (such as the replacement of an ethoxylated alcohol by another)
• which serves the same purpose or function (such as the replacement of one surfactant by another)

If you want to file an application that includes alternate formulations, the application should meet all of these criteria:

• The alternate formulations should:
  • support all label claims
  • not change the biocide's pH
  • have the same safety profile and safety labelling as the basic formulation
• A scientific rationale is included to support the equivalence of the alternate formulations in terms of safety, efficacy and quality, such as:
  • the biocide's chemistry is substantially similar (demonstrating only minor differences in the physical and chemical characteristics)
  • reference to domestic or international scientific databases
  • toxicological information to demonstrate the formulations have the same hazard classification
• Confirmatory data is included to support the efficacy equivalence of the alternate formulations.

You don't need to provide a scientific rationale or confirmatory data in your application if your formulation variations are limited to differences from the basic formulation in fragrances or dyes that are less than or equal to 1.0% of the total formulation. All other aspects of the biocide formulation should be identical to qualify for this exemption.

If your application contains an alternate formulation that requires confirmatory data, use either the:

• full review - novel biocide pathway
• full review application pathway

We'll review the information in the application, including applicable scientific rationale and confirmatory data, to determine if the alternate formulations meet these criteria and are acceptable.

If they are acceptable, they can be included in 1 market authorization.

If they are not acceptable, you will need to:

• remove these alternate formulations from the application
• file a separate application for their own market authorization with a complete data package, as applicable, depending on the application pathway

Learn more:

• Guidance on labelling requirements for biocides
• Guidance on efficacy requirements for biocides

Use of foreign decisions applications

You may use this pathway to apply for a market authorization of a biocide with alternate formulations only if all of the formulants that the biocide contains are among the formulants contained under the authorization to sell the foreign biocide. For a given quantity of biocide, the quantity of each formulant that the biocide contains must also be the same as the quantity of that formulant the foreign biocide may contain under the authorization to sell the foreign biocide.

This means that the alternate formulations in your application must be the same as those authorized for the foreign biocide under the foreign authorization to sell. As with all applications, we will review the information submitted in the application to determine whether a market authorization must be issued. This includes evaluating if the benefits of the biocide outweigh the risks, taking into account associated uncertainties.

Applications based on comparison

You can include alternate formulations under these application pathways, but only if they have been approved for the comparison biocide. Note:

• Comparison - administrative application: all formulation variations authorized for the comparison biocide must be included in the application based on comparison
• Comparison - labelling only application: all or a subset of the formulation variations may be included in the application based on comparison, if desired

No other differences in formulation are allowed in these pathways because the biocide in the application based on comparison must be the same as the comparison biocide. An example of one of these differences could include a new alternate formulation not authorized for the comparison biocide.

Monograph applications

For monograph applications, you can include multiple brand names and variations for differences in fragrances or dyes that do not exceed 1.0% of the total formulation under this application pathway. No other differences in formulation are allowed in this pathway because any other variation requires review of a scientific rationale and confirmatory data. All other aspects of the biocide formulation must be identical other than these variations in fragrance or dye.

Kits

A "kit" is when you package a biocide together with another product to create a combined benefit (for instance, overarching claims or brand name). This includes 2-step biocides. A biocide when sold with an adjuvant or other product (for instance, a cleaner or hand sanitizer) may also be a kit if, when the products are packaged and sold together, there are new:

• claims made
• directions for use

A new market authorization is required if any of the following apply to co-packaged products:

• There is a new overarching brand name.
• There are changes to the labelling beyond what is approved for each product when sold separately.

A new market authorization is not required if all of the following apply:

• Each product is compliant with its respective regulatory framework and has its own market authorization (if required).
• The products are contained in 1 package for the purpose of consumer convenience.
• The packaging is marked as containing 2 or more products, or simply consists of a transparent outer wrap.
• It is obvious to the consumer and user from the packaging that the products are for different intended uses or purposes.
• There is no brand name associated with the products packaged together.
• There is no change to the labelling associated with the products packaged together beyond what is provided for each product separately.

Products packaged together must be appropriate to be used together and there must not be any contraindications for the use of the products together. For example, a cleaner and a biocide packaged together must be compatible and not react to produce dangerous gasses if they accidentally come in contact with each other.

If you are intending on packaging a biocide together with another biocide or other product, you should contact us before submitting an application. We will help you verify whether the product is a kit.

Cross promotion and co-packaging

Cross promotion is when the label of a biocide recommends the use of another product. Co-packaging is when 2 different products are included in the same packaging.

Each product that is cross promoted together or within a co-package must comply with their respective regulatory requirements, including labelling. The cross promotion or co-packaging of certain products may:

• require a new authorization (for example, a kit)
• pose a safety concern (for example, a cleaner and biocide that would create a toxic gas when mixed)

For this reason, your application for a market authorization or through a post-authorization change, as applicable, needs to disclose if your biocide will:

• include cross promotion on its label
• be co-packaged with another related product

This would make up part of the information in the application regarding:

• the benefits and risks associated with the biocide
• any uncertainties relating to those benefits and risks

We will then review the cross promotion or co-packaging as part of the assessment of benefits and risks.

Examples of products that may be cross promoted or co-packaged with a biocide include:

• an activator or an adjuvant
• a medical device (for example, medical face mask)
• another biocide with its own identification number
• a non-drug product (for example, cloth, spray bottle or cleaner)
• a drug product (for example, non-prescription drug or natural health product)

You could cross promote or co-package your biocide for use with either related or unrelated products.

Related products could:

• have potential implications on the safety, efficacy or quality of the biocide
• include products that are meant to be used together or one after another regardless of if they are the same type of product

Products do not need to share part of a brand name or common identifier to be considered related. Cross promotion or co-packaging with related products could include products meant to be used:

• one after another, such as a cleaner followed by a biocide
• separately or instead of, such as product substitutions
• at the same time as one another, such as:
  • personal protective equipment and a biocide
  • a biocide with an adjuvant or activator

Unrelated products:

• have no connection between one another, such as in terms of:
  • use or purpose
  • method of application
  • directions for use
  • a general statement which does not identify a specific product, such as "try out other brand X products"
• do not have any effect (safety, efficacy, or quality) on the biocide

An unrelated product is not intended to be used at the same time as, immediately before, after or instead of the biocide.

These other products must be in compliance with all applicable acts or regulations.