Guidance for post-authorization changes for biocides: Overview

Purpose

After you've obtained market authorization for a biocide, you must use post-authorization change pathways when you want to make a change to:

your biocide
the information provided to us in connection with the biocide

This guidance provides information on:

the available post-authorization change pathways
what you need to provide to us when making a change to your biocide
the categories of changes that determine the appropriate post-authorization change pathway

The changes listed in this guidance are not exhaustive.

Introduction

A market authorization for a biocide under the Biocides Regulations (the regulations) allows you to import, sell or advertise a biocide according to the parameters it outlines. You can request changes to:

your existing market authorization
the information provided to us in connection with the biocide

You can request these changes by filing through an appropriate post-authorization change pathway. We'll review your request and update the market authorization as applicable.

There are 5 categories of changes described in this guidance:

Changes that create a new biocide
Major changes
Minor changes: product information
Minor changes: company information
Non-notifiable changes

We screen each post-authorization application or notification to confirm:

what type of changes are being proposed
whether the changes would be appropriate for the pathway chosen

Changes to the information provided in the initial application to obtain a market authorization for a biocide can include:

additions
removals
revisions

Formulation variations

A market authorization that includes formulation variations means the variations have the same benefits and risks. Only similar formulations of a biocide can be included in 1 market authorization.

If you want to change a specific formulation variation, you must specify in your post-authorization change application or notification what is changing in that formulation. The change could be major or minor. For information on what types of changes are considered major or minor changes, refer to:

A change to the conditions of use must apply to the entire market authorization. However, when marketing a biocide, you can label it with a subset of uses, settings, directions for use and so on as outlined in the market authorization.

Guidance on labelling requirements for biocides

Cross-promotion and co-packaging

You may wish to add a cross-promotion on the label of your biocide or co-package related products (and this co-packaging is not a kit). The addition could be considered a major or a minor change, depending on the impact to the biocide's:

quality
risks
benefits
uncertainties

Cross-promotion or co-packaging with unrelated products is non-notifiable.

Learn more about cross promotion, co-packaging and what constitutes a related product or an unrelated product.

Changes that create a new biocide

In some cases, changes to a biocide are so significant that they create a new biocide. These require a new market authorization with a new identification number.

We don't allow changes to an existing market authorization that create a new biocide because they significantly affect the biocide's benefits and risks.

Changes that create a new biocide are changes to the:

active ingredients (including Chemical Abstracts Service registry number (CAS number), if applicable)
quantity of the active ingredients
physical form, including developing a kit through changes to the:
- packaging
- labelling
- brand name

Active ingredient

An active ingredient is directly responsible for a biocide's ability to achieve its intended effects. A change to an active ingredient may alter a biocide's benefits and risks.

An active ingredient's CAS number uniquely identifies the substance. When a change to the active ingredient is being proposed, the CAS number would also change. There are a few exceptions when an ingredient has multiple CAS numbers.

Changes to a CAS number for an active ingredient that would be considered changes that creates a new biocide

Active ingredient quantity

You cannot change the quantity of an active ingredient in a biocide without obtaining a new market authorization. However, a change to widen the upper or lower tolerance limits of an active ingredient in a biocide's specifications (potency tolerance limits) would be a minor change.

Table 1: Summary of scope of changes

Physical form

The physical form of the biocide is the form in which it is sold and used. Changes to how a biocide is applied to a surface (its method of application) are not considered changes that create a new biocide. An exception to this is if the physical form of the biocide has also changed (for example, from a solution to a towelette product).

Learn more:

Kits

You will need to apply for a new market authorization if you wish to both:

package your biocide with another product, for example:
- another biocide
- a cleaner
- a foaming agent
- a hand sanitizer
market the biocide and the other product as a single product with an overarching brand name or different labelling, for example:
- with a new claim
- as a result of changes to the properties of the biocide

This is because you would be making a change to the biocide's physical form.

When products are packaged and represented for use together, they are considered kits. They require a new market authorization that includes the active ingredients and physical form of all products packaged together.

You may have a kit that has already been authorized and want to add, remove or substitute 1 of the products in the kit with a new product. This type of change is also considered a change that creates a new biocide and requires a new market authorization.

Guidance on application pathways and general requirements for biocides

Major changes

A biocide's market authorization must be updated before importing, selling or advertising any version of the biocide affected by a major change. Major changes are changes to the information provided to us in connection with a biocide that are reasonably expected to have a major impact on the:

quality of the biocide
benefits or risks associated with the biocide or
uncertainties related to the benefits and risks

As such, you must provide scientific information to support a major change for our review through an application for a notice of acceptance. The options available to file your application for a major change depend on how the biocide was initially authorized and what is changing.

Filing pathways for major change applications

Minor changes to product information

A minor change does not require you to submit data to support the change. Minor changes are changes to the information you provided to us in connection with a biocide that are reasonably expected to have a minor impact on the:

quality of the biocide
benefits or risks associated with the biocide or
uncertainties related to the benefits and risks

You must submit a notification to us at least 30 days before making a minor change to your biocide if the change is within your control. If the change is not within your control, you must notify us as soon as feasible after you become aware of the change.

Multiple brand names under a market authorization

All brand names must be unique. If you wish to transfer a brand name to a new market authorization from an already authorized biocide, you first need to:

remove the brand name from the existing market authorization or
cancel the biocide's market authorization that has the brand name you wish to transfer

You can remove a brand name from a market authorization using the minor change pathway.

Minor changes to company information

Changes related to company information are minor changes. You must notify us of these changes as soon as feasible. These include a change to:

the name or contact information of:
- the authorization holder
- a person that manufactures the biocide
- a person that imports of the biocide
the location where the biocide is manufactured

You are not required to file changes relating to the packager and labeller information with us. However, you must maintain this information on file and provide it to us, if requested.

You should file changes to an importer name or contact information, including adding or removing an importer, as early as possible (even more than 30 days before making the change). This enables us to capture the updated importer information in the product database, which border agents can verify when a shipment comes into Canada. Before initiating your import, check the product database to verify that the importer information has been updated to facilitate importation.

As with other minor changes, we aim to process changes to an importer within 30 days.

How to notify us of changes to company information

Non-notifiable changes

There are also changes to a biocide that do not meet the definition of a major or minor change. These are non-notifiable changes.

Your biocide label may include information that is not required by the regulations. Changes to this information does not require a post-authorization application or notification to us, unless the change could affect the biocide's:

benefits
risks
related uncertainties

However, we request that you incorporate these changes (except non-notifiable changes specific to label text) into your next post-authorization (major or minor change) filing for the biocide.

If your biocide is a comparison biocide for other biocides authorized based on comparison to it, file all non-notifiable changes (except non-notifiable changes specific to label text) through a minor change application. This way we have the most up-to-date information available for when we review any subsequent new or post-authorization change applications for licensees.

Examples of non-notifiable changes include:

editorial changes to directions for storage
changes to non-therapeutic claims
new cross-promotion with unrelated products
shelf life or stability data, if major change criteria are not met
changes to the label that only impact design elements such as colour and font size
changes to the format of the lot/batch code or universal product code (UPC)
change to the product specifications that narrows the acceptable range of variation in potency of an active ingredient
no longer selling a version of the biocide (for example, a formulation variation or brand name, if it was authorized for more than 1)

Any therapeutic claim on a biocide label requires our authorization before you can sell the biocide. Non-therapeutic claims often include descriptions of the biocide as supported by evidence (for example, marketing claims that include descriptions of fragrance, texture or colour). Non-therapeutic claims must not:

directly or indirectly imply a health effect (therapeutic claim)
be false, misleading or deceptive
be likely to create an erroneous impression of the biocide's character, value, quantity, composition, merit or safety
imply a:
- drug use under the Food and Drugs Act
- device use under the Food and Drugs Act
- different classification of the product (for example, a use under the Pest Control Products Act)