Guidance on labelling requirements for biocides: General labelling considerations

Biocide labels must include information that indicates the potential risks associated with its use and storage, and relevant information to mitigate these risks. This section will help you develop labelling with adequate directions for use and risk information.

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Use of foreign decisions application pathway

The Canadian label text included in an application for a biocide market authorization filed through the use of foreign decisions application pathway (UFD) must:

When preparing the Canadian label text, you should remove claims from the foreign biocide label text (and associated directions for use) that do not fall under the purview of the Biocides Regulations (regulations). This includes non-therapeutic claims. This should be done before filing an application to Health Canada and should be reflected in the label text submitted with the application.

Find information on the applicable regulatory frameworks for other chemical products such as pest control products in the scope and application section of the Guidance on biocides.

Under the regulations, your biocide must have the same conditions of use as the foreign biocide. Thus, the risk information and directions for use (as applicable to the foreign authorized biocide claims) must be identical to the foreign biocide label.

Editorial changes between the foreign biocide label text and Canadian label text may be acceptable and allow you to capture minor variations in the way you present the same information on labels. However, you must not change the meaning or interpretation of a given statement.

Biocides packaged in designated containers must follow the associated requirements set out in the regulations. For more information on the requirements, also consult:

Changing or removing any risk information that's on the foreign biocide label from the Canadian label must be done post-authorization. Appropriate supporting safety information may be required if the change is major.

For a biocide, conditions of use means:

Private brand labelling

A private label is the label of an authorized biocide that is sold under the trade dress of a retail store that is not the market authorization holder. Private labelling is acceptable for biocides as long as all aspects of the label for the private brand are identical to the initial biocide, with the exception of label design elements (trade dress). For example, the brand name, market authorization holder name, conditions of use and identification number must be identical to the initial biocide's label.

Private labelling is different from an application for a market authorization based on a comparison product (through a licensing agreement). This is because the private brands would be marketed under the same brand name, market authorization and identification number as the initial biocide.

For more information on licensing agreements, consult:

The biocide that is private labelled must also be identical in formulation and packaging as the initial biocide, with the same specifications.

For private labels, the contact listed on the label must be the market authorization holder contact, as the market authorization holder remains responsible for the biocide.

Introducing additional private brands to the market after market authorization is considered a non-notifiable change.

For more information, consult:

Marketed label

When marketing your biocide, you can design a marketed label that only contains a subset of its approved uses, settings or methods of application and associated directions for use, under a given authorized label text.

For example, if your:

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

You may label a biocide with fewer uses, settings or methods of application and associated directions for use than approved on the market authorization if no changes from what was authorized for the biocide would be necessary to the:

Non-therapeutic (marketing) claims

Non-therapeutic (marketing) claims indicated on marketed labels and in advertising must not be false, misleading or likely to create an erroneous impression of the biocide. The claims must be appropriate for the biocide's intended uses or purposes and the biocide should perform as marketed.

Non-therapeutic claims are those that do not imply a:

Non-therapeutic claims should not be included on the label text that is submitted to us in the application for a biocide market authorization.

It's the responsibility of the applicant/market authorization holder to make sure that non-therapeutic claims do not imply any therapeutic use.

For more information, consult:

Advertising preclearance agencies are also available to review advertising for biocides to confirm that therapeutic claims and their depiction of use align with a biocide's market authorization. We do not evaluate the accuracy of non-therapeutic claims for biocides unless they are expected to pose health and safety risks, even if these types of claims are on the label text submitted in the application.

Common types of non-therapeutic claims include:

The following examples of non-therapeutic statements may be misleading and inappropriate for biocides:

Claims that a biocide is low-risk, safe, non-toxic or harmless (or similar) can be misleading without significant context. A claim that a particular biocide poses a reduced risk may create a wrong impression about its risks or the risks posed by other biocides. All biocides must have benefits that outweigh their risks.

Claims such as "natural" and "naturally derived" are unclear about what ingredients are natural. They can mislead consumers about the biocide's composition, safety or value.

All claims, including non-therapeutic claims, about biocides must be substantiated by reliable evidence.

For more information on the broad principles related marketing practices in Canada and on "green" claims:

Decontamination procedures

The steps to take to contain, clean up and dispose of a spill do not have to be included on the label text submitted to us in an application for a biocide market authorization. They should be included on your biocide marketed label, as applicable. These steps are required to help prevent a spill from impacting the environment or posing a risk to humans or animals.

The instructions should be appropriate for the chemical and physical properties of your biocide and be consistent with the directions for disposal.

Decontamination procedures must comply with any other applicable act or regulations.

Directions for disposal

Directions for disposal do not have to be included on the label text submitted to us in an application for a biocide market authorization. However, the market authorization holder is responsible for determining any appropriate directions for disposal that should be included on the marketed label. These directions should tell the purchaser or user how to dispose of the biocide's container or packaging and any unused biocide appropriately.

All disposal statements on your biocide's marketed label must:

For information on how to manage the lifecycle of your biocide, contact the municipal, provincial or territorial organization responsible for product stewardship.

One or more of the following statements may be appropriate, depending on the intended uses and settings of the biocide and its container type:

Disclosing formulants

Though recommended, there is no regulatory requirement for market authorization holders to list formulants on their biocide label. Formulants included on the label should be listed in alphabetical order or descending order of quantity.

You should disclose any potential allergens in the biocide on the label.

You should include the statement "Contains the allergen (insert name of allergen)" on labels of biocides containing formulants that are common allergenic substances known to cause anaphylactic-type reactions. This statement should be placed close to and on the same label panel as all other risk information associated with the biocide.

When the allergenic formulant is a derivative, the name of the allergen source may be included. For example, for soya lecithin, it would be sufficient to indicate "contains the allergen soy" on the biocide label.

If the derivative's name does not indicate the allergen source and you wish to disclose the derivative, you should indicate the allergen source in brackets after the name of the derivative.

For example:

Adding activator or adjuvant

For biocides that are intended to have an activator added before use, the label should specify the:

Biocides that should be activated and stored for an extended period of time should have efficacy data or a scientific rationale approved to support the claim.

Otherwise, the labelling should clearly specify that the biocide is to be activated immediately before being used.

Your biocide label should not indicate the use of an adjuvant unless:

Your biocide may be packaged with an optional adjuvant if:

Hazard classification criteria and precautions

The Food and Drugs Act and the regulations do not generally specify hazard classification criteria or precautionary statements for biocides. The 1 exception concerns the regulatory requirements for labelling designated containers, outlined in aspects of safety labelling.

For guidance on hazard classification criteria and precautionary and hazard statements that may be appropriate for biocides, consult:

Consider the level of risk when determining your biocide's hazard classification and precautionary statements. For example, if a biocide is labelled for use in commercial settings, the hazard and precautionary statements on the label should be appropriate for a commercial setting (because of occupational exposure).

Signal words and primary hazard statements

Biocide labels should contain on their principal display panel (PDP):

The words and statements should be appropriate for the potential acute and chronic toxicity hazards of the biocide.

Hazards to humans and domestic animals

Specific hazard statements should be on biocide labels. They should be appropriate for the biocide's potential acute and chronic toxicity hazards it poses to humans and domestic animals.

Examples of statements:

Personal protective equipment

Personal protective equipment statements should be indicated on biocide labels to ensure the biocide is used safely in accordance with the label directions. The type of personal protective equipment specified should be appropriate to the potential hazard to a user and include:

Physical and chemical hazard statements

Physical and chemical hazard statements should be indicated on the biocide label and be appropriate to a biocide's potential physical and chemical hazards. Examples of such hazards are flammability, explodability, chemical reactivity and chemical incompatibility. A hazard statement should also be included on the label of biocides with known chemical incompatibilities (for example, sodium hypochlorite forms toxic chlorine gas when mixed with acids or ammonia compounds).

Signal words (Danger, Caution) and primary hazard statements (Flammable, Explosive) should also be indicated. They should be appropriate to a biocide's potential physical and chemical hazards.

The label should also include information on any known surface compatibility concerns (for example, the potential for sodium hypochlorite to cause damage to aluminum surfaces).

Label statements for claims against certain microorganisms

Due to safety and efficacy concerns, we recommend or permit (as applicable) specific label statements when a label includes claims against certain microorganisms, such as:

Claims against blood-borne viral pathogens

Biocides labelled with efficacy claims against blood-borne viral pathogens (for example, human immunodeficiency virus, hepatitis B virus, hepatitis C virus) need additional specific directions for use on the label. These include:

Claims against spores of Clostridioides difficile (formerly Clostridium difficile)

Labelling a biocide with the following claims is not appropriate:

Only specific claims for a biocide that has been demonstrated to be effective against specific bacterial spores should be indicated on the biocide label.

For example:

You should use the current nomenclature for this bacterial spore on your biocide label.

Biocides labelled with efficacy claims against the spore form of Clostridioides difficile should indicate specific directions for use. These include:

Claims against Candida auris

Biocides labelled with efficacy claims against C. auris need additional specific directions for use on the label. These include:

Claims against emerging viral pathogens

You can immediately use qualifying language such as "expected to be effective" and "likely to be effective" about the expected efficacy of certain market authorized biocides when the:

This includes communications through their websites, toll-free consumer information services and similar media.

You may make indirect efficacy claims against emerging enveloped or large non-enveloped viral pathogens if the biocide you received a market authorization for is:

You may add claims against enveloped and large non-enveloped emerging viral pathogens to authorized biocide labels, provided the biocide qualifies for the claims. This can be done through the major change pathway.

For more information, consult:

Claims against emerging small non-enveloped viral pathogens may require additional efficacy data, given they are harder to inactivate than enveloped or large non-enveloped viruses. Contact us before you add claims against emerging small non-enveloped viral pathogens to authorized biocide labels.

Email: nnhpd-dpsnso@hc-sc.gc.ca

For more information on our approach for emerging viral pathogens, visit the Surface disinfectants for emerging viral pathogens web page.

Claims against prions

You should refer to the United States Environmental Protection Agency's 810.2700 product performance test guideline for labelling considerations for prion-related biocides.

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