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Guidance on labelling requirements for biocides: Inner and outer labels

This section outlines the information that must be shown on the inner and outer labels of biocides as set out in the Biocides Regulations (regulations).

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Introduction

If there's no outer label, the information that's required on the outer label must be on the inner label.

Unless included on the PDP of your biocide's label, other parts of the inner and outer label must include:

You must also include information about the manufacture and formulation of your biocide on the inner and outer label:

Additional intended uses or purposes (claims)

Biocide labels must indicate their intended uses or purposes (claims). In addition to indicating at least 1 of the uses or purposes and settings on the PDP of your biocide label, other claims may be included elsewhere on the label.

Claims may be specific. In other words, they may refer to efficacy against (for example, "kills" or "effective against") 1 or more microorganisms:

For specific claims, you should use the current nomenclature for the microorganism on your biocide label.

Claims may also be non-specific. In other words, they do not refer to a specific microorganism. Examples of non-specific claims:

For more examples and the evidence requirements to make specific and non-specific claims, consult:

Some claims call for specific label statements. For more information, refer to the section on label statements for claims against certain microorganisms.

Directions for use

You must include adequate directions for all intended uses or purposes of your biocide on the label. This helps ensure the safety and efficacy of the biocide when used in accordance with the label directions. It is your responsibility to ensure the directions for use reflect the efficacy testing provided in the submission to support the claims, as applicable.

For more information, consult:

Your biocide label must include directions on how to apply the product, such as:

Some directions for use that should be included on a biocide label only apply to certain products, depending on their physical form, packaging, uses or purposes, settings and efficacy testing. These include:

You should present the directions for use on the label in a logical way and in an appropriate sequence. For example:

Method of application

A biocide's safety and efficacy may change based on how it is applied to the intended surface. Biocide labels must include appropriate methods of application within the directions for use. Some examples of methods of application are:

The method of application must be appropriate for both the surface and the properties of your biocide, including its:

Surfaces to which the biocide may be applied

The nature of the surface to which your biocide is applied may affect its efficacy. For example, a surface can be:

A surface can also be:

The appropriate application surfaces for the biocide (supported by efficacy testing) must be included within the directions for use on your biocide label.

Examples of soft surfaces:

Examples of non-porous hard surfaces:

Examples of porous hard surfaces:

You may further specify examples of the intended surfaces or objects (for example, floors, walls, countertops).

Application rate

The application rate of a biocide is the quantity of product that the user must apply to the intended surface. There may be more than 1 application rate for a biocide (if supported by efficacy testing).

Depending on the biocide's physical form and format, the application rate may be:

Biocides with fast evaporation rates should include instructions for re-application. The application rate differs from the dilution instructions as it refers to how to directly apply the biocide. Dilution instructions describe the steps necessary before the biocide is used.

Contact time

The directions for use must specify that a target surface is to be exposed to the biocide for the duration of the contact time. The contact times specified on the label should correspond with those used for efficacy testing.

For example:

Your biocide label may indicate multiple contact times (if supported by efficacy testing). If this is the case, the labelling must clearly indicate which contact times are to be used for which intended applications and target microorganisms.

Alternatively, you may include 1 contact time. However, your label must indicate the longest contact time for the stated microorganisms in the directions for use.

For example, efficacy against most viruses on the label generally require a 2-minute contact time. Efficacy against Norovirus requires a 5-minute contact time. In this case, the label should indicate 5 minutes rather than 2 minutes, to ensure that the longest contact time is met.

Pre-clean statement (if applicable)

Where pre-cleaning is not required as indicated on the label, testing must show the biocide is effective in low to moderate amounts of soil (a 5% organic soil load or alternate soil load as described by the method).

For example:

The directions for use for all other biocides should specify the need to pre-clean surfaces before disinfection or sanitization.

The directions for use for all biocides should also specify that heavy amounts of soil present on a target surface should be removed through a pre-cleaning step before disinfection or sanitization. This applies even to biocides represented for use as 1-step products.

For example:

Rinse and contamination statements (if applicable)

The labels of biocides for use in food premises or animal housing areas should include certain statements to ensure food, water, animals and young children are not exposed to or contaminated by the product.

Where appropriate, directions for use should include instructions for removing residual amounts of the biocide at the end of the required contact time. This includes surfaces or objects that may come into direct contact with:

You may provide rationales or safety data for omitting associated rinse statements related to residues in your application for a biocide market authorization. We will consider these in our review of the biocide.

For more information on residues, consult:

Food processing and preparation areas

Biocides represented for use on surfaces or objects that may come into direct contact with food or beverages (counters, eating and drinking utensils, and food processing equipment) should include a label statement to help prevent contamination.

For example:

These biocide labels should also indicate whether a rinse with potable water is recommended at the end of the contact time to remove potential residues from treated surfaces or objects.

For example:

A potable water rinse is not required if the biocide is used at or below the maximum in-use concentrations in Table 1 of the Guidance on Safety Requirements for Biocides. For biocides that exceed these in-use concentrations, an appropriate rinse statement should be indicated on the labelling. To support not having a rinse statement, applicants may submit information for evaluation as part of their application for market authorization.

Animal housing areas

The labels of biocides represented for use on surfaces or objects (such as floors, walls, cages and animal equipment) in animal housing areas (such as farms, poultry plants, veterinary clinics, kennels) should have appropriate directions for use. These are required to avoid contaminating feed and water, as well as exposure to animals.

Examples of statements:

For biocides recommended for use on surfaces or objects that will come into direct contact with animal feed or drinking water (troughs, automatic feeders, fountains, waterers), labels should indicate that at the end of the contact time, a rinse with potable water is recommended. This rinse is recommended to remove potential residues from the treated surfaces or objects.

Example of statement:

There could be a safety issue if the biocide or any remaining residues from its use were to come into direct contact with or be ingested by any animals in animal housing areas. If you wish to omit these statements, you should contact the Veterinary Drugs Directorate to ask for an evaluation of your biocide.

Email: hc.vdd.vetdrugs-medsvet.dmv.sc@canada.ca

Surfaces or objects in contact with young children

For biocides represented for use on surfaces or objects that young children may come into contact with (such as toys in daycare centres, schools, hospitals and household settings), you should recommend a rinse with potable water after the contact time to remove potential residues.

Examples of statements:

Or, you may submit a scientific rationale and/or safety data to address the presence and insignificance of potential residues on disinfected or sanitized surfaces or objects.

Restrictive use statements (if applicable)

For biocides recommended for use in hospital or health care settings on medical devices that are not invasive or indirectly invasive (such as stethoscopes, hospital beds and wheelchairs), you should specify the surface(s) that they should not be used on.

Examples of statements:

Dilution instructions (if applicable)

If a user needs to dilute a biocide into another container before use, the label must have clear directions specifying how to do this. The dilution directions must correspond with those used for efficacy testing and should use metric units of measurement or ratios.

For example:

When the type and temperature of diluent are not specified in the directions for use, the use of 18oC to 25oC tap water (room temperature) may be assumed.

The label must also specify the amount of time that a diluted solution may be stored or used without becoming less effective. The label must indicate that the diluted solution is effective for a defined number of days after preparation.

Biocides that are intended to be diluted and stored for an extended period of time in a secondary container should have confirmatory efficacy data or a scientific rationale (for example, chemical assay report) included in the application to support the claim. The information (data and/or rationale) should address whether the biocide's stability changes once diluted and stored.

Otherwise, you should include 1 of the following statements on the label:

If the user may store the diluted biocide in a secondary container following first use, the secondary container should be marked with information on what it contains. This will help avoid inadvertent contamination or notable or serious incidents associated with the biocide. To ensure this, you should include a statement on your biocide label such as:

If your biocide has multiple dilution instructions, you should clearly indicate which dilution the user should use for each intended applications and/or target microorganisms.

Application temperature (if applicable)

For biocides that have been tested and found to be effective at temperatures other than 18oC to 25oC (such as those for use in heated immersion baths), the directions for use must specify that heating or cooling to the specified temperature is required before disinfection or sanitization.

Re-use applications (if applicable)

For biocides that are intended for re-use applications (such as those intended for immersion applications), the directions for use indicate the duration of time that they may be re-used without a decrease in efficacy.

For biocides that are represented as being effective for an extended period of time for re-use applications (label indicates the solution remains effective for a defined number of days and can be re-used), the application must contain efficacy data or a scientific rationale to support the claim. Otherwise, include a statement on the label such as:

Risk information

Risk information must be indicated on your biocide label. It should:

The risk information must reflect the highest level of risk associated with your biocide when used according to its label directions. For example, if the biocide is labelled for use in commercial settings, the risk information must be appropriate for use in that setting (because of occupational exposure). This applies to a biocide that's also labelled for use in household settings.

You may choose to market the biocide for use in 1 or fewer of the approved settings (for example, household use only). In this case, the marketed label must still reflect the risk information required by the market authorization.

To help you determine appropriate risk information for biocides, refer to the hazard classification criteria and precautions section.

Signal words, precautionary and prevention statements

To ensure the biocide is used safely and according to the label directions, you should include appropriate signal words and hazard, precautionary and prevention statements on the label. These statements should be relevant to the:

First aid statements

You should indicate first aid statements on your biocide label. They should be appropriate for the potential acute and chronic toxicity hazards of the biocide, such as potential hazards associated with the following routes of exposure:

We also recommend that you include the following statement on the label:

Designated containers

To ensure the safe use and storage of biocides, biocides packaged in designated containers require additional safety statements on their label, as set out in the regulations.

Learn more:

Biocides packaged in designated containers must also include on 1 panel of its inner label (and outer label, if there is one) the following statements in English and French:

Biocides packaged in designated containers that have a flame projection or flashback must also include on 1 panel of its inner label (and outer label, if there is one) the following statements in English and French:

These statements help ensure the benefits of the biocide outweigh its risks.

Directions for storage

You must include on the label directions for storage appropriate to the level of hazard and packaging of your biocide. These directions should address the factors that might alter the product's shelf life, such as extreme temperatures, excessive moisture, heat or humidity, or sunlight.

Directions for storage should be relevant to the biocide's:

Examples of storage instructions:

Unless your biocide is intended to be diluted and be stored in a secondary container, you should include a statement informing purchasers and users not to store the biocide in another container. Doing so could result in the biocide being accidentally mixed with other chemicals (which can cause dangerous chemical reactions). This could also lead to the biocide being used improperly or affect the shelf life of the biocide.

If the biocide is not meant to be diluted in a secondary container, you should include a statement on the label.

Examples of statements:

Active ingredients and quantities

The identity and quantity (percent nominal concentration) of each active ingredient, expressed as a percentage on a weight-per-weight basis (% w/w), must be indicated on your biocide label.

This labelling requirement permits the user to calculate the concentration of the active ingredient(s), expressed as parts per million (ppm), in the biocide when used according to the label directions.

For biocides marketed as single-use, pre-saturated or impregnated towelettes, the percent nominal concentration of each active ingredient is the amount of the active ingredient present in the liquid that can be expressed from the towelette.

Lot number

The lot number must appear on your biocide label. It makes it possible to trace and identify a production batch through its manufacture and distribution.

The lot number may be any combination of letters, figures or both. It should be preceded by a designation to distinguish it from the expiry date and identification number.

Examples include:

You may stamp the lot number onto the immediate container or packaging, if desired. Indicate you have done this on the label text or in a note to the reviewer submitted in the application.

Expiry date

The expiry date indicates the shelf life of the biocide (the period that it retains its labelled potency, purity and physical characteristics) when stored according to the labelled directions. The market authorization holder recommends that the biocide not be used after this date.

You must indicate the expiry date on the label, unless your biocide:

The expiry date should be preceded by a designation such as "EXP" to distinguish it from the lot and identification numbers. It should be expressed in full or in a way that the general public or user will understand.

Examples of appropriate formats:

Note: The last 3 examples are for when only the last day of the corresponding month is used.

You may use dashes (-), slashes (/) or spaces to separate information within the expiry date.

It's not acceptable to indicate the date of manufacture on the label and a statement that the biocide should be used within so many months of manufacture. An exact expiry date (at minimum, the month and year) must be given on the label.

You may also stamp the expiry date on the immediate container or packaging. Indicate you have done this on the label text or in a note to the reviewer submitted in the application.

Name of authorization holder and contact information

You must provide the name and contact information of the market authorization holder of a biocide on the label in case someone experiences any problems with the biocide or has a question or concern. The contact information must provide a contact method that is without cost for persons in Canada, such as a toll-free number, a website or an email address.

Examples:

Physical form of the biocide

Unless it's obvious, the physical form of the biocide must be stated on the label.

This is the form in which the biocide is sold. For example, the physical form of a powder biocide that requires the user to dissolve it in water before using would be "powder for solution."

Other examples:

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