Guidance on labelling requirements for biocides: Overview

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• Purpose
• General labelling requirements
• Contact us

Purpose

You are required to provide label text for your biocide so that the Minister of Health (the Minister) can determine if the biocide's benefits outweigh its risks taking into account any uncertainties relating to those benefits and risks. This requirement is set out in both the Food and Drugs Act (act) and Biocides Regulations (regulations).

This guidance gives information on the labelling requirements and recommendations for a biocide to help applicants and market authorization holders comply with the act and regulations. Using this guidance may reduce the number of times we need to clarify an item in an application. It will also help us make a decision on your biocide more quickly.

This guidance:

• describes the information you must include on your label and how to organize it
• identifies best practices for labelling to ensure that purchasers and users can appropriately identify, select, use and store the biocide

If the Minister does not have sufficient information to conclude that the benefits outweigh the risks of your biocide, taking into consideration any related uncertainties, we will either:

• request additional information to support your biocide or
• refuse to issue a market authorization for your biocide

Examples of situations where we may request additional information or revised label text for your biocide include:

• when we are aware of an efficacy or safety concern related to the biocide
• when the intended use or purpose (claim) on the label text is inconsistent with the efficacy data submitted for your biocide
  • for example, your biocide is labelled as a fungicide but lacks supporting efficacy data against the representative fungus
• when the proposed risk information on the label text is inconsistent with the hazard profile of your biocide
  • for example, your biocide is labelled as an irritant when it's known to be corrosive
• when you have used different hazard classification approaches than those published in Canadian regulations
• if you have submitted the minimum application requirements, but there is insufficient information in your application for the Minister to make a decision
• when information in your efficacy or safety summary shows there is a specific concern that should be addressed within your biocide label

For guidance on navigating the biocide application process, consult:

• Guidance on management of biocide applications

The guidance on management of biocide applications outlines the mechanisms that we can use to request additional information or revised label text from you during our assessment of your biocide application.

You should contact us if you wish to deviate from the approaches in this guidance.

General labelling requirements

Your biocide must have an inner label. This is the label that's on or attached to the immediate container of your biocide. If the immediate container of your biocide is packaged in additional packaging, then it must also have an outer label.

An outer label is not required if the inner label is clearly visible through the packaging (for example, clear cellophane). An outer label is required if the packaging or the way multiple products are packaged together obscures the biocide label in any way.

Your labels must be:

• bilingual (English and French)
• clear and accessible
• accurate (not false or misleading)

Bilingual labelling

Any information that is required by the regulations must be displayed on your biocide label in both English and French. Your label text and marketed labels must also comply with the Food and Drugs Act, as well as provincial, territorial, municipal and other applicable legislation.

When possible, you should organize the information on your biocide label by language for better readability. You may alternate separate blocks of English and French text or combine them in 1 section. For example, you may use a single bilingual principal display panel (PDP) or, when space permits, 2 unilingual PDPs (1 English and 1 French).

You may group text in English and separately group text in French (refer to example 1). Or, you may alternate English and French under 1 subheading (refer to example 2).

Example 1:

The market authorization holder is responsible for ensuring the translation on the marketed labels is accurate and reflects the market authorization.

Label legibility and format

Mock-up labels are not required in an application for a biocide market authorization. However, in the application you must provide draft text of every label that will be used in connection with your biocide. This includes leaflets, package inserts or other types of supplementary information on using the biocide that would be provided to users on request. The exception is marketing or other information not required by the regulations.

When designing a biocide's marketed label, all information required by the regulations must be clearly and prominently displayed.

A purchaser or user who isn't able to read and understand the label could choose, use or store a biocide improperly. A biocide that's not used correctly could lead to increased notable or serious incidents, failure in effectiveness or cause other concerns.

How the information is arranged on the label, including how text and graphics are displayed, must not make it hard for purchasers or users to understand the information.

Find design and format guidelines to help you:

• Guidance on labelling requirements for non-prescription drugs

Consider the following best practices when developing your biocide label:

• font style: a non-decorative, sans-serif font
• font size: a minimum 6-point font size
• font weight: boldface font for only headings and subheadings
• print colour: black text on a white background (for adequate contrast between the text and background)

Also consider the following:

• container size and label design when developing your product
• size and orientation of key information on small containers to enhance readability
  • for example, the orientation of text should be the same as the field of view and not be limited by the container itself (such as curvature)
• using a larger container, larger labels or innovative package and label designs when space is limited
  • such as tag, fold-out or peel-back labels

Leaflets, package inserts or other types of documents with additional information on using your biocide that are given to users on request are not an acceptable replacement for adequate inner and outer labels.

The marketed label should be designed to accommodate all required label information. Stating there's not enough space is not an acceptable reason to exclude information that helps ensure the safe and effective selection, use and storage of your biocide.

Follow these guidelines:

• innovative package and label designs when space is limited
• small package labelling guidelines if your container isn't large enough to accommodate an inner label that conforms to the regulations

Purchasers and users should be able to easily read and understand the information on the label. The information should:

• be direct
• avoid technical language, when possible
• be written at a grade 6 to grade 8 reading level
• be written in short sentences or bullet form wherever possible

False and misleading labelling

The label of your biocide must not be misleading to the public. Section 9 (1) of the Food and Drugs Act states:

"No person shall label, package, treat, process, sell or advertise any drug in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety."

Biocides may contain chemical compounds that can be harmful if used inappropriately. The safe and effective use of a biocide depends on adequate and appropriate labelling. Examples of misleading labelling that may cause a health risk include a failure to:

• kill a pathogenic microbe for a biocide that claims it can do so on its marketed label, but is not authorized to make this claim
• communicate relevant safety information for those using it in a commercial setting when the biocide is only authorized for use in a household setting

Health Canada reviews the information provided in an application for a market authorization as it relates to the labelled conditions of use. Only information consistent with the market authorization may be included on your biocide's marketed label.

Before you update your labels or the contents of your market authorization, you should consult the following guidance document:

• Guidance for post-authorization changes for biocides

Contact us

Contact the Natural and Non-prescription Health Products Directorate to:

• request pre-submission advice or set up a pre-submission meeting
• discuss alternative labelling approaches for your biocide
  • for example, using different hazard classification approaches
• add indirect claims against emerging small non-enveloped viral pathogens to authorized biocide labels

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