Guidance on labelling requirements for biocides: Overview

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Purpose

This guidance gives information on the labelling requirements for a biocide to help applicants and market authorization holders comply with the Food and Drugs Act and the Biocides Regulations (regulations).

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 labelling

Any information that is required by the regulations must be displayed on your biocide label in both English and French.

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:

Label panel 1

Directions
English text

Precautionary statemens
English text

Label panel 2

Mode d’emploi
French text

Mises en garde
French text

or

Example 2:

Label panel 1

Directions / Mode d'emploi
English text / French text

Precautionary statements / Mises en garde
English text / French text

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:

Consider the following best practices when developing your biocide label:

Also consider the following:

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:

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

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:

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:

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