Guidance on the transition of disinfectants and surface sanitizers to the Biocides Regulations: Packaging and labelling

On this page

• Introduction
• Labelling requirements
• Packaging requirements

Introduction

The Biocides Regulations (regulations) include revised packaging and labelling requirements from the:

• Food and Drug Regulations (FDR)
• Pest Control Products Regulations (PCPR)

Once a biocide is authorized under the regulations, it must be labelled and packaged according to the regulations. For more detailed packaging and labelling information, refer to the guidance on:

• labelling requirements for biocides
• safety requirements for biocides
• quality requirements for biocides

This section will summarize how packaging and labelling requirements differ from those outlined in the FDR and PCPR and how some requirements are staying the same.

Labelling requirements

The regulations require that you must have all labelling information on your biocide:

• clearly and prominently displayed
• displayed in both English and French

Transitioning disinfectants: Differences

New labelling requirements for your disinfectant on the principal display panel (PDP) include:

• the statement "sterile" and "stérile", if the biocide is sterile
• the net quantity (previously could appear on other parts of the label)
• the statements "Keep out of reach of children" and "Tenir hors de la portée des enfants"
• the setting in which it will be used. This could be 1 or more of 5 main settings or sub-settings within those 5 main settings:
  • household (for personal use in residential settings)
  • institutional or industrial
  • hospital or health care
  • food premises
  • animal housing area
• at least 1 use or purpose for your biocide. This may be a single word indicator or combination of words, such as:
  • disinfectant
  • sanitizer
  • fungicide
  • germicide

New labelling requirements for your disinfectant on other parts of the label include:

• adding the directions for storage
• adding the physical form of your biocide, unless it is obvious
• formalized flexibility to remove an expiry date for household biocides if:
  • they have a shelf life of more than 1 year and
  • the package contains a quantity of the biocide that may reasonably be expected to be used within 1 year after it is sold

Transitioning disinfectants: What's the same

Your PDP must continue to include:

• brand name
• identification number and the "DIN" designation
• requirements related to products packaged in a designated (pressurized) container

Other parts of your label must continue to include:

• a lot number
• risk information
• an expiry date, if applicable
• intended use or purpose (other claims, if not included on the PDP)
• a quantitative list of the active ingredients of the biocide
• adequate directions for use of the biocide, including:
  • application rates
  • contact time
  • surfaces for application
  • frequency of application
  • any limitations on its use
• the name and contact information of the market authorization holder, for which the contact information must allow persons in Canada to contact the holder without cost
  • Previously under the FDR, the requirement was for the name and address of the:
    • manufacturer or applicant
    • importer, if the manufacturer or applicant was not in Canada

Transitioning sanitizers: Differences

New labelling requirements for your sanitizer on the PDP include:

• requirements for biocides packaged in a designated (pressurized) container
• the statement "sterile" and "stérile", if the biocide is sterile

New labelling requirements for your sanitizer on other parts of the label include:

• lot number
• expiry date, if applicable
• "DIN" designation and identification number issued under the regulations instead of a pest control product registration number and designation

New labelling requirements for your sanitizer on other parts of the label (that were previously required on the PDP), include:

• the physical form of your biocide, unless it is obvious
• quantitative list of the active ingredients of the biocide
• the name and contact information of the market authorization holder
  • The contact information must allow persons in Canada to contact the holder without cost.

Under the regulations, sanitizers are not required to include certain directions and statements on other parts of the label. However, we recommend you maintain these directions and statements on your marketed label, as they help to ensure the safe and effective use of the biocide and are helpful to users (especially those in commercial settings). These statements include:

• directions for disposal
• directions for decontamination
• the statements "Read the label before using" and "Lire l'étiquette avant utilisation"

They should not be included on the label text submitted to Health Canada in an application for a biocide market authorization.

The regulations have a flexibility for small packages to facilitate compliance with labelling requirements for their inner labels.

Transitioning sanitizers: What's the same

You must continue to include on your PDP:

• net quantity
• brand name
• the statements "Keep out of the reach of children" and "Tenir hors de la portée des enfants"
• at least 1 use or purpose of the biocide. This may be a single word indicator or combination of words, such as:
  • disinfectant
  • sanitizer
  • fungicide
  • germicide
• the setting in which it will be used. This could be 1 or more of 5 main settings or sub-settings within those 5 main settings:
  • household (for use in residential settings)
• industrial or institutional
• hospital or health care
• food premises
• animal housing areas

You must continue to include on other parts of your label:

• risk information
• intended use or purpose (other claims, if not included on the PDP)
• directions for use of the biocide, including:
  • application rates
  • contact time
  • surfaces for application
  • frequency of application
  • any limitations on its use

Packaging requirements

Packaging requirements for biocides in the regulations align with the requirements in the PCPR. These requirements help to ensure that your package:

• permits safe withdrawal and closure
• contains the biocide (for example, no leaks and can be closed again)
• minimizes degradation or change of its contents (for example, minimize moisture loss or photodegradation)