Guidance for post-authorization changes for biocides: Types of changes

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Summary of scope of changes

The regulations outline examples of the types of changes and whether they are major or minor. As these lists are examples, they do not capture the full scope of types of changes that must be submitted through post-authorization pathways.

This table provides clarity on possible types of changes that need to be filed to us. Contact us if you have questions about the classifications of changes not captured in this table.

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Table 1: Summary of scope of changes
Aspect Addition, revision or removal Conditions Type of change
Active ingredientFootnote 1
  • Addition
  • Revision
  • Removal
Not applicable Change that creates a new biocide
Active ingredient quantity Revision Not applicable
Brand name
  • Addition
  • Revision
  • Removal
At least 1 brand name must remain Minor
Co-packaging, cross promotion
  • Addition
  • Revision
  • Removal
Related productsFootnote 2 intended to be used concomitantly with the biocide Major
Related productsFootnote 2 not intended to be used concomitantly with the biocide Minor
Unrelated productsFootnote 2, and the other product or products, must not impact the biocide's safety, efficacy or quality Non-notifiable
Directions for storage
  • Addition
  • Revision
  • Removal
Change outside of comparable temperature range and conditions for major change to shelf life met Major
Revision Change outside of comparable temperature range and conditions for major change to shelf life not met Minor
Change within comparable temperature range Non-notifiable
Directions for use
  • Addition
  • Revision
  • Removal
Directions that affect the biocide's efficacy Major
Directions that do not affect the biocide's efficacy Minor
Removal

Due to a removal of a related:

  • use or purpose
  • method of application
Formulant or formulant quantityFootnote 1 Revision Confirmatory efficacy data required Major
No confirmatory efficacy data required Minor
Formulation (alternate)
  • Addition
  • Revision
Confirmatory efficacy data required Major
No confirmatory efficacy data required Minor
Removal At least 1 formulation must remain
Kit
  • Addition
  • Revision
  • Removal

(of a product within the kit)

Not applicable Change that creates a new biocide
Method of application
  • Addition
  • Revision
Dissimilar method of application: impact to efficacy data Major
Similar method of application: no impact to efficacy data Minor
Removal
  • At least 1 method of application must remain (as supported by the efficacy data)
  • Associated conditions of use must also be removed
Package type, material or net quantity
  • Addition
  • Revision
Impact to shelf life and conditions for major change to shelf life met Major
Results in a change to directions for use Refer to directions for use changes
No impact to shelf life or impact to shelf life and conditions for major change to shelf life not met Minor
Change to net quantity is within range of net quantities authorized Non-notifiable
Removal At least 1 package type, material and net quantity must remain
Physical form Revision Not applicable Change that creates a new biocide
Private brand name or trade dress on labels Revision If it only affects label design elements Non-notifiable
Product specifications Revision Any change to specifications other than to narrow purity, potency, identity or tolerance limits Minor
Narrowing tolerance limits for purity, potency, or identity and no impact to shelf life Non-notifiable
Narrowing tolerance limits for purity, potency, or identity and an impact to shelf life Refer to shelf life changes
Risk information Addition Not applicable Minor
Risk information
  • Revision
  • Removal
This includes hazard symbols Major
Setting
  • Addition
  • Revision
Main settingFootnote 3 Major
Sub-setting Minor
Removal At least 1 main setting must remain
Shelf life Revision Commercial use Major

Household use only and before or after the change 1 or more of the following applies:

  • Has a shelf life of less than 1 year.
  • Packaged in a quantity greater than may reasonably be expected to be used within 1 year after it's sold.
  • Contains a novel active ingredient.
  • Contains an ingredient with known stability issues.
Revision is a result of a stability failure
A commitment was provided in the initial or subsequent application to conduct further stability studies

Meets all 3 criteria:

  • Does not meet the conditions for major change to shelf life.
  • Stability data to support the proposed shelf life is available.
  • The biocide is subject to a continuing stability program.
Non-notifiable
Sterile
  • Addition
  • Revision
  • Removal
Not applicable Minor
Use or purpose Addition or revision of therapeutic claim Claim or condition of use requires new efficacy data Major
  • Editorial change
  • Change where claim or condition of use is supported by previously submitted efficacy data
Minor
Removal of therapeutic claim At least 1 use or purpose must remain and related conditions of use removed
1

If you are changing the CAS number of an ingredient (formulant or active) in your biocide, it's generally considered a different ingredient. However, some ingredients have multiple CAS numbers, depending on the manufacturer of the ingredient. In those cases, a change to the CAS number is not considered a change to the ingredient, but instead a minor change to the ingredient's unique numeric identifier.

Return to footnote 1 referrer

2

More information on related and unrelated products.

Return to footnote 2 referrer

3

Main settings:

  • household
  • institutional or industrial
  • animal housing areas
  • hospital or health care
  • food premises

More information on main settings and sub-settings

Return to footnote 3 referrer

This table provides examples for some of the types of changes captured in Table 1. It does not capture the full scope of possible changes to a biocide. Contact us if you have questions about the classifications of changes not captured in this table.

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Table 2: Examples of types of changes
Description Addition, removal or revision Example Type of change
Active ingredient Addition

From: benzalkonium chloride 8% w/w, didecyl dimethyl ammonium chloride 4% w/w

To: benzalkonium chloride 8% w/w, didecyl dimethyl ammonium chloride 4% w/w, octyl decyl dimethyl ammonium chloride 2% w/w

Change that creates a new biocide
Removal

From: didecyl dimethyl ammonium chloride 6% w/w, octyl decyl dimethyl ammonium chloride 3% w/w

To: didecyl dimethyl ammonium chloride 6% w/w

Revision

From: 4.0% w/w citric acid

To: 4.0% w/w hydrogen peroxide

From: 0.004% w/w silver oxide

To: 0.004% w/w silver oxide (nanoparticles)

From: Alkyl (68%C12, 32%C14) dimethyl ethyl benzyl ammonium chloride, CAS 85409-23-0

To: Alkyl (C12-C18) dimethyl ethyl benzyl ammonium chloride, CAS 68956-79-6

Minor
Active ingredient quantity Revision

From: 4.0% w/w citric acid

To: 3.0% w/w citric acid

Change that creates a new biocide
Brand name Addition

Authorized for: brand name X and brand name Y

Adding: brand name Z

Minor
Co-packaging Revision

Packaging a biocide with a cleaning product using clear outer wrapping with no overarching brand name, claims or label

Major (not a kit, related product, for use together)
Cross-promotion Addition

"Mix with 1 mL product X to keep killing bacteria for up to 24 hours"

Major (related product, for use together)
Directions for storage Revision

From: Store at room temperature

To: Store between 0 and 25°C, commercial use biocide

Major

From: Store at room temperature

To: Store between 15 and 25°C

Non-notifiable (comparable range)
Directions for use Revision

From: Allow surface to remain wet for 5 minutes

To: Allow surface to remain wet for 2 minutes

Major

From: Rinse thoroughly with potable water, and air dry

To: Rinse surface before using and allow to air dry

Minor

From: Do not use on fabrics, carpets or textiles

To: This product is not intended for use on textiles, fabrics or carpets

Non-notifiable (editorial change)
Removal

"For plastic and painted surfaces, spot test on an inconspicuous area before use."

Minor
Formulant Revision

From: 0.15% ammonium hydroxide (pH adjustor)

To: 0.15% ammonium carbonate (pH adjustor)

Major

Removal of formulant (pH adjustor) with adjustment of water concentration to account for difference

Formulant Revision

From: 1-Dodecanol CAS #112-53-8

To: 1-Dodecanol CAS #68551-07-5

Minor
Formulant Revision

From: 0.25% blue dye

To: 0.25% red dye

Minor
Formulant quantity Revision

From: 0.15% ammonium hydroxide (pH adjustor)

To: 0.45% ammonium hydroxide (pH adjustor), with reduction in water concentration to account for difference

Major
Formulant quantity Revision

From: 0.25% blue dye

To: 0.3% blue dye, with reduction in water concentration to account for difference

Minor
Formulation (alternate) Addition

New alternate formulation with a change to a surfactant formulant from the base formulation

Major

New alternate formulation with a change to the 0.5% fragrance ingredient from the base formulation

Minor
Removal

Authorized for: 3 formulations

Removing: 1 formulation from the market authorization

Minor
Kit Addition

Authorized for: Product A and Product B sold together in 1 package with an overarching brand name

Adding: Product C to the kit

Change that creates a new biocide
Revision

Authorized for: Product A and Product B sold together in 1 package with an overarching brand name

Revising: Product B to Product C in the kit

Removal

Authorized for: Product A, Product B and Product C sold together in 1 package with an overarching brand name

Removing: Product B from the kit to only sell Product A and Product C together

Label layout Revision

Moving use or purpose from the principal display panel (PDP) to other parts of the label

Minor (at least 1 use or purpose must appear on the PDP)
Method of application Addition

Authorized for: Coarse trigger spray

Adding: Electrostatic spray

Major
Revision

From: Apply with sponge/cloth

To: Apply with mop

Minor
Package material Revision

From: twist-cap opaque plastic bottle

To: twist-cap clear plastic bottle and change to shelf life and directions for storage

Refer to shelf life changes

From: twist-cap clear glass bottle

To: twist-cap clear plastic bottle and no change to shelf life

Minor
Net quantity Revision

From: 100 ml and 300 ml twist-cap HDPE bottles

To: 250 ml twist-cap HDPE bottle and no impact to shelf life

Non-notifiable (within range of net quantity authorized)
Package type Revision

From: twist-cap bottle

To: child-resistant twist cap-bottle resulting in a change to directions for use unrelated to efficacy (how to open bottle) but no change to shelf life

Minor
Physical form Revision

From: solution

To: a powder, towelette or aerosol (in a pressurized container) and so forth

Change that creates a new biocide
Product specifications Revision

Widen purity tolerance limit for an impurity

Minor

Reduce tolerance limit for active ingredient potency to align with specifications for the same product marketed internationally and no impact to shelf life

Non-notifiable
Risk information Addition

"Avoid contact with skin"

Minor
Revision

From: If on skin, rinse well with water

To: If on skin, pat off with a towel

Major
Removal

"Wear rubber gloves when using"

Setting Addition

Authorized for: hospital, animal housing areas

Adding additional main setting: household

Major (not within authorized main settings)

Authorized for: hospital, animal housing areas

Adding sub-setting within an authorized main setting: dental office, nursing home, veterinary hospital

Minor (within authorized main settings)
Shelf life Revision

From: 2 years for a commercial biocide

To: 3 years for a commercial biocide

Major

From: 2 years for a household biocide with no novel active ingredients, no ingredients with known stability concerns, packaged in a quantity reasonably expected to be used within 1 year after it's sold

To: 1 year for the same biocide (no other changes)

Non-notifiable
Sterile Revision

From: Non-sterile

To: Sterile

Minor
Use or purpose Addition of therapeutic claim

Authorized for: Kills Escherichia coli O157:H7 (E. coli)

Adding: Kills Salmonella enterica

Major
Revision of therapeutic claim

From: Kills Escherichia coli O157:H7 (E. coli)

To: Kills Escherichia coli O157:H7 (E. coli) in 3 minutes

Minor ("in 3 minutes" is supported by previously submitted and reviewed efficacy data)
  • w/w: weight per weight
  • HDPE: High-density polyethylene

Shelf life

All biocide market authorization holders should have:

Some biocides have more risk or uncertainty associated with them than others. These biocides require stability data in the initial application to demonstrate that the biocide's benefits continue to outweigh its risks throughout its shelf life considering associated uncertainties. These types of biocides are outlined in the quality requirements guidance and include biocides that:

You must file a major change application if you wish to make a post-authorization change for a biocide that meets 1 or more of these criteria either before or because of the change. This is because the change is reasonably expected to have a major impact on the biocide's quality, benefits, risks or associated uncertainties.

A change to shelf life is also considered a major change if:

An expiry date is not required to appear on your biocide's labels if all of the following conditions are met:

File any changes to the shelf life as a major change if:

All other changes to shelf life are non-notifiable. The market authorization holder should have stability data supporting the change in shelf life kept on file. If you've committed to conducting additional stability studies during your initial or a subsequent application, you should incorporate them into your next post-authorization filing for the biocide.

Other changes to a biocide can impact the stability and shelf life of the biocide, such as changes to:

The market authorization holder is responsible for determining if any of these changes affect the shelf life of the biocide. If they do, and the changes are considered to be major, file a major change application, even if the initial change is not considered a major change itself.

Guidance on quality requirements for biocides

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