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.
Aspect | Addition, revision or removal | Conditions | Type of change |
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Active ingredientFootnote 1 |
|
Not applicable | Change that creates a new biocide |
Active ingredient quantity | Revision | Not applicable | |
Brand name |
|
At least 1 brand name must remain | Minor |
Co-packaging, cross promotion |
|
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 |
|
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 |
|
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:
|
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Formulant or formulant quantityFootnote 1 | Revision | Confirmatory efficacy data required | Major |
No confirmatory efficacy data required | Minor | ||
Formulation (alternate) |
|
Confirmatory efficacy data required | Major |
No confirmatory efficacy data required | Minor | ||
Removal | At least 1 formulation must remain | ||
Kit |
(of a product within the kit) |
Not applicable | Change that creates a new biocide |
Method of application |
|
Dissimilar method of application: impact to efficacy data | Major |
Similar method of application: no impact to efficacy data | Minor | ||
Removal |
|
||
Package type, material or net quantity |
|
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 |
|
This includes hazard symbols | Major |
Setting |
|
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:
|
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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:
|
Non-notifiable | ||
Sterile |
|
Not applicable | Minor |
Use or purpose | Addition or revision of therapeutic claim | Claim or condition of use requires new efficacy data | Major |
|
Minor | ||
Removal of therapeutic claim | At least 1 use or purpose must remain and related conditions of use removed | ||
|
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.
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 |
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Revision | From: 4.0% w/w citric acid To: 4.0% w/w hydrogen peroxide |
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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 |
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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 |
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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" |
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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) | |
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Shelf life
All biocide market authorization holders should have:
- stability data or information available to support the shelf life of the biocide and
- an ongoing stability program implemented to ensure compliance with the approved shelf life
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:
- are not for household use only
- are for household use only and 1 or more of the following applies:
- Have a shelf life less than 1 year.
- Packaged in a quantity greater than may reasonably be expected to be used within 1 year after it's sold.
- Contain a novel active ingredient.
- Contain an ingredient with known stability issues (for example, hypochlorous acid which has a high rate of degradation).
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:
- it's because of a stability failure
- stability data was requested for review in the initial application or any subsequent application
An expiry date is not required to appear on your biocide's labels if all of the following conditions are met:
- It is for use in household settings only.
- It has a shelf life of more than 1 year.
- The package contains a quantity of the biocide that may reasonably be expected to be used within 1 year after it's sold.
File any changes to the shelf life as a major change if:
- the shelf life is longer than 1 year
- you choose to indicate an expiry date on the label of your biocide that meets these criteria
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:
- net quantity of the biocide in the package
- packaging material or type
- directions for storage
- formulants
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.
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