Guidance on quality requirements for biocides: Quality summary

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About the quality summary

Certain applications must contain a summary of the information included in your application about the risks and any related uncertainties of your biocide, including for quality information. Find information in the guidance on biocide application pathways and general requirements on when a quality data summary is required.

Your quality summary should summarize your biocide's specifications and stability and shelf life results.

Your quality summary should contain a copy of your specifications (as defined in subsection 1(1) of the regulations), which includes a:

Do not include detailed information on quality data reporting in your summary. The quality summary should include a summary of the quality reports submitted in support of your biocide.

If you're using in-house methods, your quality summary should include:

If you do not know the chemical identity or chemical composition of an ingredient because it's proprietary or trade secret information, you must ensure the supplier or producer of the ingredient provides this information.

Example of a summary template for quality information

To summarize your quality information for a biocide, use:

Section A contains information that all quality summaries for biocides should include.

Section B contains additional information we may ask to be included in the quality summary (for example, for novel biocides and sterile products).

Section A: Quality information for all biocides

Biocide information

Aspect Description
Company (applicant) name and address  
Primary brand name  
Method of application  
Settings for use  
Single or multiple formulation  

Product specifications

Biocide formulation information

Active ingredients:

Provide the following information for each active ingredient within the biocide.

Aspect Description
Chemical and common name (if any) and trade name, if applicable  
Chemical Abstracts Service (CAS) registry number  
Nominal concentration (%w/w) of the biocide (potency)  
Upper and lower tolerance limits (%w/w) within the biocide  
w/w: weight per weight

Biocide potency and pH testing:

Provide the following information for your finished biocide.

Active ingredient potency testing
Batches tested Method used Concentration of active ingredient in the tested batches
     
pH variation testing
Batches tested Method used Measured pH
     

Formulants:

Provide the following information for each formulant within the biocide.

Aspect Description
Chemical and common name (if any) and trade name, if applicable and known  
CAS registry number  
Nominal concentration (%w/w) in the biocide (potency)  
Upper and lower tolerance limits (%w/w) within the biocide  
w/w: weight per weight

Impurities:

List all potential impurities.

For each impurity associated with the biocide and its active ingredients and formulants that are toxicologically significant, provide:

List of impurities
Impurity identification Chemical name of impurity Nominal concentration of impurity Tolerance upper limit or rationale if not included in the product specification for routine testing
       

Stability information

Summary of stability protocol

Protocol parameter Description
Real time, accelerated or in-use?  
Storage conditions (for example, temperature, humidity)  
Testing frequency  
Number of batches  
Tests and acceptance criteria  
Other (for example, physical changes)  
Summary of results obtained  

Stability factors

List any factors that would affect the efficacy and stability of the biocide (for example, the presence of certain formulants, impurities, temperature, pH, UV light)

Section B: Additional information that may be requested

Biocide formulation information

Active ingredients

Include:

Impurities not routinely tested

Describe the impurities that may be present in the biocide and why they may be present. Your description should include:

You should base this description on:

Impurity identification Nominal concentration Upper tolerance limit Rationale
       

Degradation products and substances of concern

List all degradation products (including CAS numbers) associated with the end-use formulation or any substances of concern (such as, analysis of N-nitroso contaminants).

Chemical and common name (if any) and trade name, if applicable Quantity Chemical Abstracts Service (CAS) registry number
     

Manufacturing information

Batch formula (name, physical form)

List of all components of the physical form you will use in the manufacturing process and their amounts on a per batch basis (including overages, if any).

Aspect Description
Strength (label claim)  
Master formula (as defined in subsection 1(1) of the regulations)
Reference number (and version, if applicable)
 
Batch size (number of dosage units, if applicable)  
Component and quality standard (and grade, if applicable) Quantity per batch
Total  

Batch analyses

You should provide certificates of analyses or a tabulated summary for:

Description of manufacturing process and process controls (name, manufacturer)

Your description should include a:

Methods information

Aspect Description (type of method, range, LOD, LOQ, precision, accuracy)
Method used to test active ingredient  
Method used to test impurities  
Other methods discussed in your submission  
LOD: Limit of detection
LOQ: Limit of quantification

Special considerations

Also include any additional quality documentation that we requested during pre-submission consultation.

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2025-08-13