Guidance on quality requirements for biocides: Product specifications and package description

On this page

• About specifications
• Package description
• Specifications for properties and qualities
• Description of test methods and tolerance limits

About specifications

Biocides available for sale must have written specifications (as defined in subsection 1(1) of the regulations) for the product and the packaging. Product and packaging specifications must be retained and implemented by every:

• importer
• manufacturer
• market authorization holder

Packaging specifications must be retained and implemented by every:

• labeller
• packager

Individuals trained in quality control and assurance of fabrication or packaging, as applicable to the role within the manufacturing of the finished product, should:

• set specifications during product development
• oversee that specifications are being met during product manufacturing
• approve (sign and date)specifications

The contents of your specifications must include:

• a package description
• properties and qualities of the biocide and its ingredients
• identity, purity and potency of the biocide and its ingredients
• a detailed description of the methods used to test and examine the biocide and its ingredients (for identity, purity and potency)
• tolerance limits for the properties and qualities of the biocide and its ingredients (for identity, purity and potency)

All quantitative tests should be according to appropriate analytical methods. Tests should be done at the finished product stage.

In general, Health Canada recognizes test methods and protocols published by international standards organizations or other regulators. You should use the current official version of the test method and you should follow all prescribed information outlined for the test method you use.

All test methods should have sufficient precision and accuracy to determine if the amount of the ingredient found in any sample of the biocide is within its tolerance limits.

In general, we recognize quality test methods published by:

• Pest Management Regulatory Agency (PMRA) Guidance for developing datasets for conventional pest control product applications: Data codes for parts 1, 2, 3, 4, 5, 6, 7 and 10
• US Environmental Protection Agency(US EPA) Series 830 – Product properties test guidelines
• Organisation for Economic Co-operation and Development (OECD) Test guidelines for chemicals
• European Chemicals Agency (ECHA)'s Guidance on the Biocidal Products Regulations: Volume I –Identity, physico-chemical properties. analytical methods
• American Society for Testing and Materials (ASTM) Annual book of ASTM standards
• Association of Official Analytical Chemists International (AOAC) Official methods of analysis

Package description

The package description you must provide in your application includes:

• size of package
  • net quantity of biocide in the package
• type of package
  • for example, bottle, carton
• a statement of the properties of the packaging material
  • for example, description of the materials, such as high-density polyethylene (HDPE) and low-density polyethylene (LDPE)
• a statement of the qualities of the packaging material
  • for example, description of what it looks like or if it's child-resistant

The information about the package that you include in the package description will depend on the biocide's:

• physical form
• method of application
• treated packaging materials (if applicable), such as:
  • interior coatings
  • siliconization of closure systems
  • sterilization of the components

Packaging material

Packaging type and packaging material must be covered by detailed written specifications. The master formula must contain a detailed description of the methods used to test and examine the packaging material. 

Each lot or batch of packaging material should be examined before use to ensure it complies with the applicable specifications. Examination and/or testing should be documented or recorded electronically. 

The records for all packaging materials released for manufacture should be reviewed by a responsible person and filed.

Packaging operations

Before any packaging operation is started, you should take steps to ensure that the work area and equipment are clean and free from any raw materials, products, product residues, labels or documents not required for the current operation.

Appropriate personnel have various responsibilities with respect to the packaging and labelling operations of a biocide. Responsibilities should include:

• issuing and checking printed packaging materials and labels to ensure the correct ones are used
• ensuring printed packaging materials and labels are withdrawn against a manufacturing/production order
• supervising packaging and labelling processes
• ensuring all packaging operations are performed following the issue of packaging orders and
• ensuring all packaging operations are performed according to written operating procedures or specifications

The following information related to packaging procedures should be recorded:

• name of the product, batch number and quantity of bulk to be packaged and
• quantity and reference number of printed materials and bulk products issued, used, destroyed and returned to stock

Every package of biocide should be:

• identified by a lot number
• held in quarantine and identified as such until released by the quality control department and
• stored and transported under conditions specified by the quality control department to preserve its potency, quality and safety

Specifications for properties and qualities

Your specifications must include a statement of all properties and qualities of the biocide and its ingredients.

This part of the specifications describes the:

• physical and chemical properties of your biocide and its ingredients
• formulation, including:
  • purity
  • potency
  • ingredient information on:
    • name and CAS number (provide the contact information of the person who can provide this information if the ingredient is not known)
    • its purpose in the formulation
    • molecular formula, structure and weight
    • nominal concentrations and upper and lower ingredient limits

Refer to the section on tolerance limits.

Physical and chemical aspects

The physical and chemical properties of your biocide describe its characteristics. Your specifications must include a description of:

• pH for liquid products
• colour
• physical state and form at room temperature
• oxidizing or reducing action
• chemical incompatibility

Depending on the unique properties of the biocide, the specifications should also include a description of the following, as applicable:

• solubility (for biocides in a solid physical state)
• viscosity (mPa•s) (for non-solid biocides)
• boiling point (for biocides with a spray method of application)
• acid reserve (for biocides with pH below 3)
• alkali reserve (for biocides with pH above 11)
• flash point or flame projection (for biocides containing flammable ingredients)
• odour (for biocides intended for household use)

Purity of formulation

You must indicate all potential impurities for your biocide and their upper tolerance limit in your product specifications (including their names, nominal concentration and upper tolerance limits).New chemicals (including impurities) can form as ingredients degrade, which can affect the benefit-risk profile of your biocide.

Examples of impurities include:

• incidental impurities
• intermediates and by-products
• isomers
• process impurities
  • including reagents and catalysts
• related substances
  • for example, degradation products when manufacturing the dosage form
• solvents
  • especially methylene chloride, chloroform, pyridine, dioxane and anilines

Sources of impurities include those:

• present in your raw materials, starting materials and intermediates
• introduced during the manufacturing or purification steps

You should use as many methods as needed to detect and quantify all potential impurities to support your results. You should also use impurity reference standards to determine:

• predominant impurities (present at higher levels than the other impurities)
• impurities of concern for which very low limits are required

Ingredient tolerance limits and nominal concentrations

The biocide is to be manufactured within the tolerance limits. It must be able to maintain its potency within those limits until the end of its shelf life, as per the master formula(as defined in subsection 1(1) of the regulations).

Tolerance limits will apply to the biocide from the date of production to the date of use. For biocides whose label has an expiry date, tolerance limits will apply until the last day of the month of the expiry date.

You can determine the tolerance limits for your active ingredients and formulants in your biocide using its nominal concentrations. The nominal concentration is the concentration of each active ingredient noted in the market authorization.

You should test at least 3 batches of your biocide to ensure the:

• manufactured batches are within the specified limits and
• biocide is expected to remain within the limits for the entire shelf life

You should provide the nominal concentration and tolerance limits for your biocide's:

• formulants
• active ingredients

Standard tolerance limits

Table 1 lists the nominal concentrations and upper and lower limits of ingredients.

Table 1: Nominal concentrations and upper and lower limits

Nominal concentrations of ingredients	Upper limit	Lower limit	Limits allowed for analytical variability
N ≤ 1%	N plus 10% N	N minus 10% N	Upper/lowerlimit plus/minus 2%
1% ≤ N ≤ 20%	N plus 5% N	N minus 5% N	Upper/lower limit plus/minus 1%
20% < N ≤ 100%	N plus 3% N	N minus 3% N	Upper/lower limit plus/minus 0.6%
N: nominal concentration ≤: less than or equal to <: less than

You may propose an alternative tolerance limit for an active ingredient that differs from the standard limits noted in this table. However, for the test results to be representative of the biocide in the application, manufacturing, efficacy and stability testing must always be consistent with the proposed tolerance limits. They should not exceed the standard ranges, between the upper and lower limits, as noted in the table. Some flexibility due to analytical variability is acceptable as noted in the table.

As described in the replicating the formulation section of the guidance on efficacy requirements for biocides, products should be tested for some microorganisms at or below the proposed lower limits. All tolerance limits should consider the manufacturing process, variability and stability of ingredients and their concentrations:

• during production, sale or distribution
• likely to be encountered in the formulation process
• when normal quality control procedures are used

For example, you may formulate active ingredients with rapid degradation and inherent instability in liquid biocides (for example, sodium hypochlorite) up to 125% of the nominal concentration claimed on the label.

Applicants are encouraged to confirm acceptability of alternative tolerance limits for their product to Health Canada prior to performing efficacy testing.

If your proposed tolerance limits are deemed unacceptable during review, we will explain our decision. We may also request revisions or additional information, such as:

• more precise limits
• a narrower range between the upper and lower tolerance limits
• a detailed explanation of how you determined the tolerance limits

For more information, consult the following US Environmental Protection Agency (USA EPA)'s test guidelines:

• 830.1750 product properties test guideline for information on establishing and declaring certified limits for biocides
• 810.2000 product performance test guideline for information on the acceptable ranges of lower certified limits for biocide efficacy testing

Raw material testing

You should confirm the quality of raw materials before they are released for manufacture of a biocide.

Each raw material should be covered by detailed written specifications to ensure their quality before use. Every lot or batch of raw material should be:

• accompanied by a Certificate of Analysis showing actual numerical results, with reference to the specifications, issued by the raw material fabricator
  • if the certificate is not available from the fabricator, each lot of raw material should be quarantined, sampled after receiving on the premises and tested using validated methods to ensure compliance with the applicable specifications in line with your market authorization
• approved by a responsible person of the quality control department before use, with the approval documented or recorded electronically
• retested after any exposure to conditions likely to adversely affect their purity, quality or composition and
• disposed of, if rejected, and document or record the disposal electronically

Finished product testing

Finished product tests complement the controls employed during the manufacturing and importing processes. Each manufacturer and importer must have accurate specifications, adequate quality systems in place, and appropriate test methods that will help ensure that each biocide sold meets its specifications and master formula.

All finished products must follow detailed written specifications, which include details on:

• identity
• purity
• potency
• tolerance limits

Specifications must also include a detailed description of the methods used to test and examine the biocide and its active ingredients and formulants. To ensure that finished products meet their established specifications, you should set up and follow written procedures that describe tests to be conducted. All test methods should be validated to ensure that they provide accurate and consistent results.

Each batch or lot of biocides in finished form should be tested to ensure compliance with its specifications prior to its availability for sale.

The market authorization holder and importer must maintain records that demonstrate that each lot or batch of the biocide that they sell has been manufactured, packaged, labelled and stored in accordance with the master formula for the biocide. You should keep records of finished product testing as evidence of compliance with specifications.

The records should:

• give the actual results of the tests demonstrating the specification is met
• specify the methods used
• identify the testing laboratory and
• give the signature and name of a responsible person of that laboratory

Description of test methods and tolerance limits

Your specifications must include a detailed description of:

• test (analytical) methods used to describe properties of your biocide and its ingredients, such as:
  • name of standard method used (if available)
  • identity and potency of your biocide and its ingredients
  • potential impurities present in your biocide and its ingredients
• acceptable tolerance limits for each test method to examine the biocide and its ingredients (test methods for identity, purity and potency)
• the frequency of tests that are not carried out routinely
• the tests that are carried out routinely on each batch of the biocide
• the tests used to determine your product specifications (method number and type of test used, for example, US EPA Method 7010 Graphite Furnace AAS)

We will allow in-house methods to be used when:

• there are no standard testing methods for your biocide
• there is improved technology that provides more accurate or precise results
• you provide a description of your verified method and results
• there is justification for your in-house method
• the testing laboratory keeps copies of the verification report used during development and routine testing