Guidance on quality requirements for biocides: Biocides requiring additional information

Certain biocides such as novel and sterile biocides require additional quality information in their application for a market authorization. The Minister needs this information to determine if your biocide's benefits outweigh its risks, taking into account any related uncertainties.

On this page

• Novel biocides
• Sterile biocides

Novel biocides

A novel biocide may contain a new:

• physical form
• method of application
• combination of active ingredients
• use or purpose
• active ingredient
  • for example, use of nano-technology

Quality requirements for novel biocides

The quality information that may be requested for a novel biocide depends on the specific characteristics of the biocide. Contact us to discuss the additional data you may need to support your novel biocide.

For biocides that are confirmed to be novel through a biocide classification request, we strongly recommend that you should request pre-submission consultation to:

• determine the unique requirements that may apply to establish the benefits and risks of your biocide
• understand how to satisfy specific quality requirements that would apply to your biocide

For more information on pre-submission meeting requests, consult:

• Guidance on application pathways and general requirements

To help us assess and confirm the quality of your novel biocide, we may require additional information and material about the finished biocide. This could include:

• a detailed description of:
  • the manufacturing process and process controls (identifying critical and intermediate steps)
    • if this information is not available to you (for example, it may be proprietary to the manufacturer), you should provide the contact information of the supplier or producer of the ingredient
  • the active ingredients (such as chemical structure, particle size and antimicrobial properties)
  • any degradation products or byproducts (and their concentration) from the manufacturing process
• a list, concentration and analysis of:
  • residues
  • degradation products
  • substances of concern
    • for example, N-nitroso contaminants
• summary of factors that would affect stability of the product, such as:
  • presence of certain formulants, impurities, temperature, pH, UV light
• copies of:
  • batch records, including formulation, manufacturing and packaging
  • executed production documents for the batches used in the studies
  • master formula (as defined in subsection 1(1) of the regulations) for each proposed strength, commercial batch size and manufacturing site
  • certificates of analyses or a tabulated summary of results for a minimum of 2 batches per strength at each proposed manufacturing site, using at least 10% of the commercial batch size (pilot scale)
• any additional information we requested for your product during pre-submission meetings, such as:
  • solubility
  • thermal stability
  • evaporation rate at room temperature
  • dissociation constants

These are only examples of the types of information that we may request. The information depends on the biocide. We encourage you to provide this information in your application, when available, to reduce the need for information requests.

The guidance on management of biocide applications outlines the mechanisms that we can use to request additional information from you during our assessment of your biocide application.

Sterile biocides

For biocides that are required to be sterile (for example, those for use in a clean room), we may ask for additional quality information and material.

Your application for a sterile biocide should include:

• validation of the sterilization technique
• a detailed description of the sterilization process used in manufacturing (parameters and equipment)
• scientific justification for the sterilization method used
• the controls used to maintain the sterility of the active ingredient during storage and transportation
• evidence to confirm that the method or process will:
  • reliably produce a sterile biocide
  • not affect the physical and chemical properties or the safety or efficacy of the biocide

Manufacturing sterile products is subject to special requirements to minimize risks of microbiological contamination and particulate and pyrogen contamination. You must always manufacture and package sterile biocides in a separate and enclosed area. You should follow effective premises and equipment cleaning as well as sanitization procedures to prevent contamination.

All personnel employed should receive regular training in disciplines relevant to the correct manufacture of sterile products. This training should include reference to hygiene and to the basic elements of microbiology. The person carrying out the manufacturing or packaging of a sterile biocide should be:

• knowledgeable in sterilization techniques
• knowledgeable of the effects of materials being sterilized and
• able to choose the appropriate terminal sterilization method for the biocide

When outside staff are needed in and who have not received training (such as, building or maintenance contractors), particular care should be taken over their instruction and supervision.

This type of manufacture must strictly follow carefully established methods of preparation and procedure. You should not rely only on a terminal process or finished product test for sterility or other quality aspects.

Although meeting good manufacturing practices (GMPs) is not a mandatory requirement for biocides, we encourage you to voluntarily adopt them as a best practice. The following GMP guidance can be used as a resource in meeting the quality requirements for sterile biocides:

• Process validation: Gaseous sterilization for pharmaceuticals (GUI-0007)
• Process validation: Irradiation sterilization for pharmaceuticals (GUI-0009)
• Process validation: Moist heat sterilization for pharmaceuticals (GUI-0010)

Contact us if you're not sure what information you may need to support your sterile biocide.

For more information on pre-submission meeting requests, consult:

• Guidance on biocide application pathways and general requirements