Guidance on quality requirements for biocides: Overview
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Purpose
This guidance document outlines the tools and approaches you can use to meet the quality requirements set out in the Biocides Regulations. These tools and approaches may reduce the number of requests you receive to clarify an aspect of your application. They may also help us make a decision on your biocide in a timely manner.
General
You are responsible for ensuring that:
- you have information to support your biocide's quality (including stability)
- specifications and master formula are established, followed and maintained for your biocide
You should contact us if you wish to deviate from this guidance. If the Minister does not have sufficient information to conclude that the benefits of your biocide outweigh its risks, taking into consideration any uncertainties, we will either:
- request additional information or
- refuse to issue you a market authorization
Include the following in your application if you are replacing the recommended information or deviating from this guidance:
- scientific rationale
- scientific evidence or data to support your rationale
- for example, an analysis of benefits and risks
- description of the proposed standard or method and
- description of how you developed your proposed alternate limit or method
- for example, sample analysis or quantitative estimate
Once you have received a market authorization for your biocide, you must ensure that all biocides for sale follow the master formula and meet its specifications.
Application requirements
You do not need to include information on your biocide's quality if:
- you rely on the quality information of another authorized biocide and
- the quality information for your product is the same as the comparison product
- such as product specifications, shelf life, stability and master formula
This applies to applications using the:
- comparison – administrative application pathway
- use of foreign decisions (UFD) pathway (except package description)
- comparison – labelling only pathway (except package description)
In all other application pathways, you must include the:
- shelf life
- product specifications
- package description
- summary of quality information
To support the shelf life of the biocide, you may need to provide stability information, including stability studies, in your application. This information may also be required for applications involving a different packaging from a comparison product (comparison – labelling only application) or foreign biocide (UFD application).
Refer to the stability and shelf life page for when stability data is required.
Additional quality information is required for:
- novel biocides
- sterile biocides
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