Request for Repeated Long-Term Stability Testing of Biocidal Products (2026 Update)
Request for Repeated Long-Term Stability Testing of Biocidal Products (2026 Update)
As announced on April 9, 2026, long-term stability tests that form the basis of biocidal product authorizations are now subject to re-evaluation and may be required to be repeated. This development introduces significant regulatory obligations and process updates for companies operating in the sector.
Why Are Stability Tests Being Requested Again?
Within the scope of the Ministry’s review:
- Stability tests conducted for authorization purposes
- Tests performed in authorized, GLP-compliant, accredited, or validated laboratories
- Analyses previously accepted and included in the authorization process
have been evaluated.
However, it has been determined that some of these tests do not fully comply with the updated guideline requirements.
What Does the Regulation Say?
Under Article 23 (“Review”) of the Biocidal Products Regulation:
- The Ministry has the authority to reassess authorizations at any time
- Additional data, documentation, or clarification may be requested from authorization holders
Based on this authority, previously authorized biocidal products have been re-examined.
New Guideline: Critical Changes in Stability and Analysis Processes
With the publication of the:
“Guideline on Physical, Chemical and Stability Testing of Biocidal Products” (October 27, 2025)
new standards have been introduced.
Accordingly:
- Missing physical parameters are not accepted
- Monthly analysis intervals must be properly applied
- Any tests not compliant with the guideline are considered invalid
When Will Stability Tests Need to Be Repeated?
Re-testing will be required in cases such as:
- Non-compliance with guideline criteria
- Missing data in stability studies
- Incorrect application of monthly testing intervals
- Inconsistencies in physical and chemical analyses
What About Products with a 24-Month Stability Requirement?
For products that include the statement:
“The authorization period will be extended upon completion of 24-month stability tests”
Authorization holders must submit product-specific applications.
Following the application:
- The justification for requesting repeated stability tests
- Relevant technical explanations
will be communicated in writing by the Ministry.
What Does This Mean for Companies?
With this regulatory update, companies are expected to:
- Review existing stability test data
- Re-plan stability studies where necessary
- Work with GLP-compliant and accredited laboratories
- Update technical dossiers and authorization documentation
Current Approach in Biocidal Product Authorization
Biocidal product stability testing plays a critical role in ensuring that products maintain their physical, chemical, and biological properties throughout their shelf life. These tests verify product efficacy, safety, and regulatory compliance.
Under current requirements, it is no longer sufficient for stability tests to simply exist; they must also be conducted using the correct methodology, appropriate intervals, and complete parameter sets. This shift necessitates stronger quality management systems within companies.
Role of Stability Testing in Regulatory Inspections
Biocidal product stability tests are not only essential during the authorization phase but also serve as a key reference point during regulatory inspections. Authorities assess whether products continue to maintain stability after being placed on the market.
Therefore, if previously conducted tests do not meet current standards, re-testing becomes unavoidable.
Additionally, stability test results directly influence product labeling, declared shelf life, and safe usage conditions. Incomplete or inaccurate testing can negatively impact both the authorization process and market reliability.
Conclusion: Proactive Process Management Is Essential
This regulatory update aims to enhance quality and safety standards in the biocidal products sector. However, it also represents a time- and cost-critical process for companies.
Early planning of stability testing activities and timely resolution of gaps are essential to ensure compliance and maintain market continuity.
For more information on biocidal products and regulatory compliance processes, you can explore our service page:
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