Stability Tests for Biocidal Products Are Being Re-Requested (2026 Updated Announcement)
Within the scope of the announcement published on April 9, 2026, long-term stability tests that form the basis for the authorization of biocidal products are now being requested to be conducted again. This development implies significant obligations and process changes for companies operating in the sector.
Why Are Stability Tests Being Requested Again?
During the evaluations carried out by the Ministry, the following criteria were assessed:
- Stability tests used for authorization
- Whether these tests were conducted in authorized, GLP-compliant, or accredited laboratories
- Inclusion of the analyses in the authorization process
However, as a result of the reviews, it has been determined that some tests do not fully comply with the current guideline criteria.
What Does the Regulation Say?
Under Article 23 (“Review”) of the Biocidal Products Regulation:
- The Ministry has the right to re-evaluate granted authorizations at any time
- Additional information, documents, and explanations may be requested from authorization holders
Based on this authority, currently authorized products have been taken under re-evaluation.
New Guideline: Critical Changes in Stability and Analysis Processes
With the publication of the:
“Guideline for Physical, Chemical and Stability Testing of Biocidal Products” (October 27, 2025)
new standards have been introduced to analysis processes.
According to this guideline:
- Missing physical parameters are not accepted
- Monthly analysis intervals must be properly applied
- Any tests not conducted in accordance with the guideline are considered invalid
In Which Cases Will Stability Tests Be Repeated?
Stability tests will need to be repeated in the following cases:
- Analyses not compliant with guideline criteria
- Missing data in stability studies
- Incorrect application of monthly intervals
- Inconsistencies in physical and chemical analyses
What About Products Requiring 24-Month Stability?
For products that include the following statement in their authorization certificate:
“The authorization period will be extended upon completion of 24-month stability tests”
Authorization holders are required to submit a product-based application.
Following the application:
- The reasons for requesting new stability tests
- Required technical explanations
will be communicated in writing by the Ministry.
What Does This Mean for Companies?
With this regulation, companies are expected to:
- Review their existing stability tests
- Re-plan tests if necessary
- Work with GLP-compliant and accredited laboratories
- Update their technical dossiers
Current Approach in Biocidal Product Authorization
Stability tests play a critical role in determining whether biocidal products maintain their physical, chemical, and biological properties throughout their shelf life. These tests verify the product’s efficacy, safety, and regulatory compliance. Environmental factors such as temperature, humidity, and light are analyzed through long-term stability studies.
According to current regulations, it is no longer sufficient for stability tests to simply exist; they must also be conducted using appropriate methodologies, at correct intervals, and with complete parameters. This necessitates stronger quality management systems within companies.
The Role of Stability Tests in Inspection Processes
Stability tests for biocidal products are not only critical during the authorization phase but also serve as a key reference during inspections. Authorities assess whether products maintain their stability even after being placed on the market. Therefore, previously conducted tests that do not meet current requirements are inevitably subject to re-evaluation.
Additionally, stability test results directly determine product labeling, shelf-life declarations, and safe use. In this context, incomplete or incorrect tests may negatively impact not only the authorization process but also the product’s reliability in the market.
Conclusion: Early Process Management Is Critical
This new regulation aims to enhance quality and safety standards within the biocidal products sector. However, it represents a time- and cost-critical process for companies.
Therefore, early planning of stability testing processes and rapid resolution of deficiencies are of great importance.
For more information on biocidal products and regulatory processes, you can visit our related service page.
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