Under the new requirements it will no longer be possible to assign a two-year shelf life to a biocidal product based on an accelerated storage stability test and data from an uncompleted test.
The new requirements
In future a long-term storage stability test must be completed before an application for approval of a biocidal product or product family is submitted to the authorities.
If the long-term storage stability test has not been initiated before the application is submitted, the applicant has 30 days to begin the test and submit product measurements for relevant physical, chemical and technical parameters at the start of the test. If the authorities do not receive data within the set deadline, the application can be rejected. Data from the long-term storage stability test must be submitted no later than 9 months after the assessment has been initiated.
The requirements for storage stability tests came into force with the release of the Technical Agreements for Biocides Analytical Methods, Physico-Chemical Properties and Physical Hazards (APCP) in September 2022. Download APCP, Version 3.0 from the ECHA website.
If you want to know more about storage stability tests of biocidal products, please contact:
Michael Fink
mif@dhigroup.com
Tel +45 4516 9156
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