In association with the update of Technical Agreements for Biocides Analytical Methods, Physico-Chemical Properties and Physical Hazards (APCP) Version 3.0, September 2022, new requirements for determination of the shelf life for biocidal products have been implemented. The long-term stability study should be completed before the application for approval of the biocidal product/family is submitted to The Danish Environmental Protection Agency. If the long-term stability study is not initiated before submission of the product application The Danish Environmental Protection Agency will give the applicant 30 days to initiate the study and submit product measurements at the start of the experiment (T0) where the active substance content and other relevant physical, chemical and technical parameters have been measured cf. ECHAS guidance on the Biocidal Products Regulation (Volume 1, Part A+B+C).
The Danish Environmental Protection Agency can reject the application if the data at T0 is not submitted within the assigned deadline. No later than 9 months within the assessment phase data from the long-term stability studies must be submitted, and the product will be assigned a shelf life supported by the submitted data at the given time if approved.
If an extension of the products shelf life is wanted, the applicant must apply for a change of the authorization cf. (EU) No. 354/2013 appendix on classification of changes of products section 2: Minor change of the product
It is no longer possible to be granted a two-year shelf life of the product by simply submitting an accelerated stability study + data from a not yet completed two-year stability study. Furthermore, it is no longer possible to grant a post-authorization requirement regarding the shelf life. It should be noted that the accelerated stability study is still relevant in relation to determining the storage temperature.
For product renewals, the completed stability studies must be available before submitting the application for renewal.
The requirements for stability studies was implemented upon publication of Technical Agreements for Biocides Analytical Methods, Physico-Chemical Properties and Physical Hazards (APCP) in September 2022.
Technical Agreements for Biocides Analytical Methods, Physico-Chemical Properties and Physical Hazards (APCP) Version 3.0, September 2022 is available on ECHAs website.