Denmark | New requirements for stability studies for products applied for approval under the biocides regulation
The requirements for the two-year stability studies for biocidal products and product families have been tightened. The stability studies must now, as a starting point, be completed before applying for approval, and it is no longer possible to give a post-authorization requirement regarding durability.
In connection with the update of Technical Agreements for Biocides Analytical Methods, Physico-Chemical Properties and Physical Hazards (APCP) Version 3.0, September 2022 , there have been new requirements for determining the durability of biocidal products. As a starting point, the long-term stability study must 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 has not started before submitting the product application, the Danish Environmental Protection Agency will give applicants 30 days to start the study and submit product measurements at the start of the experiment (T 0 ) where active substance content and other relevant physical, chemical and technical parameters have been measured, cf. ECHA's guide to the biocides regulation (Volume 1, Part A+B+C).
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