In a recent move, the European Commission has announced the postponement of the expiry date for the approval of cholecalciferol used in biocidal products of product-type 14. This decision, encapsulated in Commission Implementing Decision (EU) 2024/733, extends the authorization until 31 December 2025.
Background on Cholecalciferol
Cholecalciferol, an active substance initially approved under the conditions detailed in Annex to Commission Implementing Regulation (EU) 2019/637, was set to see its approval expire on 30 June 2024. However, a renewal application submitted on 22 December 2022 prompted a re-evaluation of this timeline.
Evaluation Process and Public Consultation
The evaluation by the competent authority in Sweden indicated a full review of the application for renewal was unnecessary. Yet, considerations from a public consultation on potential candidates for substitution, organized by the European Chemicals Agency (ECHA), influenced a delay in the evaluation report submission, pushing the timeline for the Agency's opinion on renewal to March 2024.
Regulatory Considerations
Cholecalciferol is noted for its endocrine-disrupting properties, potentially causing adverse effects in humans, thereby meeting the exclusion criterion set out in Regulation (EU) No 528/2012. The impending decision on its renewal, which awaits the ECHA's opinion, necessitated postponing its expiry date to ensure adequate time for a comprehensive examination of the application.
Implications of the Decision
This postponement means that cholecalciferol remains approved for use in biocidal products of product-type 14, under the conditions previously established, until the new expiry date. This extension ensures regulatory procedures are thoroughly followed and provides stakeholders with clarity on the substance's status in the EU market.
