New implementing regulation for biocidal products

Biocides play a key role in disease prevention and environmental protection, which is why their use is very precisely regulated and controlled.

Of utmost importance for biocidal products is the news of 15 January 2024. In fact, Implementing Regulation (EU) 2024/235 was published, approving ADBAC/BKC (C12-C16) for PT 2 (existing active substance, Competent Authority Italy). The approval date will be 1 July 2025, expiring on 30 June 2035. In the annex to the regulation, the characteristics of ADBAC/BKC (C12-C16) are specified; in particular, the minimum purity that the active substance must assume is given.

The biocide regulation stipulates that all nationally authorised disinfectant products (PMCs) containing this active substance must be authorised to remain on the market. To do this, a dossier for the product or product family must be prepared and submitted by the date of approval, 1 July 2025, in order to take advantage of the transition period and ensure continuity of trade.

In addition, at national level, it is recalled that a new ADBAC/BKC-based PMC product (C12-C16) can be applied for approval no later than 1 July 2024.

LabAnalysis Life Science can support you through consultancy services to help you stay within local and international legal limits.

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