Update on the longstop of data protection for biocidal active substances
Update on the longstop of data protection for biocidal active substances
There has been a lot of uncertainty regarding the longstop of data protection for biocidal active substances, with the date of expiry due to be on December 31st, 2025. If an active substance (PT combination) was not already approved before September 1st, 2013, all data protection periods for that active substance (PT combination) still under review remained until December 31st, 2025. This meant that in some cases the period of data protection that would normally apply would be cut off.
On December 16th, 2025, the European Commission put forward a proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) No. 528/2012 as regards the extension of certain data protection periods. This amendment to the Biocidal Products Regulation (Regulation (EU) No 528/2012) proposes to extend the data protection period for existing active substances under review until December 31st, 2030. The amendment can be found here 16.12.25 COM(2025) 1020 final 2025/0408. This applies to all relevant data, not limited to those related to endocrine disrupting (ED) properties.
Additionally, from January 1st, 2026, until the new regulation enters into force, data will temporarily lose protection. The Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Data owners may claim compensation for access to their data during the period of no protection. This period started on the 1st of January 2026 until the date of entry into force of this amending regulation.
For advice on data protection and with the regulation of biocides in the EU and UK the Kerona Regulatory team can be contacted at info@kerona.ie