Updates from the biocidal active substances review programme
Extensions of approvals, new authorisations and non-approvals: the latest updates from the European regulatory landscape
22 Jun 2025The European Commission has recently published a number of implementing decisions, many of which concern extensions of the approval expiry dates for several biocidal active substances.
Below is a list of the substances concerned, along with details on the new expiry dates:
- Decanoic acid (PT 4): expiry date extended from 31 August 2025 to 29 February 2028
- Povidone-iodine (PT 1 and 3): expiry date extended from 31 August 2025 to 29 February 2028
- 1R-trans Phenothrin (PT 18): expiry date extended from 31 August 2025 to 29 February 2028
- Octanoic acid (PT 4): expiry date extended from 31 August 2025 to 29 February 2028
- Iodine (PT 3): expiry date extended from 31 August 2025 to 29 February 2028
- Nonanoic acid (PT 2): expiry date extended from 30 September 2025 to 31 March 2028
- Medetomidine (PT 21): expiry date extended from 30 June 2025 to 30 June 2026
- bis[1-cyclohexyl-1,2-dihydroxy-kO diazeniate(2-)]-copper (Cu-HDO) (PT 8): expiry date extended from 31 August 2025 to 29 February 2028
- IPBC (PT 8): expiry date extended from 31 July 2025 to 31 July 2026
- S-methoprene (PT 18): expiry date extended from 31 August 2025 to 29 February 2028
- Didecyldimethylammonium carbonate (PT 8): expiry date extended from 31 July 2025 to 31 January 2028
Additional news concerns the approval of formic acid for its use in PT 6, starting from 1 October 2026, under Regulation (EU) 2025/1043. Companies placing biocidal products and treated articles containing this substance on the market are advised to consult the implementing regulation, particularly the specific conditions outlined in its annex.
Finally, the European Commission has adopted Implementing Decision (EU) 2025/1074, which establishes the non-approval of ethylene oxide as an active substance for use in PT 2. This decision stems from the fact that the proposed uses by the applicant - sterilisation of medical devices, pharmaceuticals and packaging - are already governed by the Medical Devices Regulation and pharmaceutical legislation; therefore, Regulation (EU) No. 528/2012 on biocides does not apply in this context.
Source:
- Implementing Decision (EU) 2025/1074, non-approval of ethylene oxide, PT 2
- Regulation (EU) 2025/1043, approval of formic acid, PT 6
- Implementing Decision (EU) 2025/949, extension of the approval expiry date for decanoic acid, PT 4
- Implementing Decision (EU) 2025/951, extension of the approval expiry date for povidone-iodine, PT 1 and 3
- Implementing Decision (EU) 2025/950, extension of the approval expiry date for 1R-trans phenothrin, PT 18
- Implementing Decision (EU) 2025/946, extension of the approval expiry date for octanoic acid, PT 4
- Implementing Decision (EU) 2025/947, extension of the approval expiry date for iodine, PT 3
- Implementing Decision (EU) 2025/945, extension of the approval expiry date for nonanoic acid, PT 2
- Implementing Decision (EU) 2025/953, extension of the approval expiry date for medetomidine, PT 21
- Implementing Decision (EU) 2025/998, extension of the approval expiry date for bis[1-cyclohexyl-1,2-dihydroxy-kO diazeniate(2-)]-copper (Cu-HDO), PT 8
- Implementing Decision (EU) 2025/970, extension of the approval expiry date for IPBC, PT 8
- Implementing Decision (EU) 2025/952, extension of the approval expiry date for S-methoprene, PT 18
- Implementing Decision (EU) 2025/944, extension of the approval expiry date for didecyldimethylammonium carbonate, PT 8