Biocidal Products Regulation (EU) 528/2012: Latest Updates

According to Article 13 of Regulation (EU) No. 528/2012 (BPR), an application for the renewal of the approval of an active substance for one or more product types (PT) can be submitted to the Agency at least 550 days before the expiry date indicated in the implementing regulation of the same active substance. If the application does not contain sufficient data to support a complete evaluation, the competent authority responsible for the assessment may request additional information, in line with Article 8 of the BPR. In such cases, the 365-day deadline for the evaluation of the application is suspended, for a maximum of six months, unless further extensions are justified due to the complexity of the requested data.

This mechanism may result in the approval of an active substance expiring before the renewal process is completed, making it necessary to extend the expiry date to allow for a full evaluation.

In this regard, the European Commission has adopted several implementing decisions extending the approval deadlines of the following active substances:

• COMMISSION IMPLEMENTING DECISION (EU) 2025/1812: the expiry date of the approval of copper oxide for use in antifouling products (PT 21) is extended to 30 June 2028.
• COMMISSION IMPLEMENTING DECISION (EU) 2025/1807: the expiry date of the approval of copper thiocyanate for use in antifouling products (PT 21) is extended to 30 June 2028.
• COMMISSION IMPLEMENTING DECISION (EU) 2025/1809: the expiry date of the approval of zineb for use in antifouling products (PT 21) is extended to 30 June 2028.
• COMMISSION IMPLEMENTING DECISION (EU) 2025/1778: the expiry date of the approval of copper pyrithione for use in antifouling products (PT 21) is extended to 30 June 2028.
• COMMISSION IMPLEMENTING DECISION (EU) 2025/1808: the expiry date of the approval of Pythium oligandrum, strain M1, for use in preservative products for construction materials (PT 10) is extended to 30 June 2028.
• COMMISSION IMPLEMENTING DECISION (EU) 2025/1779: the expiry date of the approval of azoxystrobin for use in film preservatives (PT 7), fibre, leather, rubber and polymerised materials preservatives (PT 9), and construction materials preservatives (PT 10) is extended to 30 April 2028.
• COMMISSION IMPLEMENTING DECISION (EU) 2025/1811: the expiry date of the approval of 4,5-dichloro-2-octyl-2H-isothiazol-3-one for use in wood preservatives (PT 8) and antifouling products (PT 21) is extended to 30 June 2028.
• COMMISSION IMPLEMENTING DECISION (EU) 2025/1814: the expiry date of the approval of lauric acid for use in repellents and attractants (PT 19) is extended to 30 April 2028.
• COMMISSION IMPLEMENTING DECISION (EU) 2025/1806: the expiry date of the approval of transfluthrin for use in insecticides, acaricides and products for the control of other arthropods (PT 18) is extended to 30 April 2028.
• COMMISSION IMPLEMENTING DECISION (EU) 2025/1791: the expiry date of the approval of imidacloprid for use in insecticides, acaricides and products for the control of other arthropods (PT 18) is extended to 31 December 2027.
• COMMISSION IMPLEMENTING DECISION (EU) 2025/1792: the expiry date of the approval of ethyl butylacetylaminopropionate for use in repellents and attractants (PT 19) is extended to 30 April 2028.

In addition, a draft implementing decision of the European Commission has been published concerning the non-approval of etofenprox for use in both wood preservatives (PT 8) and insecticides, acaricides and products for the control of other arthropods (PT 18). At the same time, the Commission also released a draft decision repealing the previous implementing decisions (EU) 2022/1487 and (EU) 2025/2012, which had extended the approval of etofenprox for the same uses.

Finally, ECHA has published the latest updates:

• Treated articles: allowed active substances. On 29 September 2025, ECHA released the latest version of the list of biocidal active substances permitted for treated articles.
• List of active substance/product type combinations (a.s./PT). On 29 September 2025, ECHA published the updated list.
• Article 95 list. On 29 September 2025, ECHA updated the list of approved suppliers of biocidal active substances.

These updates confirm the dynamic nature of the regulatory framework for biocides and highlight the importance of continuous monitoring to ensure regulatory compliance and market continuity.