Prováděcí rozhodnutí Komise (EU) 2025/970 ze dne 22. května 2025, kterým se odkládá datum skončení platnosti schválení IPBC pro použití v biocidních přípravcích typu 8 v souladu s nařízením Evropského parlamentu a Rady (EU) č. 528/2012

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal productsOJ L 167, 27.6.2012, p. 1 , ELI: http://data.europa.eu/eli/reg/2012/528/oj. , and in particular Article 14(5) thereof,

After consulting the Standing Committee on Biocidal Products,

The expiry date of the approval of IPBC for use in biocidal products of product-type 8 set out in Implementing Decision (EU) 2022/1485 is postponed to 31 July 2026 .

OJ L 167, 27.6.2012, p. 1 , ELI: http://data.europa.eu/eli/reg/2012/528/oj.

(1) IPBC was included in Annex I to Directive 98/8/EC of the European Parliament and of the CouncilDirective 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1 , ELI: http://data.europa.eu/eli/dir/1998/8/oj). as an active substance for use in biocidal products of product-type 8. Pursuant to Article 86 of Regulation (EU) No 528/2012, it was therefore considered approved until 30 June 2020 under that Regulation subject to the conditions set out in Annex I to Directive 98/8/EC.

(2) On 20 December 2018 , an application was submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for the renewal of the approval of IPBC for use in biocidal products of product-type 8 (the application).

(3) On 11 April 2019 , the evaluating competent authority of Denmark informed the Commission that it had decided, pursuant to Article 14(1) of Regulation (EU) No 528/2012, that a full evaluation of the application was necessary. Pursuant to Article 8(1) of that Regulation, the evaluating competent authority is to perform a full evaluation of the application within 365 days of its validation.

(4) The evaluating competent authority may, as appropriate, require the applicant to provide sufficient data to carry out the evaluation, in accordance with Article 8(2) of Regulation (EU) No 528/2012. In that event, the 365-day period is suspended for a period that may not exceed 180 days in total unless a longer suspension is justified by the nature of the data requested or by exceptional circumstances.

(5) Within 270 days of receipt of a recommendation from the evaluating competent authority, the European Chemicals Agency (the Agency) is to prepare and submit to the Commission an opinion on renewal of the approval of the active substance in accordance with Article 14(3) of Regulation (EU) No 528/2012.

(6) Commission Implementing Decision (EU) 2019/1969Commission Implementing Decision (EU) 2019/1969 of 26 November 2019 postponing the expiry date of approval of IPBC for use in biocidal products of product-type 8 (OJ L 307, 28.11.2019, p. 45 , ELI: http://data.europa.eu/eli/dec_impl/2019/1969/oj). postponed the expiry date of the approval of IPBC for use in biocidal products of product-type 8 to 31 December 2022 , in order to allow sufficient time for the examination of the application.

(7) Commission Implementing Decision (EU) 2022/1485Commission Implementing Decision (EU) 2022/1485 of 7 September 2022 postponing the expiry date of the approval of IPBC for use in biocidal products of product-type 8 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 233, 8.9.2022, p. 81 , ELI: http://data.europa.eu/eli/dec_impl/2022/1485/oj). further postponed the expiry date of the approval of IPBC for use in biocidal products of product-type 8 to 31 July 2025 due to the need of the evaluating competent authority to assess additional data requested from the applicant related to the criteria for the determination of endocrine-disrupting properties for non-target organisms.

(8) The evaluating competent authority submitted the renewal assessment report to the Agency on 5 July 2024 . The Agency plans to submit to the Commission an opinion on renewal of the approval of the active substance in the first quarter of 2025.

(9) Consequently, for reasons beyond the control of the applicant, the approval is likely to expire before a decision has been taken on its renewal. It is therefore appropriate to further postpone the expiry date of the approval for a period of time sufficient to enable the examination of the application. Taking into account the time-limits for preparation and submission by the Agency of its opinion and the time needed for the Commission to decide whether to renew the approval of IPBC for use in biocidal products of product-type 8, the expiry date should be postponed to 31 July 2026 .

(10) After the further postponement of the expiry date of the approval, IPBC remains approved for use in biocidal products of product-type 8 subject to the conditions set out in Annex I to Directive 98/8/EC,

This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1 , ELI: http://data.europa.eu/eli/dir/1998/8/oj).

Article 1 Article 1

Article 2 Article 2

Commission Implementing Decision (EU) 2019/1969 of 26 November 2019 postponing the expiry date of approval of IPBC for use in biocidal products of product-type 8 (OJ L 307, 28.11.2019, p. 45 , ELI: http://data.europa.eu/eli/dec_impl/2019/1969/oj).

Commission Implementing Decision (EU) 2022/1485 of 7 September 2022 postponing the expiry date of the approval of IPBC for use in biocidal products of product-type 8 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 233, 8.9.2022, p. 81 , ELI: http://data.europa.eu/eli/dec_impl/2022/1485/oj).

HAS ADOPTED THIS DECISION: