Prováděcí nařízení Komise (EU) 2025/2215 ze dne 31. října 2025, kterým se mění prováděcí nařízení (EU) 2022/964, pokud jde o administrativní změny povolení Unie pro kategorii biocidních přípravků SOPUROXID

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 50(2) thereof,

The Annex to Implementing Regulation (EU) 2022/964 is replaced by the text set out in the Annex to this Regulation.

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

(1) On 10 June 2022 , Commission Implementing Regulation (EU) 2022/964Commission Implementing Regulation (EU) 2022/964 of 10 June 2022 granting a Union authorisation for the biocidal product family SOPUROXID (OJ L 166, 22.6.2022, p. 1 , ELI: http://data.europa.eu/eli/reg_impl/2022/964/oj). granted a Union authorisation, under number EU-0026179-0000, to SOPURA for the making available on the market and use of the biocidal product family SOPUROXID. The Annex to that Implementing Regulation provides a summary of the biocidal product characteristics for that biocidal product family.

(2) On 15 November 2022 , SOPURA submitted to the European Chemicals Agency (the Agency), in accordance with Article 11(1) of Commission Implementing Regulation (EU) No 354/2013Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4 , ELI: http://data.europa.eu/eli/reg_impl/2013/354/oj). , a notification of administrative changes to the Union authorisation for the biocidal product family SOPUROXID, as referred to in Title 1 of the Annex to that Regulation. The notification was recorded in the Register for Biocidal Products (the Register) under case number BC-TW081932-95. The notified proposed changes to that authorisation concern changes to the name of the biocidal product.

(3) On 9 January 2023 , the Agency submitted to the Commission, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013, an opinionECHA opinion UAD-C-1633880-27-00/F of 9 January 2023 on administrative changes of the Union authorisation of the biocidal product family SOPUROXID, https://echa.europa.eu/documents/10162/3443008/opinion_for_ua-admin_changes_bc-tw081932-95_en.pdf/7d0a4f78-9465-a87e-9c6e-5c0fb13cf6b2?t=1686103128867. on the notified administrative changes to the Union authorisation for the biocidal product family SOPUROXID. In the opinion, the Agency concludes that the proposed changes are administrative changes as referred to in Article 50(3), point (a), of Regulation (EU) No 528/2012 and as specified in Title 1, Section 1, of the Annex to Implementing Regulation (EU) No 354/2013, and that after the implementation of the changes, the conditions of Article 19 of Regulation (EU) No 528/2012 will still be met.

(4) On 9 January 2023 , the Agency transmitted to the Commission a revised summary of the biocidal product characteristics of the Union authorisation for the biocidal product family SOPUROXID in all official languages of the Union, covering all administrative changes applied for, in accordance with Article 11(6) of Implementing Regulation (EU) No 354/2013.

(5) The Commission concurs with the opinion of the Agency and therefore considers it appropriate to amend the Union authorisation for the biocidal product family SOPUROXID to introduce the administrative changes requested by SOPURA.

(6) Except for the amendments regarding the administrative changes, all other information included in the summary of the biocidal product characteristics of SOPUROXID as set out in the Annex to Implementing Regulation (EU) 2022/964 remains unchanged.

(7) In order to enhance clarity and to ease the access of users and interested parties to the consolidated version of the summary of the biocidal product characteristics which is to be published by the Agency, the Annex to Implementing Regulation (EU) 2022/964 should be replaced in its entirety. Due to a change in the format used for the generation of the summary of biocidal product characteristics in the Register in February 2024, the summary of biocidal product characteristics in that Annex should also include some minor editorial and layout changes.

(8) Implementing Regulation (EU) 2022/964 should therefore be amended accordingly,

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

Commission Implementing Regulation (EU) 2022/964 of 10 June 2022 granting a Union authorisation for the biocidal product family SOPUROXID (OJ L 166, 22.6.2022, p. 1 , ELI: http://data.europa.eu/eli/reg_impl/2022/964/oj).

Article 1 Article 1

Article 2 Article 2

Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4 , ELI: http://data.europa.eu/eli/reg_impl/2013/354/oj).

ECHA opinion UAD-C-1633880-27-00/F of 9 January 2023 on administrative changes of the Union authorisation of the biocidal product family SOPUROXID, https://echa.europa.eu/documents/10162/3443008/opinion_for_ua-admin_changes_bc-tw081932-95_en.pdf/7d0a4f78-9465-a87e-9c6e-5c0fb13cf6b2?t=1686103128867.

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