Prováděcí nařízení Komise (EU) 2025/2553 ze dne 17. prosince 2025, kterým se mění prováděcí nařízení (EU) 2020/1147, pokud jde o administrativní změny povolení Unie pro jednotlivý biocidní přípravek ClearKlens product based on IPA

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) 2020/1147 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 31 July 2020 , Commission Implementing Regulation (EU) 2020/1147Commission Implementing Regulation (EU) 2020/1147 of 31 July 2020 granting a Union authorisation for the single biocidal product ClearKlens product based on IPA (OJ L 252, 4.8.2020, p. 1 , ELI: http://data.europa.eu/eli/reg_impl/2020/1147/oj). granted a Union authorisation, under number EU-0022128-0000, to Diversey Europe Operations B.V. for the making available on the market and use of the single biocidal product ClearKlens product based on IPA. Annex to that Implementing Regulation provides the summary of product characteristics for that single biocidal product.

(2) On 21 October 2021 , Diversey Europe Operations B.V. 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 change to the Union authorisation for the single biocidal product ClearKlens product based on IPA, recorded in the register for biocidal products under case number BC-DN070816-28. The notified proposed change concern the addition of a manufacturer of the active substance.

(3) On 10 November 2021 , the Agency submitted to the Commission, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013, an opinionECHA opinion UAD-C-1543546-33-00/F of 10 November 2021 on administrative changes of the Union authorisation of the single biocidal product ClearKlens product based on IPA, https://echa.europa.eu/opinions-on-union-authorisation. on the notified administrative change to the Union authorisation for the single biocidal product ClearKlens product based on IPA. In the opinion, the Agency concludes that the proposed change is an administrative change 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 change, the conditions of Article 19 of Regulation (EU) No 528/2012 will still be met.

(4) On 3 January 2022 , the Agency transmitted to the Commission the revised summary of the biocidal product characteristics of the Union authorisation for the single biocidal product ClearKlens product based on IPA in all official languages of the Union, covering the administrative change 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 single biocidal product ClearKlens product based on IPA to introduce the administrative change requested by Diversey Europe Operations B.V.

(6) Except for the amendments regarding the administrative change, all other information included in the summary of the biocidal product characteristics of ClearKlens product based on IPA as set out in Annex to Implementing Regulation (EU) 2020/1147 remain 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) 2020/1147 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 for biocidal products 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) No 2020/1147 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) 2020/1147 of 31 July 2020 granting a Union authorisation for the single biocidal product ClearKlens product based on IPA (OJ L 252, 4.8.2020, p. 1 , ELI: http://data.europa.eu/eli/reg_impl/2020/1147/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-1543546-33-00/F of 10 November 2021 on administrative changes of the Union authorisation of the single biocidal product ClearKlens product based on IPA, https://echa.europa.eu/opinions-on-union-authorisation.

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