Commission Implementing Regulation (EU) 2026/299 of 9 February 2026 amending Implementing Regulation (EU) 2023/2703 as regards administrative changes to the Union authorisation of the single biocidal product EuLA oxi-lime 23

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 products (1), and in particular Article 50(2) thereof,

Whereas:

(1) On 4 December 2023, Commission Implementing Regulation (EU) 2023/2703 (2) granted a Union authorisation, under number EU-0028963-0000, to European Lime Association aisbl for the making available on the market and use of the single biocidal product ‘EuLA oxi-lime 23’. The Annex to that Implementing Regulation provides the summary of product characteristics for that single biocidal product.

(2) On 28 February 2024, European Lime Association aisbl submitted to the European Chemicals Agency (‘the Agency’), in accordance with Article 11(1) of Commission Implementing Regulation (EU) 354/2013 (3), a notification of administrative changes to the Union authorisation for the single biocidal product ‘EuLA oxi-lime 23’, recorded in the Register for Biocidal Products (‘Register’) under case number BC-PP093305-18. The notified proposed changes to that authorisation concern the inclusion of an active substance manufacturer and a biocidal product manufacturer.

(3) On 5 April 2024, the Agency submitted to the Commission, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013, an opinion (4) on the notified administrative changes to the Union authorisation for the single biocidal product ‘EuLA oxi-lime 23’. In its opinion, the Agency concluded 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, Sections 1 and 2 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 3 May 2024, the Agency transmitted to the Commission a revised summary of the product characteristics for the single biocidal product ‘EuLA oxi-lime 23’ in all official languages of the Union, covering the 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 single biocidal product ‘EuLA oxi-lime 23’ to introduce the administrative changes requested by European Lime Association aisbl.

(6) Except for the amendments regarding the proposed administrative changes, all other information included in the summary of the product characteristics of ‘EuLA oxi-lime 23’, as set out in the Annex to Implementing Regulation (EU) 2023/2703, 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 product characteristics which is to be published by the Agency, the Annex to Implementing Regulation (EU) 2023/2703 should be replaced in its entirety. Due to a change in the format used for the generation of the summary of product characteristics in the Register in February 2024, the summary of product characteristics in that Annex should also include some minor editorial and layout changes.

(8) Implementing Regulation (EU) 2023/2703 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Implementing Regulation (EU) 2023/2703 is replaced by the text set out in the Annex to this Regulation.

Article 2

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

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 9 February 2026.

For the Commission The President Ursula VON DER LEYEN

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

(2) Commission Implementing Regulation (EU) 2023/2703 of 4 December 2023 granting a Union authorisation for the single biocidal product EuLA oxi-lime 23 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L, 2023/2703, 5.12.2023, ELI: http://data.europa.eu/eli/reg_impl/2023/2703/oj).

(3) 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).

(4) ECHA Opinion No UAD-C-1724389-20-00/F of 5 April 2024 on the administrative changes of the Union authorisation of the single biocidal product ‘EuLA oxi-lime 23’, https://echa.europa.eu/opinions-on-applications-for-union-authorisation.