Commission Implementing Regulation (EU) 2025/2104 of 21 October 2025 amending Implementing Regulation (EU) 2019/2029 as regards administrative changes to the Union authorisation for the single biocidal product CVAS Disinfectant product based on Propan-2-ol

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 29 November 2019, Commission Implementing Regulation (EU) 2019/2029 (2) granted a Union authorisation, under number EU-0020461-0000, to CVAS Development GmbH for the making available on the market and use of the single biocidal product ‘CVAS Disinfectant product based on Propan-2-ol’. The Annex to that Implementing Regulation provides a summary of product characteristics for that single biocidal product.

(2) On 30 November 2022 and 11 February 2025, CVAS Development GmbH submitted to the European Chemicals Agency (‘the Agency’), in accordance with Article 11(1) of Commission Implementing Regulation (EU) No 354/2013 (3), notifications of administrative changes to the Union authorisation for the single biocidal product ‘CVAS Disinfectant product based on Propan-2-ol’, as referred to in Title 1 of the Annex to that Regulation. The notifications were recorded in the Register for Biocidal Products (‘Register’) under case numbers BC-QB082302-54 and BC-CC104178-64. The notified proposed changes to that authorisation concern changes to the address of the authorisation holder, changes to the address of one of the manufacturers of the biocidal product and the addition of two production sites.

(3) On 10 January 2023 and 18 March 2025, the Agency submitted to the Commission, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013, opinions (4) on the notified administrative changes to the Union authorisation for the single biocidal product ‘CVAS Disinfectant product based on Propan-2-ol’. In the opinions, 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, 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 18 March 2025, the Agency transmitted to the Commission a revised summary of the biocidal product characteristics of the Union authorisation for the single biocidal product ‘CVAS Disinfectant product based on Propan-2-ol’ 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 opinions of the Agency and therefore considers it appropriate to amend the Union authorisation for the single biocidal product ‘CVAS Disinfectant product based on Propan-2-ol’ to introduce the administrative changes requested by CVAS Development GmbH.

(6) Except for the amendments regarding the administrative changes, all other information included in the summary of the biocidal product characteristics of ‘CVAS Disinfectant product based on Propan-2-ol’ as set out in Annex to Implementing Regulation (EU) 2019/2029 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) 2019/2029 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) 2019/2029 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Implementing Regulation (EU) 2019/2029 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, 21 October 2025.

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) 2019/2029 of 29 November 2019 granting a Union authorisation for the single biocidal product ‘CVAS Disinfectant product based on Propan-2-ol’ (OJ L 313, 4.12.2019, p. 41, ELI: http://data.europa.eu/eli/reg_impl/2019/2029/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 opinions of 10 January 2023 and 18 March 2025 on administrative changes of the Union authorisation of the single biocidal product ‘CVAS Disinfectant product based on Propan-2-ol’, Opinions Nos UAD-C-1635714-34-00/F and UAD-C-1810381-35-00/F https://echa.europa.eu/documents/10162/3443008/opinion_for_ua-admin_changes_bc-qb082302-54_en.pdf/4d1b6b3f-e7d9-1891-c6f8-d33708602bd0?t=1686103139710 and https://echa.europa.eu/documents/10162/95571017/ua_adc_echa-opinion_bc-cc104178-64_en.pdf/cbae0e96-6933-67ee-5d70-0da3e1fd6a0e?t=1742289737846.