Commission Implementing Regulation (EU) 2026/488 of 4 March 2026 amending Implementing Regulation (EU) 2025/455 as regards minor change to the Union authorisation of the single biocidal product SatPax® 70/30 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 products (1), and in particular Article 50(2) thereof,

Whereas:

(1) On 7 March 2025, Commission Implementing Regulation (EU) 2025/455 (2) granted a Union authorisation, under number EU-0032869-0000, to CSI-Ireland for the making available on the market and use of the single biocidal product ‘SatPax® 70/30 IPA’. The Annex to that Implementing Regulation provides the summary of product characteristics for that biocidal product.

(2) On 30 April 2025, CSI-Ireland submitted to the European Chemicals Agency (‘Agency’), in accordance with Article 12(1) of Commission Implementing Regulation (EU) No 354/2013 (3), an application for a minor change to the Union authorisation of the single biocidal product ‘SatPax® 70/30 IPA’, as referred to in Title 2 of the Annex to that Regulation. The application was recorded in the Register for Biocidal Products (‘the Register’) under case number BC-QY105662-08. The proposed change to that authorisation concerns the extension of the shelf life of the product from 2 years to 3 years.

(3) On 9 September 2025, the Agency submitted to the Commission, in accordance with Article 12(4) of Implementing Regulation (EU) No 354/2013, an opinion (4) on the applied minor change to the Union authorisation of the single biocidal product ‘SatPax® 70/30 IPA’ together with a revised summary of product characteristics and a revised assessment report. The opinion concluded that the proposed change is a minor change as referred to in Article 50(3), point (b), of Regulation (EU) No 528/2012 and as specified in Title 2 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 10 September 2025, the Agency transmitted to the Commission the revised summary of product characteristics of the Union authorisation of the single biocidal product ‘SatPax® 70/30 IPA’ in all official languages of the Union, covering the minor change applied for, in accordance with Article 12(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 of the single biocidal product ‘SatPax® 70/30 IPA’ to introduce the minor change requested by CSI-Ireland.

(6) Except for the amendments regarding the proposed minor change, all other information included in the summary of product characteristics of ‘SatPax® 70/30 IPA’, as set out in the Annex to Implementing Regulation (EU) 2025/455, 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) 2025/455 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) 2025/455 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Implementing Regulation (EU) 2025/455 is replaced by the text 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, 4 March 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) 2025/455 of 7 March 2025 granting a Union authorisation for the single biocidal product ‘SatPax® 70/30’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L, 2025/455, 10.3.2025, ELI: http://data.europa.eu/eli/reg_impl/2025/455/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) Biocidal Products Committee (BPC) opinion on the minor change to the Union authorisation of the single biocidal product ‘SatPax® 70/30 IPA’ of 9 September 2025, ECHA/BPC/487/2025 https://echa.europa.eu/opinions-on-union-authorisation.