Commission Implementing Regulation (EU) 2025/1876 of 16 September 2025 granting a Union authorisation for the single biocidal product Septihol IPA products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

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 44(5), first subparagraph, thereof,

Whereas:

(1) On 18 December 2024, STERIS Ireland Limited submitted an application to the European Chemicals Agency (‘the Agency’) in accordance with Article 43(1) of Regulation (EU) No 528/2012 and Article 4 of Commission Implementing Regulation (EU) No 414/2013 (2) for Union authorisation of the same single biocidal product, as referred to in Article 1 of Implementing Regulation (EU) No 414/2013, named ‘Septihol IPA products’, of product-types 2 and 4, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-TY101997-90 in the Register for Biocidal Products. The application referred to the single biocidal product ‘Isopropanol 70 Biocide’ (authorisation number EU-0027707-0022), which is a part of the related reference biocidal product family ‘Brenntag GmbH Propan-2-ol Product Family’, authorised by Commission Implementing Regulation (EU) (EU) 2022/2252 (3), (authorisation number EU-0027707-0000).

(2) The single biocidal product ‘Septihol IPA products’ contains propan-2-ol as the active substance, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 2 and 4.

(3) On 24 January 2025, the Agency submitted to the Commission its opinion (4),in accordance with Article 6 of Implementing Regulation (EU) No 414/2013, and the draft summary of the biocidal product characteristics (‘SPC’) of ‘Septihol IPA products’ in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

(4) In its opinion, the Agency concludes that the proposed differences between the single biocidal product ‘Septihol IPA products’ and the related single reference biocidal product ‘Isopropanol 70 Biocide’, which is a part of the related reference biocidal product family ‘Brenntag GmbH Propan-2-ol Product Family’ are limited to information which can be the subject of an administrative change in accordance with Commission Implementing Regulation (EU) No 354/2013 (5), and that based on the assessment of the related reference biocidal product family ‘Brenntag GmbH Propan-2-ol Product Family’ and subject to compliance with the draft SPC, the same single biocidal product ‘Septihol IPA products’ meets the conditions laid down in Article 19(1) of Regulation (EU) No 528/2012.

(5) The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the same single biocidal product ‘Septihol IPA products’.

(6) The expiry date of the authorisation should be aligned with the expiry date of the authorisation of the related reference biocidal product family ‘Brenntag GmbH Propan-2-ol Product Family’.

(7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS REGULATION:

Article 1

A Union authorisation with authorisation number EU-0034093-0000 is hereby granted to STERIS Ireland Limited for the making available on the market and use of the same single biocidal product ‘Septihol IPA products’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 7 October 2025 until 30 November 2032.

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, 16 September 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) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 125, 7.5.2013, p. 4, ELI: http://data.europa.eu/eli/reg_impl/2013/414/oj).

(3) Commission Implementing Regulation (EU) 2022/2252 of 11 November 2022 granting a Union authorisation for the biocidal product family ‘Brenntag GmbH Propan-2-ol Product Family’ (OJ L 297, 17.11.2022, p. 1, ELI: http://data.europa.eu/eli/reg_impl/2022/2252/oj).

(4) European Chemicals Agency opinion of 24 January 2025 on the Union authorisation of the same single biocidal product ‘Septihol IPA products’, https://echa.europa.eu/opinions-on-union-authorisation.

(5) 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).