Commission Implementing Regulation (EU) 2025/2074 of 16 October 2025 granting a Union authorisation for the biocidal product family B. Braun Medical Propanol Family 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 12 April 2019, B. Braun Medical AG submitted an application to the European Chemicals Agency (‘the Agency’) in accordance with Article 43(1) of Regulation (EU) No 528/2012 for Union authorisation of a biocidal product family named ‘B. Braun Medical Propanol Family’ of product-types 1, 2 and 4 as described in Annex V to that Regulation, providing written confirmation that the competent authority of the Netherlands had agreed to evaluate the application. The application was recorded under case number BC-CP050930-37 in the Register for Biocidal Products.

2. ‘B. Braun Medical Propanol Family’ contains propan-1-ol and propan-2-ol as the active substances, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 1, 2 and 4.

3. On 7 June 2024, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency.

4. On 13 December 2024, the Agency submitted to the Commission its opinion⁽²⁾, the draft summary of the biocidal product characteristics (‘SPC’) of ‘B. Braun Medical Propanol Family’ and the final assessment report on the biocidal product family, in accordance with Article 44(3) of Regulation (EU) No 528/2012.

5. The opinion concludes that ‘B. Braun Medical Propanol Family’ is a biocidal product family within the meaning of Article 3(1), point (s), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that, subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(6) of that Regulation.

6. On 8 January 2025, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

7. The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the biocidal product family ‘B. Braun Medical Propanol Family’.

8. In its opinion, the Agency recommends that the authorisation holder conducts a long-term storage stability test as a condition in the authorisation to confirm the storage stability. The Commission agrees with that recommendation and considers that the submission of the results of that test should be a condition relating to the making available on the market and use of the biocidal product family pursuant to Article 22(1) of Regulation (EU) No 528/2012. The Commission also considers that the fact that data is to be provided after the authorisation is granted does not affect the conclusion on the fulfilment of the condition under Article 19(1), point (d), of that Regulation based on existing data.

9. The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS REGULATION: