Commission Implementing Regulation (EU) 2025/975 of 16 May 2025 granting a Union authorisation for the biocidal product family Transfluthrin emanators UA BPF 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 29 October 2015, Henkel AG & Co. KGaA submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for Union authorisation of a biocidal product family named ‘Transfluthrin emanators UA BPF’ of product-type 18, 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-DT020592-32 in the Register for Biocidal Products.

(2) ‘Transfluthrin emanators UA BPF’ contains transfluthrin 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-type 18.

(3) On 3 June 2023, 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 10 October 2024, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘Transfluthrin emanators UA BPF’ 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 ‘Transfluthrin emanators UA BPF’ 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 24 October 2024, 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 ‘Transfluthrin emanators UA BPF’.

(8) In its opinion, the Agency recommends that the authorisation holder conducts a long-term storage stability test for the products in meta SPC 2 of ‘Transfluthrin emanators UA BPF’ to confirm a shelf-life of 24 months at ambient temperature. That test should be performed in the commercial packaging in which the products are to be made available on the market and address the relevant physical, chemical and technical properties of that product both prior to and after storage. The Commission agrees with that recommendation of the Agency 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 products of the biocidal product family ‘Transfluthrin emanators UA BPF’ 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:

Article 1

A Union authorisation with authorisation number EU-0033413-0000 is hereby granted to Henkel AG & Co. KGaA for the making available on the market and use of the biocidal product family ‘Transfluthrin emanators UA BPF’ subject to compliance with the terms and conditions set out in Annex I and in accordance with the summary of the biocidal product characteristics set out in Annex II.

The Union authorisation is valid from 12 June 2025 to 31 May 2035.

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 May 2025.

For the Commission The President Ursula VON DER LEYEN

(1) OJ L 167, 27.6.2012, p. 1.

(2) ECHA opinion of 18 September 2024 on the Union authorisation of Transfluthrin emanators UA BPF (ECHA/BPC/439/2024), https://echa.europa.eu/opinions-on-union-authorisation.