Commission Implementing Regulation (EU) 2024/1653 of 4 June 2024 granting a Union authorisation for the biocidal product family Thonhauser PAA 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 27 September 2017, THONHAUSER GmbH submitted to the European Chemicals Agency (‘the Agency’) an application 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 biocidal product family, as referred to in Article 1 of Implementing Regulation (EU) No 414/2013, named ‘Thonhauser PAA’, of product-types 2, 3 and 4, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-CN034171-51 in the Register for Biocidal Products (‘the Register’). The application also indicated the application number of the related reference biocidal product family ‘Airedale PAA product family’, later authorised by Commission Implementing Regulation (EU) 2023/1200 (3), recorded in the Register under case number BC-EW057176-14.

(2) The same biocidal product family ‘Thonhauser PAA’ contains peracetic acid 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, 3 and 4.

(3) On 14 October 2022, the Agency submitted to the Commission its opinion (4) and the draft summary of the biocidal product characteristics (‘SPC’) of ‘Thonhauser PAA’ in accordance with Article 6(1) and (2) of Implementing Regulation (EU) No 414/2013.

(4) In its opinion, the Agency concludes that the proposed differences between ‘Thonhauser PAA’ and the biocidal product family ‘Airedale PAA product family’ are limited to information which can be the subject of an administrative change in accordance with Article 11 of Commission Implementing Regulation (EU) No 354/2013 (5), and that based on the assessment of the related reference biocidal product family ‘Airedale PAA product family’ and subject to compliance with the draft SPC, ‘Thonhauser PAA’ meets the conditions laid down in Article 19(1) and (6) of Regulation (EU) No 528/2012.

(5) On 21 December 2023, the Agency transmitted to the Commission the draft SPC of ‘Thonhauser PAA’ in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012 and based on the SPC of the related reference biocidal product family ‘Airedale PAA product family’.

(6) The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the same biocidal product family ‘Thonhauser PAA’.

(7) The expiry date of this authorisation is aligned to the expiry date of the authorisation of the related reference biocidal product family ‘Airedale PAA product family’.

(8) 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-0029721-0000 is hereby granted to THONHAUSER GmbH for the making available on the market and use of the same biocidal product family ‘Thonhauser PAA’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 27 June 2024 until 30 June 2033.

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 June 2024.

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) 2023/1200 of 21 June 2023 granting a Union authorisation for the biocidal product family ‘Airedale PAA product family’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 159, 22.6.2023, p. 3, ELI: http://data.europa.eu/eli/reg_impl/2023/1200/oj)

(4) ECHA opinion of 14.10.2022 on the Union authorisation of the same biocidal product family ‘Thonhauser PAA’, Opinion number UBP-C-1616217-22-00/F, 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)