Commission Implementing Regulation (EU) 2025/930 of 21 May 2025 granting a Union authorisation for the single biocidal product Fernox Biocide AF10 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 22 June 2017, MacDermid Hungary Kft 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 ‘Fernox Biocide AF10’, of product-types 6, 11, 12 and 13, as described in Annex V to Regulation (EU) No 528/2012. The related reference product is the single biocidal product ‘No 06-05: Preservative 06-05’ (Authorisation number EU-0031652-0025), which is a part of the related reference biocidal product family ‘LANXESS CMIT/MIT biocidal product family’. The application was recorded under case number BC-UP032735-15 in the Register for Biocidal Products. The related reference biocidal product family ‘LANXESS CMIT/MIT biocidal product family’ was authorised by Commission Implementing Regulation (EU) 2024/2750 (3), with authorisation number EU-0031652-0000.

(2) The single biocidal product ‘Fernox Biocide AF10’ contains CMIT/MIT (3:1) 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 6, 11, 12 and 13.

(3) On 19 July 2024, the Agency submitted to the Commission its opinion (4) and the draft summary of the biocidal product characteristics (‘SPC’) of ‘Fernox Biocide AF10’ in accordance with Article 6 of Implementing Regulation (EU) No 414/2013.

(4) In its opinion, the Agency concludes that the proposed differences between the single biocidal product ‘Fernox Biocide AF10’ and the related single biocidal product ‘No 06-05: Preservative 06-05’, which is a part of the related reference biocidal product family ‘LANXESS CMIT/MIT biocidal product family’, are limited to information which can be subject to 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 ‘LANXESS CMIT/MIT biocidal product family’ and subject to compliance with the draft SPC, the same single biocidal product ‘Fernox Biocide AF10’ meets the conditions laid down in Article 19(1) of Regulation (EU) No 528/2012.

(5) On 10 January 2025, the Agency transmitted to the Commission the revised SPC of ‘Fernox Biocide AF10’ in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

(6) 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 ‘Fernox Biocide AF10’.

(7) The expiry date of the authorisation should be aligned with the expiry date of the authorisation of the related reference biocidal product family ‘LANXESS CMIT/MIT biocidal 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-0032996-0000 is granted to MacDermid Hungary Kft for the making available on the market and use of the same single biocidal product ‘Fernox Biocide AF10’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 11 June 2025 until 31 October 2034.

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, 21 May 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) 2024/2750 of 25 October 2024 granting a Union authorisation for the biocidal product family ‘LANXESS CMIT/MIT biocidal product family’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L, 2024/2750, 28.10.2024, ELI: http://data.europa.eu/eli/reg_impl/2024/2750/oj).

(4) European Chemicals Agency opinion of 19 July 2024 on the Union authorisation of the same single biocidal product ‘Fernox Biocide AF10’, 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).