Commission Implementing Regulation (EU) 2025/1977 of 1 October 2025 granting a Union authorisation for the single biocidal product Aqua-Clean in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

Type Implementing Regulation
Publication 2025-10-01
State In force
Department European Commission, SANTE
Source EUR-Lex
Reform history JSON API

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 31 January 2017, Kanters Special Products B.V. 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 the single biocidal product ‘Aqua-Clean’ of product-types 2, 3 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-PT029767-00 in the Register for Biocidal Products.

(2) ‘Aqua-Clean’ contains hydrogen peroxide 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 29 August 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 21 March 2025, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘Aqua-Clean’ and the final assessment report on the single biocidal product, in accordance with Article 44(3) of Regulation (EU) No 528/2012.

(5) The opinion concludes that ‘Aqua-Clean’ is a single biocidal product within the meaning of Article 3(1), point (r), 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(1) of that Regulation.

(6) On 15 April 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 single biocidal product ‘Aqua-Clean’.

(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-0034622-0000 is hereby granted to Kanters Special Products B.V. for the making available on the market and use of the single biocidal product ‘Aqua-Clean’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 23 October 2025 until 30 September 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, 1 October 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) Opinion of 27 February 2025 on the Union authorisation of the single biocidal product ‘Aqua-Clean’ (ECHA/BPC/463/2025), https://echa.europa.eu/opinions-on-union-authorisation.

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