Prováděcí nařízení Komise (EU) 2026/829 ze dne 10. dubna 2026 o udělení povolení Unie pro jednotlivý biocidní přípravek Bioxal – Soproper v souladu s nařízením Evropského parlamentu a Rady (EU) č. 528/2012

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 productsOJ L 167, 27.6.2012, p. 1 , ELI: http://data.europa.eu/eli/reg/2012/528/oj. , and in particular Article 44(5), first subparagraph, thereof,

A Union authorisation with authorisation number EU-0035787-0000 is hereby granted to BIOXAL SA for the making available on the market and use of the single biocidal product Bioxal – Soproper in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 6 May 2026 until 30 April 2036 .

OJ L 167, 27.6.2012, p. 1 , ELI: http://data.europa.eu/eli/reg/2012/528/oj.

(1) On 30 September 2020 , BIOXAL SA 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 single biocidal product named Bioxal – Soproper of product-type 2, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Germany had agreed to evaluate the application. The application was recorded under case number BC-YH062085-30 in the Register for Biocidal Products.

(2) Bioxal – Soproper 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-type 2.

(3) On 21 February 2025 , 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 25 September 2025 , the Agency submitted to the Commission its opinionECHA opinion of 10 September 2025 on the Union authorisation of the biocidal product Bioxal – Soproper (ECHA/BPC/494/2025), https://echa.europa.eu/opinions-on-union-authorisation. , the draft summary of the biocidal product characteristics (SPC) of Bioxal – Soproper 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 Bioxal – Soproper 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 10 October 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 Bioxal – Soproper.

(8) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

ECHA opinion of 10 September 2025 on the Union authorisation of the biocidal product Bioxal – Soproper (ECHA/BPC/494/2025), https://echa.europa.eu/opinions-on-union-authorisation.

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HAS ADOPTED THIS REGULATION: