Prováděcí nařízení Komise (EU) 2025/2288 ze dne 13. listopadu 2025, kterým se mění prováděcí nařízení (EU) 2021/1044, pokud jde o významnou změnu povolení Unie pro jednotlivý biocidní přípravek Pesguard® Gel 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 50(2) thereof,

The Annex to Implementing Regulation (EU) 2021/1044 is replaced by the Annex to this Regulation.

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

(1) On 22 June 2021 , the Commission by means of its Implementing Regulation (EU) 2021/1044Commission Implementing Regulation (EU) 2021/1044 of 22 June 2021 granting a Union authorisation for the single biocidal product Pesguard® Gel in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 225, 25.6.2021, p. 54 , ELI: http://data.europa.eu/eli/reg_impl/2021/1044/oj). granted a Union authorisation, under number EU-0024951-0000, to Sumitomo Chemical Agro Europe SAS for the making available on the market and use of the single biocidal product Pesguard® Gel. The Annex to that Implementing Regulation provides a summary of biocidal product characteristics for that single biocidal product

(2) On 21 March 2023 , Sumitomo Chemical Agro Europe SAS submitted to the European Chemicals Agency (the Agency), in accordance with Article 13(1) of Commission Implementing Regulation (EU) No 354/2013Commission 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). , an application for a major change to the Union authorisation for the single biocidal product Pesguard® Gel, as referred to in Title 3 of the Annex to that Regulation. The proposed change to that authorisation concerns a change to the composition of the non-active ingredients.

(3) On 5 March 2025 , the evaluating competent authority submitted, in accordance with Article 13(5), first subparagraph, of Implementing Regulation (EU) No 354/2013, an assessment report and the conclusions of its evaluation to the Agency.

(4) On 5 June 2025 , the Agency submitted to the Commission, in accordance with Article 13(7) of Implementing Regulation (EU) No 354/2013, an opinionBiocidal Products Committee (BPC) opinion of 15 May 2025 on the major change of the Union authorisation of the biocidal product Pesguard® Gel (ECHA/BPC/480/2025). Available online: https://echa.europa.eu/de/opinions-on-union-authorisation. on the major change to the Union authorisation of the single biocidal product Pesguard® Gel, together with a revised summary of the biocidal product characteristics and a revised assessment report. In the opinion, the Agency concludes that the proposed change is a major change as referred to in Article 50(3), point (c), of Regulation (EU) No 528/2012 and as specified in Title 3 of the Annex to Implementing Regulation (EU) No 354/2013, and that, after the implementation of the change, the conditions of Article 19 of Regulation (EU) No 528/2012 will still be met.

(5) On 26 June 2025 , the Agency transmitted to the Commission the revised summary of the biocidal product characteristics of the Union authorisation for the single biocidal product Pesguard® Gel, in all official languages of the Union, covering the major change applied for, in accordance with Article 13(8) of Implementing Regulation (EU) No 354/2013.

(6) The Commission concurs with the opinion of the Agency that the conditions of Article 19 of Regulation (EU) No 528/2012 will still be met if the major change is implemented and therefore considers it appropriate to amend the Union authorisation for the single biocidal product Pesguard® Gel to introduce the major change requested by Sumitomo Chemical Agro Europe SAS.

(7) Except for the amendments regarding the major change, all other information included in the summary of the biocidal product characteristics of Pesguard® Gel, as set out in the Annex to Implementing Regulation (EU) 2021/1044, remains unchanged.

(8) In order to enhance clarity and to ease the access of users and interested parties to the final consolidated version of the summary of the biocidal product characteristics which is to be published by the Agency, the Annex to Implementing Regulation (EU) 2021/1044 should be replaced in its entirety. Due to a change in the format used for the generation of the summary of biocidal product characteristics in the register for biocidal products in February 2024, that summary as it is to appear in that Annex should also include some minor editorial and layout changes.

(9) Implementing Regulation (EU) 2021/1044 should therefore be amended accordingly,

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

Commission Implementing Regulation (EU) 2021/1044 of 22 June 2021 granting a Union authorisation for the single biocidal product Pesguard® Gel in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 225, 25.6.2021, p. 54 , ELI: http://data.europa.eu/eli/reg_impl/2021/1044/oj).

Article 1 Article 1

Article 2 Article 2

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).

Biocidal Products Committee (BPC) opinion of 15 May 2025 on the major change of the Union authorisation of the biocidal product Pesguard® Gel (ECHA/BPC/480/2025). Available online: https://echa.europa.eu/de/opinions-on-union-authorisation.

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