Prováděcí nařízení Komise (EU) 2026/367 ze dne 19. února 2026, kterým se mění prováděcí nařízení (EU) 2019/2030, pokud jde o administrativní změny v povolení Unie pro kategorii biocidních přípravků PAL IPA PRODUCT FAMILY

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) 2019/2030 is replaced by the text in 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 29 November 2019 , Commission Implementing Regulation (EU) 2019/2030Commission Implementing Regulation (EU) 2019/2030 of 29 November 2019 granting a Union authorisation for the biocidal product family PAL IPA PRODUCT FAMILY (OJ L 313, 4.12.2019, p. 51 , ELI: http://data.europa.eu/eli/reg_impl/2019/2030/oj). granted a Union authorisation, under number EU-0020463-0000, to Pal Hygiene Products Limited for the making available on the market and use of the biocidal product family Pal IPA Product Family. The Annex to that Implementing Regulation provides the summary of product characteristics for that biocidal product family.

(2) On 17 October 2024 , Pal Hygiene Products Limited submitted notification to the European Chemicals Agency (the Agency), in accordance with Article 11(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). , of administrative changes to the Union authorisation of the biocidal product family PAL IPA PRODUCT FAMILY, as referred to in Title 1 of the Annex to that Regulation. The notification was recorded in the Register for Biocidal Products (the Register) under case number BC-KT100508-25. The notified proposed changes to that authorisation concern the addition of trade names and a change in the address of the manufacturing location of the biocidal product and the manufacturer.

(3) On 11 November 2024 , the Agency submitted to the Commission, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013, an opinionECHA Opinion No UAD-C-1775477-16-00/F of 11 November 2024 on the administrative change of the Union authorisation of the biocidal product family PAL IPA PRODUCT FAMILY, https://echa.europa.eu/opinions-on-union-authorisation. on the notified administrative changes to the Union authorisation of the biocidal product family PAL IPA PRODUCT FAMILY, together with a revised summary of product characteristics. In its opinion, the Agency concluded that the proposed changes are administrative changes as referred to in Article 50(3), point (a), of Regulation (EU) No 528/2012 and as specified in Title 1, Section 1, of the Annex to Implementing Regulation (EU) No 354/2013, and that, after the implementation of the changes, the conditions of Article 19 of Regulation (EU) No 528/2012 will still be met.

(4) On 11 November 2024 , the Agency transmitted to the Commission a revised summary of product characteristics of the Union authorisation of the biocidal product family PAL IPA PRODUCT FAMILY in all official languages of the Union, covering all the administrative changes applied for, in accordance with Article 11(6) of Implementing Regulation (EU) No 354/2013.

(5) The Commission concurs with the opinion of the Agency and therefore considers it appropriate to amend the Union authorisation of the biocidal product family PAL IPA PRODUCT FAMILY to introduce the administrative changes requested by Pal Hygiene Products Limited.

(6) Except for the amendments regarding the proposed administrative changes, all other information included in the summary of product characteristics of PAL IPA PRODUCT FAMILY, as set out in the Annex to Implementing Regulation (EU) 2019/2030, remains unchanged.

(7) In order to enhance clarity and to ease the access of users and interested parties to the consolidated version of the summary of product characteristics which is to be published by the Agency, the Annex to Implementing Regulation (EU) 2019/2030 should be replaced in its entirety. Due to a change in the format used for the generation of the summary of product characteristics in the Register in February 2024, the summary of product characteristics in that Annex should also include some minor editorial and layout changes.

(8) Implementing Regulation (EU) 2019/2030 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) 2019/2030 of 29 November 2019 granting a Union authorisation for the biocidal product family PAL IPA PRODUCT FAMILY (OJ L 313, 4.12.2019, p. 51 , ELI: http://data.europa.eu/eli/reg_impl/2019/2030/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).

ECHA Opinion No UAD-C-1775477-16-00/F of 11 November 2024 on the administrative change of the Union authorisation of the biocidal product family PAL IPA PRODUCT FAMILY, https://echa.europa.eu/opinions-on-union-authorisation.

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