Commission Implementing Regulation (EU) 2024/2209 of 5 September 2024 amending Implementing Regulation (EU) 2022/1423 as regards administrative and minor changes to the Union authorisation for the biocidal product family Hydrogen Peroxide Family 1
Commission Implementing Regulation (EU) 2024/2209of 5 September 2024amending Implementing Regulation (EU) 2022/1423 as regards administrative and minor changes to the Union authorisation for the biocidal product family Hydrogen Peroxide Family 1(Text with EEA relevance)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,Whereas:(1)On 22 July 2022, Commission Implementing Regulation (EU) 2022/1423Commission Implementing Regulation (EU) 2022/1423 of 22 July 2022 granting a Union authorisation for the biocidal product family "Hydrogen Peroxide Family 1" (OJ L 222, 26.8.2022, p. 1; ELI: http://data.europa.eu/eli/reg_impl/2022/1423/oj). granted a Union authorisation with authorisation number EU-0024303-0000 to Ecolab Deutschland GmbH for the making available on the market and use of the biocidal product family "Hydrogen Peroxide Family 1".(2)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). lays down the procedural rules for the different categories of changes referred to in Article 50(3) of Regulation (EU) No 528/2012. On receipt of an opinion from the European Chemicals Agency ("the Agency") on an application from an authorisation holder of a Union authorisation seeking to change any of the information submitted for the initial application for authorisation, the Commission is to decide whether the conditions of Article 19 or, where relevant, Article 25 of Regulation (EU) No 528/2012, are still met and whether the terms and conditions of the authorisation need to be amended.(3)On 28 September 2022, Ecolab Deutschland GmbH submitted a notification to the Agency, in accordance with Article 11(1) of Implementing Regulation (EU) No 354/2013, regarding administrative changes to the Union authorisation for the biocidal product family "Hydrogen Peroxide Family 1", as referred to in Title 1 of the Annex to that Regulation. Ecolab Deutschland GmbH proposed the addition of trade names for five biocidal products of the family, the addition of four product manufacturers and a change in the administrative details of two of the product manufacturers. The notification was recorded under the case number BC-RU080137-08 in the Register for Biocidal Products ("the Register").(4)On 13 October 2022, Ecolab Deutschland GmbH submitted an application to the Agency, in accordance with Article 12(1) of Implementing Regulation (EU) No 354/2013, for a minor change to the Union authorisation for the biocidal product family "Hydrogen Peroxide Family 1", as referred to in Title 2 of the Annex to that Regulation. Ecolab Deutschland GmbH applied for the extension of the shelf-life from 6 months to 18 months for the products in meta summary of biocidal product characteristics (SPC) 8. The application was recorded in the Register under case number BC-SX080682-96.(5)On 5 December 2022, Ecolab Deutschland GmbH submitted a further application to the Agency, in accordance with Article 12(1) of Implementing Regulation (EU) No 354/2013, for a minor change to the Union authorisation for the biocidal product family "Hydrogen Peroxide Family 1". In that application Ecolab Deutschland GmbH asked for the addition of several packaging materials and pack sizes for the products in meta SPC 1, 5 and 11, addition of new wipe material for the products in meta SPC 1 and the removal of one packaging material for the products in meta SPC 1. The application was recorded in the Register under case number BC-SR082474-07.(6)On 4 November 2022, the Agency submitted an opinionECHA Opinion of 4 November 2022 on the administrative change of the Union authorisation of the biocidal product family Hydrogen Peroxide Family 1, Opinion N° UAD-C-1622642-38-00/F, https://echa.europa.eu/documents/10162/3443008/opinion_for_ua-admin_changes_bc-ru080137-08_en.pdf/469baca4-81c1-8874-38b5-9c2527e91b22?t=1686113940831. on the notified administrative changes to the Commission, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013, together with a revised summary of the biocidal product characteristics. The opinion concludes that the amendments to the existing authorisation sought by the authorisation holder fall under Article 3(1), point (aa), of Regulation (EU) No 528/2012, and that after the implementation of the changes the conditions of Article 19 of that Regulation are still met.(7)On 11 October 2023, the Agency submitted the opinions of the Biocidal Products CommitteeOpinion of the Biocidal Products Committee of 10 October 2023 on the minor change to the Union authorisation of the biocidal product family "Hydrogen Peroxide Family 1", ECHA/BPC/398/2023, https://echa.europa.eu/documents/10162/79839763/hydrogen_peroxide_fam1_ua_mic_bc_SX080682_96_final_bpc_opinion_en.pdf/cd4031f2-7320-012f-abf1-f2a3cde1b836?t=1714715369299, and Opinion of the Biocidal Products Committee of 10 October 2023 on the minor change to the Union authorisation of the biocidal product family "Hydrogen Peroxide Family 1", ECHA/BPC/399/2023, https://echa.europa.eu/documents/10162/3443008/hydrogen_peroxide_fam1_ua_mic_bc_SR082474_07_final_bpc_opinion_en.pdf/f2800274-60a5-ec70-011b-57a6ab561b7e?t=1714716331548. on the two applications for minor changes to the Commission, in accordance with Article 12(4) of Implementing Regulation (EU) No 354/2013, together with a revised summary of the biocidal product characteristics and a revised assessment report. Both opinions conclude that after the implementation of the changes the conditions of Article 19 of Regulation (EU) No 528/2012 are still met.(8)On 10 November 2023, the Agency transmitted to the Commission the revised summary of biocidal product characteristics of the Union authorisation for the biocidal product family "Hydrogen Peroxide Family 1" in all official languages of the Union covering all administrative and minor changes notified and applied for, in accordance with Article 11(6) and Article 12(6) of Implementing Regulation (EU) No 354/2013.(9)The Commission concurs with the opinions of the Agency and therefore considers it appropriate to amend the Union authorisation for the biocidal product family "Hydrogen Peroxide Family 1" to introduce the administrative and minor changes requested by Ecolab Deutschland GmbH.(10)Except for the amendments regarding the administrative and minor changes, all other information included in the summary of the biocidal product characteristics of "Hydrogen Peroxide Family 1" as set out in the Annex to Implementing Regulation (EU) 2022/1423 remains unchanged.(11)In order to enhance clarity and to ease the access of users and interested parties to the final consolidated version of the summary of biocidal product characteristics which is to be published by the Agency, the Annex to Implementing Regulation (EU) 2022/1423 should be replaced in its entirety.(12)Implementing Regulation (EU) 2022/1423 should therefore be amended accordingly,HAS ADOPTED THIS REGULATION: