Commission Implementing Regulation (EU) 2024/2194 of 4 September 2024 amending Implementing Regulation (EU) 2020/1991 as regards administrative and minor changes to the Union authorisation for the biocidal product family perform-IPA
Commission Implementing Regulation (EU) 2024/2194of 4 September 2024amending Implementing Regulation (EU) 2020/1991 as regards administrative and minor changes to the Union authorisation for the biocidal product family perform-IPA(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 27 November 2020, a Union authorisation with authorisation number EU-0023656-0000 was granted to Schülke & Mayr GmbH for the making available on the market and use of the biocidal product family "perform IPA" by Commission Implementing Regulation (EU) 2020/1991Commission Implementing Regulation (EU) 2020/1991 of 27 November 2020 granting a Union authorisation for the biocidal product family "perform-IPA" (OJ L 410, 7.12.2020, p. 1; ELI: http://data.europa.eu/eli/reg_impl/2020/1991/oj).. The Annex to that Implementing Regulation provides the summary of product characteristics ("SPC") for the biocidal product family "perform-IPA" in accordance with Article 22 of Regulation (EU) No 528/2012.(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). provides for 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 are required to be amended.(3)On 20 December 2021, Schülke & Mayr GmbH submitted to the Agency a notification of administrative changes in accordance with Article 11(1) of Implementing Regulation (EU) No 354/2013, recorded in the register for biocidal products ("the Register") under case number BC-AB072184-64, and an application for a minor change in accordance with Article 12(1) of that Implementing Regulation, recorded in the Register under case number BC-SN072185-20, to the Union authorisation for the biocidal product family "perform-IPA". In respect of the administrative changes, Schülke & Mayr GmbH notified a change in the administrative details of two of the product formulators, the addition of five product formulators, the addition of a trade name in the section meta-SPC 1 of the SPC and the removal of a claim that products can be used in clean rooms class A/B in the sections meta-SPC 1 to 6 of the SPC. Regarding the minor change, Schülke & Mayr GmbH applied for a change of the pack-size range (all for the sections meta-SPC 1 and 3 of the SPC: extension of pack size range for canisters from 5-10 L to 5-30 L, addition of 200-220 L HDPE drums and addition of 900-1000 L containers (IBC)).(4)On 1 February 2023, Schülke & Mayr GmbH submitted to the Agency an application for a further minor change to the Union authorisation for the biocidal product family "perform-IPA" in accordance with Article 12(1) of Implementing Regulation (EU) No 354/2013, recorded in the Register under case number BC-NJ084251-38, for the addition of a claim for limited spectrum virucidal activity to all product-type 2 uses (disinfectants and algaecides not intended for direct application to humans and animals) in the sections meta-SPC 1 to 6 of the SPC.(5)On 11 February 2022, the Agency submitted an opinionECHA Opinion on the administrative change of the Union authorisation of the biocidal product family: perform-IPA of 11 February 2022, Opinion N° UAD-C-1560029-43-00/F, https://echa.europa.eu/opinions-on-union-authorisation. to the Commission on the notified administrative changes to the Union authorisation for the biocidal product family "perform-IPA", 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 proposed changes are administrative changes in accordance with Article 50(3), point (a), of Regulation (EU) No 528/2012 and as specified in Title 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 are still met. On 7 March 2022, the Agency transmitted to the Commission the revised summary of biocidal product characteristics of the Union authorisation for the biocidal product family "perform-IPA" in all official languages of the Union covering all administrative changes applied for, in accordance with Article 11(6) of Implementing Regulation (EU) No 354/2013.(6)On 10 October 2023, the Agency submitted its opinionsBiocidal Products Committee (BPC) opinion on the minor change to the Union authorisation of the biocidal product family "perform-IPA", 10 October 2023, ECHA/BPC/397/2023 and BPC opinion on the minor change to the Union authorisation of the biocidal product family "perform-IPA", 10 October 2023, ECHA/BPC/400/2023, https://echa.europa.eu/opinions-on-union-authorisation. to the Commission on the two applications for minor changes to the Union authorisation for the biocidal product family "perform-IPA", 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 concluding that the proposed changes are minor changes in accordance with Article 50(3), point (b), of Regulation (EU) No 528/2012 and as specified in Title 2 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 are still met.(7)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 "perform-IPA" in all official languages of the Union covering all administrative and minor changes applied for, in accordance with Article 12(6) of Implementing Regulation (EU) No 354/2013.(8)The Commission concurs with the opinions of the Agency and therefore considers it appropriate to amend the Union authorisation for the biocidal product family "perform-IPA" to introduce the administrative and minor changes requested by Schülke & Mayr GmbH.(9)Except for the amendments regarding the administrative and minor changes, all other information included in the summary of the biocidal product characteristics of "perform-IPA" as set out in the Annex to Implementing Regulation (EU) 2020/1991 remains unchanged.(10)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) 2020/1991 should be replaced in its entirety.(11)Implementing Regulation (EU) 2020/1991 should therefore be amended accordingly,HAS ADOPTED THIS REGULATION: