Commission Implementing Regulation (EU) 2024/2199 of 4 September 2024 amending Implementing Regulation (EU) 2021/1044 as regards administrative and minor changes to the Union authorisation for the single biocidal product Pesguard® Gel
Commission Implementing Regulation (EU) 2024/2199of 4 September 2024amending Implementing Regulation (EU) 2021/1044 as regards administrative and minor changes to the Union authorisation for the single biocidal product Pesguard® Gel(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 June 2021, a Union authorisation with authorisation number EU-0024951-0000 was granted to Sumitomo Chemical Agro Europe SAS for the making available on the market and use of the single biocidal product "Pesguard® Gel" by Commission 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" (OJ L 225, 25.6.2021, p. 54, ELI: http://data.europa.eu/eli/reg_impl/2021/1044/oj).. The Annex to that Implementing Regulation provides the summary of product characteristics ("SPC") for the single biocidal product "Pesguard® Gel" 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). 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 8 April 2022, Sumitomo Chemical Agro Europe SAS submitted to the Agency an application for a minor change to the Union authorisation for the single biocidal product "Pesguard® Gel" in accordance with Article 12(1) of Implementing Regulation (EU) No 354/2013, recorded in the register for biocidal products ("the Register") under case number BC-BL074962-31, for the increase of the concentration of two substances of concern in the product. In addition, the authorisation holder notified changes in the manufacturing site and administrative details of active substances manufacturers in accordance with Article 11(1) of that regulation.(4)On 31 July 2023, Sumitomo Chemical Agro Europe SAS submitted to the Agency a notification of further administrative change to add a trade name to the Union authorisation for the single biocidal product "Pesguard® Gel", in accordance with Article 11(1) of Implementing Regulation (EU) No 354/2013, recorded in the Register under case number BC-RB088051-50.(5)On 7 September 2023, the Agency submitted an opinionECHA Opinion on the administrative change of the Union authorisation of the single biocidal product "Pesguard® Gel" of 7 September 2023, Opinion N° UAD-C-1680571-32-00/F (https://echa.europa.eu/opinions-on-union-authorisation). to the Commission on the notified administrative change to the Union authorisation for the single biocidal product "Pesguard® Gel" of 31 July 2023, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013, together with a revised SPC. The opinion concludes that the proposed addition of a new trade name is an administrative change in accordance with Article 3(1), point (aa), 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 change, the conditions of Article 19 of Regulation (EU) No 528/2012 will still be met.(6)On 9 October 2023, the Agency submitted an opinionBiocidal Products Committee (BPC) opinion on the minor change to the Union authorisation of the single biocidal product "Pesguard® Gel" of 9 October 2023, ECHA/BPC/395/2023 (https://echa.europa.eu/opinions-on-union-authorisation). to the Commission on the application for minor changes to the Union authorisation for the biocidal product "Pesguard® Gel" of 8 April 2022, in accordance with Article 12(4) of Implementing Regulation (EU) No 354/2013, together with a revised SPC and a revised assessment report. This opinion concluded that the increase of the concentration of two substances of concern in the product is not a minor change in accordance with Article 3(1), point (ab), of Regulation (EU) No 528/2012 and as specified in Title 2 of the Annex to Implementing Regulation (EU) No 354/2013. However, the Agency concluded that the changes related to the addition of a new manufacturing site for the active substance chlothianidin and a change in the address of the manufacturer of the two active substances are administrative changes in accordance with Article 3(1), point (aa), of Regulation (EU) No 528/2012 as specified in Title 1 of the Annex to Implementing Regulation (EU) No 354/2013, and that after the implementation of those changes, the conditions of Article 19 of Regulation (EU) No 528/2012 will still be met.(7)On 10 November 2023, the Agency transmitted to the Commission the revised SPC of the Union authorisation for single the biocidal product "Pesguard® Gel" 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.(8)The Commission concurs with the opinions of the Agency and therefore considers it appropriate to amend the Union authorisation for the single biocidal product "Pesguard® Gel" to introduce the administrative changes requested by Sumitomo Chemical Agro Europe SAS and supported by the Agency.(9)The application for the increase of the concentration of two substances of concern in the product cannot be considered as a minor change in accordance with Article 3(1), point (ab), of Regulation (EU) No 528/2012 and as specified in Title 2, point 1, of the Annex to Implementing Regulation (EU) No 354/2013. Such a change would be a major change, for which an application for major change, in accordance with Article 13 of Implementing Regulation (EU) No 354/2013, would be necessary in order to ensure its appropriate evaluation. Due to the absence of such assessment, the Commission cannot determine whether the conditions of Article 19 of Regulation (EU) No 528/2012 would still be met and whether the authorisation could be amended. This part of the application for the increase of the concentration of two substances of concern should therefore be rejected.(10)Except for the amendments regarding the administrative changes, all other information included in the SPC of "Pesguard® Gel" as set out in the Annex to Implementing Regulation (EU) 2021/1044 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 SPC which is to be published by the Agency, the Annex to Implementing Regulation (EU) 2021/1044 should be replaced in its entirety.(12)Implementing Regulation (EU) 2021/1044 should therefore be amended accordingly,HAS ADOPTED THIS REGULATION: