Commission Implementing Regulation (EU) 2024/2679 of 15 October 2024 amending Implementing Regulation (EU) 2019/2076 as regards administrative and minor changes to the Union authorisation for the biocidal product family Contec IPA Product Family
Commission Implementing Regulation (EU) 2024/2679of 15 October 2024amending Implementing Regulation (EU) 2019/2076 as regards administrative and minor changes to the Union authorisation for the biocidal product family Contec IPA Product Family(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. ("the BPR"), and in particular Article 50(2) thereof,Whereas:(1)On 29 November 2019, a Union authorisation with authorisation number EU-0020460-0000 was granted to Contec Europe for the making available on the market and use of the biocidal product family "Contec IPA Product Family" by Commission Implementing Regulation (EU) 2019/2076Commission Implementing Regulation (EU) 2019/2076 of 29 November 2019 granting a Union authorisation for the biocidal product family "Contec IPA Product Family" ( OJ L 316, 6.12.2019, p. 19 ELI: http://data.europa.eu/eli/reg_impl/2019/2076/oj). ("the authorisation"). Annex II to that Implementing Regulation provides the summary of product characteristics ("SPC") for the biocidal product family "Contec IPA Product Family".(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 rules for the different categories of changes of biocidal products sought in accordance with Article 50(2) of Regulation (EU) No 528/2012.(3)On 4 August 2021, Contec Europe submitted a notification to the European Chemicals Agency (the "Agency") in accordance with Article 11(1) of Implementing Regulation (EU) No 354/2013 of administrative changes to the authorisation. The notification was recorded in the register for biocidal products ("the Register") under case number BC-QS069138-06. The notified changes concern the additions of a trade name in meta SPC 1, a manufacturer of the active substance and a manufacturer of the biocidal products and the removal of information on the carrier material in Section 6 of meta SPC 2.(4)On 28 February 2022, Contec Europe 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 authorisation. The application was recorded in the Register under case number BC-LM074066-29 and concerns an extension of the pack size range of products in meta SPC 1.(5)On 19 October 2021, the Agency submitted an opinionAgency Opinion of 19 October 2021 on the administrative change of the Union authorisation of the biocidal product family Contec IPA Product Family, Opinion N° UAD-C-1539242-29-00/F, https://echa.europa.eu/documents/10162/2166576/ua-adc_echa_op_contect-ipa-product-family_en.pdf/f0d3b0d1-63b6-b37b-b084-be1d4b31535b?t=1654511978949. to the Commission on the notified administrative changes to the authorisation, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013, together with a revised SPC. The opinion concludes that the proposed changes regarding the additions of a trade name in meta SPC 1, a manufacturer of the active substance and a manufacturer of biocidal products are administrative changes within the meaning of 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 changes, the conditions of Article 19 of Regulation (EU) No 528/2012 will still be met.(6)However, the Agency concluded that the change related to the removal of information on the carrier in Section 6 of meta SPC 2 is not an administrative change within the meaning of 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 should therefore be rejected.(7)On 9 October 2023, the Agency submitted its opinionBiocidal Products Committee (BPC) opinion of 9 October 2023 on the minor change to the Union authorisation of the biocidal product family "Contec IPA Product Family", ECHA/BPC/396/2023,https://echa.europa.eu/documents/10162/3443008/contec_ipa_pf_ua_mic_final_bpc_opinion_en.pdf/885ca367-1d42-6402-be13-bb2f6ab49399?t=1714650903988. to the Commission on the application for a minor change to the authorisation, in accordance with Article 12(4) of Implementing Regulation (EU) No 354/2013, together with a revised SPC and a revised assessment report. The opinion concluded that the proposed change is a minor change within the meaning of 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, and that after the implementation of the change, the conditions of Article 19 of Regulation (EU) No 528/2012 will still be met.(8)On 10 November 2023, the Agency transmitted to the Commission the revised SPC of the biocidal product family "Contec IPA Product Family" in all official languages of the Union in accordance with Article 11(6) and Article 12(6) of Implementing Regulation (EU) No 354/2013, covering all the administrative and minor changes applied for.(9)The Commission concurs with the opinions of the Agency except for the assessment of the notification of an administrative change concerning the removal of information on the carrier in Section 6 of meta SPC 2. The Commission considers that the list of administrative changes in Title 1 of the Annex to Implementing Regulation (EU) No 354/2013 is not exhaustive and the notified change falls within the definition of administrative change set out in Article 3(1), point (aa), of Regulation (EU) No 528/2012. However, the Commission, having regard to the practice in the Member States, considers that the description of the nature of the carrier should remain in Section 6 of meta SPC 2 whereas the information on the active substance content and weight of the carrier should be removed. Taking this into account, the Commission considers it appropriate to amend the authorisation to introduce the administrative and minor changes requested by Contec Europe and accepted by the Commission.(10)Except for the accepted amendments regarding the administrative and minor changes, all other information included in the SPC of "Contec IPA Product Family" as set out in Annex II to Implementing Regulation (EU) 2019/2076 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, Annex II to Implementing Regulation (EU) 2019/2076 should be replaced in its entirety.(12)Implementing Regulation (EU) 2019/2076 should therefore be amended accordingly,HAS ADOPTED THIS REGULATION: