(Utkast) Kommisjonens gjennomføringsbeslutning (EU) .../... om utsettelse av utløpsdatoen for godkjenning av basisk kobberkarbonat til bruk i biocidprodukter i type 8 i samsvar med europaparlaments- og rådsforordning (EU) nr. 528/2012
Biocider: utsettelse av utløpsdatoen for godkjenningen av basisk kobberkarbonat til bruk i produkttype 8
Utkast til kommisjonsbeslutning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 4.3.2026
Bakgrunn
(fra kommisjonsbeslutningen)
(1) Basic copper carbonate was included in Annex I to Directive 98/8/EC of the European Parliament and of the Council2 as an active substance for use in biocidal products of product-type 8. Pursuant to Article 86 of Regulation (EU) No 528/2012, it was therefore considered approved until 31 January 2024 under that Regulation subject to the conditions set out in Annex I to Directive 98/8/EC.
(2) On 28 July 2022, an application was submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for the renewal of the approval of basic copper carbonate for use in biocidal products of product-type 8 (‘the application’).
(3) On 21 March 2023, the evaluating competent authority of France informed the Commission that it had decided, pursuant to Article 14(1) of Regulation (EU) No 528/2012, that a full evaluation of the application was necessary. Pursuant to Article 8(1) of that Regulation, the evaluating competent authority is to perform a full evaluation of the application within 365 days of its validation.
(4) The evaluating competent authority may, as appropriate, require the applicant to provide sufficient data to carry out the evaluation, in accordance with Article 8(2) of Regulation (EU) No 528/2012. In that event, the 365-day period is suspended for a period that may not exceed 180 days in total unless a longer suspension is justified by the nature of the data requested or by exceptional circumstances.
(5) Within 270 days of receipt of a recommendation from the evaluating competent authority, the European Chemicals Agency (‘the Agency’) is to prepare and submit to the Commission an opinion on renewal of the approval of the active substance in accordance with Article 14(3) of Regulation (EU) No 528/2012.
(6) Commission Implementing Decision (EU) 2023/23803 postponed the expiry date of the approval of basic copper carbonate for use in biocidal products of product-type 8 to 31 July 2026, in order to allow sufficient time for the examination of the application.
(7) On 8 October 2025, the evaluating competent authority informed the Commission that the evaluation is delayed. The evaluating competent authority expects to submit the renewal assessment report to the Agency in the first quarter of 2028.
(8) Consequently, for reasons beyond the control of the applicant, the approval is likely to expire before a decision has been taken on its renewal. It is therefore appropriate to further postpone the expiry date of the approval for a period of time sufficient to enable the examination of the application. Taking into account the time-limits for evaluation by the evaluating competent authority, for preparation and submission by the Agency of its opinion and the time needed for the Commission to decide whether to renew the approval of basic copper carbonate for use in biocidal products of product-type 8, the expiry date should be postponed to 31 July 2029.
(9) After the further postponement of the expiry date of the approval, basic copper carbonate remains approved for use in biocidal products of product-type 8 subject to the conditions set out in Annex I to Directive 98/8/EC,