(Utkast) Kommisjonens gjennomføringsbeslutning (EU) …/… om utsettelse av utløpsdatoen for godkjenningen av spinosad til bruk i biocidprodukter av type 18 i samsvar med europaparlaments- og rådsforordning (EU) nr. 528/2012
Biocider: utsettelse av utløpsdatoen for godkjenningen av spinosad i produkttype 18
Utkast til kommisjonsbeslutning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 3.2.2025
Bakgrunn
(fra kommisjonsbeslutningen)
(1) Spinosad was included in Annex I to Directive 98/8/EC of the European Parliament and of the Council as an active substance for use in biocidal products of product-type 18. Pursuant to Article 86 of Regulation (EU) No 528/2012, it was therefore considered approved until 31 October 2022 under that Regulation subject to the conditions set out in Annex I to Directive 98/8/EC.
(2) On 27 April 2021 and 28 April 2021, two applications were submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for the renewal of the approval of spinosad for use in biocidal products of product-type 18 (‘the applications’).
(3) On 13 September 2021, the evaluating competent authority of the Netherlands informed the Commission that it had decided, pursuant to Article 14(1) of Regulation (EU) No 528/2012, that a full evaluation of the applications 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 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) 2022/1489 postponed the expiry date of the approval of spinosad for use in biocidal products of product-type 18 to 30 April 2025, in order to allow sufficient time for the examination of the applications.
(7) On 26 September 2024, the evaluating competent authority informed the Commission that an additional extension of the approval is needed due to delays in the evaluation of the applications, proposing a further extension of the expiry date of the approval for additional 2,5 years.
(8) Consequently, for reasons beyond the control of the applicants, 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 applications. Taking into account the time-limits for evaluation by the evaluating competent authority, for preparation and submission by the European Chemicals Agency of its opinion and the time needed for the Commission to decide whether to renew the approval of spinosad for use in biocidal products of product-type 18, the expiry date should be postponed to 31 October 2027.
(9) After the further postponement of the expiry date of the approval, spinosad remains approved for use in biocidal products of product-type 18 subject to the conditions set out in Annex I to Directive 98/8/EC,