(Utkast) Kommisjonens gjennomføringsbeslutning om utsettelse av utløpsdatoen for godkjenningen av K-HDO til bruk i biocidprodukter av type 8
(Draft) Commission Implementing Decision postponing the expiry date of approval of K-HDO for use in biocidal products of product-type 8
Utkast til kommisjonsbeslutning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 19.10.2019
BAKGRUNN (fra kommisjonsbeslutningen, engelsk utgave)
(1) The active substance K-HDO was included in Annex I to Directive 98/8/EC of the European Parliament and of the Council for use in biocidal products of product-type 8, and pursuant to Article 86 of Regulation (EU) No 528/2012 is therefore considered approved under that Regulation subject to the specifications and conditions set out in Annex I to that Directive.
(2) The approval of K-HDO for use in biocidal products of product-type 8 will expire on 30 June 2020. On 14 December 2018, an application was submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for the renewal of the approval of K-HDO.
(3) On 6 May 2019, the evaluating competent authority of Austria 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 Regulation (EU) No 528/2012, 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, request the applicant to provide sufficient data to carry out the evaluation, in accordance with Article 8(2) of that Regulation. In such case, 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) Consequently, for reasons beyond the control of the applicant, the approval of K-HDO for use in biocidal products of product-type 8 is likely to expire before a decision has been taken on its renewal. It is therefore appropriate to postpone the expiry date of approval of K-HDO for use in biocidal products of product-type 8 for a period of time sufficient to enable the examination of the application. Considering the time-limits for the evaluation by the evaluating competent authority and for the preparation and submission of the opinion by the Agency, it is appropriate to postpone the expiry date of approval to 31 December 2022.
(7) Except for the expiry date of the approval, K-HDO remains approved for use in biocidal products of product-type 8 subject to the specifications and conditions set out in Annex I to Directive 98/8/EC
Klima- og miljødepartementet