(Utkast) Kommisjonens gjennomføringsbeslutning (EU) .../... om utsettelse av utløpsdatoen for godkjenningen av N,N-dietyl-meta-toluamid til bruk i biocidprodukter av produkttype 19 i samsvar med europaparlaments- og rådsforordning (EU) nr. 528/2012
Biocider: utsettelse av utløpsdatoen for godkjenningen av N,N-dietyl-meta-toluamid til bruk i produkter av type 19
Utkast til kommisjonsbeslutning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 3.11.2026
Bakgrunn
(fra kommisjonsbeslutningen)
(1) N,N-diethyl-meta-toluamide 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 19 by Commission Directive 2010/51/EU of 11 August 2010 amending Directive 98/8/EC . Pursuant to Article 86 of Regulation (EU) No 528/2012, it was therefore considered approved until 31 July 2022 under that Regulation subject to the specifications and conditions set out in Annex I to Directive 98/8/EC.
(2) On 26 January 2021, an application was submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for the renewal of the approval of N,N-diethyl-meta-toluamide for use in biocidal products of product-type 19 (‘the application’).
(3) On 4 June 2021, 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.
(4) Commission Implementing Decision (EU) 2021/2146 postponed the expiry date of the approval of N,N-diethyl-meta-toluamide for use in biocidal products of product-type 19 to 31 January 2025, in order to allow sufficient time for the examination of the application. That expiry date was again postponed to 31 January 2027 by Commission Implementing Decision (EU) 2024/2950 , due to additional delays in the evaluation of the application.
(5) On 9 September 2026, the evaluating competent authority informed the Commission that the evaluation has been further delayed for reasons beyond the control of the applicant, due to the additional time needed by the authority for the assessment of data related to the impurities of the substance and to the examination of its endocrine-disrupting properties. From the information provided by the evaluating competent authority it appears that the authority will be able to submit a renewal assessment report to the European Chemicals Agency (‘the Agency’) by the fourth quarter of 2026.
(6) Within 270 days of receipt of a recommendation from the evaluating competent authority, the Agency is to prepare and submit to the Commission an opinion on the renewal of the approval of the active substance in accordance with Article 14(3) of Regulation (EU) No 528/2012.
(7) 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 full 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 N,N-diethyl-meta-toluamide for use in biocidal products of product-type 19, the expiry date should be postponed to 31 January 2029.
(8) After the further postponement of the expiry date of the approval, N,N-diethyl-meta-toluamide remains approved for use in biocidal products of product-type 19 subject to the requirements set out in Annex I to Directive 98/8/EC,