(Utkast) Kommisjonens gjennomføringsforordning om godkjenning av alkyl(C12-16)dimetylbenzylammoniumklorid som et aktivt stoff til bruk i biocidprodukter av type 3 og 4
(Draft) Commission Implementing Regulation approving alkyl (C12-16) dimethylbenzyl ammonium chloride as an active substance for use in biocidal products of product-types 3 and 4
Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 10.6.2021
BAKGRUNN (fra kommisjonsforordningen, engelsk utgave)
(1) Commission Delegated Regulation (EU) No 1062/2014 establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes alkyl (C12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC (C12-C16)) to be renamed for the purposes of this Regulation as alkyl (C12-16) dimethylbenzyl ammonium chloride as a result of its evaluation.
(2) Alkyl (C12-16) dimethylbenzyl ammonium chloride has been evaluated for use in biocidal products of product-type 3, veterinary hygiene biocidal products and product-type 4, food and feed area disinfectants, as defined in Annex V to Directive 98/8/EC of the European Parliament and of the Council, which correspond respectively to product-types 3 and 4 as defined in Annex V to Regulation (EU) No 528/2012.
(3) Italy was designated as the rapporteur Member State and its evaluating competent authority submitted the assessment report together with its conclusions to the Commission on 10 September 2012.
(4) In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the Biocidal Products Committee adopted the opinions of the European Chemical Agency (‘the Agency’) on 6 October 2020, having regard to the conclusions of the evaluating competent authority.
(5) According to those opinions, biocidal products of product-types 3 and 4 containing alkyl (C12-16) dimethylbenzyl ammonium chloride may be expected to satisfy the requirements laid down in Article 5(1)(b), (c) and (d) of Directive 98/8/EC, provided that certain specifications and conditions concerning their use are complied with.
(6) Taking into account the opinions of the Agency, it is appropriate to approve alkyl (C12-16) dimethylbenzyl ammonium chloride as an active substance for use in biocidal products of product-types 3 and 4, subject to compliance with certain specifications and conditions.
(7) A reasonable period should be allowed to elapse before an active substance is approved in order to permit interested parties to take the preparatory measures necessary to meet the new requirements.
(8) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products
Klima- og miljødepartementet