(Utkast) Kommisjonens gjennomføringsforordning om godkjenning av 2-octyl-isothiazol-3(2H)-on som et aktivt stoff for bruk i biocidprodukter i produkttype 8
(Draft) Commission Implementing Regulation approving 2-octyl-isothiazol-3(2H)-one as an active substance for use in biocidal products of product-type 8
Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 10.8.2017
BAKGRUNN (fra kommisjonsforordningen, engelsk utgave)
(1) The United Kingdom received on 27 April 2010 an application, in accordance with Article 11(1) of Directive 98/8/EC of the European Parliament and of the Council , for the inclusion of the active substance 2-octyl-isothiazol-3(2H)-one in Annex I to that Directive for use in products of product-type 8, wood preservatives, as described in Annex V to that Directive, which corresponds to product-type 8 as described in Annex V to Regulation (EU) No 528/2012.
(2) The United Kingdom submitted the assessment report together with its recommendations on 4 February 2016 in accordance with Article 90(2) of Regulation (EU) No 528/2012.
(3) The opinion of the European Chemicals Agency was formulated on 15 December 2016 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.
(4) According to that opinion, biocidal products of product-type 8 and containing 2-octyl-isothiazol-3(2H)-one may be expected to satisfy the criteria of Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain specifications and conditions concerning their use are complied with.
(5) It is therefore appropriate to approve 2-octyl-isothiazol-3(2H)-one for use in biocidal products of product-type 8, subject to compliance with certain specifications and conditions.
(6) Since 2-octyl-isothiazol-3(2H)-one meets the criteria for classification as skin sensitiser sub-category 1A as specified in Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council , treated articles treated with or incorporating 2-octyl-isothiazol-3(2H)-one should be appropriately labelled when placed on the market.
(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,
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