(Utkast) Kommisjonens gjennomføringsforordning om godkjenning av 2-methylisothiazol-3(2H)-on som et eksisterende aktivt stoff for bruk i biocidprodukter i produkttype 11
(Draft) Commission Implementing Regulation approving 2-methylisothiazol-3(2H)-one as an existing active substance for use in biocidal products of product-type 11
Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 10.8.2017
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 2-methylisothiazol-3(2H)-one.
(2) 2-methylisothiazol-3(2H)-one has been evaluated for use in products of product-type 11, preservatives for liquid-cooling and processing systems, as described in Annex V to Regulation (EU) No 528/2012.
(3) Slovenia was designated as evaluating competent authority and submitted the assessment report together with its recommendations on 7 April 2016.
(4) In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, 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.
(5) According to that opinion, biocidal products of product-type 11 containing 2-methylisothiazol-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.
(6) It is therefore appropriate to approve 2-methylisothiazol-3(2H)-one for use in biocidal products of product-type 11, subject to compliance with certain specifications and conditions.
(7) Since 2-methylisothiazol-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-methylisothiazol-3(2H)-one should be appropriately labelled when placed on the market.
(8) 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.
(9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,
Klima- og miljødepartementet