Commission Implementing Regulation (EU) 2016/1935 of 4 November 2016 approving calcium dihydroxide (hydrated lime) as an existing active substance for use in biocidal products of product-types 2 and 3 (Text with EEA relevance )
Commission Implementing Regulation (EU) 2016/1935of 4 November 2016approving calcium dihydroxide (hydrated lime) as an existing active substance for use in biocidal products of product-types 2 and 3(Text with EEA relevance) THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal productsOJ L 167, 27.6.2012, p. 1., and in particular the third subparagraph of Article 89(1) thereof,Whereas:(1)Commission Delegated Regulation (EU) No 1062/2014Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1). establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes calcium dihydroxide (hydrated lime).(2)Calcium dihydroxide (hydrated lime) has been evaluated in accordance with Article 16(2) of Directive 98/8/EC of the European Parliament and of the CouncilDirective 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1). for use in products of product-type 2, disinfectants and algaecides not intended for direct application to humans or animals, and product-type 3, veterinary hygiene, as described in Annex V to that Directive, which correspond to product-types 2 and 3 respectively, as described in Annex V to Regulation (EU) No 528/2012.(3)The United Kingdom was designated as evaluating competent authority and submitted the assessment reports together with its recommendations on 19 September 2011.(4)In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinions of the European Chemicals Agency were formulated on 14 April 2016 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.(5)According to those opinions, biocidal products of product-types 2 and 3 and containing calcium dihydroxide (hydrated lime) may be expected to satisfy the requirements of Article 5 of Directive 98/8/EC, provided that certain specifications and conditions concerning their use are complied with.(6)It is therefore appropriate to approve calcium dihydroxide (hydrated lime) for use in biocidal products of product-types 2 and 3, 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,HAS ADOPTED THIS REGULATION:
Article 1Calcium dihydroxide (hydrated lime) is approved as an active substance for use in biocidal products of product-types 2 and 3, subject to the specifications and conditions set out in the Annex.
Article 2This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 4 November 2016.For the CommissionThe PresidentJean-Claude JunckerANNEX
The purity indicated in this column was the minimum degree of purity of the active substance evaluated in accordance with Article 89(1) of Regulation (EU) No 528/2012. The active substance in the product placed on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance.
Common NameIUPAC NameIdentification NumbersMinimum degree of purity of the active substanceDate of approvalExpiry date of approvalProduct typeSpecific conditions
Calcium dihydroxide (hydrated lime)IUPAC Name:Calcium dihydroxideEC No: 215-137-3CAS No: 1305-62-0800 g/kg(the value provides the content of Ca expressed as Ca(OH)2)1 May 201830 April 20282The authorisations of biocidal products are subject to the following conditions:1.The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any use covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance.2.In view of the risks identified for the uses assessed, the product assessment shall pay particular attention to industrial and professional users.
3The authorisations of biocidal products are subject to the following conditions:1.The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any use covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance.2.In view of the risks identified for the uses assessed, the product assessment shall pay particular attention to professional users.