EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10789/2016 (POOL/E4/2016/10789/10789-EN.doc) […](2016) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
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) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
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) 
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 avai lable on the market and use of biocidal 
products
1, and in particular the third subpa ragraph of Article 89(1) thereof, 
Whereas: (1) Commission Delegated Re gulation (EU) No 1062/2014
2 establishes a list of existing 
active substances to be evaluated for thei r possible approval for use in biocidal 
products. That list includes cal cium 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 Council3 for 
use in products of product-type  2, disinfectants and algaecid es not intended for direct 
application to humans or animals, and produc t-type 3, veterinary hygiene, as described 
in Annex V to that Directive, which co rrespond 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 eval uating competent authority and submitted 
the assessment reports toge ther with its recommendations on 19 September 2011. 
(4) In accordance with Article 7(2) of De legated 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 di hydroxide (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 cal cium dihydroxide (hydrated lime) for use in 
biocidal products of product-types 2 and 3, subject to comp liance with certain 
specifications and conditions. 
                                                
 
1 OJ L 167, 27.6.2012, p. 1. 
2 Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for 
the systematic examination of all existing active substan ces 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). 
3 Directive 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).  
EN 3   EN (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 th e new requirements. 
(8) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on Biocidal Products, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Calcium 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 2 
This 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, 
 For the Commission 
 The President  Jean-Claude JUNCKER