EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10788/2016 
(POOL/E4/2016/10788/10788-EN.doc) […](2016) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving calcium magnesium te trahydroxide (hydra ted dolomitic 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 magnesium tetrahydroxide (hydrated dolomitic 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 calcium magne sium tetrahydroxide (hydrated dolomitic 
lime). 
(2) Calcium magnesium tetrahydroxide (hydrated dolomitic 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 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 corre spond to product-types 
2 and 3 respectively, as described in Annex V to Regulati on (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 magnesium tetrahydroxi de (hydrated dolomitic lime) may be 
expected to satisfy the requirements of Ar ticle 5 of Directive 98/8/EC, provided that 
certain specifications an d conditions concerning thei r use are complied with. 
                                                
 
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 (6) It is therefore appropriate to approve calcium magnesium tetrahydroxide (hydrated 
dolomitic lime) for use in biocidal products of product-types 2 and 3, subject to compliance with certain sp ecifications 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 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 magnesium tetrahydroxide (hydrated  dolomitic lime) is approved as an active 
substance for use in biocidal products of produc t-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