EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11720/2016 
(POOL/E4/2016/11720/11720 -EN.doc)  
[…](2016) XXX  draft  
  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving silicon dioxide Kieselguhr as an existing active substance for use in biocidal 
products of product -type 18 
(Text with EEA relevance)   EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving silicon dioxide Kieselguhr as an existing active substance for use in biocidal 
products of product -type 18 
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on t he 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 
products1, and in particular the third subpara graph of Article  89(1) thereof,  
Whereas:  
(1) Commission Delegated Regulation (EU) No  1062/20142 establishes a list of existing 
active substances to be evaluated for their possible approval for use in biocidal 
products.  That list includes silicon dioxide Kiesel guhr. 
(2) Silicon dioxide Kieselguhr  has been evaluated for use in products of product -type 18, 
insecticides, acaricides and products to control other arthropods , as d escribed  in 
Annex  V to Regulation (EU) No  528/2012 . 
(3) France  was designated as evaluating compe tent authority and submitted the 
assessment report to gether with its recommendations  on 18 December 2015 . 
(4) In accordance with Article 7( 2) of Delegated Regulation  (EU) No  1062/2014, the 
opinion  of the European Chemicals Agency w as formulated on  11 October  2016 by 
the Biocidal Product s Committee, having regard to the conclusions of the evaluating 
competent authority.  
(5) According to th at opinion, biocidal products of product -type 18 containing silicon 
dioxide Kieselguhr  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 silicon dioxide Kieselguhr  for use in  biocidal 
products of product -type 18, 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 requi rements.  
                                                 
1 OJ L  167, 27.6.2012, p.  1. 
2 Commission Delegated Regula tion (EU) No 1062 /2014 of 4 August 2 014 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). EN 3   EN (8) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing  Committee on Biocidal Product s, 
HAS ADOPTED THIS REGULATION:  
Article  1 
Silicon dioxide Kieselguhr  is approved as an active substance for use in biocida l products of 
product -type 18, 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 Re gulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER