EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11721/2016 Rev. 1 
(POOL/E4/2016/11721/11721R1 -
EN.doc)  
[…](2017) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving pyrogenic, synthetic amorphous silicon dioxide, nano, surface treated 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 pyrogenic, synthetic amorphous silicon dioxide, nano, surface treated as an 
existing active substance for use in biocidal products of product -type 18 
(Text with EEA relevance)  
THE EUROPEAN C OMMISSION,  
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 
products1, and in particular the third subparagraph 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 pyrogenic, synthetic amorphous silicon dioxide, nano, 
surface treated . 
(2) Pyrogenic, synthetic amorphous silicon dioxide, nano, surface treated  has been 
evaluated for use in products of product -type 18, insecticides, acaricides and produc ts 
to control other arthropods , as d escribed  in Annex  V to Regulation (EU) No  528/2012 . 
(3) France  was designated as evaluating competent authority and submitted the 
assessment report to gether with its recommendations  on 18 December 2015 . 
(4) In accordance with Ar ticle 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 pyrogenic, 
synthetic amorphous silicon dioxide, nano, surface treated  may be expected to satisfy 
the criteria  of Article  19(1)(b) of Regulation (EU) No 528/2012 , provided that certain 
specificatio ns and conditions concerning their use are complied with . 
(6) It is therefore appropriate to approve pyrogenic, synthetic amorphous silicon dioxide, 
nano, surface treated  for use in  biocidal products of product -type 18, subject to 
compliance with certain speci fications and conditions . 
(7) Since pyrogenic, synthetic amorphous silicon dioxide, nano, surface treated as 
evaluated is a nanomaterial, the approval should cover such nanomaterials pursuant to 
                                                 
1 OJ L  167, 27.6.2012, p.  1. 
2 Commission Delegate d Regula tion (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). EN 3   EN Article 4(4) of Regulation (EU) No 528/2012 provided that certain  specifications and 
conditions relating to their use are satisfied.  
(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 requ irements.  
(9) 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 
Pyrogenic, synthetic amorphous silicon dioxide, nano, surface treated  is approv ed as an active 
substance for use in biocidal 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 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