EN    EN  
 EUROPEAN 
COMMISSION  
Brussels, XXX   
CA-Sept13-Doc.4.2 
[…](2013) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
approving synthetic amorphous silicon dioxide as  an existing active substance for use in 
biocidal products for product-type 18 
(Text with EEA relevance) 
 EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
approving synthetic amorphous s ilicon dioxide as an existing active substance for use in 
biocidal products for product-type 18 
(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 av ailable on the market and use of biocidal 
products
1, and in particular the third subpa ragraph of Article 89(1) thereof, 
Whereas: (1) Commission Regulati on (EC) No 1451/2007
2 establishes a list of active substances to 
be assessed, with a view to their possible in clusion in Annex I, IA or IB to Directive 
98/8/EC of the European Parliament and of the Council3. That list includes silicon 
dioxide. 
(2) Silicon dioxide has been evaluated in acco rdance with Article 11(2) of Directive 
98/8/EC for use in product-type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to  that Directive, which corresponds to 
product-type 18 as defined in Anne x V to Regulation (EU) No 528/2012. 
(3) The data submitted for the purpose of the evaluation allowed conclusions to be drawn 
only regarding a certain form of silicon dioxide, i.e. synthetic amorphous silicon 
dioxide described as wet silica CAS n°  112926-00-8. The evalua tion did not allow 
conclusions to be drawn regarding any othe r substance complying with the definition 
of silicon dioxide CAS 7631-86-9 in the above mentioned list of active substances in 
Regulation (EC) No 1451/2007. Therefore, only synthetic amorphous silicon dioxide 
should be covered by the approval. 
(4) France was designated as Rapporteur Member State and submitted the competent 
authority report, together  with a recommendation, to the Commission on 16 April 
2009 in accordance with Article 14(4) a nd (6) of Regulati on (EC) No 1451/2007. 
(5) The competent authority report was re viewed by the Member States and the 
Commission. In accordance with Article 15 (4) of Regulation (EC) No 1451/2007, the 
findings of the review were incorporated in  an assessment report reviewed within the 
Standing Committee on Biocidal  Products on [date SCB]. 
                                                 
1 OJ L 167, 27.6.2012, p. 1. 
2 Commission Regulation (EC) No 1451/2007 of 4 Decem ber 2007 on the second phase of the 10-year 
work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3). 
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) According to that assessment report, bioc idal products used for product-type 18 and 
containing synthetic amorphous  silicon dioxide may be expected to satisfy the 
requirements laid down in Article 5 of Directive 98/8/EC, provided that certain 
specifications and conditions rela ting to its use are satisfied. 
(7) It is therefore appropriate to approve synthetic amorphous silicon dioxide for use in 
biocidal products for product- type 18 subject to complian ce with such specifications 
and conditions. 
(8) Since synthetic amorphous silicon dioxide as evaluated is a nanomat erial, the approval 
should cover such materials pursuant to Article 4(4) of Regul ation (EU) No 528/2012. 
(9) A reasonable period should be allowed to elapse before an active substance is 
approved, in order to permit interested pa rties to take the preparatory measures 
necessary to meet the ne w requirements laid down.  
(10) 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 
Synthetic amorphous silicon diox ide shall be approved as an active substance for use in 
biocidal products for 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 
 José Manuel BARROSO 
EN 4   EN ANNEX  
Common 
Name IUPAC Name 
Identification Numbers Minimum degree 
of purity of the 
active substance4  Date of 
approval Expiry date 
of approval Produ
ct 
type Specific conditions5 
800 g/kg 
 
Structural 
characteristics6 Synthetic 
amorphous silicon 
dioxide, as a 
nanomaterial according to 
the definition 
set out in 
Article 
3(1)(z) of Regulation 
(EU) No 
528/2012. IUPAC Name :  
Silicon dioxide EC n° : 231-545-4  CAS n° : 112926-00-8 
Synthetic amorphous silicon dioxide in 
the form of stable aggregated particules of particle size > 1µm, with primary 
particules of nanosize. 
 - Primary particle 
size < 25nm 
- Volume 
specific surface 
area > 600 m²/cm3 
 1 
Novembe
r 2015 31 October 
2025 18 The product assessment shall pay 
particular attention to the exposures, the risks and the efficacy linked to any 
uses covered by an application for 
authorisation, but not addressed in the Union level risk assessment of the 
active substance. 
 
                                                 
4 The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in a ccordance with Article 8 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  technically equivalent with the evaluated 
active substance. 
5 For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of ass essment reports are available on the 
Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm .  
6 The structural characteristics indicated in this column were the ones of the active substance used for the evaluation made in accordance with Article 8 of Regulation (EU) 
No 528/2012.