EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11721/2016 ANNEX Rev. 1 
(POOL/E4/2016/11721/11721R1 -EN 
ANNEX.doc)  
[…](2017) XXX  draft  
ANNEX 1  
  
ANNEX  
to the  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
approving pyrogenic, synthetic amorphous silicon dioxide, nano, surface treated as an 
existing active substance for use in biocidal products of product -type 18    
EN 2   EN ANNEX  
Common Name  IUPAC Name  
Identification Numbers  Minimum 
degree of 
purity of 
the active 
substance1 Reference 
structural 
characteristics2 Date of 
approval  Expiry date of 
approval  Prod
uct 
type Specific conditions  
Pyrogenic, 
synthetic 
amorphous 
silicon  dioxide, 
nano, surface 
treated  IUPAC Name:   
Silanamine, 1,1,1 -trimethyl -N-
(trimethylsilyl) -, hydrolysis 
products with silica  
 
EC No: 272-697-1 
CAS No: 68909 -20-6 998 g/kg 
(purity of 
core 
measured 
after 
ignition).  - Carbon content: 
3.0-4.0%;  
- Primary part icle 
size: 6.9 -8.6 nm;  
- Specific surface 
area: 217 -225 
m²/g;  
- Size of stabl e 
aggregated 
particles: > 70 nm;  
- Surface treatment : 
with >  90% of the 
surface surface -
treated with 
hexamethylsilazan
e (CAS 999 -97-3) 1 
November 
2018  31 October 
2028 18 The auth orisations of biocidal products are subject to the 
following conditions:  
1) The product assessment shall pay particular attention to 
the exposures, the risks and the efficacy linked to any use 
covered by an application for authorisation, but not 
addressed in the Union -level risk assessment of the active 
substance.  
2) In view of the risks identified for the uses assessed, the 
product assessment sh all pay particular attention to 
professional users.  
3) For products that may lead to residues in food or feed, the 
need to  set new or to amend existing maximum residue 
levels (MRLs) in accordance with Regulation (EC) 
No 470/2009 of the European Parliament and of the 
Council3 or Regulation (EC) No 396/2005 of the European 
Parliament and of the Council4 shall be verified, and a ny 
appropriate risk mitigation measures shall be taken to 
ensure that the applicable MRLs are not exceeded.  
                                                 
1 The purity indicated in this column was the minimum degree of purity of the active substance evaluated in accordance with Article 89(1) of Regul ation (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 to be technically equivalent to the evaluated active 
substance . 
2 The structural characteristics indicated in this co lumn were the ones of the active substance used for the evaluation made in accordance with Article 8 9(1) of Regulation 
(EU) No 528/2012.  
3 Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedu res for the establishment of residue limits of 
pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amendin g Directive 2001/82/EC of the European 
Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).  
4 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pe sticides in or on food and feed of p lant 
and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1 ).  
EN 3   EN