EN   EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10116/2020 ANNEX (POOL/E2/2020/10116/10116-EN ANNEX.docx)  D066794/03 […](2020) XXX  draft 
ANNEX 
 
ANNEX 
to the 
COMMISSION REGULATION (EU) …/… 
amending the Annex t o Regulation (EU) No 231/2012 laying down s pecifications for food 
additives listed in Annexes II  and III to Regulation (EC) No 13 33/2008 of the European 
Parliament and of the Council a s regards specifica tions for tit anium dioxide (E 171) 
 EN 1  EN ANNEX  
In the Annex to Regulation (EU) No 231/2012, the entry for E 17 1 titanium dioxide is 
replaced by the following:  
‘E 171 TITANIUM DIOXIDE  
Synonyms  CI Pigment White 6  
Definition  Titanium dioxide consists essen tially of pure anatase and/or 
rutile titanium dioxide. It may contain small quantities (< 
0.5%) of constituent particle growth and crystal phase 
control agents (alumina, sodium or potassium in 
combination with phosphate). It has no surface treatments 
or coatings. 
The anatase grades of pigmenta ry titanium dioxide can only 
be made by the sulphate process which creates a large 
amount of sulphuric acid as a by-product. The rutile grades 
of titanium dioxide may be made by the chloride or the 
sulphate process.  
Certain rutile grades of titanium dioxide are produced using 
mica (also known as potassium aluminium silicate) as a 
template to form the basic platelet structure. The surface of 
the mica is coated with titanium dioxide using a specialised 
patented process.  
Rutile titanium dioxide, platelet form is manufactured by 
subjecting titanium dioxide (rutile) coated mica nacreous 
pigment to an extractive disso lution in acid followed by an 
extractive dissolution in alkali. All of the mica is removed 
during this process and the re sulting product is a platelet 
form of rutile titanium dioxide. 
Excluded from these specifications are potassium 
aluminium silicate-based pearlescent pigments. 
Colour Index No 77891 
Einecs 236-675-5  
Chemical name Titanium dioxide  
Chemical formula TiO 2 
Molecular weight 79,88 
Constituent particle size Median minimum external dimension by particle number 
shall be higher than 100 nm, measured by electron 
microscopy. This means that i n the measured sample less 
than 50% of constituent partic les by number are particles EN 2  EN with a minimum externa l dimension below 100 nm.  
Assay Content not less than 99 % on an alumina and silica-free 
basis 
Description    White to slightly coloured powder 
Identification  
Solubility  Insoluble in water a nd organic solvents. Dissolves slowly in 
hydrofluoric acid and in hot c oncentrated sulphuric acid 
Purity   
Loss on drying Not more than 0,5 % (105 °C, 3 hours) 
Loss on ignition Not more than 1,0 %  on a volatile matter free basis (800 
°C) 
Alumina and silica Tot al not more than 0.5% 
Matter soluble in 0,5 N 
HCl Not more than 0,5 % calculate d as the sum  of aluminium 
(as Al), sodium (as Na), potassium (as K) and phosphate 
(as P) 
Water soluble matter Not more than 0,5 % 
Cadmium Not more than 0,5 mg/kg a fter an extraction with 0,5 N HCl 
Antimony Not more th an 1 mg/kg after an e xtraction with 0,5 N H Cl 
Arsenic Not more than 1 mg/kg af ter an extraction with 0,5 N HC l 
Lead Not more than 5 mg/kg afte r an extraction with 0,5 N HCl 
Mercury Not more than 0,2 mg/kg a fter an extraction with 0,5 N HCl 
’.