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Substance : Titanium dioxide (nano)

Substance Titanium dioxide (nano) 
CAS # 13463-67-7[1]/ 1317-70-0[2]/ 1317-80-2[3]  
EC # 236-675-5[1] /215-280-1[2]/ 215-282-2[3]  
Name of Common Ingredients Glossary TITANIUM DIOXIDE (NANO) 
INN/ISO/AN  
Regulation (EU) 2019/1857
Other Directives/Regulations
Annex/Ref # VI/27a
Product Type, body parts  
Maximum concentration in ready for use preparation 25%
- In case of combined use of Titanium Dioxide and Titanium Dioxide (nano), the sum shall not exceed the limit of 25%. 
Other  
Wording of conditions of use and warnings Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation
Only nanomaterials having the following characteristics are allowed:
— purity ≥ 99 %,
— rutile form, or rutile with up to 5 % anatase, with crystalline structure and physical appearance as clusters of spherical, needle, or lanceolate shapes,
— median particle size based on number size distribution ≥ 30 nm,
— aspect ratio from 1 to 4,5, and volume specific surface area ≤ 460 m2/cm3,

— coated with Silica, Hydrated Silica, Alumina, Aluminium Hydroxide, Aluminium Stearate, Stearic Acid, Trimethoxycaprylylsilane, Glycerin, Dimethicone, Hydrogen Dimethicone, Simethicone;

or coated with one of the follow­ing combinations:
—Silica at a maximum concen­tration of 16 % and Cetyl Phosphate at a maximum concentration of 6 %,
—Alumina at a maximum con­centration of 7 % and Manga­nese Dioxide at a maximum concentration of 0,7 % (not to be used in lip products), —Alumina at a maximum con­centration of 3 % and Triethoxycaprylylsilane at a maximum concentration of 9 %,

— photocatalytic activity ≤ 10 % compared to corresponding non-coated or non-doped re­ference,
— nanoparticles are photostable in the final formulation.

Wording of conditions of use and warnings:
For face products containing Tita­nium Dioxide (nano) coated with the combination Alumina and Manganese Dioxide: Not to be used on the lips. 
SCCS opinions
Chemical/IUPAC Name Titanium dioxide [1];Anatase (TiO2) [2];Rutile (TiO2) [3] 
Identified INGREDIENTS or substances e.g.  
Note VI (2) For use as a colorant, see Annex IV, No. 143 
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