cosmetics-uv-filters

EU. Cosmetics Regulation Annex VI, Allowed UV Filters

This list contains substances designated as UV filters which cosmetic products marketed in the European Union may contain. The list contains concentration limits and additional restrictions, as well as labeling requirements for some substances.

Titanium dioxide

EC / List no: 215-282-2 CAS no: 1317-80-2
Ref No.
27a
Substance Identification Name
Titanium dioxide
EC Number
215-282-2
CAS
1317-80-2
Physical form
Nano
Conditions Product type, body parts
All cosmetic products
Function(s)
UV Filter
Maximum Threshold
25 %
Restriction(s)
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

Warning Label
For face products containing Titanium Dioxide (nano) coated with the combination Alumina and Manganese Dioxide: Not to be used on the lips.
Notes
For use as a colorant, see Annex IV, No. 143

In case of combined use of Titanium Dioxide and Titanium Dioxide (nano), the sum shall not exceed the limit given in column g


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