Newsflash | Europe | Amending Annex V and VI of Cosmetics Regulation

Chemical name/INN

Name of Common Ingredients Glossary

CAS number

EC number

Maximum concentration in ready for use preparation

Other

Wording of conditions of use and warnings

Titanium dioxide (*)

Titanium Dioxide (nano)

13463-67-7/1317-70-0/1317-80-2

236-675-5/215-280-1/215-282-2

25 % (**)

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

For face products containing Titanium Dioxide (nano) coated with the combination Alumina and Manganese Dioxide:

Not to be used on the lips.

Chemical name/INN

Name of Common Ingredients Glossary

CAS number

EC number

Product type, Body parts

Maximum concentration in ready for use preparation

Wording of conditions of use and warnings

4-(3-ethoxy-4-hydroxyphenyl)butan-2-one

Hydroxyethoxyphenyl Butanone

569646-79-3

933-435-8

0,7 %