Annex VI LIST OF UV FILTERS ALLOWED IN COSMETIC PRODUCTS

F7Product types—

(a) skin products, other than those listed in paragraph (b), including all propellant and pump spray skin products;

(b) face products, hand products and lip products (excluding propellant and pump spray face products, hand products and lip products);

(c) all other cosmetic products.

F8For product types—

(a) 2.2%;

(b) 6%;

(c) 0.5%.

F9For product types (a) and (b), not to be used at more than 0.5% to protect product formulation.

If used at 0.5% to protect product formulation, the levels used as UV filter must not exceed, for product types—

(a) 1.7%;

(b) 5.5%.

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 ≥ 98,5 %, with 2,2′-methylene-bis-(6(2H-benzotriazol-2-yl)-4-(isooctyl)phenol) isomer fraction not exceeding 1,5 %;

• Solubility < 5 ng/L in water at 25 °C;

• Partition coefficient (Log Pow): 12,7 at 25 °C;

• Uncoated;

• Median particle size D50 (50 % of the number below this diameter): ≥ 120 nm of mass distribution and/or ≥ 60 nm of number size distribution.

13463-67-7/

1317-70-0/

1317-80-2

236-675-5/

215-280-1/

215-282-2

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 m ² /cm ³ ,

• 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.

Tris-biphenyl triazine

Tris-biphenyl triazine (nano)

Not to be used in sprays.

Only nanomaterials having the following characteristics are allowed:

• median primary particle size > 80 nm;

• Purity ≥ 98 %;

• Uncoated

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 ≥ 96 %, with wurtzite crystalline structure and physical appearance as clusters that are rod-like, star-like and/or isometric shapes, with impurities consisting only of carbon dioxide and water, whilst any other impurities are less than 1 % in total,

• median diameter of the particle number size distribution D50 (50 % of the number below this diameter) > 30 nm and D1 (1 % below this size) > 20 nm,

• water solubility < 50 mg/L

• uncoated, or coated with triethoxycaprylylsilane, dimethicone, dimethoxydiphenylsilanetriethoxycaprylylsilane cross-polymer, or octyl triethoxy silane.

• Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation

• Do not use with nitrosating agents – Maximum nitrosamine content: 50 μg/kg

• Keep in nitrite-free containers

In case of combined use of Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine and Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine (nano), the sum shall not exceed 10 %.

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 ≥ 97 %,

• Median particle size D50 (50 % of the number below this diameter): ≥ 50 nm of number size distribution.

Not to be used in applications that may lead to exposure of the end user’s lungs by inhalation.

In case of combined use of Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine and Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine (nano), the sum shall not exceed 10 %.