ANNEX VILIST OF UV FILTERS ALLOWED IN COSMETIC PRODUCTS

Annotations:
Amendments (Textual)

Reference number

Substance identification

Conditions

Wording of conditions of use and warnings

Chemical name/INN/XAN

Name of Common Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration in ready for use preparation

Other

a

b

c

d

e

f

g

h

i

F11

2

N,N,N-Trimethyl-4-(2-oxoborn-3-ylidenemethyl) anilinium methyl sulfate

Camphor Benzalkonium Methosulfate

52793-97-2

258-190-8

6 %

3

Benzoic acid, 2-hydroxy-, 3,3,5-trimethylcyclohexyl ester/Homosalate

Homosalate

118-56-9

204-260-8

10 %

F74

2-Hydroxy-4-methoxybenzophenone/Oxybenzone

Benzophenone-3

131-57-7

205-031-5

6 %

Not more than 0,5 % to protect product formulation

Contains Benzophenone-368

5

Moved or deleted

6

2-Phenylbenzimidazole-5-sulfonic acid and its potassium, sodium and triethanolamine salts/Ensulizole

Phenylbenzimidazole Sulfonic Acid

27503-81-7

248-502-0

8 %(as acid)

7

3,3'-(1,4-Phenylenedimethylene) bis(7, 7-dimethyl-2-oxobicyclo-[2.2.1]hept-1-yl-methanesulfonic acid) and its salts/Ecamsule

Terephthalylidene Dicamphor Sulfonic Acid

92761-26-7, 90457-82-2

410-960-6

10 %(as acid)

8

1-(4-tert-Butylphenyl)-3-(4-methoxyphenyl)propane-1,3-dione/Avobenzone

Butyl Methoxydibenzoylmethane

70356-09-1

274-581-6

5 %

9

alpha-(2-Oxoborn-3-ylidene)-toluene-4-sulphonic acid and its salts

Benzylidene Camphor Sulfonic Acid

56039-58-8

6 % (as acid)

10

2-Cyano-3,3-diphenyl acrylic acid, 2-ethylhexyl ester/Octocrilene

Octocrylene

6197-30-4

228-250-8

10 % (as acid)

11

Polymer of N-{(2 and 4)-[(2-oxoborn-3-ylidene)methyl]benzyl} acrylamide

Polyacrylamidomethyl Benzylidene Camphor

113783-61-2

6 %

12

2-Ethylhexyl 4-methoxycinnamate/Octinoxate

Ethylhexyl Methoxycinnamate

5466-77-3

226-775-7

10 %

13

Ethoxylated ethyl-4-aminobenzoate

PEG-25 PABA

116242-27-4

10 %

14

Isopentyl-4-methoxycinnamate/Amiloxate

Isoamyl p-Methoxycinnamate

71617-10-2

275-702-5

10 %

15

2,4,6-Trianilino-(p-carbo-2'-ethylhexyl-1'-oxy)-1,3,5-triazine

Ethylhexyl Triazone

88122-99-0

402-070-1

5 %

16

Phenol,2-(2H-benzotriazol-2-yl)-4-methyl-6-(2-methyl-3-(1,3,3,3-tetramethyl-1-(trimethylsilyl)oxy)-disiloxanyl)propyl)

Drometrizole Trisiloxane

155633-54-8

15 %

17

Benzoic acid, 4,4-((6-((4-(((1,1-dimethylethyl)amino)carbonyl)phenyl)amino)-1,3,5-triazine-2,4-diyl)diimino)bis-, bis (2-ethylhexyl) ester/Iscotrizinol (USAN)

Diethylhexyl Butamido Triazone

154702-15-5

10 %

18

3-(4-Methylbenzylidene)-d1 camphor/Enzacamene

4-Methylbenzylidene Camphor

38102-62-4/36861-47-9

- / 253-242-6

4 %

F8

20

2-Ethylhexyl salicylate/Octisalate

Ethylhexyl Salicylate

118-60-5

204-263-4

5 %

21

2-Ethylhexyl 4-(dimethylamino)benzoate/Padimate O (USAN:BAN)

Ethylhexyl Dimethyl PABA

21245-02-3

244-289-3

8 %

22

2-Hydroxy-4-methoxybenzophenone-5-sulfonic acid and its sodium salt/Sulisobenzone

Benzophenone-4, Benzophenone-5

4065-45-6/6628-37-1

223-772-2 / -

5 % (as acid)

F923

2,2′-Methylene- bis(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol)/Bisoctrizole

Methylene Bis-Benzotriazolyl Tetramethylbutylphenol

103597-45-1

403-800-1

10 %72

F623a

2,2′-Methylene- bis(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol)/Bisoctrizole

Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (nano)

103597-45-1

403-800-1

10 %72

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.

24

Sodium salt of 2,2'-bis(1,4-phenylene)-1H-benzimidazole-4,6-disulfonic acid) / Bisdisulizole disodium (USAN)

Disodium Phenyl Dibenzimidazole Tetrasulfonate

180898-37-7

429-750-0

10 % (as acid)

25

2,2'-(6-(4-Methoxyphenyl)-1,3,5-triazine-2,4-diyl)bis(5-((2-ethylhexyl)oxy)phenol) / Bemotrizinol

Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine

187393-00-6

10 %

26

Dimethicodiethylbenzalmalonate

Polysilicone-15

207574-74-1

426-000-4

10 %

F327

Titanium dioxide69

Titanium Dioxide

13463-67-7/

1317-70-0/

1317-80-2

236-675-5/

215-280-1/

215-282-2

25 %71

F527a

Titanium dioxide69

Titanium Dioxide (nano)

13463-67-7/

1317-70-0/

1317-80-2

236-675-5/

215-280-1/

215-282-2

25 %71

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;

  • photocatalytic activity ≤ 10 % compared to corresponding non-coated or non-doped reference,

  • nanoparticles are photostable in the final formulation.

F128

Benzoic acid, 2-[-4-(diethylamino)-2-hydroxybenzoyl]-. Hexylester

Diethylamino Hydroxy benzoyl Hexyl Benzoate

302776-68-7

443-860-6

10 %

F2X129

1,3,5-Triazine, 2,4,6-tris[1,1'-biphenyl]-4-yl-, including as nanomaterial

Tris-biphenyl triazine

Tris-biphenyl triazine (nano)

31274-51-8

10 %

Not to be used in sprays.

Only nanomaterials having the following characteristics are allowed:

  • median primary particle size > 80 nm;

  • Purity ≥ 98 %;

  • Uncoated

F430

Zinc oxide

Zinc Oxide

1314-13-2

215-222-5

25 %70

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

30a

Zinc oxide

Zinc Oxide (nano)

1314-13-2

215-222-5

25 %70

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 required if concentration is 0,5 % or less and when it is used only for product protection purposes.

For use as a colorant, see Annex IV, No 143.

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

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

In case of combined use of Methylene Bis-Benzotriazolyl Tetramethylbutylphenol and Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (nano), the sum shall not exceed the limit given in column g.