Regulation (EC) No 1223/2009 of the European Parliament and of the CouncilShow full title

Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) (Text with EEA relevance)

ANNEX VIU.K.LIST OF UV FILTERS ALLOWED IN COSMETIC PRODUCTS

a

Not required if concentration is 0,5 % or less and when it is used only for product protection purposes.

b

[F1For use as a colorant, see Annex IV, No 143.]

c

[F2In case of combined use of zinc oxide and zinc oxide (nano), the sum shall not exceed the limit given in column g.]

d

[F3In case of combined use of Titanium Dioxide and Titanium Dioxide (nano), the sum shall not exceed the limit given in column g.]

e

[F4In 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.]

Reference numberSubstance identificationConditionsWording of conditions of use and warnings
Chemical name/INN/XANName of Common Ingredients GlossaryCAS numberEC numberProduct type, body partsMaximum concentration in ready for use preparationOther
abcdefghi
[F51 ]
2 N,N,N-Trimethyl-4-(2-oxoborn-3-ylidenemethyl) anilinium methyl sulfateCamphor Benzalkonium Methosulfate52793-97-2258-190-86 %
3Benzoic acid, 2-hydroxy-, 3,3,5-trimethylcyclohexyl ester/HomosalateHomosalate118-56-9204-260-810 %
[F64 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-3] a
5Moved or deleted
62-Phenylbenzimidazole-5-sulfonic acid and its potassium, sodium and triethanolamine salts/EnsulizolePhenylbenzimidazole Sulfonic Acid27503-81-7248-502-08 %(as acid)
73,3'-(1,4-Phenylenedimethylene) bis(7, 7-dimethyl-2-oxobicyclo-[2.2.1]hept-1-yl-methanesulfonic acid) and its salts/EcamsuleTerephthalylidene Dicamphor Sulfonic Acid92761-26-7, 90457-82-2410-960-610 %(as acid)
81-(4-tert-Butylphenyl)-3-(4-methoxyphenyl)propane-1,3-dione/AvobenzoneButyl Methoxydibenzoylmethane70356-09-1274-581-65 %
9alpha-(2-Oxoborn-3-ylidene)-toluene-4-sulphonic acid and its saltsBenzylidene Camphor Sulfonic Acid56039-58-86 % (as acid)
102-Cyano-3,3-diphenyl acrylic acid, 2-ethylhexyl ester/OctocrileneOctocrylene6197-30-4228-250-810 % (as acid)
11Polymer of N-{(2 and 4)-[(2-oxoborn-3-ylidene)methyl]benzyl} acrylamidePolyacrylamidomethyl Benzylidene Camphor113783-61-26 %
122-Ethylhexyl 4-methoxycinnamate/OctinoxateEthylhexyl Methoxycinnamate5466-77-3226-775-710 %
13Ethoxylated ethyl-4-aminobenzoatePEG-25 PABA116242-27-410 %
14Isopentyl-4-methoxycinnamate/AmiloxateIsoamyl p-Methoxycinnamate71617-10-2275-702-510 %
152,4,6-Trianilino-(p-carbo-2'-ethylhexyl-1'-oxy)-1,3,5-triazineEthylhexyl Triazone88122-99-0402-070-15 %
16Phenol,2-(2H-benzotriazol-2-yl)-4-methyl-6-(2-methyl-3-(1,3,3,3-tetramethyl-1-(trimethylsilyl)oxy)-disiloxanyl)propyl)Drometrizole Trisiloxane155633-54-815 %
17Benzoic 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 Triazone154702-15-510 %
183-(4-Methylbenzylidene)-d1 camphor/Enzacamene4-Methylbenzylidene Camphor38102-62-4/36861-47-9- / 253-242-64 %
[ F7 ]
202-Ethylhexyl salicylate/OctisalateEthylhexyl Salicylate118-60-5204-263-45 %
212-Ethylhexyl 4-(dimethylamino)benzoate/Padimate O (USAN:BAN)Ethylhexyl Dimethyl PABA21245-02-3244-289-38 %
222-Hydroxy-4-methoxybenzophenone-5-sulfonic acid and its sodium salt/SulisobenzoneBenzophenone-4, Benzophenone-54065-45-6/6628-37-1223-772-2 / -5 % (as acid)
[F823 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 % e ]
[F423a 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 % e

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.

]
24Sodium salt of 2,2'-bis(1,4-phenylene)-1H-benzimidazole-4,6-disulfonic acid) / Bisdisulizole disodium (USAN)Disodium Phenyl Dibenzimidazole Tetrasulfonate180898-37-7429-750-010 % (as acid)
252,2'-(6-(4-Methoxyphenyl)-1,3,5-triazine-2,4-diyl)bis(5-((2-ethylhexyl)oxy)phenol) / BemotrizinolBis-Ethylhexyloxyphenol Methoxyphenyl Triazine187393-00-610 %
26DimethicodiethylbenzalmalonatePolysilicone-15207574-74-1426-000-410 %
[F127 Titanium dioxide b Titanium Dioxide

13463-67-7/

1317-70-0/

1317-80-2

236-675-5/

215-280-1/

215-282-2

25 % d ]
[F327a Titanium dioxide b Titanium Dioxide (nano)

13463-67-7/

1317-70-0/

1317-80-2

236-675-5/

215-280-1/

215-282-2

25 % d

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;

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

  • nanoparticles are photostable in the final formulation.

]
[F528 Benzoic acid, 2-[-4-(diethylamino)-2-hydroxybenzoyl]-. Hexylester Diethylamino Hydroxy benzoyl Hexyl Benzoate 302776-68-7 443-860-6 10  % ]
[F9 [X129 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

] ]
[F230 Zinc oxide Zinc Oxide 1314-13-2 215-222-5 25 % c 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 % c

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.

]
[F1031 3,3′-(1,4-Phenylene)bis(5,6-diphenyl-1,2,4-triazine) Phenylene Bis-Diphenyltriazine 55514-22-2 700-823-1 5 % Not to be used in applications that may lead to exposure of the end user's lungs by inhalation. ]

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