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)

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

Reference number	Substance identification				Conditions			Wording of conditions of use and warnings
^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 number	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	Wording of conditions of use and warnings
a	b	c	d	e	f	g	h	i
[F51 ]
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 %
[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
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 %
F7
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)
[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.]
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 %
[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
[F927a	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 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.]
[F528	Benzoic acid, 2-[-4-(diethylamino)-2-hydroxybenzoyl]-. Hexylester	Diethylamino Hydroxy benzoyl Hexyl Benzoate	302776-68-7	443-860-6		10 % ]
[F10[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.]
[F1131	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. ]
[F1232	2-ethoxyethyl (2Z)-2-cyano-2-[3-(3-methoxypropylamino) cyclohex-2-en-1-ylidene]acetate	Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate	1419401-88-9	700-860-3		3 %	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]
[F1333	1,1’-(1,4-piperazinediyl)bis[1-[2-[4-(diethylamino)-2-hydroxybenzoyl]phenyl]-methanone	Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine	919803-06-8	485-100-6		10%	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.]
[F1334	11,1’-(1,4-piperazinediyl)bis[1-[2-[4-(diethylamino)-2-hydroxybenzoyl]phenyl]-methanone	Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine (nano)	919803-06-8	485-100-6		10%	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 %.]