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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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Version Superseded: 01/07/2014
Point in time view as at 01/04/2014.
There are currently no known outstanding effects for the Regulation (EC) No 1223/2009 of the European Parliament and of the Council, ANNEX V.
Revised legislation carried on this site may not be fully up to date. At the current time any known changes or effects made by subsequent legislation have been applied to the text of the legislation you are viewing by the editorial team. Please see ‘Frequently Asked Questions’ for details regarding the timescales for which new effects are identified and recorded on this site.
‘Salts’ is taken to mean: salts of the cations sodium, potassium, calcium, magnesium, ammonium and ethanolamines; salts of the anions chloride, bromide, sulphate, acetate.
‘Esters’ is taken to mean: esters of methyl, ethyl, propyl, isopropyl, butyl, isobutyl, phenyl.
a For use other than as a preservative, see Annex III, No. 98. | ||||||||
b Solely for products which might be used for children under 3 years of age and which remain in prolonged contact with the skin. | ||||||||
c For use other than as a preservative, see Annex III, No. 13. | ||||||||
d For use other than as a preservative, see Annex III. No. 101. | ||||||||
e For use other than as a preservative, see Annex III, No. 99. | ||||||||
f For use other than as a preservative, see Annex III, No. 100. | ||||||||
g [F1For other uses than preservatives, see Annex III, entry No 45.] | ||||||||
h For use other than as a preservative, see Annex III, No. 54. | ||||||||
i Only if the concentration exceeds 0,05 %. | ||||||||
j For use other than as a preservative, see Annex III, No. 65. | ||||||||
l Solely for products, other than bath products/shower gels and shampoo, which might be used for children under 3 years of age. | ||||||||
k Solely for products which might be used for children under 3 years of age. | ||||||||
m Concerns any products aimed to be applied on a large part of the body. | ||||||||
n [F2For other uses than preservatives, see Annex III, entry No 197.] | ||||||||
Reference number | Substance identification | Conditions | Wording of conditions of use and warnings | |||||
---|---|---|---|---|---|---|---|---|
Chemical name/INN | 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 |
1 | Benzoic acid and its sodium salt | Benzoic acid Sodium Benzoate | 65-85-0 532-32-1 | 200-618-2 208-534-8 | Rinse-off products, except oral products | 2,5 % (acid) | ||
Oral products | 1,7 % (acid) | |||||||
Leave-on products | 0,5 % (acid) | |||||||
1a | Salts of benzoic acid other than that listed under reference number 1 and esters of benzoic acid | Ammonium benzoate, calcium benzoate, potassium benzoate, magnesium benzoate, MEA-benzoate, methyl benzoate, ethyl benzoate, propyl benzoate, butyl benzoate, isobutyl benzoate, isopropyl benzoate, phenyl benzoate | 1863-63-4, 2090-05-3, 582-25-2, 553-70-8, 4337-66-0, 93-58-3, 93-89-0, 2315-68-6, 136-60-7, 120-50-3, 939-48-0, 93-99-2 | 217-468-9, 218-235-4, 209-481-3, 209-045-2, 224-387-2, 202-259-7, 202-284-3, 219-020-8, 205-252-7, 204-401-3, 213-361-6, 202-293-2 | 0,5 % (acid) | |||
2 | Propionic acid and its salts | Propionic acid, ammonium propionate, calcium propionate, magnesium propionate, potassium propionate, sodium propionate | 79-09-4, 17496-08-1, 4075-81-4, 557-27-7, 327-62-8, 137-40-6 | 201-176-3, 241-503-7, 223-795-8, 209-166-0, 206-323-5, 205-290-4 | 2 % (acid) | |||
3 | Salicylic acida and its salts | Salicylic acid, calcium salicylate, magnesium salicylate, MEA-salicylate, sodium salicylate, potassium salicylate, TEA-salicylate | 69-72-7, 824-35-1, 18917-89-0, 59866-70-5, 54-21-7, 578-36-9, 2174-16-5 | 200-712-3, 212-525-4, 242-669-3, 261-963-2, 200-198-0, 209-421-6, 218-531-3 | 0,5 % (acid) | Not to be used in products for children under 3 years of age, except for shampoos | Not to be used for children under 3 years of ageb | |
4 | Hexa-2,4-dienoic acid and its salts | Sorbic acid, calcium sorbate, sodium sorbate, potassium sorbate | 110-44-1, 7492-55-9, 7757-81-5, 24634-61-5 | 203-768-7, 231-321-6, 231-819-3, 246-376-1 | 0,6 % (acid) | |||
5 | Formal-dehyde, paraformaldehydec | Formaldehyde Paraformaldehyde | 50-00-0, 30525-89-4 | 200-001-8 | Oral products | 0,1 % (free formaldehyde) | Not to be used in aerosol dispensers (sprays) | |
Other products | 0,2 % (free formaldehyde) | |||||||
6 | Moved or deleted | |||||||
7 | Biphenyl-2-ol, and its salts | o-Phenylphenol, sodium o-phenylphenate, potassium o-phenylphenate, MEA o-phenylphenate | 90-43-7, 132-27-4, 13707-65-8, 84145-04-0 | 201-993-5, 205-055-6, 237-243-9, 282-227-7 | 0,2 % (as phenol) | |||
8 | Pyrithione zincd | Zinc pyrithione | 13463-41-7 | 236-671-3 | Hair products | 1,0 % | Only in rinse-off products Not to be used in oral products | |
Other products | 0,5 % | |||||||
9 | Inorganic sulphites and hydrogen- sulphitese | Sodium sulfite, ammonium bisulfite, ammonium sulfite, potassium sulfite, potassium hydrogen sulfite, sodium bisulfite, sodium metabisulfite, potassium metabisulfite | 7757-83-7, 10192-30-0, 10196-04-0, 10117-38-1, 7773-03-7, 7631-90-5, 7681-57-4, 16731-55-8 | 231-821-4, 233-469-7, 233-484-9, 233-321-1, 231-870-1, 231-548-0, 231-673-0, 240-795-3 | 0,2 % (as free SO2) | |||
10 | Moved or deleted | |||||||
11 | Chlorobutanol | Chlorobutanol | 57-15-8 | 200-317-6 | 0,5 % | Not to be used in aerosol dispensers (sprays) | Contains Chlorobutanol | |
12 | 4-Hydroxybenzoic acid and its salts and esters | 4-Hydroxybenzoic acid, methylparaben, butylparaben, potassium ethylparaben, potassium paraben, propylparaben, isobutylparaben, sodium methylparaben, sodium ethylparaben, sodium propylparaben, sodium butylparaben, sodium isobutylparaben, ethylparaben, sodium paraben, isopropylparaben, potassium methylparaben, potassium butylparaben, potassium propylparaben, sodium propylparaben, calcium paraben, phenylparaben | 99-96-7, 99-76-3, 94-26-8, 36457-19–9,16782-08-4, 94-13-3, 4247-02-3, 5026-62-0, 35285-68-8, 35285-69-9, 36457-20-2, 84930-15-4, 120-47-8, 114-63-6, 4191-73-5, 2611-07-2, 38566-94-8, 84930-17-4, 35285-69-9, 69959-44-0, 17696-62-7 | 202-804-9, 202-785-7, 202-318-7, 253-048-1, 240-830-2, 202-307-7, 224-208-8, 225-714-1, 252-487-6, 252-488-1, 253-049-7, 284-595-4, 204-399-4, 204-051-1, 224-069-3, 247-464-2, 254-009-1, 284-597-5, 252-488-1, 274-235-4, 241-698-9 | 0,4 % (as acid) for single ester, 0,8 % (as acid) for mixtures of esters | |||
13 | 3-Acetyl-6-methylpyran-2,4 (3H)-dione and its salts | Dehydroacetic acid, sodium dehydroacetate | 520-45-6, 4418-26-2, 16807-48-0 | 208-293-9, 224-580-1 | 0,6 % (as acid) | Not to be used in aerosol dispensers (sprays) | ||
14 | Formic acid and its sodium salt | Formic acid, sodium formate | 64-18-6, 141-53-7 | 200-579-1, 205-488-0 | 0,5 % (as acid) | |||
15 | 3,3'-Dibromo-4,4'-hexamethylenedioxydi-benzamidine and its salts (including isethionate) | Dibromohexamidine Isethionate | 93856-83-8 | 299-116-4 | 0,1 % | |||
16 | Thiomersal | Thimerosal | 54-64-8 | 200-210-4 | Eye products | 0,007 % (of Hg) If mixed with other mercurial compounds authorised by this Regulation, the maximum concentration of Hg remains fixed at 0,007 % | Contains Thiomersal | |
17 | Phenylmercuric salts (including borate) | Phenyl Mercuric Acetate, Phenyl Mercuric Benzoate | 62-38-4, 94-43-9 | 200-532-5, 202-331-8 | Eye products | 0,007 % (of Hg) If mixed with other mercurial compounds authorised by this Regulation, the maximum concentration of Hg remains fixed at 0,007 % | Contains Phenylmercuric compounds | |
18 | Undec-10-enoic acid and its salts | Undecylenic acid, potassium undecylenate, sodium undecylenate, calcium undecylenate, TEA-undecylenate, MEA-undecylenate | 112-38-9, 6159-41-7, 3398-33-2, 1322-14-1, 84471-25-0, 56532-40-2 | 203-965-8, 222-264-8, 215-331-8, 282-908-9, 260-247-7 | 0,2 % (as acid) | |||
19 | 5- Pyrimidinamine, 1,3-bis (2-ethylhexyl) hexahydro-5-methyl- | Hexetidine | 141-94-6 | 205-513-5 | 0,1 % | |||
20 | 5-Bromo-5-nitro-1,3-dioxane | 5-Bromo-5-nitro-1,3-dioxane | 30007-47-7 | 250-001-7 | Rinse-off products | 0,1 % | Avoid formation of nitrosamines | |
21 | Bronopol | 2-Bromo-2-nitropropane-1,3-diol | 52-51-7 | 200-143-0 | 0,1 % | Avoid formation of nitrosamines | ||
22 | 2,4-Dichlorobenzyl alcohol | Dichlorobenzyl Alcohol | 1777-82-8 | 217-210-5 | 0,15 % | |||
23 | 1-(4-Chlorophenyl)-3-(3,4-dichlorophenyl) ureaf | Triclocarban | 101-20-2 | 202-924-1 | 0,2 % | Purity criteria: 3,3',4,4'-Tetrachloroazobenzene <1 ppm 3,3',4,4'-Tetrachloroazoxybenzene <1 ppm | ||
24 | Chlorocresol | p-Chloro-m-Cresol | 59-50-7 | 200-431-6 | Not to be used in products applied on mucuous membranes | 0,2 % | ||
25 | 5-Chloro-2- (2,4- dichlorophenoxy) phenol | Triclosan | 3380-34-5 | 222-182-2 | 0,3 % | |||
26 | Chloro-xylenol | Chloroxylenol | 88-04-0 | 201-793-8 | 0,5 % | |||
27 | N,N″-methylenebis[N′-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]urea] | Imidazolidinyl urea | 39236-46-9 | 254-372-6 | 0,6 % | |||
28 | Poly(methylene),.alpha.,.omega.-bis[[[(aminoiminomethyl)amino]iminomethyl] amino]-, dihydrochloride | Polyaminopropyl biguanide | 70170-61-5, 28757-47-3, 133029-32-0 | 0,3 % | ||||
29 | 2-Phenoxyethanol | Phenoxyethanol | 122-99-6 | 204-589-7 | 1,0 % | |||
30 | Methenamine | Methenamine | 100-97-0 | 202-905-8 | 0,15 % | |||
31 | Methenamine 3-chloroallylochloride | Quaternium-15 | 4080-31-3 | 223-805-0 | 0,2 % | |||
32 | 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one | Climbazole | 38083-17-9 | 253-775-4 | 0,5 % | |||
33 | 1,3-Bis (hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione | DMDM Hydantoin | 6440-58-0 | 229-222-8 | 0,6 % | |||
[F134 | Benzyl alcohol g | Benzyl Alcohol | 100-51-6 | 202-859-9 | 1,0 % | ] | ||
35 | 1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl) 2-pyridon and its monoethanolamine salt | 1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl) 2-pyridon, Piroctone Olamine | 50650-76-5, 68890-66-4 | 272-574-2 | Rinse-off products | 1,0 % | ||
Other products | 0,5 % | |||||||
36 | Moved or deleted | |||||||
37 | 2,2'-methylenebis(6-bromo-4-chlorophenol) | Bromochlorophene | 15435-29-7 | 239-446-8 | 0,1 % | |||
38 | 4-Isopropyl-m-cresol | o-Cymen-5-ol | 3228-02-2 | 221-761-7 | 0,1 % | |||
39 | Mixture of 5-Chloro-2-methyl-isothiazol-3(2H)-one and 2-methylisothiazol-3(2H)-one with magnesium chloride and magnesium nitrate | Methylchloroisothiazolinone and Methylisothiazolinone | 26172-55-4, 2682-20-4, 55965-84-9 | 247-500-7, 220-239-6 | 0,0015 % (of a mixture in the ratio 3:1 of 5-chloro-2-methylisothiazol 3(2H)-one and 2-methylisothiazol-3 (2H)-one | |||
40 | 2-Benzyl-4-chlorophenol | Chlorophene | 120-32-1 | 204-385-8 | 0,2 % | |||
41 | 2-Chloroacetamide | Chloroacetamide | 79-07-2 | 201-174-2 | 0,3 % | Contains chloroacetamide | ||
42 | N,N″-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine and its digluconate, diacetate and dihydrochloride | Chlorhexidine, Chlorhexidine Diacetate, Chlorhexidine Digluconate, Chlorhexidine Dihydrochloride | 55-56-1, 56-95-1, 18472-51-0, 3697-42-5 | 200-238-7, 200-302-4, 242-354-0, 223-026-6 | 0,3 % (as chlorhexidine) | |||
43 | 1-Phenoxypropan-2-olh | Phenoxyisopropanol | 770-35-4 | 212-222-7 | Only for rinse-off products | 1,0 % | ||
44 | Alkyl (C 12-22) trimethyl ammonium bromide and chloride | Behentrimonium chloride, cetrimonium bromide, cetrimonium chloride, laurtrimonium bromide, laurtrimonium chloride, steartrimonium bromide, steartrimonium chloride | 17301-53-0, 57-09-0, 112-02-7, 1119-94-4, 112-00-5, 1120-02-1, 112-03-8 | 241-327-0, 200-311-3, 203-928-6, 214-290-3, 203-927-0, 214-294-5, 203-929-1 | 0,1 % | |||
45 | 4,4-Dimethyl-1,3-oxazolidine | Dimethyl Oxazolidine | 51200-87-4 | 257-048-2 | 0,1 % | pH > 6 | ||
46 | N-(Hydroxymethyl)-N-(dihydroxymethyl-1,3-dioxo-2,5-imidazolidinyl-4)-N'-(hydroxymethyl) urea | Diazolidinyl Urea | 78491-02-8 | 278-928-2 | 0,5 % | |||
47 | Benzenecarboximidamide, 4,4'-(1,6-hexanediylbis (oxy))bis- and its salts (including isethionate and p-hydroxybenzoate) | Hexamidine, Hexamidine diisethionate, Hexamidine paraben | 3811-75-4, 659-40-5, 93841-83-9 | 211-533-5, 299-055-3 | 0,1 % | |||
48 | Glutaraldehyde (Pentane-1,5-dial) | Glutaral | 111-30-8 | 203-856-5 | 0,1 % | Not to be used in aerosols (sprays) | Contains glutarali | |
49 | 5-Ethyl-3,7-dioxa-1-azabicyclo [3.3.0] octane | 7-Ethylbicyclooxazolidine | 7747-35-5 | 231-810-4 | 0,3 % | Not to be used in oral products and in products applied on mucous membranes | ||
50 | 3-(p-Chlorophenoxy)-propane-1,2 diol | Chlorphenesin | 104-29-0 | 203-192-6 | 0,3 % | |||
51 | Sodium hydroxymethylamino acetate | Sodium Hydroxymethylglycinate | 70161-44-3 | 274-357-8 | 0,5 % | |||
52 | Silver chloride deposited on titanium dioxide | Silver chloride | 7783-90-6 | 232-033-3 | 0,004 % (as AgCl) | 20 % AgCl (w/w) on TiO2. Not to be used in products for children under 3 years of age, in oral products and in eye and lip products | ||
53 | Benzenemethanaminium, N,N-dimethyl-N-[2-[2-[4-(1,1,3,3,-tetramethylbutyl)phenoxy]ethoxy] ethyl]-, chloride | Benzethonium Chloride | 121-54-0 | 204-479-9 | (a) Rinse-off products (b) Leave-on products other than oral products | 0,1 % | ||
54 | Benzalkonium chloride, bromide and saccharinatej | Benzalkonium chloride, benzalkonium bromide, benzalkonium saccharinate | 8001-54-5, 63449-41-2, 91080-29-4, 68989-01-5, 68424-85-1, 68391-01-5, 61789-71-7, 85409-22-9 | 264-151-6, 293-522-5, 273-545-7, 270-325-2, 269-919-4, 263-080-8, 287-089-1 | 0,1 % (as benzalkonium chloride) | Avoid contact with eyes | ||
55 | Methanol, (phenylmethoxy-) | Benzylhemiformal | 14548-60-8 | 238-588-8 | Rinse-off products | 0,15 % | ||
56 | 3-Iodo-2-propynylbutylcarbamate | Iodopropynyl butylcarbamate | 55406-53-6 | 259-627-5 | (a) Rinse-off products (b) Leave-on products (c) Deo-dorants/anti-perspirants | (a) 0,02 % (b) 0,01 %, (c) 0,0075 % | Not to be used in oral and lip products (a) Not to be used in products for children under 3 years of age, except in bath products/shower gels and shampoo (b) Not to be used in body lotion and body creamm (b) and (c) Not to be used in products for children under 3 years of age | |
57 | 2-Methyl-2H-isothiazol-3-one | Methylisothiazolinone | 2682-20-4 | 220-239-6 | 0,01 % | |||
[F258 | Ethyl-N-alpha-dodecanoyl-L-arginate hydrochloride n | Ethyl Lauroyl Arginate HCl | 60372-77-2 | 434-630-6 | 0,4 % | Not to be used in lip products, oral products and spray products | ] |
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