ANNEX VU.K.LIST OF PRESERVATIVES ALLOWED IN COSMETIC PRODUCTS
PreambleU.K.
1.For the purposes of this list:U.K.
‘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.
2.All finished products containing formaldehyde or substances in this Annex and which release formaldehyde must be labelled with the warning ‘contains formaldehyde’ where the concentration of formaldehyde in the finished product exceeds 0,05 %.U.K.
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.] | ||||||||
p For use other than as a preservative, see Annex III, No 286.] ] | ||||||||
q [F4Methylisothiazolinone is also regulated in entry 57. The two entries are mutually exclusive: the use of the mixture of Methylchloroisothiazolinone (and) Methylisothiazolinone is incompatible with the use of Methylisothiazolinone alone in the same product. | ||||||||
r Methylisothiazolinone is also regulated in entry 39 in a mixture with Methylchloroisothiazolinone. The two entries are mutually exclusive: the use of the mixture of Methylchloroisothiazolinone (and) Methylisothiazolinone is incompatible with the use of Methylisothiazolinone alone in the same product.] | ||||||||
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 | |
[F512 | 4-Hydroxybenzoic acid and its Methyl- and Ethyl- esters, and their salts | 4-Hydroxybenzoic acid methylparaben potassium ethylparaben potassium paraben sodium methylparaben sodium ethylparaben ethylparaben sodium paraben potassium methylparaben calcium paraben | 99-96-7 99-76-3 36457-19-9 16782-08-4 5026-62-0 35285-68-8 120-47-8 114-63-6 26112-07-2 69959-44-0 | 202-804-9 202-785-7 253-048-1 240-830-2 225-714-1 252-487-6 204-399-4 204-051-1 247-464-2 274-235-4 | 0,4 % (as acid) for single ester 0,8 % (as acid) for mixtures of esters | ] | ||
[F612a | Butyl 4-hydroxybenzoate and its salts Propyl 4-hydroxybenzoate and its salts | Butylparaben propylparaben sodium propylparaben sodium butylparaben potassium butylparaben potassium propylparaben | 94-26-8 94-13-3 35285-69-9 36457-20-2 38566-94-8 84930-16-5 | 202-318-7 202-307-7 252-488-1 253-049-7 254-009-1 284-597-5 | 0,14 % (as acid) for the sum of the individual concentrations 0,8 % (as acid) for mixtures of substances mentioned in entry 12 and 12a, where the sum of the individual concentrations of butyl- and propylparaben and their salts does not exceed 0,14 % | Not to be used in leave-on products designed for application on the nappy area of children under three years of age. | For leave-on products designed for children under three years of age: ‘ Do not use on the nappy area ’] | |
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 % | ||
[F725 | 5-Chloro-2- (2,4- dichlorophenoxy) phenol | Triclosan | 3380-34-5 | 222-182-2 | (a) ToothpastesHand soaps Body soaps/Shower gels Deodorants (non-spray) Face powders and blemish concealers Nail products for cleaning the fingernails and toenails before the application of artificial nail systems | (a) 0,3 % | ||
(b) Mouthwashes | (b) 0,2 % | ] | ||||||
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 % | |||
[F839 | Mixture of 5-Chloro-2-methyl-isothiazol-3(2H)-one and 2-methylisothiazol-3(2H)-one | Methylchloroisothiazolinone (and) Methylisothiazolinone q | 26172-55-4, 2682-20-4, 55965-84-9 | 247-500-7, 220-239-6 | Rinse-off products | 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 % | ||
[F9 [X144 | Alkyl (C 12-22 ) trimethyl ammonium bromide and chloride | Behentrimonium chloride o , | 17301-53-0, | 241-327-0, | 0,1 % | |||
cetrimonium bromide, | 57-09-0, | 200-311-3, | ||||||
cetrimonium chloride p , | 112-02-7, | 203-928-6, | ||||||
laurtrimonium bromide, | 1119-94-4, | 214-290-3, | ||||||
laurtrimonium chloride, | 112-00-5, | 203-927-0, | ||||||
steartrimonium bromide, | 1120-02-1, | 214-294-5, | ||||||
steartrimonium chloride p | 112-03-8 | 203-929-1] ] | ||||||
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 | |
[F857 | 2-Methyl-2H-isothiazol-3-one | Methylisothiazolinone r | 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 | ] | |
[F3 [X159 | 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, monohydrate and 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, silver(1+) salt, monohydrate | Citric acid (and) Silver citrate | — | 460-890-5 | 0,2 %, corresponding to 0,0024 % of silver | Not to be used in oral products and eye products | ] ] |
Editorial Information
X1 Substituted by Corrigendum to Commission Regulation (EU) No 866/2014 of 8 August 2014 amending Annexes III, V and VI to Regulation (EC) No 1223/2009 of the European Parliament and the Council on cosmetic products (Official Journal of the European Union L 238 of 9 August 2014).
Textual Amendments
F1 Substituted by Commission Regulation (EU) No 344/2013 of 4 April 2013 amending Annexes II, III, V and VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance).
F2 Inserted by Commission Regulation (EU) No 344/2013 of 4 April 2013 amending Annexes II, III, V and VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance).
F3 Inserted by Commission Regulation (EU) No 866/2014 of 8 August 2014 amending Annexes III, V and VI to Regulation (EC) No 1223/2009 of the European Parliament and the Council on cosmetic products (Text with EEA relevance).
F4 Inserted by Commission Regulation (EU) No 1003/2014 of 18 September 2014 amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance).
F5 Substituted by Commission Regulation (EU) No 1004/2014 of 18 September 2014 amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance).
F6 Inserted by Commission Regulation (EU) No 1004/2014 of 18 September 2014 amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance).
F7 Substituted by Commission Regulation (EU) No 358/2014 of 9 April 2014 amending Annexes II and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance).