欧盟化妆品法规(EC)No 1223/2009 化妆品防腐剂清单（附录 V）
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 V
LIST OF PRESERVATIVES ALLOWED IN COSMETIC PRODUCTS
Preamble
1. For the purposes of this list:
— | ‘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 %.
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 acid (1) 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 age (2) |
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, paraformaldehyde (3) | 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 zinc (4) | 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- sulphites (5) | 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) urea (6) | 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 % |
|
|
34 | Benzyl alcohol (7) | 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-ol (8) | 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 glutaral (9) |
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 saccharinate (10) | 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 cream (13)(b) and (c)Not to be used in products for children under 3 years of age | (a)Not to be used for children under 3 years of age (11)(b) and (c)Not to be used for children under 3 years of age (12) |
57 | 2-Methyl-2H-isothiazol-3-one | Methylisothiazolinone | 2682-20-4 | 220-239-6 |
| 0,01 % |
|
|
(1) For use other than as a preservative, see Annex III, No. 98.
(2) Solely for products which might be used for children under 3 years of age and which remain in prolonged contact with the skin.
(3) For use other than as a preservative, see Annex III, No. 13.
(4) For use other than as a preservative, see Annex III. No. 101.
(5) For use other than as a preservative, see Annex III, No. 99.
(6) For use other than as a preservative, see Annex III, No. 100.
(7) For use other than as a preservative, see Annex III, No. 45, 68.
(8) For use other than as a preservative, see Annex III, No. 54.
(9) Only if the concentration exceeds 0,05 %.
(10) For use other than as a preservative, see Annex III, No. 65.
(11) Solely for products, other than bath products/shower gels and shampoo, which might be used for children under 3 years of age.
(12) Solely for products which might be used for children under 3 years of age.
(13) Concerns any products aimed to be applied on a large part of the body.
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