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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)

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ANNEX VLIST 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 %.

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

For use other than as a preservative, see Annex III, No. 45, 68.

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.

Reference numberSubstance identificationConditionsWording of conditions of use and warnings
Chemical name/INNName of Common Ingredients GlossaryCAS numberEC numberProduct type, Body partsMaximum concentration in ready for use preparationOther
abcdefghi
1Benzoic 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 products2,5 % (acid)
Oral products1,7 % (acid)
Leave-on products0,5 % (acid)
1aSalts of benzoic acid other than that listed under reference number 1 and esters of benzoic acidAmmonium benzoate, calcium benzoate, potassium benzoate, magnesium benzoate, MEA-benzoate, methyl benzoate, ethyl benzoate, propyl benzoate, butyl benzoate, isobutyl benzoate, isopropyl benzoate, phenyl benzoate1863-63-4, 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, 93-99-2217-468-9, 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, 202-293-20,5 % (acid)
2Propionic acid and its saltsPropionic acid, ammonium propionate, calcium propionate, magnesium propionate, potassium propionate, sodium propionate79-09-4, 17496-08-1, 4075-81-4, 557-27-7, 327-62-8, 137-40-6201-176-3, 241-503-7, 223-795-8, 209-166-0, 206-323-5, 205-290-42 % (acid)
3Salicylic acida and its saltsSalicylic acid, calcium salicylate, magnesium salicylate, MEA-salicylate, sodium salicylate, potassium salicylate, TEA-salicylate69-72-7, 824-35-1, 18917-89-0, 59866-70-5, 54-21-7, 578-36-9, 2174-16-5200-712-3, 212-525-4, 242-669-3, 261-963-2, 200-198-0, 209-421-6, 218-531-30,5 % (acid)Not to be used in products for children under 3 years of age, except for shampoosNot to be used for children under 3 years of ageb
4Hexa-2,4-dienoic acid and its saltsSorbic acid, calcium sorbate, sodium sorbate, potassium sorbate110-44-1, 7492-55-9, 7757-81-5, 24634-61-5203-768-7, 231-321-6, 231-819-3, 246-376-10,6 % (acid)
5Formal-dehyde, paraformaldehydec

Formaldehyde

Paraformaldehyde

50-00-0, 30525-89-4200-001-8Oral products0,1 % (free formaldehyde)Not to be used in aerosol dispensers (sprays)
Other products0,2 % (free formaldehyde)
6Moved or deleted
7Biphenyl-2-ol, and its saltso-Phenylphenol, sodium o-phenylphenate, potassium o-phenylphenate, MEA o-phenylphenate90-43-7, 132-27-4, 13707-65-8, 84145-04-0201-993-5, 205-055-6, 237-243-9, 282-227-70,2 % (as phenol)
8Pyrithione zincdZinc pyrithione13463-41-7236-671-3Hair products1,0 %

Only in rinse-off products

Not to be used in oral products

Other products0,5 %
9Inorganic sulphites and hydrogen- sulphiteseSodium sulfite, ammonium bisulfite, ammonium sulfite, potassium sulfite, potassium hydrogen sulfite, sodium bisulfite, sodium metabisulfite, potassium metabisulfite7757-83-7, 10192-30-0, 10196-04-0, 10117-38-1, 7773-03-7, 7631-90-5, 7681-57-4, 16731-55-8231-821-4, 233-469-7, 233-484-9, 233-321-1, 231-870-1, 231-548-0, 231-673-0, 240-795-30,2 % (as free SO2)
10Moved or deleted
11ChlorobutanolChlorobutanol57-15-8200-317-60,5 %Not to be used in aerosol dispensers (sprays)Contains Chlorobutanol
124-Hydroxybenzoic acid and its salts and esters4-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, phenylparaben99-96-7, 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, 17696-62-7202-804-9, 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

133-Acetyl-6-methylpyran-2,4 (3H)-dione and its saltsDehydroacetic acid, sodium dehydroacetate520-45-6, 4418-26-2, 16807-48-0208-293-9, 224-580-10,6 % (as acid)Not to be used in aerosol dispensers (sprays)
14Formic acid and its sodium saltFormic acid, sodium formate64-18-6, 141-53-7200-579-1, 205-488-00,5 % (as acid)
153,3'-Dibromo-4,4'-hexamethylenedioxydi-benzamidine and its salts (including isethionate)Dibromohexamidine Isethionate93856-83-8299-116-40,1 %
16ThiomersalThimerosal54-64-8200-210-4Eye 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
17Phenylmercuric salts (including borate)Phenyl Mercuric Acetate, Phenyl Mercuric Benzoate62-38-4, 94-43-9200-532-5, 202-331-8Eye 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
18Undec-10-enoic acid and its saltsUndecylenic acid, potassium undecylenate, sodium undecylenate, calcium undecylenate, TEA-undecylenate, MEA-undecylenate112-38-9, 6159-41-7, 3398-33-2, 1322-14-1, 84471-25-0, 56532-40-2203-965-8, 222-264-8, 215-331-8, 282-908-9, 260-247-70,2 % (as acid)
195- Pyrimidinamine, 1,3-bis (2-ethylhexyl) hexahydro-5-methyl-Hexetidine141-94-6205-513-50,1 %
205-Bromo-5-nitro-1,3-dioxane5-Bromo-5-nitro-1,3-dioxane30007-47-7250-001-7Rinse-off products0,1 %Avoid formation of nitrosamines
21Bronopol2-Bromo-2-nitropropane-1,3-diol52-51-7200-143-00,1 %Avoid formation of nitrosamines
222,4-Dichlorobenzyl alcoholDichlorobenzyl Alcohol1777-82-8217-210-50,15 %
231-(4-Chlorophenyl)-3-(3,4-dichlorophenyl) ureafTriclocarban101-20-2202-924-10,2 %

Purity criteria:

3,3',4,4'-Tetrachloroazobenzene <1 ppm

3,3',4,4'-Tetrachloroazoxybenzene <1 ppm

24Chlorocresolp-Chloro-m-Cresol59-50-7200-431-6Not to be used in products applied on mucuous membranes0,2 %
255-Chloro-2- (2,4- dichlorophenoxy) phenolTriclosan3380-34-5222-182-20,3 %
26Chloro-xylenolChloroxylenol88-04-0201-793-80,5 %
27N,N″-methylenebis[N′-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]urea]Imidazolidinyl urea39236-46-9254-372-60,6 %
28Poly(methylene),.alpha.,.omega.-bis[[[(aminoiminomethyl)amino]iminomethyl] amino]-, dihydrochloridePolyaminopropyl biguanide70170-61-5, 28757-47-3, 133029-32-00,3 %
292-PhenoxyethanolPhenoxyethanol122-99-6204-589-71,0 %
30MethenamineMethenamine100-97-0202-905-80,15 %
31Methenamine 3-chloroallylochlorideQuaternium-154080-31-3223-805-00,2 %
321-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-oneClimbazole38083-17-9253-775-40,5 %
331,3-Bis (hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dioneDMDM Hydantoin6440-58-0229-222-80,6 %
34Benzyl alcoholgBenzyl alcohol100-51-6202-859-91,0 %
351-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl) 2-pyridon and its monoethanolamine salt1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl) 2-pyridon, Piroctone Olamine50650-76-5, 68890-66-4272-574-2Rinse-off products1,0 %
Other products0,5 %
36Moved or deleted
372,2'-methylenebis(6-bromo-4-chlorophenol)Bromochlorophene15435-29-7239-446-80,1 %
384-Isopropyl-m-cresolo-Cymen-5-ol3228-02-2221-761-70,1 %
39Mixture of 5-Chloro-2-methyl-isothiazol-3(2H)-one and 2-methylisothiazol-3(2H)-one with magnesium chloride and magnesium nitrateMethylchloroisothiazolinone and Methylisothiazolinone26172-55-4, 2682-20-4, 55965-84-9247-500-7, 220-239-60,0015 % (of a mixture in the ratio 3:1 of 5-chloro-2-methylisothiazol 3(2H)-one and 2-methylisothiazol-3 (2H)-one
402-Benzyl-4-chlorophenolChlorophene120-32-1204-385-80,2 %
412-ChloroacetamideChloroacetamide79-07-2201-174-20,3 %Contains chloroacetamide
42N,N″-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine and its digluconate, diacetate and dihydrochlorideChlorhexidine, Chlorhexidine Diacetate, Chlorhexidine Digluconate, Chlorhexidine Dihydrochloride55-56-1, 56-95-1, 18472-51-0, 3697-42-5200-238-7, 200-302-4, 242-354-0, 223-026-60,3 % (as chlorhexidine)
431-Phenoxypropan-2-olhPhenoxyisopropanol770-35-4212-222-7Only for rinse-off products1,0 %
44Alkyl (C 12-22) trimethyl ammonium bromide and chlorideBehentrimonium chloride, cetrimonium bromide, cetrimonium chloride, laurtrimonium bromide, laurtrimonium chloride, steartrimonium bromide, steartrimonium chloride17301-53-0, 57-09-0, 112-02-7, 1119-94-4, 112-00-5, 1120-02-1, 112-03-8241-327-0, 200-311-3, 203-928-6, 214-290-3, 203-927-0, 214-294-5, 203-929-10,1 %
454,4-Dimethyl-1,3-oxazolidineDimethyl Oxazolidine51200-87-4257-048-20,1 %pH > 6
46N-(Hydroxymethyl)-N-(dihydroxymethyl-1,3-dioxo-2,5-imidazolidinyl-4)-N'-(hydroxymethyl) ureaDiazolidinyl Urea78491-02-8278-928-20,5 %
47Benzenecarboximidamide, 4,4'-(1,6-hexanediylbis (oxy))bis- and its salts (including isethionate and p-hydroxybenzoate)Hexamidine, Hexamidine diisethionate, Hexamidine paraben3811-75-4, 659-40-5, 93841-83-9211-533-5, 299-055-30,1 %
48Glutaraldehyde (Pentane-1,5-dial)Glutaral111-30-8203-856-50,1 %Not to be used in aerosols (sprays)Contains glutarali
495-Ethyl-3,7-dioxa-1-azabicyclo [3.3.0] octane7-Ethylbicyclooxazolidine7747-35-5231-810-40,3 %Not to be used in oral products and in products applied on mucous membranes
503-(p-Chlorophenoxy)-propane-1,2 diolChlorphenesin104-29-0203-192-60,3 %
51Sodium hydroxymethylamino acetateSodium Hydroxymethylglycinate70161-44-3274-357-80,5 %
52Silver chloride deposited on titanium dioxideSilver chloride7783-90-6232-033-30,004 % (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
53Benzenemethanaminium, N,N-dimethyl-N-[2-[2-[4-(1,1,3,3,-tetramethylbutyl)phenoxy]ethoxy] ethyl]-, chlorideBenzethonium Chloride121-54-0204-479-9
(a)

Rinse-off products

(b)

Leave-on products other than oral products

0,1 %
54Benzalkonium chloride, bromide and saccharinatejBenzalkonium chloride, benzalkonium bromide, benzalkonium saccharinate8001-54-5, 63449-41-2, 91080-29-4, 68989-01-5, 68424-85-1, 68391-01-5, 61789-71-7, 85409-22-9264-151-6, 293-522-5, 273-545-7, 270-325-2, 269-919-4, 263-080-8, 287-089-10,1 % (as benzalkonium chloride)Avoid contact with eyes
55Methanol, (phenylmethoxy-)Benzylhemiformal14548-60-8238-588-8Rinse-off products0,15 %
563-Iodo-2-propynylbutylcarbamateIodopropynyl butylcarbamate55406-53-6259-627-5
(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

(a)

Not to be used for children under 3 years of agel

(b) and (c)

Not to be used for children under 3 years of agek

572-Methyl-2H-isothiazol-3-oneMethylisothiazolinone2682-20-4220-239-60,01 %

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