ANNEX VLIST OF PRESERVATIVES ALLOWED IN COSMETIC PRODUCTS

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 acid43 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 age44

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, paraformaldehyde45

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 zinc46

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- sulphites47

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

F312

4-Hydroxybenzoic acid and its salts and esters, other than the esters of isopropyl, isobutyl, phenyl, benzyl and pentyl

4-Hydroxybenzoic acid

99-96-7

202-804-9

0,4 % (as acid) for single ester,

0,8 % (as acid) for mixtures of esters

methylparaben

99-76-3

202-785-7

butylparaben

94-26-8

202-318-7

potassium ethylparaben

36457-19-9

253-048-1

potassium paraben

16782-08-4

240-830-2

propylparaben

94-13-3

202-307-7

sodium methylparaben

5026-62-0

225-714-1

sodium ethylparaben

35285-68-8

252-487-6

sodium propylparaben

35285-69-9

252-488-1

sodium butylparaben

36457-20-2

253-049-7

ethylparaben

120-47-8

204-399-4

sodium paraben

114-63-6

204-051-1

potassium methylparaben

26112-07-2

247-464-2

potassium butylparaben

38566-94-8

254-009-1

potassium propylparaben

84930-16-5

284-597-5

calcium paraben

69959-44-0

274-235-4

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) urea48

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 %

F325

5-Chloro-2- (2,4- dichlorophenoxy) phenol

Triclosan

3380-34-5

222-182-2

(a)Toothpastes

Hand 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 alcohol49

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-ol50

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 glutaral51

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

  1. (a)

    Rinse-off products

  2. (b)

    Leave-on products other than oral products

0,1 %

54

Benzalkonium chloride, bromide and saccharinate52

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

  1. (a)

    Rinse-off products

  2. (b)

    Leave-on products

  3. (c)

    Deo-dorants/anti-perspirants

  1. (a)

    0,02 %

  2. (b)

    0,01 %,

  3. (c)

    0,0075 %

Not to be used in oral and lip products

  1. (a)

    Not to be used in products for children under 3 years of age, except in bath products/shower gels and shampoo

  2. (b)

    Not to be used in body lotion and body cream55

  3. (b) and (c)

    Not to be used in products for children under 3 years of age

  1. (a)

    Not to be used for children under 3 years of age53

  2. (b) and (c)

    Not to be used for children under 3 years of age54

57

2-Methyl-2H-isothiazol-3-one

Methylisothiazolinone

2682-20-4

220-239-6

0,01 %

F258

Ethyl-N-alpha-dodecanoyl-L-arginate hydrochloride56

Ethyl Lauroyl Arginate HCl

60372-77-2

434-630-6

0,4 %

Not to be used in lip products, oral products and spray products

For use other than as a preservative, see Annex III, No. 98.

Solely for products which might be used for children under 3 years of age and which remain in prolonged contact with the skin.

For use other than as a preservative, see Annex III, No. 13.

For use other than as a preservative, see Annex III. No. 101.

For use other than as a preservative, see Annex III, No. 99.

For use other than as a preservative, see Annex III, No. 100.

For other uses than preservatives, see Annex III, entry No 45.

For use other than as a preservative, see Annex III, No. 54.

Only if the concentration exceeds 0,05 %.

For use other than as a preservative, see Annex III, No. 65.

Solely for products, other than bath products/shower gels and shampoo, which might be used for children under 3 years of age.

Solely for products which might be used for children under 3 years of age.

Concerns any products aimed to be applied on a large part of the body.

For other uses than preservatives, see Annex III, entry No 197.