ANNEX V / LIST 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)

▼M36

3

Salicylic acid (1) and its salts

Salicylic acid

69-72-7

200-712-3

0,5 % (acid)

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

Not to be used for children under 3 years of age (12)

Not to be used in oral products.

Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation.

Calcium salicylate, magnesium salicylate, MEA- salicylate, sodium salicylate, potassium salicylate, TEA- salicylate

824-35-1, 18917-89-0, 59866- 70-5, 54-21-7, 578-36-9, 2174-16-5

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)

▼B

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)

▼M32 —————

▼B

6

Moved or deleted

▼M53

7

Biphenyl-2-ol; 2-phenylphenol; 2-hydroxybiphenyl

Sodium 2-biphenylate

o-Phenylphenol

Sodium o-Phenylphenate

90-43-7

132-27-4

201-993-5

205-055-6

(a)  Rinse-off products

(b)  Leave-on products

(a)  0,2 % (as phenol

(b)  0,15 % (as phenol)

When o-Phenylphenol and Sodium o-Phenylphenate are used together, the combined concentration (as phenol) shall not exceed 0,2 % in rinse-off and 0,15 % in leave-on products.

Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation. Not to be used in oral products.

Avoid contact with eyes

▼M42 —————

▼B

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

▼M8

12

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

▼M8

12a

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’

▼B

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 %

▼M51

23

1-(4-Chlorophenyl)-3-(3,4-dichlorophenyl)urea (22) (6)

Triclocarban

101-20-2

202-924-1

All cosmetic products, with the exception of mouthwash.

0,2 %

Purity criteria:

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

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

Not to be used in toothpaste intended for children under 6 years of age.

For toothpaste containing Triclocarban the following labelling is obligatory: ‘Not to be used for children under 6 years of age’.

▼B

24

Chlorocresol

p-Chloro-m-Cresol

59-50-7

200-431-6

Not to be used in products applied on mucuous membranes

0,2 %

▼M51

25

5-Chloro-2- (2,4- dichlorophenoxy) phenol (22)

Triclosan

3380-34-5

222-182-2

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;

0,3 %

Not to be used in toothpaste intended for children under 3 years of age.

For toothpaste containing Triclosan the following labelling is obligatory: ‘Not to be used for children under 3 years of age’.

▼B

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 %

▼M32

28

Polyhexamethylene biguanide hydrochloride

Polyaminopropyl biguanide

32289-58-0,

27083-27-8,

28757-47-3,

133029-32-0

608-723-9

608-042-7

0,1 %

Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation

▼B

29

2-Phenoxyethanol

Phenoxyethanol

122-99-6

204-589-7

1,0 %

30

Methenamine

Methenamine

100-97-0

202-905-8

0,15 %

▼M32 —————

▼M31

32

1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one (20)

Climbazole

38083-17-9

253-775-4

(a)  Hair lotions (21)

(b)  Face creams (21)

(c)  Foot care products (21)

(d)  Rinse-off shampoo (21)

(a)  0,2 % (21)

(b)  0,2 % (21)

(c)  0,2 % (21)

(d)  0,5 % (21)

▼B

33

1,3-Bis (hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione

DMDM Hydantoin

6440-58-0

229-222-8

0,6 %

▼M1

34

Benzyl alcohol (7)

Benzyl Alcohol

100-51-6

202-859-9

1,0  %

▼B

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 %

▼M7

39

Mixture of 5-Chloro-2-methyl-isothiazol-3(2H)-one and 2-methylisothiazol-3(2H)-one

Methylchloroisothiazolinone (and) Methylisothiazolinone (17)

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)

▼M32 —————

▼B

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 %

▼M6

44

Alkyl (C12-22) trimethyl ammonium bromide and chloride

Behentrimonium chloride (15),

17301-53-0,

241-327-0,

0,1 %

cetrimonium bromide,

57-09-0,

200-311-3,

cetrimonium chloride (16),

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 (16)

112-03-8

203-929-1

▼B

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 %

▼M46

51

Sodium N-(hydroxymethyl) glycinate

Sodium Hydroxymethylglycinate

70161-44-3

274-357-8

0,5  %

Not to be used unless it can be shown that the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is < 0,1 % w/w

▼B

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)

▼M22

57

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

Methylisothiazolinone (18)

2682-20-4

220-239-6

Rinse-off products

0,0015 %

▼M1

58

Ethyl-N-alpha-dodecanoyl-L-arginate hydrochloride (14)

Ethyl Lauroyl Arginate HCl

60372-77-2

434-630-6

(a)  Mouthwashes

(a)  0,15 %

(a)  Not to be used in preparations for children under 10 years of age

(a)  Not to be used for children under 10 years of age

(b)  Other products

(b)  0,4 %

(b)  Not to be used in lip products, oral products (other than mouthwashes), and spray products

▼M6

59

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

▼M35

60

4-(3-ethoxy-4-hydroxyphenyl)butan-2-one

Hydroxyethoxyphenyl Butanone

569646-79-3

933-435-8

0,7 %

▼M54

61

Silver zinc zeolite

Ammonium Silver Zinc Aluminium Silicate

130328-20-0

603-404-0

(a)  Deodorant spray

(b)  Powder foundation

(a) and (b)

1 %

For (a) and (b) the silver content in Ammonium Silver Zinc Aluminium Silicate must not exceed 2,5 %.

▼B