F2ANNEX VILIST OF PRESERVATIVES WHICH COSMETIC PRODUCTS MAY CONTAIN

Annotations:
Amendments (Textual)

PART 1LIST OF PRESERVATIVES ALLOWED

Annotations:
Amendments (Textual)

Reference number

Substance

Maximum authorized concentration

Limitations and requirements

Conditions of use and warnings which must be printed on the label

a

b

c

d

e

F201

Benzoic acid (CAS No 65-85-0) and its sodium salt (CAS No 532-32-1)

Rinse-off products, except oral care products: 2,5 % (acid)

Oral care 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

0,5 % (acid)

2

Propionic acid and its salts F21(*)

2 % (acid)

3

Salicylic acid and its salts (*)

0,5 % (acid)

Not to be used in F1mixtures for children under three years of age, except for shampoos

Not to be used for children under three years of age34

4

Sorbic acid (hexa-2,4-dienoic acid) and its salts F21(*)

0,6 % (acid)

5

Formaldehyde paraformaldehyde F14(*)

0,2 % (except for products for oral hygiene)

0,1 % (products for oral hygiene)

expressed as free formaldehyde

Prohibited in aerosol dispensers (sprays)

F18missing text

7

Biphenyl-2-ol (o-phenylphenol) and its salts F21(*)

0,2 % expressed as the phenol

F208

Zinc pyrithione (*)

(CAS No 13463-41-7)

Hair products: 1,0 %

Other products: 0,5 %

Rinse-off products only.

No use in products for oral hygiene

9

Inorganic sulphites and hydrogen- sulphites (*)

0,2 % expressed as free SO2

F17

11

Chlorobutanol (INN)

0,5 %

Prohibited in aerosol dispensers (sprays)

Contains chlorobutanol

12

4-Hydroxybenzoic acid and its salts and esters F21(*)

0,4 % (acid) for 1 ester,

0,8 % (acid) for mixtures of esters

13

3-Acetyl-6-methylpyran-2,4 (3H)-dione (Dehydracetic acid) and its salts

0,6 % (acid)

Prohibited in aerosol dispensers (sprays)

F1014

Formic acid and its sodium salt F21(+)

0,5 % (expressed as acid)

F215

3,3‘-Dibromo-4,4‘-hexamethylenedioxydi-benzamidine (Dibromohexamidine) and its salts (including isethionate)

0,1 %

16

Thiomersal (INN)

0,007 % (of Hg)

If mixed with other mercurial compounds authorized by this Directive, the maximum concentration of Hg remains fixed at 0,007 %

For eye make-up and eye make-up remover only

Contains thiomersal

17

Phenylmercuric salts (including borate)

Ditto

Ditto

Contains phenylmercuric compounds

18

Undec-10-enoic acid and salts F21(*)

0,2 % (acid)

See Annex VI, Part 2, No 8

19

Hexetidine (INN) F21(*)

0,1 %

F5missing text

20

5-Bromo-5-nitro-1,3-dioxane

0,1 %

Rinse-off products only

Avoid formation of nitrosamines

F4missing text

21

Bronopol (INN) F21(*)

0,1 %

Avoid formation of nitrosamines

22

2,4-Dichlorobenzyl alcohol F21(*)

0,15 %

23

Triclocarban (INN) (*)

0,2 %

Purity criteria:

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

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

24

4-Chloro-m-cresol F21(*)

0,2 %

Prohibited in the products intended to come into contact with mucous membranes

25

Tricolosan (INN) F21(*)

0,3 %

26

4-Chloro-3,5-xylenol F21(*)

0,5 %

27

3,3'-Bis (1-hydroxymethyl-2,5-dioxoimidazolidin-4-yl)-1,1'-methylenediurea (Imidazolidinyl urea) F21(*)

0,6 %

28

Poly (1-hexamethylenebiguanide hydrochloride F21(*)

0,3 %

29

2-Phenoxyethanol F21(*)

1,0 %

30

Hexamethylenetetramine F21(*) (methenamine) (INN)

0,15 %

31

Methenamine 3-chloroallylochloride (INNM)

0,2 %

32

1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one F21(*)

0,5 %

33

1,3-Bis (hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione F21(*)

0,6 %

34

Benzyl alchohol (*)

1,0 %

35

1-Hydroxy-4-methyl-6(2,4,4-trimethylpentyl) 2-pyridon and its monoethanolamine salt F21(*)

1,0 %

0,5 %

Products rinsed off

For other products

F21

37

6,6-Dibromo-4,4-dichloro2,2‘-methylene-diphenol (Bromochlorophen) F21(*)

0,1 %

38

4-Isopropyl-m-cresol

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

F80,0015 %(of a mixture in the ratio 3:1 of 5-chloro-2-methylisothiazol 3(2H)-one and 2-methylisothiazol-3 (2H)-one

F640

2-Benzyl-4-chlorophenol (clorophene)

0.2 %

F741

2-Chloroacetamide

0,3 %

Contains chloroacetamide

42

Chlorhexidine (INN) and its digluconate, diacetate and dihydrochloride F21(+)

0,3 % expressed as clorhexidine

43

1-Phenoxypropan-2-ol F14(*)

1,0 %

Only for rinse-off products

F344

Alkyl (C12-C22) trimethyl ammonium, bromide and chloride (*)

0,1 %

45

4,4-dimethyl-1,3-oxizalidine

0,1 %

The pH of the finished product must not be lower than 6

46

N-(Hydroxymethyl)-N-(dihydroxymethyl-1,3-dioxo-2,5-imidazolidinyl-4)-N'-(hydroxymethyl) urea

0,5 %

F947

1,6-Di (4-amidinophenoxy)-n-hexane (Hexamidine) and its salts (including isethionate and p-hydroxybenzoate) F21(+)

0,1 %

F1048

Glutaraldehyde (Pentane-1,5-dial)

0,1 %

Prohibited in aerosols (sprays)

Contains glutaraldehyde (where glutaraldehyde concentration in the finished product exceeds 0,05 %)

49

5-Ethyl-3,7-dioxa-1-azabicyclo [3.3.0] octane

0,3 %

Prohibited in oral hygiene products and in products intended to come into contact with mucous membranes

F1150

3-(p-chlorophenoxy)-propane-1,2 diol (chlorphenesin)

0,3 %

51

Sodium hydroxymethylamino acetate (Sodium Hydroxymethylglycinate)

0,5 %

52

Silver chloride deposited on titanium dioxide

0,004 % calculated as AgCl

20 % AgCl (W/W) on TiO2. Prohibited in products for children under three years of age, in oral hygiene products and in products intended for application around the eyes and on the lips

F2253

Benzethonium Chloride (INCI)

0,1 %

(a)

Rinse-off products,

(b)

Leave-on products other than for oral care use

F1254

Belzalkonium chloride, bromide and saccharinate (+)

0,1 % calculated as benzalkonium chloride

Avoid contact with eyes

F1655

Benzylhemiformal

0,15 %

Only for products to be removed by rinsing

F2356

iodopropynyl butylcarbamate

(IPBC)

3-iodo-2-propynylbutylcarbamate

CAS No: 55406-53-6

(a)

rinse-off products: 0,02 %

(b)

leave-on products: 0,01 %, except in deodorants/antiperspirants: 0,0075 %

Not to be used in oral hygiene and lip care products

  1. (a)

    Not to be used in F1mixtures for children under three years of age, except in bath products/shower gels and shampoo

  2. (b)
    • Not to be used in body lotion and body cream35

    • Not to be used in F1mixtures for children under three years of age

(a)

Not to be used for children under three years of age36

(b)

Not to be used for children under three years of age37

F1357

Methylisothiazolinone (INCI)

0,01 %

F1558

Ethyl Lauroyl Arginate HCl (INCI) (*)38

Ethyl-Να-dodecanoyl-L-arginate hydrochloride

CAS No 60372-77-2

EC No 434-630-6

0,4 %

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

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

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

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

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

For other uses than preservatives, see Annex III, Part I, entry No 207.