ANNEX VI List of preservatives allowed for use in cosmetic products

ANNEX VI LIST OF PRESERVATIVES WHICH COSMETIC PRODUCTS MAY CONTAIN

Preamble 1. Preservatives are substances which may be added to cosmetic products for the primary purpose of inhibiting the development of micro-organisms in such products. 2. The substances marked with the symbol (+) may also be added to cosmetic products in concentration other than those laid down in this ANNEX for other purposes apparent from the presentation of the products, e.g. as deodorants in soaps or as anti-dandruff agents in shampoos. 3. Other substances used in the formulation of cosmetic products may also have anti-microbial properties and thus help in the preservation of the products, as, for instance, many essential oils and some alcohols. These substances are not included in the ANNEX. 4. 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. 5. 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%.

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ANNEX VI List of preservatives allowed for use in cosmetic products

ANNEX VI PART 1 LIST OF PRESERVATIVES ALLOWED

Reference Number a 1 Substance Maximum authorized concentration c 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 those listed under reference number 1 and esters of benzoic acid Propionic acid and its salts Salicylic acid and its salts (+)
(1)

Limitations and requirements d

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

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

0.5 % (acid)

2 3

2% (acid) 0.5% (acid) Not to be used in preparations for children under 3 years of age, except for shampoos - Not to be used for children under 3 years of 12 age ( )

Sorbic acid (hexa-2,4-dienoic acid) and its salts 0.6% (acid)

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ANNEX VI List of preservatives allowed for use in cosmetic products

Reference Number a 5

Substance

Maximum authorized concentration c 0.2% (except for products for oral hygiene) 0.1% (products for oral hygiene) expressed as free formaldehyde

Limitations and requirements d Prohibited in aerosol dispensers (sprays)

b Formaldehyde and paraformaldehyde

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

7 8

Biphenyl-2-ol (o-phenylphenol) and its salts Zinc pyrithione (+)

(3)

0.2% expressed as phenol Hair products; 1.0 % Other products; 0.5% Rinse off products only. Not for use in products for oral care

(CAS No 13463-41-7)

9 10

Inorganic sulphites and hydrogensulphites (+) Entry deletedDeleted

(4)

0.2% expressed as free SO2

11 12

Chlorobutanol (INN) 4-Hydroxybenzoic acid its salts and esters

0.5% 0.4% (acid) for 1 ester; 0.8% (acid) for mixtures of esters

Prohibited in aerosol dispensers (sprays)

- Contains chlorobutanol

13 14

3-Acetyl-6-methylpyran-2,4 (3H)-dione (Dehydroacetic acid) and its salts Formic acid and its sodium salt

0.6% (acid) 0.5% (expressed as acid)

Prohibited in aerosol dispensers (sprays)

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ANNEX VI List of preservatives allowed for use in cosmetic products

Reference Number a 15

Substance

Maximum authorized concentration c 0.1%

Limitations and requirements d

b 3,3'-Dibromo-4,4'-hexamethylenedioxydibenzamidine (Dibromohexamidine) and its salts ( including isethionate) Thiomersal (INN)

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

16

0.007% (of Hg) If mixed with other mercurial compunds 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 18

Phenylmercuric salts (including borate) Undec-10-enoic acid and salts (+)

Ditto 0.2% (acid)

Ditto

- Contains phenyljmercuric compounds

19 20

Hexetidine (INN) 5-Bromo-5-nitro-1,3 dioxane

0.1% 0.1% Rinse-off products only Avoid formation of nitrosamines Avoid formation of nitrosamines

21

Bronopol (INN)

0.1%

22

2,4-Dichlorobenzyl alcohol

0.15%

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ANNEX VI List of preservatives allowed for use in cosmetic products

Reference Number a 23

Substance

Maximum authorized concentration c 0.2%

Limitations and requirements d Purity criteria: 3,3,4,4Tetrachloroazobenzene less than 1 ppm; 3,3,4,4-Tetrachloroazoxybenzene less than 1 ppm Prohibited in products intended to come into contact with mucous membranes

b Triclocarban (INN) (+)

(5)

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

24

4-Chloro-m-cresol

0.2%

25 26 27

Triclosan (INN) (+) 4-Chloro-3,5-xylenol

0.3% 0.5%

3,3'-Bis(1-hydroxymethyl-2,5-dioxoimidazolidin- 0.6% 4-yl)-1,1'- methylenediurea ("Imidazolidinyl urea") Poly(1-hexamethylenebiguanide hydrochloride) 2-Phenoxyethanol Hexamethylenetetramine (methenamine) (INN) Methenamine 3-chloroallylochloride (INNM) 1-(4-Chlorophenoxy)-1-(imidazol-1-yl) 3,3dimethylbutan-2-one (+) 1,3-Bis(hydroxymethyl)-5,5dimethylimidazolidine-2,4-dione Benzyl alcohol 1-Hydroxy-4-methyl-6(2,4,4-trimethylpentyl)-2pyridon and its monoethanolamine salt (+) 0.3% 1.0% 0.15% 0.2% 0.5%

28 29 30 31 32

33 34 35

0.6% 1% 1% 0.5% Products rinsed-off For other products ASEAN Cosmetic Documents 5

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ANNEX VI List of preservatives allowed for use in cosmetic products

Reference Number a 36 37 38

Substance

Maximum authorized concentration c 0.1% 0.1%

Limitations and requirements d

b Entry deletedDeleted 6,6-Dibromo-4,4-dichloro-2,2'-methylenediphenol:Bromochlorophen) 4-Isopropyl-m-cresol

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

39

Mixture of 5-Chloro-2-methyl-isothiazol-3(2H)one and 2-methylisothiazol-3(2H)-one with magnesium chloride and magnesium nitrate

0.0015% (of a mixture in the ratio 3:1 of 5-Chloro-2methyl-isothiazol-3(2H)-one and 2-methylisothiazol3(2H)-one) 0.2% 0.3% 0.3% expressed as chlorhexidine 1.0% 0.1% 0.1% The pH of the finished product must not be lower than 6 Only for rinse-off products - Contains chloroacetamide

40 41 42 43 44 45

2-Benzyl-4-chlorophenol (Chlorophene) 2-Chloroacetamide Chlorhexidine (INN) and its digluconate, diacetate and dihydrochloride (+) 1-Phenoxypropan-2-ol Alkyl (C12-C22) trimethyl ammonium, bromide and chloride (+) 4,4-Dimethyl-1,3-oxazolidine

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ANNEX VI List of preservatives allowed for use in cosmetic products

Reference Number a 46

Substance

Maximum authorized concentration c 0.5%

Limitations and requirements d

b N-(Hydroxymethyl)-N-(dihydroxymethyl-1,3dioxo-2,5-imidazolinidyl-4)-N'-(hydroxymethyl) urea 1,6-Di(4-amidinophenoxy)-n-hexane (Hexamidine) and its salts (including isethionate and p-hydroxy- benzoate (+) Glutaraldehyde (Pentane-1,5-dial)

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

47

0.1%

48

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

50 51 52

3-(p-Chlorophenoxy)-propane-1,2-diol (chlorphenesin) Sodium hydroxymethylamino acetate (Sodium hydroxymethylglycinate) Silver chloride deposited on Titanium dioxide

0.3% 0.5% 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

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ANNEX VI List of preservatives allowed for use in cosmetic products

Reference Number a 53

Substance

Maximum authorized concentration c 0.1%

Limitations and requirements d (a) Rinse-off products only (b) Leave on products other than for oral care use.

b Benzethonium chloride (INCI)

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

54 55 56

Benzalkonium chloride, bromide and saccharinate* Benzylhemiformal iodopropynyl butyl-carbamate (IPBC) 3-iodo-2-propynylbutylcarbamate CAS No: 55406-53-6 (b) (a)

0.1% calculated as Benzalkonium chloride 0.15% rinse-off products: 0.02 % leave-on products: 0.01 % except in deodorants & antiperspirants: 0.0075 % Only for products to be removed by rinsing Not to be used in oral hygiene and lip care products (a) Not to be used in preparations for children under three years of age, except in bath products/shower gels and shampoo. (b) Not to be used in body lotion and body cream (*) Not to be used in preparations for children under three years of age.

- Avoid contact with the eyes

(a) Not to be used for children under three years of age (**) (b) Not to be used for children under three years of age (***)

57

Methylisothiazolinone (INCI)

0.01 %

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ANNEX VI List of preservatives allowed for use in cosmetic products

Reference Number a 58

Substance

Maximum authorized concentration c

6

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

b Ethyl Lauroyl Arginate HCl (INCI) ( ) Ethyl- dodecanoyl- L-arginate hydrochloride CAS No 60372-77-2 EC No 434-630-6

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

0.4%

1. 2. 3. 4.

For non-preservative usage see Annex III. Part 1, entry 98 Solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin For non-preservative usage see Annex III. Part 1, entry 101 For non-preservative usage see Annex III. Part 1, entry 99

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ANNEX VI List of preservatives allowed for use in cosmetic products

5. For non-preservative usage see Annex III. Part 1, entry 100 6. For non-preservative usage see Annex III. Part 1, entry 206 (*) (**) (***) 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.

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ANNEX VI List of preservatives allowed for use in cosmetic products

ANNEX VI PART 2 LIST OF PRESERVATIVES PROVISIONALLY ALLOWED

Colipa Number Reference Number a Substance Maximum authorized concentration c Limitations and requirements d Conditions of use and warnings which must be printed on the label e

Note: no preservative is listed in this section for the present time.

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