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[F1ANNEX VI U.K. LIST OF PRESERVATIVES WHICH COSMETIC PRODUCTS MAY CONTAIN

Textual Amendments

PREAMBLE U.K.

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 specific 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 this 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 %.

PART 1 U.K. LIST OF PRESERVATIVES ALLOWED

a

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

b

[F2Concerns any products aimed to be applied on a large part of the body.

c

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

d

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

e

[F3For other uses than preservatives, see Annex III, Part I, entry No 207.] ]

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
[F41 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 [F5(*)] 2 % (acid)
3 Salicylic acid and its salts (*) 0,5 % (acid) Not to be used in [F6mixtures] for children under three years of age, except for shampoos Not to be used for children under three years of age a
4 Sorbic acid (hexa-2,4-dienoic acid) and its salts [F5(*)] 0,6 % (acid)
5 Formaldehyde paraformaldehyde [F7(*)]

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

0,1 % (products for oral hygiene)

expressed as free formaldehyde

Prohibited in aerosol dispensers (sprays)
[F8missing text]
7 Biphenyl-2-ol (o-phenylphenol) and its salts [F5(*)] 0,2 % expressed as the phenol
[F48

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 SO 2
[ F9 ]
11 Chlorobutanol (INN) 0,5 % Prohibited in aerosol dispensers (sprays) Contains chlorobutanol
12 4-Hydroxybenzoic acid and its salts and esters [F5(*)]

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 [F5(+)] 0,5 % (expressed as acid) ]
[F115 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 [F5(*)] 0,2 % (acid) See Annex VI, Part 2, No 8
19 Hexetidine (INN) [F5(*)] 0,1 % [F11missing text]
20 5-Bromo-5-nitro-1,3-dioxane 0,1 %

Rinse-off products only

Avoid formation of nitrosamines

[F12missing text]

21 Bronopol (INN) [F5(*)] 0,1 % Avoid formation of nitrosamines
22 2,4-Dichlorobenzyl alcohol [F5(*)] 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 [F5(*)] 0,2 % Prohibited in the products intended to come into contact with mucous membranes
25 Tricolosan (INN) [F5(*)] 0,3 %
26 4-Chloro-3,5-xylenol [F5(*)] 0,5 %
27 3,3'-Bis (1-hydroxymethyl-2,5-dioxoimidazolidin-4-yl)-1,1'-methylenediurea (‘Imidazolidinyl urea’) [F5(*)] 0,6 %
28 Poly (1-hexamethylenebiguanide hydrochloride [F5(*)] 0,3 %
29 2-Phenoxyethanol [F5(*)] 1,0 %
30 Hexamethylenetetramine [F5(*)] (methenamine) (INN) 0,15 %
31 Methenamine 3-chloroallylochloride (INNM) 0,2 %
32 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one [F5(*)] 0,5 %
33 1,3-Bis (hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione [F5(*)] 0,6 %
34 Benzyl alchohol (*) 1,0 %
35 1-Hydroxy-4-methyl-6(2,4,4-trimethylpentyl) 2-pyridon and its monoethanolamine salt [F5(*)]

1,0 %

0,5 %

Products rinsed off

For other products

[ F5 ]
37 6,6-Dibromo-4,4-dichloro2,2‘-methylene-diphenol (Bromochlorophen) [F5(*)] 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 [F130,0015 %] (of a mixture in the ratio 3:1 of 5-chloro-2-methylisothiazol 3(2H)-one and 2-methylisothiazol-3 (2H)-one ]
[F1440 2-Benzyl-4-chlorophenol (clorophene) 0.2 % ]
[F1541 2-Chloroacetamide 0,3 % Contains chloroacetamide
42 Chlorhexidine (INN) and its digluconate, diacetate and dihydrochloride [F5(+)] 0,3 % expressed as clorhexidine
43 1-Phenoxypropan-2-ol [F7(*)] 1,0 % Only for rinse-off products ]
[F1644 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 % ]
[F1747 1,6-Di (4-amidinophenoxy)-n-hexane (Hexamidine) and its salts (including isethionate and p-hydroxybenzoate) [F5(+)] 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 ]
[F1850 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 TiO 2 . 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 ]
[F1953 Benzethonium Chloride (INCI) 0,1 %

(a) Rinse-off products,

(b) Leave-on products other than for oral care use

]
[F2054 Belzalkonium chloride, bromide and saccharinate (+) 0,1 % calculated as benzalkonium chloride Avoid contact with eyes]
[F2155 Benzylhemiformal 0,15 % Only for products to be removed by rinsing
[F2256

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

(a)

Not to be used in [F6mixtures] 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 b

  • Not to be used in [F6mixtures] for children under three years of age

(a) ‘ Not to be used for children under three years of age ’c

(b) ‘ Not to be used for children under three years of age] ]’d

[F2357 Methylisothiazolinone (INCI) 0,01 % ]
[F358

Ethyl Lauroyl Arginate HCl (INCI) (*) e

Ethyl-Ν α -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. ]

Textual Amendments

[F1PART 2 U.K. LIST OF PRESERVATIVES PROVISIONALLY ALLOWED

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