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The Cosmetic Products (Safety) Regulations 2008

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PART 1LIST OF PRESERVATIVES ALLOWED

Reference numberSubstancesMaximum authorised concentrationLimitations and requirementsConditions of use and warnings which must be printed on the label
abcde
(1)

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

(2)

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

(3)

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

(4)

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

1Benzoic acid (CAS No 65-85-0) and its sodium salt (CAS No 532-32-1)Rinse-off products, except oral care products 2.5% (expressed as acid)
Oral care products: 1.7% (expressed as acid)
Leave-on products: 0.5% (expressed as acid)
1aSalts and esters of benzoic acid other than those listed under reference number 10.5% (expressed as acid)
2Propionic acid and its salts2% (expressed as acid)
3Salicylic acid and its salts0.5% (expressed as acid)Not to be used in preparations for children under three years of age, except for shampoosNot to be used for children under three years of age(1)
4Sorbic acid (hex-2,4-dienoic acid) and its salts0.6% (expressed as acid)
5Formaldehyde paraformaldehyde (*)0.2% (except for oral hygiene products) expressed as free formaldehydeProhibited in aerosol dispensers (sprays)
0.1% (products for oral hygiene) expressed as free formaldehyde
6[omitted]
7Biphenyl-2-ol (o-phenylphenol) and its salts0.2% expressed a phenol
8Zinc pyrithione (CAS No 13463-41-7)(*)

Hair products: 1,00%

Other products: 0,5%

Rinse-off products only
Prohibited in products for oral hygiene
9Inorganic sulfites and hydrogen-sulfites (*)0.2% expressed as free SO(2)
10Sodium iodate0.1%Rinse-off products only
Entry deleted from 18/10/2008
11Chlorobutanol (INN)0.5%Prohibited in aerosol dispensers (sprays)Contains chlorobutanol
124-Hydroxybenzoic acid and its salts and esters0.4% (expressed as acid) for a single ester,
0.8% (expressed as acid) for mixtures of esters
133-Acetyl-6-methylpyran-2,4 (3H)-dione (Dehydracetic acid) and its salts0.6% (acid)Prohibited in aerosol dispensers (sprays)
14Formic acid and its sodium salt0.5% (expressed as acid)
153,3’-Dibromo-4,4’-hexamethylenedioxydi-benzamidine (Dibromohexamidine) and its salts (including isethionate)0.1%
16Thiomersal (INN) For eye0.007% (of Hg)For eye make up and eye make-up remover onlyContains thiomersal
If mixed with other mercurial compounds authorised by this Regulation, the maximum concentration of Hg remains fixed at 0.007%
17Phenylmercuric salts (including borate)0.007% (of Hg) If mixed with other mercurial compounds authorised by this Regulation, the maximum concentration of Hg remains fixed at 0.007%For eye make up and eye make-up remover onlyContains phenylmercuric compounds
18Undec-1-0-enoic acid and salts0.2% (expressed as acid)See Schedule 6, Part 2, No 8
19Hexetidine (INN)0.1%
205-Bromo-5-nitro-1,3-dioxane0.1%Rinse off products only
Avoid formation of nitrosamines
21Bronopol (INN)0.1%Avoid formation of nitrosamines
222.4-Dichlorobenzyl alcohol0.15%
23Triclocarban (INN) (*)0.2%Purity criteria:3,3’,4,4’-Tetrachloroazo-benzene ≤1 mg/kg 3,3’,4,4’-
Tetrachloroazoxybenzene ≤1 mg/kg
244-Chrloro-m-cresol0.2%Prohibited in products intended to come into contact with mucous membranes
25Triclosan (INN)0.3%
264-Chloro-3,5-xylenol0.5%
273,3’-Bis (1-hydroxymethyl-2,5-dioxoimidazolidin-4-yl)-1,1’-methylenediurea (‘Imidazolidinyl urea)0.6%
28Poly (1-hexamethylenebiguanide hydrochloride0.3%
292-Phenoxyethanol1.0%
30Hexamethylenetetramine (methenamine) (INN)0.15%
31Methenamine 3-chloroallylochloride (INN)0.2%
321-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one0.5%
331,3-Bis (hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione0.6%
34Benzyl alchohol (*)1%
351-Hydroxy-4-methyl-6(2,4,4-trimethyl-pentyl) 2-pyridon and its monoethanolamine salt

1,0%

0.5%

Rinse off products

Other products

36Entry deleted
376,6-Dibromo-4,4-dichloro2,2’-methylenediphenol (Bromochlorophen)0.1%
384-Isopropyl-m-cresol0.1%
39Mixture of 5-Chloro-2-methyl-isothiazol-3(2H)-one and 2-methylisothiazol-3(2H)-one with magnesium chloride and magnesium nitrate0.0015 % (of a mixture in the ratio 3:1 of 5-chloro-2-methylisothiazol 3 (2H)-one and 2-methylisothiazol-3 (2H)-one
402-Benzyl-4-chlorophenol (clorophene)0.2%
412-Chloroacetamide0.3%Cointains chloroacetamide
42Chlorhexidine (INN) and its digluconate, diacetate and dihydrochloride0,3% expressed as chlorhexidine
431-Phenoxypropan-2-ol(*)1.0%Only rinse-off products
44Alkyl (C12-C22) trimethyl ammonium, bromide and chloride (*)1.0%
454,4-dimethyl-1,3-oxizalidine0.1%The pH of the finished product must not be lower than 6
46N-(Hydroxymethyl)-N-(dihydroxymethyl-1,3-dioxo-2,5-imidazolidinyl-4)-N’-(hydroxymethyl) urea0.5%
471,6-Di (4-amidinophenoxy)-n-hexane (Hexamidine) and its salts (including isethionate and p-hydroxybenzoate)0,1%
48Glutaraldehyde (Pentane-1,5-dial)0.1%Prohibited in aerosols (sprays)Contains glutaraldehyde (where glutaraldehyde concentration in the finished product exceeds 0.5%)
495-Ethyl-3,7-dioxa-1-azabicyclo [3.3.0] octane0.3%Prohibited in oral hygiene products and in products intended to come into contact with mucous membranes
503-(p-chlorophenoxy)-propane-1,2 diol (chlorphenesin)0.3%
51Sodium hydroxymethylamino acetate (Sodium Hydroxymethylglycinate)0.5%
52Silver chloride deposited on titanium dioxide0.004% calculated as AgC1The ratio of titanium dioxide to silver chloride shall be 4:1 by mass. 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
53Benzethonium Chloride (INCI)0.1%(a) Rinse off products,
(b) Leave-on products other than for oral care use
54Benzalkonium chloride, bromide and saccharinate (*)0,1% calculated as benzalkonium chlorideAvoid contact with eyes
55Benzylhemiformal0.15%Only for products to be removed by rinsing
56                    Entry deleted from 18/10/20083-Iodo-2-propynylbutylcarbamate0.05%1. Not to be used for oral hygiene and lipcare productsContains iodine
2. If the concentration on products intended to remain on the skin exceeds 0.02% add the phrase: Contains iodine
56                    Entry inserted from 18/10/2008Iodopropynyl butyl-carbamate(a) rinse-off products: 0.02%Not to be used in oral hygiene and lip care products(a) “Not to be used for children under three years of age”(3)
(IPBC)(a) Not to be used in preparations for children under three years of age, except in bath products/shower gels and shampoo
3-iodo-2-propynl-butylcarbamate(b) leave-on products: 0.01% except in deodorants/anti-perspirants: 0.0075%(b) - not to be used in body lotion and body cream(2)(b)“Not to be used for children under three years of age”(4)
CAS No: 55406-53-6    - not to be used in preparations for children under three years of age
57Methylisothiazolinone (INCI)0.01%

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