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Regulation (EC) No 1223/2009 of the European Parliament and of the CouncilShow full title

Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) (Text with EEA relevance)

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ANNEX VU.K.LIST OF PRESERVATIVES ALLOWED IN COSMETIC PRODUCTS

PreambleU.K.

1.For the purposes of this list:U.K.

  • ‘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.

[F12. All finished products containing 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 %] U.K.

a

[F2[X1For uses other than preservative, see Annex III, No 98.]]

b

Solely for products which might be used for children under 3 years of age and which remain in prolonged contact with the skin.

c

[F3For use other than as a preservative, see Annex III, No. 13.]

d

For use other than as a preservative, see Annex III. No. 101.

e

For use other than as a preservative, see Annex III, No. 99.

f

For use other than as a preservative, see Annex III, No. 100.

g

[F4For other uses than preservatives, see Annex III, entry No 45.]

h

For use other than as a preservative, see Annex III, No. 54.

i

Only if the concentration exceeds 0,05 %.

j

For use other than as a preservative, see Annex III, No. 65.

l

Solely for products, other than bath products/shower gels and shampoo, which might be used for children under 3 years of age.

k

Solely for products which might be used for children under 3 years of age.

m

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

n

[F5For other uses than preservatives, see Annex III, entry No 197.]

o

[F6[X2For use other than as a preservative, see Annex III, No 287.

p

For use other than as a preservative, see Annex III, No 286.]]

q

[F7Methylisothiazolinone is also regulated in entry 57. The two entries are mutually exclusive: the use of the mixture of Methylchloroisothiazolinone (and) Methylisothiazolinone is incompatible with the use of Methylisothiazolinone alone in the same product.]

r

[F8Methylisothiazolinone is also regulated in entry 39 of Annex V in a mixture with methylchloroisothiazolinone. The two entries are mutually exclusive: the use of the mixture of Methylchloroisothiazolinone (and) Methylisothiazolinone is incompatible with the use of Methylisothiazolinone alone in the same product.]

s

[F9From 17 June 2019 cosmetic products containing Biphenyl-2-ol and not complying with those conditions shall not be placed on the Union market. From 17 September 2019 cosmetic products containing Biphenyl-2-ol and not complying with those conditions shall not be made available on the Union market.]

t

[F10For use other than as a preservative, see Annex III, entry 310.

u

From 27 November 2019 cosmetic products containing 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one and not complying with those conditions shall not be placed on the Union market.

From 27 February 2020 cosmetic products containing 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one and not complying with those conditions shall not be made available on the Union market.]

Reference numberSubstance identificationConditionsWording of conditions of use and warnings
Chemical name/INNName of Common Ingredients GlossaryCAS numberEC numberProduct type, Body partsMaximum concentration in ready for use preparationOther
abcdefghi
1Benzoic 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 products2,5 % (acid)
Oral products1,7 % (acid)
Leave-on products0,5 % (acid)
1aSalts of benzoic acid other than that listed under reference number 1 and esters of benzoic acidAmmonium benzoate, calcium benzoate, potassium benzoate, magnesium benzoate, MEA-benzoate, methyl benzoate, ethyl benzoate, propyl benzoate, butyl benzoate, isobutyl benzoate, isopropyl benzoate, phenyl benzoate1863-63-4, 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, 93-99-2217-468-9, 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, 202-293-20,5 % (acid)
2Propionic acid and its saltsPropionic acid, ammonium propionate, calcium propionate, magnesium propionate, potassium propionate, sodium propionate79-09-4, 17496-08-1, 4075-81-4, 557-27-7, 327-62-8, 137-40-6201-176-3, 241-503-7, 223-795-8, 209-166-0, 206-323-5, 205-290-42 % (acid)
[F2[X13 Salicylic acid a 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 k
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]] b
4Hexa-2,4-dienoic acid and its saltsSorbic acid, calcium sorbate, sodium sorbate, potassium sorbate110-44-1, 7492-55-9, 7757-81-5, 24634-61-5203-768-7, 231-321-6, 231-819-3, 246-376-10,6 % (acid)
F3
F3
6Moved or deleted
[F117 Biphenyl-2-ol s o-Phenylphenol 90-43-7 201-993-5
(a) Rinse-off Products
(a) 0,2 % (as phenol)
Avoid contact with eyes
(b) Leave-on products
(b) 0,15 % (as phenol)]
F12. . .F12. . .F12. . .F12. . .F12. . .F12. . .F12. . .F12. . .
9Inorganic sulphites and hydrogen- sulphiteseSodium sulfite, ammonium bisulfite, ammonium sulfite, potassium sulfite, potassium hydrogen sulfite, sodium bisulfite, sodium metabisulfite, potassium metabisulfite7757-83-7, 10192-30-0, 10196-04-0, 10117-38-1, 7773-03-7, 7631-90-5, 7681-57-4, 16731-55-8231-821-4, 233-469-7, 233-484-9, 233-321-1, 231-870-1, 231-548-0, 231-673-0, 240-795-30,2 % (as free SO2)
10Moved or deleted
11ChlorobutanolChlorobutanol57-15-8200-317-60,5 %Not to be used in aerosol dispensers (sprays)Contains Chlorobutanol
[F1312 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 ]

[F1412a

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 ’]

133-Acetyl-6-methylpyran-2,4 (3H)-dione and its saltsDehydroacetic acid, sodium dehydroacetate520-45-6, 4418-26-2, 16807-48-0208-293-9, 224-580-10,6 % (as acid)Not to be used in aerosol dispensers (sprays)
14Formic acid and its sodium saltFormic acid, sodium formate64-18-6, 141-53-7200-579-1, 205-488-00,5 % (as acid)
153,3'-Dibromo-4,4'-hexamethylenedioxydi-benzamidine and its salts (including isethionate)Dibromohexamidine Isethionate93856-83-8299-116-40,1 %
16ThiomersalThimerosal54-64-8200-210-4Eye 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
17Phenylmercuric salts (including borate)Phenyl Mercuric Acetate, Phenyl Mercuric Benzoate62-38-4, 94-43-9200-532-5, 202-331-8Eye 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
18Undec-10-enoic acid and its saltsUndecylenic acid, potassium undecylenate, sodium undecylenate, calcium undecylenate, TEA-undecylenate, MEA-undecylenate112-38-9, 6159-41-7, 3398-33-2, 1322-14-1, 84471-25-0, 56532-40-2203-965-8, 222-264-8, 215-331-8, 282-908-9, 260-247-70,2 % (as acid)
195- Pyrimidinamine, 1,3-bis (2-ethylhexyl) hexahydro-5-methyl-Hexetidine141-94-6205-513-50,1 %
205-Bromo-5-nitro-1,3-dioxane5-Bromo-5-nitro-1,3-dioxane30007-47-7250-001-7Rinse-off products0,1 %Avoid formation of nitrosamines
21Bronopol2-Bromo-2-nitropropane-1,3-diol52-51-7200-143-00,1 %Avoid formation of nitrosamines
222,4-Dichlorobenzyl alcoholDichlorobenzyl Alcohol1777-82-8217-210-50,15 %
231-(4-Chlorophenyl)-3-(3,4-dichlorophenyl) ureafTriclocarban101-20-2202-924-10,2 %

Purity criteria:

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

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

24Chlorocresolp-Chloro-m-Cresol59-50-7200-431-6Not to be used in products applied on mucuous membranes0,2 %
[F1525 5-Chloro-2- (2,4- dichlorophenoxy) phenol Triclosan 3380-34-5 222-182-2
(a) 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

(a) 0,3 %
(b) Mouthwashes
(b) 0,2 % ]
26Chloro-xylenolChloroxylenol88-04-0201-793-80,5 %
27N,N″-methylenebis[N′-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]urea]Imidazolidinyl urea39236-46-9254-372-60,6 %
[F128 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 ]
292-PhenoxyethanolPhenoxyethanol122-99-6204-589-71,0 %
30MethenamineMethenamine100-97-0202-905-80,15 %
F3
[F1632 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one t Climbazole 38083-17-9 253-775-4
(a)

Hair lotions u

(b)

Face creams u

(c)

Foot care products u

(d)

Rinse-off shampoo u

(a)

0,2 % u

(b)

0,2 % u

(c)

0,2 % u

(d)

0,5 % ]u

331,3-Bis (hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dioneDMDM Hydantoin6440-58-0229-222-80,6 %
[F434 Benzyl alcohol g Benzyl Alcohol 100-51-6 202-859-9 1,0  % ]
351-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl) 2-pyridon and its monoethanolamine salt1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl) 2-pyridon, Piroctone Olamine50650-76-5, 68890-66-4272-574-2Rinse-off products1,0 %
Other products0,5 %
36Moved or deleted
372,2'-methylenebis(6-bromo-4-chlorophenol)Bromochlorophene15435-29-7239-446-80,1 %
384-Isopropyl-m-cresolo-Cymen-5-ol3228-02-2221-761-70,1 %
[F1739 Mixture of 5-Chloro-2-methyl-isothiazol-3(2H)-one and 2-methylisothiazol-3(2H)-one Methylchloroisothiazolinone (and) Methylisothiazolinone q 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) ]
F3
F3
42N,N″-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine and its digluconate, diacetate and dihydrochlorideChlorhexidine, Chlorhexidine Diacetate, Chlorhexidine Digluconate, Chlorhexidine Dihydrochloride55-56-1, 56-95-1, 18472-51-0, 3697-42-5200-238-7, 200-302-4, 242-354-0, 223-026-60,3 % (as chlorhexidine)
431-Phenoxypropan-2-olhPhenoxyisopropanol770-35-4212-222-7Only for rinse-off products1,0 %
[F18[X244 Alkyl (C 12-22 ) trimethyl ammonium bromide and chloride Behentrimonium chloride o , 17301-53-0, 241-327-0, 0,1 %
cetrimonium bromide, 57-09-0, 200-311-3,
cetrimonium chloride p , 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 p 112-03-8 203-929-1]]
454,4-Dimethyl-1,3-oxazolidineDimethyl Oxazolidine51200-87-4257-048-20,1 %pH > 6
46N-(Hydroxymethyl)-N-(dihydroxymethyl-1,3-dioxo-2,5-imidazolidinyl-4)-N'-(hydroxymethyl) ureaDiazolidinyl Urea78491-02-8278-928-20,5 %
47Benzenecarboximidamide, 4,4'-(1,6-hexanediylbis (oxy))bis- and its salts (including isethionate and p-hydroxybenzoate)Hexamidine, Hexamidine diisethionate, Hexamidine paraben3811-75-4, 659-40-5, 93841-83-9211-533-5, 299-055-30,1 %
48Glutaraldehyde (Pentane-1,5-dial)Glutaral111-30-8203-856-50,1 %Not to be used in aerosols (sprays)Contains glutarali
495-Ethyl-3,7-dioxa-1-azabicyclo [3.3.0] octane7-Ethylbicyclooxazolidine7747-35-5231-810-40,3 %Not to be used in oral products and in products applied on mucous membranes
503-(p-Chlorophenoxy)-propane-1,2 diolChlorphenesin104-29-0203-192-60,3 %
51Sodium hydroxymethylamino acetateSodium Hydroxymethylglycinate70161-44-3274-357-80,5 % [F19Not to be used if the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is ≥ 0,1 % w/w]
52Silver chloride deposited on titanium dioxideSilver chloride7783-90-6232-033-30,004 % (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
53Benzenemethanaminium, N,N-dimethyl-N-[2-[2-[4-(1,1,3,3,-tetramethylbutyl)phenoxy]ethoxy] ethyl]-, chlorideBenzethonium Chloride121-54-0204-479-9
(a)

Rinse-off products

(b)

Leave-on products other than oral products

0,1 %
54Benzalkonium chloride, bromide and saccharinatejBenzalkonium chloride, benzalkonium bromide, benzalkonium saccharinate8001-54-5, 63449-41-2, 91080-29-4, 68989-01-5, 68424-85-1, 68391-01-5, 61789-71-7, 85409-22-9264-151-6, 293-522-5, 273-545-7, 270-325-2, 269-919-4, 263-080-8, 287-089-10,1 % (as benzalkonium chloride)Avoid contact with eyes
55Methanol, (phenylmethoxy-)Benzylhemiformal14548-60-8238-588-8Rinse-off products0,15 %
563-Iodo-2-propynylbutylcarbamateIodopropynyl butylcarbamate55406-53-6259-627-5
(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 creamm

(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 agel

(b) and (c)

Not to be used for children under 3 years of agek

[F857 2-Methyl-2H-isothiazol-3-one Methylisothiazolinone r 2682-20-4 220-239-6 Rinse-off products 0,0015 % ]
[F5[F2058 Ethyl-N-alpha-dodecanoyl-L-arginate hydrochloride n 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]]
[F6[X259 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 ]]
[F2160 4-(3-ethoxy-4-hydroxyphenyl)butan-2-one Hydroxyethoxyphenyl Butanone 569646-79-3 933-435-8 0,7 % ]

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