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

ANNEX V U.K. LIST OF PRESERVATIVES ALLOWED IN COSMETIC PRODUCTS

Preamble U.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.

[F1 2. 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.

Textual Amendments

F1 Substituted by Commission Regulation (EU) 2019/831 of 22 May 2019 amending Annexes II, III and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance).

a [F2 [X1 For 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 [F3 For 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 [F4 For 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 [F5 For other uses than preservatives, see Annex III, entry No 197.]
o [F6 [X2 For 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 [F7 Methylisothiazolinone 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 [F8 Methylisothiazolinone 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 [F9 From 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 [F10 For 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 number	Substance identification				Conditions			Wording of conditions of use and warnings
	Chemical name/INN	Name of Common Ingredients Glossary	CAS number	EC number	Product type, Body parts	Maximum concentration in ready for use preparation	Other
a	b	c	d	e	f	g	h	i
1	Benzoic 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 products	2,5 % (acid)
					Oral 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	Ammonium benzoate, calcium benzoate, potassium benzoate, magnesium benzoate, MEA-benzoate, methyl benzoate, ethyl benzoate, propyl benzoate, butyl benzoate, isobutyl benzoate, isopropyl benzoate, phenyl benzoate	1863-63-4, 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, 93-99-2	217-468-9, 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, 202-293-2		0,5 % (acid)
2	Propionic acid and its salts	Propionic acid, ammonium propionate, calcium propionate, magnesium propionate, potassium propionate, sodium propionate	79-09-4, 17496-08-1, 4075-81-4, 557-27-7, 327-62-8, 137-40-6	201-176-3, 241-503-7, 223-795-8, 209-166-0, 206-323-5, 205-290-4		2 % (acid)
[F2 [X1 3	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
4	Hexa-2,4-dienoic acid and its salts	Sorbic acid, calcium sorbate, sodium sorbate, potassium sorbate	110-44-1, 7492-55-9, 7757-81-5, 24634-61-5	203-768-7, 231-321-6, 231-819-3, 246-376-1		0,6 % (acid)
[ F3
F3 ]
6	Moved or deleted
[F11 7	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)]
8	Pyrithione zincd	Zinc pyrithione	13463-41-7	236-671-3	Hair products	1,0 %	Only in rinse-off products Not to be used in oral products
					Other products	0,5 %
9	Inorganic sulphites and hydrogen- sulphitese	Sodium sulfite, ammonium bisulfite, ammonium sulfite, potassium sulfite, potassium hydrogen sulfite, sodium bisulfite, sodium metabisulfite, potassium metabisulfite	7757-83-7, 10192-30-0, 10196-04-0, 10117-38-1, 7773-03-7, 7631-90-5, 7681-57-4, 16731-55-8	231-821-4, 233-469-7, 233-484-9, 233-321-1, 231-870-1, 231-548-0, 231-673-0, 240-795-3		0,2 % (as free SO2)
10	Moved or deleted
11	Chlorobutanol	Chlorobutanol	57-15-8	200-317-6		0,5 %	Not to be used in aerosol dispensers (sprays)	Contains Chlorobutanol
[F12 12	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		]
[F13 12a	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 ’]
13	3-Acetyl-6-methylpyran-2,4 (3H)-dione and its salts	Dehydroacetic acid, sodium dehydroacetate	520-45-6, 4418-26-2, 16807-48-0	208-293-9, 224-580-1		0,6 % (as acid)	Not to be used in aerosol dispensers (sprays)
14	Formic acid and its sodium salt	Formic acid, sodium formate	64-18-6, 141-53-7	200-579-1, 205-488-0		0,5 % (as acid)
15	3,3'-Dibromo-4,4'-hexamethylenedioxydi-benzamidine and its salts (including isethionate)	Dibromohexamidine Isethionate	93856-83-8	299-116-4		0,1 %
16	Thiomersal	Thimerosal	54-64-8	200-210-4	Eye 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
17	Phenylmercuric salts (including borate)	Phenyl Mercuric Acetate, Phenyl Mercuric Benzoate	62-38-4, 94-43-9	200-532-5, 202-331-8	Eye 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
18	Undec-10-enoic acid and its salts	Undecylenic acid, potassium undecylenate, sodium undecylenate, calcium undecylenate, TEA-undecylenate, MEA-undecylenate	112-38-9, 6159-41-7, 3398-33-2, 1322-14-1, 84471-25-0, 56532-40-2	203-965-8, 222-264-8, 215-331-8, 282-908-9, 260-247-7		0,2 % (as acid)
19	5- Pyrimidinamine, 1,3-bis (2-ethylhexyl) hexahydro-5-methyl-	Hexetidine	141-94-6	205-513-5		0,1 %
20	5-Bromo-5-nitro-1,3-dioxane	5-Bromo-5-nitro-1,3-dioxane	30007-47-7	250-001-7	Rinse-off products	0,1 %	Avoid formation of nitrosamines
21	Bronopol	2-Bromo-2-nitropropane-1,3-diol	52-51-7	200-143-0		0,1 %	Avoid formation of nitrosamines
22	2,4-Dichlorobenzyl alcohol	Dichlorobenzyl Alcohol	1777-82-8	217-210-5		0,15 %
23	1-(4-Chlorophenyl)-3-(3,4-dichlorophenyl) ureaf	Triclocarban	101-20-2	202-924-1		0,2 %	Purity criteria: 3,3',4,4'-Tetrachloroazobenzene <1 ppm 3,3',4,4'-Tetrachloroazoxybenzene <1 ppm
24	Chlorocresol	p-Chloro-m-Cresol	59-50-7	200-431-6	Not to be used in products applied on mucuous membranes	0,2 %
[F14 25	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 %		]
26	Chloro-xylenol	Chloroxylenol	88-04-0	201-793-8		0,5 %
27	N,N″-methylenebis[N′-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]urea]	Imidazolidinyl urea	39236-46-9	254-372-6		0,6 %
[F1 28	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	]
29	2-Phenoxyethanol	Phenoxyethanol	122-99-6	204-589-7		1,0 %
30	Methenamine	Methenamine	100-97-0	202-905-8		0,15 %
[ F3 ]
[F15 32	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		]
33	1,3-Bis (hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione	DMDM Hydantoin	6440-58-0	229-222-8		0,6 %
[F4 34	Benzyl alcohol g	Benzyl Alcohol	100-51-6	202-859-9		1,0  %		]
35	1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl) 2-pyridon and its monoethanolamine salt	1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl) 2-pyridon, Piroctone Olamine	50650-76-5, 68890-66-4	272-574-2	Rinse-off products	1,0 %
					Other products	0,5 %
36	Moved or deleted
37	2,2'-methylenebis(6-bromo-4-chlorophenol)	Bromochlorophene	15435-29-7	239-446-8		0,1 %
38	4-Isopropyl-m-cresol	o-Cymen-5-ol	3228-02-2	221-761-7		0,1 %
[F16 39	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 ]
42	N,N″-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine and its digluconate, diacetate and dihydrochloride	Chlorhexidine, Chlorhexidine Diacetate, Chlorhexidine Digluconate, Chlorhexidine Dihydrochloride	55-56-1, 56-95-1, 18472-51-0, 3697-42-5	200-238-7, 200-302-4, 242-354-0, 223-026-6		0,3 % (as chlorhexidine)
43	1-Phenoxypropan-2-olh	Phenoxyisopropanol	770-35-4	212-222-7	Only for rinse-off products	1,0 %
[F17 [X2 44	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] ]
45	4,4-Dimethyl-1,3-oxazolidine	Dimethyl Oxazolidine	51200-87-4	257-048-2		0,1 %	pH > 6
46	N-(Hydroxymethyl)-N-(dihydroxymethyl-1,3-dioxo-2,5-imidazolidinyl-4)-N'-(hydroxymethyl) urea	Diazolidinyl Urea	78491-02-8	278-928-2		0,5 %
47	Benzenecarboximidamide, 4,4'-(1,6-hexanediylbis (oxy))bis- and its salts (including isethionate and p-hydroxybenzoate)	Hexamidine, Hexamidine diisethionate, Hexamidine paraben	3811-75-4, 659-40-5, 93841-83-9	211-533-5, 299-055-3		0,1 %
48	Glutaraldehyde (Pentane-1,5-dial)	Glutaral	111-30-8	203-856-5		0,1 %	Not to be used in aerosols (sprays)	Contains glutarali
49	5-Ethyl-3,7-dioxa-1-azabicyclo [3.3.0] octane	7-Ethylbicyclooxazolidine	7747-35-5	231-810-4		0,3 %	Not to be used in oral products and in products applied on mucous membranes
50	3-(p-Chlorophenoxy)-propane-1,2 diol	Chlorphenesin	104-29-0	203-192-6		0,3 %
51	Sodium hydroxymethylamino acetate	Sodium Hydroxymethylglycinate	70161-44-3	274-357-8		0,5 %
52	Silver chloride deposited on titanium dioxide	Silver chloride	7783-90-6	232-033-3		0,004 % (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
53	Benzenemethanaminium, N,N-dimethyl-N-[2-[2-[4-(1,1,3,3,-tetramethylbutyl)phenoxy]ethoxy] ethyl]-, chloride	Benzethonium Chloride	121-54-0	204-479-9	(a) Rinse-off products (b) Leave-on products other than oral products	0,1 %
54	Benzalkonium chloride, bromide and saccharinatej	Benzalkonium chloride, benzalkonium bromide, benzalkonium saccharinate	8001-54-5, 63449-41-2, 91080-29-4, 68989-01-5, 68424-85-1, 68391-01-5, 61789-71-7, 85409-22-9	264-151-6, 293-522-5, 273-545-7, 270-325-2, 269-919-4, 263-080-8, 287-089-1		0,1 % (as benzalkonium chloride)		Avoid contact with eyes
55	Methanol, (phenylmethoxy-)	Benzylhemiformal	14548-60-8	238-588-8	Rinse-off products	0,15 %
56	3-Iodo-2-propynylbutylcarbamate	Iodopropynyl butylcarbamate	55406-53-6	259-627-5	(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
[F8 57	2-Methyl-2H-isothiazol-3-one	Methylisothiazolinone r	2682-20-4	220-239-6	Rinse-off products	0,0015 %		]
[F5 [F18 58	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 [X2 59	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	] ]
[F19 60	4-(3-ethoxy-4-hydroxyphenyl)butan-2-one	Hydroxyethoxyphenyl Butanone	569646-79-3	933-435-8		0,7 %		]

Editorial Information

X1 Substituted by Corrigendum to Commission Regulation (EU) 2019/1966 of 27 November 2019 amending and correcting Annexes II, III and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Official Journal of the European Union L 307 of 28 November 2019).

X2 Substituted by Corrigendum to Commission Regulation (EU) No 866/2014 of 8 August 2014 amending Annexes III, V and VI to Regulation (EC) No 1223/2009 of the European Parliament and the Council on cosmetic products (Official Journal of the European Union L 238 of 9 August 2014).

Textual Amendments

F2 Substituted by Commission Regulation (EU) 2019/1966 of 27 November 2019 amending and correcting Annexes II, III and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance).

F3 Deleted by Commission Regulation (EU) 2019/831 of 22 May 2019 amending Annexes II, III and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance).

F4 Substituted by Commission Regulation (EU) No 344/2013 of 4 April 2013 amending Annexes II, III, V and VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance).

F5 Substituted by Commission Regulation (EU) 2016/1121 of 11 July 2016 amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance).

F6 Inserted by Commission Regulation (EU) No 866/2014 of 8 August 2014 amending Annexes III, V and VI to Regulation (EC) No 1223/2009 of the European Parliament and the Council on cosmetic products (Text with EEA relevance).

F7 Inserted by Commission Regulation (EU) No 1003/2014 of 18 September 2014 amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance).

F8 Substituted by Commission Regulation (EU) 2017/1224 of 6 July 2017 amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance).

F9 Inserted by Commission Regulation (EU) 2018/1847 of 26 November 2018 amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance).

F10 Inserted by Commission Regulation (EU) 2019/698 of 30 April 2019 amending Annexes III and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance).

F11 Substituted by Commission Regulation (EU) 2018/1847 of 26 November 2018 amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance).

F12 Substituted by Commission Regulation (EU) No 1004/2014 of 18 September 2014 amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance).

F13 Inserted by Commission Regulation (EU) No 1004/2014 of 18 September 2014 amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance).

F14 Substituted by Commission Regulation (EU) No 358/2014 of 9 April 2014 amending Annexes II and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance).

F15 Substituted by Commission Regulation (EU) 2019/698 of 30 April 2019 amending Annexes III and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance).

F16 Substituted by Commission Regulation (EU) No 1003/2014 of 18 September 2014 amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance).

F17 Substituted by Commission Regulation (EU) No 866/2014 of 8 August 2014 amending Annexes III, V and VI to Regulation (EC) No 1223/2009 of the European Parliament and the Council on cosmetic products (Text with EEA relevance).

F18 Inserted by Commission Regulation (EU) No 344/2013 of 4 April 2013 amending Annexes II, III, V and VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance).

F19 Inserted by Commission Regulation (EU) 2019/1858 of 6 November 2019 amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance).