F2ANNEX VILIST 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 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 1LIST OF PRESERVATIVES ALLOWED
Deleted by Commission Directive of 2 February 1987 (87/137/EEC).
Inserted by Commission Directive of 29 June 1994 (94/32/EC).
Deleted by Commission Directive of 2 March 1988 (88/233/EEC).
Deleted by Commission Directive of 21 February 1989 (89/174/EEC).
Inserted by Commission Directive of 21 February 1989 (89/174/EEC).
Inserted by Commission Directive of 2 February 1987 (87/137/EEC).
Inserted by Commission Directive of 2 March 1988 (88/233/EEC).
Inserted by Commission Directive of 12 March 1991 (91/184/EEC).
Inserted by Commission Directive of 21 October 1992 (92/86/EEC).
Inserted by Commission Directive of 25 June 1996 (96/41/EC).
Inserted by Commission Directive of 3 September 1998 (98/62/EC).
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 |
1 | Benzoic acid, its salts and esters (*) | 0,5 % (acid) | ||
2 | Propionic acid and its salts (*) | 2 % (acid) | ||
3 | Salicylic acid and its salts (*) | 0,5 % (acid) | Not to be used in preparations for children under three years of age, except for shampoos | Not to be used for children under three years of age23 |
4 | Sorbic acid (hexa-2,4-dienoic acid) and its salts (*) | 0,6 % (acid) | ||
5 | Formaldehyde paraformaldehyde | 0,2 % (except for products for oral hygiene) 0,1 % (products for oral hygiene) expressed as free formaldehyde | Prohibited in aerosol dispensers (sprays) | |
7 | Biphenyl-2-ol (o-phenylphenol) and its salts (*) | 0,2 % expressed as the phenol | ||
8 | Pyrithione zinc (INN) (*) | 0,5 % | Authorized in products rinsed off Forbidden in products for oral hygiene | |
9 | Inorganic sulphites and hydrogen- sulphites (*) | 0,2 % expressed as free SO2 | ||
10 | Sodium iodate | 0,1 % | Rinse-off products only | |
11 | Chlorobutanol (INN) | 0,5 % | Prohibited in aerosol dispensers (sprays) | Contains chlorobutanol |
12 | 4-Hydroxybenzoic acid and its salts and esters (*) | 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 (+) | 0,5 % (expressed as acid) | ||
F215 | 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 (*) | 0,2 % (acid) | See Annex VI, Part 2, No 8 | |
19 | Hexetidine (INN) (*) | 0,1 % | ||
20 | 5-Bromo-5-nitro-1,3-dioxane | 0,1 % | Rinse-off products only Avoid formation of nitrosamines | |
21 | Bronopol (INN) (*) | 0,1 % | Avoid formation of nitrosamines | |
22 | 2,4-Dichlorobenzyl alcohol (*) | 0,15 % | ||
23 | Triclocarban (INN) (*) | 0,2 % | Purity criteria:
| |
24 | 4-Chloro-m-cresol (*) | 0,2 % | Prohibited in the products intended to come into contact with mucous membranes | |
25 | Tricolosan (INN) (*) | 0,3 % | ||
26 | 4-Chloro-3,5-xylenol (*) | 0,5 % | ||
27 | 3,3'-Bis (1-hydroxymethyl-2,5-dioxoimidazolidin-4-yl)-1,1'-methylenediurea (‘Imidazolidinyl urea’) (*) | 0,6 % | ||
28 | Poly (1-hexamethylenebiguanide hydrochloride (*) | 0,3 % | ||
29 | 2-Phenoxyethanol (*) | 1,0 % | ||
30 | Hexamethylenetetramine (*) (methenamine) (INN) | 0,15 % | ||
31 | Methenamine 3-chloroallylochloride (INNM) | 0,2 % | ||
32 | 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one (*) | 0,5 % | ||
33 | 1,3-Bis (hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione (*) | 0,6 % | ||
34 | Benzyl alchohol (*) | 1,0 % | ||
35 | 1-Hydroxy-4-methyl-6(2,4,4-trimethylpentyl) 2-pyridon and its monoethanolamine salt (*) | 1,0 % 0,5 % | Products rinsed off For other products | |
F136 | 1,2-Dibromo-2,4-dicyanobutane (methyldibromo glutaronitrile) | 0,1 % | Rinse-off products only | |
37 | 6,6-Dibromo-4,4-dichloro2,2‘-methylene-diphenol (Bromochlorophen) (*) | 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 | F80,0015 %(of a mixture in the ratio 3:1 of 5-chloro-2-methylisothiazol 3(2H)-one and 2-methylisothiazol-3 (2H)-one | ||
F640 | 2-Benzyl-4-chlorophenol (clorophene) | 0.2 % | ||
F741 | 2-Chloroacetamide | 0,3 % | Contains chloroacetamide | |
42 | Chlorhexidine (INN) and its digluconate, diacetate and dihydrochloride (+) | 0,3 % expressed as clorhexidine | ||
43 | 1-Phenoxypropan-2-ol | 1,0 % | Only for rinse-off products | |
F344 | 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 % | ||
F947 | 1,6-Di (4-amidinophenoxy)-n-hexane (Hexamidine) and its salts (including isethionate and p-hydroxybenzoate) (+) | 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 | |
F1150 | 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 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 | |
F1853 | Benzethonium Chloride (INCI) | 0,1 % |
| |
F1254 | Belzalkonium chloride, bromide and saccharinate (+) | 0,1% calculated as benzalkonium chloride | Avoid contact with eyes | |
F1555 | Benzylhemiformal | 0,15 % | Only for products to be removed by rinsing | |
56 | 3-Iodo-2-propynylbutylcarbamate | 0,05 % |
| |
| Contains iodine | |||
F1357 | Methylisothiazolinone (INCI) | 0,01 % | ||
Solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin. | ||||
F2PART 2LIST OF PRESERVATIVES PROVISIONALLY ALLOWED
Deleted by Commission Directive of 25 June 1996 (96/41/EC).
Deleted by Commission Directive of 12 March 1991 (91/184/EEC).
Deleted by Commission Directive of 10 July 1995 (95/34/EC).
Deleted by Commission Directive of 3 September 1998 (98/62/EC).
Deleted by Commission Directive of 21 October 1992 (92/86/EEC).
Deleted by Commission Directive of 29 June 1994 (94/32/EC).
Inserted by Commission Directive of 26 March 1986 (86/199/EEC).