Textual Amendments
F1 Inserted by Commission Directive of 26 March 1986 (86/199/EEC).
| 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:
| |
| 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 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
F2 Inserted by Commission Directive 2007/22/EC of 17 April 2007 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purposes of adapting Annexes IV and VI thereto to technical progress (Text with EEA relevance).
F3 Inserted by Commission Directive 2010/3/EU of 1 February 2010 amending, for the purpose of adaptation to technical progress, Annexes III and VI to Council Directive 76/768/EEC concerning cosmetic products.
F4 Substituted by Commission Directive 2007/17/EC of 22 March 2007 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purposes of adapting Annexes III and VI thereto to technical progress (Text with EEA relevance).
F5 Deleted by Commission Directive 2007/17/EC of 22 March 2007 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purposes of adapting Annexes III and VI thereto to technical progress (Text with EEA relevance).
F6 Substituted by Directive 2008/112/EC of the European Parliament and of the Council of 16 December 2008 amending Council Directives 76/768/EEC, 88/378/EEC, 1999/13/EC and Directives 2000/53/EC, 2002/96/EC and 2004/42/EC of the European Parliament and of the Council in order to adapt them to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (Text with EEA relevance).
F7 Inserted by Commission Directive 2007/17/EC of 22 March 2007 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purposes of adapting Annexes III and VI thereto to technical progress (Text with EEA relevance).
F9 Deleted by Commission Directive 2007/22/EC of 17 April 2007 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purposes of adapting Annexes IV and VI thereto to technical progress (Text with EEA relevance).
F10 Inserted by Commission Directive of 29 June 1994 (94/32/EC).
F11 Deleted by Commission Directive of 2 March 1988 (88/233/EEC).
F13 Inserted by Commission Directive of 21 February 1989 (89/174/EEC).
F14 Inserted by Commission Directive of 2 February 1987 (87/137/EEC).
F15 Inserted by Commission Directive of 2 March 1988 (88/233/EEC).
F16 Inserted by Commission Directive of 12 March 1991 (91/184/EEC).
F17 Inserted by Commission Directive of 21 October 1992 (92/86/EEC).
F18 Inserted by Commission Directive of 25 June 1996 (96/41/EC).
F19 Substituted by Commission Directive 2005/42/EC of 20 June 2005 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purposes of adapting Annexes II, IV and VI thereto to technical progress (Text with EEA relevance).
F20 Inserted by Commission Directive of 3 September 1998 (98/62/EC).
F21 Inserted by Commission Directive 2000/6/EC of 29 February 2000 adapting to technical progress Annexes II, III, VI and VII to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (Text with EEA relevance).