ANNEX III
F1PART 1LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS AND CONDITIONS LAID DOWN
Inserted by Council Directive of 17 May 1982 (82/368/EEC).
Inserted by Commission Directive of 2 March 1988 (88/233/EEC).
Deleted by Commission Directive of 21 October 1992 (92/86/EEC).
Inserted by Commission Directive of 22 June 1993 (93/47/EEC).
Inserted by Commission Directive of 29 June 1983 (83/341/EEC).
Inserted by Commission Directive of 2 February 1987 (87/137/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 28 February 1986 (86/179/EEC).
Inserted by Commission Directive of 30 March 1983 (83/191/EEC).
Inserted by Commission Directive of 18 July 1984 (84/415/EEC).
Inserted by Commission Directive of 16 July 1985 (85/391/EEC).
Deleted by Commission Directive of 21 February 1989 (89/174/EEC).
Inserted by Commission Directive of 12 March 1991 (91/184/EEC).
Inserted by Commission Directive of 3 September 1998 (98/62/EC).
Inserted by Commission Directive of 29 June 1994 (94/32/EC).
F1Reference number | Substance | Restrictions | Conditions of use and warnings which must be printed on the label | ||
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Field of application and/or use | Maximum authorized concentration in the finished cosmetic product | Other limitations and requirements | |||
a | b | c | d | e | f |
F231a | F21Boric acid, borates and tetraborates with the exception of substance No in Annex II |
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1b | Tetraborates |
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F132a | Thioglycollic acid and its salts |
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(b) and (c):
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The abovementioned percentages are calculated as thioglycollic acid | ||||
2b | Thioglycollic acid esters | Hair waving or straightening products: | The directions for use drawn up in the national or official language(s) must obligatorily incorporate the following sentences:
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The abovementioned percentages are calculated as thioglycollic acid | |||||
F13 | Oxalic acid, its esters and alcaline salts | Hair care products | 5 % | For professional use only | |
4 | Ammonia | 6 % calculated as NH3 | Above 2 %: contains ammonia | ||
5 | Tosylchloramide sodium (*) | 0·2 % | |||
6 | Chlorates of alkali metals |
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7 | Dichloromethane | 35 % (when mixed with 1,1,1-trichloroethane, total concentration must not exceed 35 %) | 0·2 % as maximum impurity content | ||
8 | F21p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine16, with exception of those derivatives listed elsewhere in this Annex | Oxidizing colouring agents for hair dyeing | 6 % calculated as free base | ||
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9 | F10Methylphenylenediamines, their N-substituted derivatives and their salts12 with the exception of substance No 364 in Annex II | Oxidizing colouring agents for hair dyeing | 10 % calculated as free base | ||
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10 | Diaminophenols12 | Oxidizing colouring agents for hair dyeing | 10 % calculated as free base | ||
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F1211 | Dichlorophen (*) | 0,5 % | Contains dichlorophen | ||
F1412 | Hydrogen peroxide, and other compounds or mixtures that release hydrogen peroxide, including carbamide peroxide and zinc peroxide |
| 12 % of H2O2 (40 volumes), present or released |
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| 4 % of H2O2, present or released |
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| 2 % of H2O2, present or released | Avoid contact with eyes. Rinse immediately if product comes into contact with them | |||
| 0,1 % of H2O2, present or released | ||||
F113 | Formaldehyde | Nail hardeners | 5 % calculated as formaldehyde | Protect cuticles with grease or oil. Contains formaldehyde13. | |
F514 | Hydroquinone14 |
| 0,3 % |
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| 0,02 % (after mixing for use) | Professional use only |
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F1715a | Potassium or sodium hydroxide |
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F815b | Lithium hydroxide |
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15c | Calcium hydroxide | Hair straighteners containing two components: calcium hydroxide and a guanidine salt |
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1-Naphthol (CAS No 90-15-3) and its salts | Oxidising colouring agents for hair dyening | 2,0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % | Can cause allergie reaction | |
17 | Sodium nitrite | Rust inhibitor | 0,2 % | Do not use with secondary and/or tertiary amines or other substances forming nitrosamines | |
18 | Nitromethane | Rust inhibitor | 0,3 % | ||
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21 | Quinine and its salts |
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22 | Resorcinol14 |
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24 | Water-soluble zinc salts with the exception of zinc 4-hydroxy-benzenesulphonate and zinc pyrithione | 1 % calculated as zinc | |||
25 | Zinc 4-hydroxybenzene sulphonate | Deodorants, antiperspirants and astringent lotions | 6 % calculated as % of anhydrous substance | Avoid contact with eyes | |
26 | Sodium monofluorophosphate | Oral hygiene products | 0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % | Contains ammonium monofluorophosphate | |
27 | Sodium monofluorophosphate | Ditto | 0,15 % Ditto | Contains sodium monofluorophosphate | |
28 | Potassium monofluorophosphate | Ditto | 0,15 % Ditto | Contains potassium monofluorophosphate | |
29 | Calcium monofluorophosphate | Ditto | 0,15 % Ditto | Contains calcium monofluorophosphate | |
30 | Calcium fluoride | Ditto | 0,15 % Ditto | Contains calcium fluoride | |
31 | Sodium fluoride | Ditto | 0,15 % Ditto | Contains sodium fluoride | |
32 | Potassium fluoride | Ditto | 0,15 % Ditto | Contains potassium fluoride | |
33 | Ammonium fluoride | Ditto | 0,15 % Ditto | Contains ammonium fluoride | |
34 | Aluminium fluoride | Ditto | 0,15 % Ditto | Contains aluminium fluoride | |
35 | Stannous fluoride | Ditto | 0,15 % Ditto | Contains stannous fluoride | |
36 | Hexadecyl ammonium fluoride | Ditto | 0,15 % Ditto | Contains hexadecyl ammonium fluoride | |
37 | 3-(N-Hexadecyl-N-2-hydroxyethylammonio) propylbis (2-hydroxyethyl) ammonium difluoride | Ditto | 0,15 % Ditto | Contains 3-(N-Hexadecyl-N-2-hydroxyethylammonio) propylbis (2-hydroxyethyl) ammonium difluoride | |
38 | NN'N'-Tris(polyoxyethylene)-N-hexadecylpropylenediamine dihydrofluoride | Ditto | 0,15 % Ditto | Contains NN'N'-tris(polyoxyethylene)-N-hexadecylpropylenediamine dihydrofluoride | |
39 | Octadecenyl-ammonium fluoride | Ditto | 0,15 % Ditto | Contains octadecenyl-ammonium fluoride | |
40 | Sodium fluorosilicate | Ditto | 0,15 % Ditto | Contains sodium fluorosilicate | |
41 | Potassium fluorosilicate | Ditto | 0,15 % Ditto | Contains potassium fluorosilicate | |
42 | Ammonium fluorosilicate | Ditto | 0,15 % Ditto | Contains ammonium fluorosilicate | |
43 | Magnesium fluorosilicate | Ditto | 0,15 % Ditto | Containes (SIC! Contains) magnesium fluorosilicate | |
F1144 | 1,3-Bis (hydroxymethyl)imidazolidine-2-thione |
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| Contains 1,3-bis (hydroxymethyl) immidazolidine-2-thione |
F145 | Benzyl alcohol | Solvents, perfumes and flavourings | |||
F346 | 6-methylcoumarin | Oral hygiene products | 0,003 % | ||
F947 | Nicomethanol hydrofluoride | Oral hygiene products | 0,15 % calculated as F When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % | Contains nicomethanol hydrofluoride | |
48 | Silver nitrate | Solely for products intended for colouring eyelashes and eyebrows | 4 % |
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F449 | Selenium disulphide | Antidandruff shampoos | 1 % |
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50 | Aluminium zirconium chloride hydroxyde complexes AlxZr(OH)yClz and the aluminium zirconium chloride sydroxide glycine complexes | Antiperspirants | 20 % as anhydrous aluminium zirconium chloride hydroxide 5,4 % as zirconium |
| Do not apply to irritated or damaged skin |
F1351 | Quinolin-8-ol and bis (8-hydroxy-quinolium) sulphate | Stabilizer for hydrogen peroxide in rinse-off hair-care preparations | 0,3 % calculated as base | ||
Stabilizer for hydrogen peroxide in non-rinse-off hair-care preparations | 0,03 % calculated as base | ||||
F1252 | Methanol | Denaturant for ethanol and isopropyl alcohol | 5 % calculated as a % ethanol and isopropyl acohol | ||
F1353 | Etidronic acid and its salts (1-hydroxyethylidene-di-phosphonic acid and its salts) |
| 1,5 % expressed as etidronic acid | ||
| 0,2 % expressed as etidronic acid | ||||
54 | 1-Phenoxy-propan-2-ol |
| 2 % | As a preservative, see Annex VI, Part 1, No 43 | |
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F656 | Magnesium fluoride | Dental hygiene products | 0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % | Contains magnesium fluoride | |
F1857 | Strontium chloride hexahydrate |
| 3,5 %, calculated as strontium. When mixed with other permitted strontium products the total strontium content must not exceed 3,5 % | Contains strontium chloride. Frequent use by children is not advisable | |
| 2,1 %, calculated as strontium. When mixed with other permitted strontium products the total strontium content must not exceed 2,1 % | ||||
F1458 | Strontium acetate hemihydrate | Toothpaste | 3,5 %, calculated as strontium. When mixed with other permitted strontium products the total strontium content must not exceed 3,5 % | Contains strontium acetate. Frequent use by children is not advisable | |
F1659 | Talc: Hydrated magnesium silicate |
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F560 | Fatty acid dialkylamides and dialkanolamides | Maximum secondary amine content: 0,5 % |
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61 | Monoalkylamines, monoalkanolamines and their salts | Maximum secondary amine content: 0,5 % |
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62 | Trialkylamines, trialkanolamines and their salts |
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F1663 | Strontium hydroxide | pH-regulator in depilatory products | 3,5 % calculated as strontium, max. pH of 12,7 |
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64 | Strontium peroxide | Rinse-off hair care preparations professional use | 4,5 % calculated as strontium in the ready-for-use preparation | All products must meet the hydrogen peroxide release requirements |
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F2665 | Benzalkonium Chloride, bromide and saccharinate |
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F1966 | Polyacrylamides |
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F267 | Amyl cinnamal (CAS No 122-40-7) | The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:
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68 | Benzyl alcohol (CAS No 100-51-6) | The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:
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69 | Cinnamyl alcohol (CAS No 104-54-1) | The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:
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70 | Citral (CAS No 5392-40-5) | The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:
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71 | Eugenol (CAS No 97-53-0) | The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:
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72 | Hydroxy-citronellal (CAS No 107-75-5) | The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:
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73 | Isoeugenol (CAS No 97-54-1) | The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:
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74 | Amylcin namyl alcohol (CAS No 101-85-9) | The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:
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75 | Benzyl salicylate (CAS No 118-58-1) | The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:
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76 | Cinnamal (CAS No 104-55-2) | The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:
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77 | Coumarin (CAS No 91-64-5) | The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:
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78 | Geraniol (CAS No 106-24-1) | The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:
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79 | Hydroxy-methylpentylcyclohexenecarboxaldehyde (CAS No 31906-04-4) | The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:
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80 | Anisyl alcohol (CAS No 105-13-5) | The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:
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81 | Benzyl cinnamate (CAS No 103-41-3) | The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:
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82 | Farnesol (CAS No 4602-84-0) | The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:
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83 | 2-(4-tert-Butylbenzyl) propionaldehyde (CAS No 80-54-6) | The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:
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84 | Linalool (CAS No 78-70-6) | The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:
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85 | Benzyl benzoate (CAS No 120-51-4) | The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:
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86 | Citronellol (CAS No 106-22-9) | The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:
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87 | Hexyl cinnam-aldehyde (CAS No 101-86-0) | The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:
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88 | d-Limonene (CAS No 5989-27-5) | The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:
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89 | Methyl heptin carbonate (CAS No 111-12-6) | The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:
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90 | 3-Methyl-4-(2,6,6-tri-methyl-2-cyclohexen-1-yl)-3-buten-2-one (CAS No 127-51-5) | The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:
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91 | Oak moss extract (CAS No 90028-68-5) | The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:
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92 | Treemoss extract (CAS No 90028-67-4) | The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:
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F2793 | 2,4-Diamino-pyrimidine-3-oxide (CAS No 74638-76-9) | Hair care formulations | 1,5 % | ||
94 | Benzoyl peroxide | Artificial nail systems | 0,7 % (after mixing) | Professional use only |
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95 | Hydroquinone methylether | Artificial nail systems | 0,02 % (after mixing for use) | Professional use only |
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F2896 | Musk xylene (CAS No 81-15-2) | All cosmetic products, with the exception of oral care products |
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97 | Musk ketone (CAS No 81-14-1) | All cosmetic products, with the exception of oral care products |
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F2298 | Salicylic acid18 (CAS No 69-72-7) |
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| Not to be used in preparations for children under three years of age, except for shampoos. For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product. | Not to be used for children under three years of age19 |
99 | Inorganic sulfites and bisulfites20 |
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| For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product. | |
100 | Triclocarban21 (CAS No 101-20-2) | Rinse-off products | 1,5 % | Purity criteria:
For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product. | |
101 | Zinc pyrithione22 (CAS No 13463-41-7) | Leave-on hair products | 0,1 % | For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product. | |
These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorized for each of them does not exceed 1. | |||||
Only if the concentration exceeds 0,05 %. | |||||
These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorized for each of them does not exceed 2. | |||||
The quantity of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In cases of mixtures, the sum should not exceed the limits given in column d. | |||||
These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorised for each of them does not exceed 1. | |||||
The concentration of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In case of mixtures, the sum should not exceed the limits given in column d. | |||||
As a preservative, see Annex VI, Part 1, No 3. | |||||
Solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin. | |||||
As a preservative, see Annex VI, Part 1, No 9. | |||||
As a preservative, See Annex VI, Part 1, No 23. | |||||
As a preservative, see Annex VI, Part 1, No 8. |
Inserted by Corrigendum, OJ No L 273, 25. 10. 1994, p. 38 (94/32/EC).