EUR-Lex - 31976L0768 - EN

EUR-Lex - 31976L0768 - EN Avis juridique important | Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products Official Journal L 262 , 27/09/1976 P. 0169 - 0200 Greek special edition: Chapter 13 Volume 4 P. 0145 Spanish special edition: Chapter 15 Volume 1 P. 0206 Portuguese special edition Chapter 15 Volume 1 P. 0206 Finnish special edition: Chapter 13 Volume 5 P. 0198 Swedish special edition: Chapter 13 Volume 5 P. 0198 COUNCIL DIRECTIVE of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (76/768/EEC) THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Parliament (1), Having regard to the opinion of the Economic and Social Committee (2), Whereas the provisions laid down by law, regulation or administrative action in force in the Member States define the composition characteristics to which cosmetic products must conform and prescribe rules for their labelling and for their packaging ; whereas these provisions differ from one Member State to another; Whereas the differences between these laws oblige Community cosmetic producers to vary their production according to the Member State for which the products are intended ; whereas, consequently, they hinder trade in these products and, as a result, have a direct effect on the establishment and functioning of the common market; Whereas the main objective of these laws is the safeguarding of public health and whereas, as a result, the pursuit of the same objective must inspire Community legislation in this sector ; whereas, however, this objective must be attained by means which also take account of economic and technological requirements; Whereas it is necessary to determine at Community level the regulations which must be observed as regards the composition, labelling and packaging of cosmetic products; Whereas this Directive relates only to cosmetic products and not to pharmaceutical specialities and medicinal products ; whereas for this purpose it is necessary to define the scope of the Directive by delimiting the field of cosmetics from that of pharmaceuticals ; whereas this delimitation follows in particular from the detailed definition of cosmetic products, which refers both to their areas of application and to the purposes of their use ; whereas this Directive is not applicable to the products that fall under the definition of cosmetic product but are exclusively intended to protect from disease ; whereas, moreover, it is advisable to specify that certain products come under this definition, whilst products containing substances or preparations intended to be ingested, inhaled, injected or implanted in the human body do not come under the field of cosmetics; Whereas in the present state of research, it is advisable to exclude cosmetic products containing one of the substances listed in Annex V from the scope of this Directive;

Whereas cosmetic products must not be harmful under normal or foreseeable conditions of use ; whereas in particular it is necessary to take into account the possibility of danger to zones of the body that are contiguous to the area of application; Whereas, in particular, the determination of the methods of analysis together with possible modifications or additions which may have to be made to them on the basis of the results of scientific and technical research, are implementing measures of a technical nature ; whereas it is advisable to entrust their adoption to the Commission, subject to certain conditions specified in this Directive, for the purpose of simplifying and accelerating the procedure; Whereas technical progress necessitates rapid adaptation of the technical provisions defined in this Directive and in subsequent Directives in this field ; whereas it is advisable, in order to facilitate implementation of the measures necessary for this purpose, (1)OJ No C 40, 8.4.1974, p. 71. (2)OJ No C 60, 26.7.1973, p. 16. to provide for a procedure establishing close cooperation between the Member States and the Commission within the Committee for adaptation to technical progress of Directives aimed at the removal of technical obstacles to trade in the cosmetic products sector; Whereas it is necessary, on the basis of scientific and technical research, to draw up proposals for lists of authorized substances which could include antioxidants, hair dyes, preservatives and ultraviolet filters, taking into account in particular the problem of sensitization; Whereas it could happen that although conforming to the provisions of this Directive and its Annexes, cosmetic products placed on the market might endanger public health ; whereas it is therefore advisable to provide for a procedure intended to remove this danger, HAS ADOPTED THIS DIRECTIVE:

Article 1

1. A "cosmetic product" means any substance or preparation intended for placing in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or principally to cleaning them, perfuming them or protecting them in order to keep them in good condition, change their appearance or correct body odours.
2. The products to be considered as cosmetic products within the meaning of this definition are listed in Annex I.
3. Cosmetic products containing one of the substances listed in Annex V and cosmetic products containing colouring agents other than those referred to in Annexes III and IV and which are not intended to come into contact with the mucous membranes are excluded from the scope of this Directive. Member States may take such measures as they deem necessary with regard to these products.

Article 4 Without prejudice to their general obligations deriving from Article 2, Member States shall prohibit the marketing of cosmetic products containing: (a) substances listed in Annex II; (b) substances listed in the first part of Annex III, beyond the limits and outside the conditions laid down; (c) colouring agents other than those listed in the second part of Annex III, if these products are intended for application in the vicinity of the eyes, on the lips, in the oral cavity or to the external genital organs; (d) colouring agents listed in the second part of Annex III, beyond the limits and outside the conditions laid down, if these products are intended for application in the vicinity of the eyes, on the lips, in the oral cavity or to the external genital organs.

Article 5 For a period of three years from notification of this Directive, Member States shall accept the marketing of cosmetic products containing: (a) the substances listed in Part 1 of Annex IV within the limits and under the conditions laid down; (b) the colouring agents listed in Part 2 of Annex IV within the limits and under the conditions laid down, if these products are intended for application in the vicinity of the eyes, on the lips, in the oral cavity, or to the external genital organs; (c) the colouring agents listed in Part 3 of Annex IV, if these products either are not intended to come into contact with the mucous membranes or are only intended to come into brief contact with the skin. On expiry of the three year period, these substances and colouring agents shall: - either be definitively permitted,

• or definitively prohibited (Annex II),
• or retained for a further period of three years in Annex IV,
• or deleted from all Annexes to this Directive.

Article 6

1. Member States shall take all measures necessary to ensure that cosmetic products may be marketed only if their packaging, containers or labels bear the following information in indelible, easily legible and visible lettering: (a) the name or style and the address or registered office of the manufacturer or the person responsible for marketing the cosmetic product who are established within the Community. Such information may be abbreviated in so far as the abbreviation makes it generally possible to identify the undertaking. Member States may require that the country of origin be specified for goods manufactured outside the Community; (b) the nominal content at the time of packaging; (c) the expiry date for products with a stability of less than three years; (d) particular precautions to be observed in use, and especially those listed in the column "Conditions of use and warnings which must be printed on the label" in Annexes III and IV, and which must appear on the container ; where this is impossible for practical reasons, this information must appear on the packaging or on an enclosed leaflet, but in the latter case an abbreviated external indication must appear on the container, referring the consumer to the information specified; (e) the batch number of manufacture or the reference for identifying the goods ; however, where this is impossible for practical reasons because the cosmetic articles are too small, such information need appear only on the multiple retail pack or sleeve of these articles.
2. Member States shall take all measures necessary to ensure that in the labelling, presentation for sale and advertising of cosmetic products, the wording, use of names, trade marks, images or other signs, figurative or otherwise, suggesting a characteristic which the products in question do not possess, shall be prohibited.

Article 7

1. Member States may not, for reasons related to the requirements laid down in this Directive and the Annexes thereto, refuse, prohibit or restrict the marketing of any cosmetic products which comply with the requirements of this Directive and the Annexes thereto.
2. They may, however, require that the particulars provided for in Article 6 (1) (b), (c) and (d) be expressed at least in their own national or official language or languages.
3. Furthermore, a Member State may require, for purposes of prompt and appropriate medicial treatment in the event of difficulties, that adequate and sufficient information regarding substances contained in cosmetic products is made available to the competent authority, which shall ensure that this information is used only for the purposes of such treatment.

Article 10

1. Where the procedure laid down in this Article is to be followed, matters shall be referred to the Committee by the chairman, either on his own initiative or at the request of the representative of a Member State.
2. The representative of the Commission shall submit to the Committee a draft of the measures to be adopted. The Committee shall deliver its opinion on the draft within a time limit set by the chairman according to the urgency of the matter. Opinions shall be adopted by a majority of 41 votes, the votes of Member States being weighted as provided for in Article 148 (2) of the Treaty. The chairman shall not vote.
3. (a) The Commission shall adopt the proposed measures when they are in accordance with the opinion of the Committee. (b) Where the proposed measures are not in accordance with the opinion of the Committee, or if no opinion is adopted, the Commission shall without delay propose to the Council the measures to be adopted. The Council shall act by a qualified majority. (c) If, within three months of the proposal being submitted to it, the Council has not acted, the proposed measures shall be adopted by the Commission.

Article 12

1. If a Member State notes, on the basis of a substantiated justification, that a cosmetic product, although complying with the requirements of the Directive, represents a hazard to health, it may provisionally prohibit the marketing of that product in its territory or subject it to special conditions. It shall immediately inform the other Member States and the Commission thereof, stating the grounds for its decision.
2. The Commission shall, within six weeks, consult the Member States concerned, following which it shall deliver its opinion without delay and take the appropriate steps.
3. If the Commission is of the opinion that technical adaptations to the Directive are necessary, such adaptations shall be adopted by either the Commission or the Council in accordance with the procedure laid down in Article 10. In that event, the Member State which has adopted safeguard measures may maintain them until entry into force of the adaptations.

Article 14

1. Member States shall bring into force the provisions needed in order to comply with this Directive within 18 months of its notification and shall forthwith inform the Commission thereof.
2. Member States may, however, for a period of 36 months from notification of this Directive, authorize the marketing in their territory of cosmetic products which do not conform to the requirements of the Directive.
3. Member States shall ensure that the texts of such provisions of national law as they adopt in the field governed by this Directive are communicated to the Commission.

Article 15 This Directive is addressed to the Member States. Done at Brussels, 27 July 1976. For the Council The President M. van der STOEL ANNEX I ILLUSTRATIVE LIST BY CATEGORY OF COSMETIC PRODUCTS

• Creams, emulsions, lotions, gels and oils for the skin (hands, face, feet, etc.).
• Face masks (with the exception of peeling products).
• Tinted bases (liquids, pastes, powders).
• Make-up powders, after-bath powders, hygienic powders, etc.
• Toilet soaps, deodorant soaps, etc.
• Perfumes, toilet waters and eau de Cologne.
• Bath and shower preparations (salts, foams, oils, gels, etc.).
• Depilatories.
• Deodorants and anti-perspirants.
• Hair care products: - hair tints and bleaches,
• products for waving, straightening and fixing,
• setting products,
• cleansing products (lotions, powders, shampoos),
• conditioning products (lotions, creams, oils),
• hairdressing products (lotions, lacquers, brilliantines).
• Shaving products (creams, foams, lotions, etc.).
• Products for making up and removing make-up from the face and the eyes.
• Products intended for application to the lips.
• Products for care of the teeth and the mouth.
• Products for nail care and make-up.
• Products for external intimate hygiene.
• Sunbathing products.
• Products for tanning without sun.
• Skin-whitening products.
• Anti-wrinkle products. ANNEX II LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN

1. N-5-Chlorobenzoxazol-2-ylacetamide
2. ß-Acetoxyethyl trimethyl ammonium hydroxide (acetylcholine and its salts)
3. Deanol aceglumate
4. Spironolactone
5. [4-(4-Hydroxy-3-iodophenoxy)-3,5-diiodophenyl] acetic acid and its salts
6. Methotrexate
7. Aminocaproic acid and its salts
8. Cinchophen, its salts, derivatives and salts of these derivatives
9. Thyropropic acid and its salts
10. Trichloroacetic acid
11. Aconitum napellus L. (leaves, roots and galenical preparations)
12. Aconitine (principal alkaloid of Aconitum napellus L.) and its salts
13. Adonis vernalis L. and its preparations
14. Epinephrine
15. Rauwolfia serpentina alkaloids and their salts
16. Alkyne alcohols, their esters, ethers and salts
17. Isoprenaline
18. Allyl isothiocyanate
19. Alloclamide and its salts
20. Nalorphine, its salts and ethers
21. Sympathicomimetic amines acting on the central nervous system : any substance contained in the first list of medicaments which are subject to medical prescription and are referred to in resolution AP (69) 2 of the Council of Europe
22. Aniline, its salts and its halogenated and sulphonated derivatives
23. Betoxycaine and its salts
24. Zoxazolamine
25. Procainamide, its salts and derivatives
26. Benzidine
27. Tuaminoheptane, its isomers and salts
28. Octodrine and its salts
29. 2-Amino-1,2-bis (4-methoxyphenyl)ethanol and its salts
30. 1,3-dimethylpentylamine and its salts () In this Directive, names followed by an asterisk are those published in "Computer print-out 1975, International Non-proprietary Names (INN) for pharmaceutical products, Lists 1-33 of proposed INN", WHO, Geneva, August 1975.

1. 4-Aminosalicylic acid and its salts
2. Toluidines, their isomers, salts and halogenated and sulphonated derivatives
3. Xylidines, their isomers, salts and halogenated and sulphonated derivatives
4. Imperatorin (9-(3-methoxylbut-2-enyloxy) furo [3,2-g] chromen-7-one)
5. Ammi majus and its galenical preparations
6. 2,3-Dichloro-2-methylbutane
7. Substances with androgenic effect
8. Anthracene oil
9. Antibiotics, with the exception of that given in Annex IV
10. Antimony and its compounds
11. Apocynum cannabinum L. and its preparations
12. Apomorphine (5,6,6a 7-tetrahydro-6-methyl-4H-dibenzo [de, g]= quinoline-10,11-dihydric alcohol) and its salts
13. Arsenic and its compounds
14. Atropa belladonna L. and its preparations
15. Atropine, its salts and derivatives
16. Barium salts, with the exception of barium sulphate, lakes prepared from barium sulphate and pigments prepared from the colouring agents listed in Annex III, Part 2 and Annex IV, Parts 2 and 3 and marked Ba
17. Benzene
18. 4,5-Dihydrobenzimidazol-4-one
19. Benzazepines and benzadiazepines, their salts and derivatives
20. 1-Dimethylaminomethyl-1-methylpropyl benzoate and its salts (amylocaine)
21. 2,2,6-Trimethyl-4-piperidyl benzoate and its salts (benzamine)
22. Isocarboxazide
23. Bendroflumethiazide and its derivatives
24. Beryllium and its compounds
25. Bromine, elemental
26. Bretylium tosilate
27. Carbromal
28. Bromisoval
29. Brompheniramine and its salts
30. Benzilonium bromide
31. Tetrylammonium bromide
32. Brucine
33. Tetracaine and its salts
34. Mofebutazone
35. Tolbutamide
36. Carbutamide
37. Phenylbutazone
38. Cadmium and its compounds
39. Cantharides, Cantharis vesicatoria
40. (1R, 2S)-Hexahydro-1,2-dimethyl-3,6-epoxyphthalic anhydride (cantharidin)
41. Phenprobamate
42. Nitroderivatives of carbazol
43. Carbon disulphide
44. Catalase
45. Cephaeline and its salts
46. Chenopodium ambrosioides (essential oil)
47. 2,2,2-Trichloroethane-1,1-diol
48. Chlorine
49. Chlorpropamide
50. Diphenoxylate (hydrochloride)
51. 4-Phenylazophenylene-1,3-diamine citrate hydrochloride (chrysoidine citrate hydrochloride)
52. Chlorzoxazone
53. 2-Chloro-6-methylpyrimidin-4-yldimethylamine (crimidine-ISO)
54. Chlorprothixene and its salts
55. Clofenamide
56. N N-bis (2-chloroethyl) methylamine N-oxide and its salts
57. Chlormethine and its salts
58. Cyclophosphamide and its salts
59. Mannomustine and its salts
60. Butanilicaine and its salts
61. Chloromezanone
62. Triparanol
63. 2-[2(4-Chlorophenyl)-2-phenylacetyl] indane-1,3-dione (chlorophacinone-ISO)
64. Chlorphenoxamine
65. Phenaglycodol
66. Chloroethane
67. Chromium ; chromic acid and its salts
68. Claviceps purpurea Tul., its alkaloids and galenical preparations
69. Conium maculatum L. (fruit, powder, galenical preparations)
70. Glycyclamide
71. Cobalt benzenesulphonate
72. Colchicine, its salts and derivatives
73. Colchicoside and its derivatives
74. Colchicum autumnale L. and its galenical preparations
75. Convallatoxin
76. Anamirta cocculus L. (fruit)

1. Croton tiglium (oil)
2. 1-Butyl-3-(N-crotonoylsulphanilyl)urea
3. Curare and curarine
4. Synthetic curarizants
5. Hydrogen cyanide and its salts

6. PIC FILE= "T9000996">

7. Cyclomenol and its salts
8. Sodium hexacyclonate
9. Hexapropymate
10. Dextropropoxyphene
11. O O-Diacetyl-N-allyl-N-normorphine
12. Pipazetate and its salts

13. PIC FILE= "T9000997">

14. N N-Pentamethylenebis (trimethylammonium salts), e.g. Pentamethonium bromide
15. N N'-[Methylimino) diethylene] bis (ethyldimethylammonium) salts, e.g. azamethonium bromide
16. Cyclarbamate
17. Clofenotane ; DDT (ISO)
18. Hexamethylenebis (trimethylammonium salts), e.g. hexamethonium bromide
19. Dichloroethanes (ethylene chlorides)
20. Dichloroethylenes (acetylene chlorides)
21. Lysergide and its salts
22. 2-Diethylaminoethyl-3-hydroxy-4-phenylbenzoate and its salts
23. Cinchocaine and its salts
24. 3-Diethylaminopropyl cinnamate
25. O O-Diethyl O-4-nitrophenyl phosphorothioate (parathion-ISO)
26. [Oxalylbis(iminoethylene)] bis [(o-chlorobenzyl)diethylammonium salts], e.g. ambenomium chloride
27. Methyprylon and its salts
28. Digitaline and all heterosides of Digitalis purpurea L.
29. 7-[2-Hydroxy-3-(2-hydroxyethyl-N-methylamino)propyl]theophylline (xanthinol)
30. Dioxethedrin and its salts
31. Piprocurarium
32. Propyphenazone
33. Tetrabenazine and its salts
34. Captodiame
35. Mefeclorazine and its salts
36. Dimethylamine
37. 1,1-Bis(dimethylaminomethyl) propyl benzoate and its salts (amydricaine, alypine)
38. Methapyrilene and its salts
39. Metamfepramone and its salts
40. Amitriptyline and its salts
41. Metformin and its salts
42. Isosorbide dinitrate
43. Malononitrile
44. Succinonitrile
45. Dinitrophenol isomers
46. Inproquone
47. Dimevamide and its salts
48. Diphenylpyraline and its salts
49. Sulfinpyrazone
50. N-(3-Carbamoyl-3, 3-diphenylpropyl)-N N-diisopropylmethylammonium salts, e.g. isopropamide iodide
51. Benactyzine
52. Benzatropine and its salts
53. Cyclizine and its salts
54. 5,5-Diphenyl-4 imidazolidone
55. Probenecid
56. Disulfiram ; thiram (ISO)
57. Emetine, its salts and derivatives
58. Ephedrine and its salts
59. Oxanamide and its derivatives
60. Eserine or physostigmine and its salts
61. Esters of 4-aminobenzoic acid, with the free amino group, with the exception of that given in Annex IV, Part 1
62. Choline salts and their esters, e.g. choline chloride
63. Caramiphen and its salts
64. Diethyl 4-nitrophenyl phosphate
65. Metethoheptazine and its salts
66. Oxpheneridine and its salts
67. Ethoheptazine and its salts
68. Metheptazine and its salts
69. Methylphenidate and its salts
70. Doxylamine and its salts
71. Tolboxane
72. Monobenzone
73. Parethoxycaine and its salts
74. Fenozolone
75. Glutethimide and its salts
76. Ethylene oxide
77. Bemegride and its salts
78. Valnoctamide
79. Haloperidol
80. Paramethasone
81. Fluanisone
82. Trifluperidol
83. Fluoresone
84. Fluorouracil
85. Hydrofluoric acid, its normal salts, its complexes and hydrofluorides with the exception of those given in Annex IV, Part 1

1. Furfuryltrimethylammonium salts, e.g. furtrethonium iodide
2. Galantamine
3. Progestogens, with the exception of those listed in Annex V
4. 1,2,3,4,5,6-Hexachlorocyclohexane (BHC-ISO)
5. (1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-1,4,4a,5,6,7,8,8a-octahydro-1,4 : 5,8-dimethanonaphthalene (endrin-ISO)
6. Hexachloroethane
7. (1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-1,4,4a,5,8,8a-hexahydro-1,4 : 5,8-dimethanonaphthalene (isodrin-ISO)
8. Hydrastine, hydrastinine and their salts
9. Hydrazides and their salts
10. Hydrazine, its derivatives and their salts
11. Octamoxin and its salts
12. Warfarin and its salts
13. Ethyl bis(4-hydoxy-2-oxo-1-benzopyran-3-yl) acetate and salts of the acid
14. Methocarbamol
15. Propatylnitrate
16. 4,4'-Dihydroxy-3,3'-(3-methylthiopropylidene) dicoumarin
17. Fenadiazole
18. Nitroxoline and its salts
19. Hyoscyamine, its salts and derivatives
20. Hyoscyamus niger L. (leaves, seeds, powder and galenical preparations)
21. Pemoline and its salts
22. Iodine
23. Decamethylenebis (trimethylammonium salts), e.g. decamethonium bromide
24. Ipecacuanha (Cephaelis ipecacuanha Brot. and related species) (roots, powder and galenical preparations)
25. (2-Isopropylpent-4-enoyl)urea (apronalide)

26. PIC FILE= "T9000998">

27. Lobelia inflata L. and its galenical preparations
28. Lobeline and its salts
29. Barbiturates
30. Mercury and its compounds, excluding the exceptions listed in Annex IV and Annex V
31. 3,4,5-Trimethoxyphenethylamine and its salts
32. Metaldehyde
33. 2-(4-Allyl-2-methoxyphenoxy)-N,N-diethylacetamide and its salts
34. Coumetarol
35. Dextromethorphan and its salts
36. 2-Methylheptylamine and its salts
37. Isometheptene and its salts
38. Mecamylamine
39. Guaifenesin
40. Dicoumarol
41. Phenmetrazine, its derivatives and salts
42. Thiamazole
43. 3,4-Dihydro-2-methoxy-2-methyl-4-phenyl-2H,5H-pyrano [3,2-c]-[1] benzopyran-5-one (cyclocoumarol)
44. Carisoprodol
45. Meprobamate
46. Tefazoline and its salts
47. Arecoline
48. Poldine metilsulfate
49. Hydroxyzine
50. 2-Naphthol
51. 1-and 2-Naphthylamines and their salts
52. 3 (1-Naphtylmethyl)-2-imidazoline
53. Naphazoline and its salts
54. Neostigmine and its salts (e.g. neostigmine bromide)
55. Nicotine and its salts
56. Amyl nitrites
57. Inorganic nitrites, with the exception of sodium nitrite
58. Nitrobenzene
59. Nitrocresols and their alkali metal salts
60. Nitrofurantoin
61. Furazolidone
62. Propane-1,2,3-triyl trinitrate
63. Acenocoumarol
64. Alkali pentacyanonitrosylferrate (2-)
65. Nitrostilbenes, their homologues and their derivatives
66. Noradrenaline and its salts
67. Noscapine and its salts
68. Guanethidine and its salts
69. Oestrogens, with the exception of those listed in Annex V
70. Oleandrin
71. Chlortalidone
72. Pelletierine and its salts
73. Pentachloroethane
74. Pentaerithrityl tetranitrate
75. Petrichloral
76. Octamylamine and its salts
77. Pheno and its alkali salts, excluding the exceptions listed in Annex III

1. Phenacemide
2. Difencloxazine
3. 2-Phenylindane-1,3-dione (phenindione)
4. Ethylphenacemide
5. Phenprocoumon
6. Fenyramidol
7. Triamterene and its salts
8. Tetraethylpyrophosphate ; TEPP (ISO)
9. Tritolyl phosphate
10. Psilocybine
11. Phosphorus and metal phosphides
12. Thalidomide and its salts
13. Physostigma venenosum Balf.
14. Picrotoxin
15. Pilocarpine and its salts
16. a-Piperidin-2-yl benzyl acetate laevorotatory threoform (Levophacetoperane) and its salts
17. Pipradrol and its salts
18. Azacyclonol and its salts
19. Bietamiverine
20. Butopiprine and its salts
21. Lead and its compounds, with the exception of that mentioned in Annex V
22. Coniine
23. Prunus laurocerasus L. ("cherry laurel water")
24. Metyrapone
25. Radioactive substances (1)
26. Juniperus sabina L. (leaves, essential oil and galenical preparations)
27. Hyoscine, its salts and derivatives
28. Gold salts
29. Selenium and its compounds
30. Solanum nigrum L. and its galenical preparations
31. Sparteine and its salts
32. Glucocorticoids
33. Datura stramonium L. and its galenical preparations
34. Strophantines, their aglucones and their respective derivatives
35. Strophantus species and their galenical preparations
36. Strychnine and its salts
37. Strychnos species and their galenical preparations
38. Narcotics, natural and synthetic : All substances listed in Tables I and II of the single Convention on narcotic drugs signed in New York on 30 March 1961
39. Sulphonamides (sulphanylamide and its derivatives obtained by substitution of one or more H-atoms of the -NH2 groups) and their salts
40. Sultiame
41. Neodymium and its salts (1)The presence of natural radioactive substances and of radioactive substances caused by artificial contamination from the environment is permitted, provided that the radioactive substances are not enriched for the manufacture of cosmetic products and that their concentration falls within the limits set in the Directive laying down the basic standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiations (OJ No 11, 20.2.1959, p. 221/59).
42. Thiotepa
43. Pilocarpus jaborandi Holmes and its galenical preparations
44. Tellurium and its compounds
45. Xylometazoline and its salts
46. Tetrachloroethylene
47. Carbon tetrachloride
48. Hexaethyl tetraphosphate
49. Thallium and its compounds
50. Thevetia neriifolia Juss., glycoside extract
51. Ethionamide
52. Phenothiazine and its compounds
53. Thiourea and its derivatives, with the exception of those listed in Annex IV, Part 1
54. Mephenesin and its esters
55. Vaccines, toxins or serums listed in the Annex to the second Council Directive of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (OJ No L 147, 9.6.1975, p. 13)
56. Tranylcypromine and its salts
57. Trichloronitromethane (chloropicrine)

1. 2,2,2-Tribromoethanol (tribromoethyl alcohol)
2. Trichlormethine and its salts
3. Tretamine
4. Gallamine triethiodide
5. Urginea scilla Stern. and its galenical preparations
6. Veratrine, its salts and galenical preparations
7. Schoenocaulon officinale Lind. (seeds and galenical preparations)
8. Veratrum album L. (roots and galenical preparations)
9. Vinyl chloride monomer
10. Ergocalciferol and cholecalciferol (vitamins D2 and D3)
11. Salts of O-alkyldithiocarbonic acids
12. Yohimbine and its salts
13. Dimethyl sulfoxide
14. Diphenhydramine and its salts
15. 4-tert-Butylphenol
16. 4-tert-Butylpyrocatechol
17. Dihydrotachysterol
18. Dioxane
19. Morpholine and its salts
20. Pyrethrum album L. and its galenical preparations
21. 2-[4-Methoxybenzyl-N-(2-pyridyl)amino] ethyldimethylamine
22. Tripelennamine
23. Tetrachlorosalicylanilides
24. Dichlorosalicylanilides
25. Tetrabromosalicylanilides
26. Dibromosalicylanilides, e.g. metabromsalan, dibromsalan
27. Bithionol
28. Thiuram monosulphides
29. Thiuram disulphides
30. Dimethylformamide
31. 4-Phenylbut-3-en-2-one
32. Benzoates of 4-hydroxy-3-methoxycinnamyl alcohol except for normal content in natural essences used
33. Furo [3,2-g] chromen-7-one and its alkyl-substituted derivatives (e.g. trioxysalan and 8-methoxypsoralen), except for normal content in natural essences used
34. Oil from the seeds of Laurus nobilis L.
35. Sassafras officinale Nees oil containing safrole
36. 5,5'-Di-isopropyl-2,2'-dimethylbiphenyl-4,4'-diyl dihypoiodite PIC FILE= "T0009550"> >PIC FILE= "T0009551"> PIC FILE= "T0009552"> PIC FILE= "T0009553"> PIC FILE= "T0009554"> PART 2 PIC FILE= "T0009555"> >PIC FILE= "T0009556"> PIC FILE= "T0009557"> >PIC FILE= "T0009558"> PIC FILE= "T0009559"> >PIC FILE= "T0009560"> PIC FILE= "T0009561"> PIC FILE= "T0009562"> PIC FILE= "T0009563"> PIC FILE= "T0009564"> PART 2 PIC FILE= "T0009565"> >PIC FILE= "T0009567"> >PIC FILE= "T0009568"> PART 3 (A) LIST OF COLOURING AGENTS PROVISIONALLY ALLOWED FOR COSMETIC PRODUCTS WHICH DO NOT COME INTO CONTACT WITH THE MUCOUS MEMBRANES Reds 12310, 12335, 12420, 12430, 12440, 16140, 16155, 16250, 17200, 18000, 18050, 18055, 18065, 26105, 45100, 50240, E121 Oranges and yellows 11680, 11710, 13065, 15575, 16230, 18690, 18736, 18745, 19120, 19130, 21230, 71105 PIC FILE= "T9001000"> (B) LIST OF COLOURING AGENTS PROVISIONALLY ALLOWED FOR COSMETIC PRODUCTS WHICH COME INTO CONTACT ONLY BRIEFLY WITH THE SKIN Reds 11210, 12090, 12155, 12170, 12315, 12370, 12459, 12460, 13020, 14895, 14905, 16045, 16180, 18125, 18130, 24790, 27300, 27306, 28160, 45220, 60505, 60710, 62015, 73300 Yellows and oranges 11720, 11725, 11730, 11765, 11850, 11855, 11860, 11870, 12055, 12140, 12700, 12740, 12770, 12790, 13900, 14600, 15970, 15975, 18820, 18900, 19555, 21090, 21096, 21100, 21108, 21110, 21115, 22910, 25135, 25220, 26090, 29020, 40215, 40640, 41000, 45376, 47035, 48040, 48055, 56205, 4-(3-chlorphenylazo)-3-hydroxy-2 naphth-0-anisidide, trisodium 3-hydroxypyren-5,8,10- trisulphonate

Blues and greens 10025, 26360, 42052, 42085, 42095, 42100, 50315, 50320, 50400, 50405, 51175, 52015, 52020, 52030, 61505, 61585, 62045, 62100, 62105, 62125, 62130, 62500, 62560, 63010, 64500, 74180 Violets, browns, blacks and whites 12145, 14805, 15685, 17580, 20285, 20470, 21010, 25410, 30045, 30235, 40625, 42510, 42520, 42525, 42535, 42650, 48013, 57020, 60730, 61100, 61105, 61705, 62030, 63165, 63615 ANNEX V LIST OF SUBSTANCES EXCLUDED FROM THE SCOPE OF THE DIRECTIVE

1. Lead acetate (for use in hair treatment products only).
2. Hexachlorophene (for all uses other than that stated in Part 1 of Annex III).
3. Hormones (a) - oestrone,

• oestradiol and its esters,
• oestriol and its esters; (b) - progesterone, - Ethisterone.

1. p-Phenylenediamine and its salts.
2. Strontium and its salts, with the exception of those used in the colouring agents listed in Part 2 of Annex III and Parts 2 and 3 of Annex IV.
3. Zirconium and its derivatives.
4. Thiomersal and phenylmercuric compounds (for use as preservatives in concentrated shampoos and creams containing non-ionic emulsifiers which render other preservatives ineffective ; maximum concentration 0.003 % calculated as Hg).
5. Lidocaine.
6. Tyrothricin.