Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products
Modified by
- Council Directiveof 24 July 1979(79/661/EEC), 379L0661, July 31, 1979
- Actconcerning the conditions of accession of the Hellenic Republic and the adjustments to the Treaties , 179H, November 19, 1979
- Commission Directiveof 11 February 1982(82/147/EEC), 382L0147, March 6, 1982
- Council Directiveof 17 May 1982(82/368/EEC), 382L0368, June 15, 1982
- Commission Directiveof 30 March 1983(83/191/EEC), 383L0191, April 26, 1983
- Commission Directiveof 29 June 1983(83/341/EEC), 383L0341, July 13, 1983
- Commission Directiveof 22 September 1983(83/496/EEC), 383L0496, October 8, 1983
- Council Directiveof 26 October 1983(83/574/EEC), 383L0574, November 28, 1983
- Commission Directiveof 18 July 1984(84/415/EEC)Corrigendum, OJ No L 255, 25. 9. 1984, p. 28 (84/4l5/EEC), 384L0415384L0415R(01), August 25, 1984
- Commission Directiveof 16 July 1985(85/391/EEC), 385L0391, August 22, 1985
- Actconcerning the conditions of accession of the Kingdom of Spain and the Portuguese Republic and the adjustments to the Treaties, 185I, November 15, 1985
- Commission Directiveof 28 February 1986(86/179/EEC), 386L0179, May 24, 1986
- Commission Directiveof 26 March 1986(86/199/EEC), 386L0199, June 3, 1986
- Commission Directiveof 2 February 1987(87/137/EEC), 387L0137, February 26, 1987
- Commission Directiveof 2 March 1988(88/233/EEC)Corrigendum, OJ No L 157, 24. 6. 1988, p. 38 (88/233/EEC), 388L0233388L0233R(03), April 26, 1988
- Council Directiveof 21 December 1988(88/667/EEC), 388L0667, December 31, 1988
- Commission Directiveof 21 February 1989(89/174/EEC)Corrigendum, OJ No L 199, 13. 7. 1989, p. 23 (89/174/EEC), 389L0174389L0174R(01), March 8, 1989
- Council Directiveof 21 December 1989(89/679/EEC), 389L0679, December 30, 1989
- Commission Directiveof 20 February 1990(90/121/EEC), 390L0121, March 17, 1990
- Commission Directiveof 12 March 1991(91/184/EEC), 391L0184, April 12, 1991
- Commission Directiveof 18 February 1992(92/8/EEC), 392L0008, March 17, 1992
- Commission Directive of 21 October 1992(92/86/EEC), 392L0086, November 11, 1992
- Council Directiveof 14 June 1993(93/35/EEC), 393L0035, June 23, 1993
- Commission Directiveof 22 June 1993(93/47/EEC), 393L0047, August 13, 1993
- Commission Directiveof 29 June 1994(94/32/EC)Corrigendum, OJ No L 273, 25. 10. 1994, p. 38 (94/32/EC), 394L0032394L0032R(01), July 15, 1994
- Commission Directiveof 10 July 1995(95/34/EC), 395L0034, July 18, 1995
- Commission Directiveof 25 June 1996(96/41/EC), 396L0041, August 8, 1996
- Commission Directiveof 10 January 1997(97/1/EC), 397L0001, January 18, 1997
- Commission Directiveof 17 April l997(97/18/EC), 397L0018, May 1, 1997
- Commission Directiveof 14 July 1997(97/45/EC), 397L0045, July 24, 1997
- Commission Directiveof 5 March 1998(98/16/EC), 398L0016, March 14, 1998
- Commission Directiveof 3 September 1998(98/62/EC), 398L0062, September 15, 1998
- Commission Directive 2000/6/ECof 29 February 2000adapting 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), 300L0006, March 1, 2000
- Commission Directive 2000/11/ECof 10 March 2000adapting to technical progress Annex II to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products(Text with EEA relevance), 300L0011, March 14, 2000
- Commission Directive 2000/41/ECof 19 June 2000postponing for a second time the date after which animal tests are prohibited for ingredients or combinations of ingredients of cosmetic products(Text with EEA relevance), 300L0041, June 20, 2000
- Commission Directive 2002/34/ECof 15 April 2002adapting to technical progress Annexes II, III 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)Corrigendum to the twenty-sixth Commission Directive 2002/34/EC of 15 April 2002 adapting to technical progress Annexes II, III and VII to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products(Official Journal of the European Communities L 102 of 18 April 2002)Corrigendum to the Twenty-sixth Commission Directive 2002/34/EC of 15 April 2002 adapting to technical progress Annexes II, III and VII to Council Directive 76/748/EEC on the approximation of the laws of the Member States relating to cosmetic products(Official Journal of the European Communities L 102 of 18 April 2002), 302L0034302L0034R(02)302L0034R(03), April 18, 2002
- Commission Directive 2003/1/ECof 6 January 2003adapting to technical progress Annex II to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products(Text with EEA relevance), 303L0001, January 10, 2003
- Commission Directive 2003/16/ECof 19 February 2003adapting to technical progress Annex III to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products, 303L0016, February 20, 2003
- Directive 2003/15/EC of the European Parliament and of the Councilof 27 February 2003amending Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products(Text with EEA relevance), 303L0015, March 11, 2003
- Commission Directive 2003/80/ECof 5 September 2003establishing a symbol indicating the durability of cosmetic products in Annex VIIIa to Council Directive 76/768/EEC(Text with EEA relevance), 303L0080, September 6, 2003
- Commission Directive 2003/83/ECof 24 September 2003adapting to technical progress Annexes II, III and VI to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products(Text with EEA relevance)Corrigendum to Commission Directive 2003/83/EC of 24 September 2003 adapting to technical progress Annexes II, III and VI to Council Directive 76/768/EEC on the approximation of the laws of Member States relating to cosmetic products(Official Journal of the European Union L 238 of 25 September 2003), 303L0083303L0083R(01), September 25, 2003
Corrected by
- Corrigendum, OJ No L 255, 25. 9. 1984, p. 28 (84/4l5/EEC), 384L0415R(01), September 25, 1984
- Corrigendum, OJ No L 157, 24. 6. 1988, p. 38 (88/233/EEC), 388L0233R(03), June 24, 1988
- Corrigendum, OJ No L 199, 13. 7. 1989, p. 23 (89/174/EEC), 389L0174R(01), July 13, 1989
- Corrigendum, OJ No L 273, 25. 10. 1994, p. 38 (94/32/EC), 394L0032R(01), October 25, 1994
- Corrigendum to the twenty-sixth Commission Directive 2002/34/EC of 15 April 2002 adapting to technical progress Annexes II, III and VII to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products, 302L0034R(02), December 17, 2002
- Corrigendum to the Twenty-sixth Commission Directive 2002/34/EC of 15 April 2002 adapting to technical progress Annexes II, III and VII to Council Directive 76/748/EEC on the approximation of the laws of the Member States relating to cosmetic products, 302L0034R(03), June 19, 2003
- Corrigendum to Commission Directive 2003/83/EC of 24 September 2003 adapting to technical progress Annexes II, III and VI to Council Directive 76/768/EEC on the approximation of the laws of Member States relating to cosmetic products, 303L0083R(01), February 26, 2004
(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 Annex IV, Part 1, with the exception of cosmetic products containing colouring agents intended solely to colour hair; (d) colouring agents listed in Annex IV, Part 1, used outside the conditions laid down, with the exception of cosmetic products containing colouring agents intended solely to colour hair; (e) preservatives other than those listed in Annex VI, Part 1; (f) preservatives listed in Annex VI, Part 1, beyond the limits and outside the conditions laid down, unless other concentrations are used for specific purposes apparent from the presentation of the product; (g) UV filters other than those listed in Part 1 of Annex VII; (h) UV filters listed in Part 1 of Annex VII, beyond the limits and outside the conditions laid down therein. (i) ingredients or combinations of ingredients tested on animals after 30 June 2002 in order to meet the requirements of this Directive.If there has been insufficient progress in developing satisfactory methods to replace animal testing, and in particular in those cases where alternative methods of testing, despite all reasonable endeavours, have not been scientifically validated as offering an equivalent level of protection for the consumer, taking into account OECD toxicity test guidelines, the Commission shall, by 1 January 1997 , submit draft measures to postpone the date of implementation of this provision, for a sufficient period, and in any case for no less than two years, in accordance with the procedure laid down in Article 10. Before submitting such measures, the Commission will consult the Scientific Committee on Cosmetology.The Commission shall present an annual report to the European Parliament and the Council on progress in the development, validation and legal acceptance of alternative methods to those involving experiments on animals. That report shall contain precise data on the number and type of experiments relating to cosmetic products carried out on animals. The Member States shall be obliged to collect that information in addition to collecting statistics as laid down by Directive 86/609/EEC on the protection of animals used for experimental and other scientific purposes. The Commission shall in particular ensure the development, validation and legal acceptance of experimental methods which do not use live animals.
(a) the marketing of cosmetic products where the final formulation, in order to meet the requirements of this Directive, has been the subject of animal testing using a method other than an alternative method after such alternative method has been validated and adopted at Community level with due regard to the development of validation within the OECD; (b) the marketing of cosmetic products containing ingredients or combinations of ingredients which, in order to meet the requirements of this Directive, have been the subject of animal testing using a method other than an alternative method after such alternative method has been validated and adopted at Community level with due regard to the development of validation within the OECD; (c) the performance on their territory of animal testing of finished cosmetic products in order to meet the requirements of this Directive; (d) the performance on their territory of animal testing of ingredients or combinations of ingredients in order to meet the requirements of this Directive, no later than the date on which such tests are required to be replaced by one or more validated alternative methods listed in Annex V to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substancesOJ 196, 16.8.1967, p. 1 . Directive as last amended by Commission Directive 2001/59/EC (OJ L 225, 21.8.2001, p. 1 ).
(a) the ingredient is in wide use and cannot be replaced by another ingredient able to perform a similar function; (b) the specific human health problem is substantiated and the need to conduct animal tests is justified and is supported by a detailed research Protocol proposed as the basis for the evaluation.
(a) "finished cosmetic product" means the cosmetic product in its final formulation, as placed on the market and made available to the final consumer, or its prototype. (b) "prototype" means a first model or design that has not been produced in batches, and from which the finished cosmetic product is copied or finally developed.
(a) the substances listed in Annex III, Part 2, within the limits and under the conditions laid down, up to the dates in column (g) of that Annex; (b) the colouring agents listed in Annex IV, Part 2, within the limits and under the conditions laid down, until the admission dates given in that Annex; (c) the preservatives listed in Annex VI, Part 2, within the limits and under the condition laid down, until the dates given in column (f) of that Annex. However, some of these substances may be used in other concentrations for specific purposes apparent from the presentation of the product; (d) the UV filters listed in Part 2 of Annex VII, within the limits and under the conditions laid down, until the dates given in column (f) of that Annex.
definitively allowed, or definitively prohibited (Annex II), or maintained for a given period specified in Part 2 of Annexes III, IV, VI and VII, or deleted from all the Annexes, on the basis of available scientific information or because they are no longer used.
the identity of each ingredient, in particular its chemical name, the CTFA name, the European Pharmacopoeia name, the international non-proprietary names recommended by the World Health Organization, the Einecs, Iupac, CAS and colour index numbers, and the common name referred to in Article 7 (2), the usual function(s) of the ingredient in the final product, where appropriate, restrictions and conditions of use and warnings which must be printed on the label by reference to the Annexes.
(a) the name or style and the address or registered office of the manufacturer or the person responsible for marketing the cosmetic product who is 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, given by weight or by volume, except in the case of packaging containing less than five grams or five millilitres, free samples and single-application packs; for pre-packages normally sold as a number of items, for which details of weight or volume are not significant, the content need not be given provided the number of items appears on the packaging. This information need not be given if the number of items is easy to see from the outside or if the product is normally only sold individually; (c) the date of minimum durability shall be indicated by the words: "best used before the end of" followed by either: the date itself, or details of where it appears on the packaging.
The date shall be clearly expressed and shall consist of either the month and year or the day, month and year in that order. If necessary, this information shall be supplemented by an indication of the conditions which must be satisfied to guarantee the stated durability. Indication of the date of durability shall not be mandatory for cosmetic products with a minimum durability of more than 30 months. For such products, there shall be an indication of the period of time after opening for which the product can be used without any harm to the consumer. This information shall be indicated by the symbol given in Annex VIIIa followed by the period (in months and/or years); (d) particular precautions to be observed in use, especially those listed in the column "Conditions of use and warnings which must be printed on the label" in Annexes III, IV, VI and VII, which must appear on the container and packaging, as well as any special precautionary information on cosmetic products for professional use, in particular in hairdressing. Where this is impossible for practical reasons, an enclosed leaflet, label, tape or card must contain that information to which the consumer is referred either by abbreviated information or the symbol given in Annex VIII, which must appear on the container and the packaging; (e) the batch number of manufacture or the reference for identifying the goods. Where this is impossible for practical reasons because the cosmetic products are too small, such information need appear only on the packaging; (f) the function of the product, unless it is clear from the presentation of the product; (g) a list of ingredients in descending order of weight at the time they are added. That list shall be preceded by the word "ingredients". Where that is impossible for practical reasons, an enclosed leaflet, label, tape or card must contain the ingredients to which the consumer is referred either by abbreviated information or the symbol given in Annex VIII, which must appear on the packaging. The following shall not, however, be regarded as ingredients: impurities in the raw materials used, subsidiary technical materials used in the preparation but not present in the final product, materials used in strictly necessary quantities as solvents or as carriers for perfume and aromatic compositions.
Perfume and aromatic compositions and their raw materials shall be referred to by the word "perfume" or "aroma". However, the presence of substances, the mention of which is required under the column "other limitations and requirements" in Annex III, shall be indicated in the list irrespective of their function in the product. Ingredients in concentrations of less than 1 % may be listed in any order after those in concentrations of more than 1 %. Colouring agents may be listed in any order after the other ingredients, in accordance with the colour index number or denomination adopted in Annex IV. For decorative cosmetic products marketed in several colour shades, all colouring agents used in the range may be listed, provided that the words "may contain" or the symbol "+/-" are added. An ingredient must be identified by the common name referred to in Article 7(2) or, failing that, by one of the names referred to in Article 5a(2), first indent. In accordance with the procedure referred to in Article 10(2), the Commission may adapt the criteria and conditions set out in Commission Directive 95/17/EC of 19 June 1995 laying down detailed rules for the application of Council Directive 76/768/EEC as regards the non-inclusion of one or more ingredients on the list used for the labelling of cosmetic productsOJ L 140, 23.6.1995, p. 26 .
(a) the qualitative and quantitative composition of the product; in the case of perfume compositions and perfumes, the name and code number of the composition and the identity of the supplier; (b) the physico-chemical and microbiological specifications of the raw materials and the finished product and the purity and microbiological control criteria of the cosmetic product; (c) the method of manufacture complying with the good manufacturing practice laid down by Community law or, failing that, laid down by the law of the Member State concerned; the person responsible for manufacture or first importation into the Community must possess an appropriate level of professional qualification or experience in accordance with the legislation and practice of the Member State which is the place of manufacture or first importation; (d) assessment of the safety for human health of the finished product. To that end the manufacturer shall take into consideration the general toxicological profile of the ingredients, their chemical structure and their level of exposure. It shall take particular account of the specific exposure characteristics of the areas on which the product will be applied or of the population for which it is intended. There shall be inter alia a specific assessment for cosmetic products intended for use on children under the age of three and for cosmetic products intended exclusively for use in external intimate hygiene.Should the same product be manufactured at several places within Community territory, the manufacturer may choose a single place of manufacture where that information will be available. In this connection, and when so requested for monitoring purposes, it shall be obliged to indicate the place so chosen to the monitoring authority or authorities concerned. In this case this information shall be easily accessible; (e) the name and address of the qualified person or persons responsible for the assessment referred to in (d). That person must hold a diploma as defined in Article 1 of Directive 89/48/EEC in the field of pharmacy, toxicology, dermatology, medicine or a similar discipline; (f) existing data on undesirable effects on human health resulting from use of the cosmetic product; (g) proof of the effect claimed for the cosmetic product, where justified by the nature of the effect or product; (h) data on any animal testing performed by the manufacturer, his agents or suppliers, relating to the development or safety evaluation of the product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of non-member countries. Without prejudice to the protection, in particular, of commercial secrecy and of intellectual property rights, Member States shall ensure that the information required under (a) and (f) shall be made easily accessible to the public by any appropriate means, including electronic means. The quantitative information required under (a) to be made publicly accessible shall be limited to dangerous substances covered by Directive 67/548/EEC.
the methods of analysis necessary for checking the composition of cosmetic products, the criteria of microbiological and chemical purity for cosmetic products and methods for checking compliance with those criteria.
(a) the authorization must be limited to a maximum period of three years; (b) the Member State must carry out an official check on cosmetic products manufactured from the substance or preparation use of which it has authorized; (c) cosmetic products thus manufactured must bear a distinctive indication which will be defined in the authorization.
(a) progress made in the development, validation and legal acceptance of alternative methods. The report shall contain precise data on the number and type of experiments relating to cosmetic products carried out on animals. The Member States shall be obliged to collect that information in addition to collecting statistics as laid down by Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposesOJ L 358, 18.12.1986, p. 1 .(b) progress made by the Commission in its efforts to obtain acceptance by the OECD of alternative methods validated at Community level and recognition by non-member countries of the results of the safety tests carried out in the Community using alternative methods, in particular within the framework of cooperation agreements between the Community and these countries; (c) the manner in which the specific needs of small and medium-sized enterprises have been taken into account.
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.
1. N-5-Chlorobenzoxazol-2-ylacetamide 2. 2 -Acetoxyethyltrimethylammonium hydroxide (acetylcholine) and its salts3. Deanol aceglumate 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. 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 salts13. Adonis vernalis L . and its preparations14. Epinephrine* 15. Rauwolfia serpentina alkaloids and their salts16. 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 31. 4-Aminosalicylic acid and its salts 32. Toluidines, their isomers, salts and halogenated and sulphonated derivatives 33. Xylidines, their isomers, salts and halogenated and sulphonated derivatives 34. Imperatorin (9-(3-methoxylbut-2-enyloxy)furo[3,2-g]chromen-7-one) 35. Ammi majus and its galenical preparations36. 2,3-Dichloro-2-methylbutane 37. Substances with androgenic effect 38. Anthracene oil 39. Antibiotics 40. Antimony and its compounds 41. Apocynum cannabinum L . and its preparations42. Apomorphine (R 5,6,6a, 7-tetrahydro-6-methyl-4 H -dibenzo [de,g]quinoline-10,11-diol) and its salts43. Arsenic and its compounds 44. Atropa belladonna L . and its preparations45. Atropine, its salts and derivatives 46. Barium salts, with the exception of barium sulphate, barium sulphide under the conditions laid down in Annex III, Part 1, and lakes, salts and pigments prepared from the colouring agents listed with the reference ( 5 ) in Annex III, Part 2 and Annex IV, Part 2.47. Benzene 48. Benzimidazol-2(3 H )-one49. Benzazepines and benzodiazepines 50. 1-Dimethylaminomethyl-1-methylpropyl benzoate (amylocaine) and its salts 51. 2,2,6-Trimethyl-4-piperidyl benzoate (benzamine) and its salts 52. Isocarboxazid* 53. Bendroflumethiazide* and its derivatives 54. Beryllium and its compounds 55. Bromine, elemental 56. Bretylium tosilate* 57. Carbromal* 58. Bromisoval* 59. Brompheniramine* and its salts 60. Benzilonium bromide* 61. Tetrylammonium bromide* 62. Brucine 63. Tetracaine* and its salts 64. Mofebutazone* 65. Tolbutamide* 66. Carbutamide* 67. Phenylbutazone* 68. Cadmium and its compounds 69. Cantharides, Cantharis vesicatoria 70. (1R,2S)-Hexahydro-1,2-dimethyl-3,6-epoxyphthalic anhydride (cantharidin) 71. Phenprobamate* 72. Nitroderivatives of carbazole 73. Carbon disulphide 74. Catalase 75. Cephaeline and its salts 76. Chenopodium ambrosioides (essential oil)77. 2,2,2-Trichloroethane-1,1-diol 78. Chlorine 79. Chlorpropamide* 80. Diphenoxylate* hydrochloride 81. 4-Phenylazophenylene-1,3-diamine citrate hydrochloride (chrysoidine citrate hydrochloride) 82. Chlorzoxazone* 83. 2-Chloro-6-methylpyrimidin-4-yldimethylamine (crimidine-ISO) 84. Chlorprothixene* and its salts 85. Clofenamide* 86. N,N -bis(2-chloroethyl)methylamineN -oxide and its salts87. Chlormethine* and its salts 88. Cyclophosphamide* and its salts 89. Mannomustine* and its salts 90. Butanilicaine* and its salts 91. Chlormezanone* 92. Triparanol* 93. 2-[2(4-Chiorophenyl)-2-phenylacetyl] indane-1,3-dione (chlorophacinone-ISO) 94. Chlorphenoxamine* 95. 2-[2-(4-Chlorophenyl)-2-phenylacetyl]indan 1,3-dione (chlorophacinone - ISO) 96. Chloroethane 97. Chromium; chromic acid and its salts 98. Claviceps purpurea Tul., its alkaloids and galenical preparations99. Conium maculatum L. (fruit, powder, galenical preparations)100. Glycyclamide* 101. Cobalt benzenesulphonate 102. Colchicine, its salts and derivatives 103. Colchicoside and its derivatives 104. Golchicum autumnale L . and its galenical preparations105. Convallatoxin 106. Anamirta cocculus L . (fruit)107. Croton tiglium (oil)108. 1-Butyl-3-( N -crotonoylsulphanilyl)urea109. Curare and curarine 110. Synthetic curarizants 111. Hydrogen cyanide and its salts 112. 2-α-Cyclohexylbenzyl( N,N,N',N', -tetraethyl)trimethylenediamine (phenetamine)113. Cyclomenol* and its salts 114. Sodium hexacyclonate* 115. Hexapropymate* 116. Dextropropoxyphene* 117. O,O' -Diacetyl-N -allyl-N -normorphine118. Pipazetate* and its salts 119. 5 -(αβ -Dibromophenethyl)-5-methylhydantoin120. N,N' -Pentamethylenebis (trimethylammonium salts), e.g. pentamethonium bromide*121. N,N' -[(Methylimino)diethylene]bis(ethyldimethylammonium) salts, e.g. azamethonium bromide*122. Cyclarbamate* 123. Clofenotane*; DDT (ISO) 124. N,N' -Hexamethylenebis(trimethylammonium) salts, e.g. hexamethonium bromide*125. Dichloroethanes (ethylene chlorides) 126. Dichloroethylenes (acetylene chlorides) 127. Lysergide* and its salts 128. 2-Diethylaminoethyl-3-hydroxy-4-phenylbenzoate and its salts 129. Cinchocaine* and its salts 130. 3-Diethylaminopropyl cinnamate 131. O,O' -DiethylO -4-nitrophenyl phosphorothioate (parathion-lSO)132. [Oxalylbisiminoethylene)]bis[( o -chlorobenzyl)diethylammonium salts], e.g. ambenomium cloride*133. Methyprylon* and its salts 134. Digitaline and all heterosides of Digitalis purpurea L .135. 7-[2-Hydroxy-3-(2-hydroxyethyl- N -methylamino)propyl]theophylline (xanthinol)136. Dioxethedrin* and its salts 137. Piprocurarium* 138. Propyphenazone* 139. Tetrabenazine* and its salts 140. Captodiame* 141. Mefeclorazine* and its salts 142. Dimethylamine 143. 1,1-Bis(dimethylaminomethyl)propyl benzoate (amydricaine, alypine) and its salts 144. Methapyrilene* and its salts 145. Metamfepramone* and its salts 146. Amitriptyline* and its salts 147. Metformin* and its salts 148. Isosorbide dinitrate* 149. Malononitrile 150. Succinonitrile 151. Dinitrophenol isomers 152. Inproquone* 153. Dimevamide* and its salts 154. Diphenylpyraline* and its salts 155. Sulfinpyrazone* 156. N -(3-Carbamoyl-3,3-diphenylpropyl)-N,N -diisopropylmethyl-ammonium salts, e.g. isopropamide iodide*157. Benactyzine* 158. Benzatropine* and its salts 159. Cyclizine* and its salts 160. 5,5-Diphenyl-4-imidazolidone 161. Probenecid* 162. Disulfiram*; thiram (ISO) 163. Emetine, its salts and derivatives 164. Ephedrine and its salts 165. Oxanamide* and its derivatives 166. Eserine or physostigmine and its salts 167. Esters of 4-aminobenzoic acid, with the free amino group, with the exception of that given in Annex VII, Part 2 168. Choline salts and their esters, e.g. choline chloride 169. Caramiphen* and its salts 170. Diethyl 4-nitrophenyl phosphate 171. Metethoheptazine* and its salts 172. Oxpheneridine* and its salts 173. Ethoheptazine* and its salts 174. Metheptazine* and its salts 175. Methylphenidate* and its salts 176. Doxylamine* and its salts 177. Tolboxane* 178. 4-Benzyloxyphenol and 4-ethoxyphenol 179. Parethoxycaine* and its salts 180. Fenozolone* 181. Glutethimide* and its salts 182. Ethylene oxide 183. Bemegride* and its salts 184. Valnoctamide* 185. Haloperidol* 186. Paramethasone* 187. Fluanisone* 188. Trifluperidol* 189. Fluoresone* 190. Fluorouracil* 191. Hydrofluoric acid, its normal salts, its complexes and hydrofluorides with the exception of those given in Annex III, Part 1 192. Furfuryltrimethylammonium salts, e.g. furtrethonium iodide* 193. Galantamine* 194. Progestogens 195. 1,2,3,4,5,6-Hexachlorocyclohexane (BHC-ISO) 196. (1 R ,4S ,5R,8S)-1,2,3,4,10,10-Hexachloro-6,7-epoxy-1,4,4a,5,6,7,8,8a-octahydro-1,4:5 ,8-dimethano-naphthalene (endrin-ISO)197. Hexachloroethane 198. (1 R ,4S ,5R ,8S )-1,2,3,4,10,10-Hexachloro-1,4,4a,5,8,8a-hexahydro-1,4:5,8-dimethano-naphthalene (isodrin-ISO)199. Hydrastine, hydrastinine and their salts 200. Hydrazides and their salts 201. Hydrazine, its derivatives and their salts 202. Octamoxin* and its salts 203. Warfarin* and its salts 204. Ethyl bis(4-hydroxy-2-oxo-1-benzopyran-3-yl) acetate and salts of the acid 205. Methocarbamol* 206. Propatylnitrate* 207. 4,4'-Dihydroxy-3,3'-(3-methylthiopropylidene) dicoumarin 208. Fenadiazole* 209. Nitroxoline* and its salts 210. Hyoscyamine, its salts and derivatives 211. Hyoscyamus niger L. (leaves, seeds, powder and galenical preparations)212. Pemoline* and its salts 213. Iodine 214. Decamethylenebis(trimethylammonium) salts, e.g. decamethonium bromide 215. Ipecacuanha (Cephaelis ipecacuanha Brot. and related species) (roots, powder and galenical preparations)216. (2-Isopropylpent.4-enoyl)urea (apronalide) 217. α-Santonin [(3S,5a R ,9bS )-3,3a,4,5,5a,9b-hexahydro-3,5a,9-trimethylnaphto [1,2-b] furan-2,8-dione]218. Lobelia inflata L . and its galenical preparations219. Lobeline* and its salts 220. Barbiturates 221. Mercury and its compounds, except those special cases included in Annex VI, Part 1 222. 3,4,5-Trimethoxyphenethylamine and its salts 223. Metaldehyde 224. 2-(4-Allyl-2-methoxyphenoxy)- N,N -diethylacetamide and its salts225. Coumetarol* 226. Dextromethorphan* and its salts 227. 2-Methylheptylamine and its salts 228. Isometheptene* and its salts 229. Mecamylamine* 230. Guaifenesin* 231. Dicoumarol* 232. Phenmetrazine*, its derivatives and salts 233. Thiamazole* 234. 3,4-Dihydro-2-methoxy-2-methyl-4-phenyl-2H,5 H -pyrano [3,2-c]-[1] benzopyran-5-one (cyclocoumarol)235. Carisoprodol* 236. Meprobamate* 237. Tefazoline* and its salts 238. Arecoline 239. Poldine metilsulfate* 240. Hydroxyzine* 241. 2-Naphthol 242. 1-and 2-Naphthylamines and their salts 243. 3-(1-Naphthyl)-4-hydroxycoumarin 244. Naphazoline* and its salts 245. Neostigmine and its salts (e.g. neostigmine bromide*) 246. Nicotine and its salts 247. Amyl nitrites 248. Inorganic nitrites, with the exception of sodium nitrite 249. Nitrobenzene 250. Nitrocresols and their alkali metal salts 251. Nitrofurantoin* 252. Furazolidone* 253. Propane-1,2,3-triyl trinitrate 254. Acenocoumarol* 255. Alkali pentacyanonitrosylferrate (2-) 256. Nitrostilbenes, their homologues and their derivatives 257. Noradrenaline and its salts 258. Noscapine* and its salts 159. Guanethidine* and its salts 260. Oestrogens 261. Oleandrin 262. Chlortalidone* 263. Pelletierine and its salts 264. Pentachloroethane 265. Pentaerithrityl tetranitrate* 266. Petrichloral* 267. Octamylamine* and its salts 268. Picric acid 269. Phenacemide* 270. Difendoxazine* 271. 2-Phenylindan-1,3-dione (phenindione) 272. Ethylphenacemide* 273. Phenprocoumon* 274. Fenyramidol* 275. Triamterene* and its salts 276. Tetraethyl pyrophosphate; TEPP (ISO) 277. Tritolyl phosphate 278. Psilocybine* 279. Phosphorus and metal phosphides 280. Thalidomide* and its salts 281. Physostigma venenosum Balf. 282. Picrotoxin 283. Pilocarpine and its salts 284. α-Piperidin-2-ylbenzyl acette (SIC! acetate) laevorotatory threoform (levophacetoperane) and its salts 285. Pipradrol* and its salts 286. Azacyclonol* and its salts 287. Bietamiverine* 288. Butopiprine* and its salts 289. Lead and its compounds, with the exception of that mentioned in Annex III, No 55 under the conditions stated 290. Coniine 291. Prunus laurocerasus L. ("cherry laurel water")292. Metyrapone* 293. Radioactive substances, as defined by Directive 96/29/Euratom OJ L 159, 29.6.1996, p. 1 .294. Juniperus sabina L. (leaves, essential oil and galenical preparations)295. Hyoscine, its salts and derivatives 296. Gold salts 297. Selenium and its compounds with the exception of selenium disulphiele under the conditions set out under reference No 49 in Annex Ill, Part 1 298. Solanum nigrum L. and its galenical preparations299. Sparteine and its salts 300. Glucocorticoids 301. Datura stramonium L. and its galenical preparations302. Strophantines, their aglucones and their respective derivatives 303. Strophantus species and their galenical preparations304. Strychnine and its salts 305. Strychnos species and their galenical preparations306. 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 307. Sulphonamides (sulphanilamide and its derivatives…) and their salts obtained by substitution of one or more H-atoms of the -NH 2 groups) and their salts308. Sultiame* 309. Neodymium and its salts 310. Thiotepa* 311. Pilocarpus jaborandi Holmes and its galenical preparations312. Tellurium and its compounds 313. Xylometazoline* and its salts 314. Tetrachloroethylene 315. Carbon tetrachloride 316. Hexaethyl tetraphosphate 317. Thallium and its compounds 318. Thevetia neriifolia Juss. , glycoside extract319. Ethionamide* 320. Phenothiazine* and its compounds 321. Thiourea and its derivatives, with the exception of the one listed in Annex III, Part 1 322. Mephenesin* and its esters 323. 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 )324. Tranylcypromine* and its salts 325. Trichloronitromethane (chloropicrine) 326. 2,2,2-Tribromoethanol (tribromoethyl alcohol) 327. Trichiormethine* and its salts 328. Tretamine* 329. Gallamine triethiodide* 330. Urginea scilla Stern. and its galenical preparations331. Veratrine, its salts and galenical preparations 332. Schoenocaulon olficinale Lind. (seeds and galenical preparations)333. Veratrum Spp . and their preparations334. Vinyl chloride monomer 335. Ergocalciferol* and cholecalciferol (vitamins D 2 and D3 )336. Salts of O -alkyldithiocarbonic acids337. Yobimbine and its salts 338. Dimethyl sulfoxide* 339. Diphenhydramine* and its salts 340. 4-tert-Butylphenol 341. 4-tert-Butylpyrocatechol 342. Dihydrotachysterol 343. Dioxane 344. Morpholine and its salts 345. Pyretbrum album L. and its galenical preparations346. 2-[4-Methoxybenzyl- N -(2-pyridyl)amino]ethyldimethylamine maleate347. Tripelennamine* 348. Tetrachlorosalicylanilides 349. Dichlorosalicylanilides 350. Tetrabromosalicylanilides 351. Dibromosalicylanilides 352. Bithionol* 353. Thiuram monosulphides 354. Thiuram disulphides 355. Dimethylformamide 356. 4-Phenylbut-3-en-2-one 357. Benzoates of 4-hydroxy-3-methoxycinnamyl alcohol except for normal content in natural essences used 358. Furocoumarines (e.g. trioxysalan*, 8-methoxypsoralen, 5-methoxypsoralen) except for normal content in natural essences used. In sun protection and in bronzing products, furocoumarines shall be below 1 mg/kg. 359. Oil from the seeds of Laurus nobilis L .360. Safrole except for normal content in the natural essences used and provided the concentration does not exceed: 100 ppm in the finished product, 50 ppm in products for dental and oral hygiene, and provided that Safrole is not present in toothpastes intended specifically for children
361. 5,5'-Di-isopropyl-2,2'-dimethylbiphenyl-4,4'-diyl dihypoiodite 362. 3'-ethyl-5',6',7,8'-tetrahydro-5',6',8,8'-tetramethyl-2'- acetonaphthone; Syn.: 1,1,4,4-tetramethyl-6-ethyl-7-acetyl-1,2,3,4-tetrahydronaphthalene (acetyl ethyl tetramethyl tetralin, AETT) 362. 3'-Ethyl-5',6',7',8'-tetrahydro-5',5',8',8'-tetramethyl-2'-acetonaphthone or 7-acetyl-6-ethyl-1,1,4,4-tetramethyl-1,2,3,4-tetrahydronaphtalen 363. O -phenylenediamine and its salts364. 4-methyl- m -phenylenediamine and its salts.365. Aristolochic acid and its salts 365. Aristolochic acid and its salts; Aristolochia spp. and their preparations366. Chloroform 367. 2,3,7,8-Tetrachlorodibenzo- p -dioxin367. 2,3,7,8-Tetra chlorodibenzo-p-dioxin 368. 2,6-Dimethyl-1,3-dioxan-4-yl acetate (Dimethoxane) 369. Pyrithione sodium (INNM) 370. N -(Trichloromethylthio)-4-cyclohexene-1,2-dicarboximide (captan)371. 2,2'-Dihydroxy-3,3',5,5',6,6'-hexachlorodiphenylmethane (hexachlorophene) 372. 6-(Piperidinyl)-2,4-pyrimidinediamine-3-oxide (Minoxidil) and its salts and derivatives 373. 34',5-Tribromosalicylanide (Tribromsalan) 374. Phytolacca spp. and their preparations372. 6-(Piperidinyl)-2,4-pyrimidinediamine 3-oxide (minoxidil) and its salts 373. 3,4',5-Tribromosalicylanilide 374. Phytolacca spp. and their preparations375. Tretinoin (retinoic acid and its salts) 376. 1-Methoxy-2,4-diaminobenzene (2,4-diaminoanisole - CI 76050) and their salts 377. 1-Methoxy-2,5-diaminobenzene (2,5-diaminoanisole) and their salts 378. Colouring agent CI 12140 379. Colouring agent CI 26105 380. Colouring agent CI 42555 Colouring agent CI 42555-1 Colouring agent CI 42555-2 381. Amyl 4-dimethylaminobenzoate, mixed isomers (Padimate A (INN)) 382. Benzoyl peroxide 383. 2-Amino.4-nitrophenol 384. 2-Amino-5-nitrophenol 385. 11 α-Hydroxypregn-4-ene-3,20-dione and its esters 385. 11α-Hydroxypregn-4-ene-3, 20-dione) and its esters 386. Colouring agent CI 42 640 386. Colouring agent C.I. 42 640 387. Colouring agent CI 13 065 388. Colouring agent CI 42 535 389. Colouring agent CI 61 554 390. Antiandrogens with steroid structure 391. Zirconium and its compounds, with the exception of the complexes under reference number 50 in Annex III (Part 1) and of zirconium lakes, salts and pigments of colouring agents listed with reference number 3 in Annex IV (Part 1) 392. Thyrothricine 393. Acetonitrile 394. Tetrahydrozoline and its salts 390. Anti-androgens of steroidal structure 391. Zirconium and its compounds, with the exception of the substances listed under reference number 50 in Annex III, Part One, and the zirconium lakes, pigments or salts of the colouring agents listed in Annex IV, Part One, with reference number 3 393. Acetonitrile 394. Tetrahydrozoline and its salts 395. Hydroxy-8-quinoline and its sulphate, except for the uses provided for in No 51 in Annex III, Part 1 396. Dithio-2,2-bispyridine-dioxide 1,1' (additive with trihydrated magnesium sulphate) - (pyrithione disulphide + magnesium sulphate) 397. Colouring agent CI 12075 and its lakes, pigments and salts 398. Colouring agent CI 45170 and CI 45170:1 399. Lidocaine 400. 1,2-epoxybutane 401. Colouring agent CI 15585 402. Strontium lactate 403. Strontium nitrate 404. Strontium polycarboxylate 405. Pramocaine 406. 4-ethoxy-m-phenylenediamine and its salts 407. 2,4-diaminophenylethanol and its salts 408. Catechol 409. Pyrogallol 410. Nitrosamines 411. Secondary alkyl- and alkanolamines and their salts 412. 4-Amino-2-nitrophenol 413. 2-Methyl-m-phenylenediamine 414. 4-tert-Butyl-3-methoxy-2,6-dinitrotoluene (Musk Ambrette) 416. Cells, tissues or products of human origin 417. 3,3-Bis(4-hydroxyphenyl)phthalide (Phenolphthalein*) 418. 3-Imidazol-4-ylacrylic acid and its ethyl ester (urocanic acid) 419. From the date referred to in Article 22(1) of Regulation (EC) No 999/2001 of the European Parliament and of the Council OJ L 147, 31.5.2001, p. 1 .Until that date, the specified risk materials as designated in Annex XI Part A to Regulation (EC) No 999/2001, and ingredients derived therefrom. However, tallow derivatives may be used provided that the following methods have been used and strictly certified by the producer: Transesterification or hydrolysis at at least 200 °C and at an appropriate corresponding pressure, for 20 minutes (glycerol, fatty acids and fatty acid esters), Saponification with NaOH 12M (glycerol and soap): Batch process: at 95 °C for three hours or Continuous process: at 140 °C, two bars ( 2000 hPa) for eight minutes or equivalent conditions.
420. Crude and refined coal tars 421. 1,1,3,3,5,-Pentamethyl-4,6-dinitroindane (moskene) 422. 5- tert- Butyl-1,2,3-trimethyl-4,6-dinitrobenzene (musk tibetene).423. Alanroot oil ( Inula helenium ) (CAS No 97676-35-2), when used as a fragrance ingredient.424. Benzyl cyanide (CAS No 140-29-4), when used as a fragrance ingredient. 425. Cyclamen alcohol (CAS No 4756-19-8), when used as a fragrance ingredient. 426. Diethyl maleate (CAS No 141-05-9), when used as a fragrance ingredient. 427. Dihydrocoumarine (CAS No 119-84-6), when used as a fragrance ingredient. 428. 2,4-Dihydroxy-3-methylbenzaldehyde (CAS No 6248-20-0), when used as a fragrance ingredient. 429. 3,7-Dimethyl-2-octen-1-ol (6,7-Dihydrogeraniol) (CAS No 40607-48-5), when used as a fragrance ingredient. 430. 4,6-Dimethyl-8- tert -butylcoumarin (CAS No 17874-34-9), when used as a fragrance ingredient.431. Dimethyl citraconate (CAS No 617-54-9), when used as a fragrance ingredient. 432. 7,11-Dimethyl-4,6,10-dodecatrien-3-one (CAS No 26651-96-7), when used as a fragrance ingredient. 433. 6,10-Dimethyl-3,5,9-undecatrien-2-one (CAS No 141-10-6), when used as a fragrance ingredient. 434. Diphenylamine (CAS No 122-39-4), when used as a fragrance ingredient. 435. Ethyl acrylate (CAS No 140-88-5), when used as a fragrance ingredient. 436. Fig leaf absolute ( Ficus carica ) (CAS No 68916-52-9), when used as a fragrance ingredient.437. trans -2-Heptenal (CAS No 18829-55-5), when used as a fragrance ingredient.438. trans -2-Hexenal diethyl acetal (CAS No 67746-30-9), when used as a fragrance ingredient.439. trans -2-Hexenal dimethyl acetal (CAS No 18318-83-7), when used as a fragrance ingredient.440. Hydroabietyl alcohol (CAS No 13393-93-6), when used as a fragrance ingredient. 441. 6-Isopropyl-2-decahydronaphthalenol (CAS No 34131-99-2), when used as a fragrance ingredient. 442. 7-Methoxycoumarin (CAS No 531-59-9), when used as a fragrance ingredient. 443. 4-(4-Methoxyphenyl)-3-butene-2-one (CAS No 943-88-4), when used as a fragrance ingredient. 444. 1-(4-Methoxyphenyl)-1-penten-3-one (CAS No 104-27-8), when used as a fragrance ingredient. 445. Methyl tran s-2-butenoate (CAS No 623-43-8), when used as a fragrance ingredient.446. 7-Methylcoumarin (CAS No 2445-83-2), when used as a fragrance ingredient. 447. 5-Methyl-2,3-hexanedione (CAS No 13706-86-0), when used as a fragrance ingredient. 448. 2-Pentylidenecyclohexanone (CAS No 25677-40-1), when used as a fragrance ingredient. 449. 3,6,10-Trimethyl-3,5,9-undecatrien-2-one (CAS No 1117-41-5), when used as a fragrance ingredient. 450. Verbena oil ( Lippia citriodora Kunth.) (CAS No 8024-12-2), when used as a fragrance ingredient.451. Methyleugenol (CAS No 93-15-2) except for normal content in the natural essences used and provided that the concentration does not exceed: (a) 0,01 % in fine fragrance (b) 0,004 % in eau de toilette (c) 0,002 % in fragrance cream (d) 0,001 % in rinse-off products (e) 0,0002 % in other leave-on products and oral hygiene products.
| Reference number | Substance | Restrictions | Conditions of use and warnings which must be printed on the label | ||
|---|---|---|---|---|---|
| Field of application and/or use | Maximum authorized concentration in the finished cosmetic product | Other limitations and requirements | |||
| a | b | c | d | e | f |
| 1a | Boric acid, borates and tetraborates |
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| 1b | Tetraborates | ||||
| 2a | Thioglycollic acid and its salts |
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| 2b | Thioglycollic acid esters | Hair waving or straightening products: |
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| The abovementioned percentages are calculated as thioglycollic acid | |||||
| 3 | Oxalic acid, its esters and alcaline salts | Hair care products | 5 % | For professional use only | |
| 4 | Ammonia | 6 % calculated as NH | Above 2 %: contains ammonia | ||
| 5 | Tosylchloramide sodium (*) | 0·2 % | |||
| 6 | Chlorates of alkali metals | ||||
| 7 | Dichloromethane | 0·2 % as maximum impurity content | |||
| 8 | m- and p-Phenylenediamines, their N-substituted derivatives and their salts; N-substituted derivatives of o-Phenylenediamines | Oxidizing colouring agents for hair dyeing | 6 % calculated as free base | ||
| 9 | Methylphenylenediamines, their | Oxidizing colouring agents for hair dyeing | 10 % calculated as free base | ||
| 10 | Diaminophenols | Oxidizing colouring agents for hair dyeing | 10 % calculated as free base | ||
| 11 | Dichlorophen (*) | 0,5 % | Contains dichlorophen | ||
| 12 | Hydrogen peroxide, and other compounds or mixtures that release hydrogen peroxide, including carbamide peroxide and zinc peroxide | 12 % of H | |||
| 4 % of H | |||||
| 2 % of H | |||||
| 13 | Formaldehyde | Nail hardeners | 5 % calculated as formaldehyde | Protect cuticles with grease or oil. Contains formaldehyde | |
| 14 | Hydroquinone | 0,3 % |
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| 0,02 % (after mixing for use) | Professional use only |
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| 15a | Potassium or sodium hydroxide | ||||
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| 15b | Lithium hydroxide | (a) | (a) | ||
| 15c | Calcium hydroxide | Hair straighteners containing two components: calcium hydroxide and a guanidine salt | |||
| 16 | 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 % | ||
| 19 | Phenol and its alkali salts | Soaps and shampoos | 1 % calculated as phenol | Contains phenol | |
| 21 | Quinine and its salts | ||||
| 22 | Resorcinol | ||||
| 23 | |||||
| 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 | Contains sodium monofluorophosphate | ||
| 28 | Potassium monofluorophosphate | Ditto | Contains potassium monofluorophosphate | ||
| 29 | Calcium monofluorophosphate | Ditto | Contains calcium monofluorophosphate | ||
| 30 | Calcium fluoride | Ditto | Contains calcium fluoride | ||
| 31 | Sodium fluoride | Ditto | Contains sodium fluoride | ||
| 32 | Potassium fluoride | Ditto | Contains potassium fluoride | ||
| 33 | Ammonium fluoride | Ditto | Contains ammonium fluoride | ||
| 34 | Aluminium fluoride | Ditto | Contains aluminium fluoride | ||
| 35 | Stannous fluoride | Ditto | Contains stannous fluoride | ||
| 36 | Hexadecyl ammonium fluoride | Ditto | Contains hexadecyl ammonium fluoride | ||
| 37 | 3-( | Ditto | Contains 3-( | ||
| 38 | Ditto | Contains | |||
| 39 | Octadecenyl-ammonium fluoride | Ditto | Contains octadecenyl-ammonium fluoride | ||
| 40 | Sodium fluorosilicate | Ditto | Contains sodium fluorosilicate | ||
| 41 | Potassium fluorosilicate | Ditto | Contains potassium fluorosilicate | ||
| 42 | Ammonium fluorosilicate | Ditto | Contains ammonium fluorosilicate | ||
| 43 | Magnesium fluorosilicate | Ditto | Containes (SIC! Contains) magnesium fluorosilicate | ||
| 44 | 1,3-Bis (hydroxymethyl)imidazolidine-2-thione | Contains 1,3-bis (hydroxymethyl) immidazolidine-2-thione | |||
| 45 | Benzyl alcohol | Solvents, perfumes and flavourings | |||
| 46 | 6-methylcoumarin | Oral hygiene products | 0,003 % | ||
| 47 | Nicomethanol hydrofluoride | Oral hygiene products | Contains nicomethanol hydrofluoride | ||
| 48 | Silver nitrate | Solely for products intended for colouring eyelashes and eyebrows | 4 % |
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| 49 | Selenium disulphide | Antidandruff shampoos | 1 % |
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| 50 | Antiperspirants | Do not apply to irritated or damaged skin | |||
| 51 | 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 | ||||
| 52 | Methanol | Denaturant for ethanol and isopropyl alcohol | 5 % calculated as a % ethanol and isopropyl acohol | ||
| 53 | 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 | ||
| 55 | Lead acetate | Only for hair-dyeing | 0,6 % calculated in lead | Keep away from children. Avoid all contact with the eyes. Wash hands after use. Contains lead acetate. Do not use to dye eyelashes, eyebrows or moustasches. If irritation develops, discountinue use. | |
| 56 | 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 | |
| 57 | 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 % | |||||
| 58 | 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 | |
| 59 | Talc: Hydrated magnesium silicate | ||||
| 60 | 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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| 63 | Strontium hydroxide | pH-regulator in depilatory products | 3,5 % calculated as strontium, max. pH of 12,7 |
| |
| 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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| 65 | Benzalkonium Chloride, bromide and saccharinate | ||||
| 66 | Polyacrylamides | ||||
| 67 |
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| 68 |
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| 69 |
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| 70 |
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| 71 |
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| 72 |
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| 73 |
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| 74 |
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| 75 |
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| 76 |
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| 77 |
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| 78 |
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| 79 |
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| 80 |
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| 81 |
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| 82 |
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| 83 |
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| 84 |
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| 85 |
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| 86 |
| ||||
| 87 |
| ||||
| 88 |
| ||||
| 89 |
| ||||
| 90 |
| ||||
| 91 |
| ||||
| 92 |
| ||||
| 93 | 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 |
|
| 95 | Hydroquinone methylether | Artificial nail systems | 0,02 % (after mixing for use) | Professional use only |
|
| Reference number | Substance | Restrictions | Conditions of use and warnings which must be printed on the label | Allowed until | ||
|---|---|---|---|---|---|---|
| Field of application and/or use | Maximum authorized concentration in the finished cosmetic product | Other limitations and requirements | ||||
| a | b | c | d | e | f | g |
| 1 | Basic Blue 7 (CAS No 2390-60-5) | Non-oxidising colouring agents for hair dyeing | 0,2 % | Can cause allergic reaction | ||
| 2 | 2-Amino-3-nitrophenol (CAS No 603-85-0) and its salts | In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 % | ||||
| 3 | 4-Amino-3-nitrophenol (CAS No 610-81-1) and its salts | In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 % | ||||
| 4 | 2,7-Naphthalenediol (CAS no 582-17-2) and its salts | Oxidising colouring agents for hair dyeing | 1,0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 0,5 % | ||
| 5 | m-Aminophenol (CAS no 591-27-5) and its salts | Oxidising colouring agents for hair dyeing | 2,0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % | Can cause allergic reaction | |
| 6 | 2,6-Dihydroxy-3,4-dimethylpyridine (CAS No 84540-47-6) and its salts | Oxidising colouring agents for hair dyeing | 2,0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % | Can cause allergic reaction | |
| 7 | 4-Hydroxypropylamino-3-nitrophenol (CAS No 92952-81-3) and its salts | In combination with hydrogen peroxide the maximum use concentration upon application is 2,6 % | ||||
| 8 | 6-Nitro-2,5-pyridinediamine (CAS No 69825-83-8) and its salts | Non-oxidising colouring agent for hair dyeing | 3,0 % | Can cause allergic reaction | ||
| 9 | HC Blue No 11 (CAS No 23920-15-2) and its salts | In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 % | ||||
| 10 | Hydroxyethyl-2-nitro-p-toluidine (CAS No 100418-33-5) and its salts | In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % | ||||
| 11 | 2-Hydroxyethylpicramic acid (CAS No 99610-72-7) and its salts | In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 % | ||||
| 12 | p-Methylaminophenol (CAS No 150-75-4) and its salts | Oxidising colouring agent for hair dyeing | 3,0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 % | Can cause allergic reaction | |
| 13 | 2,4-Diamino-5-methylphenoxyethanol (CAS No 141614-05-3) and its salts | Oxidising colouring agent for hair dyeing | 3,0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 % | Can cause allergic reaction | |
| 14 | HC Violet No 2 CAS No 104226-19-9) and its salts | Non-oxidising colouring agent for hair dyeing | 2,0 % | |||
| 15 | Hydroxyethyl-2,6-dinitro-p-anisidine (CAS No 122252-11-3) and its salts | Non-oxidising colouring agent for hair dyeing | 3,0 % | Can cause allergic reaction | ||
| 16 | HC Blue No 12 (CAS No 104516-93-0) and its salts | In combination with hydrogen peroxide the maximum use concentration upon application is 0,75 % | ||||
| 17 | 2,4-Diamino-5 methyphenetol (CAS No 113715-25-6) and its salts | Oxidising colouring agents for hair dyeing | 2,0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % | Can cause allergic reaction | |
| 18 | 1,3-Bis-(2,4-diaminophenoxy)propane (CAS No 81892-72-0) and its salts | Oxidising colouring agents for hair dyeing | 2,0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % | Can cause allergic reaction | |
| 19 | 3-Amino-2,4-dichlorophenol (CAS No 61693-43-4) and its salts | Oxidising colouring agents for hair dyeing | 2,0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % | Can cause allergic reaction | |
| 20 | Phenyl methyl pyrazolone (CAS No 89-25-8) and its salts | Oxidising colouring agents for hair dyeing | 0,5 % | In combination with hydrogen peroxide the maximum use concentration upon application is 0,25 % | ||
| 21 | 2-Methyl-5-hydroxyethylaminophenol (CAS No 55302-96-0) and its salts | Oxidising colouring agents for hair dyeing | 2,0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % | Can cause allergic reaction | |
| 22 | Hydroxybenzomorpholine (CAS No 26021-57-8) and its salts | Oxidising colouring agents for hair dyeing | 2,0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % | Can cause allergic reaction | |
| 23 | 1,7-Naphthalenediol (CAS No 575-38-2) and its salts | Oxidising colouring agents for hair dyeing | 1,0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 0,5 % | Can cause allergic reaction | |
| 24 | HC Yellow No 10 (CAS No 109023-83-8) and its salts | Non-oxidising colouring agents for hair dyeing | 0,2 % | |||
| 25 | 2,6-Dimethoxy-3,5-pyridinediamine (CAS No 85679-78-3) and its salts | Oxidising colouring agents for hair dyeing | 0,5 % | In combination with hydrogen peroxide the maximum use concentration upon application is 0,25 % | Can cause allergic reaction | |
| 26 | HC Orange No 2 (CAS No 85765-48-6) and its salts | Non-oxidising colouring agents for hair dyeing | 1,0 % | |||
| 27 | HC Violet No 1 (CAS No 82576-75-8) and its salts | In combination with hydrogen peroxide the maximum use concentration upon application is 0,25 % | ||||
| 28 | 3-Methylamino-4-nitro-phenoxyethanol (CAS No 59820-63-2) and its salts | Non-oxidising colouring agents for hair dyeing | 1,0 % | |||
| 29 | 2-Hydroxy-ethylamino-5-nitro-anisole (CAS No 66095-81-6) and its salts | Non-oxidising colouring agents for hair dyeing | 1,0 % | |||
| 30 | 2-Chloro-5-nitro-N-hydroxyethyl-p-phenylenediamine (CAS No 50610-28-1) and its salts | In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % | ||||
| 31 | HC Red No 13 (CAS No 94158-13-1) and its salts | In combination with hydrogen peroxide the maximum use concentration upon application is 1,25 % | ||||
| 32 | 1,5-Naphthalenediol (CAS No 83-56-7) and its salts | Oxidising colouring agents for hair dyeing | 1,0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 0,5 % | ||
| 33 | Hydroxypropyl bis (N-hydroxyethyl-p-phenylenediamine) (CAS No 128729-30-6) and its salts | Oxidising colouring agents for hair dyeing | 3,0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 % | Can cause allergic reaction | |
| 34 | o-Aminophenol (CAS No 95-55-6) and its salts | Oxidising colouring agents for hair dyeing | 2,0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % | ||
| 35 | 4-Amino-2-hydroxytoluene (CAS No 2835-95-2) and its salts | Oxidising colouring agents for hair dyeing | 3,0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 % | ||
| 36 | 2,4-Diaminophenoxyethanol (CAS No 66422-95-5) and its salts | Oxidising colouring agents for hair dyeing | 4,0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 2,0 % | ||
| 37 | 2-Methylresorcinol (CAS No 608-25-3) and its salts | Oxidising colouring agents for hair dyeing | 2,0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % | ||
| 38 | 4-Amino-m-cresol (CAS No 2835-99-6) and its salts | Oxidising colouring agents for hair dyeing | 3,0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 % | ||
| 39 | 2-Amino-4-hydroxyethylaminoanisole (CAS No 83763-47-7) and its salts | Oxidising colouring agents for hair dyeing | 3,0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 % | ||
| 40 | 3,4-Diamino-benzoicacid (CAS No 619-05-6) and its salts | Oxidising colouring agents for hair dyeing | 2,0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % | ||
| 41 | 6-Amino-o-cresol (CAS No 17672-22-9) and its salts | Oxidising colouring agents for hair dyeing | 3,0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 % | ||
| 42 | 2-Aminomethyl-p-aminophenol (CAS No 79352-72-0) and its salts | Oxidising colouring agents for hair dyeing | 3,0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 % | ||
| 43 | Hydroxyethylamino-methyl-p-aminophenol (CAS No 110952-46-0) and its salts | Oxidising colouring agents for hair dyeing | 3,0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 % | ||
| 44 | Hydroxyethyl-3,4-methylenedioxyaniline (CAS No 81329-90-0) and its salts | Oxidising colouring agents for hair dyeing | 3,0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 % | ||
| 45 | Acid Black 52 (CAS No 3618-58-4) and its salts | Oxidising colouring agents for hair dyeing | 2,0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % | ||
| 46 | 2-Nitro-p-phenylenediamine (CAS No 5307-14-2) and its salts | In combination with hydrogen peroxide the maximum use concentration upon application is 0,15 % | ||||
| 47 | HC Blue No 2 (CAS No 33229-34-4) and its salts | Non-oxidising colouring agents for hair dyeing | 2,8 % | |||
| 48 | 3-Nitro-p-hydroxyethylaminophenol (CAS No 65235-31-6) and its salts | In combination with hydrogen peroxide the maximum use concentration upon application is 3,0 % | ||||
| 49 | 4-Nitrophenyl aminoethylurea (CAS No 27080-42-8) and its salts | In combination with hydrogen peroxide the maximum use concentration upon application is 0,25 % | ||||
| 50 | HC Red No 10 + HC Red No 11 (CAS No 95576-89-9 + 95576-92-4) and its salts | In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % | ||||
| 51 | Yellow No 6 (CAS No 104333-00-8) and its salts | In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % | ||||
| 52 | HC Yellow No 12 (CAS No 59320-13-7) and its salts | In combination with hydrogen peroxide the maximum use concentration upon application is 0,5 % | ||||
| 53 | HC Blue No 10 (CAS No 102767-27-1) and its salts | Oxidising colouring agents for hair dyeing | 2,0 % | In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % | ||
| 54 | HC Blue No 9 (CAS No 114087-47-1) and its salts | In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % | ||||
| 55 | 2-Chloro-6-ethylamino-4-nitrophenol (CAS No 131657-78-8) and its salts | In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 % | ||||
| 56 | 2-Amino-6-chloro-4-nitrophenol (CAS No 6358-09-4) and its salts | In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % | ||||
| 57 | Basic Blue 26 (CAS No 2580-56-5) (CI 44045) and its salts | In combination with hydrogen peroxide the maximum use concentration upon application is 0,25 % | ||||
| 58 | Acid Red 33 (CAS No 3567-66-6) (CI 17200) and its salts | Non-oxidising colouring agents for hair dyeing | 2,0 % | |||
| 59 | Ponceau SX (CAS No 4548-53-2) (CI 14700) and its salts | Non-oxidising colouring agents for hair dyeing | 2,0 % | |||
| 60 | Basic Violet 14 (CAS No 632-99-5) (CI 42510) and its salts | In combination with hydrogen peroxide the maximum use concentration upon application is 0,15 % | ||||
| 61 | Musk xylene (CAS no 81-15-2) | All cosmetic products, with the exception of oral care products | ||||
| 62 | Musk ketone (CAS No 81-14-1) | All cosmetic products, with the exception of oral care products | ||||
| Colour index number or denomination | Colour | Field of application | Other limitations and requirements | |||
|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | |||
| 10006 | Green | X | ||||
| 10020 | Green | X | ||||
| 10316 | Yellow | X | ||||
| 11680 | Yellow | X | ||||
| 11710 | Yellow | X | ||||
| 11725 | Orange | X | ||||
| 11920 | Orange | X | ||||
| 12010 | Red | X | ||||
| 12085 | Red | X | 3 % maximum concentration in the finished product | |||
| 12120 | Red | X | ||||
| 12150 | Red | X | ||||
| 12370 | Red | X | ||||
| 12420 | Red | X | ||||
| 12480 | Brown | X | ||||
| 12490 | Red | X | ||||
| 12700 | Yellow | X | ||||
| 13015 | Yellow | X | E 105 | |||
| 14270 | Orange | X | E 103 | |||
| 14700 | Red | X | ||||
| 14720 | Red | X | E 122 | |||
| 14815 | Red | X | E 125 | |||
| 15510 | Orange | X | ||||
| 15525 | Red | X | ||||
| 15580 | Red | X | ||||
| 15620 | Red | X | ||||
| 15630 | Red | X | 3 % maximum concentration in the finished product | |||
| 15800 | Red | X | ||||
| 15850 | Red | X | ||||
| 15865 | Red | X | ||||
| 15880 | Red | X | ||||
| 15980 | Orange | X | E 111 | |||
| 15985 | Yellow | X | E 110 | |||
| 16035 | Red | X | ||||
| 16185 | Red | X | E 123 | |||
| 16230 | Orange | X | ||||
| 16255 | Red | X | E 124 | |||
| 16290 | Red | X | E 126 | |||
| 17200 | Red | X | ||||
| 18050 | Red | X | ||||
| 18130 | Red | X | ||||
| 18690 | Yellow | X | ||||
| 18736 | Red | X | ||||
| 18820 | Yellow | X | ||||
| 18965 | Yellow | X | ||||
| 19140 | Yellow | X | E 102 | |||
| 20040 | Yellow | X | maximum 3,3'-dimethylbenzidine concentration in the colouring agent: 5 ppm | |||
| 20170 | Orange | X | ||||
| 20470 | Black | X | ||||
| 21100 | Yellow | X | maximum 3,3'-dimethylbenzidine concentration in the colouring agent: 5 ppm | |||
| 21108 | Yellow | X | ditto | |||
| 21230 | Yellow | X | ||||
| 24790 | Red | X | ||||
| 26100 | Red | X |
| |||
| 27290 | Red | X | ||||
| 27755 | Black | X | E 152 | |||
| 28440 | Black | X | E 151 | |||
| 40215 | Orange | X | ||||
| 40800 | Orange | X | ||||
| 40820 | Orange | X | E 160 e | |||
| 40825 | Orange | X | E 160 f | |||
| 40850 | Orange | X | E 161 g | |||
| 42045 | Blue | X | ||||
| 42051 | Blue | X | E 131 | |||
| 42053 | Green | X | ||||
| 42080 | Blue | X | ||||
| 42090 | Blue | X | ||||
| 42100 | Green | X | ||||
| 42170 | Green | X | ||||
| 42510 | Violet | X | ||||
| 42520 | Violet | X | 5 ppm maximum concentration in the finished product | |||
| 42735 | Blue | X | ||||
| 44045 | Blue | X | ||||
| 44090 | Green | X | E 142 | |||
| 45100 | Red | X | ||||
| 45190 | Violet | X | ||||
| 45220 | Red | X | ||||
| 45350 | Yellow | X | 6 % maximum concentration in the finished product | |||
| 45370 | Orange | X | not more than 1 % 2-(6-hdroxy-3-oxo-3H-xanthen-9-y1) benzoic acid and 2 % 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid | |||
| 45380 | Red | X | ditto | |||
| 45396 | Orange | X | when used in lipstick, the colouring agent is allowed only in free acid form and in a maximum concentration of 1 % | |||
| 45405 | Red | X | not more than 1 % 2-(6-hydroxy-3-oxo-3Η xanthen-9-yl) benzoic acid and 2 % 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid | |||
| 45410 | Red | X | ditto | |||
| 45425 | Red | X | not more than 1 % 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid and 3 % 2-(iodo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid | |||
| 45430 | Red | X | E 127 ditto | |||
| 47000 | Yellow | X | ||||
| 47005 | Yellow | X | E 104 | |||
| 50325 | Violet | X | ||||
| 50420 | Black | X | ||||
| 51319 | Violet | X | ||||
| 58000 | Red | X | ||||
| 59040 | Green | X | ||||
| 60724 | Violet | X | ||||
| 60725 | Violet | X | ||||
| 60730 | Violet | X | ||||
| 61565 | Green | X | ||||
| 61570 | Green | X | ||||
| 61585 | Blue | X | ||||
| 62045 | Blue | X | ||||
| 69800 | Blue | X | E 130 | |||
| 69825 | Blue | X | ||||
| 71105 | Orange | X | ||||
| 73000 | Blue | X | ||||
| 73015 | Blue | X | E 132 | |||
| 73360 | Red | X | ||||
| 73385 | Violet | X | ||||
| 73900 | Violet | X | ||||
| 73915 | Red | X | ||||
| 74100 | Blue | X | ||||
| 74160 | Blue | X | ||||
| 74180 | Blue | X | ||||
| 74260 | Green | X | ||||
| 75100 | Yellow | X | ||||
| 75120 | Orange | X | E 160 b | |||
| 75125 | Yellow | X | E 160 d | |||
| 75130 | Orange | X | E 160 a | |||
| 75135 | Yellow | X | E 161 d | |||
| 75170 | White | X | ||||
| 75300 | Yellow | X | E 100 | |||
| 75470 | Red | X | E 120 | |||
| 75810 | Green | X | E 140 and E 141 | |||
| 77000 | White | X | E 173 | |||
| 77002 | White | X | ||||
| 77004 | White | X | ||||
| 77007 | Blue | X | ||||
| 77015 | Red | X | ||||
| 77120 | White | X | ||||
| 77163 | White | X | ||||
| 77220 | White | X | E 170 | |||
| 77231 | White | X | ||||
| 77266 | Black | X | ||||
| 77267 | Black | X | ||||
| 77268:1 | Black | X | E 153 | |||
| 77288 | Green | X | free from chromate ion | |||
| 77289 | Green | X | free from chromate ion | |||
| 77346 | Green | X | ||||
| 77400 | Brown | X | ||||
| 77480 | Brown | X | E 175 | |||
| 77489 | Orange | X | E 172 | |||
| 77491 | Red | X | E 172 | |||
| 77492 | Yellow | X | E 172 | |||
| 77499 | Black | X | E 172 | |||
| 77510 | Blue | X | free from cyanide ions | |||
| 77713 | White | X | ||||
| 77742 | Violet | X | ||||
| 77745 | Red | X | ||||
| 77820 | White | X | E 174 | |||
| 77891 | White | X | E 171 | |||
| 77947 | White | X | ||||
| Lactoflavin | Yellow | X | E 101 | |||
| Caramel | Brown | X | E 150 | |||
| Capsanthin, capsorubin | Orange | X | E 160 c | |||
| Beetroot red | Red | X | E 162 | |||
| Anthocyanins | Red | X | E 163 | |||
| Aluminium, zinc, magnesium and calcium stearates | White | X | ||||
| Bromothymol blue | Blue | X | ||||
| Bromocresol green | Green | X | ||||
| Acid red 195 | Red | X | ||||
| Colour index number or denomination | Colour | Field of application | Other limitations and requirements | Authorization valid until | |||
|---|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | ||||
5. Strontium and its compounds, with the exception of strontium lactate, strontium nitrate and strontium polycarboxylate listed in Annex II, strontium sulphide, strontium chloride, strontium acetate, strontium hydroxide, strontium peroxide, under the conditions laid down in Annex III, Part 1 and of strontium lakes, pigments and salts of the colouring agents listed with the reference ( 3 ) in Annex IV, Part 1.
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 %.
| 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 age |
| 4 | Sorbic acid (hexa-2,4-dienoic acid) and its salts (*) | 0,6 % (acid) | ||
| 5 | Formaldehyde paraformaldehyde | 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 SO | ||
| 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 (*) | |||
| 13 | 3-Acetyl-6-methylpyran-2,4 (3H)-dione (Dehydracetic acid) and its salts | 0,6 % (acid) | Prohibited in aerosol dispensers (sprays) | |
| 14 | Formic acid and its sodium salt (+) | 0,5 % (expressed as acid) | ||
| 15 | 3,3‘-Dibromo-4,4‘-hexamethylenedioxydi-benzamidine (Dibromohexamidine) and its salts (including isethionate) | 0,1 % | ||
| 16 | Thiomersal (INN) | 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 % | ||
| 21 | Bronopol (INN) (*) | 0,1 % | Avoid formation of nitrosamines | |
| 22 | 2,4-Dichlorobenzyl alcohol (*) | 0,15 % | ||
| 23 | Triclocarban (INN) (*) | 0,2 % |
| |
| 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 (*) | |||
| 36 | 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 | 0,0015 %(of a mixture in the ratio 3:1 of 5-chloro-2-methylisothiazol 3(2H)-one and 2-methylisothiazol-3 (2H)-one | ||
| 40 | 2-Benzyl-4-chlorophenol (clorophene) | 0.2 % | ||
| 41 | 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 | |
| 44 | 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 % | ||
| 47 | 1,6-Di (4-amidinophenoxy)-n-hexane (Hexamidine) and its salts (including isethionate and p-hydroxybenzoate) (+) | 0,1 % | ||
| 48 | Glutaraldehyde (Pentane-1,5-dial) | 0,1 % | Prohibited in aerosols (sprays) | Contains glutaraldehyde (where glutaraldehyde concentration in the finished product exceeds |
| 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 | |
| 50 | 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 | |
| 53 | Benzethonium chloride | 0,1 % | Rinse-off products only | |
| 54 | Belzalkonium chloride, bromide and saccharinate (+) | 0,1% calculated as benzalkonium chloride | Avoid contact with eyes | |
| 55 | Benzylhemiformal | 0,15 % | Only for products to be removed by rinsing | |
| 56 | 3-Iodo-2-propynylbutylcarbamate | 0,05 % | ||
| Contains iodine |
| Reference number | Substance | Maximum authorized concentration | Limitations and requirements | Conditions of use and warnings which must be printed on the label | Allowed until |
|---|---|---|---|---|---|
| a | b | c | d | e | f |
| 21 | Benzylhemiformal | 0,03 % | For rinse-off products only | ||
| 29 | 3-lodo-2-propynyl butylcarbamate (iodopropynyl butylcarbamate) | 0,05 % | Not for oral hygiene and lip products | ||
| — |
| Reference No | Substances | Maximum authorized concentration | Other limitations and requirements | Conditions of use and warnings which must be printed on the label |
|---|---|---|---|---|
| a | b | c | d | e |
| 1 | 4-Aminobenzoic acid | 5 % | ||
| 2 | 6 % | |||
| 3 | Homosalate (INN) | 10 % | ||
| 4 | Oxybenzone (INN) | 10 % | Contains oxybenzone | |
| 6 | 2-phenylbenzimidazole-5-sulphonic acid and its potassium, sodium and triethanolamine salts | |||
| 7 | 3,3'-(1,4-Phenylenedimethylene) bis (7, 7-dimethyl-2-oxobicyclo-[2,2,1]hept-1-yl-methanesulfonic acid) and its salts | |||
| 8 | 1-(4-tert-butylphenyl)-3-(4-methoxyphenyl)propane-1,3-dione | 5 % | ||
| 9 | alpha-(2-Oxoborn-3-ylidene)-toluene-4-sulphonic acid and its salts | |||
| 10 | 2-cyano-3,3-diphenyl acrylic acid, 2-ethylhexyl ester (Octocrylene) | |||
| 11 | Polymer of N-{(2 and 4)-[(2-oxoborn-3-ylidene)methyl]benzyl}acrylamide | 6 % | ||
| 12 | Octyl methoxycinnamate | 10 % | ||
| 13 | Ethoxylated Ethyl-4-Aminobenzoate (PEG-25 PABA) | 10 % | ||
| 14 | Isopentyl-4-methoxycinnamate (Isoamyl p-Methoxycinnamate) | 10 % | ||
| 15 | 2,4,6-Trianilino-(p-Carbo-2‘-Ethylhexyl-1‘Oxy)-1,3,5-Triazine (Octyl Triazone) | 5 % | ||
| 16 | Phenol,2-(2H-Benzotriazol-2-yl)-4-Methyl-6-(2-Methyl-3-(1,3,3,3-Tetramethyl-I-(Trimethylsilyl)Oxy)-Disiloxanyl)Propyl) (Drometrizole Trisiloxane) | 15 % | ||
| 17 | Benzoic acid, 4,4-((6-(((1,1-dimethylethyl)amino)carbonyl)phenyl)amino) 1,3,5-triazine-2,4-diyl)diimino)bis-,bis-(2-ethylhexyl)ester) | 10 % | ||
| 18 | 3-(4‘-Methylbenxylidene)-d-1 camphor (4-Methylbenzylidene Camphor) | 4 % | ||
| 19 | 3-Benzylidene camphor (3-Benzylidene Camphor) | 2 % | ||
| 20 | 2-Ethylhexyl salicylate (Octyl-salicylate) | 5 % | ||
| 21 | 4-Dimethyl-amino-benzoate of ethyl-2-hexyl (octyl dimethyl PABA) | 8 % | ||
| 22 | 2-Hydroxy-4-methoxybenzophenone-5-sulfonic acid (Benzophenone-5) and its sodium salt | 5 % (of acid) | ||
| 23 | 2,2'-Methylene-bis-6-(2H-benzotriazol-2yl)-4-(tetramethyl-butyl)-1,1,3,3-phenol | 10 % | ||
| 24 | Monosodium salt of 2-2'-bis-(1,4-phenylene)1H-benzimidazole-4,6-disulphonic acid) | 10 % (of acid) | ||
| 25 | (1,3,5)-Triazine-2,4-bis((4-(2-ethyl-hexyloxy)-2-hydroxy)-phenyl)-6-(4-methoxyphenyl) | 10 % | ||
| 26 | Dimethicodiethylbenzalmalonate (CAS No 207574-74-1) | 10 % | ||
| 27 | Titanium dioxide | 25 % |
| Reference number | Substances | Maximum authorized concentration | Other limitations and requirements | Conditions of use and warnings which must be printed on the label | Allowed until |
|---|---|---|---|---|---|
| a | b | c | d | e | f |
| 5 | 2-Ethylhexyl 4-dimethylamino-benzoate | 8 % | |||
| 17 | 2-Hydroxy-4-methoxybenzophenone-5 sulphonic acid and sodium salt (Sulisobenzone and Sulisobenzone sodium) | ||||
| 29 | 4-Isopropylbenzyl salicylate | 4 % | |||
