Decree No. 444 / 2004 Coll.
Decree amending Decree No. 26 / 2001 Coll. of the Ministry of Health, on sanitary requirements for cosmetic products, on the particulars of the application for non-inclusion of ingredients on the packaging of cosmetic products and on the requirements for the education and practice of a natural person responsible for the manufacture of cosmetic products (cosmetic products decree), as amended by Decree No. 268 / 2001 Coll.
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444
DECLARATION
of 16 July 2004
amending Decree No. 26 / 2001 of the Ministry of Health Coll., on sanitary requirements for cosmetic products, on the particulars of the application for the non-inclusion of ingredients on the packaging of cosmetic products and on the requirements for the education and practice of a natural person responsible for the manufacture of cosmetic products (Cosmetic products decree), as amended by Decree No. 268 / 2001 Coll.
According to Article 108 (1) of Act No. 258 / 2000 Coll., on the Protection of Public Health and on the Amendment of Certain Related Acts, as amended by Act No. 274 / 2003 Coll., (hereinafter referred to as "the Act"), the Ministry of Health provides for the implementation of § 26 (1) (b) and (d) and § 4, § 27 and § 28 (1) of the Act:
Decree No. 26 / 2001 Coll., on sanitary requirements for cosmetic products, on the particulars of the application for the non-inclusion of ingredients on the packaging of cosmetic products and on the requirements for the education and practice of a natural person responsible for the manufacture of cosmetic products (for cosmetic products), as amended by Decree No. 268 / 2001 Coll., is amended as follows:
1. Paragraph 1, including footnote 1, reads as follows:
This Decree, in accordance with the law of the European Communities (1), lays down the hygiene requirements for the composition and properties of cosmetic products, their labelling and labelling on the packaging and equipment by means of instructions for use, requirements for the extent of stored data on cosmetic products, the particulars of the application for non-inclusion of ingredients on the packaging of cosmetic products and the particulars of the application for authorisation of the admissibility of substances other than those listed in the lists of authorised substances.
1) Council Directive 76 / 768 / EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products, as amended by Commission Directive 2003 / 83 / EC of 23 September 2003 adapting Annexes II, III and VI to Council Directive 76 / 738 / EEC on the approximation of the laws of the Member States relating to cosmetic products to technical progress. ';
Paragraph 1 is renumbered Article 1a and footnote 1 is renumbered footnote 2, including references to this footnote.
2. Paragraph 2, including footnotes 1a and 1b, reads as follows:
(1) The following particulars shall appear on the packaging of the cosmetic product in which the cosmetic product is filled and on any outer packaging of the cosmetic product in a comprehensible, legible and indelible manner:
(a) the company or name of the manufacturer or importer (1a) and the address of its registered office, if any, if it is a legal person, or the name and surname of the manufacturer or importer, the address of the place of business, if any, and the country of origin of the cosmetic product. Such data may be presented in abbreviation if they allow identification of the manufacturer or importer;
(b) the nominal content of the product at the time of packaging, given by weight (g) or volume (ml), except cosmetic products containing less than 5 g or 5 ml, non-sales samples and disposable packaging. For products pre-packaged and sold as several packages where the weight or volume data are not of major importance, the content need not be given provided the number of packages is indicated on the packaging. This indication need not be provided if the number of packages is easily visible from the outside or if the product is sold under normal conditions only individually;
(c) the date of minimum durability, specifying the minimum period during which the cosmetic product retains its original function and is safe, while complying with specified storage conditions. The date of minimum durability shall be indicated by the words "use best by... 'followed by an indication of the date or indication on the packaging. The date shall be clearly indicated and shall contain either the month and the year or the day, month and year in that order. If necessary, the durability information shall be supplemented by an indication of the conditions to be complied with in order to maintain that durability. The date of minimum durability need not be stated on the packaging of a cosmetic product with a minimum durability exceeding 30 months. For these products, an indication shall be given of the time during which the device may be used after opening without damaging the consumer. This information shall be marked with the symbol of the open cream container set out in Annex 8a followed by an indication of the time (months and / or years);
(d) specific measures to be followed when a cosmetic product is used or stored, in particular those listed in the column "Conditions of use and warnings to be printed on the packaging" in Annexes 3, 4, 6 and 7, as well as special safety information on cosmetic products for professional use, in particular in the hairdresser. This information must be given in the Czech language. Where, for practical reasons, this information cannot be given on the packaging, it may be indicated on the sticker, tape or package leaflet which is inserted or attached to the cosmetic product. This method of indication shall be made known to the consumer either by shortened verbal information or by a symbol on the appropriate packaging, a specimen of which is given in Annex 8;
(e) identification of the production batch. If, for practical reasons, because the product is too small, this indication cannot be given on the packaging, it may only be given on the outer packaging;
(f) the function of the product, unless it is evident from the presentation of the product to the consumer in the Czech language;
(g) a list of ingredients (ingredients) in descending order of weight at the time of addition. The list must be preceded by the word "Ingredients." Where, for practical reasons, the list of ingredients cannot be indicated on the packaging, it may be indicated on the sticker, tape or package leaflet which is inserted or attached to the cosmetic product. This mode of indication shall be made known to the consumer either by the abbreviated word information or by the symbol placed on the packaging, the specimen of which appears in Annex 8. The presence of perfumes is referred to as "perfume 'and the presence of flavourings by" aroma'. Substances whose presence must be indicated in accordance with the requirements of Annex 3 shall be included in the list of ingredients irrespective of their function in the product. Ingredients at concentrations below 1% may be listed in any order after ingredients whose concentration exceeds 1%. Colouring agents may be listed in any order after other ingredients; shall be indicated by the index number of the colouring matters or by the name given in Annex No 4. For decorative cosmetic products placed on the market in several colour shades, all colouring agents used in the range may be indicated on the condition that the words "may contain" or the symbol "+ / - 'are attached. The name of the ingredient must be given in accordance with the specific legislation1b) according to the common nomenclature INCI (International Nomenclature for Cosmetic Ingredients) or, if not possible, by the chemical name, CTFA (), European Pharmacopoeia name, INN (International Non-proprietary Names) recommended by the WHO, EINEX, IUPAC, CAS or CI (colour index). For soap, bath balls and other small cosmetic products, the list of ingredients may be indicated as an alert in the immediate vicinity of the place where the product is put up for sale.
(2) Where the nature of the cosmetic product so requires, the manufacturer or importer shall indicate in the instructions for use the method of use of the cosmetic product. The instructions for use of the cosmetic product must be in the Czech language and must be attached to the cosmetic product.
(3) The ingredients referred to in paragraph 1 (g) shall not be considered as:
(a) impurities in the raw materials used;
(b) auxiliary technical materials used in the manufacture but not in the finished product;
(c) materials used only in the necessary quantities as solvents or carriers for perfumes and aromatic mixtures.
(4) The indication of the data referred to in paragraph 1 (d) shall be without prejudice to the obligation to compensate for damage.
(1a) § 2 paragraphs 11 and 13 of Act No. 258 / 2000 Coll.
1b) Decree No. 75 / 2003 Coll., establishing the nomenclature of ingredients of cosmetic products. '
3. in Article 3 (d), including footnote 1c, the following shall be added:
"(d) an assessment of the safety for the health of individuals to the extent provided for by law 1c);
1c) Paragraph 29 (2) of Act No. 258 / 2000 Coll., on the Protection of Public Health and on the amendment of certain related laws, as amended. '
4. In Article 3, at the end of point (g), the dot is replaced by a semicolon and the following point (h) is added:
"(h) data on any animal testing carried out by the manufacturer, his intermediary or supplier which is related to the development or evaluation of the safety of the cosmetic product or its ingredients, including data on any animal testing carried out to meet the requirements of the legislation or measures of countries not members of the European Union.";
5. In Paragraph 4 (2), the words "into circulation 'are replaced by the words" to the market'.
6.
7. Annex 2 shall read as follows:
"Annex No 2 to Decree No 26 / 2001 Coll.
List of substances which may not be part of the composition of cosmetic products
1. N- (5-Chlorobenzoxazol-2-yl) acetamide ●;
N-5-Chlorbenzoxazole-2-ylacetamide °
2. (2-Acetoxyethyl) trimethylammonium hydroxide ● (acetylcholine and its salts);
ß-Acetoxyethyl trimethyl ammonium hydroxide (acetylcholine and its salts) °
3. Deanol aceglumate; Deanol aceglumate *
4. Spironolactone; Spironolactone *
5. Acid [4- (4-hydroxy-3-iodophenoxy) -3,5-diiodophenyl] acetic acid and its salts;
[4- (4-Hydroxy-3-iodophenoxy) -3,5-diiodophphenyl] acetic acid and its salts °
6. Methotrexate; Methoxate *
7. Amino-caproic acid and its salts; Aminocaproic acid * and its salts
8. Cinchophen, its salts, derivatives and salts of these derivatives;
Cinchophen *, its salts, derivatives and salts of these derivatives
9. Triiodothyropropionic acid and its salts;
Thyropropic acid * and its salts
10. Trichloroacetic acid ●;
Trichloroacetic acid and its salts °
11. Aconitum napellus L. (leaves, roots and preparations thereof)
12. Aconitine (the main alkaloid of Aconitum napellus L.) and its salts;
Aconitine and its salts °
13. Adonis vernalis L. and preparations thereof
14. Epinephrine; Epinephrine *
15. Alkaloids of Rauwolfia serpentina and their salts
16. alkynols, their esters, ethers and salts;
Alkyne alcohols, their esters, ethers and salts °
17. isoprenaline; Isoprenaline *
18. Allylisothiocyanate ●;
Allyl isothiocyanate °
19. Allocholanic acid amide and its salts;
Alloclamide * and its salts
20. Nalorphine, its salts and ethers;
Nalorphine *, its salts and ethers
21. Sympathomimetic amines acting on the central nervous system:
all active substances and medicinal products subject to medical prescription;
22. Aniline ●, its salts and its halogenated and sulphonated derivatives;
Aniline, its salts and its halogenated and sulphonated derivatives °
23. Betoxycaine and its salts; Betoxycaine * and its salts
24. Zoxazolamine; Zoxazolamine *
25. Procainamide, its salts and derivatives; Procainamide *, its salts and derivatives °
26. Benzidine ●; Benzidine °
27. Tuaminoheptane, its isomers and salts; Tuaminoheptane *, its isomers and salts
28. Octodrin and its salts; Octodrine * and its salts
29.2-Amino-1,2-bis (4-methoxyphenyl) ethan-1-ol ● and its salts;
2-Amino-1,2-bis (4-methoxyphenyl) ethanol and its salts °
30.1.3 Dimethylpentylamine and its salts;
1,3-Dimethylpentylamine and its salts °
31. 4-aminosalicylic acid (4-amino-2-hydroxybenzoic acid) ● and its salts;
4-Aminosalicylic acid and its salts °
32. Toluidines ●, their isomers, salts, halogenated and sulphonated derivatives;
Toluidines, their isomers, salts and halogenated and sulphonated derivatives °
33. Xylidines ●, their isomers, salts, halogenated and sulphonated derivatives;
Xylidine, their isomers, salts and halogenated and sulphonated derivatives °
34. Imperatorin (9- [(3-methoxybut-2-en-1-yl) oxy] furo [3,2-g] chromen- 7-one) ●;
Imperatorin [9- (3-methoxylbut-2-enyloxy) furo (3,2-g) chromene-7-one] °
35. ammi majus and preparations thereof;
36.2,3-Dichloro-2- methylbutane ●;
2,3- Dichloro-2- methylbutane °
37. Substances with androgenic effect
38. anthracene oil; anthracene oil °
39. Antibiotics
40. Antimony and its compounds; Antimony and its compounds °
41. Apocynum cannabinum L. (hemp toad) and preparations thereof
42. Amorphine (6- methyl-5,6,6a, 7- tetrahydro-4H-dibenzo [de, g] quinoline-10,11-diol ●) and its salts;
Amorphine (5,6,6a, 7- tetrahydro-6-methyl-4H-dibenzo (de, g) -quinoline-10,11-dihydric alcohol) and its salts °
43. Arsenic and its compounds; Arsenic and its compounds °
44. Atropa belladonna L. and preparations thereof
45. atropine, its salts and derivatives; Atropine, its salts and derivatives °
46. barium salts (Barium salts °), excluding barium sulphate, barium sulphide under the conditions laid down in Annex 3, Part 1, and complexes, salts and pigments prepared from the colours referred to in the reference (3) in Annex 4.
47. Benzene °
48. Benzimidazol-2 (3H) -on ●; Benzimidazol-2 (3H) -one °
49. Benzazepines and benzodiazepines; Benzazepines and benzadiazepines °
51- [(Dimethylamino) methyl] -1-methylpropyl benzoate • (amylocaine) and its salts;
1-Dimethylaminomethyl-1-methylpropyl benzoate (amylocaine) and its salts °
51.6-Trimethyl-4-piperidyl benzoate ● (benzamine) and its salts;
2,2,6-Trimethyl-4-piperidyl benzoate (benzamine) and its salts °
52. Isocarboxazide; Isocarboxazide *
53. Bendroflumethiazide and its derivatives; Bendroflumethiazide * and its derivatives
54. Beryllium and its compounds; Beryllium and its compounds °
55. Bromine, elementary; Bromine, elementary °
56. Bretylium tosilate; Bretylium tosilate *
57. Carbromal; Carbromal *
58. Bromised; Bromised *
59. Bromfeniramine and its salts; Brompheniramine * and its salts
60. Benzilonium bromide; Benzilonium bromide *
61. Tetrylammonium bromide; Tetrylammonium bromide *
62. Brucin; Brucine °
63. Tetracaine and its salts; Tetracaine * and its salts
64. Mofebutazone; Mofebutazone *
65. Tolbutamide; Tolbutamide *
66. Carbutamide; Carbutamide *
67. phenylbutazone; Phenylbutazone *
68. cadmium and its compounds; Cadmium and its compounds °
69. Cantharides, Cantharis vesicatoria
70. (1R, 2S) -1,2-Dimethyl-3,6-epoxyhexahydrophthalane anhydride ● (3α, 7α-dimethylhexahydro-4,7-epoxyisobenzofuran-1,3-dione, cantharidine);
(1R, 2S) -Hexahydro-1,2-dimethyl-3,6-epoxyphthalic anhydride (cantharidine) °
71. Fenprobamat; Phenbrobamate *
72. Nitroderivatives of carbazole ●; Nitroderivatives of carbazole °
73. Syringe ●; Carbon disulfide °
74. Catalase; Catalase °
75. Kefaelin and its salts; Cephaline and its salts °
76. Chenopodium ambrosioides (essential oil)
77.2,2-Trichloroethane-1,1diol ● (chloralhydrate); 2,2,2-Trichloroethane-1,1diol °
78. Chlorine; Chlorine °
79. Chlorpropamide; Chlorpropamide *
80. Diphenoxylate hydrochloride; Diphenoxylate * hydrochloride
81.4 (Phenylazo) -1,3-phenylenediamine citrate hydrochloride ● (chrysoidine citrate hydrochloride);
4-Phenylazophenylene- 1,3-diamine citrate hydrochloride (chrysoidine citrate hydrochloride) °
82. Chlorzoxasone; Chlorzoxasone *
83.2-Chloro-4-dimethylamino-6-methylpyrimidine ● (crimidine - ISO);
2-Chloro-6-methylpyrimidine-4-yldimethylamine (crimidine - ISO) °
84. Chlorprothixene and its salts; Chlorprothixene * and its salts
85. Clofenamide; Clofenamide *
86. Bis (2-chloroethyl) methylamine oxide ● and its salts;
N, N-bis (2-chloroethyl) methylamine
87. Chlormethine and its salts; Chlormethine * and its salts
88. Cyclophosphamide and its salts; Cyclops
89. Mannomustine and its salts; Mannomustine * and its salts
90. Butanilicaine and its salts; Butanilicaine * and its salts
91. Chlormezanone; Chloromezanone *
92nd Triparanoia; Triprasil *
93.2- [2- (4-Chlorophenyl) -2-phenylacetyl] indan-1,3-dione ● (chlorfacinone-ISO);
2- [2- (4-Chlorophenyl) -2-phenylacetyl) indane -1,3-dione (chlorophacinone-ISO) °
94. Chlorfenoxamine; Chlorphenoxamine *
95. Phenaglycodol; Phenaglycodol *
96. Chloroethane ●; Cloroethane °
97. Chromium, chromium acid and its salts; Chromium, Chromium acid and its salts °
98. Claviceps purpurea tul., its alkaloids and preparations thereof;
99. Conium maculatum L. (fruits, powder, preparations thereof)
100. Glycyclamide; Glycyclamide *
101. Cobalt benzenesulphonate; Cobalt benzenesulfonate °
102. Colchicine, its salts and derivatives; Colchicine, its salts and derivatives °
103. Kolchikoside and its derivatives; Colchicoside and its derivatives °
104. Colchicum autumnale L. and preparations thereof;
105. Convallatoxin; Convallatoxin °
106. Anamirta cocculus L. (fruit)
107. Croton tiglium L. (croton oil)
108. (E) -1- [4- (But- 2-enamido) benzenesulfonyl] -3-butylurea ●;
1-Butyl-3- (N-crotonoylsulfanilyl) urea °
109. Curare and curarin; Curare and curarine °
110. Synthetic curarizants; Synthetic curarizants °
111. Hydrogen cyanide and its salts; Hydrogen cyanide and its salts °
11.2-[ Cyclohexyl (phenyl) methyl] -N, N, N, N-tetraethylpropan-1,3-diamine ● (phenetamine);
2-α-Cyclohexylbenzyl (N, N, N ′ -tetraethyl) trimethylenediamine (phenetamine) °
113. Cyclomenol and its salts; Cyclomenol * and its salts
114. Sodium hexacyclonate; Sodium hexacyclonate *
115. Hexapropymate; Hexapropymate *
116. Dextropropoxyphene; Dextropropoxyphene *
117. O, O '-diacetyl-N-allyl-N-normorphine ●; O, O-Diacetyl-N-allyl-N-normorphine °
118. Pipazetate and its salts; Pipazetate * and its salts
119.5- (1,2-Dibromo-2-phenylethyl) -5-methylhydantoin ●;
5- (α, ß-Dibromophenethyl) -5-methylhydantoin °
120. Pentan-1,5-diylbis (trimethylammonium salts) ●, e.g. Pentamethonium bromide;
N, N '-Pentamethylenebis (trimethylammonium) salts °, e.g.Penthamethonium bromide *
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Regulation Information
| Citation | Decree No. 444 / 2004 Coll., amending Decree of the Ministry of Health No. 26 / 2001 Coll., on sanitary requirements for cosmetic products, on the particulars of the application for non-inclusion of ingredients on the packaging of cosmetic products and on the requirements for the education and practice of a natural person responsible for the manufacture of cosmetic products (cosmetic products decree), as amended by Decree No. 268 / 2001 Coll. |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 30.07.2004 |
|---|---|
| Effective from | 01.08.2004 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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