Decree No. 174 / 1998 Coll.
Government Regulation on Technical Requirements for Cosmetic Products and amending Government Regulation No. 173 / 1997 Coll.
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Regulation
Effective from 01.09.1998
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01.09.1998
24.07.1998
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174
GOVERNMENT REGULATION
of 10 June 1998
on technical requirements for cosmetic products and amending Government Regulation No. 173 / 1997 Coll., laying down selected products for conformity assessment
The Government orders pursuant to Section 22 of Act No. 22 / 1997 Coll., on Technical Requirements for Products and on the Amendment and Addition of Certain Acts (hereinafter referred to as "the Act") to implement Sections 12 (1) and (4) and 13 (2) and (4) of the Act:
(1) A cosmetic product shall be considered to be a substance or a device intended to come into contact with external parts of the human body, teeth and mucous membranes of the oral cavity, with a view to cleaning, changing their appearance, protecting them, maintaining them in good condition, or correcting human odours. However, a cosmetic product of the nature of a cosmetic product is not considered to be a cosmetic product, but may, for its pharmacological properties, take into account the state of scientific knowledge, the manner and extent of use and the knowledge of consumers to influence physical functions. An example of cosmetic products is set out in Annex 1.
(2) The products provided for in Article 12 (1) of the Act are cosmetic products placed on the market, including those intended for use in barbers, hairdressers, cosmetics, pedicures, manicures, 1) massage services and other similar body care services.
(1) For the manufacture of cosmetic products only substances may be used which, by their properties in the concentrations used in the product receptor, make the production of a safe cosmetic production.2)
(2) Cosmetic agents must not contain substances listed in Annex 2. Only the presence of trace amounts of these substances is permitted, if technically unavoidable and the product is safe even if the correct process is followed. 2)
(3) Selected substances may only be present in cosmetic products in quantities, purity and under the conditions laid down in Annexes 3 to 6,
(a) Annex 3 sets out a list of substances permitted in cosmetic products only with restrictions, maximum permitted concentrations of selected substances and conditions of use including labelling on consumer packaging;
(b) Annex 4 sets out the list of permitted colours which may be used for the colouring of cosmetic products, the area of use, the maximum permitted concentrations and the purity requirements of the colours selected. The purity of dyes shall correspond to the purpose of their use and, unless the purity of dyes is laid down in Annex 4, the purity requirements of the substances for food purposes laid down in the specific regulation.3) The list of permitted dyes and the maximum permitted concentrations shall not apply to cosmetic products intended solely for hair colour,
(c) Annex 5 establishes a list of substances which may be added to cosmetic products for the purpose of suppressing the growth of micro-organisms in cosmetic products (hereinafter referred to as preservatives), maximum permitted concentrations, purity requirements for selected preservatives and conditions of use including labelling on consumer packaging. For the purposes of this Regulation, the salts of the substances listed in Annex 5, namely potassium salts, sodium, calcium, magnesium, ammonium, ethanolamine, and chlorides, bromides, sulphates, acetate and esters: methyl, ethyl, propyl, isopropyl, butyl, isobutyl, phenyl-,
(d) Annex 6 sets out the substances and devices which may be added to cosmetic products both for the protection of the consumer's skin against the harmful effects of ultraviolet radiation and for the protection of cosmetic products against ultraviolet radiation (UV filters), the maximum permitted concentrations and the conditions for their use, including labelling on consumer packaging.
(4) For cosmetic products, Annex 7 provides for a tolerated quantity of micro-organisms, specific micro-organisms whose presence in the cosmetic product is completely excluded, and a maximum quantity of micro-organisms which must not be exceeded.
(1) The packaging of the cosmetic product produced or imported shall bear the following particulars in clear, legible and indelible form:
(a) the trade name of the manufacturer or importer or supplier, where appropriate (4) and its registered office, if any, if it is a legal person, and permanent residence or place of business, if it is a natural person. This information may be presented in abbreviation if it allows identification of the manufacturer, importer or supplier,
(b) the name of the cosmetic product;
(c) the nominal content of the product at the time of packaging, given by weight (g) or volume (ml), with the exception of cosmetic products of less than 5 g or 5 ml, non-sales samples and disposable packaging;
(d) the date of minimum durability defining the minimum period during which the cosmetic product retains its specific declared properties while complying with storage conditions and is safe. (2) The date of minimum durability shall be indicated by the words "use preferably by..." or "minimum durability by..." indicating the month and year, or the conditions which guarantee minimum durability if necessary, given the nature of the product. The date of minimum durability need not be stated on the packaging of a cosmetic product, the durability of which exceeds 30 months,
(e) identification of the production lot, such as the date of manufacture or the batch number,
(f) the function of the product and the method of its use where the nature of the cosmetic product so requires. These data may be included in the instructions for use. However, they must always be in the Czech language,
(g) substances of synthetic or natural origin used in the composition of a cosmetic product (hereinafter referred to as ingredients), the presence of perfumes and flavourings being referred to as "perfumes" and "flavours" (flavours). The incorporation shall be given in descending order of weight at the time of manufacture. Where it is impossible to indicate this on the packaging of a cosmetic product, it shall be provided in the accompanying information. The names of the ingredients must be given in the Czech nomenclature or in the nomenclature according to the International Nomenclature Cosmetic Ingredients. The list of ingredients shall be preceded by the word "ingredients." Ingredients at concentrations of less than 1% may be given without order after ingredients at concentrations of more than 1%. Colouring agents may be listed in any order after other ingredients; shall be indicated by the index number of the colouring matters referred to in Annex 4 In the case of decorative cosmetic products sold in several colour shades, all colouring agents may be indicated on condition that the words "may contain 'or" may contain' are preceded,
(h) special precautions to be taken when a cosmetic product is used or stored. In particular, the specific safety measures are those listed in the column "Labelling on consumer packaging 'in Annexes 3, 5 and 6, as well as special safety information on cosmetic products for professional use, in particular in hairdressers. This information must be given in the Czech language.
(2) Where the information referred to in points (g) and (h) of paragraph 1 cannot be given due to the size or shape of the product on its packaging intended for the consumer, these may be indicated on the label, sticker or package leaflet accompanying 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 a symbol on the packaging, a specimen of which is given in Annex 8. In the case of soap, bath balls and other small cosmetic products, the data referred to in paragraph 1 (g) may be indicated as a warning in the immediate vicinity of the place where the product is put up for sale. Where a cosmetic product is used for the purposes set out in Annex 3, the cosmetic product shall be accompanied by instructions for use containing the particulars set out in the Annexes.
(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.
For cosmetic products, the conformity assessment shall be ensured by their manufacturer or importer prior to placing on the market [Paragraph 12 (4) (a) of the Act]. The evidence of the conformity assessment method used (Section 13 (4) of the Act) includes technical documentation containing:
(a) the qualitative and quantitative composition of the product and the indication of the function of the raw materials used;
(b) physical, chemical and microbiological data on the raw materials used, the purity of the raw materials and the labelling of the raw material manufacturer; for the company names of the raw materials and their chemical nature. The names of the raw materials must be clear and understandable, in an indication customary in international contact, for example according to International Nomenclature Cosmetic Ingredients. For perfume compositions and fragrances, the code number, name and designation of the supplier shall be indicated,
(c) a description of the procedure whereby the manufacturer ensures conformity of cosmetic products with the technical requirements laid down;
(d) the characteristics of the cosmetic product by means of chemical, physical sensory or other characteristics,
(e) evaluation of the cosmetic product in terms of the health and safety of persons and the safety of property, results of examinations and analyses;
(f) evaluation of the cosmetic product in relation to the declared function, methods of determination and test results;
(g) the address of the place of manufacture of the cosmetic product,
(h) the name of the person responsible for the accuracy of the information referred to in (e) and the degree and type of qualification of the person concerned.
The declaration of conformity shall be drawn up in the Czech language and shall contain the following particulars:
(a) identification details of the manufacturer or importer issuing the certificate of conformity (first name and last name, residence, place of business and identification number of the natural person or trade name, registered office and legal person identification number),
(b) identification of the cosmetic product (in particular name, identification of the production batch, function of the product),
(c) description and identification of the cosmetic product (in particular the purpose of use, method of preservation, special safety data and, where appropriate, product toxicity),
(d) the technical regulation used in the conformity assessment;
(e) in the event that the conformity assessment has been carried out by an authorised or accredited person, the identification details of that person (trade name, registered office, identification number), the number and the date of issue of its finding (certificate);
(f) confirmation by the manufacturer or importer that the properties of the cosmetic product comply with the technical requirements laid down in this Regulation, that the cosmetic product is safe under normal conditions and, where appropriate, by the manufacturer or importer of the intended use, and that he has taken measures to ensure that all cosmetic products placed on the market comply with the technical documentation and the technical requirements laid down;
(g) the date and place of issue of the certificate of conformity, the name and function of the responsible person of the manufacturer or importer and its signature.
The evidence of the conformity assessment method used and the declaration of conformity, together with the supporting documents, shall be kept by the manufacturer or importer for 5 years from the end of production, import or placing on the market.
Cosmetic products whose production or import began before the date of application of this Regulation shall comply with it within 30 months of its date of application.
Proceedings which have not been terminated before the date of entry into force of this Regulation shall be treated in accordance with existing legislation.
In Government Regulation No. 173 / 1997 Coll., establishing selected products for conformity assessment, the entry under serial number 13 of Annex No 1 is deleted.
This Regulation shall enter into force on 1 September 1998.
Prime Minister:
Ing. Tošovský v. r.
Minister for Health:
Dr. Roith, MBA v. r.
Příloha č. 1
Annex No. 1 to Decree No. 174 / 1998 Coll.
Examples of cosmetic products
Soap (toilet, deodorant and others),
bath and wash products (salts, foams, oils and other products),
toothpaste and other oral care,
dental detergents,
shaving preparations (both before and after shaving),
massage aids,
skin repellent,
the means to reduce sweating,
disodorant means,
waxing agents;
skin softening agents and chicken eyes,
stones and means to stop bleeding,
emulsions, creams, lotions, gels and solutions on the skin (face, hands, legs and whole body),
make-up and make-up,
skin masks and wraps,
cologne water,
toilet waters,
perfumes,
tanning preparations (protective and aftertanning preparations),
powder powder, solid, liquid, powder,
dyeing, dressing and lip care products,
hair and scalp shampoo,
dyeing and discoloration, forming and care of hair, beard, eyelashes and eyebrows (water, solutions, emulsions, brilliance, varnishes and other means),
the means of continuous waving for so-called cold wave,
nail fixing and nail care products,
a means of darkening the skin without the presence of radiation,
skin lightening devices,
means against wrinkles,
means for external personal intimate hygiene,
skin cleansing agents,
make-up, adhesives, varnishes and plastic materials for masking and dissolving,
teeth whitening products,
Příloha č. 2
Annex No 2 to Decree No. 174 / 1998 Coll.
List of substances which may not be part of the composition of cosmetic products
N- (5-chlorobenzoxazol-2-yl) acetamide
2. β-acetoxyethyltrimethylammonium hydroxide (acetylcholine) and its salts
3. Deanol aceglumate (*)
4. Spironolactone (*)
5,4- (4hydroxy-3-iodophenoxy) -3,5-diiodophenylacetic acid and its salts
6. Methotoxate
7. Aminocaproic acid (*) and its salts
8. Cinchophen (*), its salts, derivatives and salts of these derivatives
9. Thyropropionic acid (*) and its salts
10. Trichloroacetic acid
11. Aconitum napellus L. (all parts of the plant and galenic preparations)
12. Aconitine (the main alkaloid of the omen) and its salts
13. Adonis vernalis L. and preparations thereof
14. Epinephrine (*)
15. Alkaloids isolated from rdesno snake root (Rauwolfia serpentina) and their salts
16. Alkinols, their esters, ethers and salts
17. Isoprenaline (*)
18. Allyl isothiocyanate
19. Allocholanic acid amide (Alloclamide (*) and its salts
20. Nalorphine (*), its salts and ethers
21. Sympathomimetic amines acting on the central nervous system
22. Aniline, its salts and its halogenated and sulphonated derivatives
23. Betoxycaine (*) and its salts
24. Zoxazolamine (*)
25. Procainamide (*), its salts and derivatives
Benzidine
27. Tuaminoheptane (*) its isomers and salts
28. Octodrin (*) and its salts
29.2-amino-1,2-bis (4-methoxyphenyl) ethanol and its salts
30.3-dimethylpentylamine and its salts
31.4-aminosalicylic acid and its salts
32. Toluidines, their isomers, salts, halogenated and sulphonated derivatives
33. Xylidines, their isomers, salts, halogenated and sulphonated derivatives
34. Imperatorin (9- (3-methoxybut-2-enyloxy-7H-furo (3,2-g) chromene-7-one)
35. Ammi majus and its galenical preparations
36.3-dichloro-2-methylbutane
37. Substances with androgenic effect
38. Antracene oil
39. Antibiotics
40. Antimony and its compounds
41. Cannabis (Apocynum cannabinum L.) and preparations thereof
42. Amorphine (5,6,6a, 7- tetrahydro-6-methyl-4H-dibenzo (d.e.g) -quinoline-10.11-dihydro-ol) and its salts
43. Arsenic and its compounds
44. Atropa belladonna L. and preparations thereof
45. Atropine, its salts and derivatives
46. Barbed salts, excluding barium sulphate, insoluble lacquers, prepared from barium sulphate, and insoluble pigments of barium used as dyes.
47.
48. Benzimidazole-2.3-one
49. Benzazepines and benzodiazepines
50.1-dimethylaminomethylpropyl benzoate (amylocaine) and its salts
51.6-Trimethylpiperidyl benzoate (benzamine) and its salts
52. Isocarboxazide (*)
53. Bendroflumethiazide (*) and its derivatives
54. Beryllium and its compounds
55. Bróm, elementary
56. Bretylium tosilate (*)
57. Karbromal (*)
58. Bromised (*)
59. Bromfeniramine (*) and its salts
60. Benzilonium bromide (*)
61. Tetrylammonium bromide (*)
62.
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-epoxyphthalanhydride (cantharidine)
71. Fenprobamat (*)
72. Nitroderivatives of carbazole
73. Syringe
74. Catalase
75. Cefaelin and its salts
76. Chenopodium ambrosioides (essential oil)
77.2,2,2- trichloroethane
78. Chlorine
79. Chlorpropamide (*)
80. Diphenoxylate hydrochloride (*)
81.4-phenylazophenylene-1.3-diamine citrate hydrochloride (chrysoidine citrate hydrochloride)
82. Chlorzoxasone (*)
83.2-chloro-6-methylpyrimidine-4-yldimethylamine (isocrimidine)
84. Chlorprothixene (*) and its salts
85. Clofenamide (*)
86.N, N-bis (2-chloroethyl) methylamine N-oxide and its salts
87. Chlormethine (*) and its salts
Contents
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Regulation Information
| Citation | Government Regulation No. 174 / 1998 Coll., on Technical Requirements for Cosmetic Products and amending Government Regulation No. 173 / 1997 Coll. |
|---|---|
| Regulation Type | Regulation |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 24.07.1998 |
|---|---|
| Effective from | 01.09.1998 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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