Decree of the Ministry of Health No. 26 / 2001 Coll.
Ordinance of the Ministry of Health 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)
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26
DECLARATION
Ministry of Health
of 8 January 2001
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 the natural person responsible for the manufacture of cosmetic products (Cosmetic products decree)
According to § 108 (1) of Act No. 258 / 2000 Coll., on the Protection of Public Health and on the amendment of certain related laws (hereinafter referred to as "the Act"), the Ministry of Health provides for the implementation of § 26 (1) (b) and (d) and paragraphs 2 to 5, § 27, 28 and 29 of the Act:
Hygienic requirements for cosmetic products
This decree implements the relevant regulations of the European Community1), and provides for
(a) hygiene requirements for the composition and characteristics of cosmetic products;
(b) the labelling of the cosmetic product and the fitting with instructions for use;
(c) requirements for the extent of stored data on cosmetic products;
(d) particulars of the application for the non-inclusion of the ingredient on the packaging of the cosmetic product;
(e) particulars of the application for authorisation of the admissibility of substances other than those included in the lists of substances authorised.
Composition of cosmetic products
(1) For the manufacture of cosmetic products only substances may be used which, by their properties in the concentrations used in the product formula, lead to the production of a cosmetic product which does not cause harm to the health of natural persons. An example of such cosmetic products is set out in Annex 1 to this Decree.
(2) Cosmetic agents must not contain substances listed in Annex 2 to this Regulation. Only the presence of trace amounts of these substances is permitted if technically unavoidable even if the correct technological practice is followed and the product does not cause health damage.
(3) Selected substances may only be present in cosmetic products in quantities, purity and under the conditions laid down in Annexes 3 to 7 to this Regulation,
(a) Annex 3, Part 1, establishes a list of substances authorised in cosmetic products only with restriction, as well as the maximum permitted concentrations of those substances and their conditions of use, including mandatory labelling on consumer packaging; in Part 2, it shall then establish a list of substances which are authorised in cosmetic products only with restriction and on a temporary basis, the maximum permitted concentrations of those substances, their conditions of use, the mandatory labelling on consumer packaging and the date on which the use of those substances is authorised;
(b) Annex 4, Part 1, sets out the list of authorised colours which may be used for colouring cosmetic products, the area of use, the maximum permitted concentrations and the purity requirements of the colours selected; in Part 2, it then sets out a list of provisionally authorised colours which may be used for colouring cosmetic products, the area of use, the maximum permitted concentrations, the purity requirements and the date on which the use of those colours is authorised. The list of authorised colouring matters set out in Annex 4 shall not apply to cosmetic products intended exclusively for hair dyeing;
(c) Annex 5 establishes a list of substances excluded from the scope of this Decree. Where a cosmetic product contains any of the substances listed in Annex 5, it is not a cosmetic product under this Decree;
(d) Annex 6, Part 1, establishes a list of substances which are permitted to be added to cosmetic products for the purpose of suppressing the growth of micro-organisms in cosmetic products (hereinafter referred to as preservatives), as well as maximum permitted concentrations, purity requirements and conditions of their use, including mandatory labelling on consumer packaging; in Part 2, it shall then establish a list of provisionally authorised preservatives, their maximum permitted concentrations, their purity requirements, their conditions of use, including mandatory labelling on consumer packaging and the date on which the use of such preservatives is permitted;
(e) Annex 7, Part 1, sets out substances which are permitted to be added to cosmetic products in order to protect the consumer's skin against harmful effects of ultraviolet radiation ("UV filters"), the maximum permitted concentrations and the conditions of their use, including mandatory labelling on consumer packaging; in Part 2, the UV filters shall then provide for temporary authorisations to cosmetic products, maximum permitted concentrations, conditions of use, including mandatory labelling on consumer packaging and the date by which their use is permitted.
(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 it is a legal person, or the name or surname of the manufacturer or importer, the address of the place of business, if it is a natural person involved, and if it has been produced outside the European Community 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, and an indication of the period in months 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." The list of ingredients can only be found on the outer packaging. If, for practical reasons, the list of ingredients cannot be indicated on the packaging, it may be indicated on the sticker, tape or package leaflet 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 shall be given according to the common nomenclature INCI adopted as a common nomenclature by the Commission of the European Communities (1b) (International Nomenclature for Cosmetic Ingredients) or, if not possible, by a chemical name, by the CTFA () name, by the European Pharmacopoeia name INN (International Non-proprietary Names) recommended by the WHO, EINEX, IUPAC, CAS or CI number (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.
Scope of stored cosmetic product data
The following particulars shall be stored on the cosmetic product:
(a) the qualitative and quantitative composition of the product; for perfume compositions and perfumes, the name and code number of the composition and the supplier's designation shall be indicated;
(b) the physical, chemical and microbiological specifications of the raw materials and the finished product and the quality and microbiological purity control criteria of the cosmetic product. The names of the raw materials must be in international terms, for example according to International Nomenclature for Cosmetic Ingredients;
(c) evidence of a production method complying with good manufacturing practice;
(d) an assessment of the safety for the health of natural persons to the extent provided for in law (1c);
(e) the name, surname, address and qualifications of the person responsible for the evaluation referred to in (d);
(f) data on adverse effects on natural persons resulting from the use of a cosmetic product;
(g) evidence of the effects declared for a cosmetic product where the nature of the effects or the product so requires;
(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.
Forms of application for non-inclusion of the ingredient on the cosmetic product packaging
(1) The application for the non-inclusion of the ingredient on the packaging of a cosmetic product shall contain the following information:
(a) the business name and registered office, if it is a legal person or place of business, if it is a natural person;
(b) the precise identification of the ingredients according to the specific regulations for classification of chemicals, or the International Nomenclature for Cosmetic Ingredients. If a substance which cannot be so indicated is used, the name of the basic material, the name of the plant or animal part used and the names of the ingredients (e.g. solvents) must be given;
(c) an assessment of the safety of the ingredient when used in the final human health product, indicating the toxicological profile of the ingredient, chemical structure and exposure levels;
(d) the intended use of the ingredient, in particular the categories of products in which it will be used;
(e) a detailed explanation of why secrecy is required;
(f) the names of all products containing the ingredient, if known, and the names under which the product is sold on the market abroad, as well as details of each of these products;
(g) a declaration indicating whether the request for confidentiality of the ingredient has been submitted in another State and the outcome of such request.
(2) Where the indication referred to in paragraph 1 (f) is not known, it may be given not later than 15 days before the product is placed on the market. Where the ingredients are used in several cosmetic products, one application shall suffice provided that the products are communicated in writing to the competent public health authority.
Forms of application for authorisation of the admissibility of other substances
(1) In the application for authorisation of the admissibility of substances other than those listed in the lists of substances authorised in Annexes 3, 4, 6 and 7, the manufacturer or importer shall indicate:
(a) the business name and registered office, if it is a legal person or place of business, if it is a natural person;
(b) the exact identification of the substance according to the specific rules for the classification of chemicals or, where appropriate, the International Nomenclature for Cosmetic Ingredients. Where a substance cannot be so indicated, the name of the basic material, the name of the part of the plant or animal used and the names of the components of the substance, such as solvents, must be given;
(c) an assessment of the safety of the substance when used in the final product for human health, indicating the toxicological profile of the substance, chemical structure and exposure levels;
(d) the intended use of the substance and its function;
(e) the categories of products in which it will be used;
(f) documentation containing the facts necessary for the health assessment of the proposed products, in particular information on the toxicity of the newly used substance, with evidence that it will not infringe the health of the product itself or its reaction or interaction with the product, packaging or other substances used in the product, and, where appropriate, their contamination;
(g) a technological justification for the use of the substance during the manufacture of the cosmetic product;
(h) the quantity of the substance used in the manufacture and its quantity in the resulting product;
(i) the available national and foreign material and product documentation.
Efficacy
This decree shall take effect on the day of its publication.
Minister:
Prof. MUDr. Fisher, CSc.
Příloha č. 1
Annex No. 1 to Decree No. 26 / 2001 Coll.
Examples of cosmetic products
- Creams, emulsions, lotions, gels, oils and solutions on the skin (intended for hands, face, feet) and similar products.
- Skin masks and wraps with the exception of those intended for chemical peeling.
- Bases containing pigments (liquid, paste, powder).
- make-up powder, bath powder, hygienic powder, powder and similar products.
- Soap (toilet, deodorant and others).
- Perfumes, toilet water, cologne water.
- Bath and shower products (salts, foams, oils, gels and other products).
- Waxing supplies.
- Deodorant agents, anti-perspirants.
- Hair care products:
• dyeing and discoloration products,
• means for permanent masturbation, means for so-called cold wave, means for hair straightening and fixation,
• hairdressing and hair care products (solutions, emulsions, foams, brilliance, varnishes and other means),
• cleaning agents (shampoos, lotions, powders),
• conditioners (lotions, creams, oils),
• hairdressing products (lotons, lacquers, brilliance and others).
- Shaving preparations (creams, foams, lotions and similar products), both before and after shaving.
- The means to make and make faces and eyes.
- Devices designed for lip application.
- Dental care and oral care.
Nail repair and nail care.
- Devices for external personal intimate hygiene.
- Means for the care of beard, eyelashes and eyebrows (solutions, emulsions, foams, brilants, varnishes and other products).
- Sunbathing products (sun protection and sun protection).
- Devices for darkening the skin without sunlight.
- Devices to illuminate the skin.
- Anti-wrinkle devices.
Příloha č. 2
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
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Regulation Information
| Citation | Decree of the Ministry of Health No. 26 / 2001 Coll., on sanitary requirements for cosmetic products, on the formalities for not placing 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) |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 23.01.2001 |
|---|---|
| Effective from | 23.01.2001 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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