Decree No. 448 / 2009 Coll.
Decree on the laying down of sanitary requirements for cosmetic products
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448
DECLARATION
of 10 December 2009
laying down hygiene requirements for cosmetic products
According to Article 108 (1) of the 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 / 2001 Coll., Act No. 320 / 2002 Coll., Act No. 274 / 2003 Coll., Act No. 392 / 2005 Coll. and Act No. 222 / 2006 Coll., ("the Act ') for the implementation of Sections 26 (1) (b) and (d) and paragraphs 4, 8 and 9, Sections 27 and 28 (1) of the Act:
This decree implements the relevant regulations of the European Community1), and provides for
(a) hygiene requirements for the characteristics and composition of cosmetic products;
(b) the labelling of cosmetic products and the fitting of instructions for use;
(c) labelling of ingredients of cosmetic products,
(d) the extent of stored cosmetic product data;
(e) particulars of the application for the non-inclusion of an additive on the packaging of a cosmetic product;
(f) particulars of the application for authorisation of the use of substances not included in the lists of authorised substances.
Hygienic requirements for cosmetic products
(1) Cosmetic medium (2) placed on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use, taking into account in particular presentation, labelling, instructions for use and disposal and any other data or information provided when it is placed on the market (3). Cosmetic means means means in particular the products listed in Annex 1 to this Decree.
(2) Only substances which, by their properties in the concentrations used in the product formula, lead to the production of a safe cosmetic product may be used for the manufacture of cosmetic products.
(3) The use of substances classified as carcinogenic, germ cell mutagenic or toxic for reproduction of categories 1A, 1B and 2 in accordance with the directly applicable European Communities regulation on classification, labelling and packaging of substances and mixtures (4) is prohibited in cosmetic products. A substance classified as category 2 may only be used in cosmetic products if it has been evaluated by the Scientific Committee on Consumer Safety and found to be admissible for use in cosmetic products.
(4) 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.
(5) 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 Decree,
(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 then establishes 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 dyes, the area of use, the maximum permitted concentrations and the purity requirements of the selected dyes set out in Annex 4, Part 1, shall not apply to cosmetic products intended exclusively for hair colour,
(c) Annex 5 establishes a list of substances excluded from the scope of this Decree. Where a cosmetic product contains one 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 such preservatives are authorised,
(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.
Labelling of cosmetic products and equipment with instructions for use
(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 business name or name of the manufacturer or importer (5) 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, of the natural person involved, otherwise the name, surname and address of the company, and if it is 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 receptacle set out in Annex 8 to this Decree and an indication of the time (months or years),
(d) the 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 to this Regulation, 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 must 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 9 to this Decree,
(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 indicated on the outer packaging,
(f) the function of the product if it is not apparent 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 must be made known to the consumer either by the abbreviated word information or by a symbol placed on the packaging, a specimen of which is given in Annex 9 to this Decree. 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 according to the common nomenclature INCI adopted as a common nomenclature by the Commission of the European Communities (6) (International Nomenclature for Cosmetic Ingredients) or, if this is not possible, by the chemical name recommended by the World Health Organisation, the European Inventory of Existing Commercial Chemical Substances, the IUPAC number (International Union of Pure and Applied Chemistry), the CAS number (Chemical Abstracts Service) or the CI number (Colour Index).
Where, for reasons of size or shape, it is not possible to indicate the details set out in points (d) and (g) on the enclosed leaflet, these particulars shall be on the label, tape or card accompanying or attached to the cosmetic product.
If, in the case of soap, bath balls or other small products due to size or shape, it is not possible to indicate the details set out in point (g) on the label, tag, tape or card or on the enclosed leaflet, these details shall be on the alert in the immediate vicinity of the container in which the cosmetic product is put up for sale. In the case of the designation referred to in Article 29 (5) of the Act, the validated alternative method used to replace the animal testing listed in Annex 10 to this Decree may be indicated.
(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.
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 appear on the labelling normally in international contact, for example according to the common nomenclature INCI (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 individuals to the extent provided for in the law (7);
(e) the name and, where appropriate, the name, surname, address and qualification 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 in the cosmetic product designation
(1) The application for the non-inclusion of an additive on the packaging of a cosmetic product shall contain the following particulars:
(a) the company or name of the applicant and the address of the applicant's registered office, if any, or the name or surname of the applicant and, where applicable, the address of his place of business, if any, the natural person involved, otherwise the applicant's name, surname and address;
(b) the precise identification of the ingredients according to the directly applicable regulation of the European Communities in the field of classification, labelling and packaging of substances and mixtures (4), or International Nomenclature for Cosmetic Ingredients, as appropriate. Where a substance which cannot be so indicated is concerned, 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 ingredient, such as solvents, shall be indicated,
(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 justification why non-inclusion is required;
(f) the names of all products containing the ingredient, if known, and the names under which the product is marketed outside the Czech Republic, as well as details of each of these products,
(g) whether the application for non-inclusion has been submitted in another Member State of the European Union or in a Contracting State of the European Economic Area and the outcome of such an application.
(2) Where the information referred to in paragraph 1 (f) is not known, it may be placed on the market no later than 15 days before the cosmetic product is placed on the market. Where ingredients are used in several cosmetic products, one application shall suffice provided that a list of cosmetic products containing the ingredient is notified in writing to the competent public health authority.
Details of the application for authorisation of the use of substances not included in the lists of authorised substances
In the application for authorisation of the use of substances in a cosmetic product other than those included in the lists of substances authorised in Annexes 3, 4, 6 and 7 to this Regulation, the manufacturer or importer shall indicate:
(a) the company or name of the applicant and the address of the applicant's registered office, if any, if it is a legal person, or the name and surname of the applicant, and the address of his place of business, if any, of the natural person in business, otherwise the name, surname and address of the applicant;
(b) the precise identification of the substance according to the specific rules for classifying chemical substances (4) or, where appropriate, the International Nomenclature for Cosmetic Ingredients. If it is a substance which 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, shall be indicated,
(c) an assessment of the safety of the substance when used in the final cosmetic product for human health, indicating the toxicological profile of the substance, chemical structures and exposure levels;
(d) the intended use of the substance and its functions;
(e) the categories of cosmetic products in which it will be used;
(f) a dossier containing the elements necessary for the assessment of the health of the cosmetic products in which the proposed substance will be used, in particular information on the toxicity of the newly used substance with evidence that the health of the cosmetic product will not be impaired by the use of that substance or by reaction or interaction with the packaging or other substances contained in the cosmetic product;
(g) 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 final cosmetic product;
(i) the available national and foreign documentation on the substance and on the cosmetic product.
Repeal
The following shall be deleted:
1. 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 the natural person responsible for the manufacture of cosmetic products (Cosmetic products decree).
2. Decree No. 268 / 2001 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).
3. 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.
4. Decree No. 126 / 2005 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 the natural person responsible for the manufacture of cosmetic products (cosmetic products decree), as amended.
5. Decree No. 104 / 2006 Coll., amending Decree No. 26 / 2001 of the Ministry of Health 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 the natural person responsible for the manufacture of cosmetic products (cosmetic products decree), as amended.
6. Decree No. 260 / 2006 Coll., amending Decree No. 26 / 2001 of the Ministry of Health 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.
7. Decree No. 474 / 2006 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, and repealing Decree No. 75 / 2003 Coll., on determining the nomenclature of ingredients of cosmetic products.
8. Decree No. 112 / 2007 Coll., amending Decree No. 26 / 2001 of the Ministry of Health 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 the natural person responsible for the manufacture of cosmetic products (cosmetic products decree), as amended.
9. Decree No. 230 / 2007 Coll., amending Decree No. 26 / 2001 of the Ministry of Health 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 the natural person responsible for the manufacture of cosmetic products (cosmetic products decree), as amended.
10. Decree No. 334 / 2007 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.
11. Decree No. 369 / 2008 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.
12. Decree No. 99 / 2009 Coll., amending Decree No. 26 / 2001 of the Ministry of Health 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.
Transitional provisions
(1) Substances listed under reference numbers 7, 9, 14, 24, 28, 47 and 58 in Annex 3, Part 2 may be used until 14 May 2010 at the latest.
(2) Section b in columns "c" and "d" relating to the substance referred to under reference number 55 in Annex 3, Part 2 may be used until 14 May 2010 at the latest.
Efficacy
This Decree shall take effect on 1 January 2010 with the exception of the provisions concerning the substance toluene with reference number 185 in Annex 3, Part 1, which shall take effect on 5 February 2010, and with the exception of the provisions concerning substances under reference numbers 189-205 in Annex 3, Part 1, which shall take effect on 15 May 2010.
Minister:
Juraskova v. r.
Příloha č. 1
Annex No 1 to Decree No 448 / 2009 Coll.
Cosmetic agents shall in particular:
1. Creams, emulsions, lotions, gels, oils and solutions on the skin (intended for hands, face, feet) and similar articles.
2. Skin masks and wraps with the exception of devices intended for chemical peeling (scanning of the upper parts of the skin by chemical means).
3. Basics containing pigments (liquid, paste, powder).
4. make-up powder, bath powder, hygienic powder, creams and similar articles.
5. Soap (toilet, deodorant and others).
6. Perfumes, toilet waters, cologne waters.
7. Bath and shower products (salts, foams, oils, gels and other products).
8. Means to wax.
9. Deodorant (deodorant), perspirant (antiperspirant).
10. Hair care products:
10.1 dyeing and discoloration products,
10.2 means of permanent masturbation, means for so-called cold wave, means for hair straightening and fixation,
10.3 hairdressing and hair care devices (solutions, emulsions, foams, brilliants, varnishes and other products),
10.4 cleaning agents (shampoos, lotions, powders),
10.5 conditioners (lotions, creams, oils),
10.6 hairdressing products (lotons, varnishes, brilliance and others).
11. Shaving preparations (creams, foams, lotions and similar products), both before and after shaving.
12. Means to make up and make up faces and eyes.
13. Devices designed for lip application.
14. Devices for dental care and oral cavity.
15. Nail repair and nail care.
16. Devices for external personal intimate hygiene.
17. Means to care for beard, eyelashes and eyebrows (solutions, emulsions, foams, brilants, varnishes and other means).
18. Sunbathing products (sun protection and after sunbathing).
19. Devices for darkening the skin without sunlight.
20. Devices to illuminate the skin.
21. Means against wrinkles.
Příloha č. 2
Annex No. 2 to Decree No. 448 / 2009 Coll.
List of substances which may not be part of the composition of cosmetic products
1. N- (5-Chlorobenzoxazol-2-yl) acetamide * *;
N-5-Chlorobenzoxazole-2-ylacetamide * * *
2. (2-Acetoxyethyl) trimethylammonium hydroxide * * (acetylcholine and its salts);
beta-Acetoxyethyltrimethyl ammonium hydroxide (acetylcholine and its salts) * * *
3. Deanol aceglumate;
Deanol aceglumate *
4. Spironolactone;
Spironolactone *
5. 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-capric acid * * and its salts;
Aminocaproic acid * and its salts
8. Cinchophen, its salts, derivatives and salts of these derivatives;
Chinchophen *, its salts, derivatives and salts of these derivatives
9. Triiodothyropropionic acid * * and its salts;
Thyropropic acid * and its salts
10. Trichloroacetic acid * *;
Three chloroacetic 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 serpentine and their salts
16. alkynols, their esters, ethers and salts;
Alkyne alcohol, 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 * * *
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Regulation Information
| Citation | Decree No. 448 / 2009 Coll., laying down sanitary requirements for cosmetic products |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 18.12.2009 |
|---|---|
| Effective from | 01.01.2010 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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