Republic of Latvia
Cabinet
Regulation No. 226
Adopted 5 June 2001
Safety Requirements and Procedures for Supervision of Cosmetic Products
Issued pursuant to Section 7 of the Law on Conformity Assessment and Section 21
of the Consumer Rights Protection Law
I. General Provisions
1. These Regulations prescribe safety requirements for cosmetic products (substances or preparations used exclusively or mainly for the cleaning and/or perfuming, and/or protecting, and/or keeping in good condition, as well as for changing the appearance of various external parts of the human body (epidermis, hair system, nails, lips, external genital organs), teeth or the mucous membranes of the oral cavity and/or for correcting body odours) and procedures for supervising the observation of these requirements, as well as requirements for the labelling of cosmetic products. Categories of cosmetic products are listed in Annex 1 of these Regulations.
2. These Regulations shall not apply to cosmetic products:
2.1. which contain substances or preparations intended for internal use, inhalation, injection or implantation in the human body;
2.2. the handling of which is regulated by the Pharmacy Law; and
2.3. which contain strontium or its compounds, except strontium lactate, nitrate and carboxylate referred to in Annex 2 of these Regulations; strontium sulphide, chloride, acetate, hydroxide and peroxide the use of which is permitted in accordance with Annex 3 of these Regulations, as well as strontium lakes, pigments and salts the use of which is permitted in accordance with Annex 4 of these Regulations.
3. Cosmetic products may not cause harm to human health if applied under normal or expected circumstances and taking into account the category of product, its labelling, any conditions of use and storage, instructions or information provided by the manufacturer or importer of a cosmetic product.
II. Requirements for Composition of Cosmetic Products
4. Cosmetic products may not contain:
4.1. ingredients referred to in Annex 2 of these Regulations;
4.2. ingredients not referred to in Annex 3 of these Regulations;
4.3. ingredients referred to in Annex 3 of these Regulations that are used in contravention to the specified restrictions;
4.4. colouring agents (substances utilised in order to give a certain colour to cosmetic products or to change the colour of skin, nails or hair), preservatives (substances protecting cosmetic products from damage caused by micro-organisms) and ultraviolet radiation filters (substances that are present in the composition of sunscreen products and which, by filtering certain ultraviolet rays, protect human skin from the negative effects of such rays) that are not referred to in Annexes 4, 5 and 6 of these Regulations; and
4.5. colouring agents, preservatives and ultraviolet radiation filters used in contravention to the conditions and restrictions specified in Annexes 4, 5 and 6 of these Regulations.
5. Cosmetic products may contain ingredients referred to in Annexes 3, 4, 5 and 6 of these Regulations if the restrictions specified in these Annexes are observed.
6. Cosmetic products may contain lakes and salts of colouring agents referred to in Annex 4 of these Regulations, in which ingredients not referred to in Annex 2 of these Regulations are utilised.
7. Cosmetic products may contain colouring agents, preservatives and ultraviolet radiation filters not referred to in Annexes 4, 5 and 6 of these Regulations if the utilisation of such colouring agents, preservatives and ultraviolet radiation filters in the manufacturing of specific cosmetic products has been approved by the following institutions:
7.1. an institution authorised by a European Union Member State – for cosmetic products imported from European Union Member States; and
7.2. the non-profit-making organisation, State undertaking “Latvijas sertifikācijas centrs” [Certification Centre of Latvia] (hereinafter – Centre) – for cosmetic products imported from other states and for cosmetic products manufactured in Latvia.
8. Utilisation of ingredients referred to in Paragraph 7 of these Regulations in specific cosmetic products is permissible for a time period not exceeding three years if such cosmetic products do not cause risk to human health and have been certified by safety evaluation of ingredients and cosmetic products in accordance with the recommendations regarding safety evaluation of cosmetic products in the European Union Member States and with the results of an expert-examination by a competent authorised institution. In such case labelling of the cosmetic product shall specifically indicate that the cosmetic product contains the relevant ingredient.
9. Cosmetic products intended for hair dyeing may contain colouring agents not referred to in Annex 4 of these Regulations. Conditions and restrictions for use of colouring agents specified in Annex 4 of these Regulations do not apply to such products.
10. Cosmetic products may contain admixtures of ingredients referred to in Annex 2 of these Regulations if, observing good manufacturing practice, it is not possible to prevent such admixtures and the cosmetic product conforms to the requirements specified in Paragraph 4 of these Regulations.
11. It is prohibited to sell cosmetic products, the testing of ingredients or ingredient combinations of which has been performed utilising animals.
12. Chemical substances referred to in Annex 7 of these Regulations shall be determined in cosmetic products in accordance with the requirements of national standards.
III. Microbiological Parameters of Cosmetic Products
13. Microbiological parameters of cosmetic products shall conform to the requirements specified in Annex 8 of these Regulations.
14. Requirements referred to in Annex 8 of these Regulations do not apply to cosmetic products (perfumes, perfumed waters, toilet waters, eau de Cologne, deodorants, nail care products, hair dyes and bleaches, hair fixing products, products for waving and fixing of hair, and other cosmetic products) that contain ethanol in a concentration exceeding 40 percent, and organic solvents, hydrogen peroxide, propellants and other similar ingredients.
15. The quantity of mesophilic aerobic microorganisms in natural hair-dye powders is not regulated.
IV. Requirements for Labelling of Cosmetic Products
16. The information included in the labelling of cosmetic products shall not be misleading in regard to the identity, characteristics, composition, quantity, date of minimum durability (date up to which a cosmetic product retains its specific characteristics and conforms to the safety requirements if the prescribed storage regime is observed), origins, conditions of use and potential risk when using such products, and such characteristics and effects to cosmetic products as the relevant products do not possess shall not be attributed.
17. The labelling of cosmetic products shall be on individual containers and their packaging, but the list of ingredients of a cosmetic product may be only on the packaging. Labelling shall be indelible and easily legible.
18. The following information shall be specified on the labelling of cosmetic products:
18.1. name of the cosmetic product;
18.2. the name and legal address of the manufacturer or importer of the cosmetic product registered in the Enterprise Register (hereinafter – manufacturer or importer of cosmetics). Such information may be abbreviated if the abbreviation allows identification of the manufacturer or importer;
18.3. information regarding the state of origin of the cosmetic product if the cosmetic product is not manufactured in Latvia or a European Union Member State;
18.4. net weight or volume of the cosmetic product at the time of packaging;
18.5. date of minimum durability of the cosmetic product;
18.6. category of the cosmetic product if the use of the cosmetic product may not be convincingly judged from its presentation;
18.7. list of ingredients of the cosmetic product (substances or preparations used in the manufacturing of the cosmetic product and present in the composition of the final product);
18.8. batch number, code or other features of the cosmetic product that allow identification of the batch of the cosmetic product; and
18.9. conditions of use and warnings if such are referred to in Annexes 3, 4, 5 and 6 of these Regulations, as well as any warning information related to professional utilisation of cosmetic products.
19. The requirements referred to in Paragraph 18 of these Regulations also apply to cosmetic products that prior to the sale thereof are packaged at the location of sale in conformity with the quantity requested by the consumer, or for immediate sale.
20. The net weight or volume need not be indicated:
20.1. for cosmetic products, the net weight of which is less than five grams or the net volume of which is less than five millilitres;
20.2. for cosmetic products intended for single use;
20.3. for pre-packaged cosmetic products, if the packaging contains several identical units of cosmetic products, which are normally sold as a unified whole and for, which indication of weight or volume is not significant. In such case, only the total number of units in the packaging shall be indicated. The indication referred to shall not be mandatory if the units are not sold as a unified whole or the units that the packaging contains are visible and can be counted without opening the packaging; or
20.4. for cosmetic products that for promotional purposes are distributed to consumers free of charge.
21. The indication of the date of minimum durability on the labelling of cosmetic products shall include the words “Ieteicams līdz… beigām” [Best before the end of …], and the year and month in decoded form or a reference to the place where the date is indicated on the labelling specified.
22. If necessary, the labelling of a cosmetic product shall indicate the storage regime that must be observed so that the cosmetic product may preserve its specific characteristics up to the date of minimum durability.
23. The date of minimum durability need not be indicated for a cosmetic product, the date of minimum durability of which exceeds 30 months.
24. The labelling of cosmetic products shall specify the ingredients in decreasing order of weight and in conformity with the initially added quantity. The list of ingredients shall be introduced by the word “Sastāvs” [Composition] or “Sastāvdaļas” [Ingredients].
25. Ingredients of cosmetic products, the concentration of which in the product is less than one per cent, and colouring agents need not be indicated in decreasing order of weight.
26. Colouring agents shall be indicated after other ingredients of a cosmetic product; perfume and aromatic compositions, and the raw materials thereof shall be indicated by the words “Smaržkompozīcija” [Perfume composition] or “Aromatizētāji” [Flavours].
27. The list of ingredients of make-up products manufactured in various shades of colour shall specify all the colouring agents used in the relevant shades, adding the words “Sastāvā var būt” [Product may contain] or a relevant symbol “+/–”.
28. The name of the colouring agent or index number of the colouring agent shall be specified in conformity with Appendix 4 of these Regulations; names of other ingredients shall be specified in accordance with the INCI – International Nomenclature for Cosmetic Ingredients. If the name of the relevant ingredient is not specified in the nomenclature, another alternative international name shall be specified in conformity with the categories prescribed in the nomenclature. If the relevant ingredient – colouring agent – is utilised for other purposes, then instead of the index number or name referred to in Annex 4 of these Regulations, the name referred to in the International Nomenclature for Cosmetic Ingredients shall be specified.
29. If ingredients of cosmetic products contain several substances, the labelling shall specify each substance separately, taking into account the concentration thereof in the finished product.
30. The labelling of cosmetic products shall not specify:
30.1. ingredient admixtures;
30.2. substances utilised in the process of manufacturing but not present in the finished product; and
30.3. substances utilised as solvents or carriers of perfume and aromatic compositions.
31. An incomplete list of ingredients of cosmetic products shall be considered misleading.
32. If for practical reasons it is impossible to provide on the containers or packaging the information specified in Sub-paragraphs 18.7 and 18.9 of these Regulations, such information shall be specified on a label, tape or leaflet accompanying the cosmetic product. Packaging units of cosmetic products shall bear an indication of such information. If it is impossible to indicate the information referred to in Sub-paragraph 18.9 of these Regulations, the container shall also bear the additional indication. The indications referred to may be provided by utilising the symbol shown in Annex 9 of these Regulations.
33. If due to the size or shape of soaps, bath balls or other cosmetic products it is impossible to provide the information specified in Sub-paragraph 18.7 of these Regulations on an attached label, tape or leaflet, such information shall be displayed in an easily visible manner at the location of sale next to the cosmetic product offered for sale.
34. If the size of the relevant cosmetic product is small, the information provided for in Sub-paragraph 18.8 of these Regulations may be specified on the packaging only.
35. If the labelling of a cosmetic product bears a reference to tests performed utilising animals, such labelling shall clearly state whether the finished product or its ingredients were tested.
36. In order to keep a commercial secret, the name of one or several ingredients may be omitted from the list of ingredients of the cosmetic product. In such case, the name of the ingredient shall be replaced in the list by the registration number of the ingredient assigned by the Centre, or by the patented name of the ingredient of the cosmetic product.
37. The registration number of ingredients referred to in Paragraph 36 of these Regulations shall be assigned by:
37.1. an institution authorised by a European Union Member State – for cosmetic products imported from European Union Member States; or
37.2. the Centre – for cosmetic products imported from other states and for cosmetic products manufactured in Latvia.
38. In order to assign a registration number for an ingredient, before offering the cosmetic product on the market the person referred to in Paragraph 48 of these Regulations shall submit to the Centre an application in which the following information is included:
38.1. name and address of the applicant and the manufacturer;
38.2. accurate identification of the ingredient for which the keeping of a commercial secret is requested:
38.2.1. chemical name or the name in the International Union of Pure and Applied Chemistry (IUPAC) nomenclature, or the name in the International Nomenclature for Cosmetic Ingredients (INCI), or the international non-patented name recommended by the World Health Organisation, or the name in the European Pharmacopoeia, or another alternative international name if such exists;