Essential Requirements for Cosmetic Products, Labelling Thereof and Procedures for Supervision

Republic of Latvia

Cabinet

Regulation No 354

Adopted 20 April 2004

Essential Requirements for Cosmetic Products, Labelling thereof and Procedures for Supervision of Compliance with these Requirements

Issued pursuant to

Section 7, Paragraph one of the Law On Conformity Assessment and

Section 21, Paragraph one of the Consumer Rights Protection Law

I. General Provisions

1. These Regulations prescribe the essential requirements for cosmetic products and the labelling thereof, as well as procedures for the supervision of compliance with these requirements in order to ensure the preservation of public health, in observance of economic and technological requirements.

2. Within the meaning of these Regulations, a cosmetic product is a substance or a product which comes into contact with certain external parts of the human body (epidermis, hair system, nails, the lips and external genital organs), or with the teeth and the mucous membranes of the oral cavity and which is used exclusively or principally for the cleaning, perfuming, changing the appearance of, keeping in good condition of the referred to parts of the body, or for the correction of body odours. The basic types of cosmetic products are specified in Annex 1 of these Regulations.

3. The final product within the meaning of these Regulations is a cosmetic product which is placed on the market and made available to the end user, or a prototype thereof (the first sample or a model which is not manufactured in batches and from which the final product is copied or developed).

4. These Regulations do not apply to cosmetic products which contain strontium or the compounds thereof, except strontium lactate, nitrate and carboxylate referred to in Annex 2 to 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 lacquers, pigments and salts in the colouring agents referred to in Annex 4 to these Regulations (under reference (3)).

5. A cosmetic product must not cause harm to human health if used under normal or intended circumstances, taking into account the category of the product, the labelling thereof, any conditions of use and storage, instructions or information provided by the producer or importer of the cosmetic product.

II. Requirements for the Composition of Cosmetic Products

6. It is prohibited to place on the market a cosmetic product if it contains in the composition thereof:

6.1. any of the ingredients referred to in Annex 2 of these Regulations;

6.2. any of the ingredients referred to in Annex 3, Paragraph 1 of these Regulations which are utilised outside the field of application specified in this Paragraph, as well as without complying with the specified restrictions on use;

6.3. any colouring agents (substances utilised in order to give a certain colour to cosmetic products or to change the colour of the skin, nails or hair) which are not referred to in Annex 4 of these Regulations, except for cosmetic products containing colouring agents which are intended only for the dyeing of hair;

6.4. any of colouring agents referred to in Annex 4 of these Regulations which are utilised outside the field of application specified in this Annex, as well as without complying with the restrictions on use specified in this Annex, except for cosmetic products containing colouring agents which are intended only for the dyeing of hair;

6.5. any preservatives (substances which may be added to a cosmetic product for hindering the development of micro-organisms in the cosmetic product) which are not referred to in Annex 5 of these Regulations;

6.6. any of the preservatives referred to in Annex 5 of these Regulations, which are used in contravention to the restrictions on use specified in this Annex. The substances referred to under reference (1) in this Annex may be added to a cosmetic product in a concentration which differs from that specified in Annex 5 if they are utilised in the cosmetic product for other specific purposes which are indicated on the labelling of the cosmetic product;

6.7. any ultraviolet radiation filters (substances that are present in the composition of sunscreen products in order to block ultraviolet rays and to protect the human skin from the negative effects of such rays) which are not referred to in Annex 6 of these Regulations. The ultraviolet radiation filters referred to in Annex 6 of these Regulations may also be added to other cosmetic products, without exceeding the concentrations specified in this Annex;

6.8. any ultraviolet radiation filters referred to in Annex 6 of these Regulations, which have been used without complying with the specified restrictions on use. These requirements do not apply to ultraviolet radiation filters which have been added in order to protect a cosmetic product from ultraviolet radiation; and

6.9. any substances which have been classified as carcinogenic, mutagenic substances and substances toxic to the reproductive system of Categories One, Two and Three and which are mentioned on the list of chemical substances approved by the Minister for the Environment. The carcinogenic, mutagenic substances and substances toxic to the reproductive system of Category Three may be used in the composition of cosmetic products if the Scientific Committee on Cosmetic Products and Non-Food Products Intended for Consumers (SCCNFP) has assessed and allowed the use thereof in cosmetic products.

7. Cosmetic products may contain admixtures of the 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.

8. The ingredients referred to in Part II of Annex 3 of these Regulations may be in the composition of a cosmetic product until the date specified in Part II (Column 8) of Annex 3 of these Regulations if the specified restrictions on use are observed.

9. Cosmetic products placed on the Latvian market may contain colouring agents, preservatives and ultraviolet radiation filters which are not referred to in Annexes 4, 5, and 6 of these Regulations. In such case a permit to use the ingredient in a particular cosmetic product shall be issued by the State Sanitary Inspection.

10. The permit referred to in Paragraph 9 of these Regulations shall be issued if the producer of a cosmetic product or a representative thereof, or a person pursuant to the order of which the cosmetic product is manufactured (hereinafter – producer), or a person who is responsible for the placement of the imported cosmetic product on the European Union market (hereinafter – importer) hands in to the State Sanitary Inspection a submission specifying the following information:

10.1. the name of the producer or importer, the number of the registration certificate in the commercial register, the actual address and registered office, the authorisation of the responsible person and a copy of a personal identification document;

10.2. an accurate identification of the ingredient for which the permit is being requested:

10.2.1. The name referred to in Sub-paragraph 46.2.1 of these Regulations;

10.2.2. if the name or number referred to in Sub-paragraph 46.2.1 of these Regulations does not exist (for example, for ingredients of natural origin), the name of the basic material, the name of the part of the plant or animal utilised as well as names of components of the ingredient, for example, a solvent, shall be specified;

10.3. a safety evaluation of the ingredient with regard to human health, taking into consideration the toxicological characteristics, chemical structure, the level of exposure and utilisation of the ingredient in the specific cosmetic product, in conformity with Sub-paragraphs 58.4 and 58.5 of these Regulations;

10.4. the name and application of the cosmetic product in which the ingredient is intended to be utilised;

10.5. a safety evaluation of the cosmetic product in relation to human health, taking into consideration the general toxicological characteristics, chemical structure and exposure level in conformity with Sub-paragraphs 58.4 and 58.5 of these Regulations; and

10.6. the function of the ingredient in the cosmetic product and benefits of the use of the ingredient compared to the application of the permitted ingredients referred to in Annexes 4, 5, and 6 of these Regulations and a detailed substantiation for the utilisation thereof.

11. The State Sanitary Inspection shall perform an expert examination of the submitted documents in accordance with the procedures and within the time periods specified in Paragraph 48 of these Regulations.

12. The State Sanitary Inspection shall issue a permit for a period of time not longer than three years.

13. The State Sanitary Inspection shall, within a period of a month after issuing the permit referred to in Paragraph 9 of these Regulations, notify thereof the Commission and competent authorities of all Member States of the European Union.

14. Not later than five months before the expiration of the term of validity of the permit referred to in Paragraph 12 of these Regulations, the producer or importer may hand in to the State Sanitary Inspection a submission with a request to include the ingredients permitted in Latvia on the list of colouring agents, preservatives and ultraviolet radiation filters permitted for cosmetic products in the European Union (hereinafter – list of ingredients permitted in the European Union). In such case the results of scientific and clinical research shall be submitted in addition to the information referred to in Paragraph 10 of these Regulations.

15. The State Sanitary Inspection shall, within a period of a month after the receipt of the documents, perform an expert examination thereof and take a motivated decision to support or to refuse support for the admission of an ingredient to the list of permitted ingredients in the European Union. The producer or importer shall be informed in writing regarding the decision taken. If a decision for refusal has been taken, the procedure and time periods for appealing against such decision shall also be specified. If due to objective reasons it is impossible to comply within the time period of a month, the State Sanitary Inspection may extend such for a period not exceeding four months from the day the submission is handed in, notifying the submitter thereof.

16. If a decision is taken for support for the admission of an ingredient to the list of ingredients permitted in the European Union, the State Sanitary Inspection shall, within a period of a month, send to the European Commission an application for admission of the ingredient to the list of ingredients permitted in the European Union. Documents, which substantiate such admission and indicate the function of the ingredient in the cosmetic product shall be appended to the application. In such case the term of validity of the permit referred to in Paragraph 12 of these Regulations shall be extended until the decision regarding the application for admission of an ingredient to the list of ingredients permitted in the European Union is taken, but not longer than 18 months from the receipt of the application at the European Commission.

17. If a cosmetic product, on the basis of the permit issued by the State Sanitary Inspection, contains in the composition thereof an ingredient referred to in Paragraph 9 of these Regulations, the labelling of the cosmetic product shall contain a special reference regarding the presence of the ingredient in the cosmetic product.

18. It is prohibited to place on the Latvian market a cosmetic product:

18.1. the check on the conformity of the end product of which has been performed utilising animals, if alternative methods (for the determination of toxicity and other health effects) referred to in Annex 7 of these Regulations (hereinafter – alternative test methods) are applicable; and

18.2. which contains ingredients or combinations of ingredients the check on the conformity of which has been performed utilising animals, if alternative test methods are applicable.

19. It is prohibited in Latvia to use animals:

19.1. for the testing of the end product of a cosmetic product in order to determine the conformity thereof with the requirements of these Regulations; and

19.2. for the testing of ingredients of a cosmetic product or a combination of cosmetic products if alternative testing methods are applicable.

20. For determining the chemical composition of a cosmetic product, the standard methods referred to in Annex 8 of these Regulations shall be utilised.

21. The criteria for microbiological purity of a cosmetic product and methods for the ascertainment thereof are specified in Annex 9 of these Regulations.

III. Requirements for the Labelling of Cosmetic Products

22. The information included on the labelling of a cosmetic product may not be misleading with regard to the identity, characteristics, functions, composition and properties of the ingredients, the quantity, date of minimum term of fitness for use (date until which the cosmetic product retains the specific characteristics and function thereof and conforms with the safety requirements if the prescribed storage regime is observed), origins, conditions of use and potential risk upon the usage thereof.

23. It is prohibited to use such text, names, trademarks, pictures or pictograms (an information sign in the form of a stylised picture) in the labelling of a cosmetic product which gives the impression that this cosmetic product has properties which it actually does not have.