The Cosmetics Act (Official Gazette RS, No. 110/03 - official consolidated text) and Act Amending Certain Act in the Field of Health (Official Gazette RS, No. 47/04) (ZdZPZ) provide for legal foundations for issuing implementing regulations that have transposed Cosmetics Directive 76/768/EEC with all amendments, and all technical directives amending and complementing it owing to any technical progress.

What are cosmetic products?

Cosmetic products are any substance or preparation in its final form intended to be placed in contact with the external parts of human body (epidermis, hair system, nails, lips and external genital organs), or with the teeth and the mocous membranes of the oral cavity, with the exclusive or main intention of cleaning, perfuming or protecting them, keeping them in good condition, altering their appearance or removing unpleasant body odours. An illustrative list of cosmetic products is available in Annex I, Directive 76/768/EGS.

The provisions of the Cosmetics Act do not apply to pharmaceutical and medicinal products used as cosmetic products entailing healing properties in terms of preventing and treating human diseases.

Equally, the provisions of the Cosmetics Act do not apply to preparations intended for ingestion, inhalation and injection.

Who is responsible for placing the product on the Slovene market?

It is a supplier that is responsible for cosmetic products suitability, i.e. any legal person or a sole proprietor with its registred offices in the Republic of Slovenia who:

• Manufactures cosmetic products,
• Presents himself as a manufacturer of cosmetic products through his company, trademark or any other sign of differentiation on cosmetic products,
• In any way changes the composition of cosmetic products or the content of labelling laid down by this Cosmetics Act, 
• Is the manufacturers representative or importer if the manufacturer's main office is not in the Republic of Slovenia or in the European Union.

What is more, any legal or natural person, placing the cosmetic product on the market is responsible for taking into account the manufacturer's instructions on proper use which are indicated on the cosmetic product.

Before placing cosmetic product on the market, the supplier is liable to provide products documentation to an address as listed on the product.

Documentation on cosmetic products should be available to any health inspector or office in Slovene or any other language that inspectors understand. The form in which data are available to inspectors is not prescribed; however, it has to provide inspectors with rapid and simple insight into all prescribed data.

Content of documentation with data on cosmetic products

Cosmetic products documentation should contain the following information:

• Qualitative and quantitative composition of the cosmetic product, while fragrances and perfumes should also include their respective composition code, as well as supplier’s address/identity,
• Physical and chemical as well as microbiological specification of starting material, as well as data on purity and criteria for checking cosmetic product’s microbiological suitability,
• Description of manufacturing procedure,
• Assessment of cosmetic product’s suitability for human health. Such assessment has to be based on the results of tests and studies, whereby special toxicological properties of ingredients used have to taken into consideration, as well as its chemical composition and consumer exposure. What is more, specific characteristics and exposure of areas that cosmetic products refer to, and population for which such cosmetic products are intended in the first place. As well, specific assessment had to be drafted for those cosmetic products intended for children younger than 3 years, as well as for cosmetic products intended exclusively for use in external intimate hygiene. 
• Name and addresses of the qualified persons who have drawn up such cosmetic products suitability assessment,
• Existing data on undesirable effects on human health resulting from use of the cosmetic product,
• Proof of the effect claimed for the cosmetic product, where justified by the nature of the effect or product,
• Data on all tests of cosmetic products or their ingredients provided that they were carried out by way of animal tests to determine cosmetic products suitability and to provide its compliance with the rules governing trade in cosmetic products, including tests performed to fulfill EU non-member states requirements.

Data from items 1 and 6 bear special significance for consumer awareness of cosmetic products, therefore they should be appropriately available, including through e-communication, to all users and stakeholders.

 
The quantitative data (data on content and concentration) should be available only for ingredients which are classified, in accordance with relevant rules on classification, packaging and labelling, as hazardous.

Advertising of cosmetic products

Misleading advertising of cosmetic products is prohibited. Words or expressions, names, trademarks, pictures or any other signs used in labelling, advertising and presenting of cosmetic products should not demonstrate any healing properties or indicate any other effects or properties that such cosmetic products do not have.

Taking into consideration a growing number of questions arising in relation to permitted advertising of cosmetic products, the National Chemicals Bureau has, according to guidelines issued by the Council of Europe, drawn up a list to help labelling and presenting cosmetic products.

Content and ways of labelling cosmetic products

Cosmetic products are liable to be labelled in line with the Rules on the Contents and Manner of Labelling Cosmetic Products. What is more, the European Commission has in line with Article 7 of the Cosmetics Act issued a recommendation on June 7th 2006 Establishing guidelines on the use of claims referring to the absence of tests on animals.

Similarly, in en effort to achieve simple and understandable labelling of sun protection products, the European Commission issued Commission Recommendation of 22 September on the efficacy of sunscreen products and the claims relating thereto.
 
New symbols for enhanced communication and information to consumers on hazards related to sun rays exposure. Having taken into account the hazards associated with sun rays exposure, the European Commission has published recommendations for improving labelling of products aimed at providing sun protection.
 
Notification of cosmetic products

Supplier of cosmetic products is liable to:

• Notify their activity to the National Chemicals Bureau by way of an notification form, Annex I Rules on the Form for the Notification of Cosmetic Product Suppliers' Activity and Procedure for the Notification of Cosmetic Products prior to Their First Placing on the Market (hereinafter: the Rules) in 
• Inform the National Chemicals Bureau of any new cosmetic products prior to their first placement of the market by way of an notification form of Annex II of the Rules.
  

Before placing cosmetic products on the market for the first time, suppliers are liable, in line with Article 13 of the Cosmetics Act (Official Gazette RS, No. 110/03 and 47/04 ZdZPZ) and in conformity with the Rules on the Form for the Notification of Cosmetic Product Suppliers' Activity and Procedure for the Notification of Cosmetic Products Prior to Their First Placing on the Market (Official Gazette RS, No. 114/03 and 40/07), to notify their activity and inform of their new cosmetic products.
 
 
The National Chemicals Bureau enters relevant data into its database without examining the suitability of cosmetic products communicated prior to their first placement on the market, nor does it have, according to relevant rules, any powers to examine cosmetic products for their suitability and issue any certificates concerning their suitability and compliance.

The supplier placing cosmetic product on the market assumes total responsibility on safety and compliance of such cosmetic products with the rules governing cosmetics. In Slovenia, cosmetics are governed by relevant rules regulating cosmetics legislation in the European Union (Directive 76/768/EEC with all relevant amendments).

PROCEDURE FOR ACTIVITY NOTIFICATION OF COSMETIC PRODUCTS AND COMMUNICATION ON NEW COSMETIC PRODUCTS

Legislative foundation

• Article 9 of the Cosmetics Act (Official Gazette RS, No 113/03 and 47/04 ZdZPZ); 
• Rule on the Form of the Notification of Cosmetic Product Suppliers’ Activity and Procedure for the Notification of Cosmetic Products Prior to Their First Placing in the Market (Official Gazette RS, 114/03).

Who?

The supplier placing cosmetic products on the market.

Where and how?

Written application is to be submitted to the National Chemicals Bureau:
by mail or in personal capacity to the following address: Ministry of Health, Štefanova 5, Ljubljana

Application for notification of cosmetic products activities shall contain:

• completed form from Annex I of the Rules;
• administrative fees attached in accordance with the Administrative Fees Act (Official Gazette RS, No. 114/05 – official consolidated text), amounting to 50 points.

Application for communication on new cosmetic products activities shall contain:

• completed form from Annex II of the Rules;
• provision of data indicated on cosmetic products packaging in line with the Rules on the Contents and Manner of Labelling Cosmetic Products, or a legible copy; 
• attached administrative charge in line with the Administrative Fee Act, amounting to 50 points.
  

Foreseen timeframe for deliberating applications and confirmation on activity notification and communication on new cosmetic products.

The time-period for addressing such applications is 15 days. After entering relevant data from Annex I and/or II into relevant databases, the supplier receives a reference number on photocopy of his application.

RAPEX (Rapid Alert System for Non-Food Products)

is a communication system in place within the EU. It allows for rapid and efficient mutual communication among EU Member States on products marketed within the EU failing to comply with safety requirements.  Information on cosmetic products failing to comply with safety requirements are available at: http://ec.europa.eu/consumers/dyna/rapex/rapex_en.cfm.

More information on cosmetic products are available at:

http//pharmacos.eudra.org/F3/cosmetic/cosm_intro_NEW.htm
http://www.colipa.com/site/index.cfm?SID=15588

Contact Point: Teja Ilc