Wholesale trade of cosmetic products

Applicants who wish to pursue this activity must register the business activity, and have the appropriate legal status.

The responsible person established in the Republic of Slovenia shall notify his activity in advance to the Chemicals Office of the Republic of Slovenia. The distributor has no obligation to notify the activity.

A distributor shall be the responsible person when he places a cosmetic product on the market under his name or trademark or modifies a product already placed on the market in such a way that compliance with the applicable requirements may be affected. The translation of information relating to a cosmetic product already placed on the market shall not be considered as a modification of that product of such a nature that compliance with the applicable requirements of the Regulation may be affected.

Legal basis

• Decree on iimplementing Regulation (EC) on cosmetic products

A distributor who makes available in a Member State a cosmetic product already placed on the market in another Member State and translates, on his own initiative, any element of the labelling of that product in order to comply with national law, shall submit, by electronic means, the following information to the European Commission:

(a) the category of cosmetic product, its name in the Member State of dispatch and its name in the Member State in which it is made available, enabling its specific identification;

(b) the Member State in which the cosmetic product is made available;

(c) his name and address;

(d) the name and address of the responsible person where the product information file is made readily accessible.

The electronic notification of a cosmetic product is done through the online notification portal for cosmetic products (Cosmetic Products Notification Portal, CPNP).

Details

The distributor shall ensure that the cosmetic product is labelled in accordance with the applicable legislation, that all language requirements are met, that the date of minimum durability has not expired, and that storage and transport conditions do not jeopardize its compliance with requirements of the Regulation.

Distributors shall report serious undesirable effects of the cosmetic product.

Legal basis

• REGULATION (EC) No 1223 /2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products (2009/1223)

Cosmetic products are available on the market only if their primary and secondary packaging include the following information in indelible, easily legible and visible lettering:

• Name and address of responsible person; country of origin:
  • Name and the address of the responsible person may be abbreviated in so far as the abbreviation makes it possible to identify that person and his address. If several addresses are indicated, the one where the responsible person makes readily available the product information file shall be highlighted.
  • The country of origin shall be specified for imported cosmetic products.
• Nominal content:
  • Nominal content at the time of packaging, given by weight or by volume, except in the case of packaging containing less than five grams or five millilitres, free samples and single-application packs; for pre-packages normally sold as a number of items, for which details of weight or volume are not significant, the content need not be given provided the number of items appears on the packaging. This information need not be given if the number of items is easy to see from the outside or if the product is normally only sold individually.
• Date until which the cosmetic product, stored under appropriate conditions, will continue to fulfil its initial function and, in particular, will remain in conformity with Article 3 (‘date of minimum durability’):
  • The date itself or details of where it appears on the packaging shall be preceded by the symbol shown in point 3 of Annex VII or the words: ‘best used before the end of’.
  • The date of minimum durability shall be clearly expressed and shall consist of either the month and year or the day, month and year, in that order. If necessary, this information shall be supplemented by an indication of the conditions which must be satisfied to guarantee the stated durability.
  • Indication of the date of minimum durability shall not be mandatory for cosmetic products with a minimum durability of more than 30 months. For such products, there shall be an indication of the period of time after opening for which the product is safe and can be used without any harm to the consumer. This information shall be indicated, except where the concept of durability after opening is not relevant, by the symbol shown in point 2 of Annex VII followed by the period (in months and/or years);
  • The particular precautions to be observed in use, and at least those listed in Annexes III to VI and any special precautionary information on cosmetic products for professional use.
  • The batch number of manufacture or the reference for identifying the cosmetic product. Where this is impossible for practical reasons because the cosmetic products are too small, such information need appear only on the packaging.
  • The function of the cosmetic product, unless it is clear from its presentation.
  • A list of ingredients. This information may be indicated on the packaging alone. The list shall be preceded by the term ‘ingredients’.

Perfume and aromatic compositions and their raw materials shall be referred to by the terms ‘parfum’ or ‘aroma’. Moreover, the presence of substances, the mention of which is required under the column ‘Other’ in Annex III, shall be indicated in the list of ingredients in addition to the terms parfum or aroma.

The list of ingredients shall be established in descending order of weight of the ingredients at the time they are added to the cosmetic product. Ingredients in concentrations of less than 1 % may be listed in any order after those in concentrations of more than 1 %.

All ingredients present in the form of nanomaterials shall be clearly indicated in the list of ingredients. The names of such ingredients shall be followed by the word ‘nano’ in brackets.

Colorants other than colorants intended to colour the hair may be listed in any order after the other cosmetic ingredients. For decorative cosmetic products marketed in several colour shades, all colorants other than colorants intended to colour the hair used in the range may be listed, provided that the words ‘may contain’ or the symbol ‘+/-’ are added. The CI (Colour Index) nomenclature shall be used, where applicable.

The ingredients are to be expressed using the common ingredient name set out in a glossary of common ingredient names for use in the labelling of cosmetic products.

Evidence

Designations on packaging

Legal basis

• REGULATION (EC) No 1223 /2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products (2009/1223)
• COMMISSION IMPLEMENTING DECISION (EU) 2022/677 of 31 March 2022 laying down rules for the application of Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the glossary of common ingredient names for use in the labelling of cosmetic products

Brief and clear clarification on the content and meaning of symbols used on the packaging of cosmetic products must be available to consumers at points of sale.

Legal basis

• Decree on iimplementing Regulation (EC) on cosmetic products
• REGULATION (EC) No 1223 /2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products (2009/1223)

Serious undesirable effect means an undesirable effect which results in:

• temporary or permanent functional incapacity;
• disability;
• hospitalization;
• congenital anomalies;
• an immediate vital risk, or
• death.

Notification of serious undesirable effects of cosmetic products is mandatory for manufacturers, importers and distributors. However, serious undesirable effects can also be reported by the end-user or healthcare professional.

Serious undesirable effects are reported via the prescribed Form A  to the Competent Authority of the country where the serious undesirable effect occurred.

Instructions for completing Form A (English)

Form A

Evidence

Completed Form A

Legal basis

• REGULATION (EC) No 1223 /2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products (2009/1223)