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Manufacture of cosmetic products

Cosmetic product means any substance or mixture intended to be placed into contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.

Only cosmetic products for which a legal or natural person is designated within Community as “responsible person” shall be placed on the market.

The manufacturer is the responsible person for a cosmetic product manufactured in the Community, and the importer is the responsible person for an imported cosmetic product. The manufacturer or importer may, by written mandate, designate a person established within the Community as the responsible person, who must accept this in writing.

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.

The responsible person shall ensure that the cosmetic product is safe for human health. To ensure the safety of a cosmetic product, the responsible person must carry out a safety assessment based on all relevant information and that a cosmetic product safety report is set up. The responsible person must keep the product information file for the cosmetic product (10 years), make an electronic notification of the cosmetic product and cosmetic product containing substances in the form of nanomaterial, label the cosmetic product in accordance with applicable legislation and communicate serious undesirable effects of the cosmetic product.

Applies for SKD:

  • Manufacture of perfumes and toilet preparations C20.420

Conditions

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

  • 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

    Competent Authority

    Ministry of Health, Chemicals Office of the Republic of Slovenia

    Ajdovščina 4
    1000 Ljubljana

  • 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

    Competent Authority

    Ministry of Health, Chemicals Office of the Republic of Slovenia

    Ajdovščina 4
    1000 Ljubljana

  • Prior to placing the cosmetic product on the market, the responsible person shall make an electronic notification of the cosmetic product to the European Commission.

    The responsible person shall submit the following information to the European Commission in electronic form:

    • the category of the cosmetic product and its name or names, enabling its specific identification;
    • the name and address of the responsible person where the product information file is made readily available;
    • the country of origin in case of import;
    • the Member State in which the cosmetic product is to be placed on the market;
    • the contact details of a physical person to contact in case of necessity;
    • the presence of substances in the form of nanomaterials;
    • name and CAS number (Chemicals Abstracts Service) or EC number of substances classified as carcinogenic, mutagenic or toxic to reproduction (CMR), category 1A or 1B;
    • the frame formulation allowing for prompt and appropriate medical treatment in the event of difficulties.

    Electronic notification of a cosmetic product is done through the online Cosmetic Products Notification Portal (CPNP).

  • The production of cosmetic products must be implemented in compliance with the principles of good manufacturing practice. The production is compliant with good manufacturing practice when it is compliant with the Guidelines on Good Manufacturing Practice (ISO 22716:2007).

    The ISO 22716:2007 Standard is an international standard giving guidelines for the production, control, storage and shipment of cosmetic products. The guidelines provide organisational and practical advice for management of human, technical and administrative factors which affect the quality of production.

    The ISO 22716:2007 Standard can be purchased at the Slovenian Institute for Standardisation.

    Legal basis

  • When a cosmetic product is placed on the market, its responsible person must keep a product information file for it.

    The file must be updated if necessary and contain the following information:

    • a description of the cosmetic product which enables the product information file to be clearly attributed to the cosmetic product,
    • cosmetic product safety report,
    • a description of the method of manufacturing and a statement on compliance with the good manufacturing practice,
    • where justified by the nature or the effect of the cosmetic product, proof of the effect claimed for the cosmetic product,
    • data on any animal testing performed by the manufacturer, his agents or suppliers, relating to the development or safety assessment of the cosmetic product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of third countries.

    The information contained in the product information file shall be available in a language which can be easily understood by the competent authorities of the Member State.

    Legal basis

  • When labelling, placing on the market and advertising, cosmetic products must not with the use of texts, names, trademarks, images and symbols be ascribed characteristics or functions which they do not actually have.

    The person responsible may indicate on the packaging that testing of the cosmetic product was not performed on animals only when providers or their suppliers did not implement any testing of the final cosmetic product or any of the contained ingredient on animals.

    Legal basis

  • 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

    Competent Authority

    Ministry of Health, Chemicals Office of the Republic of Slovenia

    Ajdovščina 4
    1000 Ljubljana

Cross-border/temporary provisions of activity

Postopek priglasitve kozmetičnega izdelka je enoten v vseh državah članicah EU.

Last modified:
15. 6. 2022