Cosmetic Products

COSMETIC PRODUCTS

Before placing a cosmetic product on the market, a manufacturer or importer must prepare product information file (PIF) of the cosmetic product and notify it into the Cosmetic Products Notification Portal (CPNP).

A distributor must notify the cosmetic product into CPNP in case they translate the label for the product sold in another EU Member State.

If you have any doubts regarding your obligations, do not hesitate to contact us. We will be pleased to help.

Documentation preparation

We prepare the product information file (PIF) for the cosmetic product with due consideration of the type of product and legal requirements.

Product notification

We will notify cosmetic products into CPNP in accordance with guideline requirements.

Responsible person

If you lack experience, we can act as the responsible person on your behalf and assume responsibility for the cosmetic product.

GET IN TOUCH

Tel. +386 59016985
email: info@bisafe.si

Distributors’ obligations

The distributors of cosmetic products must verify whether the products are labelled correctly and in the language of the country where it is placed on the market.

If the label was not translated into Slovenian by the manufacturer, this must be done by the distributor, who must also report the change in labelling to the CPNP.

Manufacturers’ obligations

Before placing a cosmetic product on the market, its safety for human health must be demonstrated in accordance with Regulation EC 1223/2009 on cosmetic products.

Therefore, manufacturers and importers must appoint a responsible person to ensure compliance with the relevant obligations. This notably applies to preparing a dossier for the cosmetic product demonstrating its safety.

The product information file (PIF) contains:

  • A description of the cosmetic product
  • The cosmetic product safety report including:
    • Quantitative and qualitative composition of the cosmetic product
    • Physical/chemical characteristics and stability of the cosmetic product
    • Microbiological quality
    • Impurities, traces, information about the packaging material
    • Normal and reasonably foreseeable use
    • Exposure to the cosmetic product
    • Exposure to the substances
    • Toxicological profile of the substance
    • Adverse effects and serious adverse effects
    • Information on the cosmetic product
    • Labelled warnings and instructions for use
    • Assessment conclusion
    • Assessor’s credentials certificate
  • A description of the method of manufacturing and a statement on compliance with good manufacturing practice
  • Proof of the label claims
  • Data on any animal testing

GET IN TOUCH

Tel. +386 59016985
email: info@bisafe.si

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