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Slovenia Cosmetic Product Registration

COSMETIC REGISTRATION IN SLOVENIA

Regulatory Authority

The Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP)

Link for Regulatory Authority

https://www.jazmp.si/en/human-medicines/

Local Regulation

Regulation EC 1223/2009 on cosmetic products.

Who can Register?

  • Manufacture
  • Importer or distributor
  • Responsible Person

Data to be Communicated

Prior to introducing a cosmetic product to the market, a manufacturer or importer is required to compile a Product Information File (PIF) for the cosmetic product and submit it for notification through the Cosmetic Products Notification Portal (CPNP). If a distributor translates the label for a product being sold in another EU Member State, they must also notify the cosmetic product into CPNP.

The Product Information File (PIF) Contains

A description of the cosmetic product.

The Cosmetic Product Safety Report Includes

  • A clear description of the cosmetic product enabling easy identification within the product information file.
  • Comprehensive cosmetic product safety report.
  • Description of the manufacturing method along with a statement confirming compliance with good manufacturing practices.
  • Provision of evidence supporting claimed effects for the cosmetic product when justified by its nature or impact.
  • Documentation of any animal testing conducted by the manufacturer, their agents, or suppliers, concerning the development or safety assessment of the cosmetic product or its ingredients. This includes testing performed to meet legislative or regulatory requirements of third countries.

All information within the product information file must be presented in a language that can be readily understood by the competent authorities of the Member State.

Cosmetic Notification

Before introducing the cosmetic product to the market, the responsible party must electronically notify the European Commission. This notification should include:

  • The cosmetic product’s category and specific name(s) for identification.
  • Name and address of the responsible person, where the product information file is accessible.
  • Country of origin for imports.
  • Member State where the cosmetic product will be marketed.
  • Contact details of a designated individual for emergency contact.
  • Declaration of the presence of nanomaterials.
  • Identification (name and CAS or EC number) of substances classified as carcinogenic, mutagenic, or toxic to reproduction (CMR), category 1A or 1B.
  • Frame formulation ensuring prompt and appropriate medical intervention in case of difficulties.

This electronic notification is carried out through the online Cosmetic Products Notification Portal (CPNP).

Designation of the Responsible Person

  • The appointment of an EU responsible person is mandatory for cosmetic products before they can be introduced to the market. The responsible person is tasked with guaranteeing the safety of the cosmetic product for human health and ensuring its compliance with cosmetic regulations.

Making a Safety Assessment of the Cosmetic Product

  • To secure the safety of the cosmetic product, conducting a safety assessment and assembling a report detailing the product’s safety is essential. This report is an integral component of the documentation containing information about the cosmetic product.

Timeframe and Fees

Additional Information

When labelling, marketing, and advertising cosmetic products, it is prohibited to attribute characteristics or functions to them through texts, names, trademarks, images, or symbols that they do not actually possess. The responsible party may state on the packaging that animal testing was not conducted on the cosmetic product only if neither the providers nor their suppliers performed any testing on animals for the final cosmetic product or any of its ingredients. Cosmetic products are permitted for sale solely if both their primary and secondary packaging prominently display the following information in permanent, easily readable, and visible lettering:

  • Name and Address of the responsible person.
  • Country of origin
  • Nominal content

Expiry date indicating until when the cosmetic product, stored under suitable conditions, will retain its intended function and compliance with Article 3 (‘date of minimum durability’)