Storitve odgovorne osebe

According to Regulation (EC) No. 1223/2009 The Responsible Person is responsible for

• Compliance of product production in accordance with requirements of Good Manufacturing Practice (GMP);

• Safety assessment and Cosmetic Product Safety Report

• Meet the requirements of the maintaining of documentation with the product information;

• Meet the required provisions for sampling and analysis;

• Compliance with the notification requirements;

• Meet the restrictions on substances identified in the Directive and it’s Anexes;

• Comply with requirements regarding animal testing;

• Compliance with labeling requirements;

• Comply with requirements regarding product claims;

• Comply with requirements regarding access to public information;

• Comply with requirements regarding the notification of serious adverse reactions;

• Comply with requirements in relation to information on the substances.

 

Slovene legislation: 

Supplier is any legal entity or individual entrepreneur  in the Republic of Slovenia, that :

  • 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 manufacturer’s representative or importer if the manufacturer’s main office is not in the Republic of Slovenia or in the European Union.

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.

 

 

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.

 

Responsible Person shall

  • Make an assessment of the safety and drawn up a report on the safety of the cosmetic product;
  • Keep a dossier (PIF) of information on the cosmetic product (10 years);
  • Make an electronic notification of cosmetic product to the European Commission;
  • Make an electronic notification of cosmetic product containing substances in the form of nanomaterials on the European Commission;
  • Cosmetic product is labeled in accordance with applicable law;
  • Reported a serious adverse effect of the cosmetic product.

 

The distributor is the responsible person where the cosmetic product on the market with their name or under their own brand or the product that is already on the market, be amended so as to affect the conformity with the applicable requirements. Translation information about the cosmetic product that is already on the market, shall not be considered as a modification of the product, which may affect compliance with the applicable requirements of the regulation.

 

The distributor shall ensure that:

  • The cosmetic product is labeled in accordance with applicable law;
  • All the requirements regarding the language;
  • Cosmetic product has not expired date of minimum durability;
  • Storage or transport conditions do not jeopardize its compliance with the requirements of the regulation;
  • Reported a serious adverse effect of the cosmetic product.