Skip to main content

RESPONSIBLE PERSON AND DISTRIBUTOR

The Responsible Person

 

A responsible person should be designated for each cosmetic product placed on the European market. The responsible person may be the manufacturer, importer or person to whose order a cosmetic product is manufactured.

The responsible person shall be based within the EU and their address should appear on the cosmetic product packaging.

 

As there is no premarket approval of cosmetic products, the responsible person is obliged to comply with the Cosmetics Regulation and must keep and maintain a product information file, demonstrating the conformity of the products with the legislation. This product information file must be readily accessible to the competent authority.

 

The key requirements of the responsible person include but are not limited to: the product information file (PIF), Good Manufacturing Practices (GMP), consumer information, communication of serious undesirable effects, traceability within the supply chain, labelling, sampling and analysis, corrective actions in the event of product non-compliance and notification.

 

The Distributor

 

The key requirements of the distributor include but are not limited to: labelling verification, traceability within the supply chain, storage and transport conditions, corrective actions in the event of product non-compliance and communication of serious undesirable effects.