Regulatory Information

Cosmetic products placed on the market in Ireland must meet the requirements outlined in Regulation (EC) No. 1223/2009 on cosmetic products, as amended (the ‘Cosmetics Regulation’) and S.I. 440 of 2013 European Union (cosmetic products) Regulations 2013. 

Guidance on cosmetic product legislation is available in our Guide to Cosmetics.

The Responsible Person

A responsible person (RP) should be designated for each cosmetic product placed on the European market. The RP 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 RP 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
  • Notification

Guidance for the responsible person is available in our Guide to Cosmetics for Responsible Persons.

The Distributor and Retailer 

The key requirements of the distributor, including the retailer, 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
  • Communication of serious undesirable effects

Guides

Guidance for distribution and retail of cosmetic products is available in our Guide to Distribution of Cosmetic Products in Ireland and our Information Leaflet  'Selling Cosmetic Products in Ireland'