The new cosmetics regulation increases safety and helps marketing

Spain - 

Fashion Law Commentary 1-2018

The European Union has one of the safest legal frameworks in the world, thanks mainly to the Cosmetics Regulation (Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of November 30, 2009). The purpose of the Regulation is twofold. Firstly, it aims to increase the safety of these products in order to ensure greater protection for European consumers. Secondly, it intends to remove barriers to intra-community trade by establishing a common framework for the entire EU. With this aim in mind, composition and labelling were unified, traceability requirements were tightened up and obligations were established to report serious undesirable effects.

Royal Decree 85/2018, of February 23, 2018 regulating cosmetics, which was published today in the Official State Gazette, does not alter the framework established by the Regulation at all. Instead, it addresses certain aspects that were not envisaged in the Regulation. By way of summary, the main points that the Royal Decree deals with are the following:

  • Determination of which authorities are to monitor the market and receive and transmit reports on serious undesirable effects and serious health risks.
  • The powers of these authorities to inspect and adopt health protection measures
  • Regulation of procedures to comply with the principle of administrative cooperation and the cosmetics national warning network
  • The language to be used in labelling and in cosmetics product information files
  • The structure of the control system following the manufacture and import of cosmetics
  • The implementation of the Spanish Cosmetovigilance System
  • Control of imports in the EU

It is therefore necessary to review the procedures followed by manufacturers and importers of cosmetics in order to ensure that they are in line with the new Royal Decree on Cosmetic Products.

The full text of the Royal Decree on Cosmetic Products published in the Official State Gazette on February 27, 2018 is available at