Cosmetics were widely regulated in the framework of the European Union through the Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of November 30, 2009 on cosmetic products.  The aim of this regulation was: i) strengthened safety requirements, ii) introduction of “responsible person” position, iii) centralized notification of cosmetic products marketed in the EU, iv) reporting of serious undesirable effects. The Spanish Royal Decree 85/2018, of February 23, 2018 regulating cosmetics addresses certain aspects that were not envisaged in the above-mentioned Cosmetics Regulation. Specifically:

  • Inclusion of all players involved in the supply chain: manufacturers, importers, distributors, sellers and professional users.
  • Determination of which authorities are responsible to monitor the market and receive and transmit reports on serious undesirable effects and health risks.
  • The powers of these authorities to inspect the different players and adopt health protection measures.
  • 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.