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The government of Spain has enforced Royal Decree 85/2018 Regulation for Cosmetic Products.

This Decree contains national provisions on cosmetic products, including aspects to be implemented by national authorities according to European Regulation (EC) 12232009 and other not specifically regulated by the same European Regulation.

This decree contains the complementary rules for the application of Regulation (EC) No. 1223/2009, in particular:

  • Spanish Agency of Medicines and Health Products as the competent authorities in the field of cosmetic products.
  • The national language of the labeling and of the Product Information File of cosmetic products, as well as the rules regarding the labeling of cosmetic products that are presented without prior packaging or are packaged at the place of sale.
  • The procedures for the communication of risks for the human health and of undesirable serious effects by the responsible people and the distributors of cosmetic products.
  • The procedures for the transmission of information on risks to human health and serious undesired effects among competent authorities.
  • The activities of market control for the supervision of compliance with the Regulation on cosmetic products, the powers of inspection and adoption of health protection measures by the authorities and the national alert network of cosmetic products.

This Decree was enforced on February 28, 2018.

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