Foods for special medical purposes

  • Foods for special medical purposes (FSMPs) are intended for the dietary management of patients and can be used only under medical supervision. They are regulated by Directive 1999/21/EC for composition and labelling. Those products have to be notified at national level and competent Authorities may request a bibliographic dossier justifying that the product meets the specific requirements of the target population.
  • Regulation (EU) N° 609/2013 concerning the revision of PARNUTS legislation provides that current directive on FSMPs will be replaced by a new specific text : Regulation (EU) 2016/128 as regards the specific compositional and information requirements for food for special medical purposes will apply instead of Directive 1999/21/EC from 22 February 2019.
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