Foods for Special Medical Purposes (FSMP)

Foods for special medical purposes (FSMP) are intended for the dietary management of patients and may be used only under medical supervision. They are regulated by Directive 1999/21/EC for composition and labeling . These products must 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 directive on FSMP is replaced by a new specific text: Regulation (EU) 2016/128 as regards the specific compositional and information requirements for Food for Special Medical Purposes applies (instead of Directive 1999/21/EC) as of 22 February 2019 for FSMP developed to satisfy the nutritional requirements of people other than infants. FSMP developed to satisfy the nutritional requirements of infants shall apply from 22 February 2020, as the delegated Regulation (EU) 2016/127 concerning infant formula and follow-up formula.

General food law (food safety, information to consumers, novel foods, nutrition and health claims,…) also applies to FSMP.

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