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 for composition and labeling by Regulation (EU) N° 609/2013 and Regulation (EU) 2016/128 as regards the specific compositional and information requirements for Food for Special Medical Purposes. This Regulation applies instead of  Directive 1999/21/EC since 22 February 2019 for FSMP developed to satisfy the nutritional requirements of people other than infants and since 22 February 2020 for FSMP developed to satisfy the nutritional requirements of infants as the delegated Regulation (EU) 2016/127 concerning infant formula and follow-up formula).

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.

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



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