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