Scientific and technical guidance on foods for special medical purposes in the context of Article 3 of Regulation (EU) No 609/2013


Panel on Dietetic Products, Nutrition and Allergies
EFSA Journal
EFSA Journal 2015;13(11):4300 [24 pp.].
Panel Members
Jean Louis Bresson, Barbara Burlingame, Tara Dean, Susan Fairweather-Tait, Marina Heinonen, Karen Ildico Hirsch-Ernst, Inge Mangelsdorf, Harry McArdle, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Kristina Pentieva, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Daniel Tomé, Dominique Turck, Hendrik Van Loveren, Marco Vinceti and Peter Willatts.
The Panel wishes to thank the members of the ad-hoc Working Group on foods for special medical purposes: Hildegard Przyrembel, Alfonso Siani, Dominique Turck and André Van Gossum for the preparatory work on this scientific opinion, and EFSA staff member Silvia Valtueña Martínez for the support provided to this scientific opinion.
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
28 October 2015
Published in the EFSA Journal
26 November 2015
European Food Safety Authority (EFSA), Parma, Italy
Following a request from the European Commission, the EFSA Panel on Dietetic products, Nutrition and Allergies (NDA) was asked to provide scientific and technical guidance on foods for special medical purposes in the context of Article 3 of Regulation (EU) No 609/2013. The guidance presented in this document is to assist in the preparation and presentation of well-structured dossiers. It presents a common format for the organisation of the information and outlines the information and scientific data which could be included in the dossier, as well as the key issues which should be addressed in the dossier in order to assess the extent to which a food product notified as FSMP falls under the scope of Regulation (EU) No 609/2013, under the proposed use. It is intended that the guidance will be kept under review and will be further amended and updated as appropriate in the light of experience gained from the evaluation of dossiers for specific food products notified as FSMP, and in the light of future Community guidelines and legislation. The scope of this guidance is limited to FSMPs in the context of Article 3 of Regulation (EU) No 609/2013. Out of the scope of this guidance are: a) other categories of food falling under Regulation (EU) No 609/2013, such as infant formula and follow-on formula, processed cereal-based food and baby food, and total diet replacement for weight control; b) meal replacements for weight control; c) “gluten-free” and “lactose-free” foods.
food product, disease, disorder, medical condition, patients, dietary management
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