Abstract
| Endorsement date | 21 January 2021 |
| Implementation date | 27 March 2021 |
Following a request from the European Commission in 2014, the EFSA Panel on Dietetic products, Nutrition and Allergies (NDA) was asked to provide scientific and technical guidance on foods for special medical purposes (FSMP) 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. Upon request from the European Commission in 2020, this guidance has been revised to inform applicants of new provisions in the pre‐submission phase and submission application procedure set out in Regulation (EC) No 178/2002, as amended by Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain, that are applicable to all applications submitted as of 27 March 2021.
Keywords: food product, disease, disorder, medical condition, patients, dietary management
Suggested citation: Scientific and technical guidance on foods for special medical purposes in the context of Article 3 of Regulation (EU) No 609/2013. EFSA Journal 10.2903/j.efsa.2021.6544
Requestor: European Commission
Question number: EFSA‐Q‐2020‐00593
Panel members in 2015: 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.
Acknowledgements: Efsa wishes to thank the Panel on Nutrition, Novel Foods and Food Allergens (NDA) that endorsed this output in 2021: Dominique Turck, Jacqueline Castenmiller, Stefaan de Henauw, Karen‐Ildico Hirsch‐Ernst, John Kearney, Helle Katrine Knutsen, Alexandre Maciuk, Inge Mangelsdorf, Harry J McArdle, Androniki Naska, Carmen Pelaez, Kristina Pentieva, Alfonso Siani, Frank Thies, Sophia Tsabouri and Marco Vinceti. 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.
The revision aims to inform stakeholders of the new requirements set out in the General Food Law (Regulation (EC) No 178/2002, as amended by Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain), and to guide to EFSA’s practical arrangements implementing these new requirements. For this purpose, the revision concerns only the administrative part. The scientific content remains unchanged.
This Guidance is applicable for applications submitted as of 27 March 2021
References
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