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

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Article
Panel on Dietetic Products, Nutrition and Allergies
EFSA Journal
EFSA Journal 2015;13(11):4300 [24 pp.].
doi
10.2903/j.efsa.2015.4300
Panel members at the time of adoption
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

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.

Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2014-00736
Adopted
28 October 2015
Published
26 November 2015
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

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.

Summary

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 (FSMPs) to advise on different aspects that the Commission may consider when taking decisions pursuant to Article 3 of Regulation (EU) No 609/2013.
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:

  • 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;
  • meal replacements for weight control;
  • “gluten-free” and “lactose-free” foods.

The questions which the Commission may ask EFSA to address in specific mandates after 20 July 2016 in order to take decisions pursuant to Article 3 of Regulation (EU) No 609/2013 on the classification of specific food products as FSMPs are the following:

  • the extent to which the specific food product is sufficiently characterised, i.e. the extent to which the information provided allows an accurate description of the specific food product regarding the characteristics which may be important for its classification as FSMP.
  • the extent to which the disease/disorder/medical condition for which the specific product is intended is sufficiently characterised, i.e. the extent to which the information provided allows to distinguish between patients for whom the specific food product is intended and other individuals for whom the specific food product is NOT intended.
  • the extent to which patients suffering from the specific disease/disorder/medical condition for the dietary management of which the product is intended; a) are in the impossibility or difficulty to take, digest, absorb, metabolise or excrete ordinary foodstuffs, or certain nutrients contained therein or metabolites, or b) have specific medically-determined nutrient requirements, typical to the disease/disorder/medical condition, that cannot be reasonably or realistically satisfied by modifying the normal diet, i.e. the extent to which it is impossible, impractical or unsafe for patients for which the specific food product is intended to consume exclusively foodstuffs (including fortified foods and food supplements) that are not FSMPs, and/or the extent to which such patients would have a nutritional or clinical disadvantage from consuming exclusively foodstuffs (including fortified foods and food supplements) that are not FSMPs.
  • the specific role of the product in the dietary management of the disease/disorder/medical condition for which it is intended, in particular the extent to which the specific product is different from / more suitable than foods that are not FSMPs, taking into account its composition, its intended use and the proposed instructions of use (including patterns of consumption); i.e. the extent to which the specific food product is different from foodstuffs (including food supplements and fortified foods) that are not FSMPs, owing to its composition, manufacturing process, physical form, mode of administration, pattern of consumption and/or other reasons; the extent to which the use of the specific food product in the dietary management of patients for whom the product is intended is necessary or more practical or safer than the exclusive use of foodstuffs (including fortified foods and food supplements) that are not FSMPs, and/or it has a nutritional or clinical advantage for the patient; the reasons why the specific food product needs to be administered under medical supervision.
    Guidance for the assessment of FSMP
  • any potential restrictions of use, i.e. whether the specific food product may be unsafe if consumed by subjects other than patients for whom the specific product is intended.

The following information could be provided in the dossier, and the structure could follow a common format, i.e. order and numbering system of different parts, headings and sub-headings. The data provided in the dossier could be organised into six Parts.

Part 1 contains administrative and technical data, such as the identification form, information related to the party responsible for the dossier, and the dossier specifications, including the proposed use(s).

Part 2 contains information relative to the characterisation of the specific food product proposed as FSMP, including its name and characteristics, list of ingredients, its energy and nutrient content, any relevant information on the special formulation or processing of the food product, a description of the manufacturing process, and stability information.

Part 3 contains information relative to the proposed use(s) for the specific food product, including the target patient population, the disease/disorder or the medical condition, the conditions of use and, where applicable, the restrictions of use.

Part 4 comprises information relative to the characterisation of the disease/disorder or the medical condition, and of the patients for whom the specific food product is intended for each proposed use, including information on the impact of the disease/disorder or the medical condition on the nutritional status of the patients, if any.

Part 5 contains information on the specific role of the food product in the dietary management of patients under each proposed use, including an explanation on why the use of the specific food product in the dietary management of patients is necessary or why it is more practical or safer than the exclusive use of foodstuffs that are not FSMPs, and/or why it has a nutritional or clinical advantage for the patient.

Part 6 comprises information on the conditions and restrictions of use for each proposed use, including information on the quantity and pattern of consumption, the route of administration, and the reasons why the product should be administered under medical supervision.
Where some of the data described in this guidance document do not apply to a specific food product or proposed use, reasons/justification could be given for the absence of such data in the dossier.

Keywords
food product, disease, disorder, medical condition, patients, dietary management
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Number of Pages
24