TY - JOUR

T1 - Scientific and technical guidance on foods for special medical purposes in the context of Article 3 of Regulation (EU) No 609/20131

T2 - (Scientific Opinion)

AU - EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)

AU - Sjödin, Anders Mikael

N1 - EFSA 2015 4300

PY - 2015/11/25

Y1 - 2015/11/25

N2 - 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 thelight 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.

AB - 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 thelight 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.

KW - Faculty of Science

KW - Food products

KW - Disease

KW - Disorder

KW - Medical condition

KW - Patients

KW - Dietary management

U2 - 10.2903/j.efsa.2015.4300

DO - 10.2903/j.efsa.2015.4300

M3 - Journal article

VL - 13

JO - E F S A Journal

JF - E F S A Journal

SN - 1831-4732

IS - 11

M1 - 4300

ER -