02/12/2015

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)  in the context of Article 3 of Regulation (EU) No 609/2013.

The main function of FSMPs is therefore to feed patients that, because of a particular disease /disorde r/medical condition, either have problems in consuming ordinary foodstuffs, or have specific medically-determined nutrient requirements whose dietary management cannot be achieved by modifying the normal diet. In both the sub-paragraphs of the definition quoted above, there is a clear indication of the difference between FSMPs and other foodstuffs that are not FSMPs: FSMPs are foods whose consumption by patients is necessary because it is impossible, very difficult or unrealistic for these patients to satisfy their nutritional needs through the consumption of foods other than FSMPs11. In this context, the Commission services have taken note of the requests of Member States to develop a guidance document that could assist Member States' competent authorities in their enforcement tasks and stakeholders in marketing their products under the appropriate legal framework.. The guidance presented in this document is to assist in the preparation  and presentation of well-structured dossiers. 

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:

1. the extent to which the specific food product is sufficiently characterised
2. the extent to which the disease/disorder/medical condition for which the specific product is intended is sufficiently characterised,
3. the extent to which patients suffering from the specific disease/disorder/medical condition for the dietary management of which the product is intended;
4. the specific role of the product in the dietary management of the disease/disorder/medical condition for which it is intended
5. 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.

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. presentation of well-structured dossiers. Work on this guidance is currently on-going.