EFSA has published Guidance on foods for special medical purposes (FSMPs) in the context of Article 3 of Regulation (EU) No 609/2013 on Foods intended for Specific Groups (FSG).
Article 3 allows the Commission to decide, on its own initiative, whether a food falls within the scope of the Regulation and to which specific category it belongs. The reason for this provision is that Member States had reported that an increasing number of products are being marketed as FSMPs but that, in many cases, they have doubts as to whether these products meet the regulatory definition of an FSMP. This may result in different interpretations and approaches to enforcement among Member States – for example a product may be classified as a food supplement in one territory and as an FSMP in another.
If the Commission decides to intervene, it may ask food business operators to make certain information available for the purpose of carrying out an assessment. EFSA may be asked to assist the Commission in determining:
(i) the extent to which the specific food product is sufficiently characterised;
(ii) the extent to which the disease/disorder/medical condition for which the specific product is intended is sufficiently characterised;
(iii) 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; and
(iv) 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).
The Guidance In anticipation of this new task. It provides a template that should be used when providing dossiers to EFSA. The template presents a common format and outlines the information and scientific data that would be needed for EFSA to advise the Commission.