Food Supplements and Foods for Special Medical Purposes (AFMS). EU review
Fedaisf editorial staff
For the purpose of distinguishing from Food Supplements, it should be noted that while the latter products comply with the regulatory definition of Directive 2002/46/EC even if they only have 4 beneficial "physiological" effects due to the supply of substances other than nutrients without any sharing in the constitution of the food ration (for example products based on plant extracts), Foods for Special Medical Purposes (AFMS) must necessarily have a "nutritive" role, as constituents of a food ration aimed at satisfying the nutritional needs of patients in specific conditions of nutritional vulnerability.
L’U.E. ha predisposto una revisione degli AFMS in vista dell’entrata in vigore del regolamento (UE) 609/2013. Il tema della effettiva rispondenza di prodotti notificati come Alimenti a Fini Medici Speciali (AFMS) alla definizione che ne dà la normativa specifica richiama da tempo grande attenzione a livello europeo, soprattutto in relazione al discrimine con l’area degli integratori alimentari (IA). La contestazione ricorrente da più parti è che molti prodotti presentati e notificati come AFMS, in riferimento a quelli nutrizionalmente incompleti, non hanno i requisiti per essere considerati tali e dovrebbero essere trattati come integratori alimentari.
With the ongoing evolution of the regulatory framework, the experience gained and the interpretative elements made available, there is a need to review some products included as AFMS in the National Register to assess whether, due to requirements and purposes, they should be reclassified as supplements food.
Tamong these, in particular, there are those products characterized by the presence of substances (in some cases even a single substance) whose activity profile, under scrutiny in the current situation, does not appear to be a poor representative for an effective "dietery management" role. The companies concerned may therefore be required to produce documentation on compliance with the regulatory definition of a product already classified as AFMS, including the elements indicated in the aforementioned "Guidance" to allow for an adequate review. If as a result of the re-evaluation it is concluded that the product does not meet the prescribed requirements, the company concerned will be notified and will have the right to resubmit the product itself as IC.
As far as AFMS are concerned, it should be considered that in the relevant section of the National Register, at the end of the preliminary procedure, all products notified as such are included and not only those payable by the NHS pursuant to the Ministerial Decree of 8 June 2001.
29/12/2015 da “Revisione degli AFMS” del Ministero della Salute
