Food Supplements and Foods for Special Medical Purposes (AFMS). EU review

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.

The EU has prepared a revision of the AFMS in view of the entry into force of Regulation (EU) 609/2013. The issue of the effective compliance of products notified as Food for Special Medical Purposes (AFMS) with the definition given by the specific legislation has attracted great attention at European level for some time, especially in relation to the distinction with the area of food supplements (IA). The recurring objection from many quarters is that many products presented and notified as AFMS, with reference to those nutritionally incomplete, do not have the requisites to be considered as such and should be treated as food supplements.

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 from "Revision of the AFMS" of the Ministry of Health

Ministry of Health. Revision of the AFMS in view of the entry into force of Regulation (EU) 609/2013 

Regulation (EU) 609/2013

Dietetic Foods/Foods for specific groups

Directive 2002/46/EC for the approximation of the laws of the Member States relating to food supplements

National registers of foods for special medical purposes

 Ministerial Decree June 8, 2001

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