16 December 2015

MNI and SNE welcomes increased clarity of the EU legal framework for Food for Special Medical Purposes

Medical Nutrition International Industry (MNI), and Specialised Nutrition Europe (SNE) welcome the EU’s efforts to create a clearer framework for the provision of Foods for Special Medical Purposes (FSMP) to patients across Europe.

In particular, MNI and SNE welcome the final opinion published by EFSA on 26 November. The opinion provides guidance on information that EFSA needs to effectively advise decision-makers. Both MNI and SNE submitted comments on the draft EFSA opinion following a period of consultation with stakeholders over the summer. EFSA’s scientific and technical guidance acknowledges important aspects of the FSMP category, in particular, the important role of the Healthcare Professional (HCP) in determining the requirements of the patient in an overall clinical management context.

MNI and SNE are supportive of a clearly defined regulatory framework that will assist in ensuring that products are appropriately classified and placed on the market as FSMPs. With a view to ensuring uniform implementation of the Regulation (EU) 609/2013 (FSG Regulation), Member States may use Article 3 to request that the Commission takes a decision on whether a specific food (FSMP) is really in the scope of this Regulation.

In order to meet the needs of the patient and HCP communities, and to support the innovation drive in our sector, the Article 3 procedure and this EFSA guidance document should be used only in circumstances where a verification regarding an FSMP classification is needed.

We now look forward to working together with the EU decision-makers on the implementation of the FSG Regulation in order to ensure uniform application of these rules for the overall benefit of those under medical care across Europe.


Notes to editors:

  • The Medical Nutrition International Industry (MNI) is an international trade association comprised of six member companies that offer specialized nutritional solutions, including oral nutritional supplements, tube feeding and parenteral (intravenous) nutrition, that are designed to meet the diverse nutritional needs of patients. MNI is dedicated to advancing better care through better nutrition, across all ages and healthcare settings. MNI works with stakeholders from a variety of geographies and healthcare systems to ensure that medical nutrition becomes an integral part of patient care.
  • Specialised Nutrition Europe (SNE) is the trade association representing the interests of the specialised nutrition industry across the European Union. SNE members are the national associations of 16 Member States and their members are the companies producing tailor made dietary solutions for populations with very specific nutritional needs including infants and young children, patients under medical supervision, sportspeople, overweight and obese consumers, and those suffering from coeliac disease.