FSMPs
Food for Special Medical Purposes may support the exclusive or partial feeding of patients whose dietary management cannot be achieved by modification of the normal diet alone.
Food for Special Medical Purposes (FSMPs) include Oral Nutritional Supplements (ONS) and Enteral Tube Feeding (EFT). The definition of FSMPs can vary across regions of the world.
The EU has strict rules covering the content and labelling of foods designed specifically for people with medical needs. Within these rules, the EU Regulation on Foods for Specific Groups defines a Food for Special Medical Purposes (FSMPs) as “food specially processed or formulated and intended for the dietary management of patients, including infants, to be used under medical supervision; it is intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients contained therein, or metabolites, or with other medically-determined nutrient requirements, whose dietary management cannot be achieved by modification of the normal diet alone”.
The Codex Standard for the Labelling of and Claims for Foods for Special Medical Purposes (CODEX STAN 180-1991) defines in section 2 (Description) Foods for Special Medical Purposes as a category of foods for special dietary uses which are specially processed or formulated and presented for the dietary management of patients and may be used only under medical supervision. FSMPs are intended for the exclusive or partial feeding of patients with limited or impaired capacity to take digest absorb or metabolize ordinary foodstuffs or certain nutrients contained therein or who have other special medically determined nutrient requirements whose dietary management cannot be achieved only by modification of the normal diet by other foods for special dietary uses or by a combination of the two.
Resources
Labelling of Food for Special Medical Purposes - an MNI-SNE explanatory document
FSMP is defined in the Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control (‘FSG Regulation’).
According to the definition of Article 2(g) of the FSG Regulation, FSMP means ‘food specially processed or formulated and intended for the dietary management of patients, including infants, to be used under medical supervision; it is intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients contained therein, or metabolites, or with other medically-determined nutrient requirements, whose dietary management cannot be achieved by modification of the normal diet alone.’
MNI Statement of Principles "Differentiation between Food for Special Medical Purposes (FSMPs) and General Food within the scope of EU Regulations (November 2022)
This document is intended to provide information on Foods for Special Medical Purposes (FSMPs) and General / Fortified Food in the context of the European Union (EU) regulatory framework. It is for general information purposes only and does not constitute legal or other professional advice. It does not replace the relevant EU laws. The information provided is without prejudice to national regulations and interpretations.
MNI-ISDI - 6 easy ways to recognise an FSMP based on Codex Alimentarius - International Food Standards (January 2023)
The Codex Standard for the Labelling of and Claims for Foods for Special Medical Purposes defines them as a category of foods for special dietary uses which are specially processed or formulated and presented for the dietary management of patients and may be used only under medical supervision.
MNI-SNE - 6 easy ways to recognise a FSMP under the EU law (December 2022
The EU has strict rules covering the content and labelling of foods designed specifically for people with medical needs.
It is easy to recognise a FSMP by checking if the six legal points listed attached (read more) are on the lable in local language.
News
International institutions’ documents and other relevant information
- SNE-MNI joint Explanatory Document on the Labelling of Food for Special Medical Purposes
- Enteral Tube Feeding
- Commission Notice on the Classification of FSMP (November 2017)
- Regulation (EU) 609/2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control
- Regulation (EU) 2016/128 as regards the specific compositional and information requirements for food for special medical purposes
- EU Guidance for FSMPs – COM notice on the classification of FSMP (2017/C 401/01)
- CODEX standards on FSMPs – CODEX STAN 180-1991
