Food for Special Medical Purposes (FSMP)

FSMPs and their regulatory compliance in the EU

On 29 June 2013, Regulation (EC) Nº 609/2013 concerning Foods intended for Special Groups (the “FSG regulation”) was published and will repeal and replace the existing legislative framework for dietetic foods, including:

• Infant formula and follow-on formula
• Processed cereal-based food and baby food
• Total diet replacement for weight control
• Food for Special Medical Purposes (FSMPs)

FSMPs are defined as foods intended for the dietary management of patients that have:

• problems consuming ordinary food or are malnourished because of a specific diagnosed disease, disorder or medical condition;
• difficulties satisfying their nutritional needs through the consumption of other foods, including food supplement

As of 20 July 2016, Member States can forward notifications to the European Commission should they have doubts about the legal category of a product that will be marketed as an FSMP. In order to decide if a notified product falls within the scope of the FSG regulation and can thus be considered an FSMP, the European Commission may ask the European Food Safety Authority (EFSA) for scientific advice to evaluate the composition and proposed uses of the product to ensure their decision is based on sound scientific judgment.

Services in the field of food for special medical purposes

• Assess the legal category of the product and identify whether it qualifies as an FSMP
• Collect information to support the classification of an FSMP
• Evaluate existing data, identify gaps and provide expert advice for the generation of additional data or justifications for omissions in case a scientific assessment by EFSA is required
• Compile, write and submit FSMP dossiers to EFSA.
• Liaise with Member States, European Commission and EFSA