Food for Special Medical Purposes (FSMP) serves the dietary needs of individuals who have specific medical conditions that make it challenging for them to meet their daily nutritional requirements through the consumption of regular foods. As per the European Union (EU) legislation, FSMP is primarily intended for patients with limited, impaired, or disturbed capacity to consume, digest, absorb, metabolize, or excrete typical foods, nutrients, or metabolites. However, FSMPs should only be used under medical supervision; also, their labeling must clearly state their intended use.

Bringing FSMP into the Market

To place Food for Special Medical Purposes (FSMP) on the market, Food Business Operators (FBOs) must notify the relevant national authority, and they also need to ensure that their product complies with EU regulations. This notification system is crucial for efficiently monitoring FSMP across EU member states.

The Rationale behind the EFSA Guidance

The European Commission (EC) sought guidance from the European Food Safety Authority (EFSA) regarding FSMP due to concerns from the Member States. Member States noted a rising number of products that were being marketed as FSMP, which raised doubts about whether these products genuinely qualified as FSMP. In turn, they found it difficult to apply a uniform legislative framework to these products, as their definition was no longer certain; owing to this ambiguity, they would often classify a product as a food supplement in one territory and an FSMP in another. To address this issue, new legal provisions were incorporated into the regulations guiding FSMP, which would help ensure a more consistent approach to the classification.

The Scope of the New Regulation

The FSG Regulation (EU No. 609/2013) covers FSMP, infant formulae, follow-on formulae, processed cereal-based foods and baby foods, and total dietary replacements for weight control. This regulation came into effect in July 2016 and has effectively replaced the previous legislative framework on “foods for particular nutritional uses.” In fact, it is the legal reference point for determining whether a food product should be classified as a Food for Special Medical Purposes (FSMP).

EFSA’s Role in Regulating FSMP

In response to a request from the EC, the EFSA Panel on Dietetic Products, Nutrition, and Allergies (NDA) was tasked with offering scientific and technical guidance regarding FSMP within the framework of Regulation (EU) No. 609/2013. This guidance document aims to assist manufacturers in the development and presentation of Regulatory dossiers. It outlines a standardized format for organizing the required information and delineates the information and scientific data that should be incorporated into the dossier. Additionally, it highlights the critical issues that necessitate attention in the dossier, thereby determining the degree to which a food product, when designated as an FSMP, aligns with the provisions of Regulation (EU) No. 609/2013 under its intended usage.

To sum up, Food for Special Medical Purposes (FSMP) plays a vital role in catering to the nutritional requirements of individuals with specific medical conditions that call for more than just daily dietary changes. The Regulatory landscape of FSMP is evolving and is rooted in EU and national guidelines, for which you can seek assistance from a Regulatory service provider like Freyr. Our experts can help you achieve compliance and facilitate your market access. With Freyr’s dedicated team by your side, navigating the intricate world of FSMP regulations will be a seamless journey. Reach out to Freyr for comprehensive Regulatory support and attain success in this specialized sector!