New guidance on the classification of food for special medical purposes
Following the increasing difficulties with the enforcement of the legislative framework applicable to Food for Special Medical Purposes (FSMP) reported by national authorities of Member States, the European Commission has published on 25 November 2017 the Notice on the classification of FSMP. This gives the opportunity to take a closer look at this type of products.
FSMP vs ‘common’ food
National authorities have been faced with an increasing number of products placed on their markets as FSMP and, in particular, whether those products correspond to the definition of FSMP and fall within the scope of the FSMP legislation. Food business operators’ (FBOs) preference to market their products as FSMP may be justified by various reasons. These may include, for instance, the price that may be charged for FSMP, the fact that they are marketed while referring to the dietary management required by a disease, disorder or medical condition, or the possibility for patients to obtain reimbursement under medical insurance scheme (in the Benelux, medical insurance schemes provide partial or full reimbursement of FSMP under certain conditions).
However, regardless of the reasons for the FBOs’ decision, the misclassification of FSMP can lead to differences in enforcement across the EU and have an impact on the protection of consumers, free movement of goods and fair competition.
The objective of the Commission’s Notice is therefore to assist national authorities in the enforcement duties and FBOs in marketing their products appropriately and complying with the EU requirements. The Notice brings more clarification to identify FSMP, and consequently, to differentiate them from ‘common’ food and other products such as medicines or food supplements.
Rights and responsibilities of FBOs, national authorities and the European Commission
FSMP is regulated under Regulation 609/2013 known as the Regulation on Food for Specific Groups and Commission Delegated Regulation 2016/128 which specifies compositional and information requirements for this category of food. Commission Delegated Regulation 2016/128 will apply from 22 February 2019 (except FSMP intended for infants which will apply from 22 February 2020) and repeal Commission Directive 1999/21which laid down specific requirements for FSMP under the former legislative framework (PARNUTS Directive).
FSMP legislation does not impose any authorisation procedure on FBOs for placing FSMP on the market but requires a notification procedure. FBOs can therefore market their products as FSMP based on their own assessment that they comply with the FSMP legislation, in particular the definition of FSMP and relevant legal requirements for the product category concerned, subject to enforcement by national authorities. FBOs should also be aware that the principle of mutual recognition is irrelevant for the FSMP classification because the FSMP legislation provides harmonised rules. Concretely, this means that it is not because a product is lawfully marketed as a FSMP in a Member State that it should automatically be classified as such in all other Member States.
Member States are responsible for the enforcement of food law under Regulation 178/2002 on general food law. National competent authorities are therefore responsible to enforce the FSMP legislation on a product-specific basis. They should take into account different characteristics of the product, verify that if placed on the market as FSMP, the product actually falls within the scope of the FSMP legislation and complies with its relevant requirements. FBOs should be aware that the national authorities may request them to demonstrate compliance with the FSMP legislation at any time;
FSMP legislation empowers the Commission to adopt ‘interpretation decisions’ on whether a given food is correctly classified as FSMP or not. This empowerment results from the flexibility given to FBOs by the legislation when it comes to deciding the detailed composition of FSMP and the divergent approaches to the classification of the same product as FSMP that it may cause in different Member States. However, the ‘interpretation decisions’ are only a complementary tool for cases where Member States’ divergent approaches on the same product may cause problems to the free movement of goods and should not be used for a systematic classification of all FSMP. The Commission has not adopted any interpretation decision so far. Caution is therefore required when conducting a case-by-case assessment of whether a product complies with the definition of FSMP and other legal requirements for FSMP. Due consideration should be taken not only of the guidance provided in the Notice but also of the European Food Safety Authority’s (EFSA) scientific and technical guidance on foods for special medical purposes in the context of Article 3 of Regulation (EU) No 609/2013 on Food for Specific Groups where the Commission may decide to consult EFSA for scientific advice.
What is a FSMP?
FSMP is specially processed or formulated food intended for the dietary management, under medical supervision, of patients (including children) who suffer from a disease, disorder or medical condition and whose dietary requirements cannot be met by modifying a normal diet only.
The definition includes different elements:
FSMP vs other products
FSMP is food and not a medicinal product. The Notice specifies that the definition of FSMP has to be interpreted narrowly in order to distinguish it from foods other than FSMP such as food supplements or fortified foods which supplement the normal diet. In addition, a novel food ingredient that has been authorised to be used in FSMP will not automatically classify the final product as FSMP unless the product complies with the FSMP definition;
'Specially processed' or ‘specially formulated’
These concepts refer respectively to the manufacturing stage where substantial alteration of the initial product takes place (e.g. giving a specific consistency or viscosity to a product for the dietary management of dysphagia) and the development stage before the manufacturing (e.g. forecasting specific levels of energy and nutrients for products for patients with kidney failure). Products that are neither specially processed nor formulated should be excluded from the FSMP definition. This does not, however, preclude FSMP from containing ingredients of a ‘natural composition’;
FSMP is intended to provide nutritional support to patients who suffer from a specific disease, disorder or medical condition which leads to either (a) ‘limited, impaired or disturbed ability to take, digest, absorb, metabolise or excrete normal foods, nutrients or metabolites’, or (b) ‘other medically-determined nutrient requirements’. These conditions can be for instance the inability to digest or absorb sufficient foods/nutrients (e.g. short bowel syndrome) or the inability to excrete certain nutrients or their metabolites (e.g. phosphate and potassium for patients with kidney failure).
When placing products on the market as FSMP, both FBOs and national authorities have to conduct their assessment on a case-by-case basis. Concretely, this implies that they have to assess how ‘impossible, impractical, unsafe or nutritionally/clinically disadvantageous’ it is for the targeted patients to satisfy their nutritional needs by exclusively modifying their normal diet. If their nutritional needs can be exclusively satisfied with foods other than FSMP, a product cannot be placed on the market as FSMP for the dietary management of those patients;
‘Under medical supervision’
Because the consumers of FSMP are patients, their use must take place under medical supervision. In the context of the FSMP legislation ‘patients’ should be understood as ‘people suffering from specific diagnosed diseases, disorders or medical conditions, who as a result of such disease, disorder or medical condition need to consume FSMP’. This means that products for consumers who do not suffer from any disease, disorder or medical condition or products which can be used without medical supervision for the dietary management of patients should not be marketed as FSMP. It is also important to note that although the role of healthcare professionals in recommending and supervising the use of FSMP is key. They have the full discretion to choose the most appropriate follow-up of their patients and may recommend the use of other products than FSMP. Therefore, the recommendation of a healthcare professional cannot be decisive to classify a product a FSMP because only a detailed case-by-case analysis by the FBO of the FSMP definition allows to classify a product as FSMP;
‘Modification of a normal diet’
This concept refers to any adjustment to the diet by consuming foods other than FSMP. The aim of food supplements or fortified foods is to supplement or add nutrients or other substances to the normal diet. By supplementing or adding to the normal diet food supplements and fortified foods can be qualified as normal foods and apt to modify the normal diet. In addition, when analysing if the use of a specific product is safer or more practical than the exclusive use of food other than FSMP or if it has a clinical or nutritional advantage for the patient, FBOs and national authorities should take into account factors such as the severity of the disease, disorder or medical condition or the role of the specific product.
Although the definition includes different elements, the Notice clearly says that it must be interpreted in its entirety.
Categories of FSMP
FSMP legislation lists three categories in which FSMP can be classified:
- Nutritionally complete food with a standard nutrient formulation used either orally or by enteral tubewhich contains all the necessary nutrients at appropriate levels and may be used as the only source of nutrition for patients, e.g. enteral formulas for gastroenterological conditions;
- Nutritionally complete food with a nutrient-adapted formulation specific for a disease, disorder or medical condition which contains all the necessary nutrients at appropriate levels and may be used as the only source of nutrition for patients, e.g. MCT (Medium Chain Triglycerides) -containing formulas for malabsorption conditions;
- Nutritionally incomplete food with a standard formulation or a nutrient-adapted formulation specific for a disease, disorder or medical condition which either does not contain all the necessary nutrients or the appropriate quantities to be used as the only source of nutrition for patients and is used in addition to normal foods, adapted diet or other FSMP, e.g. a protein substitute for metabolic conditions.
All in all, the Commission’s Notice on FSMP attempts to give FBOs a sort of a check-list of required data they should compile in order to demonstrate that their product falls within the scope of FSMP legislation. FBOs should, however, carry out their assessment on a case-by-case basis. The necessary data should objectively demonstrate that ‘the specific group of patients suffering from a disease, disorder or medical condition for which the product is intended have nutritional needs that are impossible, impractical or unsafe or nutritionally or clinically disadvantageous to satisfy through the exclusive consumption of food other than FSMP’.
People for whom FSMP is intended should be easily distinguishable from those who are not in need of FSMP. When assessing the possibility to modify the normal diet through food other than FSMP, FBOs should refer to a typical person who suffers from the disease, disorder or medical condition for which the FSMP is considered. Finally, EFSA’s scientific and technical guidance on FSMP can also be helpful for FBOs when deciding whether their product is correctly marketed as FSMP or not.
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