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EFSA News Item, 26 November 2015
EFSA has published scientific and technical guidance that will help the European Commission to apply new rules on foods for special medical purposes (FSMPs). But what are these products and how will the new rules work? Our nutrition specialists answer the key questions.
What are FSMPs?
FSMPs are designed to feed patients who, because of a particular disease, disorder or medical condition, have nutritional needs that cannot be met by consuming standard foodstuffs. Specifically, according to EU legislation they are intended for patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary foods, or certain nutrients or metabolites; or with other medically nutrient requirements whose dietary management cannot be achieved by modification of the normal diet alone.
FSMPs should be used only under medical supervision and must carry labelling information about their intended use.
How are FSMPs placed on the market?
Food business operators can place an FSMP on the market after notifying a national authority, provided that the product complies with the relevant EU rules. This notification system is designed to enable the efficient monitoring of such foods in Member States.
Why did the European Commission ask EFSA to produce this guidance?
Member States report that an increasing number of products are being marketed as FSMPs but that, in many cases, they have doubts as to whether these products meet the regulatory definition of an FSMP. This makes the application of the legislative framework for FSMPs increasingly challenging and may result in different interpretations and approaches to enforcement among Member States – for example a product may be classified as a food supplement in one territory and as an FSMP in another. In this context, a new legal provision has been included in the regulation that will in future apply to FSMPs in the EU to ensure a more consistent approach to their classification.
What does the new regulation cover?
The Regulation on Foods intended for Specific Groups – the “FSG Regulation”, or (EU) No 609/2013 – applies to FSMPs, as well as infant formula and follow-on formulae, processed cereal-based foods and baby foods, and total diet replacements for weight control. It repeals and replaces the existing framework legislation on products previously known as “foods for particular nutritional uses” and will come into effect in July 2016. One of its provisions allows the Commission to step in and decide whether a given food falls within the scope of the regulation and should be classified as an FSMP or not.
EFSA has already provided scientific advice to the Commission on the essential composition of infant and follow-on formulae, and total diet replacements for weight control to assist with the implementation of the FSG regulation.
How will EFSA be involved?
If the Commission decides to intervene, it may ask EFSA to evaluate information about the composition and proposed uses of the product, to ensure that its decision is based on sound scientific judgment. In anticipation of this new task, the Commission asked EFSA to draft a template that should be used when providing dossiers to EFSA. The template presents a common format and outlines the information and scientific data that would be needed for EFSA to advise the Commission. Further details will be made available by the Commission on how its “interpretation decisions” will be prepared and on the procedure for collecting data for submission to EFSA.
What information could be included in the dossiers?
The template is divided into six sections, ranging from simple administrative and technical data to information on the nutritional profile of the product, the target patient population and the disease, disorder or medical condition for the dietary management of which the product is designed. Crucially, the dossier will have to explain why the use of the specific food product is necessary or is more practical or safer than the exclusive use of non-FSMP foodstuffs.
Is the EFSA scientific and technical guidance ‘set in stone’?
As for any new task, EFSA will update and amend the scientific and technical guidance in the light of experiences gained in the evaluation of dossiers. However, EFSA has already carried out an extensive public consultation and believes that this guidance is a solid basis for the assessments that it will be asked to carry out after July 2016.
For more details on the EFSA website, see: Scientific and technical guidance on foods for special medical purposes in the context of Article 3 of Regulation (EU) No 609/2013