On November 26, 2015, the European Food Safety Authority
("EFSA") published a guidance document, Scientific and technical guidance on foods for
special medical purposes in the context of Article 3 of Regulation
(EU) No. 609/2013. Foods for Special Medical Purposes
("FSMPs") are designed to feed patients who have a
limited, impaired, or disturbed capacity to take, digest, absorb,
metabolize, or excrete ordinary foods, or certain nutrients or
metabolites, or who have specific medical nutrient requirements,
typical to a disease/disorder/medical condition, that cannot be
reasonably or realistically satisfied by modifying the normal diet.
Regulation 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. The guidance
presented in this document is aimed at assisting in the preparation
and presentation of well-structured dossiers by establishing: (i) a
common format for the organization of the information, (ii) the
information and scientific data that could be included in the
dossier, and (iii) the key issues that should be addressed in the
dossier.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
