Abstract
The characterization and stability evaluation of food and food constituents (chemical active ingredient/microorganism) for which nutrition or health claims want to be requested are essential for the success of an application to EFSA. This work reviews the requirements that must be fulfilled for a full characterization of the active substance, comprising origin, elaboration, or extraction method, and chemical/microbiological composition, using validated analytical methods. The review focuses not only on establishing the specifications of the final active ingredient or food but also on ensuring homogeneity between batches. In addition, the article discusses the methodologies and conditions of the stability studies that need to be performed on food and food constituents to verify that the relevant compounds – chemical and microbiological active ingredients – will get to the consumer in the intended state and concentration to accomplish the claimed health effect over shelf life.
Acknowledgements
The authors also wish to acknowledge Dr Ana Romo Hualde (Centre for Nutrition Research) for her great support and help all along the development of the project INCOMES (Guide for the Support of Health Claims in foods: Immune and Cognitive functions and Metabolic Syndrome).
Declaration of interest
The authors report that they have no conflicts of interest. This work has been supported by the Project INCOMES (Barry Callebaut-La Morella Nuts SA, Biosearch SA, Biotecnologías Aplicadas SA, Bodega Matarromera SL, Miguel Torres SA, Galletas Gullón SA, Iberfruta SA, Laboratorios Ordesa SL, Newbiotechnic SA and Soria Natural SA), co-funded by the Spanish Ministerio de Economía y Competitividad (Centro para el Desarrollo Tecnológico Industrial) and FEDER. Also CIBERobn and SEN (Spanish Society of Nutrition) are gratefully acknowledged for their overall support concerning the presentations of this guide.