Non-clinical toxicity studies on bioactive compounds within the framework of nutritional and health claims

Abstract

The growing presence of products on the market with added value in terms of health makes essential their regulation and harmonization in critical aspects such as safety. The toxicology applied to the bioactive compounds should demonstrate the absence of toxic effects at doses advised for consumption, as well as evaluate the potential toxic effects in the assumption that the products are used in quantities superior to those recommended. The specific strategy should be defined case by case; therefore, prior to any toxicological development, it is essential to study all the information regarding the bioactive compounds (BACs) characterization, nutridynamics and nutrikinetics, that is available. In this guideline, a general strategy to be applied in the development of BACs is proposed. It includes a first in vitro phase to discard genotoxicity and endocrine effects and a second in vivo phase with different possibilities regarding the duration and the extension of the studies.

• Bioactive compounds
• development strategy safety
• endocrine effects
• genotoxicity
• non-clinical toxicology

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

All authors declare no conflict of interest concerning this supplement. This work has been supported by the Project INCOMES (Barry Callebaut-La Morella Nuts SA, Biosearch, Biotecnologías Aplicadas SA, Bodega Matarromera SL, Miguel Torres SA, Galletas Gullón SA, Iberfruta SA, Laboratorios Ordesa SL, Newbiotechnic SA and Soria Natural), co-funded by the Spanish Ministerio de Economía y Competitividad (Centro para el Desarrollo Tecnológico Industrial) and FEDER. Also CIBERobn and SEÑ (Spanish Society of Nutrition) are gratefully acknowledged for global support concerning the presentations of this guide.