In Vitro Genotoxicity Assessment of Functional Ingredients: Betaine, Choline, and Taurine.

Julen Sanz-Serrano,Damian Muruzabal,Ariane Vettorazzi,Adela López De Cerain,Amaya Azqueta

doi:10.3390/foods10020339

Abstract

This article focuses on a complete in vitro genotoxicity assessment of three nutrients widely used as functional ingredients in the European market: betaine, choline, and taurine. The European Food Safety Authority (EFSA) tiered approach for food additives in concordance with the safety assessment of chemicals in food developed by Food and Agriculture Organization/World Health Organization (FAO/WHO) was followed; the miniaturized Ames test in Salmonella typhimurium TA97a, TA98, TA100, TA102, and TA1535 strains (following the principles of Organization for Economic Co-operation and Development (OECD) 471), and the micronucleus test (OECD 487) in TK6 cells were performed. In addition, the in vitro standard and enzyme-modified (human 8-oxoguanine DNA glycosylase 1 (hOGG), endonuclease III (EndoIII), human alkyladenine DNA glycosylase (hAAG)) comet assay (S9−/S9+) was conducted in order to assess the potential premutagenic lesions in TK6 cells. None of the compounds produced any signs of genotoxicity in any of the conditions tested. This article increases the limited evidence available and complements the EFSA recommendations for the in vitro genotoxicity testing of nutrients.

Highlights

Over the past decade, new foods have emerged containing intentionally added compounds with a specific beneficial effect on health beyond their food counterparts
The responsibility for the safety of these foods lies with the food business operator, the addition of any substance in food is regulated in the European Union (EU) by the establishment of positive lists annexed to the above-mentioned regulations
Choline, and taurine were evaluated following the principles of the genotoxicity testing strategy proposed by European Food Safety Authority (EFSA) [18]

Summary

Introduction

New foods have emerged containing intentionally added compounds with a specific beneficial effect on health beyond their food counterparts. Choline, and taurine are three non-essential nutrients naturally present in food, but they can be intentionally added to food [2–4]. These compounds are part of many vital functions in the body and have been related with different health effects. The safety assessment of functional foods might fall under three regulations, “novel food” [13], “fortified foods” [14], or in “foods for specific groups” such as in infant formula or diet replacement foods [3]. The EU general food law [15] and the above-mentioned regulations specify that the safety should be guaranteed. The responsibility for the safety of these foods lies with the food business operator, the addition of any substance in food is regulated in the European Union (EU) by the establishment of positive lists annexed to the above-mentioned regulations

Methods

Results

Discussion

Conclusion