A critical review of synthetic novel foods within the European regulation: proposed classification, toxicological concerns and potential health claims.

The NF concept was first established by Regulation (EC) 258/97 and includes any food that has not been used to a significant extent for human consumption in the EU before 15 May 1997. Synthetic novel foods (SNF) are a currently undefined group of NF without a universal definition. The objectives of this work are to perform an analysis of those currently authorized in the EU, identify their potential adverse effects and health benefits, and their health claims. For that, an extensive review of the available legislative documents and scientific literature regarding SNF was performed, and a market analysis was performed regarding their commercial availability. This review considers SNF as those that are obtained by chemical synthesis, excluding genetically modified foods. A total of 29 SNF were identified and classified into 9 categories, and their potential risks and benefits were described. All SNF were considered safe and different health benefits were studied and suggested for various categories. Currently, 22 SNF are available on the EU market. This work characterizes a previously unexplored food group and expands the knowledge in a new and promising research area combining health and toxicological perspectives with legislation for more optimal risk management in the EU.