Demanding safe foods – Safety testing under the novel food regulation (2015/2283)

Abstract

BackgroundA legal framework cannot ensure that a food will never pose a risk to any consumer. Risk management procedures are put in place to control potential risks occurring from food consumption. In the EU, this is translated into premarket authorisation decisions to allow novel food products on the market, laid down in the Novel Food Regulation (NFR). Scope and approachIn the authorisation decision under the NFR, the scientific dossier dealing with the food product's safety is key. Various adjustments were made in updating the 1997 NFR to the new NFR (Regulation 2015/2283), but scientific dossier requirements seem comparable between both versions. This paper aims to optimise the crosstalk between the two corner stones of the NFR, science and regulation, and therefore reviews methodological requirements to establish food safety. Key findings and conclusionsFor novel foods, the scientific dossier must provide evidence that no adverse effects are elicited by consuming the product and consequently, kinetics, toxicology, nutritional information and allergenicity must be analysed. Methodological developments within these fields and specifically in toxicology will reduce required resources as well as the need for large numbers of experimental animals in conducting risk assessments. New methods should be embraced throughout the EU by promoting their (of course critical) use in safety assessments of foods.