Grey Area Novel Foods: An Investigation into Criteria with Clear Boundaries.

In the European Union novel foods are defined by the Novel Foods Regulation as food products and food ingredients that have not been consumed to a significant degree in the European Union before May 1997. However, there are new foods for some reason not considered as novel foods, although it may not be excluded that they differ from conventional foods to such an extent that an assessment of their safety prior to their entry to the market would be called for. Previously, we reported that this ‘grey area’ of novel foods exists and comprises: (1) food products or ingredients for which the current Novel Foods Regulation leaves too much space for different interpretations and (2) food products or ingredients that are not novel according to the current Novel Foods Regulation because it contains gaps. This paper focuses on how to handle these interpretation differences and gaps and provides recommendations to improve these pitfalls of the current Novel Foods Regulation. To this end, we propose criteria with clear boundaries as part of an assessment tool to reduce the uncertainties in interpretation with respect to consumption to a significant degree in the European Union, which take into account the commercial availability, length, extent and frequency of use of the particular food/ingredient. In addition, biological relevant boundaries for the criteria regarding changes in the nutritional value, metabolism (better all aspects of absorption, distribution, metabolism and excretion), and levels of undesirable substances are proposed for significant changes in the composition of foods due to changes in the production process. In addition, criteria are proposed to cover ambiguities and gaps in the Novel Foods Regulation dealing with food products and food ingredients obtained from 1) animals on a new feeding regime, 2) new varieties of organisms, 3) other growth stages of crops. Finally, a criterion that takes into account the total ingredient intake rather than single product intake is added to deal with the risk of overexposure to substances. Taken together, the proposed boundaries and criteria may contribute to diminishing the interpretation issues regarding the Novel Foods Regulation and thus to reducing the extent of the grey area of novel foods.