Grey Area Novel Foods: An Investigation into Criteria with Clear Boundaries
Corinne Sprong
National Institute for Public Health and the Environment (RIVM); PO Box 1, 3720 BA Bilthoven, The Netherlands.
Rick van den Bosch
WageningenUniversity, PO Box 9101, 6701 BH Wageningen, The Netherlands
Sven Iburg
WageningenUniversity, PO Box 9101, 6701 BH Wageningen, The Netherlands.
Kathelijne de Moes
WageningenUniversity, PO Box 9101, 6701 BH Wageningen, The Netherlands.
Elleander Paans
WageningenUniversity, PO Box 9101, 6701 BH Wageningen, The Netherlands.
Sofia Sutherland Borja
WageningenUniversity, PO Box 9101, 6701 BH Wageningen, The Netherlands
Hannah van der Velde
WageningenUniversity, PO Box 9101, 6701 BH Wageningen, The Netherlands.
Henk van Kranen
National Institute for Public Health and the Environment (RIVM); PO Box 1, 3720 BA Bilthoven, The Netherlands.
Henk van Loveren
National Institute for Public Health and the Environment (RIVM); PO Box 1, 3720 BA Bilthoven, The Netherlands.
Bernd van der Meulen
WageningenUniversity, PO Box 8130, 6700 EW Wageningen, The Netherlands.
Hans Verhagen *
National Institute for Public Health and the Environment (RIVM); PO Box 1, 3720 BA Bilthoven, The Netherlands and University of Ulster, Northern Ireland Centre for Food and Health (NICHE), Cromore Road, Coleraine, BT52 1SA, Northern Ireland.
*Author to whom correspondence should be addressed.
Abstract
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.
Keywords: Novel foods, EU regulation 258/97, food safety, grey area.