In the European Union (EU), novel foods and Genetically Modified Organisms (GMOs) are subject to long and costly authorisation procedures and post-marketing requirements. The regulatory frameworks applicable to novel foods and GMOs come into effect based on perceived factors of risk. These “risk triggers” are characteristics of novel foods and GMOs which differentiate them from traditional foods, creating a presumption of risk. Within the EU, consumer acceptance of genetically modified foods and novel foods like insects or cultivated meat is shaped by heuristics and biases, mainly focusing on the “novelty” and “unnaturalness” of these products, resulting in a predominantly negative perception. This paper investigates the close connection between cognitive biases identified in consumer perception literature and the implementation of specific risk triggers in the regulation of novel foods and GMOs in the EU. It subsequently raises concerns about the appropriateness of these risk triggers in forming a presumption of risk for these innovative products.

Responding to mistrust in the European agencies’ risk assessments in politically salient cases, the European Union (EU) legislator, the European Food Safety Authority and the European Medicines Agency alike have accelerated their efforts to foster EU regulatory science transparency. These simultaneous endeavours have, however, taken place in a fragmented legislative and administrative context, with each agency operating under a different legal framework. By focusing on authorisation procedures, from registration of studies to authorisation of novel foods, pesticides and human medicines, this article examines the resulting regimes governing the disclosure of scientific data by EU agencies to identify common trends and sectoral specificities. Against the background of an overall shift towards enhanced transparency, we shed light on, first, the circulation of institutional arrangements and practices among agencies and, second, the new dimensions of transparency emerging from these developments. We also highlight the remaining sectoral differences and argue that they could have potentially large impacts on the amount and type of information disclosed and on the level of transparency perceived by stakeholders and citizens. We argue that more coherence across the sectoral transparency regimes is needed, in particular in light of the agencies’ contested legitimacy and of their increasing cooperation on cross-cutting issues like antimicrobial resistance and medicine and pesticide residues in food.

The human diet has undergone profound changes over recent generations and this trend is likely to accelerate in the 21st century. Innovations in food technology, new ways of producing and processing foods and the increasing use of artificial vitamins and novel ingredients are changing the human diet in ways that our dietary monitoring systems struggle to keep pace with. There is a growing awareness of the importance of diet, but little understanding of how these changes may affect the health of current and future generations. Epigenetic programming, and specifically the persistence of functional epigenetic states following nutritional exposure, is particularly relevant to the issue of dietary change. Epigenetics is emerging as perhaps the most important mechanism through which diet and nutrition can directly influence the genome and there is now considerable evidence for nutritional epigenetic programming of health and the response to diet itself. A number of nutrients and food components that are changing in the human diet have been shown to produce epigenetic states that are stable across different timescales. We need to better understand the nutritional programming of epigenetic states, the persistence of these marks in time and their effect on biological function and the response to diet.

European Union Regulation 258/97 defines novel foods 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 that for some reason are not considered as novel foods, though we think that safety of these products is not always a priori established. We defined a ‘grey area’ which consists of such foods, and the present paper intends to raise awareness of this ‘grey area’ of unidentified novel foods. The grey area of novel foods is divided into two categories: (1) food products or ingredients for which the current Regulation leaves too much space for different interpretations and (2) food products or ingredients that are not novel according to the current Regulation, because the current Regulation contains gaps. These categories are illustrated by means of products already on the market in The Netherlands. We found about two dozen examples of products that had not been identified as novel foods according the current Regulation, yet could be considered to be classified as novel foods and hence for which a safety evaluation (toxicological and/or nutritional) would be indicated.

There are few good sources of natural food folates apart from green leafy vegetables and these may have a limited potential to increase folate status because of substantial losses that can occur during cooking. Fortified foods can overcome this but are controversial because of safety concerns regarding chronic exposure to high-dose folic acid (FA; the synthetic form). The aim of the present study was to develop eggs with an enriched natural folate content and minimal unmetabolised FA. Forty-eight, 30-week-old laying hens were randomised to receive the basal feed (formulated to provide 1 mg folate/kg feed) to which had been added one of the following FA levels (0, 2, 4, 8, 16, 32 mg/kg feed). Total folate was measured in eggs collected throughout the 12-week study period and the FA content estimated at 12 weeks. Results showed that the maximal egg folate content was achieved by adding 16 mg FA/kg feed. At this optimal dose, the total folate content per egg was 75 μg (compared with 32 μg in a regular egg) of which FA represented at most 10 %, a level which would probably be converted into natural folates by humans after ingestion. The results demonstrate that it is possible to use synthetic FA at high doses to produce novel animal foods enriched with natural folates in a cost-efficient process. Such foods may be particularly relevant to European populations without access to FA fortification and therefore dependent on natural food folate sources for the primary prevention of folate-related disease.

Foods represent important stimuli for humans, especially for human children. After weaning, it is important that children quickly acquire knowledge about their food environment to avoid ingesting potentially dangerous substances. This paper discusses this process and its implications in terms of schemas. The effects of providing positive taste information to novel foods and of adding familiar flavors to novel foods are interpreted by means of the schema construct. A means of changing schemas through exposure to schema-inconsistent information is presented and evidence for its efficacy is described. Finally, the effect of early variety on subsequent willingness to eat unfamiliar foods is described and once again interpreted by means of the schema construct.

Concerns have been expressed that the introduction of novel foods into the diet might lead to the development of new food allergies in consumers. Novel foods can be conveniently divided into GM and non-GM categories. Decision-tree approaches (e.g. International Life Sciences Institute-International Food Biotechnology Council and WHO/FAO) to assess the allergenic potential of GM foods were developed following the discovery, during product development, of the allergenic potential of GM soyabean expressing a gene encoding a storage protein from Brazil nut (Bertolletia excelsa). Within these decision trees considerations include: the source of the transgene; amino acid homology with known allergens; cross-reactivity with IgE from food-allergic individuals; resistance to proteolysis; prediction using animal models of food allergy. Such decision trees are under constant review as new knowledge and improved models emerge, but they provide a useful framework for the assessment of the allergenic potential of GM foods. For novel non-GM foods the assessment of allergenic potential is more subjective; some foods or food ingredients will need no assessment other than a robust protein assay to demonstrate the absence of protein. Where protein is present in the novel non-GM food, hazard and risk assessments need to be made in terms of the quantity of protein that might be consumed, the identity of individual protein components and their relationships to known food allergens. Where necessary, this assessment would extend to serum screening for potential cross-reactivities, skin-prick tests in previously-sensitised individuals and double-blind placebo-controlled food challenges.