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The Role of Heuristics and Biases in the Choice of Risk Triggers for Novel Foods and GMOs in the European Union

Published online by Cambridge University Press:  18 September 2024

Alessandro Monaco Open the ORCID record for Alessandro Monaco [Opens in a new window]
Alessandro Monaco*
Affiliation:
Chair of Food Law, Faculty of Life Sciences: Food, Nutrition and Health, University of Bayreuth, Fritz-Hornschuch-Straße 13, 95326 Kulmbach, Germany
*
Email: alessandro.monaco@uni-bayreuth.de
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Abstract

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.

Keywords

GMOsnovel foodsrisk regulation

Information

Type
Articles
Information
European Journal of Risk Regulation , Volume 16 , Special Issue 1: Special Issue on Charting the Landscape of Automation of Regulatory Decision-Making , March 2025 , pp. 217 - 227
Creative Commons
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This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution and reproduction, provided the original article is properly cited.
Copyright
© The Author(s), 2024. Published by Cambridge University Press

I. Introduction

Despite their potential to mitigate the negative effects of population growth, climate change, biodiversity loss, and environmental degradation,Footnote 1 novel foods and genetically modified organisms (GMOs) face severe regulatory burdens in the European Union (EU). Novel foods and GMOs are legally presumed to be risky and are subject to strict requirements, namely pre-market approval, mandatory labelling and traceability requirements.Footnote 2 Scholars have criticised these regulatory measures for slowing down the innovation process in the EU food sectorFootnote 3 and for delaying the realisation of the benefits these innovations can bring.Footnote 4

Foods are categorised as novel foods and GMOs when they exhibit particular features that warrant regulatory oversight in the eyes of the legislators, the “risk triggers.” Risk triggers are thus characteristics of innovative products and/or processes identified by the legislator as factors of risk that differentiate innovations from comparable, traditional alternatives.

Risk triggers and subsequent regulatory requirements are determined by legislators and policymakers taking into consideration several factors. First, the legislation’s objectives to protect human health, the environment, and consumer interests, along with ensuring the functioning of the internal market: authorisation procedures are designed to assess and manage the potential harm posed by those products that are presumed to be risky. Second, the disruptive potential of novel foods and GMOs could provoke hostility from established industries, which might lobby against their widespread adoption. For example, the dairy and meat sectors oppose the use of terms like “steak,” “milk,” and “butter” for plant and fermentation-based alternatives to animal products.Footnote 5 Third, legislators and policymakers consider the perception of these products by the general public.Footnote 6 Consumers’ acceptance of novel foods and GMOs is shaped by emotions, personal attitudes, and cultural and social identity, which lead to the formation of heuristics, mental shortcuts humans instinctively use to make decisions under uncertainty, and related biases.Footnote 7 Heuristics and biases subsequently affect consumers’ willingness to adopt novel foods and GMOs.Footnote 8

This paper investigates the close connection between cognitive biases identified in consumer perception literature and the implementation of particular 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.

1. Structure of the paper

In the first section, I introduce the role that heuristics and biases play in decision-making, and shed light on which heuristics and biases affect the general public’s perception of novel foods and GMOs according to literature.

Afterwards, I illustrate the general principles of the legal framework applicable to novel foods and GMOs in the EU and investigate the use of risk triggers in their regulation, focusing on “novelty” and “unnaturalness.”

Finally, I explore the link between heuristics and biases identified in consumer perception literature, and the use of “novelty” and “unnaturalness” as risk triggers in the regulatory framework applicable to novel foods and GMOs in the EU. I then discuss whether such risk triggers constitute suitable indicators of risk and whether they are appropriate for regulating food innovations.

II. Heuristics and biases in consumer perception of novel foods and GMOs

1. Heuristics and biases

Heuristics are mental shortcuts used to solve problems and guide our minds to make decisions under uncertainty.Footnote 9 Heuristic theory is based on the dual process of decision-making, in which “System 1” is an instinctive, not mentally demanding response to the situation, and, by contrast, “System 2” is the process of evaluating all data and information to make informed choices through effortful mental activities.Footnote 10

Heuristics are the base of “System 1” thinking. Considering that making optimal decisions under uncertainty is, at best, improbable, the role heuristics play does not necessarily have to be negative. It would be impossible to always consider all relevant data and information.Footnote 11 For this reason, mental shortcuts are essential for responding to information overload.Footnote 12 Unfortunately, heuristics can sometimes promote long-term biases, systematic errors in thinking that interfere with our decision-making and influence our perception of risk.Footnote 13 Taking as an example a flight booking: a photo or a report of an airplane crash might influence the perceived risk of flying more than any statistics showing that airplanes are safer than cars. This would ultimately prompt us to decide to use a car, a result of the “availability heuristic”.Footnote 14 Heuristics and subsequent biases are generated by emotions, personal attitudes, membership in social groups, and cultural and social identity, and are context dependent.Footnote 15

2. Consumer perception of GMOs and novel foods

Despite some fluctuations over the years,Footnote 16 consumer perception of GMOs in the EU has never been positive.Footnote 17 Even if scientific evidence has consistently proved that GMOs do not pose adverse effects on human health and/or the environment, GMOs trigger emotional responses based on ethics and risk aversion towards potential long-term effects.Footnote 18 In particular, the general public has difficulties in perceiving the benefits of GMOs for food uses.Footnote 19 The opposition towards GMOs has been linked to the intuitive appeal of anti-GMO messages, explained in part by cognitive processes such as the fear of unnatural products and emotions like disgust.Footnote 20 The aversion is further fuelled by anti-biotech advocates and their negative (visual) portrayals of GMOs.Footnote 21

On the contrary, assessing public perception of novel foods as a whole is difficult, because of how diverse novel food categories are. One market segment, however, includes a large number of novel foods, whose number is deemed to increase in the future: the alternative protein sector. Alternative proteins are meant to substitute traditional animal protein sources and are produced from plants or animal cells, or by way of fermentation.Footnote 22 For example, cultivated meat, products of precision fermentation, and insects.Footnote 23 Studies on alternative proteins represent the majority of the literature evaluating consumer perception of novel foods, focusing mainly on insects and cultivated meat.Footnote 24 Factors that negatively affect the perception of novel foods are disgust, food neophobia, and perception of unnaturalness.Footnote 25 On the contrary, familiarity is related to higher consumer acceptance.Footnote 26

Siegrist and HartmannFootnote 27 point to disgust sensitivity, neophobia, and cultural factors as the main emotions and personality traits affecting the perception of gene technology and novel foods. They cluster them into three heuristic cues: the “affect heuristic,” the “natural-is-better heuristic” and the “trust heuristic.”

Under the effect of the “affect heuristic,” people rely on emotions derived from single traits or attached to images to judge risks and benefits associated with novel foods and GMOs. For example, the feeling of disgust that insects cause drives consumers to reject products that contain them, despite the nutritional and environmental benefits that the consumption of insects might bring. The affect heuristic leads to a “status quo bias,” the tendency to reject changes, and to the preference for familiar products.Footnote 28

The “natural-is-better heuristic” postulates that the perceived level of naturalness of a food product points to its health benefits and overall quality, leading to a misconception of nature, which is thought of as pure, safe and benign.Footnote 29 Biological hazards like bacterial contamination are perceived as far less threatening than potential, nonproven, bad outcomes of artificial manipulations like gene editing.

The “trust heuristic” substitutes the conscious assessment of the innovation with the level of trust towards the source of the innovation. An example is the intuitive preference for products developed by local companies or young start-ups over those from multinational corporations with global presence. When approaching and processing information, particularly when the issues at stake are culturally controversial, people subject to the “trust heuristic” tend to be conditioned by the “framing effect,” according to which decisions are taken based on how information is presented,Footnote 30 and to a “confirmation bias,” which builds up a certain position by considering only information and data in line with their a priori considerations.Footnote 31

III. Risk triggers in the Legal Framework applicable to GMOs and Novel Foods in the EU

1. Legal Framework applicable to GMOs and Novel Foods in the EU

Regulation (EU) 2015/2283Footnote 32 on novel foods (from here on referred to as the “Novel Food Regulation” or NFR) defines novel foods as foods that were not used for human consumption to a significant degree within the EU before 15 May 1997, and that fall under at least one of the novel food categories.Footnote 33 Examples include insects and cultivated meat, plant extracts and products of fermentation.

GMOs, on the other hand, are defined in Directive (EC) 2001/18 on the release into the environment of genetically modified organisms as “organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination.”Footnote 34

In the EU, the NFR and Regulation (EC) 1829/2003Footnote 35 on the placing on the market of genetically modified food and feed (the “GMOR”) are the two pieces of legislation that regulate the market entrance of novel foods and foods produced from or containing GMOs. Together, they cover almost all innovative food sources.

Article 114 of the Treaty on the Functioning of the European Union provides the legal base for the NFR and the GMOR;Footnote 36 Accordingly, they both aim at protecting human health, the environment, and consumer interests, along with ensuring the functioning of the internal market.

The NFR and the GMOR follow the principle of risk analysis, as stipulated in Article (6)(1) of Regulation (EC) No 178/2002Footnote 37 laying down the general principles and requirements of food law. Thus, both the NFR and the GMOR require pre-market approval for products within their scope. The objective is to ensure that a science-based risk assessment, carried out independently by the European Food Safety Authority (EFSA), is coupled with a risk management process overseen by political authorities.Footnote 38 The latter are supposed to make decisions based on EFSA’s opinion, relevant legal provisions, the precautionary principle and other legitimate factors.Footnote 39 The authorisation procedures guarantee that novel foods and GMOs pose no additional risks compared to conventional food products before they are allowed entry into the market. This is essential for ensuring the safety of these products for human consumption and for protecting the interests of consumers.

2. Risk triggers for novel foods and GMOs: “novelty” and “unnaturalness”

Products become subject to the NFR and the GMOR when some of their features and characteristics serve as “risk triggers.” Risk triggers can be derived by examining the definitions and relevant provisions of the legal frameworks. In the eyes of the legislators, the presence of risk triggers potentially undermines the primary objectives of ensuring food safety, protecting human health and the environment, and safeguarding consumer interests. Hence, risk triggers prompt the enforcement of the legislation.

When considering definitions and regulatory provisions, “novelty” and “unnaturalness” emerge as the primary risk triggers for novel foods and GMOs, serving as the key factors that distinguish them from comparable, traditional food products.Footnote 40

Novel foods are foods not consumed to a significant degree within the Union before 15 May 1997. Novel foods are considered risky because they were not consumed before 1997 in the EU. The fact that they are novel on the EU market constitutes a risk factor in itself. The EU definition is particularly restrictive. For example, in Singapore, the definition of novel foods does not include a geographical limitation to determine whether a novel food was consumed by a significant population before,Footnote 41 while in Australia–New Zealand, foods without a history of consumption in the jurisdiction are considered novel foods and are subject to the authorisation procedure only when they require an assessment of public health and safety considerations against specific indicators included in the definition.Footnote 42

Alongside “novelty,” “unnaturalness” is also used as a trigger in the novel foods framework. The “traditional foods from third countries,” despite falling within the novel food definition, enjoy a facilitated “notification procedure” instead of the full “authorisation procedure.”Footnote 43 The “notification procedure,” in absence of duly justified safety objections from the EFSA or the Member States, requires significantly less time to place products on the market. Such preferential treatment is granted only to foods with an history of safe use in a third country, derived from primary production and that can be classified into one of the novel food categories (ii), (iv), (v), (vi).Footnote 44 Primary production is defined as: “the production, rearing or growing of primary products including harvesting, milking and farmed animal production prior to slaughter. It also includes hunting and fishing and the harvesting of wild products.” Footnote 45 The logic behind the “traditional food category” is to facilitate the placing on the market of products of plant and animal origin commonly consumed in third countries,Footnote 46 which fall under the affected novel food categories, excluding novel foods developed using new technological processes. For example, novel foods falling under the categories “food with a new or intentionally modified molecular structure” or “food consisting of, isolated from or produced from cell culture or tissue culture,” which presume the use of modern and artificial production techniques, cannot be classified as traditional foods, even when they could hypothetically demonstrate a history of consumption in third countries.

Similarly, the definition of GMOs establishes that only those organisms whose genome has been modified in a way that cannot occur naturally should be subject to the framework. The use of “unnaturalness” as a risk trigger does not consider the specific properties of the GMOs. Artificial intervention is considered a presumption of risk in itself, particularly when the intervention does not fit into traditional processes familiar to the majority of the population.Footnote 47 For this reason, manipulation of the genome through hybridisation is acceptable, while lab modification of the genome is not, a false belief based on a misunderstood and unscientific conception of what “genetically modified organisms” means.Footnote 48

In addition to “unnaturalness,” “novelty” is used as a risk trigger also in the GMO framework. An example is the regulatory debate over new plant breeding techniques (NPBTs). These revolutionary techniques, such as CRISPR-Cas9, have been developed in the past decade and allow for a simple and precise modification of a plant’s DNA. NPBTs are subject to the GMO framework, despite firm opposition from the scientific community,Footnote 49 since NPBTs show similarities with traditional mutagenesis techniques, which are exempted from the application of the GMO framework.Footnote 50 Their regulatory treatment was upheld by the Court of Justice of the EU in Confédération paysanne and Others,Footnote 51 in which the Court interpreted the “mutagenesis exemption” in Article 3 of Directive 2001/18 as covering only traditional mutagenesis techniques developed before 2001. The decision relied on the “intention of the EU legislature” to exclude “novel” techniques from the scope of the mutagenesis exemption.Footnote 52 The exemption is meant to cover only techniques conventionally used before the entry into force of the Directive, implying that NPBTs might pose more significant risks than conventional mutagenesis techniques. This approach has been criticised by the scientific communityFootnote 53 and is likely to have a negative impact on innovation and growth in the EU.Footnote 54

IV. The use of “novelty” and “unnaturalness” as risk triggers

1. The adoption of novelty and unnaturalness as risk triggers

Several theories point to legal, cultural, political, and economic considerations when explaining regulatory choices. The Institutionalist Theory suggests that policymakers are influenced by the rules, norms, and procedures that define the institutions within which they operate,Footnote 55 while the Political Culture Theory emphasises that political behaviour is shaped by shared beliefs and cultural values.Footnote 56

Alternative theories focus more on the psychology of policymakers. From this standpoint, legislators are perceived as ordinary individuals susceptible to the same instincts and beliefs as any other people. While the Public Choice Theory describes legislators as mere pursuers of their self-interest,Footnote 57 the Cognitive Psychology Theory highlights the importance of psychological traits and attitudes shaping the decision-making processes of the legislators. According to cognitive psychology, legislators are influenced by biases and heuristics.Footnote 58 Authors such as SlovicFootnote 59 or Kuran and SunsteinFootnote 60 have illustrated how heuristics and biases shape legislators’ attitudes towards risks, influencing their decision-making with potentially undesirable and costly consequences for society.

The influence of heuristics and biases on people in charge of decision-making has a huge impact on regulatory choices.Footnote 61 They might lead legislators to underestimate certain costs and benefits, or vice versa,Footnote 62 and to adopt different risk management strategies in different contexts. One example is the World Trade Organisation (WTO) dispute settlement case between the EU and US over the interpretation of the precautionary principle in the context of GMO regulation. While in international law the precautionary principle stipulates that provisional measures aimed at ensuring a high level of health protection may be adopted when the possibility of harmful effects on health is identified, and scientific evidence on such risks is absent or inconclusive, in the EU, policymakers have often interpreted the precautionary principle as necessitating the demonstration of the absolute absence of any risk.Footnote 63

Assuming a cognitive psychology perspective, heuristics and biases influence the process of creating and applying the law by legislators, either by directly guiding the individual behaviours of the policymakers, or indirectly, by nudging public perception in particular directions.Footnote 64 As a result, policymakers are keener to redirect limited resources to issues that are considered critical by public perception or relevant interest groups.Footnote 65 Accordingly, the recognition of “novelty” and “unnaturalness” as risk triggers for the regulation of novel foods and GMOs aligns with those biases and heuristics cues, like the “affect” or the “natural-is-better” heuristics, that influence the consumer perception of novel foods and GMOs.

2. Better risk triggers for better regulation?

The equation “novelty and unnaturalness → threat” cannot be immediately invoked: “novelty” and “unnaturalness” do not automatically imply an immediate threat to human health, consumers, or the environment. “Novelty” and “unnaturalness” are intrinsic characteristics of novel foods and GMOs. Their use as risk triggers results in an over-inclusive application of the legislation, which potentially hampers the work of innovators in the EU.Footnote 66 Moreover, even when scientific authorities deem the products to be safe, after thorough and robust authorisation procedures, the authorisation of innovations can still be delayed and/or not granted due to the political stances and biases of member states and policymakers.Footnote 67 Davison and AmmannFootnote 68 highlight how the votes over the final authorisations of GMOs crop almost always align with the a priori positions of the member states, ignoring scientific evidence and the EFSA’s assessment. Another example is the recent Italian law banning the production and sale of cultivated meat in the country, when not one application has been submitted at the EU level yet.Footnote 69

The NFR and the GMO framework do not explicitly list the promotion of innovation as one of their objectives. While there are grounds to claim that facilitating innovation can be considered an implicit objective within the NFR,Footnote 70 it is evident that EU legislators did not regard innovation promotion as a secondary goal in the GMO framework.Footnote 71 However, it can be argued that purposely delaying the benefits that food innovations might bring contradicts the legal basis of the framework, when such innovations can contribute to achieving the legislation´s objectives.Footnote 72

In response to the influence of non-scientific biases in the regulation of novel foods and GMOs, some scholars have argued for a reduction of the role of politics in the authorisation process of innovations.Footnote 73 Others have called for “better politics,” involving more communication between the public and scientific authorities.Footnote 74 Paying more attention to the role of risk triggers can be a good starting point. Risk triggers enable the capture of novel foods and GMOs by the NFR and the GMO regulatory framework. When present, risk triggers initiate the application of the legislation and the related burdens and controversies. Separating risk triggers from biases and emotional perception of consumers could help to reduce both the anxiety of the society and the burden on regulators and innovators. To do so, risk triggers could be identified by focusing on the products rather than the processes from which they are obtained.Footnote 75 For example, when determining which genetic modifications should be deemed to be risky and thus fall under the GMO framework a trait-based model could be employed.Footnote 76 Similarly, taking inspiration from other jurisdictions like Singapore or Australia–New Zealand, novel foods with a proven history of consumption outside of the EU or that are not deemed to pose particular risks for human consumption could be exempted from the scope of the NFR.

Considering the number of innovations that will enter the food sector in the near future, it is critical to ensure that resources are allocated for the regulation of those products and processes more likely to pose risks for consumers. Adopting efficient and risk-based triggers is a crucial starting point to ensure that the adoption of innovations and the subsequent realisation of their benefits are not unduly delayed.

V. Conclusions

Heuristics are mental shortcuts that help humans make good decisions in uncertain situations. However, these shortcuts can sometimes lead to biases that negatively affect decision-making. Concerning the regulation of novel foods and GMOs, specific heuristics and biases affecting consumer perception of these products and processes are closely related to the factors that initiate the application of the legislation. The close relationship between biases and risk riggers shows how the regulation of innovative products tends to be built on prejudices and biased perceptions, thus affecting the innovation process. Understanding the role of heuristics and biases when dealing with novel foods and GMOs is key for designing regulatory systems capable of favouring the innovation process, alongside ensuring the protection of human health, the environment and consumer interests.

Financial support

This work was supported by the Deutsche Forschungsgemeinschaft (DFG), grant agreement 465588286 and by the Oberfrankenstiftung, grant agreement No. FP00535, as part of the project “Regulating Food Innovation - Technical Innovation requires Regulatory Innovation” conducted at the Food Law Chair of the University of Bayreuth.

Competing Interests

The author has no conflicts of interest to declare.

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