A Peculiar Category of Novel Foods: Traditional Foods Coming from Third Countries and the Regulatory Issues Involving Sustainability, Food Security, Food Safety, and the Free Circulation of Goods

Abstract

Since 1997, traditional foods coming from Third Countries and not regularly consumed in the European territory before 1997 are included in the definition of Novel Foods provided by the EC Legislator. This peculiar category of ‘new’ foods has raised significant issues, also at the international level, due to the important and strict link between the marketing of such foods and the promotion of sustainable development. The chapter aims at deeply analysing the legislative debate, as well as the regulatory solutions finally approved by the EU legislator, by highlighting the persistent challenges, paying particular attention to the difficult balance-point determined—or still to be determined—among the free circulation of goods, food safety, food security and sustainability.

1 Introduction

‘New’ and previously unknown foods, deriving from scientific and technological progress or as a direct consequence of an expanding globalisation of trade and markets, are gaining increasing momentum in the European Union (EU). If it is undoubtedly true that food circulation and ‘hybridisation’ of diets and food habits are recurrent in world history—e.g., tomatoes, potatoes, and cocoa, which were not originally part of the European diet and were initially received with diffidence—, it is similarly true that the quantity of ‘Novel Foods’ entering the EU market has greatly increased in recent decades. Fast-paced innovation and the global dimension of commercial exchanges, together with a renewed attention for sustainable and healthy products, have had a significant impact on the marketing of new foods,¹ especially in high-income countries.

Notwithstanding the potentialities linked to an expansion of the agri-food market towards innovative products,² the EU legislation concerning new foods remains particularly cautious, paying great attention to the protection of consumer health and the guarantee of a high level of food safety. This ‘precautionary’³ approach, characterising the Novel Food regime since the Regulation dated 1997, takes the form of a stringent prior risk assessment and a long preventive authorisation procedure.⁴ The approach taken with this first legislation thus negatively affected the marketing of Novel Foods in the EU territory, also significantly impacting the commercialisation of traditional foods coming from Third Countries, which represent a peculiar category of Novel Foods according to the definition provided by Reg. (EC) 258/97.⁵

Considered a novelty from the European perspective, but also at the same time part of the ‘food heritage’ of populations outside EU borders, traditional foods have been at the centre of an intense and complex political and regulatory debate at both the international and the EU levels. More specifically, representatives of national food business operators in developing countries interested in exporting their products to the EU accused the European legislator of establishing restrictive rules and barriers to trade, placing a disproportionate and unnecessary burden on business.

The lively debate, present also within the World Trade Organization (WTO), had serious repercussions. The EU legislator was forced to re-think the established balance between the free circulation of goods on the one hand, and food safety on the other, also with regard to the effects and proportionality of the European ‘preventive’ approach impacting Third Country food producers. The legislative reform process of the Novel Foods Regulation consequently represented an opportunity for EU regulators to evaluate the strict links among the circulation of goods, sustainable development, and food (in)security. Indeed, the marketing of traditional foods has been an important source of income for poor and middle-income communities in Latin America, Asia or Africa, representing a way to prompt environmentally but also socially sustainable methods of production through the valorisation of traditions and the promotion of social inclusion in rural areas. This complex relationship therefore reveals the paramount importance of correctly understanding the difficulties faced during the long legislative debate that led to the approval, in 2015, of Reg. (EU) 2015/2283.⁶

With the aim of shedding light on the persistent issues and shortcomings of the European Novel Foods legislation that regulates traditional food marketing today, the present chapter intends to provide a brief overview of two key concepts, recurrent in the whole Volume, and crucial for an informed understanding of the challenges at stake: sustainable development and food security (Sect. 2). This will be followed by an analysis of the previously in-force Reg. (CE) 258/97, its effects, and the criticalities that have emerged in the international arena (Sect. 3). The chapter concludes with an examination of the regulatory evolution in the EU context, paying specific attention to the improvements that have been introduced so far, as well as the remaining shortcomings and possibilities for future development (Sect. 4).

2 A Preliminary Analysis of Two Key Concepts: Sustainable Development and Food (In)Security

The world is currently facing crucial challenges destined to produce effects on present and—especially—future generations: the often reckless consumption and waste of non-renewable resources⁷ and the closely related climate changes⁸ are at the very basis of the current dramatic energy crisis,⁹ which is destined to profoundly affect not only the economy of both so-called Developed and Developing Countries, but also many aspects of daily human life, from housing to transport, from work to the food system.¹⁰

In the face of these urgent issues and their detrimental consequences, the call for sustainable solutions has increased in recent years, putting sustainable development at the centre of a lively economic and political debate, at different yet fundamental regulatory levels: international, European, national, and sub-national. But the concept of ‘sustainable development’ remains difficult to define concretely, implement in policies, and mange politically,¹¹ especially when applied to the food sector.¹²

More generally, sustainable development has been notably described in the 1987 Brundtland Report titled “Our Common Future” as, “development that meets the needs of the present without compromising the ability of future generations to meet their own needs. (..) In essence, sustainable development is a process of change in which the exploitation of resources, the direction of investments, the orientation of technological development and institutional change are all in harmony and enhance both current and future potential to meet human needs and aspirations.”¹³ After more than two decades during which political and academic attention to this principle gained ever more momentum—even if with limited concrete results¹⁴—the United Nations (UN) General Assembly adopted in 2015 the so-called 2030 Agenda for Sustainable Development, also elaborating 17 Sustainable Development Goals (SDGs).¹⁵ This document is considered a milestone, providing a comprehensive, integrated strategy and objectives intended to prompt the international community into “achieving sustainable development in its three dimensions—economic, social and environmental—in a balanced and integrated manner.”¹⁶ This tripartite composition is usually depicted as three intersecting circles with ‘sustainable development’ in the central intersecting area. In this view, ‘sustainability’ is seen as the reconciliation of economic development with social and environmental issues. It includes the promotion of growth that nullifies or limits any possible negative impacts on the environment, such as climate change deriving from human activities.¹⁷ Societal impact, for example the effects of economic growth on respect for human rights, workers’ rights, and access to welfare services, is also considered.¹⁸ This vision has broadly inspired the ‘institutionalisation path’ of the sustainable development concept, which has also been recognised by the European Union legislator: Art. 3, para. 3 of the Treaty on European Union explicitly refers to sustainable development as a common objective, considered as “based on balanced economic growth and price stability, a highly competitive social market economy, aiming at full employment and social progress, and a high level of protection and improvement of the quality of the environment.”¹⁹

Notwithstanding the critiques levied on such a broad principle, which has often fallen short of having any operative repercussions for regulatory choices and policies,²⁰ sustainable development has been identified, especially in recent decades, as a key concept to be placed at the centre of current political decisions and strategies which must not ignore the needs of future generations²¹ and should bring to bear the duties of present generations.²²

As a consequence, ‘sustainability’ has assumed paramount importance also in the determination of food strategies and policies, becoming an essential paradigm for facing critical issues and challenges related to the functioning of food systems. It comes as no surprise that the UN SGDs recognized the access to safe, nutritious, and sufficient food for all people as a fundamental target (Target 2.1.), together with the eradication of all forms of malnutrition (Target 2.2.). This document therefore clearly affirms the urgent necessity to defeat hunger and ensure food access for all in order to achieve a real and concrete ‘sustainable development.’²³ The ambitious aim of “peace and prosperity for people and the planet, now and into the future”²⁴ could, consequently, also be reached through the guarantee of food security, which represents a second key concept of this Volume.

Differently from food safety,²⁵ food security is defined as the situation that emerges “when all people, at all times, have physical and economic access to sufficient, safe and nutritious food that meets their dietary needs and food preferences for an active and healthy life.”²⁶ This ambitious concept has lately been specified by the Food and Agriculture Organization of the United Nations (FAO), who identified four dimensions of food security: availability, access, utilization, and the stability of the other three dimensions over time. The document states that, “food availability addresses the ‘the supply side’ of food security and is determined by the level of food production, stock levels and net trade,” utilisation, and “the way the body makes the most of various nutrients in the food.” The concept of stability aims at underlining that “even if your food intake is adequate today, you are still considered to be food insecure if you have inadequate access to food on a periodic basis, risking a deterioration of your nutritional status.”²⁷

The complexity that emerges from such a composite meaning of food security prompts us to think about the comprehensive and articulated actions and guarantees necessary to ensure adequate, sufficient, and nutritious food for all in a stable way. The present situation, characterised by extreme weather events such as drought or floods—but also the pandemic²⁸ and the Ukrainian war²⁹_—severely impacts the capability of the current food system to ensure food security all over the world.³⁰ The fight against food insecurity has thus become one of the most urgent challenges present generations are called to face.³¹ In order to do so, food security must be read together with—or better, as part of—the attainment of sustainable development:³² famine, malnutrition and hunger cannot be overcome only by looking at present day necessities but must also consider the needs of future generations. Consequently, the promotion of a sustainable food system assumes paramount importance for the creation of a food-chain that encompasses all the different phases of food production: from agriculture, to transformation, from transport to retailing. Such a system must, at the same time, be resilient to climate changes and able to limit its effects on the environment and on natural resources. It must also promote economic and social sustainability by protecting rural communities’ rights, workers’ fundamental rights, and by furthering equality and non-discrimination.

The European Union legislator has been called to tackle these issues and to implement a regulatory framework that considers all the intertwined dimensions and profiles of sustainability and food security.³³ In this context, finding a reasonable balance between market needs and adequate food safety and food security has proved difficult, as seen in the challenges presented by the approval of the Novel Food Regulation(s), in recent decades. Facing the need to regulate these unusual foods, which can make important contributions to the enhancement of a more sustainable food system,³⁴ EU Institutions have had to consider all the key concepts here analysed, recognising that a more food safety-oriented legislation could significantly affect the achievement of food security as well as of sustainability goals. This delicate aspect, highlighted in the pages of this Volume, appears with more strength and emphasis with reference to a peculiar category of Novel Foods: traditional foods coming from Third Countries.

3 How Novel Foods Regulation (EC) 258/97 Affected the Marketing of Traditional Foods Coming from Third Countries: Criticalities and Concerns Expressed in the International Arena

As already analysed in the previous chapter,³⁵ according to the first Novel Foods legislation adopted by the European Community back in 1997, a food was considered ‘new’ when it met both these conditions: (1) the food has not been used for human consumption to a significant degree within the Community before the entry into force of the Regulation (15 May 1997); (2) it falls under one of the categories expressly listed in Art. 1, para. 2.³⁶ This definition consequently imposes the qualification as Novel Foods (as per Reg. 258/97/EC) of not only ‘innovative’ foods, inexistent before 1997 and resulting from scientific and technological processes—such as intentionally modified foods or foods with new molecular structures or based on engineered nanomaterials—but also ‘traditional foods’ coming from Third Countries. This term refers to food that, despite being habitually eaten outside the EU territory—and therefore part of the traditional diets of Third Country populations—were absent from the EU food market in 1997. This category thus includes, for example, chia seeds, noni fruit juice, exotic fruits, herbs and nuts, some kinds of tea leaf and, in some cases, also insects.³⁷

As a result, traditional foods coming from outside the EU have had to undergo the same authorisation procedure required for ‘new’ foods considered strictu sensu because the history of safe use in Third Countries was not sufficient to exclude—or limit—the prior (expensive and complex) approval path. As clearly synthesized by Hyde et al., “if an applicant can demonstrate that food has a history of use within the EU prior to 1997, the food will not require authorisation. However, foods with history of use outside the EU require authorisation and must therefore go through the regulatory process.”³⁸ The EU legislator’s choice to absorb traditional foods coming from Third Countries into the definition of Novel Foods is the direct product of the particularly ‘relativist’ European approach, that considers the ‘novelty’ of a product by adopting a specific—and, in this sense, ‘limited’—European perspective. This regulatory decision appeared consistent with the premarket approval scheme itself, aimed at safeguarding and ensuring a high level of food safety in the EU: “the European legislator seems to work from the presumption that conventional foods, that is to say foods that have a tradition of use in the EU, can be considered safe unless new scientific findings indicate otherwise. (..) For other products, that is products that are in some way artificial or new, the safety must be proven before they may come to the market.”³⁹ Following this approach, the 1997 Regulation therefore did not properly consider the fact that traditional foods were part of a Third Country ‘food heritage’, so that no ad hoc authorisation procedures were determined for traditional foods coming from outside the EU: food producers interested in marketing this category of Novel Food were then obliged to follow the unique process established by the Regulation and characterised by a ‘precautionary’ scheme that “structurally shifts the burden of proof from authorities to businesses.”⁴⁰ Moving from this consideration, if the pursued purpose was only to admit in the EU market new products assessed and proven to be safe for consumers, a specific technical and scientific dossier was considered proportionate and necessary to provide useful studies that could demonstrate the lack of danger to human health as well as the safety of the product.

But the expensive studies and documents required to submit an application only represented the first step of a long and articulated procedure,⁴¹ complicated by the lack of a centralised authorisation process. The complexity of the described authorisation process significantly limited the marketing of new foods in the EU territory: according to the ‘Briefing paper – Economic impact assessment of the way in which the EU Novel Food regulatory approval procedures affect the EU food sector,’ published in 2007 by Brookes for the Confederation of the food and drink industries of the EU and the Platform for ingredients in Europe, the estimated time necessary to obtain a Novel Food authorisation was identified as thirty-five months on average, while the costs required to meet all the regulatory requirements—including the research and development costs necessary to produce the studies for the application—were estimated between 0.3 and 0.75 million per Novel Food application.⁴² Moreover, as revealed in a study elaborated by the European Parliamentary Research Service, another relevant disincentive to Novel Food marketing in the EU was the limited “predictability of the process. Uncertainty as to the successful outcome of the process was more of a problem for smaller companies who could only rely on a small range of products, as opposed to larger companies that have the capacity to absorb these uncertainties.”⁴³ ‘Grey areas’, legal doubts and opacities were mainly due to the inconsistent approaches and interpretations of the national authorities. These made it so that cost, time, and approval rate—i.e., the probability of success and the seriousness of the evaluation analysis taken by the national authorities—significantly differed according to the Member State in which the application was submitted.⁴⁴ As a consequence, only well established and economically solid food producers were able to afford the long and expensive path imposed by the European legislation. Small and mid-sized enterprises were usually less likely to invest in new foods products, often considering the costs to be unacceptable when compared to the merely uncertain future profits. The European authorisation procedure thus discouraged innovation in the food field, as clearly demonstrated by the minimal number of applications presented until 2008: “around 7-10 applications were submitted per year. It seems impossible to assess the real size of the novel food market because of its diversity (covering many different products) as well as confidentiality policies and intellectual property rights issues. However, given the market potential in Europe and the high level of innovation in the food industry, this number has to be considered very low.”⁴⁵ In other words, “although the regulation still achieves the key goals of protecting public health and protecting the internal market by subjecting novel foods to a single safety assessment, few would disagree that the system is too lengthy and cumbersome and it is outdated because it relies on risk assessments by multiple national authorities rather than a single centralized assessment by the EFSA.”⁴⁶

All the above analysed criticalities and shortcomings caused by Reg. (EC) 258/97 have strongly affected the marketing of traditional foods coming from Third countries. This particular category of Novel Foods, as described at the beginning of this Section, suffered acutely the weaknesses and failures characterising the European legislation, resulting in a ‘marginalisation’⁴⁷ of Novel Foods’ producers from developing or under-developed Countries. Limited economic resources, lack of technical and scientific expertise, and the need for peer-reviewed studies elaborated by qualified authorities and experts to document the food safety of the product made it almost impossible for small and mid-sized farmers and food business operators in African, Latin American or Asian countries to bear the costs of an authorisation submission compliant with the EU Novel Foods Regulation. Beyond producing a mere economic effect, these concrete obstacles have seriously impacted the promotion and implementation of sustainable food systems in already disadvantaged areas of the world. The production and marketing of traditional foods such as exotic fruits or tea leaves, represented—and still represents—a precious source of ‘sustainable income’ for rural communities in the global South. Traditional foods in this sense can foster social inclusion among small communities and provide fair work and equitable contractual conditions for peasants, thus avoiding exploitation, discrimination, and inequality, and thereby strengthening the support for the guarantee of fundamental rights. Traditional food production systems are typically more respectful of the environment and of biodiversity since the production methods traditionally employed by rural communities are usually more attentive to the preservation of natural resources. In short, the opportunity to commercialise traditional foods in wealthy markets, such as that of the European Union, could be an instrument for the achievement of the SDGs clearly established by the UN, by alleviating poverty without dismantling or exploiting rural communities who are already grounded in more environmentally sustainable practices.

Confirming the close link between the commercialisation in the EU territory of traditional foods coming from Third Countries and the social, economic, and environmental sustainable development of small and mid-size enterprises or communities in Africa, Asia and Latin America, donors and Non-Governmental Organizations (NGOs) as well as governmental authorities have paid particular attention to the promotion in under-developed areas of projects and activities aimed at fostering traditional food production and trade.⁴⁸ In this context, it comes as no surprise that under Novel Foods Regulation (EC) 258/97, governmental and non-governmental organisations have decided in several cases to support small businesses preparing the complex and expensive application dossiers required by the European legislation. Hermann’s study reported, for example, that the authorisation of Baobab fruit pulp as a Novel Food in the EU was possible only because Phytotrade was supported by a fifty-five-member consortium which presented all the complex documents required by the EU provisions. Similarly, “Unilever submitted the application in the context of the Novella Africa Partnership, a ‘textbook’ public-private partnership involving overseas development donors, the World Agroforestry Centre, the World Conservation Union, NGOs, local communities, and the private sector. Motivated by the lesser ecological footprint of allanblackia oil vis-à-vis its substitutes (e.g., palm oil) and recognizing the commercial potential of allanblackia seed oil in the global food market, this partnership seeks to assist allanblackia producers in five Sub-Saharan countries with improving supply and market access.”⁴⁹ The application of another traditional food, the noni fruit historically used in Polynesia, was made possible only because of the interest manifested by a big US company, Morinda Inc., which bore the costs of two different submissions: one for the juice deriving from this product and one for the leaves. Thanks to this application, several other smaller companies, based both in the EU and abroad, were able to commercialise this Novel Food by activating the so called ‘substantial equivalence’ simplified procedure established by Reg. (CE) 258/9. Indeed, according to that legislation, the authorisation’s effect was only nominative, meaning that it was referred only to the applicant’s specific product and not to the Novel Food per se; once a Novel Food was authorised, it was nonetheless possible for other business operators interested in commercialising the same Novel Food to market it following a faster and more affordable procedure: the dossier to be submitted was only required to contain data and information demonstrating the ‘substantial equivalence’ of the product with another already authorised Novel Food. Although the payment of application costs and the preparation of the scientific dossier proving the equivalence to marketed new foods were mandatory, the simplified ‘equivalence’ procedure surely helped the diffusion of already authorised traditional food products coming from Third Countries.

Even so, these positive results could not be considered a definitive solution to the severe impact the Novel Food Regulation has produced on the marketing of foods already part of Third Countries’ food heritage: on the contrary, with reference to this peculiar category of Novel Foods, the difficulties that have emerged from the European pre-market approval requirement have begun to be strongly opposed by developing countries, who were particularly worried about the economic and also social impacts of the restrictive authorisation procedure imposed by Reg. (CE) 258/97. Specifically, this legislation has been considered an illegitimate ‘non-tariff’ barrier to trade: Government representatives and private stakeholders have denounced how “barring export of traditional foods (..) has negative effects on trade relations between the EU and Developing Countries. It restricts the use of some countries’ comparative advantage—their rich natural biodiversity. It also works against economic development efforts that focus on expanding trade opportunities for local exporters who need these opportunities to improve the socio-economic position of poor and very poor groups. Reducing such opportunities may result in increased illicit activities—for example, production of coca leaves or unsustainable exploitation of forests. Non-tariff trade barriers also appear to contravene World Trade Organization (WTO) trade objectives.”⁵⁰ These accusations were designed to provoke a profound legislative reform of the European regulatory scheme by introducing different procedural requirements for traditional foods coming from Third Countries. More specifically, some developing countries considered it manifestly disproportionate and unreasonable to subject both foods considered ‘innovative’—thus ‘new’ because previously unknown or not used as foods for human consumption—and foods already consumed by different populations outside the EU territory to the same authorisation process. While the former raised concerns related to the guarantee of food safety and consumer protection, the latter did not present the same risk level, given their inclusion in other populations’ diets. Considering these fundamental differences, developing countries have required the EU legislator to diversify the burden of proof imposed on the food producer. From this perspective, the potential dangers the EU sought to avoid by establishing a prior risk assessment procedure seemed to be insufficient to justify undifferentiated processes and requirements for both ‘new’ and ‘traditional’ Novel Foods.

Faced with the inaction of EU Institutions, unable to find a compromise over the approval of a revised Novel Food legislation,⁵¹ Peru and other Latin America Countries expressed their concerns about the legitimacy of Reg. (EC) 258/97 through a communication to the WTO, specifically to the Committee on Sanitary and Phytosanitary measures. The obligations deriving from the so-called Sanitary and Phytosanitary Agreement (SPS Agreement)⁵² established some limits on the States’ discretional power to adopt measures necessary to protect human, animal or plant life and health. This kind of provision, having a strong impact on the free circulation of goods and free trade, could not be applied “in a manner which would constitute a means of arbitrary or unjustifiable discrimination between Members where the same conditions prevail or a disguised restriction on international trade.” In other words, measures resulting in a barrier to trade must: (a) be limited to what is strictly necessary to guarantee health and consumer protection; (b) be based on scientific principles and evidence (Art. 2.2); (c) be based on the use of appropriate risk assessment techniques; (d) minimise negative trade effects by imposing only what is proportionate and necessary to the pursued objective (Arts. 5.1, 5.4, 5.6). Considering these rigid requirements, the Peruvian Government—while still recognising the legitimacy of the prior risk assessment scheme established by the EU legislation—contested as excessive and disproportionate the complex procedure and the documents/proofs required of traditional foods. The history of safe use and habitual consumption of traditional foods in non-European diets should not be ignored but rather properly considered in order to lower the level of controls and risk assessment evaluations required.⁵³ Moreover, Peru underlined how “implementation of the Regulation also has adverse social effects such as disincentives to the development of promising economic activities, increased cultivation of illicit crops for economic ends, failure to contribute improving the health of the world as a whole through the consumption of traditional foods with a high nutritional value and a decline in the income of poorest sectors of the population.” This serves as confirmation of the above analysed strict link between sustainable development and the promotion, production, and marketing of traditional foods in developing countries characterised by rich biodiversity and natural resources. It also seeks the protection of poor rural communities whose economic growth is mainly dependent upon the export of agricultural and food products. At the end of the examined communication, Peru “reiterates its request to the EU not to include traditional products in the novel foods category, and deems that a distinction needs to be drawn between foods and ingredients that are new in the strict sense and those that are new only to the EU.”⁵⁴ Similar considerations were also shared by scholars, who have begun to underline the importance of a legislative reform able to consider “the proposal’s likely consequences on developing countries and (..) how alternative measures will affect both food safety and the developing countries. And lastly, the European Community should strengthen its provision of development assistance to enable the developing countries to comply with the food safety standards.”⁵⁵

While affirming the need to seriously consider the concerns expressed by several countries before international institutions, the European Commission considered that the compliance of the European regulatory measures needed to be evaluated according to the requirements and conditions established by the Technical Barriers to Trade Agreement (so called TBT Agreement) and not the SPS Agreement, as affirmed by the Peruvian Government. The Novel Food Regulation disciplined the registration, identification, and labelling requirements affecting ‘new’ products, so that it could not be considered to directly respond to food safety purposes specifically regulated by the SPS Agreement.

Without lingering on the details of these ‘formal’ and ‘technical’ aspects, mainly pertaining to the international law field,⁵⁶ what seems relevant is the practical and ‘substantial’ result of the debate opened in the international arena and prompted by developing countries. Despite the real opportunity—and possibility or legitimacy—to activate formal charges against the EU based on the SPS Agreement’s provisions, the evident merits of Peru’s intervention, followed by other interested governments, lay in the precipitation of a serious discussion on the proportionality of the risk assessment measures implemented by the European legislation. Indeed, the urgent necessity to reform the 1997 Regulation became even clearer when considering the consequences of a high level of food safety protection and ‘preventive’ approach on the attainment of sustainability goals in those developing countries interested in fostering the commercialisation of traditional foods as an instrument to boost economic, social, and environmentally sustainable development. As we will see in the next paragraph, the concerns raised before the WTO acted as a ‘leverage’ on European Institutions and, specifically, on the revision of Novel Food Regulation, which was begun in 2013 after the first reform proposal failed in 2011. This renewed attempt by the European authorities, intended to confront and solve the denounced shortcomings of the 1997 legislation, made it unnecessary for developing countries to activate a formal complaint against EU: “notwithstanding the tenuous basis of the legal arguments, the number of countries voicing complaints and the frequency of comments created a dynamic for regulatory change to which the European Commission felt compelled to respond.”⁵⁷

4 The EU Legislator’s Recognition of the Specificities of Traditional Foods Coming from Third Countries: Significant Improvements and Persistent Issues

The serious shortcomings and criticalities derived from the 1997 Novel Food Regulation and signalled by food producers, Third Countries, consumers, and scholars, prompted the European Institutions to rediscuss the established balance between food safety, innovation, free circulation of goods, and sustainability. Such a pressing need was considered even more compelling starting from 2003, when foods containing or deriving from Genetically Modified Organisms (GMOs) were removed from the Novel Food definition and regulated in a specific legislation. This decision “led to concerns that the Novel Food Regulation imposed too high a level of scrutiny on foods that were not as risky as the GM foods that the drafters intended to target at the beginning”.⁵⁸

In this complex context, the Commission decided to initiate a public consultation, started in 2002 and finished in 2006, and to finally adopt, in January 2008, a proposal to revise the Novel Foods provisions.⁵⁹ Notwithstanding the highly awaited reform and the importance, highlighted by the stakeholders participating in the consultation, to speed up the legislative procedure,⁶⁰ the Council, the European Parliament and the Commission took, during the reform process, irreconcilable positions that even the Conciliation Committee was unable to resolve. Not surprisingly, the most contentious issues leading to the failure of this first proposal revision involved debated ethical topics, such as the provisions regarding foods derived from cloned animals⁶¹ or engineered nanomaterials. With respect to traditional foods coming from Third Countries, the 2008 revised text represented a first serious attempt to face the charges and drawbacks that had emerged from the 1997 Regulation: in particular, the Commission proposed the introduction of a simplified notification procedure by eliminating the previously required expensive and time-consuming toxicological data and dossiers, so that ‘compositional data’ and ‘evidence of use-data’ were considered sufficient. But, on this specific point, Member States, the Council, as well as EFSA expressed serious doubts, so that the faster and easier procedure for traditional foods coming from outside the EU became one of the most disputed and delicate issues.⁶² The ‘friction’ between different stakeholders and the food safety concerns were put at the centre of the legislative debate, leading to significant modifications of the initial proposal. After the first reading before the European Parliament, the notification process for traditional foods was replaced by a normal authorisation procedure characterised by the introduction of provisions aimed at speeding up the different authorisation phases. Consequently, what emerged from the legislative discussion was a new balance point between different needs: in particular, a faster process was considered a proper solution for traditional foods coming from Third Countries.

As already underlined, this first attempt failed due to the incompatible positions expressed by the multiple legislative actors on delicate aspects of the Novel Foods legislation; but the importance of reforming the outdated and increasingly inefficient 1997 Regulation, together with the ‘push’ derived from the concerns expressed by developing countries at the international level, led the European institutions to re-discuss their positions and promote a new legislative proposal on ‘new’ foods. Thus, in 2013 the Commission presented a new package of legislative proposals, including the revision of the Novel Food Regulation and two different proposals regarding animal cloning and food deriving from cloned animals. Overcoming all the challenges that had previously brought the reform attempt to fail, the proposal was finally approved in November 2015, so that the Reg. (EC) 258/97 was replaced by the current Reg. (EU) 2015/2283, applied since 1st January 2018.

The new discipline contains many novelties intended to overcome past inefficiencies and criticalities: from the centralised procedure, managed by the European Commission, to the unique and centralised risk assessment evaluation provided by EFSA. The provisions also include the introduction of a clearer definition of the scope of application of the Regulation and a more defined procedure and timeline. The creation of a transparent Union list of authorized Novel Foods is accompanied by a significant reform of the efficacy of the authorisation itself, that is not specifically addressed to the applicant, as it was in the past, but it has general effects.⁶³

In this scenario, the European legislator also introduced a crucial innovation by establishing a new simplified notification procedure expressly dedicated to traditional foods coming from Third Countries. In order to do so, the legislator has provided, for the first time, a specific definition of ‘traditional foods’ considered as a Novel Food, “other than novel food as referred to in points (a) (i), (iii), (vii), (viii), (ix) and (x) thereof which is derived from primary production as defined in point 17 of Article 3 of Regulation (EC) No 178/2002 with a history of safe food use in a Third Country” (Art. 3, lett. c). With reference to this particular category of ‘new’ foods, the applicant is asked to demonstrate that the product has been consumed continuatively “in at least one third country for at least 25 years as a part of the customary diet of a significant number of people. The history of safe food use should not include non-food uses or uses not related to normal diets,” Recital 15.⁶⁴ This different burden of proof concerning the food safety of the product is to be considered one of the main differences—and a simplification—from the ‘standard’ authorisation procedure: the dossier required of the food business operator should only include “documented data demonstrating the history of safe food use in a third country” (Art. 14) and not the “scientific evidence demonstrating that the novel food does not pose a safety risk to human health,” as demanded for ‘new’ foods, considered strictu sensu. As clearly emerges, the costs and the level of complexity of the procedural requirements as well as the necessary documentation and expertise appear to be significantly reduced if compared to the previous 1997 legislation, thus addressing the serious requests of reform proposed by different stakeholders in previous years.⁶⁵

In addition, the notification procedure too is now characterised by a relevant time reduction and simplification. The submitted notification is evaluated by the European Commission who is asked to control the validity and the completeness of the dossier; within one month the Commission must forward the notification to Member States and EFSA; these authorities then have four months to present “duly reasoned safety objections” to the marketing of the traditional food. If no objection is submitted, the Commission authorises the Novel Food which will be formally included in the Union List. On the contrary, if objections are presented, the notified product cannot be authorised, and the applicant is required to submit a standard application. In this case, the food business operator does not benefit from the simplified documentation necessary for the notification and is instead obliged to include specific scientific data addressing the objections proposed. In this more complex scenario, the procedure is similar to the ‘standard’ one, even if with some important differences, mainly regarding the timeline: EFSA provides, within six months, a precise risk assessment, evaluating both the safety of the traditional food for human health and the reliability of history-of-safe-use data. Even when a faster EFSA intervention occurs, the Regulation specifies that, in duly justified cases, an extension of the established timing can be allowed if the need for additional information from the applicant emerges. The Opinion, resulting from the EFSA analysis, should then be properly evaluated by the Commission, which must prepare a draft implementing act, authorising—or not—the marketing of the traditional food, to be submitted within three months to the Standing Committee on Plants, Animals, Food and Feed. In the case of a favourable vote of the Committee members, the traditional food can be lawfully placed on the European Union market.

The 2015 Regulation, therefore, clearly recognises the sui generis category of traditional food coming from Third Countries by attributing a different and specified risk assessment procedure and admitting that the ‘history of safe food use’ must be properly taken into account. By not excluding this peculiar category of ‘new’ foods from the scope of application of the 2015 Regulation, the legislator decided to confirm the importance of a pre-authorisation procedure; at the same time, the possibility to opt for a faster and simplified notification path allows for a more proportionate burden of proof, reflecting the reduced level of risk these already consumed foods represent, on the one side, but also guaranteeing, on the other side, a proper food safety control, should scientific doubts or objections be proposed.

These improvements had an immediate positive effect on traditional foods coming from Third Countries’ marketing: since 2018, fifteen notifications have been submitted and seven traditional foods have already been authorised (until February 2022). These data represent a significant and evident amelioration if compared to the situation registered before the 2015 Regulation entered into force (from 1997 to 2008, only four traditional foods coming from Third Countries were authorised, with an average duration of the authorisation procedure of more than 2 years).

Despite this encouraging information, a critical analysis of the current legislation cannot ignore some persistent issues related to traditional foods. First of all, by allowing EFSA and Member States to block, in the initial phase, the notification procedure by proposing duly reasoned safety objections, the procedure does not provide the applicant with the opportunity to clarify or answer the questions and doubts raised by national or centralised authorities. This automatic rejection of the notification procedure, without the possibility to promote a moment of dialogue and confrontation between the interested actors could potentially frustrate the specific provisions established for the benefit of traditional foods producers: the interruption of the notification procedure and the obligation to submit a new application, more similar to the ‘standard’ authorisation process, implying longer times and more detailed and expensive documents, increases the cost for food business operators. In addition, the ‘reasonableness’ of the objections proposed represents quite a vague requirement to assess and evaluate.⁶⁶ As a consequence, the effectiveness and efficacy of the simplified procedure promoted by the 2015 Regulation depends on the approach taken by Member States and EFSA: if they submit objections to traditional foods notifications frequently, this will de facto compromise the legislators’ choice to offer a different procedure for this category of Novel Foods. For this reason, it will be important to monitor now and in the future the functioning of this simplified procedure and its impact on the marketing of traditional foods coming from outside the EU.

Though the possible evolution and material implementation of the novelties introduced in 2015 are still unfolding, the reform of the traditional foods legislative regime undoubtedly reveals important risks that a generalized prior authorisation scheme could cause to the marketing of ‘new’ foods; these reflect the strict links among trade of food products, sustainable development, adequate income, and access to food. As the previous 1997 Regulation demonstrated, stringent marketing conditions, even when aimed at guaranteeing a high level of food safety, could result in disproportionate costs and procedural burdens,⁶⁷ with negative economic, social, and environmental implications for Third Countries interested in trading goods in the EU.⁶⁸ In the specific case of traditional foods, the exacting requirements imposed by the previous legislation ended up jeopardising the efforts by governmental and non-governmental authorities to promote sustainable methods of production, with a detrimental effect on the development of low-income societies in poor rural areas. In this specific case, such a significant restriction—or, at least, disincentive—to traditional foods’ access to the EU market did not appear to be entirely motivated by food safety concerns: the lack of proper consideration of the safe use of such foods in Third Country diets made it difficult to accept the complex and expensive scientific data required as proportionate.

The new Regulation, on the contrary, demonstrates that a different legislative solution is possible, by determining—after a protracted and lively legislative debate—a new balance point between food safety and the marketing of new foods; the legislator seems to have taken into proper consideration the impact of its legislative choices on the promotion of sustainable practices even outside the EU, thus considering sustainability and economic, social, and environmental aspects as significant elements to be evaluated in the difficult balancing exercise.