1 Introduction

The regulation of new technologies constitutes a daunting challenge for policymakers and regulators. The changes brought by innovation hold great potential to enhance prosperity and sustainability for society, but they may also entail significant risks and potential adverse effects for citizens.Footnote 1 Regulatory approaches in this context, thus, require a sensible balance between fostering innovation, protecting consumers, and addressing the potential unintended consequences of disruption. This balance is particularly delicate in the field of Novel Food technologies where a vast array of conflicting values, including scientific, economic, traditional, ethical and environmental instances, are inherently interlinked with cultural sensibilities and consumer perceptions on what is safe to be consumed.

Defining a regulatory framework which can unlock the potential of food technology and innovation while safeguarding high food safety standards may prove to be a complex legislative endeavour. Arguably, the success of the regulatory approach requires not only the adoption of substantive provisions which enshrine a careful consideration of all the legitimate interests in question, but also procedural mechanisms able to include and reconcile divergent instances within the actual decision-making. Therefore, especially in the EU multi-layered institutional landscape, governance design and its articulation across different levels is of particular importance. It should accommodate and prevent the potential tensions between the EU institutions and the Member States, thus touching upon crucial issues of institutional balance in the EU legal system.Footnote 2 At the same time, a successful structure entails clear definition of the role of science and of expertise in the adoption of decisions which will have social, environmental and moral implications.

Paying particular attention to this institutional dimension of the regulatory framework, this chapter will describe the main elements of the regulation of Novel Foods in the EU, including the definition of Novel Food, the objective of the legislative measures (Sect. 2) and the procedure for the authorisation of Novel Foods (Sect. 3). The analysis will focus especially on the evolution of this procedure, reflecting on the role of the diverse actors involved and in its collocation in the broader context of the European space of integrated administration (Sect. 4). More substantive regulatory issues,Footnote 3 and in particular the specific issue of the authorisation of edible insects as Novel Foods,Footnote 4 will be addressed more in detail in other chapters of this volume.

2 Regulating Novel Foods in the Internal Market

2.1 The Definition of Novel Foods

The EU legislator has undertaken the challenge of regulating Novel Food technologies for the first time in the adoption of Regulation (EC) 258/97, which subjected the marketing of ‘Novel Foods’ in the EU territory to the granting of a specific authorisation by the competent authorities.Footnote 5 Novel Foods were defined as “foods and food ingredients which have not hitherto been used for human consumption to a significant degree within the Community” and which belonged to one of the ten categories listed in Article 1.Footnote 6 These categories included foods and food ingredients containing or consisting of genetically modified organisms (GMOs), which were later regulated in a separate legislative act.Footnote 7 The two components of the definition were cumulative and were to be assessed by the Member States’ authorities.Footnote 8 The wording of the definition, however, presented relevant ambiguities which gave rise to significant litigation before the Court of Justice of the EU (CJEU).Footnote 9 The interpretation of the concepts determining the scope of application and effects of the different procedures required several interventions by the CJEU, and not only. The rapid developments in food technologiesFootnote 10 and international tradeFootnote 11 soon called for the reform of a regulatory framework which increasingly appeared fragmented and outdated.Footnote 12

After the failure in the adoption of the legislative proposal presented by the European Commission in 2008,Footnote 13 the EU legislator enacted Regulation (EU) 2015/2283 which represents the legislative framework currently in force.Footnote 14 This Regulation maintains a definition of Novel Food composed of two elements. On the one hand, Novel Food is “any food that was not used for human consumption to a significant degree within the Union before 15 May 1997”, thus keeping the day of the entry into force of Regulation (EC) 258/97 as a chronological reference in the new legislative framework.Footnote 15 On the other hand, the scope of the regime includes only those Novel Foods which fall into one of the ten updated categories.Footnote 16 They include not only products derived from the deployment of innovative food technologies, such as nanotechnologies, cell culture or tissue culture, but also products from animals obtained by non-traditional breeding practices. The latter comprises insectsFootnote 17 and, in the absence of a specific regulation, cloned animals.Footnote 18

2.2 The Objectives of the Regulation of Novel Foods

Since 1997, the marketing of Novel Foods within the EU has been subject to specific rules established by the EU legislator to harmonise the differences between national laws relating to Novel Foods or food ingredients. These differences could hinder the free movement of foodstuffs and create conditions of unfair competition, thereby directly affecting the smooth functioning of the internal market.Footnote 19 At the same time, the rules adopted aimed to protect public health and safety, guaranteeing the “high level of protection” of human health required by its legal basis in primary law.Footnote 20 As effectively recognised by the CJEU in Monsanto v Italy, the objective of the Novel Food regime is thus twofold: on the one hand, “to ensure the functioning of the internal market in new foodstuffs” and, on the other hand, “to protect public health against the risks to which they may give rise”.Footnote 21

Strictly related to these objectives, Regulation (EU) 2015/2283 added the further dimension of consumer protection, thus aligning it to the fundamental objectives of EU general food law: guaranteeing the safety of food products which reach the table of the European consumer, while preserving their free movement within the EU internal market.Footnote 22 As has clearly emerged from the parliamentary debates during the approval of Regulation (EU) 2015/2283, however, concerns related to animal health and welfare, the environment, transparency and innovation within the agri-food industry are also relevant in relation to this regulatory framework.Footnote 23

In line with these objectives, the placing on the market of new food products is subject to a specific authorisation. In particular, the marketing of Novel Food is allowed only where the food does not pose a safety risk to human health on the basis of the scientific evidence available.Footnote 24 The assessment of the safety of the Novel Food is clearly based on scientific grounds and, where scientific information is insufficient, inconclusive, or uncertain, the precautionary principle is applied.Footnote 25 Moreover, when the Novel Food is intended to replace another food and there is a significant change in the nutritional value, the Novel Food’s intended use must not mislead the consumer nor differ from that other food in such a way that its normal consumption would be nutritionally disadvantageous for the consumer.Footnote 26 Thus, consumers’ interests are safeguarded.

3 The Procedure for the Authorisation of Novel Foods

3.1 The Historical Development of the Authorisation Procedure

While the requirements for safety and consumer protection and the first component of the definition of Novel Food have remained a constant in EU law, the procedure for their authorisation underwent a radical reform in 2015.Footnote 27 Regulation (EC) 258/97, which first introduced the authorisation procedures in the regulation of Novel Foods, distinguished between foods or food ingredients “substantially equivalent to existing foods or food ingredients”,Footnote 28 whose placing on the EU market simply required a notification procedure to the European Commission,Footnote 29 and other Novel Foods, which were subject to a more articulated authorisation procedure.Footnote 30 The latter procedure (the so-called ‘ordinary’ procedure)Footnote 31 generally consisted in two phases situated at different levels of governance.Footnote 32 Pursuant to Article 4 of Regulation (EC) 258/97, the person responsible for placing on the EU market had to submit a request to the Member State in which the product was to be placed on the market for the first time, contextually forwarding a copy of the request to the Commission. Within 3 months, the competent authority of the Member State had to carry out an initial assessment, which was communicated to the European Commission and then forwarded to the other Member States in order to give them the possibility to object to the assessment.Footnote 33 Where an additional assessment was deemed necessary or an objection was raised, the procedure moved to the European level through the involvement of the Standing Committee for Foodstuffs and the final decision of the Commission.Footnote 34 As such, the initial procedure represented a typical example of composite administrative procedureFootnote 35 with remarkably decentralised characteristics.

The application of the regime established in Regulation (EC) 258/97 raised significant conceptual and practical issues.Footnote 36 Among these shortcomings, the authorisation procedure itself was considered inadequate - being too long, expensive, and non-transparent.Footnote 37 The financial burden of the application constituted an obstacle to the placing on the market of Novel Foods, especially for small- and medium-size enterprises which could not afford the (often unpredictable) costs of the procedure.Footnote 38 The procedure generally took more than 3 yearsFootnote 39—a duration which discouraged companies from investing in research and innovation.Footnote 40 The reasons behind this situation were probably linked to the lack of binding deadlines for the competent authorities, especially at the European level, and to the multi-level structure of the procedure. In fact, it was often the case that in their initial assessments the national authorities were not able to reach a conclusion on the safety of the Novel Food, and an additional assessment by the European authorities was required.Footnote 41 Therefore, the assessment of the product was essentially conducted twice (at the national and then at the European level), consequently doubling the time for the decision.Footnote 42

With a view to addressing these shortcomings and simplifying the authorisation procedure, as well as taking account of the significant developments in EU law and food technologies, Regulation (EU) 2015/2283 promoted a substantial overhaul of the legislative framework. In particular, it introduced a revised ordinary procedure, meant to be more “efficient, time-limited and transparent” than the previous one,Footnote 43 together with a new, simplified procedure for the recognition of traditional foods coming from third countries and having a history of safe food use.Footnote 44 Both procedures were put firmly in the hands of the European Commission and the European Food Safety Authority (EFSA), centralising the powers for assessment and decision on the new applications for Novel Food at the European level.

3.2 The Procedure for the Authorisation of Novel Foods: The Role of the Commission and EFSA

The new ‘ordinary’ authorisation procedure can be launched either on the Commission’s initiative or following an application to the Commission by a Member State, a third country, or a natural or legal person who has an interest in placing a new item on the Novel Food market. The application shall contain the administrative and scientific information listed in Article 10 (2) of the Regulation, including scientific evidence demonstrating that the Novel Food does not pose a safety risk to human health.Footnote 45 The application is made available to the Member States without delay and a summary of it (containing in particular the name of the applicant, the name of the Novel Food and the abovementioned scientific evidence) is published on the Commission’s website.Footnote 46 The transparency of the studies on the safety of Novel Foods was recently further enhanced by the specific guarantees established by Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain,Footnote 47 which applies also to this procedure as of 27 March 2021.

On receipt of the application, the Commission verifies whether the application falls within the scope of Regulation (EU) 2015/2283 and whether the application fulfils all the requirements.Footnote 48 In the positive case, it can request an opinion from the European Food Safety Authority (EFSA) within 1 month.Footnote 49 Established in 2002 and located in Parma,Footnote 50 EFSA is one of the most important EU decentralised agencies which support the EU institutions and Member States with the performance of highly specialised tasks of a scientific and technical nature.Footnote 51 Although the Commission has discretion on the decision to consult this agency, its involvement in the assessment of a Novel Food complies with the fundamental tenets of EU food policy which, since the White Paper on food safety of 2000, is based on scientific evidence and risk analysis.Footnote 52 According to these principles, the analysis of the risk posed by food products is divided in three phases: risk assessment, risk management, and risk communication.Footnote 53 While risk management and risk communication are mainly entrusted within the political institutions (in primis, the European Commission), the specialised activities related to risk assessment are generally carried out by EFSA and its scientific panels, whose technical and scientific expertise make them adequately equipped for dealing with these issues. The new procedure for the authorisation of Novel Food, hence, reflects more clearly this separation between risk assessment and risk regulation which characterises the fundamental architecture of food policy at the supranational level as it has developed in the last decades.Footnote 54

EFSA shall adopt its opinion within 9 months, which can be extended where additional information is needed from the applicant.Footnote 55 The opinion is forwarded to the Commission, to the Member States and, where applicable, to the applicant. It provides an essential input for the decision of the Commission, which should be based on this opinion, on any relevant provision of Union law (including the precautionary principle), and on ‘any other legitimate factors relevant to the application under consideration.’Footnote 56 The concept of ‘other legitimate factors’ is of particular interest. While irrational fears or other purely emotional reactions (such as the “yuck factor” or “the wisdom of repugnance”)Footnote 57 cannot be considered legitimate factors since they lack the legitimacy generally associated with this notion,Footnote 58 certain non-scientific considerations may be relevant in the risk management phase of the decision. Other legitimate factors can include, for example, societal, economic, traditional, ethical and environmental factors.Footnote 59 Especially in situations where scientific evidence is inconclusive, insufficient or uncertain,Footnote 60 this arguably creates “some real space for the incorporation into decision of values and concerns which go beyond technical and scientific reasons”.Footnote 61

In any event, within 7 months from the date of publication of the Authority’s opinion, the Commission drafts an implementing act to be presented to the Standing Committee on Plants, Animals, Food and Feed (PAFF).Footnote 62 This draft implementing act contains the specification of the Novel Food and, where appropriate, the conditions under which the Novel Food may be used. It also includes any additional specific labelling requirements which may be imposed upon its sale in the EU market.Footnote 63

3.3 The Procedure for the Authorisation of Novel Foods: The Role of Comitology

The Standing Committee on Plants, Animals, Food and Feed is part of a highly idiosyncratic system of committees (the so-called comitology system) established under EU law for the adoption of implementing acts according to Article 291 TFEU.Footnote 64 The committees are composed of representatives of Member States and are chaired by the Commission.Footnote 65 The powers and the functioning of the committees depend on the procedure they follow as established by Regulation 182/2011 in relation to the type and relevance of the act to be adopted.Footnote 66

For the adoption of implementing acts concerning Novel Foods the most intrusive and complex procedure is applicable, namely, the examination procedure, which aims to ensure that these implementing acts cannot be adopted by the Commission if they are not in accordance with the opinion of the committee.Footnote 67 According to this procedure, the committee discusses the Commission’s draft and delivers its vote by qualified majority, determined according to the ponderation set forth in the Treaties for the adoption of legislative acts by the Council.Footnote 68 The outcome of this vote determines the following steps in the procedure, depending on whether the committee delivers a positive opinion, a negative opinion, or a ‘no opinion’. Where the outcome is a positive opinion, i.e., the qualified majority of Member States’ representatives has approved the draft measure, the Commission is under an obligation to adopt it.Footnote 69 However, as specified in an interinstitutional statement on the adoption of the Comitology Regulation, “this provision does not preclude that the Commission may, as is the current practice, in very exceptional cases, take into consideration new circumstances that have arisen after the vote and decide not to adopt a draft implementing act, after having duly informed the committee and the legislator.”Footnote 70 Therefore, although obliged to adopt the draft implementing act, the Commission exceptionally enjoys a certain margin of discretion where new circumstances arise after the vote.

Where the outcome is a negative opinion, i.e., the qualified majority of Member States’ representatives has opposed the draft text, the Commission is precluded from adopting the implementing act.Footnote 71 In this case, the Commission is confronted with three alternatives: either to drop the act, to amend it, or to refer it to the Appeal committee. In the procedure for the authorisation of a Novel Food, where an applicant is expecting a decision on its application, the option of letting the draft implementing act simply drop is not viable. Therefore, in the procedure for the authorisation of a Novel Food the Commission can submit an amended version of the draft implementing act to the same committee within 2 months, hoping for a different outcome to overcome the veto. Otherwise, it can decide to submit the same draft implementing act to the Appeal committee within one month from the negative opinion.

When the outcome is ‘no opinion’, i.e., the committee did not reach a qualified majority either in favour or against the draft implementing measure, the Commission generally “may adopt the draft implementing act.”Footnote 72 This outcome, hence, generally guarantees some discretion to the Commission. However, in the authorisation procedure for Novel Foods, the possibility to adopt the act is expressly precluded to the Commission by Article 30 (3) of Regulation (EU) 2015/2283. The Commission is thus left with the same options applicable in the case of a negative opinion: it can either submit an amended version of that act to the same committee within 2 months of the vote or submit the draft implementing act within 1 month of the vote to the Appeal committee for further deliberation.Footnote 73

The submission to the Appeal committee initiates a new phase in the procedure, governed by specific rules. The Appeal committee, which actually represents one of the major innovations of the Regulation 182/2011,Footnote 74 is composed of Member States’ representatives who meet “at the appropriate level” of representation.Footnote 75 The underlying idea is that the representatives in the Appeal committee should have “the necessary authority to decide on highly sensitive issues”, taking a clear stance on the matter and not leaving discretion to the Commission to decide in case of disagreements in the first phase of the comitology procedure.Footnote 76 In the prevailing practice, the appeal committee is generally composed of members of the Permanent Representation,Footnote 77 who were initially the deputy permanent representatives (thus mirroring the composition of Coreper I) and, more recently, attachés at a lower level.Footnote 78

The voting rules in the Appeal committee follow those established for the examination procedure.Footnote 79 Therefore, also in the case of the appeal committee, the possible outcomes of the vote are threefold, as are their consequences. Firstly, when the Appeal committee delivers a positive opinion, the Commission must adopt the draft implementing measure. Secondly, when the appeal committee delivers a negative opinion, the Commission cannot adopt the measure.Footnote 80 Thirdly, when no opinion is delivered, the Commission has discretion as to whether to adopt or not adopt the draft implementing measure.Footnote 81 Considering that the discretion of the Commission in this phase of the procedure is not limited by Article 30 of the Regulation (EU) 2015/2283,Footnote 82 in case of no opinion at the examination committee phase it may be strategically useful for the Commission to refer the matter to the Appeal committee when it expects the same outcome at the higher level.

3.4 The Union List of Authorised Novel Foods and Data Protection

Once approved through the comitology procedures, the implementing act is adopted by the European Commission and published in the Official Journal. The placing on the EU market of the Novel Food is thus authorised under the specifications, conditions of use, additional specific labelling requirements, or post-market monitoring requirements associated with the authorisation.Footnote 83 Different from the previous practice, the authorisation is not in the form of a decision with an individual addressee, namely the applicant, but it has general effects. It consists in the inclusion of the relevant Novel Food in the Union List of Authorised Novel Foods.Footnote 84 This list, established by the Commission on 30 December 2017,Footnote 85 contains the 125 Novel Foods authorised under the previous Regulation and the new entries added through the implementing acts resulting from the described procedure.Footnote 86

The establishment of the Union List and the demise of individual authorisations represented an important shift in the regulation of Novel Foods, paving the way for a less burdensome and more extensive production of these products.Footnote 87 Aiming at the simplification and transparency of the system, this major change is intended to favour in particular the small- and medium-sized enterprises since it reduces the unnecessary administrative expenditure and avoids superfluous studies and experiments.Footnote 88 At the same time, however, this system risks penalising the applicant which invested in the development of new food technologies by allowing an undue exploitation of the results by other producers and competitors.Footnote 89 Therefore, in order to stimulate research and development, and consequently innovation within the agri-food industry, Regulation (EU) 2015/2283 sets forth a balanced form of protection of the investment made by the applicants in gathering the information and data provided in support of an application for a Novel Food.Footnote 90

According to Articles 26 and 27, the applicant can request the protection of newly developed scientific evidence and proprietary data provided in support of an application under certain conditions. Where granted, these data cannot be used for the benefit of a subsequent application during a period of five years from the date of the authorisation of the Novel Food without the agreement of the initial applicant.Footnote 91 Although on paper this represents a reasonable compromise between the individual protection of the applicant’s investment and the general promotion of Novel Foods at larger scale, the current application of these provisions has been strongly criticised as de facto impeding effective competition in the market for a significant period of time.Footnote 92

4 The Centralisation of the Procedure and the Role of the Member States

4.1 Novel Food Governance in the European Space of Integrated Administration

From an institutional perspective, the evolution of the legal framework for Novel Foods authorisation—with the described shift from a decentralised to a centralised procedure and with the systematic involvement of EFSA—epitomises significant trends which can be recognised in the overall development of the governance structure of EU law implementation in the last decades. At the same time, it puts into sharp relief the tensions underlying the regulation of controversial policy areas such as those related to risk regulation, where scientific complexities, value judgments, and consumer sensibilities need to be accommodated in the design of the decision-making procedure.

With regard to the centralisation of the procedure, it is important to recognise that its evolution reflects the broader trend towards the progressive emergence of a European space of integrated administration.Footnote 93 While the EU original governance model was essentially based on the harmonisation of divergent national legislation through the adoption of directives and regulations whose implementation was essentially demanded from national authorities separately (the so-called indirect administration),Footnote 94 the EU integration process led to the increasing development of forms of horizontal recognition of transnational acts, and of mutual cooperation between national authorities.Footnote 95 With the deepening of the internal market, and the consolidation of EU policies towards “an ever closer Union”,Footnote 96 cooperation mechanisms were established not only horizontally between Member States, but also vertically between the European Commission and national authorities, often in the form of procedural linkages between diverse actors and across different levels.Footnote 97 The decentralised composite procedure of Regulation (EC) 258/97 was thus the expression of this particular phase of the EU integration process, characterised by multi-level procedural cooperation among the different actors.

This model of governance has, however, been increasingly dismissed in cases in which the application of EU legislation by national authorities led to persistent inconsistencies and divergences,Footnote 98 also in light of the unsolved issues of effective judicial protection that composite procedures may raise.Footnote 99 As in the case of Novel Foods, the tendency is hence towards the centralisation of the implementing tasks, resulting in forms of direct administration by the European Commission and/or EU agencies.Footnote 100 Only recently has this trend perhaps slowed down its pace, with the re-nationalisation of the implementation of certain polices in the name of a more ‘active subsidiarity’.Footnote 101

With specific regard to the Novel Food authorisation procedure, it was argued that such centralisation of the governance model resulted in the expansion of the powers of EU institutions which, hence, manage to maximise their competences to the detriment of the national authorities.Footnote 102 Regulation (EU) 2015/2283 has certainly affected the role of the national authorities which were previously responsible for the assessment of the safety of Novel Foods. The demise of their role and the consequent loss of the expertise acquired in the two decades in which the decentralised procedure was in place was indeed an object of debate during the approval of the Regulation.Footnote 103

Against this backdrop, Article 4 of the Regulation provides for a specific procedure for determination of Novel Food status before the national authorities. Any business operator who is unsure whether or not a food which they intend to place on the market falls within the scope of this Regulation can consult the competent authorities of the Member State where they first intend to place the Novel Food, providing the necessary information for this assessment.Footnote 104 The decision on the Novel Food status of a food is taken by the Member State and communicated to the business, the other Member States, and the Commission.Footnote 105 The Commission then makes the information on the Novel Food status publicly available on the Commission’s website.Footnote 106 Forms of cooperation and information sharing across different levels are thus retained in the new legal framework, blurring the lines of a strict distinction between direct and indirect administration.Footnote 107

4.2 The (Lack of) Tensions Within the Comitology System

A significant role is maintained by the Member States also within the described comitology procedure which allows them, by qualified majority voting, to oppose the adoption of the Commission’s decision. In such a system of intensive interaction between national and supranational representatives, the complex operational rules described ensure the control of the Member States over the exercise of the implementing powers by the Commission, while providing the Commission with the expertise and technical information of experts and national officials working in this field in the Member States.Footnote 108

Interestingly, in the approval of Novel Foods Member States have never made use of their veto power against the Commission: all 392 relevant votes of the Standing Committee on Plants, Animals, Food and Feed have resulted in a positive opinion.Footnote 109 This is in line with the practice of most comitology committees where positive opinions represent the most common outcome of the procedure, confirming that the comitology system is, also in the field of Novel Foods, a highly consensual exercise.Footnote 110 However, these data contrast sharply with the ones available on the procedure for authorising a GMO for food or feed, where similar economic, scientific, and societal issues are at stake.

In the authorisation of GMO food and feed, a significant number of comitology procedures result in a ‘no opinion’ scenario before the examination committee and, subsequently, before the Appeal committee.Footnote 111 In fact, the majority of cases tackled by the Appeal committee relate to this controversial area or to the authorisation of plant protection products.Footnote 112 In these areas, the discretion granted to the Commission in case of a ‘no opinion’ scenario at appeal level is increasingly perceived as problematic since it pushes the Commission to act on politically sensitive matters which have a direct impact on citizens and business, and where the public opinion is strongly polarised, without clear backing from the Member States.Footnote 113 Arguably, in recent years the Member States appear to have used this mechanism strategically to abstain from assuming responsibility for controversial decisions before the electorate. For these reasons, in 2017 significant amendments to the comitology system were proposed by the Commission to tackle this issue.Footnote 114 Should these amendments be adopted by the Parliament and the Council, the rules applicable in the case of no opinion and the correlated balance between the Commission and the Member States would be altered significantly.Footnote 115

It is thus remarkable that, while in relation to GMO the adoption of decisions through a centralised procedure was perceived to be so controversial that unprecedented amendments to the comitology system were proposed,Footnote 116 the approval of Novel Foods did not raise similar tensions between levels of governance. On the one hand, this may be partially explained by the authority enjoyed by EFSA’s opinion in the authorisation procedure which, different from the case of plant protection products for instance, has never been called into question.Footnote 117 In fact, decisions on Novel Food authorisations are systematically aligned to the outcome of the risk assessment, leaving limited room for debate on the non-scientific legitimate factors in risk management.Footnote 118 On the other hand, the Novel Foods authorised so far have not polarised the public debate to the same extent as GMOs or plant protection products (especially, glyphosate), thus shielding the representatives of the Member States from the pressure of national politics. From the travaux préparatoires of the Regulation it could be expected that strong opposition may be raised in relation to edible insects and cloned animals.Footnote 119 Although Regulation 2015/2283 entered into force in 2018, the first authorisations for edible insects were issued only starting from summer 2021. Apart from this and the authorisation of stevia,Footnote 120 it is arguable that the institutional design of the centralised authorisation procedure has thus not yet been put to the test of a significant tension between different governance levels.

5 Conclusions

The regulation of Novel Foods in the internal market inevitably touches a vast array of delicate and conflicting issues, such as innovation and safety in the agri-food sector, sustainability concerns and ethical values, as well as cultural sensibilities and consumer perceptions.Footnote 121 Certainly, the growing global population and the consequent food needs urgently require new sustainable solutions for the future of food production, which innovative food technologies and non-traditional breeding techniques may provide. Nevertheless, food safety concerns and societal values need to be taken into account to guarantee a high level of consumer protection and to endow the regulatory approach with legitimacy and transparency. A careful weighing of the divergent interests and values is, therefore, crucial in the design of the substantive and procedural rules applicable in this field.

The EU legislator strove to find this delicate balance, initially with the Regulation (EC) 258/97 which laid down detailed provisions on the definition and the placing into the EU market of Novel Foods, and subsequently with Regulation (EU) 2015/2283 which updated, strengthened and simplified the applicable regulatory framework. This legislative reform purposefully maintained continuity in the main elements of the definition of Novel Food, the regulatory objectives, and the level of food safety to be guaranteed to European consumers. Conversely, it realised a paradigm shift in the structure of the authorisation procedure and in the legal effects of this authorisation, centralising decision-making powers in the hands of the European Commission and establishing the Union list.

While this change from a form of decentralised composite procedure to a clearer expression of direct administration is in line with the general development of EU food law and of the European space of integrated administration, the reform of the procedure entailed a fundamental re-shaping of the reciprocal roles, both of the Member States and their national authorities, and of the European Commission and EFSA. Despite these changes, the practice of Novel Foods authorisation has proven to be less problematic and controversial than what one could have expected in light of the tensions underlying the field, and given the reality of the parallel system of GMO authorisations. This may show that the new procedure has successfully accommodated the tensions between scientific and non-scientific factors (through the clearer distinction between risk assessment and risk management), and between national and European levels. It is, however, undeniable that the new procedure has yet to be tested against truly controversial matters. Considering the importance of the interests at stake for the future of food and feed in Europe, and for the future of our planet, it remains to be seen whether the institutional structure and the governance model adopted in Regulation (EU) 2015/2283 will manage to reconcile differing values and uphold the fundamental tenets of EU food policy.