Regulating and Managing Food Safety in the EU

This chapter provides a general overview of the contents of this book. The chapter-contributions’ order follows different dimensions that can be discerned for describing regulatory content and effect: public-private, mandatory-voluntary, prescription-persuasion, rules-principles, ex-ante-ex-post and centralisation-decentralisation. The book shows that the regulatory toolbox to provide food safety has become more diverse in course of time and that the insight in the social effects of the application of such tools has increased.

Food safety regulation in the EU is a complex arrangement of public laws and private food standards. This chapter discusses the structure of private food safety standards and the complex relationship of these private standards with public regulation in the EU. Private standards are very common in the food industry in many European countries. Food safety standards such as BRC, IFC and FSSC22000 are initiated and supported by powerful retailers and food manufacturers. Although compliance with these standards is not obliged by law, food business operators in particular markets are in fact forced to join a private certification scheme. Private standards are managed by a standard-owner. Verification of compliance of the major standards is delegated to accredited third-party certification bodies. The norms of private standards are built upon public standards (Codex, EU, ISO). The EU legal framework reinforced the proliferation of private food standards. Private standards did pioneering work in modernizing food regulation. Current EU food law benefitted from the experience of standard-owners, certification bodies and food industry with private standards. The EU legal framework allows public authorities in the Member States to take account of private food safety assurance schemes in their official controls. In several countries, authorities responsible for official food safety controls are investigating ways to collaborate with private food safety assurance systems as part of their monitoring and enforcement tasks. This development raises questions about the reliability of third party certification, the exchange of information between private and public actors, and the risks of regulatory capture and conflicts of interest.

Regulation of voluntary sustainability standards (VSSs) may increase their capacity to promote sustainable consumption. To determine if, when and where public or private institutions should intervene, an overview of the current regulatory structure of VSSs is needed. To provide such an overview the regulatory structure of 65 VSSs underlying sustainability food labels in the Dutch market was examined. This study shows a plurality of VSSs with different types of certification schemes, i.e. first-, second- or third-party certification, and with multiple actors involved. The majority of these VSSs resemble a structure where NGOs are highly involved in standard-setting and certification is mainly conducted through private, third-party certification. While these structural characteristics may be considered reliable and credible by consumers, several VSSs do not reflect this structure. The present coexistence of VSSs with different regulatory structures may negatively affect consumer confidence. Future research should aim to examine if, how and where private and public actors could intervene in the regulatory structures of VSSs to increase consumer confidence effectively.

The food system and the natural environment are closely linked. Indeed, food production strongly relies on environmental resources and services, and releases outputs into the environment. This implies that food-related activities can create negative externalities for the environment, for example related to overexploitation and pollution, given that the market fails to deliver the socially optimum level of resource use and/or pollution. Given this market failure, public intervention is required to regulate such activities. Public intervention can take different forms, from no intervention to simple guidelines up to strict regulation. Indeed, regulation can follow either an approach that outlines general principles or that fixes specific standards, or that promotes information and education.

The aim of this chapter is to highlight the issues of environmental sustainability in the context of the agri-food system and to discuss current public and private initiatives that regulate the market from an environmental perspective. Thus, in this chapter we firstly introduce the concept of sustainability, including all the three pillars (profit, people and planet) and then discuss the issues of environmental sustainability related to food. Moreover, we discuss the different forms of public intervention and then we present European regulation that relates to environmental sustainability within the food system, including public and private voluntary initiatives. Furthermore, we discuss the interest of consumers for environmental sustainability and their perception of the impact of food production on the environment. Moreover, we analyse synergies between environmental sustainability and health issues. Concluding remarks follow.

Health claims can inform consumers about important nutritional qualities of food products that would otherwise go unnoticed, and influence consumer choice. This chapter reviews consumer behaviour literature related to health claims, and discusses this in the context of the EU legislation. It addresses the influence of textual as well as pictorial health claims, how consumers form inferences based on health claims, and the potential influence of health claims on consumer motivation to choose healthful products. Consumer choice is argued to be based on the fit between inferred product benefits and the goals that are accessible at the moment of choice. This relates to the dual goal of the legislation on health claims, namely information transparency as well as consumer health motivation. The scientific insights from consumer studies are confronted with the current legislation on health claims. Important bottlenecks for reaching the objectives of the legislation are a lack of attention by policy makers to the non-textual information on product packaging, a lack of ability of health claims to increase consumer motivation by themselves, and difficulty of consumers in correctly understanding health claims.

The area of functional foods has seen an investment of millions of dollars and increase in interest from all stakeholders over the past years. In the EU, the Nutrition and Health Claims Regulation (EC) No. 1924/2006 (NHCR) was adopted in year 2007. This regulation is based on a premarket approval system and sets harmonized rules to govern nutrition and health claims. It aims at consumer protection, fair competition and fostering innovation in the EU food sector. This chapter investigates the topic of companies’ compliance with respect to the NHCR, firstly by focusing on their perceived challenges and then by probing into their possible compliance strategies. The NHCR brings along numerous challenges related to the wording of claims, missing transparencies, financial and R&D resources etc. Companies seem to implement different strategies to deal with this regulation. Existing literature indicates that the compliance strategies that companies may adopt with respect to the NHCR could range from working on the data and reapplying for a claim, to circumventing the regulation altogether by changing communication methods or marketing products without using any health claims.

Conveying food information to consumers is a complex issue given both the vast array of European consumers, as well as the threefold purpose of the display of food information: it is required to communicate about the safety of a product and its ingredients, it assists consumers in making informed choices, and it is also a tool that may have an impact on the functioning of the internal market.

This chapter assesses whether nudging techniques can be argued to be a less restrictive but equally effective way to regulate diets in EU law, when contrasted to classical information-related or content-related regulation. It has been argued that nudging techniques, due to their freedom-preserving nature, might influence the proportionality test in such a way that authorities need to give preference to nudging techniques over content-related or information regulation. We will illustrate on the example of EU food law how behavioural sciences have first altered the EU food law’s goal from the mere provision of safety to also steering behaviour towards healthier diets. In line with this development, the regulatory toolbox advanced beyond the traditional dichotomy of content-related vs. information-related regulation, eventually adding nudging as a third way to regulate. Drawing on previous works of legal scholars we will then present the hypothesis that nudging techniques, according to their choice preserving nature on the one hand and steering character on the other, may be less restrictive but equally effective when contrasted with information-related or content-related regulation. With reference to recent CJEU case law that such a claim would better be backed up by scientific evidence, we will evaluate several nudging studies in the area of food that test the effectiveness of this approach. We will illustrate that, while nudging indeed has a choice-preserving nature and therefore might be less restrictive, it may also be classified under certain circumstances equally effective to information-related regulation. The EU judiciary has introduced an interpretation of the proportionality principle which requires a general preference for information-related rules. The evidence presented, however, may call for a different interpretation of the proportionality principle in some cases to the end that it may require policy makers in the EU to primarily use nudges instead of information-related regulation.

The question that is addressed in this chapter is whether food fraud can be mitigated using principles, next to or instead of rules. In many ways, principles may be preferred, as they reduce the regulatory burdens and avoid formal compliance while at the same time violating the purpose of food information rules. Food fraud implicates not only a violation of substantive product and/or food processing norms, but also an information violation. With principles fraudulent behaviour can be obstructed, especially what we have depicted as ‘fraud-by-effect’: formal compliance while at the same time misleading the consumer. The adoption of the ‘substance over form’-principle, well-known in financial accounting law and practice, can enrich the tool bag of instruments to protect the consumer.

The precautionary principle has been invoked to support stringent European food law. By its nature, the principle is particularly relevant to food security. This chapter discusses how precaution has been applied in EU food law generally, and finds that its application has been both controversial and selective. We then turn to two specific cases in which the precautionary principle played a prominent role: antibiotic residues in food and micronutrient malnutrition. On this basis, we revisit the precautionary principle’s role in EU food law. We conclude that the precautionary principle is best understood as a political tool, rather than an intellectual concept.

Taking the substantive law dimension as a given, this contribution assesses the enforcement policy of European food laws from a law and economics point of view. In this exercise the roles of the European Food Safety Authority and the national enforcement authorities in the Member States are being evaluated. National authorities are primarily responsible to ensure businesses’ compliance with food laws and handle situations of non-compliance. Aside of the public law dimension, the private law enforcement dimension is explored also. Overall, when critically assessing the current system against the law and economics criteria as developed by Steven Shavell for the choice between regulation or liability laws, the EU enforcement system can be seen in a rather positive light. Both, the strong role given to public regulators, same as the supplementary role given to private litigation can be supported by economic arguments. In the light of a resource-saving enforcement strategy placing some emphasis on self-regulation, also called “private regulation” within this volume, is likewise warranted.

This chapter applies the economics of federalism to the harmonization of food law in the EU. The economic criteria for centralization (more particularly transboundary externalities, the risk of a race to the bottom and a reduction of transaction costs) are used to ask the question whether some centralization of food law may be warranted. The question is also asked whether harmonization of food law could serve the goal of market integration.

In addition to sketching the economic principles of centralization the evolution of EU food law is sketched and compared to the economic theory. It is sketched how EU food law now represents a hybrid system. Still, an important Law and Economics scholarship argues that even though there may be strong arguments for some intervention at the EU level, currently directives go much too far in prescribing requirements concerning food, which may not always reflect the diverging preferences of citizens as far as food safety is concerned.

Pre-market approval is a high barrier to market entry. Its impact on innovation and competitiveness of food businesses depends to a large extent on the requirements and duration of the authorisation process. The higher the number of unknown variables in the equation, the more reluctant businesses are with their decision to invest in innovation. The European authorisation process for Novel Foods contains a number of elements that make it difficult for companies to form a reliable plan for their route to market. Key issues are the lack of binding time lines for regulatory decisions, of effective protection of the applicant’s proprietary scientific data and of a transparent process for the consideration of so-called “other legitimate factors”. These shortcomings are not addressed by Regulation (EU) No. 2015/2283 (the new Novel Foods Regulation) and can only be eliminated if the European Commission, Member States and the European Food Safety Authority tackle these issues in the implementation of the Regulation.

Biotechnology has played an increasingly important role in agriculture since the commercialization of genetically engineered crops, now planted globally on 185 million hectares. Animal applications of biotechnology include transgenic and cloned animals. In the US and the EU, legislative measures described in this chapter govern authorisation of GE crops, with a focus on food and feed safety and protection of the environment; transgenic and cloned animals are also subject to regulation. The US and the EU share some regulatory priorities, including scientific risk assessment, and face similar issues (a lengthy regulatory process and coexistence of GE and other crops). Significant differences in regulation, particularly in risk management, exist. Moreover regulatory barriers caused by asynchronous approvals of GE crops have reduced trade between the US and EU. Innovative genetic technologies, which may escape regulation under current laws, may require amendments to US and EU regulatory measures. This chapter suggests that despite differences in approach, regulatory systems should facilitate the development of new products of biotechnology and help to make these products available to global producers and consumers.