The key requirement for GMO authorisation is the submission of analytical methods for the detection, identification and quantification (DIQ), which has proven challenging in the case of New Genomic Techniques (NGTs). Currently available non-analytical approaches, such as blockchain traceability and probabilistic analysis, while potentially useful for monitoring, are insufficient for authorisation purposes. The lack of reliable DIQ methods hinders the authorisation of NGT products and raises concerns for both organic and conventional agriculture, where the presence of NGT products goes undetected. Therefore, the existing GMO regulatory framework requires reevaluation to address the challenges posed by NGTs while ensuring compliance with the broader EU food law framework.

This article conceptualises regulatory sandboxes in the food area, considering them as unique spaces with varying degrees of openness. Through an analysis of closed, semi-open and open spaces, it illustrates the regulatory landscape surrounding regulatory sandboxes of novel foods in the EU, particularly focusing on the concept of “placing on the market.” The article contends that the degree of openness of regulatory sandboxes impacts the application of the precautionary principle within these spaces. It explores scenarios where the sandbox tests various aspects of novel foods under EU soft and hard law. The characteristics of the regulatory sandbox (open, semi-open, closed) changes corresponding to what the regulatory sandbox tests in relation to a novel food, eg, a sensory characteristics or safety or other data points, such as effectiveness of labelling. This article contributes to the ongoing discourse on innovation-friendly laws surrounding regulatory frameworks applicable to novel foods in the EU.

Toxic substances and endocrine disruptors are present in consumer goods on the European Union (EU) market, such as in food contact materials like cookware. This article investigates whether a legal recall obligation of such products exists in EU law, and in the absence of such an obligation, how the EU legislature has ensured that such products are disposed of in a manner that does not compromise human health and the environment when they become waste. For this purpose, this Article analyses recall obligations for food contact materials containing persistent organic pollutants, as well as their waste regulations. It focuses on a class of substances with non-stick properties, some of them formerly used in cookware, such as pentadecafluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS). We show that there is no single legal recall obligation; rather, many legal obligations are scattered among different provisions of EU law. When read together, they form a complex web of obligations, which may lead to recall measures for most of these products. However, doubts over the feasibility and effectiveness of such recalls remain.

What type of enforcement is the most effective to punish violations of food law or to prevent them from occurring in the first place? This article examines the question of which mix of private and public enforcement exists in European Union (EU) food law and whether this mix corresponds to the recommendations of existing social science research. Based on this research, we contend that EU-determined enforcement mechanisms differ in effectiveness across Member States. New technologies have the potential to stimulate a novel mix of public and private enforcement tools at the EU and national levels.

In July 2018 the Court of Justice of the European Union (CJEU) ruled that organisms obtained from most New Plant Breeding Technologies (NPBT) fulfil the requirements of the GMO definition of Directive 2001/18. Practically, organisms created with NPBT have since been legally treated as GMOs. While we do not seek to contest the judgment in itself, in the present contribution we draw attention to the effects of such a categorisation from the perspective of communication science. Extrapolating from communication research conducted in adjacent technology domains, we will argue that by putting organisms obtained from NPBT semantically in the same basket as GMOs may carry a serious risk – transferring analogous communication problems that GMOs encountered in the past, to organisms obtained from NPBT, while they may not address similar risks. Possible consequences such as these can hardly be considered at the stage of legal interpretation (such as with the CJEU). Rather, as discussion now unfolds whether and how to change the legal definition, insights from communication science and risk perception research on the effect of such a definition should be taken into account.

This report examines the pending Proposal for a directive on unfair trading practices in business-to-business relationships in the food supply chain, and its proposed amendments. It provides a general overview of the current content of the Proposal and analyses the proposed rules from a legal perspective. We find that: (1) the CAP legal basis may prove insufficient for regulation that covers the entire agri-food chain; and may (2) result in a strained relationship with the competition and consumer acquis; (3) the empirical basis for the prevalence of unfair trading practices, and the effect of their prohibition is relatively dire, which results in uncertainty with regard to the achievement of the future UTPD’s intended effect and effectiveness; (4) the choice for specific targeted prohibitions instead of general umbrella clauses may lead to ad hoc regulation that leaves large loopholes; (5) the institutional enforcement mechanism makes it likely that the Proposal contributes to the foundation for a new area of EU law, which will increasingly regulate practices in business-to-business relationships.

When determining the Appropriate Level of Protection (ALOP) in food safety law, developed countries rely on the Food Safety Objective (FSO) to meet the requirements of World Trade Organization (WTO) law and to provide a high level of protection based on insights from food safety science. Implementing an FSO/ALOP is resource-intensive and costly. Developing countries who would like to provide similar levels of protection are restricted by limited resources and often face difficulties implementing such an FSO-based ALOP. As a consequence, developing countries may base their ALOP on other legally acceptable reasons, which are non-scientific and less effective. We illustrate a less resource-intensive way to implement the FSO in the ALOP, which enables developing countries to design an ALOP that is based on food safety science. Depending on the resources available in the respective country, we map different possibilities to determine a science-based FSO/ALOP concept for developing countries, which also takes into account the requirements of WTO law.

The ageless question regarding the interpretation of the average consumer benchmark at EU level recently gained momentum. The Court of Justice of the European Union has de facto deviated in a judgment from a strict application of the formula of the “reasonably well informed and reasonably observant and circumspect” consumer established in Gut Springenheide. This report investigates the possible implications of this judgment on the implementation of behavioural sciences in the “average consumer” benchmark.

Rarely has international law been investigated from a Business to Agency (B2A) or even Agency to Agency (A2A) perspective. In recent years, the “mushrooming” of agencies at European level has triggered the importance of looking more closely into the relationship of the agencies towards each other. Is there a struggle over competences and regulatory objects, and would such competition lead to desirable outcomes? In this paper I will first show that, due to the historical development of administrative law in Europe and the USA, the perception of the desirability of agency competition differs. I will then contrast these findings with EU pharmaceutical law and show that it tends to avoid competition. Also, in practice, competition among agencies is still exceptional for European pharmaceutical regulation. Finally, I conclude these findings and hint at the limits of the desired process for further coherence. Although a move towards even greater convergence in European risk regulation is desirable, it does have its limits set by the principle of conferral in Article 5 (1, 2) EU read in conjunction with the areas of shared competence and the competence to support, coordinate and supplement.

Courts in Europe increasingly acknowledge an individual right to emission reduction against states. Such a right forms a new policy tool that can be used to enforce emission reduction. It can also be used to enforce scientifically sound environmental policy, as Courts recognise science as a default position when determining the content of the right. The individual right to emission reduction is another tool in the making to consider when implementing scientific insights into policy making.

Examples abound of highly politicized instances of risk controversies, such as the climate debate, counterterrorism, and the commercialization of genetically modified organisms (GMOs). Numerous reasons, such as divergent perspectives, ways of communication, and interests, explain why involved actors often find themselves locked in a controversy.

For instance, in the GMO debates environmental politicians, NGOs, industrial parties, consumers, and GMO scientists have exerted very distinct ways of communication, resulting in a highly polarized and contested gene-risk landscape. As a consequence, some industrial players have left or terminated R&D activities in the EU, while other scientists escape the gaze of EU-regulations and started experimenting in places with a different approach to GMO regulation and control.

The European Commission's (Commission) Better Regulation Strategy (BRS) is the major guideline for the Commission to assess legislation. It draws on regulatory impact assessment (RIA) via cost–benefit analysis (CBA), expert advice, and simplification in EU law–making. Yet, the practice of RIA by the Commission as well as in EU member states, while unavoidably incomplete, has shown avoidable shortcomings. The Commission's New Better Regulation Strategy of 2015 (NBRS) contains language that appears to address these shortcomings. If pursued consequentially, it would require an approach that resembles what has been called responsive behavioural regulation. At the same time, global initiatives from inter alia the World Bank emerge to include behavioural insights into policy analysis in the form of responsive regulation. This piece assesses potential models of RIA that can help to articulate the behavioural assumptions which are implied by NBRS as enshrined in the policy document “Better regulation for better results”. The methodological implications of the NBRS require a significant departure from the reliance on classical CBA, which is characteristic for the previous “Better Regulation” documents submitted by the Commission and which we term Old Better Regulation Strategy (OBRS).

Article 1(2) of Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27 must, apart from the case of substances or combinations of substances intended for the purpose of making a medical diagnosis, be interpreted as meaning that a product which includes in its composition a substance which has a physiological effect when used in a particular dosage is not a medicinal product by function where, having regard to its content in active substances and under normal conditions of use, it constitutes a risk to health without, however, being capable of restoring, correcting or modifying physiological functions in human beings (…) (official headnote).