Kai P. Purnhagen

The European Union Court’s Advocate General’s Opinion and new plant breeding techniques

573 25. Medema, M.H. & Osbourn, A. Nat. Prod. Rep. 33, 951–962 (2016). 26. Yim, G., Wang, W., Thaker, M.N., Tan, S. & Wright, G.D. ACS Infect. Dis. 2, 642–650 (2016). 27. Wink, J. Microbiol. Aust. 32, 81–85 (2011). 23. Blin, K., Medema, M.H., Kottmann, R., Lee, S.Y. & Weber, T. Nucleic Acids Res. 45 D1, D555–D559 (2017). 24. Eisenhaber, B. et al. Methods Mol. Biol. 1415, 477– 506 (2016). product compounds against the bacterial enzyme sortase A was able to identify several hits active with IC50 < 30μM. In summary, we offer several complementary screening approaches to mine the 160K NOL for useful natural substances with a wide range of applications. As the library and its usage opportunities continue to expand, we invite interested academic and industrial parties to explore the BII NOL as a tool for their research and the NPDP for collaborations.

Better Regulatory Impact Assessment: Making Behavioural Insights Work for the Commission’s New Better Regulation Strategy

The Commission’s New Better Regulation Strategy of 2015 (NBRS) seeks to address shortcomings of Old Better Regulation by promoting an approach resembling what elsewhere has been called responsive behavioural regulation. By discussing the weaknesses of Old Better Regulation, we argue that limited validity of its preferred methodology, CBA, poses core issues. Differentiating between internal (legal and scientific) and external (social) validity, we find that legal evaluation and behavioural insights need to be included in a structured manner into RIA to provide a robust methodology which matches state of the art standards in science and societal dialogue. First, NBR has to acknowledge that it operates in a legal environment of EU law, where some decisions are already predetermined. Generic EU law hence already contains certain requirements at normative level, which need to be taken into account when developing NBR strategies. Second, the methods applied for IA have to ensure a degree of internal and external validity that is acceptable for regulatory purposes. In order to meet the value commitments embedded in EU law on the assessment of impacts of EU legislation and to provide internal and external validity in a structured manner we propose to use the “homo oeconomicus institutionalis” model as a guidance for methodological design of RIA.

The Essential Elements of a Risk Governance Framework for Current and Future Nanotechnologies

Societies worldwide are investing considerable resources into the safe development and use of nanomaterials. Although each of these protective efforts is crucial for governing the risks of nanomaterials, they are insufficient in isolation. What is missing is a more integrative governance approach that goes beyond legislation. Development of this approach must be evidence based and involve key stakeholders to ensure acceptance by end users. The challenge is to develop a framework that coordinates the variety of actors involved in nanotechnology and civil society to facilitate consideration of the complex issues that occur in this rapidly evolving research and development area. Here, we propose three sets of essential elements required to generate an effective risk governance framework for nanomaterials. (1) Advanced tools to facilitate risk-based decision making, including an assessment of the needs of users regarding risk assessment, mitigation, and transfer. (2) An integrated model of predicted human behavior and decision making concerning nanomaterial risks. (3) Legal and other (nano-specific and general) regulatory requirements to ensure compliance and to stimulate proactive approaches to safety. The implementation of such an approach should facilitate and motivate good practice for the various stakeholders to allow the safe and sustainable future development of nanotechnology.

The “Honey” Judgment of Bablok and Others Versus Freistaat Bayern in the Court of Justice of the European Union: Implications for Co-existence

This piece analyses the CJEU’s Bablok Case from the perspective of law and economics. It uses doctrinal and economic argumentation to test its effects on international trade as well as on the legal order of the EU. It tests whether these insights live up to the expectations of the lawmaker. Furthermore, it makes policy recommendations how these insights can be used to further policy making in this area at EU level. We proceed in five steps. We will first introduce the background of the case and the regulatory environment, before we turn to describing the facts and findings of the Court. We will subsequently illustrate the changes in the regulatory system triggered by the Court’s judgment, before we turn to a more thorough analysis of the judgment on the EU and the global trade system from a socio-economic perspective. From these findings, we will conclude with concrete policy recommendations.

The Potential Use of Visual Packaging Elements as Nudges

Regulators legislate businesses’ use of claims on product packaging by mostly focusing on textual claims and the extent to which they could potentially mislead consumers. Interpreting textual claims generally requires consumers to engage in extensive and deliberate processing (so-called type 2 processing in dual processing models in social psychology). In real life competitive choice settings, however, businesses preferably make use of colours and other visual elements to successfully attract consumers. In case this approach supports consumers in making healthier food decisions, it can be seen as a form of nudging, as this approach largely appeals to consumers’ reactive, intuitive modes of decision making (i.e., system 1 processing). Nevertheless, visuals may mislead consumers to a larger extent than textual claims in that they overpromise health benefits of consuming the product. In order to effectively regulate health claims in the EU, we claim that regulation has to devote attention to the regulation of pictorial claims. We will first illustrate such a mechanism and its potential for effective nudging on the example of health and nutrition claims in the EU. We will then investigate on the example of the differences between textual and pictorial claims whether the EU health claims regulation is effective in making sure that sales techniques of food companies are being regulated as effective nudging instead of misleading marketing tactics.

Conclusions and Way Forward

Legislatures should ensure that all elements of a robust responsive and principles based regulatory system for food safety governance are in place and applicable to nanofoods. The scientific community must proceed in identifying risks and methods of detection and risk assessment. Risk assessment authorities should achieve mutual recognition.

On How to Assess a Medicinal Product by Function

Case Note on ECJ, C-27/08 BIOS Naturprodukte GmbH v. Saarland: 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 (…)

EU court casts new plant breeding techniques into regulatory limbo

799 To the Editor: We previously published a Correspondence in the June issue of Nature Biotechnology1 discussing the potential implications of the Court of Justice of the European Union (CJEU) Advocate General’s interpretation of how products generated by new plant breeding techniques (NBPTs) would be subject to regulation under European Union (EU; Brussels) law2. At that time, it appeared possible that the EU’s decision to exempt ‘mutagenesis’ from Directive 2001/18/ EC might also apply to all future mutagenic technology, regardless of the use of novel techniques. After the final ruling of the Grand Chamber of the CJEU on 25 July 2018 (ref. 3), it is now clear that that view is wrong. Europe is now on a course to take a much more sweeping and precautionary view of the NBPT products that fall under the remit of the directive than was first suggested by the Advocate General; indeed, only a very narrow set of products generated by conventional mutagenesis are now exempt from EU regulatory oversight. In a sense, the CJEU decision now puts the ball back squarely in the court of European legislators, who must decide whether they want to do nothing—except appease some environmentalists and other lobbyists—or change a European regulatory system that currently regulates mutagenized plant products that are completely indistinguishable from nonregulated mutagenized products. The CJEU decision is that any organism obtained through an NPBT that applies mutagenesis will be classified from now on with a retrospective effect from the day that the directive went into force as a genetically modified organism (GMO) within the scope of the EU court casts new plant breeding techniques into regulatory limbo

Consumer Protection Legislation

This contribution sets out in a very brief overview the consumer protection legislation with regard to health and food at the inter-, supra-, and transnational and local levels. It introduces basic concepts as well as the most important legislations.

Regulating and Managing Food Safety in the EU : A Legal-Economic Perspective

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.