By making the headlines in the major European newspapers in 2013, the horsemeat scandal impaired consumer confidence in the transparency of the European food chain to a significant extent. In spite of its negative economic impact on the European Union (EU) market, the scandal in question has stimulated an unprecedented reflection in the area of food fraud by the EU institutions, national authorities, other stakeholders as well as by members of academia and the legal profession in general.

On an EU level, the European Commission swiftly responded to the scandal with the adoption of a wide-ranging action plan consisting of targeted policy, legislative and enforcement measures.

As a part of its Better Regulation agenda, the European Commission increasingly stresses the link between different types of regulatory evaluations. Predictions made by Impact Assessments (IAs) could be verified during ex–post legislative evaluations, while ex–post evaluations in turn could recommend amendments to be studied in future IAs. This article combines a dataset of 309 ex–post legislative evaluations (2000-2014) and a dataset of 225 IAs of legislative updates (2003-2014) to show how many ex–post evaluations of the Commission use IAs and vice versa. This way, it explores if the Commission's rhetoric of a ‘regulatory cycle’ holds up in practice. Building on the literature of evaluation use, we formulate the hypotheses that the timeliness, quality and focus of the IAs and evaluations are key explanations for use. Our results show that so far only ten ex–post evaluations have used IAs of EU legislation, while thirty three IAs have used ex–post legislative evaluations. Using Fuzzy set Qualitative Comparative Analysis, we find that timeliness is a necessary condition of the use of ex–post evaluations by IAs, suggesting that for the regulatory cycle to function properly, it is crucial to complete an ex–post evaluation before an IA is launched. Future research could repeat our analysis for evaluations of non–regulatory activities or study the causal mechanisms behind our findings.

An issue that may arise for both the plaintiff and defendant in a patent dispute involving pharmaceutical technology concerns the risks associated with selling an allegedly infringing product prior to the dispute being resolved. The plaintiff has the option to seek a preliminary injunction. Deciding whether to grant an injunction involves fact specific analysis. The economic components in such an analysis, which are addressed in this report, are: assessing whether the plaintiff will suffer irreparable harm without an injunction, measuring the balance of harms to the plaintiff and defendant, and evaluating whether the public interest will be served by an injunction.

Occupational exposures of pregnant workers can give rise to foetal damage. Two major types of strategies against detrimental effects on the foetus are described: differentiated protection that reduces only the exposure of pregnant workers (or only of female workers) and unified protection that reduces the exposure of all workers to a level that is sufficiently low to protect against detrimental effects on the foetus. The former strategy is shown to be inefficient, as it does not provide the desired protection. Protection only of pregnant workers is insufficient since protection is needed early in pregnancy when it is not known, and in the case of substances that are accumulated in the woman's body even prior to conception. Protection of all women is also insufficient to protect the foetus since evidence indicates that preconception exposure of the father can also give rise to malformations. Furthermore, differentiated protection that requires more costly protective measures for women tends to aggravate the already prevalent discrimination of women on the labour market. It is therefore concluded that unified protection is the only efficient and non-discriminatory strategy against foetal damage.

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.

On 18 February 2016, the European Ombudsman delivered a decision (case 12/2013/MDC) that has the potential to thoroughly shake up the manner in which the European Commission authorises plant protection products (PPPs).Pesticide Action Network Europe (PAN-Europe) brought the case before the Ombudsman. It alleged that the Commission approves potentially unsafe PPPs and disregards data gaps in the risk assessment, thereby ignoring concerns raised by the European Food and Safety Authority. PAN-Europe also argued that the Commission fails to set appropriate risk mitigation measures and to check Member States’ compliance with those measures. The Ombudsman largely agreed with PAN-Europe. She found that the Commission indeed authorised substances, even when it was unclear whether a substance met the legal health and environmental safety requirements. The Ombudsman made several recommendations to the Commission for bringing its approval practice, which constitutes maladministration, in conformity with EU pesticide law.

Setting a minimum unit price for the sale of alcoholic beverages has been on the agenda of the Scottish government for many years. As far back as 1999 the then newly formed Scottish Government decided to review data on the use of alcohol that revealed trends in Scottish alcohol consumption such as the fact that in the two decades following 1994 alcohol sales went from being split equally between the on-trade and off-trade to the off-trade comprising around 70 per cent of sales. Further studies reveal that the affordability of alcohol throughout the whole United Kingdom increased steadily between 1987 and 2007, with duty increases frequently short of inflation, and with supermarkets continuing to use alcohol as a loss leader. The result has been an increase in the affordability of wines and beers by 129% and 153% respectively.

Food producers and consumers are confronted with ever-growing choices and increasing competition within the EU and around the world. This has already led to various cases of food fraud and a call for political and legal action. Food fraud can be defined as ‘‘the deliberate and intentional substitution, addition tampering or misrepresentation of food, food ingredients or food packaging, labelling, product information, or false or misleading statements made about a food product’’. Meanwhile, the issue of “food fraud”, by means of employing names, symbols and images of third countries and thereby inducing a false impression on the consumer, appears to have been neglected despite its increasing economic impact. While the EU recently approved two new Geographical Indications (hereinafter, GIs) from third countries, the issue of the protection of Italian products against “rip–off Italian products” with Italian sounding names has taken centre–stage again.

On 5 February 2016, the National Oceanic and Atmospheric Administration (hereinafter, NOAA),within the United States (hereinafter, US) Department of Commerce, published a Proposed Rule to create a seafood traceability programme. The programme intends to combat illegal, unreported and unregulated (hereinafter, IUU) fishing, prevent fraudulent trade and to serve as the contribution of the US to the global action to combat IUU fishing, along the lines of other similar regulatory frameworks, such as the EU's extensive regulationon IUU fishing. However, despite the legitimate objectives of the measure, it is imperative that regulators take into account the potential consequences for international trade when designing such programmes.

Case T-397/13, Tilly Sabco v Commission, Judgment of the General Court (Fifth Chamber) of 14 January 2016, ECLI:EU:T:2016:8

Article 263 TFEU allows applicants to challenge regulatory acts which are of direct concern to them and do not entail implementing measures. In this judgment the General Court held effectively that the implementing measure cannot be hypothetical but must follow-on naturally from the underlying regulatory act. This note discusses the significance of this seemingly new element in the meaning of ‘entail implementing measures’ and its potential consequences.

In Europe, medicines can only be marketed once they have passed through a strict regulatory process, designed primarily to protect patient safety. It is only after in–depth testing on the targeted disease population, including three phases of clinical assessment and clinical trials, that a medicine will obtain a ‘marketing authorisation’. Given its primary goal of ensuring patient safety, EU law only allows a few narrow exceptions to the requirement of amarketing authorisation. Adrug can only be used “off–label”, meaning outside the limits of its marketing authorization, in authorised clinical trials or under one of the strictly defined exceptions, such as severe public health risk, compassionate use for groups of patients or for individual patients on a named patient basis.

However, in recent years, a trend has emerged Among Member States to push the boundaries of the existing regulatory system, and actively promote the off–label use of medicines on the ground that they are cheaper than the alternative, authorised medicine. It is questionable whether this trend is in line with EU law.