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.

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.

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.

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.

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.

Leather is one of the most efficient, natural and renewable resource, a unique and highly versatile material which contributes to the quality of everyday life and has done so for centuries. Due to its resilience, comfort and beauty, leather has played an important role since the beginning of times in satisfying man's clothing and decorative needs. Technically speaking, leather is a fundamental output of the leather tanning industry. Tanneries recover the hides and skins that are discarded by-products of the food industry producing meat for human consumption and convert them into leather, a stable material with a wide range of applications in downstream sectors of the consumer goods industry. Footwear, garment, furniture, automotive and leather goods industries are the most important outlets for EU tanners’ production. More specifically, the footwear Directive provides a definition of “leather”, which reserves the use of the word and its synonyms to products resulting from the processing of animal remains that retain the natural structure of the fibres undamaged.

International investment agreements (IIAs) emerged in the 1960's as an instrument to lower political risk for foreign investors and to facilitate political risk insurance when investing in developing countries with weak governance structures. Political risk is constituted by interferences to the investment by host states once the investor has entered the market and which would render the execution of the investment unduly burdensome, deprive the investor of the control or enjoyment of the investment or discriminate or treat the foreign investor arbitrarily. The legal provisions in IIAs include non–discrimination provisions, fair and equitable treatment, full protection and security, rights to compensation in case of expropriations, including indirect regulatory ones with the effect of depriving the investor of the control and benefits of the investment, provisions on free transfer of capital and, occasionally, non–precluded measures clauses as well as stabilization clauses in which the host state promises not to change the regulatory environment affecting the investment.

Cases C-517/14 P and C-519/P, Schutzgemeinschaft Milch und Milcherzeugnisse e.V. v European Commission, Kingdom of the Netherlands, Nederlandse Zuivelorganisatie, unreported 24 October 2014 (Seventh Chamber).

In the two related cases commented on, the Court of Justice of the European Union (CJEU) dealt with assessment of locus standi in the case of an applicant who disputed the validity of registration of two indications of geographical origin (IGOs), namely Edam Holland and Gouda Holland, being compound designations and containing a famous generic word designation (name), i.e. Edam and Gouda respectively. The importance of both cases relates, on the one hand, to the fact that registration of these IGOs was challenged on the basis of the generic names Edam and Gouda which are extensively used in practice, occupying a considerable market share. On the other, both cases could be a signal whether the CJEU re–affirms its restrictive approach to assessment of locus standi under Article 263 (4) TFEU. Although the CJEU re–affirmed its longstanding case law on restrictive assessment of locus standi also concerning registration of a compound geographical designation on the basis of a generic name, yet, as is argued in this case note, this approach did not take into account the specifics of registering IGOs (author's summary).

On 7 October 2015 the High Court of Australia unanimously allowed the appeal on D’Arcy v. Myriad Genetics Inc and ordered that claims 1, 2 and 3 of Australian Patent No 686004, entitled “In vivo mutations and polymorphisms in the 17q-linked breast and ovarian cancer susceptibility gene”, be revoked.

The High Court's judgment overturned the decisions of Justice Nicholas of the Federal Court, at first instance, and the Full Federal Court. This case note provides an overview of the High Court's decision and discusses its meaning and implications for patenting isolated nucleic acids in Australia.