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Personalised nutrition, the tailoring of nutrition products, services or advice to individual characteristics such as genetics, phenotype, nutritional intake and/or exercise routine, is increasingly attracting the interest of industry, consumers and researchers. This article provides an overview of the current European Union (EU) regulatory framework as applying to personalised nutrition and draws attention to the important role of EU food law in the regulation of this innovative approach to nutrition. It is argued that personalised nutrition challenges the regulatory borderline between health and lifestyle products or services and, furthermore, also pushes the boundaries of current food safety and health claims legislation.

This article examines the development of mutual recognition of marketing authorizations for pharmaceuticals, arguing that the sui generis approach to mutual recognition in this policy area is based, first of all, on the harmonisation of regulatory requirements. However, it additionally also required the procedural integration of mutual recognition in trans-national administrative procedures, and institutional innovation. This has created a curious mix of centralized and decentralized authorisation routes with various stages of collaboration and arbitration. In this regard, the creation of the complex, composite procedures in place to facilitate the mutual recognition of pharmaceuticals raises several questions with regard to the judicial and political accountability of the actors involved. The developments and problems described in this article with regard to pharmaceuticals are also mirrored in other risk regulation areas, where mutual recognition seems to require the integration into administrative procedures on intra-administrative and/or EU level, leading to proliferation of sui generis approaches to mutual recognition.

In the EU, pharmaceuticals are subject to a marketing authorisation requirement that, depending on the type of product concerned, can be obtained either centrally through a Commission decision with EU-wide effects or in the Member States, potentially subject to mutual recognition in composite authorisation procedures. These composite decision-making processes can nowadays be considered a standard way of administrative decision-making in the EU internal market. Yet, judicial supervision remains anchored in the separation of jurisdictions between the national and the EU level, and between national levels. This article explores the challenges posed to judicial review in the case of pharmaceutical marketing authorisations when European administrative composite structures are used.

The PhD research ‘The Interplay of Global Standards and EU Pharmaceutical Regulation’ discusses the EU implementation of pharmaceutical standards set by the International Council for Harmonisation (ICH). It is argued that the process of standard-setting in the ICH does not adhere to the same level of participation, transparency and independence of expertise as would be ensured through administrative procedure in the Union. This leads to legitimacy flaws of the ICH standards. With the implementation of ICH standards in the Union, its flaws are imported as well. These legitimacy flaws are not compensated through the Union’s implementation procedure.