Sabrina Röttger-Wirtz

• Professor (Assistant) at Maastricht University

This article analyses the setting of global pharmaceutical standards in the International Council for Harmonization (ICH) and the implementation of these global standards in the European framework of pharmaceutical regulation. It thereby highlights the conflict between the publicprivate nature of the ICH process and the European administrative law...

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-makin...

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 framewo...

Contribution to the REconciling sCience, Innovation and Precaution through the Engagement of Stakeholders Project (RECIPES) funded by the Horizon 2020 Framework Programme of the European Union under Grant Agreement no. 824665.

The approval renewal of glyphosate as an active substance for pesticides in the EU has also kept the Court of Justice occupied. Within this line of case law, the Blaise case is the most recent one. In this preliminary reference procedure the Court was asked to review the validity of the Plant Protection Products Regulation 1107/2009, examined again...

Responding to mistrust in the European agencies’ risk assessments in politically salient cases, the European Union (EU) legislator, the European Food Safety Authority and the European Medicines Agency alike have accelerated their efforts to foster EU regulatory science transparency. These simultaneous endeavours have, however, taken place in a frag...

This book analyses, and questions the impact and legitimacy of, the implementation of global pharmaceutical standards in the European risk regulation framework for pharmaceuticals. Global standards increasingly shape risk regulation law and policy in the European Union, and the area of pharmaceuticals is no exception. As this book shows, global ph...

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...

The Regulation of E-cigarettes – International, European and National Challenges Lukasz Gruszczynski (ed) Cheltenham/Northampton: Edward Elgar Publishing, 2019, 320 pp. - Sabrina RÖTTGER-WIRTZ

Sulphites or sulphiting agents refer to sodium hydrogen sulphite, sodium metabisulphite, potassium metabisulphite, calcium sulphite, calcium hydrogen sulphite, and potassium hydrogen sulphite. As food additives, they are widely used by the food industry with a variety of commercial uses in food and beverages. Sulphites are effective bleaching agent...