The Regulatory Landscape in the EU for Dairy Products Derived from Precision Fermentation An Analysis on the Example of Cheese

This book assesses the EU legal framework applicable to dairy products obtained through precision fermentation. It maps the authorisation and labelling requirements for these products to be placed on the EU market. It compares these provisions to those governing the food markets in the USA and Singapore, which are considered to be more innovation-friendly. At the time of writing, the precision-fermented dairy sector is still in the developmental phase, with only a few precision-fermented dairy alternatives available on the market, none of which are present in the EU. Regulatory uncertainty has been cited as significant obstacle for food business operators seeking to introduce alternative protein products in the EU. The book confirms these reports, as the current EU regulatory framework presents several legal uncertainties that are challenging for food business operators to overcome. Broadly speaking, there are two authorisation frameworks applicable to dairy products obtained through precision fermentation in the EU. The choice between these frameworks depends on the presence of genetically modified organisms (GMOs) or residues thereof in the final product. If such GMOs or residues are present, the pre-market authorisation procedure is governed by the Genetically Modified Food and Feed Regulation (GMFR). If the final product does not contain any GMOs or residues, it falls under the scope of the Novel Food Regulation (NFR), and the pre-market authorisation procedure is governed accordingly. Both of these authorisation pathways entail high regulatory requirements, which can pose challenges for the development of the precision fermentation sector. Despite the difficulty in accurately classifying products, it is crucial for food business operators to comprehend the applicable legal framework early in the product development process, given that the authorisation paths differ in their standards. In addition to pre-market authorisation requirements, companies must address labelling issues. Food labelling shall provide a basis for consumers to make informed choices in relation to the foods they consume. The primary objective of EU food labelling law is to prevent consumer deception , making it crucial for dairy products and their animal-free alternatives, to adhere to a stringent naming law as stipulated in the Common Market Organisation and specific accompanying legislation. Moreover, it is imperative to consider regulations regarding the use of health and nutrition claims, as well as labels such as “vegan” or “organic”, etc. Furthermore, the labelling of novel foods and genetically modified foods may necessitate mandatory information specified in the authorisation process. The book serves as a comprehensive guideline for food business operators involved in the production of precision-fermented dairy alternatives, aiding them in navigating the intricate European regulatory landscape.

1 Executive Summary.- 2 Background.- 3 Precision Fermentation and GMMs.- 4 Pre-market Authorization.- 5 Labelling: General Product Naming Requirements.- 6 Comparative Analysis.

Federica Ronchetti works as food law expert at the Competence center for the Food Chain of the Austrian Agency for Health and Food Safety since September 2023. During the development of this publication, she worked as scientific employee at the Chair of Food Law, University of Bayreuth, Campus Kulmbach and the Research Center for Food law of the University of Bayreuth since 2020, where she focused on interdisciplinary studies in the area of food law, in particular on the regulation of food innovations in the EU. She holds a BSc in Nutritional sciences from the University of Vienna, a Dipl.-Ing. In Safety in the food chain from the University of Natural Resources and Life Sciences, Vienna and an LL.M. in Food law from Luiss Guido Carli, Rome. In 2022, she co-founded the „Bayreuth-Kulmbach Alt Protein Project“ of the Good Food Institute.

Laura Springer works as scientific employee at the Chair of Food Law, University of Bayreuth, CampusKulmbach since 2021 with a focus on Food Law, Food Waste Law and European Law. She holds the German “Erstes Staatsexamen”, a law degree which she completed in Bayreuth in 2021.

Kai P. Purnhagen is Full Professor and Director of the Research Center for German and European Food Law at the University of Bayreuth. He works in the areas of European Union Law, International Economic Law and the interdisciplinary and comparative analysis of law, with emphasis on the food market. He studied Law, Political Science, Economics, Philosophy and Sociology at the Justus-Liebig-University Gießen and at the Fernuniversity Hagen, he continued as LL.M. - Fellow at the University of Wisconsin-Madison, before he was admitted to the PhD programme of the European University Institute in Florence, he undertook a Post-doc at the University of Amsterdam and at the Ludwig-Maximilians-University Munich, before he was appointed Assistant and Associate Professor in Law at Wageningen University. He held visiting or short-term appointments at the University of Lucerne, the London School of Economics and Political Science, the University of Wisconsin-Madison, and the Justus-Liebig-University Giessen.