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What are the legal requirements for commercialising foods from precision fermentation in the EU? A research project by the Chair of Food Law at the University of Bayreuth's Kulmbach campus is investigating this question. The background to this is the unclear legal framework for products from precision fermentation for use in food. The research team is also looking at possible declarations for the innovative products, as it has not yet been clarified whether claims such as "animal-free" are even possible for artificial proteins.
Precision fermentation is still a relatively new approach in the field of food technology. Microorganisms such as yeasts, bacteria or fungi are used to produce specific metabolic products (e.g. proteins). Such specific proteins can ultimately be used as ingredients in food production. The first companies in this field are working on the production of nature-identical milk proteins for the manufacture of "animal-free" cheese. "Categorising such novel products within the existing European legal framework is quite complex. In order to provide reliable guidance, our team has been working intensively on the question of how such products can be authorised in the European Union and how they can be declared," reports Prof. Dr Kai Purnhagen, holder of the Chair of Food Law at the University of Bayreuth.
On the one hand, start-ups and industry stakeholders were interviewed and asked about their assessments and goals. Secondly, the research team analysed various legal texts on classification, approval and declaration. Essentially, two authorisation routes for precision fermentation products appear to be possible: the Novel Food Regulation (REGULATION (EC) 2015/2283) or the Regulation on genetically modified food and feed (REGULATION (EC) No 1829/2003).
The microorganisms used in precision fermentation are often genetically modified beforehand. This is done so that they produce the proteins that are actually needed. These proteins formed by the microorganisms are ultimately contained in the finished food, not the modified microorganisms themselves. This raises the question: is the food therefore genetically modified? Or must the "Novel Food Regulation" be applied because the food has been produced in a novel way?
The decisive factor may ultimately be the content of recombinant DNA, which means that if the end product still contains the modified DNA of the microorganisms, the Novel Food Regulation applies. "Ordinance on Genetically Modified Food" applies. However, if the microorganisms (and their DNA) could be separated during the process and are therefore no longer present in the end product, the "Novel Food Regulation" may apply. It is still unclear exactly where the limit lies. Can we assume a zero tolerance, or can the discussed limit of 10 nanograms of recombinant DNA per gram of food also be used for food? These are the questions raised by the Kulmbach researchers.
In addition to the different routes to authorisation, the research team also looked at possible declarations for the innovative products, because: Is a cheese from precision fermentation vegan, for example? Can it even be called "cheese"? Are claims such as "animal-free" possible? The researchers can already answer some of these questions, but others remain unanswered as the new products cannot always be categorised. As with plant-based alternatives, it will be a challenge to find the right words to ensure clarity and provide consumers with sufficient information without misleading them.
The legal framework for food innovations in the EU is very complex and the processes are lengthy. This is one reason why start-ups in the field of precision fermentation often consider entering the market in other regions. Singapore and the USA, for example, are considered to be very innovation-friendly. This project therefore also analysed the approval processes in these two countries and compared them with the European system. The research report provides a comprehensive guide for companies in the food industry that need to navigate the complex legal issues surrounding dairy products from precision fermentation.
The work was financially supported by the Adalbert Raps Foundation.
Adalbert Raps Foundation: For 40 years, the Adalbert Raps Foundation, based in Kulmbach, has been supporting people from all over Upper Franconia in the areas of senior citizen or youth work or in other social need situations. In addition, the foundation, which was established in 1978 by pharmacist Adalbert Raps, also supports numerous scientists and institutes in Germany and abroad as a funding partner for food research. In addition to its involvement in individual projects and collaborations, the foundation sets the tone by launching programmes and initiatives for Upper Franconia that provide the right scientific and social framework for pressing issues of the future.
Prof. Dr. Kai Purnhagen
University Professor and Chair of Food Law
Faculty of Life Sciences: Food, Nutrition and Health
Universität Bayreuth
Fritz-Hornschuch-Straße 13
95326 Kulmbach
E-mail: kai.purnhagen@uni-bayreuth.de
Original publication:
Federica Ronchetti, Laura Springer , Kai P. Purnhagen: "The Regulatory Landscape in the EU for Dairy Products Derived from Precision Fermentation. An Analysis on the Example of Cheese";
https://link.springer.com/book/9783031496912
Prof. Dr. Kai Purnhagen, Chair Food Law University of Bayreuth
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Prof. Dr. Kai Purnhagen, Chair Food Law University of Bayreuth
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