An analysis of the regulatory environment of precision fermentation dairy products.

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 targeted metabolic products such as proteins. These specific proteins can then be used as ingredients for food production.

In this environment, there are already initial companies involved in the production of nature-identical milk proteins for the manufacture of animal-free cheese. Classifying these novel products within the existing European legal framework is quite complex. In order to provide reliable guidance, a team from the University of Bayreuth has been working intensively on the question of how such products can be approved in the European Union and how they can be declared.

Novel or genetically modified food?

For this purpose, on the one hand, start-ups and stakeholders in the industry were interviewed and asked about their assessments and goals. Secondly, various legal texts on classification, approval and declaration were analyzed. Essentially, two approval paths seem possible for products from precision fermentation:

- the Novel Food Regulation (REGULATION (EC) 2015/2283) or

- the Regulation on genetically modified food and feed (REGULATION (EC) No 1829/2003).

This is because the microorganisms used in precision fermentation are often genetically modified beforehand so that they form precisely the proteins that are needed. However, the finished food no longer contains the modified microorganisms themselves, but only the proteins formed by them. So is the food genetically modified? Or does the Novel Food Regulation apply because the food has been produced in a novel way?

In the end, the content of recombinant DNA may be decisive: If the modified DNA of the microorganisms is still present in the end product, the Regulation 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 final product, the Novel Food Regulation may apply. However, the exact course of the limit is still unclear at the moment. Is a zero tolerance to be assumed? Or can the discussed limit of 10 nanograms of recombinant DNA per gram of food also be used for food?

In addition to the different routes to approval, the research team also looked at possible declarations for the innovative products. For example, is a cheese from precision fermentation vegan? 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 because the novel products do not always fit into existing categories. As with plant-based alternatives, it will be a challenge to find the right words to adequately inform and not mislead consumers.

In summary, the legal framework for 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 innovation-friendly. In conclusion, this project therefore analyzed the approval processes in these two countries and compared them with the European system. Thus, the report provides a comprehensive guide for companies in the food industry to navigate through multi-layered legal issues in the field of dairy products from precision fermentation.

A revised version of the study will be published as a book by Springer Science.

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Chair of Food Law, Research Center for German and European Food Law, University of Bayreuth, Kulmbach Campus

Project Management: Prof. Dr. Kai Purnhagen, LL.M.

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Final report"An analysis of the regulatory environment applicable to dairy products obtained from precision fermentation"

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