Research protocol - Interview study on stakeholders' perspective on risk assessment of cellular agriculture-produced dairy proteins

The current interview study focusses on the regulatory procedure to get cellular agriculture-produced dairy proteins to the market. Producing dairy products via cellular agriculture, either via biomass fermentation or precision fermentation, is a rather new development and these products have not yet been marketed in the European Union. Therefore, risk assessment is required as one of the steps to get access to the market, as is laid down in the General Food Law.

Risk assessment is a purely scientific evaluation to assure all food on the European market is safe for human consumption. It is performed by the European Food Safety Authority (EFSA), which is an independent agency that consists of panels of experts in the field of food and health. When a company requests market entrance for a new protein and the relevant EFSA panel comes to a positive risk assessment, the European Commission in collaboration with the member states are responsible for the risk management, where it is decided whether or not the new protein is allowed on the market.

The current study focusses on the first step of the scientific risk assessment. Since cellular agriculture-produced dairy proteins are a new development and the proteins are more complex compared to other novel foods, it is expected that the duration of the risk assessment is longer and more complex, for all involved parties. Additionally, the development of cellular agriculture-produced dairy proteins create an interesting tension point between sustainable innovations and food safety.

Namely, sustainable food innovations are useful and desired in light of sustainability, but food safety remains the main goal of EU food law. The objective of the current interview study is to gain insight in how the risk assessment procedure of cellular agriculture-produced dairy proteins currently works in practice and how it is perceived by the different stakeholders. The stakeholders are divided into three groups: (1) food business operators developing these alternative proteins and developing the required risk assessment dossier; (2) consultants who help food business operators with building and submitting a risk assessment dossier; and (3) EFSA panel members involved in conducting the risk assessment of cellular agriculture-produced dairy proteins.

By this means, we will use the protein transition as a critical case to theorise how regulatory risk assessment systems adapt to sustainability-driven socio-technical transitions.