- Innovate Food LawHide
Innovations in food products and processes are critical to deliver progress on food safety and food security, to tackle environmental degradation and climate change, and to achieve the UN Sustainable Development Goals. New food categories e.g. insects, meatless products, plant-based drinks and supplements, and applications of biotechnology e.g. CRISPR-Cas9, together promise beneficial health effects and positive environmental impacts that will meet the demands of individual consumers (vegan foods, functional foods) and of the society as a whole (sustainability, animal welfare). However, food innovations´ development and adoption are highly interlinked with regulatory challenges. In the European Union, novel foods require approval prior to being placed on the market. As for Genetically Modified Organisms (GMOs), heavy requirements are imposed not only as regards their placing on the market, but also their use, labelling, traceability and co-existence. Both novel foods and GMOs are subject to risk assessment under the auspices of EFSA, and to a Standing Committee voting procedure. This is quite costly in terms of both time and money.
Despite the breadth of the literature, little has been written on how a regulatory regime can be designed to enable innovations that deliver on existential societal challenges as well as protect human health, safety and the environment. New research must therefore address the question of linkages between different regulatory objectives. It must first of all consider the question of regulatory effectiveness – whether the current regulatory regime is fit for the regulatory objectives. In second place, it must equally address numerous assumptions behind the regulatory design – why certain innovations are regulated in the first place and on which (scientific) criteria one ought to decide whether an innovation should fall within the remit of a regulation. Different regulatory objectives do not merely represent different interests. They equally represent different analytical accounts of different disciplines, hence requiring tackling the research from a number of angles. This project will fill these gaps.
With a view to pre-market regulation, it will provide for the first time a clear and tangible analysis of whether, and how, the current legal regimes strike a balance between the protection of health, safety and the environment and innovation in the food sector. It will further suggest new and innovative regulatory solutions, which enable innovations and protect society from potential risks originating from those innovations.
Project website: http://innovatefoodlaw.eu/
- Project: "Deciding on 'Benefits' of emerging technologies under international and European law - The case of CRISPR: A law in context approach"Hide
We are excited to announce the start of our new project here at the Chair of Food Law, Campus Kulmbach, University Bayreuth, in cooperation with the Federal Office of Consumer Protection and Food Safety (BVL), the Hasso Plattner Institute in Potsdam and Stanford University.
The CRISPR technology is new and risks remain unclear for certain applications. At the same time the potential benefits are enormous. This research project is innovative in that it is the first to propose a comprehensive insight into the concept of 'benefits' that lies beyond the traditional risk-based regulatory mechanisms. The project seeks to generate an understanding of the benefits of new technologies in biosciences under EU law and provide arguments that could be used in CRISPR regulation.
- Project: “An analysis of the regulatory environment applicable to products obtained from mushrooms and fungal mycelium” -Hide
The production of animal proteins is one of the most environmentally impacting industries. Responding to the growing demand for sustainable alternatives, heavy investments are made into the development of innovative solutions such as cell cultures, insects breeding or plant-based protein brewing. Among others, food products obtained from mushrooms and mycelium (Mushroom and Mycelium Products or MMP) are important, as a number of start-ups and food companies are or begin operating in the sector.
The EU regulatory framework concerning MMP has never been subject to a comprehensive study or review. The lack of legal certainty constitutes a major problem for food companies willing to access the market and engage in the sector.
Therefore, the main objective of this research project was to map the EU regulatory environment applicable to MMP, offering food companies a regulatory guidance, an instrument to navigate through the regulatory framework. At the same time, the project highlighted gaps in EU law and pinpointed areas for further research.
Among others, the following topics were covered:
- Classification of MMP as foods or medicinal products or as agricultural products
- Novel Food Regulation as applicable to MMP
- Requirements to obtain a novel food authorization
- Use of agricultural by-products as substrates for MMP
- Use of food additives in MMP and use of MMP to produce food additives
- Labeling of MMP: mandatory and voluntary information (such as a correct name for MMP; use of nutrition and health claims)
Despite the existence of official regulatory guidance on novel food applications, MMP represent a specific category of novel foods, and as the research showed, further guidance is needed. So far, regulatory specificities of MMP have been only recognized as regards the application for food enzymes. Uncertainties exist as regards the appropriate toxicological and allergenicity strategies for MMP risk assessment. The picture further complicates the experimentation with different substrates originating from agricultural by-products. Labelling of MMP in the EU continues facing regulatory uncertainties. The use of food additives in MMP, as well as the use of MMP to produce food additives, face comparable regulatory challenges to other food additives.
To download our report: https://www.raps-stiftung.de/projekte/analysis-of-the-regulatory-environment-applicable-to-products-obtained-from-mushrooms-and-fungal-mycelium