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Chair of Food Law | Prof Dr Kai Purnhagen LLM

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Europe Horizon DETECTIVEHide

The European Green Deal and the Farm to Fork Strategy prioritise transitioning to sustainable farming and food systems. They acknowledge the potential of new innovative techniques to enhance sustainability, provided they ensure safety for consumers and the environment while benefiting society. Traceability, authenticity, and transparency are key priorities of the Farm to Fork Strategy. Existing GMO detection methods may not apply to products derived from new genomic techniques (NGTs), as defined by the European Commission’s Joint Research Centre in 2021. These products often lack specific targets used in traditional GMO detection, such as promoters/terminators or event-specific sequences. The challenge lies not only in methodology but also in differentiating these genetically modified products from non-regulated ones. Given this context, DETECTIVE aims to develop and validate methods for detecting, identifying, and quantifying plant and animal products derived from NGTs. Through these efforts, DETECTIVE seeks to facilitate the traceability and authentication of NGT products, enhancing market control, ensuring legal enforcement reliability, and supporting consumer choice within the EU.

The specific objectives of DETECTIVE are to:

• Create a common understanding of the traceability, authenticity and transparency needs regarding NGT products by stakeholder type through the systems mapping approach (SMA) and the Responsible Research and Innovation (RRI RoadmapTM);

• Develop analytical techniques capable of detecting, identifying and quantifying known and unknown mutations, off-target mutations, and cisgenic events and validate these methods in accredited laboratories;

• Develop a data space as a cluster of databases covering a multitude of gene-edited and cisgenic organisms, gene sequences, natural and breeding-related variability (breeders’ gene pool);

• Analyse the socio-economic and regulatory implications of various technical and non-technical strategies for detection, traceability and authenticity of NGT plant and animal products;

• Empower enforcement authorities, certified laboratories, private laboratories, developers and agrifood operators through a co-created empowerment plan with train-the-trainers and capacity-building programme by applying the RRI RoadmapTM; and

• Establish a community of practice (CoP) to facilitate knowledge sharing among laboratories across.

In the context of this project, it is the task of our chair in the form of Ms. Aleksandra Hubar-Kolodziejczyk to coordinate the project.

You can find more information at: https://detective-ngt.eu/

(Source: https://detective-ngt.eu/goalsandobjectives/)

Regulating Food Innovation - Technical Innovation requires Regulatory InnovationHide

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


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