The regulatory landscape for alternative proteins and precision fermentation novel foods in the EU and UK: Challenges and opportunities

About the speaker: 

Prof Dr Hans Verhagen has over 43 years of experience in food safety and nutrition. He studied chemistry at the Universities of Nijmegen (NL) and Paris (FR) (MSc 1983), and finished his PhD in food toxicology at the University of Maastricht (NL; thesis in 1989). From 1990-2000 he worked at the TNO Nutrition and Food Research Institute in Zeist (NL), and from 2000-2005 for Unilever in Vlaardingen (NL). From May 2005 he was employed at the National Institute for Public Health and the Environment (RIVM), Bilthoven, NL (www.rivm.nl/en): 2005-2012 Head of the Centre for Nutrition and Health, and 2013-2015 Senior Scientific Adviser ‘Nutrition and Food Safety’. He was editor-in-chief of “Food & Chemical Toxicology” (http://www.elsevier.com/locate/foodchemtox; 1999-2004), and Chief Editor of the “European Journal of Nutrition & Food Safety” (http://www.sciencedomain.org/journal-home.php?id=30; 2011-2015). He was member of staff at the European Food Safety Authority, Parma, Italy (http://www.efsa.europa.eu/): head of the Risk Assessment and Scientific Assistance Department (2015-2018), Senior Scientific Officer (2018-2020). 

Prof Verhagen is a board-certified toxicologist (since 1990) and a board-certified nutritionist (since 2005). From 2006-2015, he was member of the EFSA-NDA panel (http://www.efsa.europa.eu/EFSA/ScientificPanels/efsa_locale-1178620753812_NDA.htm). He is a visiting professor at the University of Ulster since 2009 (NI; http://biomed.science.ulster.ac.uk/niche). From January 2021, he is also an adjunct professor at the Technical University of Denmark (https://www.food.dtu.dk/english/research/risk-benefit). As of November 2020, Prof Verhagen is owner and consultant at Food Safety & Nutrition Consultancy, NL (https://www.fsnconsultancy.nl/; https://www.fsnconsultancy.nl/about-me).  

January 2026: Peer-reviewed papers: 187. Hirsch Index: Web of Science: 63; Google Scholar: 69; Scopus: 51

Presentation:

Novel Foods are foods that were not consumed to a significant degree by humans in the European Union (EU) before 15 May 1997. They include newly developed foods, foods produced using innovative technologies or processes, and foods traditionally consumed outside the EU. To protect consumers, Novel Foods placed on the EU/UK market must undergo regulatory assessment to demonstrate that they are safe and do not have nutritional disadvantages. Since 1 January 2018, these requirements have been governed by Regulation (EU) 2015/2283, which established procedures for the authorisation of Novel Foods and, for traditional foods from third countries, a notification procedure.

Despite the increasing prominence of Novel Foods, their assessment and market introduction present significant challenges. These include the management of numerous and often complex dossiers, the development and application of appropriate scientific approaches for assessing food safety and nutritional risks, and practical issues associated with novel products, including sensory evaluation and tasting prior to market introduction. These challenges are particularly relevant for emerging alternative protein sources, where innovative production methods, novel ingredients and limited histories of consumption may require new approaches to risk assessment and regulatory evaluation.

Precision fermentation is an emerging technology of particular relevance to alternative proteins. It uses microorganisms as production hosts to produce specific proteins or other compounds under controlled conditions. Its application raises specific questions for Novel Food assessment, including the safety of the production organism and process, product composition, potential residuals, allergenicity and nutritional properties.

The recently concluded EU-funded Giant Leaps project, focusing on alternative proteins, addressed several of these challenges and resulted, among other outputs, in a set of nine Policy Briefs. These briefs provide insights and recommendations that can support the further development, assessment and responsible introduction of novel alternative proteins in the EU and UK. Together, they highlight the need for regulatory frameworks and scientific assessment approaches that are robust and protective of consumers while being sufficiently responsive to technological innovation. The findings provide a basis for continued dialogue among policymakers, regulators, scientists and industry to facilitate the safe and sustainable development of Novel Foods and alternative proteins.