Regulatory landscape of microalgae-based novel foods in the European Union: Current status, trends, and challenges

The rapid advancement of food technology and the globalization of food trade necessitates robust regulatory frameworks to ensure consumer safety while promoting innovation. The European Union's Novel Food Regulation, established in 1997 and updated in 2015, serves as a critical framework for evaluating foods that lack a history of significant consumption within the EU. This paper focuses on the emerging category of microalgae, recognized for their high nutritional value, sustainable production methods, and diverse applications ranging from dietary supplements to specialized food ingredients. The research methodology involved collecting metadata from European Commission online sources. Data was categorized according to genus, product type, year of submission or approval, and geographical location of applicant companies. Notably, the genus Schizochytrium emerged as a significant player in the microalgae sector, particularly in France, where a company has gained attention for its DHA- and EPA-rich oils. Despite the promising potential of microalgae-based novel foods, the approval processes remain complex and lengthy, with approval times exceeding three years in many cases, despite regulatory updates aimed at streamlining applications. This paper outlines the overview of the current state of microalgae in the EU novel foods and offers targeted insights for researchers, industry professionals, and policymakers. By synthesizing recent scientific findings and regulatory developments, the study contributes to the ongoing dialogue on the safe and sustainable integration of microalgae into the European food market.