Scientific Opinion on Animal Toxicological Studies for the Safety Assessment of Cultivated Food Products

Background As the field of cultivated meat and seafood progresses, traditional approaches to risk assessment, particularly whole-food animal feeding studies, require critical evaluation. Animal testing, especially long-term feeding studies, are resource and time-intensive, poses unreliable interpretation, and are ethically contentious. Given the controlled production environment of cultivated foods and the availability of compositional, molecular, and exposure data, this paper examines the applicability of a weight-of-evidence framework as a scientifically robust approach to safety assessment. Scope and approach The objective is to critically evaluate the scientific justification for in vivo toxicological studies in the safety assessment of cultivated food products and examine alternative, non-animal based methods. Key findings and conclusions Drawing on regulatory precedents, analytical frameworks, and case studies, this review demonstrates that a tiered, weight-of-evidence framework integrating compositional analysis, exposure assessment, and New Approach Methodologies offers a scientifically rigorous and proportionate strategy in comparison to applying uniform requirements for animal studies.