New Scientific Report Spotlights Effective Alternatives to Animal Toxicological Studies for the Safety Assessment of Cultivated Foods

As the cellular agriculture field advances, unreliable approaches to risk assessment—particularly whole-food animal feeding studies—are ripe for replacement.

SINGAPORE – As national regulatory authorities around the world seek to develop guidelines for evaluating the safety of cultivated food and food ingredients, many scientists have raised concerns about the reliability, cost, time-intensiveness, and ethics surrounding long-term, whole-food animal feeding studies. To address this timely issue, members and observers of the APAC Regulatory Coordination Forum critically evaluated whether whole-food animal toxicological studies are appropriate for such assessments, given that alternative, non-animal-based testing methods can provide more relevant, specific, timely, and humane solutions for safety evaluation.

The resulting review paper, titled Scientific Opinion on Animal Toxicological Studies for the Safety Assessment of Cultivated Food Products, consolidates expert insights from cultivated food companies, industry associations, think tanks, and governmental agencies and regulators across ten APAC jurisdictions. The review also includes a real-life case study of a 90-day oral toxicity study, which expert analysis shows provided limited added value for whole cultivated food products.

Leading regulatory bodies are increasingly adopting the “three Rs” (replace, reduce, and refine) as guiding principles for food safety assessments, so this new paper will serve as a key scientific reference document to inform and empower global regulators to construct rigorous review frameworks that reflect modern scientific best practices.

This review paper has been submitted to the prestigious journal Trends in Food Science & Technology, and open access has been provided by the Good Food Institute APAC to ensure that the research is freely available to all. The pre-print paper is currently undergoing peer review.

Speaking to the objectives of this review paper, first authors Dr. Kimberly Ong and Dr. Fernando Rivero-Pino noted that:

“This commentary highlights a growing consensus that traditional whole-food animal studies are often ill-suited for cultivated foods, and that modern evidence-based approaches offer a more meaningful path forward. My hope is that this paper helps align industry and regulators around rigorous, science-driven frameworks that maintain high safety standards without relying on unnecessary animal testing.” – Dr. Kimberly J. Ong, Ph.D, Toxicologist, Vireo Advisors

“As with any other (novel) food, toxicological studies are not always required to assess safety. In the case of cultivated foods, traditional animal studies may not be the most appropriate way to address potential concerns. Instead, a weight-of-evidence approach that relies on process understanding, analytical data, and new approach methodologies, can provide a more relevant and reliable basis for safety evaluation. I hope this commentary helps move the discussion about how to properly assess the safety of these products.” – Dr. Fernando Rivero-Pino, Ph.D, Regulatory Scientist and Toxicologist, Atova Regulatory Consulting

APAC Society for Cellular Agriculture Senior Project Manager Calisa Lim adds that, “One of the main tenets of the cultivated foods industry is to avoid the pain and suffering of animals. We hope that this review paper can be a key document in the broader acceptance of alternative methods in food safety evaluation and support ongoing international effort on the 3R principles to replace, reduce, or refine the use of animal models.”

For more information, please visit https://www.cellagforum.info/.

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Dedicated to effectively bring cultivated food products to the market, APAC-SCA worked with GFI APAC to establish the APAC Regulatory Coordination Forum in 2023 as a formal mechanism for continuous and systematic cross-border dialogue between companies, industry associations, think tanks, governmental agencies and food regulators in different jurisdictions.