BRUSSELS, BELGIUM – Despite decades of research demonstrating the health benefits of prebiotics, the EU has yet to authorize the use of the term “prebiotic” in official health claims. A new paper, resulting from a workshop organized on October 25, 2023, addresses this challenge by outlining a strategic roadmap to gain regulatory recognition for prebiotics within the EU.
Over the past three decades, research has revealed a complex interplay between prebiotic-induced changes in the human microbiota and specific health benefits, including positive effects on digestion, immunity, metabolism, and cognition. The current scientific consensus, published by the International Scientific Association of Pro- and Prebiotics (ISAPP) in 2017, defines prebiotics as substrates that are selectively utilized by host microorganisms to confer health benefits, and they have recently proposed key criteria to classify prebiotics.
The European Food Safety Authority (EFSA) has set strict criteria for approving health claims, requiring robust scientific evidence that demonstrates a direct benefit to human health. Certain health claims related to non-digestible carbohydrates, which include some prebiotics endorsed by ISAPP, have been already approved in Europe. Yet, the specific term "prebiotic" has not been authorized in the EU for use as a health claim nor are there recommendations on how to achieve this..
Elaine Vaughan, Health Science & Regulatory Affairs Leader from Sensus noted: “Guidelines for a prebiotic health claim for food ingredients by a regulatory body like EFSA is so important as they will give consumers trust and credibility that the healthy food product has been scientifically validated. In addition, approved health claims can educate consumers about the benefits of proven prebiotics and stimulate investment in innovation by food industry in further healthier food products, which ultimately contributes to consumer and public health.”
In October 2023, the ILSI Europe Prebiotics Task Force held a workshop that gathered experts from academia, industry, and regulatory authorities to discuss the current regulatory landscape and the future of prebiotics in health claims. The paper resulting from this workshop was recently published in gut microbes. It provides:
- An overview of regulatory requirements for authorized health claims in the EU.
- Key findings from prebiotic research, particularly concerning their benefits for digestive, immune, metabolic, and cognitive health.
- Identification of research gaps and documentation challenges, including the need to understand mechanisms of action, the relationship between prebiotic structure and function, and establishing clear cause-and-effect relationships on host health.
The paper proposes a roadmap for achieving authorisation of “prebiotic” in the wording of future EU health claims.
The document emphasizes the necessity for standardized research protocols and validated biomarkers to effectively demonstrate the health effects of prebiotics. Addressing these challenges is crucial to achieving the authorization of "prebiotic" in future EU health claims.
Lead author and expert group chair Kieran Tuohy from university of Leeds commented: “This review presents a clear and concise summary of the prebiotic concept and gives a balanced discussion as to their potential health effects in relation to gut, immune and metabolic health, and cognitive function. It identifies gaps in current understanding of how prebiotics work and discusses the current regulatory challenges at length. As a report from a cross-sector expert prebiotic sandpit, it brings together key insights from both academic and industrial stakeholders and serves the community well in communicating the current state of play in terms of prebiotics as efficacious functional ingredients”.
How to cite the paper
Tuohy, K., Vaughan, E. E., Harthoorn, L. F., Blaak, E. E., Burnet, P. W. J., Busetti, A., … Calder, P. C. (2024). Prebiotics in food and dietary supplements: a roadmap to EU health claims. Gut Microbes, 16(1). https://doi.org/10.1080/19490976.2024.2428848
About the authors
The expert group contributed to this work - Kieran Tuohy, Ellen Blaak, Philip Burnet, Nathalie Delzenne, Paul de Vos, Louise Dye, Lesley Houghton, Seppo Salminen, Gemma Walton, Philip Calder, Anirikh Chakrabarti, Elaine Vaughan, Lucien Harthoorn and Damien Guillemet – are among the leading scientists in the field from both industry and academia. This representation across multiple sectors ensures objective and reliable content.
For more information about the Task Force, please visit: https://ilsi.eu/scientific-activities/nutrition/prebiotics/
About ILSI Europe
ILSI Europe is the European branch of the International Life Sciences Institute (ILSI), a global, non-profit federation with 10 entities around the world. Our mission is to develop, communicate and disseminate science-based guidance to tackle food, public health, and sustainability challenges. We facilitate collaboration and consensus-building between academic, industry and public service experts. Learn more at ilsi.eu.
Contact
- For questions regarding ILSI Europe or the Prebiotics Task Force, please contact Georgia Chatonidi at gchatonidi@ilsieurope.be
- For questions regarding the paper, please contact Kieran Tuohy at K.M.Tuohy@leeds.ac.uk, or Georgia Chatonidi at gchatonidi@ilsieurope.be