The term “prebiotic” was coined in 1995 by Prof. Glenn Gibson and Prof. Marcel Roberfroid. Despite decades of research reporting a wide range of health benefits of prebiotics, the European Union has not yet authorized a health claim using the term “prebiotic”.
A new paper, resulting from a workshop convened by ILSI Europe’s Prebiotics Task Force on October 25, 2023, addresses this challenge by outlining a strategic roadmap to gain regulatory recognition for prebiotics within the EU. The paper
The new paper, which was published recently in Gut Microbes, also provides an overview of regulatory requirements for authorized health claims in the EU; the current knowledge about prebiotic health benefits (including digestive, immune, metabolic, and cognitive health); and a summary of the research gaps and documentation challenges.
Prebiotic definition
“A substrate that is selectively utilized by host microorganisms conferring a health benefit” – ISAPP, 2017
“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,” said lead author and expert group chair Kieran Tuohy from the University of Leeds in the UK.
“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”.
“International experts who should be listened to”
Commenting independently on the new paper, Prof. Glenn Gibson, who is head of food microbial sciences at the University of Reading in the UK, and a world-renowned expert in prebiotics and probiotics, told NutraIngredients-USA: “It had long perplexed me as to why independent health claims for both prebiotics and probiotics are so lacking in Europe. This goes against the vast body of in vivo evidence in thousands of peer review publications.”
Prof. Gibson said the most cited reason for a lack of a health claim is an absence of proof for cause vs effect, a reason he describes as “spurious (aka ridiculous) given that such evidence hardly ever exists even in pharmaceuticals. The situation has really got out of hand with the attempted ‘banning’ of the terms on reliable products. This is ludicrous and is failing to putting science or the health of European citizens first.
“As such, I really welcome this initiative,” added Prof. Gibson. “It is balanced, well-presented and clear. A group of international experts who know the field like this should be listened to. I hope this paves the way for fair, robust claims that at last give consumers clear evidence-based choice that improves their gut health - a situation that sadly does not exist to date.”
IPA: A significant effort
IPA: A meaningful contribution
A spokesperson for the International Probiotics Association, which expanded its scope to include prebiotics in 2023, told us that this paper provides valuable insights into the evolving understanding of prebiotics from a scientific and regulatory perspective as well as their role in promoting health through gut microbiota modulation.
“It represents a significant effort and positive steps forward in the regulatory discussion of prebiotics in Europe,” said IPA. “Collaborative efforts among scientists, industry stakeholders, and regulators are critical to ensure that the latest research informs practical, inclusive, and forward-thinking regulations. It is also essential to recognize that scientific research does not always translate seamlessly into regulatory action.
“Encouragingly, however, the ILSI paper has set a foundation for these discussions by providing a comprehensive starting point about the future of prebiotic regulation in the EU.”
The association also noted that it agrees with the authors regarding the stated ISAPP criteria for classifying a compound as a prebiotic but would also suggest to expand the criteria so as to restrict the possible compounds that would classify under the definition. A broader category “increases the regulatory complexity and potential safety concerns due the wide array of compounds/ingredients to account for. It is analogous to strain specificity in probiotics – prebiotic compounds are all unique.
“A common misunderstanding is that the prebiotic criteria in their entirety must be used - the criteria cannot be used in isolation of each other to classify a prebiotic compound,” added IPA. “We encounter situations where oversimplifications have diluted critical concepts and generated misunderstandings of what is a true prebiotic.”
Guidelines
The European Food Safety Authority (EFSA) has set strict criteria for approving health claims. While certain health claims related to non-digestible carbohydrates have been approved – like a 2015 claim for Chicory inulin and stool frequency that did not make mention of the term “prebiotic” – 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.
“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,” stated Elaine Vaughan, Health Science & Regulatory Affairs Leader from Sensus.
“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.”
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.
Source: Gut Microbes
16(1). doi: 10.1080/19490976.2024.2428848
“Prebiotics in food and dietary supplements: a roadmap to EU health claims”
Authors: K. Tuohy, et al.