Numerous studies have established that prebiotic ingredients in foods and dietary supplements may play a role in supporting human health. Over the three decades that have passed since prebiotics were first defined as a concept, research has revealed a complex universe of prebiotic-induced changes to the human microbiota. There are strong indications of a direct link between these prebiotic-induced changes and specific health benefits. However, at the present time, the EU has not permitted use of the term 'prebiotic' in connection with an approved health claim. This paper is the outcome of a workshop organized on the 25th October 2023 by the European branch of the International Life Science Institute (ILSI). It provides an overview of the regulatory requirements for authorized health claims in the EU, key areas of prebiotic research, and findings to date in relation to prebiotics and digestive, immune, metabolic and cognitive health. Research gaps and documentation challenges are then explored and a roadmap proposed for achieving authorization of 'prebiotic' in the wording of future EU health claims.

中文翻译：

---

食品和膳食补充剂中的益生元：欧盟健康声明路线图。


大量研究已经确定，食品和膳食补充剂中的益生元成分可能在支持人类健康方面发挥作用。自益生元首次被定义为一个概念以来的三十年里，研究揭示了益生元诱导的人类微生物群变化的复杂世界。有强烈的迹象表明，这些益生元诱导的变化与特定的健康益处之间存在直接联系。然而，目前，欧盟不允许在批准的健康声明中使用“益生元”一词。本文是国际生命科学研究所 （ILSI） 欧洲分会于 2023 年 10 月 25 日组织的研讨会的成果。它概述了欧盟授权健康声明的监管要求、益生元研究的关键领域，以及迄今为止与益生元和消化、免疫、代谢和认知健康相关的发现。然后探讨了研究差距和文献挑战，并提出了在未来欧盟健康声明的措辞中实现“益生元”授权的路线图。