Prebiotics on the map – ILSI’s new roadmap for prebiotic health claims in Europe
The landscape of prebiotic science continues to evolve, and an important new milestone has been reached in the journey towards regulatory recognition in the European Union (EU).
A new paper published in Gut Microbes outlines a strategic roadmap for gaining EU health claims for prebiotics, developed through a collaborative workshop held in October 2023 by ILSI Europe’s Prebiotics Task Force, in Brussels, Belgium. Click here to read the paper in full.
The International Life Sciences Institute (ILSI) is a global, non-profit organisation committed to improving public health through evidence-based scientific research, bringing together international experts from academia, public sector, private sector and NGOs (non-government organisations) to advance understanding in key areas of nutrition and food science.
Clasado is proud to have contributed to this important initiative through the participation of our R&D Director, Dr Lucien Harthoorn, who joined leading scientists from both industry and academia to help document the requirements, key research areas and findings, and regulatory challenges related to prebiotics in Europe. For formulators operating in today’s global nutrition market, particularly in regions where gut health awareness is accelerating such as Asia-Pacific and North America, this represents a progressive step towards the clarity needed for the EU region.
Despite extensive scientific research demonstrating the positive impacts of prebiotics on digestive health, immunity, metabolism and cognition, the term ‘prebiotic’ has yet to be authorised for use in consumer facing communications in the majority of member states of the EU, with select countries like Italy being exceptions to this approach. This new roadmap represents a progressive step forward in communicating the challenges and what the requirements are for the term “prebiotic” to be authorised.[SR1] [DG2]
The paper provides a comprehensive framework for achieving authorisation of the term ‘prebiotic’ in future EU health claims wording, including standardised research protocols and validated biomarkers to effectively demonstrate health effects. This guidance is particularly valuable as it helps align the extensive body of existing prebiotic research, including the studies led by Clasado, with the strict criteria set by the European Food Safety Authority (EFSA) for approving health claims. For health and nutrition brands developing prebiotic products, this clarity could prove invaluable in product development, marketing strategy and accelerate commercialisation.
As a business built on a foundation of scientific excellence, we understand the importance of robust evidence in supporting health claims.
Our own galactooligosaccharide (GOS) prebiotic, Bimuno® GOS, is supported by over 125 scientific publications including more than 20 clinical trials, demonstrating our commitment to advancing the scientific understanding of prebiotics. This extensive research portfolio enables formulators to develop products with confidence, knowing their new gut health focused products are backed by comprehensive scientific validation.
The roadmap identifies key research priorities, including the need to better understand mechanisms of action, establish clearer cause-and-effect relationships on host health, and explore the connection between prebiotic structure and function. These align closely with our own research objectives at Clasado as we utilise our prebiotic expertise across applications and explore the benefits of prebiotic supplementation, from dedicated supplements through to functional foods and beverages.
“With consumer interest in gut health continuing to rise, this initiative represents an important step forward for the prebiotic category” notes Dr Harthoorn. “By establishing clear and standardised guidelines for achieving health claims, we can help ensure that consumers have access to products with scientifically validated benefits, while supporting continued innovation in the field.
Looking ahead, this roadmap provides valuable direction for both academic researchers and industry partners working to advance prebiotic science. The collaborative approach taken in developing these guidelines, bringing together expertise from across the sector, demonstrates the industry’s commitment to establishing rigorous standards for prebiotic products.
As we continue our own journey of scientific discovery at Clasado, we remain committed to supporting initiatives that advance the understanding and recognition of prebiotics’ role in supporting human health.
Click here Bimuno® GOS – Clasado Biosciences to learn more about the scientific evidence behind the prebiotic functional ingredient, Bimuno GOS.
