A word with

Steve Morrison

Member of AgroFOOD Industry Hi Tech's Scientific Advisory Board

Regulatory Manager

It is now 16 years since the introduction of the health claims legislation. Why are health claims so important?

The health claims legislation, implemented 16 years ago in the European market, aimed to safeguard consumers by ensuring that health claims on food products were accurate, transparent, and trustworthy.

Can you share your experience of first functional food ingredient which gained the health claims status?

One of the early success stories in obtaining health claims status was Fruitflow™, a water-soluble tomato concentrate. This ingredient secured a proprietary health claim by presenting a robust body of scientific evidence demonstrating its mild, aspirin-like effect on blood platelets, which contributed to healthy blood flow and cardiovascular health. The research team conducted a series of high-quality human intervention studies that showcased the ingredient's acute and chronic effects, dose response, and safety. These were some of the key factors that contributed to the success of Fruitflow™ in obtaining a health claim status. However, despite the scientific validity of the claim, the challenge lay in ensuring that consumers understood the role of platelet function in maintaining healthy circulation.

Any examples you can share about other recent successful applications? What are their critical success factors?

In recent years, there has been a notable decline in successful applications for health claims. The lack of published opinions since October 2021 indicates a slowdown in the process. The most recent successful claim was for green kiwi fruit, which demonstrated its effectiveness in maintaining normal defecation. Other approved applications in the past have focused on addressing similar health benefits, such as constipation relief provided by ingredients like lactitol, native chicory inulin, and sugar beet fiber. The health claim for green kiwi fruit was supported by multiple studies, albeit with some methodological limitations, that collectively showed an increase in stool frequency and a plausible mechanism of action.


Analyzing the successful applications provides valuable insights into the critical success factors. These include conducting multiple high-quality human intervention studies in line with good clinical practice principles, clearly reporting key aspects of study design and delivery, using appropriate statistical methodology, and demonstrating a plausible mode of action and dose-response relationship, if applicable.

What is the experience that companies have gained during all this period?

Companies have gained valuable experience during this period, realizing the significance of conducting high-quality human intervention studies. Randomized controlled trials have emerged as the gold standard, while uncontrolled studies or those lacking proper controls and randomization have weakened the evidence supporting health claims. EFSA's scientific panels have issued both positive and negative opinions, highlighting the importance of detailed reporting and reproducible cause-and-effect relationships. What are the key factors that EFSA's scientific panels consider when evaluating health claim applications? Multiple studies are necessary to establish such relationships, and the quality of data delivery plays a vital role in EFSA's assessment.

“Enabling healthy and nutritious foods for people and planet”

Why is there limited success and what needs to be changed according to you about this regulation? 

The limited number of approved health claims can be attributed to several reasons. Early applications often relied on older studies that lacked comprehensive reporting, while some focused on biochemical markers or microbiome changes instead of directly measuring the health benefit. In recent years, methodological weaknesses in individual study delivery have hindered applications from providing sufficient evidence. The global COVID-19 pandemic has further impacted research and the conduct of human studies, potentially contributing to the overall slowdown. Additionally, the European Transparency Regulation, introduced in March 2021, has had a significant impact, requiring companies to notify research studies before their commencement and introducing new submission procedures.

Can you give us a few insights on the European Transparency Regulation in effect since March 2021? How does the Transparency Regulation enhance risk assessment and the independence of scientific studies?

The Transparency Regulation aims to enhance risk assessment and scientific study independence by promoting openness and transparency in safety assessments. This is the primary objective of the European Transparency Regulation. However, its implementation has created challenges for companies, such as increased competition in securing study sites and recruiting participants, as well as the potential for others to publish similar studies ahead of the original applicant.

The Health claims approved until now are only a few. Why according to you? Is this due to a lack or to a rejection of new applications?

Companies need to adapt their strategies to comply with the new requirements while ensuring the confidentiality of proprietary data and maintaining a competitive edge. Overcoming these challenges requires collaboration among stakeholders to foster innovation and generate high-quality evidence. Food companies, academia, and regulatory agencies need to work together to share experiences and knowledge, enhancing their understanding of EFSA's requirements and refining the health claims process. Improved collaboration and knowledge sharing will contribute to the development of evidence-based health claims, benefiting both the industry and consumers.

Companies need to adapt their strategies to comply with the new requirements while ensuring the confidentiality of proprietary data and maintaining a competitive edge. Overcoming these challenges requires collaboration among stakeholders to foster innovation and generate high-quality evidence. Food companies, academia, and regulatory agencies need to work together to share experiences and knowledge, enhancing their understanding of EFSA’s requirements and refining the health claims process. Improved collaboration and knowledge sharing will contribute to the development of evidence-based health claims, benefiting both the industry and consumers. Collaboration can help overcome the challenges in some cases i.e. for the safety questions EFSA have posed regarding the safety of cannabidiol (CBD) as a functional food ingredient. The work involved in answering these types of challenges will not be easily addressed by single applicants. In conclusion, the European health claims legislation has had a significant impact on the functional food sector, aiming to ensure that health claims are accurate, transparent, and based on robust scientific evidence. 

What has been the impact of the European health claims legislation on the functional food sector? 

While early successes were observed, the number of approved health claims has declined in recent years. Overcoming this decline requires conducting multiple high-quality human intervention studies, using appropriate statistical methodologies, demonstrating plausible mechanisms of action, and providing detailed and transparent reporting. Challenges such as methodological weaknesses, the impact of the COVID-19 pandemic, and the European Transparency Regulation have contributed to the slowdown in health claims approvals. Improved collaboration and knowledge sharing among stakeholders can help overcome these challenges and advance the development of evidence-based health claims for the benefit of consumers.

References and notes