In its scientific opinion, the EFSA Scientific Panel on Nutrition, Novel Foods and Food Allergens considered the ingredient to be sufficiently characterized but concluded that changes in appetite ratings cannot, in themselves, be regarded as a beneficial physiological effect. As the applicant did not identify a specific beneficial physiological effect resulting from these changes, EFSA concluded that a cause-and-effect relationship could not be established.
“The beneficial physiological effect of Appethyl is improved appetite control through increased satiety and reduced postprandial food cravings, leading to reduced subsequent energy intake and supporting body-weight management,” said Jan Bruhn, senior vice president of R&D at Mimer Medical, commenting on the decision. “Today, satiety and appetite regulation is understood to be complex, involving both physiological and psychological factors. Still, EFSA asked us to show only one physiological effect.”
EFSA’s decision drew on its 2012 guidance on health claims related to appetite ratings, weight management and blood glucose concentrations. Under this guidance, changes in subjective appetite ratings alone are insufficient to substantiate a health claim unless they demonstrate beneficial physiological effect, such as reduced energy intake or sustained reductions in body weight or body fat.
A second chance saloon
Appethyl is a spinach extract enriched for thylakoids, the cellular membranes responsible for photosynthesis which are reported to slow fat digestion and increase the body’s production of satiety hormones glucagon-like peptide-1 (GLP-1) and cholecystokinin (CCK). Studies detailing the ingredient’s benefits have been published since 2009.
Originally launched in the United States by Swedish company Greenleaf Medical in 2014, Appethyl disappeared from the market in 2023 following an unsuccessful EFSA health claim application for weight management. The set back coincided with the loss of a key investor and pandemic-related funding challenges.
Mimer Medical purchased the rights to the ingredient before filing the new health claim application in September last year.
Speaking to NutraIngredients at the time of the application, Bruhn explained that, despite the team’s significant pharmaceutical experience, they were unprepared for the lengthy and often confusing process of substantiation a health claim with EFSA.
“EFSA has been quite a minefield of regulation, and you have to be qualified in various fields to submit an application,” he commented at the time. “We are used to dealing with OTC drugs and are used to submitting applications and dealing with authorities, but this has been something quite extra... There are few new claims approved by EFSA, and that is probably because it is so difficult!”
‘Overly restrictive’ decision
Sergio Oya, director general at regulation consultancy LegaleGo Regulatory, said this case reflects a “particularly strict approach to the assessment of health claims”.
He noted that while it is not unusual for EFSA to issue unfavorable opinions, this case is interesting because EFSA has not found that Appethyl is ineffective or that the clinical studies fail to demonstrate its effects.
“From our perspective, this interpretation could be considered overly restrictive,” he said. “EU legislation requires evidence of a health benefit, but there is room for debate as to whether sustained improvements in appetite control, in a specific population and context, should be recognized as beneficial without necessarily having to demonstrate a reduction in body weight.”
He did however note that the applicant did not identify a specific beneficial physiological effect suitable for assessment.
Jerome Le Bloch, head of scientific affairs at FoodChain ID, noted that in order to obtain a favorable assessment the applicant should demonstrate that the effect on satiety can affect another physiological function, such as by decreasing body weight.
“The scientific evidence for this effect should be sufficiently strong to convince EFSA,” he said. “In this case, the clinical studies should demonstrate a reduction in appetite ratings, which is associated with a reduction in energy intake or body weight.”
This represents a considerable challenge, particularly as EFSA had already issued an unfavorable opinion regarding body weight reduction, noted Oya.
“Ultimately, we believe this case highlights EFSA’s very high evidentiary standards and raises a legitimate debate about the extent to which physiological effects such as satiety should be recognized as health benefits in their own right,” Oya added.
Optimism for the future
Despite the negative opinion, Mimer Medical views as positive the absence of EFSA questions about the ingredient itself and remains remains confident in its potential in markets across the globe.
“EFSA states that the food Appethyl, is sufficiently characterized,” Bruhn said. “There is no criticism of production, quality control, clinical documentation, statistical analysis or safety assessment.”
He noted that Appethyl still qualifies for an appetite control structure-function claim in the United States and other markets, providing a significant opportunity at a time when the obesity epidemic is driving people to search for satiety boosting interventions.
”That is why we argue that prolonged satiety and reduced cravings after a meal are beneficial physiological effects to support appetite control for both individual and public health,” he added.
Mimer has been open to a potential acquisition of Appethyl since summer 2026 and has engaged Clairfield International, a New York- based M&A firm, to serve as point of contact for interested parties.
