EFSA published a positive opinion on Rhamnogalacturonan-I (RG-I)—the active fiber in Benicaros—at the end of August, following an assessment that determined it as safe for adult consumption.
“Despite being a natural, upcycled ingredient, its high purity of 80% led EFSA to classify it as a novel food in 2019, a status that was initially surprising to the company,” Jan Jongsma, chief executive officer at NutriLeads, told NutraIngredients.
In the United States, Benicaros received a letter of no questions (LONQ) from the Food and Drug Administration regarding its Generally Recognized as Safe (GRAS) status in 2021.
Although the EFSA opinion took much longer, there is an administrative phase underway, which NutriLeads expects to conclude in the first half of next year.
“At that point, we will have the official novel food approval,” Jongsma said. “This opens up much greater potential in Europe, which was our initial focus, but since the process took longer than expected, we first expanded into the rest of the world.”
Jongsma called the recent decision a “major step” toward gaining formal authorization from the European Commission, which will allow the Dutch ingredients supplier to pursue distribution in Europe.
NutriLeads gains EU approval, eyes global growth
NutriLeads expects the approval to accelerate product adoption, not just within Europe but also globally.
“Europe has a big impact on the rest of the world,” Jongsma said. “In many of the countries where we operate, regulators ask us about the status in Europe because they see it as a reference point.”
He explained that some countries, such as South Korea, accept European legislation, and others use EU regulation as a model when they evaluate products.
Regions including Australia, Malaysia, Thailand and China have also granted approval, allowing imports once their food legislation requirements are met.
Benicaros shifts focus to gut health benefits
NutriLeads initially positioned Benicaros for immune health, which, as Jongsma explained, was strongly influenced by the global focus on immunity during COVID-19.
Since then, Benicaros has evolved its positioning to focus on gut health and prebiotic benefits, a “natural evolution,” according to Jongsma.
“One of our major clinical studies targeted immune health, and from the beginning, we knew there was a strong connection between immunity and gut health,” he said.
“At the same time, there has been a growing global awareness of nutrition, particularly the importance of fiber for human health, so there’s been a natural movement toward gut health alongside the company’s work.
From the initial research, he said noted that NutriLeads recognized the ingredient’s dual mode of action—supporting both innate immune cells while also working through the gut.
Because the immune results were strongest initially, the company positioned the product around immunity, but as research into the ingredients has continued in parallel with product launches that align with consumer demands, the company learned more about its prebiotic benefits, showing consistent and robust gut health effects across different microbiomes.
“That was a breakthrough for the company—we realized this was also a very powerful story to bring to the market,” Jongsma said.
Functional beverage market drives gut health trend
Benicaros is now being integrated into a wide range of consumer products, and the functional food and beverage formats are gaining quick traction in Europe, Leilah Thiart, senior communications manager at NutriLeads, told NutraIngredients.
“When we look at the requests for Benicaros coming in from interested customers in Europe, we’re seeing a lot of innovation in beverages, and we’re seeing that functional foods and beverages are already helping to build awareness,” she said.
When novel food approval is confirmed, NutriLeads expects more functional beverage product launches with Benicaros, which may also contribute to enhancing consumer understanding of gut health.
“For example, many sodas now highlight gut health benefits, which contribute to consumer understanding,” Thiart said.
“The introduction of gut health benefits in food and beverages is helping to educate consumers, and that increased awareness goes hand in hand with the growing trend in gut health. It’s definitely an interesting development”.
