The upcycled carrot pomace ingredient developed by Dutch biotech company NutriLeads was bought earlier this month in an asset deal that transferred full intellectual property, clinical data, trademarks and manufacturing know-how.
After a positive opinion on Rhamnogalacturonan-I (RG-I) at the end of August 2025 the European Commission has now authorized the carrot extract enriched with RG-I (cRG-I) as a novel food under Regulation (EU) 2026/1306.
As Jerome Le Bloch, head of scientific affairs at Foodchain ID explained, the authorization is a ‘major milestone’, permitting the extract to be used in food supplements at a maximum of 1500 mg per day for individuals over 3-years-old, as well as across a wide range of food products.
The regulation also grants the company exclusive commercial rights to the ingredient in the EU until July 2031, protecting its underlying safety and analytical data assessed by the European Food Safety Authority.
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.
Benicaros and its role in the gut microbiome
Benicaros was originally positioned as an immune health ingredient, largely reflecting heightened consumer interest in immunity during the COVID-19 period. However, as clinical research progressed, the company shifted its focus toward gut health and prebiotic benefits thanks to growing scientific understanding and consumer demand for fiber-based nutrition.
Research shows it can modulate the gut microbiome, increase beneficial bacteria like Bifidobacterium, and boost production of short-chain fatty acids linked to gut and metabolic health.
Since its 2021 launch, Benicaros has been used in supplements and functional foods globally, including immune and gut health products, and has been recognized for its clinical evidence and innovation in microbiome modulation. It is now fully integrated into Ingredion’s global ingredient platform as part of its strategy to grow in functional, science-backed nutrition solutions.
Benicaros secures five-year exclusivity in EU Novel Food approval
Le Bloch noted that exclusive commercial rights for five years is sufficient time for the company to establish cRG-I as a category-defining ingredient, noting that there is currently no meaningful competition in this space.
He added that an additional point of interest for the applicants is the specifications set out in the regulation: Beyond the already highly specific composition of the extract, the specifications describe the manufacturing process, including an enzymatic reaction.
As Benicaros’ development process is protected through a patent, it would be difficult for competitors to replicate. As a result, even after the five-year protection period expires, only the owning company is able to use the authorization, since any competitor seeking to obtain a comparable composition would need to use the same process and would therefore risk infringing the patent.
“A competitor would need to develop an independent dossier from scratch, including all analytical, stability, and toxicological studies,” Le Bloch noted.
Generating valid production batches and compiling the necessary supporting data would likely require at least three to four years. In addition, the Novel Food authorization process itself typically takes a further three to four years from dossier submission to final authorization. Consequently, a competitor would be unlikely to obtain authorization for a comparable ingredient in less than six to seven years, Le Bloch explained.
“The only advantage for a competitor now is that we know what is required by EFSA thanks to the opinion published last year (August 2025),” he said. “It is always easier to copy an application than to obtain authorization for a totally new ingredient.”
