NutriLeads’s Benicaros prebiotic considered safe for human consumption

In a recent press release¹, NutriLeads announced that carrot Rhamnogalacturonan-I (RG-I), which is the active fiber in the company’s precision prebiotic Benicaros SF Pure P product, has been deemed safe for human consumption. With this decision, it will allow for a path in obtaining formal authorization by the European Commission. This may help bring new ways for gut and immune health benefits to help consumers throughout the European Union.¹

“This positive EFSA opinion is a major milestone for NutriLeads and the food and dietary supplement industry,” said Joana Carneiro-Wakefield, Ph.D., Chief Executive Officer of NutriLeads.¹ “With its unique dual mode of action, Benicaros SF Pure P provides manufacturers with a clinically validated, plant-based ingredient that delivers proven benefits for gut and immune health — now backed by the safety endorsement of Europe’s most trusted authority. We encourage manufacturers to begin their innovation and testing processes now, so that by the time their product development is complete, EU novel food approval will be in place, and they can move swiftly to market.”

NutriLeads submitted an application on December 17, 2022 to the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), which spurred the organization to provide an opinion regarding the rhamnogalacturonan-I enriched carrot fibre (cRG-I) ingredient and its consideration as a novel food (NF) pursuant to Regulation (EU) 2015/2283.² Stemming from carrot pomace, the NF was mentioned as a “high molecular weight polysaccharide.”² The 90 day study was published in the EFSA Journal and mentions that the “Panel considers that the production process is sufficiently described and does not raise safety concerns. The novel food is intended for use as ingredient in various food products targeting the general population, in food for special medical purposes, meal replacement for weight control and food supplements targeting the general population excluding infants, and in total diet replacement for weight control targeting the adult population. Taking into account the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous.”² The application was in compliance with Article 10 of Regulation (EU) 2015/2283 and was made to provide authorize rhamnogalacturonan-I enriched carrot fibre (cRG-I) to be utilized as a novel food in a variety of food applications.

Data that was given to the Panel showed no concerns involving genotoxicity.

The study explained how “EFSA's definition of dietary fiber (For example, non-digestible carbohydrates plus lignin; EFSA NDA Panel, 2010) does not reflect the additional requirement of having a beneficial physiological effect demonstrated by generally accepted scientific evidence laid down in Annex I of Regulation (EC) 1169/20115 for:

1. edible carbohydrate polymers which have been obtained from food raw material by physical, enzymatic or chemical means and,
2. edible synthetic carbohydrate polymers.

It is out of the scope of this opinion to establish whether the fraction of non-digestible carbohydrates present in the NF meets the legal definition of dietary fibre in the EU or not.”²

In Europe, eating carrots is a largely consumed vegetable in both Europe and outside of Europe.² With the application, NutriLeads was interested in utilizing the carrot pomace derived cRG-I, a rhamnogalacturonan-rich polysaccharide, to be used in several food products specific to the general population, as well as food used for special medical purposes, a total diet replacement for weight control regarding the adult population, food supplements that do not include use for infants, and weight control meal replacement.²

The Panel concluded from their review, “that the NF, cRG-I, a rhamnogalacturonan-rich polysaccharide fraction derived from carrot pomace, is safe under the proposed conditions of use.”²

References

1. https://nutrileads.com/news_events/news/efsa-deems-nutrileads-precision-prebiotic-benicaros-safe-for-human-consumption/ (accessed Aug 29, 2025).
2. Turck, D., Bohn, T., Cámara, M., Castenmiller, J., De Henauw, S., Jos, Á., Maciuk, A., Mangelsdorf, I., McNulty, B., Naska, A., Pentieva, K., Siani, A., Thies, F., Aguilera-Gómez, M., Cubadda, F., Frenzel, T., Heinonen, M., Knutsen, H. K., H. J., … Hirsch-Ernst, K. I. (2025). Safety of rhamnogalacturonan-I enriched carrot fibre (cRG-I) as a novel food pursuant to Regulation (EU) 2015/2283, EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens). EFSA Journal, 23(7), e9537. https://doi.org/10.2903/j.efsa.2025.9537