EU Authorizes Benicaros® (cRG-I) as a Novel Food, Granting Five-Year Market Exclusivity

The European Commission has authorized rhamnogalacturonan-I enriched carrot extract (cRG-I), the active ingredient marketed as Benicaros®, as a Novel Food in the European Union under Commission Implementing Regulation (EU) 2026/1306. The regulation was adopted on 11 June 2026 and published in the Official Journal of the European Union on 12 June 2026.The authorization follows a positive scientific opinion issued by the European Food Safety Authority (EFSA), which concluded that cRG-I, a rhamnogalacturonan-rich polysaccharide fraction derived from carrot pomace, is safe for human consumption under the proposed conditions of use.

Under the authorization, cRG-I may be used in a variety of food categories, including food supplements, foods for special medical purposes, meal replacements, breakfast cereals, cereal bars, fruit-based beverages, soups, dairy alternatives, and other functional food applications. Food supplements containing the ingredient must carry a statement indicating that they should not be consumed by children under three years of age. The approval also grants NutriLeads B.V. five years of proprietary data protection and exclusive commercialization rights within the European Union from 2 July 2026 until 2 July 2031. During this period, other applicants may only market the ingredient if they obtain authorization based on their own data or with the agreement of NutriLeads.

Benicaros® is a precision prebiotic ingredient derived from upcycled carrot pomace and is designed to support gut microbiome and immune health. The EU authorization represents a significant regulatory milestone for the ingredient and expands opportunities for its use in functional foods and dietary supplements across the European market.

Key Points
1.European Commission authorized rhamnogalacturonan-I enriched carrot extract (cRG-I) as a Novel Food.
2.Authorization published under Commission Implementing Regulation (EU) 2026/1306.
3.EFSA concluded the ingredient is safe under the proposed conditions of use.
4.Approved for use in food supplements and multiple food categories.
5.Food supplements containing cRG-I must include a warning against use by children under three years of age.
The authorization supports expansion of Benicaros® into the European functional food and dietary supplement market.