TY - JOUR
T1 - Safety of rhamnogalacturonan-I enriched carrot fibre (cRG-I) as a novel food pursuant to Regulation (EU) 2015/2283
AU - Turck, Dominique
AU - Bohn, Torsten
AU - Cámara, Montaña
AU - Castenmiller, Jacqueline
AU - De Henauw, Stefaan
AU - Jos, Ángeles
AU - Maciuk, Alexandre
AU - Mangelsdorf, Inge
AU - McNulty, Breige
AU - Naska, Androniki
AU - Pentieva, Kristina
AU - Siani, Alfonso
AU - Thies, Frank
AU - Aguilera-Gómez, Margarita
AU - Cubadda, Francesco
AU - Frenzel, Thomas
AU - Heinonen, Marina
AU - Knutsen, Helle Katrine
AU - McArdle, Harry J.
AU - Neuhäuser-Berthold, Monika
AU - Poulsen, Morten
AU - Prieto Maradona, Miguel
AU - Schlatter, Josef Rudolf
AU - Siskos, Alexandros
AU - van Loveren, Henk
AU - Rossi, Annamaria
AU - Gelbmann, Wolfgang
AU - Roldán-Torres, Ruth
AU - Azzollini, Domenico
AU - Hirsch-Ernst, Karen Ildico
AU - EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)
N1 - © 2025 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.
PY - 2025/8/29
Y1 - 2025/8/29
N2 - Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on rhamnogalacturonan-I enriched carrot fibre (cRG-I) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a high molecular weight polysaccharide derived from carrot pomace. 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. Based on the data provided the Panel considers that there are no concerns regarding genotoxicity. Results from the 90-day study did not show effects of toxicological relevance for humans up to the highest dose tested (7753 mg/kg bw per day). The NF may retain the allergenic potential of carrots and allergic reactions to the NF may occur, but they will not be dissimilar from those triggered by the consumption of carrots. The Panel considers the margins of exposure to be sufficient considering that the source (i.e. carrots), nature, composition and production of the NF do not raise safety concerns. The Panel concludes that the NF, cRG-I, a rhamnogalacturonan-rich polysaccharide fraction derived from carrot pomace, is safe under the proposed conditions of use.
AB - Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on rhamnogalacturonan-I enriched carrot fibre (cRG-I) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a high molecular weight polysaccharide derived from carrot pomace. 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. Based on the data provided the Panel considers that there are no concerns regarding genotoxicity. Results from the 90-day study did not show effects of toxicological relevance for humans up to the highest dose tested (7753 mg/kg bw per day). The NF may retain the allergenic potential of carrots and allergic reactions to the NF may occur, but they will not be dissimilar from those triggered by the consumption of carrots. The Panel considers the margins of exposure to be sufficient considering that the source (i.e. carrots), nature, composition and production of the NF do not raise safety concerns. The Panel concludes that the NF, cRG-I, a rhamnogalacturonan-rich polysaccharide fraction derived from carrot pomace, is safe under the proposed conditions of use.
KW - carrot
KW - cRG-I
KW - food for special medical purposes
KW - food supplement
KW - novel foods
KW - pectin
KW - safety
KW - total daily diet replacement for weight reduction
UR - https://www.scopus.com/pages/publications/105014879389
UR - https://pubmed.ncbi.nlm.nih.gov/40894468/
U2 - 10.2903/j.efsa.2025.9537
DO - 10.2903/j.efsa.2025.9537
M3 - Article
C2 - 40894468
AN - SCOPUS:105014879389
SN - 1831-4732
VL - 23
JO - EFSA Journal
JF - EFSA Journal
IS - 8
M1 - e9537
ER -