TY - JOUR
T1 - Safety of rapeseed protein–fibre concentrate 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 - Frenzel, Thomas
AU - McArdle, Harry J.
AU - Moldeus, Peter
AU - Neuhäuser-Berthold, Monika
AU - Poulsen, Morten
AU - Maradona, Miguel Prieto
AU - Schlatter, Josef Rudolf
AU - van Loveren, Henk
AU - Laganaro, Marcello
AU - Turla, Emanuela
AU - Pieger, Anna Maria
AU - Hirsch-Ernst, Karen Ildico
AU - EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)
N1 - Publisher Copyright:
© 2025 European Food Safety Authority. EFSA Journal published by Wiley-VCH GmbH on behalf of European Food Safety Authority.
PY - 2025/9/29
Y1 - 2025/9/29
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 the safety of rapeseed protein-fibre concentrate as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a powder mainly composed of protein and fibre, which is obtained after aqueous and organic solvent extraction applied to cold-pressed rapeseed cake. The source rape plants are non-genetically modified double low (00) cultivars of Brassica rapa L. and Brassica napus L., which are bred to obtain low erucic acid and glucosinolate content. The information provided on the production process, composition and specifications of the NF, when accounting for recommendations proposed by the Panel, does not raise safety concerns. The NF is proposed to be used as a food ingredient in several foods (for the general population), and in food supplements and in food for special medical purposes for individuals above 10 years of age. Considering the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous when consumed within a mixed diet. There is a potential concern related to manganese when consuming the NF as a food ingredient and supplement on the same day. Taking into account the nature of the NF, the production process, the composition of the NF and the toxicological profile of similar rapeseed powders already assessed, the Panel considers that no toxicological studies are required with the NF. The Panel concludes that the NF, rapeseed protein–fibre concentrate, is safe under the proposed conditions of use, provided that individuals above 10 years of age do not consume foods containing the NF and food supplements containing the NF on the same day.
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 the safety of rapeseed protein-fibre concentrate as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a powder mainly composed of protein and fibre, which is obtained after aqueous and organic solvent extraction applied to cold-pressed rapeseed cake. The source rape plants are non-genetically modified double low (00) cultivars of Brassica rapa L. and Brassica napus L., which are bred to obtain low erucic acid and glucosinolate content. The information provided on the production process, composition and specifications of the NF, when accounting for recommendations proposed by the Panel, does not raise safety concerns. The NF is proposed to be used as a food ingredient in several foods (for the general population), and in food supplements and in food for special medical purposes for individuals above 10 years of age. Considering the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous when consumed within a mixed diet. There is a potential concern related to manganese when consuming the NF as a food ingredient and supplement on the same day. Taking into account the nature of the NF, the production process, the composition of the NF and the toxicological profile of similar rapeseed powders already assessed, the Panel considers that no toxicological studies are required with the NF. The Panel concludes that the NF, rapeseed protein–fibre concentrate, is safe under the proposed conditions of use, provided that individuals above 10 years of age do not consume foods containing the NF and food supplements containing the NF on the same day.
KW - Brassica
KW - food ingredient
KW - food supplement
KW - novel foods
KW - plant
KW - rapeseed
KW - safety
UR - https://www.scopus.com/pages/publications/105019048128
U2 - 10.2903/j.efsa.2025.9631
DO - 10.2903/j.efsa.2025.9631
M3 - Article
AN - SCOPUS:105019048128
SN - 1831-4732
VL - 23
JO - EFSA Journal
JF - EFSA Journal
IS - 9
M1 - e9631
ER -