Turck Dominique, Bohn Torsten, Cámara Montaña, Castenmiller Jacqueline, De Henauw Stefaan, Jos Ángeles, Maciuk Alexandre, Mangelsdorf Inge, McNulty Breige, Naska Androniki, Pentieva Kristina, Siani Alfonso, Thies Frank, Aguilera-Gómez Margarita, Cubadda Francesco, Frenzel Thomas, Heinonen Marina, Knutsen Helle Katrine, McArdle Harry J, Neuhäuser-Berthold Monika, Poulsen Morten, Prieto Maradona Miguel, Schlatter Josef Rudolf, Siskos Alexandros, van Loveren Henk, Rossi Annamaria, Gelbmann Wolfgang, Roldán-Torres Ruth, Azzollini Domenico, Hirsch-Ernst Karen Ildico
EFSA J. 2025 Aug 29;23(8):e9537. doi: 10.2903/j.efsa.2025.9537. eCollection 2025 Aug.
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.
应欧盟委员会的要求，欧洲食品安全局营养、新型食品和食品过敏原小组（NDA）被要求根据欧盟法规（EU）2015/2283，就富含鼠李半乳糖醛酸聚糖-I的胡萝卜纤维（cRG-I）作为新型食品发表意见。该新型食品是一种源自胡萝卜渣的高分子量多糖。该小组认为生产过程已得到充分描述，不存在安全问题。这种新型食品旨在用作各类面向普通人群的食品、特殊医学用途食品、用于体重控制的代餐食品以及面向除婴儿外普通人群的食品补充剂中的成分，还可用作面向成年人群体用于体重控制的全代餐食品。考虑到该新型食品的成分和拟议的使用条件，食用该新型食品在营养方面并无不利之处。根据所提供的数据，该小组认为不存在基因毒性方面的担忧。90天研究的结果表明，在最高测试剂量（每天7753毫克/千克体重）下，对人类没有毒理学相关影响。该新型食品可能保留胡萝卜的致敏潜力，可能会发生对该新型食品的过敏反应，但这些反应与食用胡萝卜引发的反应并无不同。鉴于该新型食品的来源（即胡萝卜）、性质、成分和生产不存在安全问题，该小组认为暴露限量是足够的。该小组得出结论，在拟议的使用条件下，源自胡萝卜渣的富含鼠李半乳糖醛酸聚糖的多糖部分cRG-I这种新型食品是安全的。
