EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Dominique Turck, Torsten Bohn, Montaña Cámara, Jacqueline Castenmiller, Stefaan De Henauw, Ángeles Jos, Alexandre Maciuk, Inge Mangelsdorf, Breige McNulty, Androniki Naska, Kristina Pentieva, Alfonso Siani, Frank Thies, Margarita Aguilera-Gómez, Francesco Cubadda, Thomas Frenzel, Marina Heinonen, Helle Katrine Knutsen, Harry J. McArdle, Monika Neuhäuser-Berthold, Morten Poulsen, Miguel Prieto Maradona, Josef Rudolf Schlatter, Alexandros Siskos, Henk van Loveren, Annamaria Rossi, Wolfgang Gelbmann, Ruth Roldán-Torres, Domenico Azzollini, Karen Ildico Hirsch-Ernst
{"title":"根据法规(EU) 2015/2283,鼠李糖半乳糖醛酸- i作为一种新型食品的安全性","authors":"EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Dominique Turck, Torsten Bohn, Montaña Cámara, Jacqueline Castenmiller, Stefaan De Henauw, Ángeles Jos, Alexandre Maciuk, Inge Mangelsdorf, Breige McNulty, Androniki Naska, Kristina Pentieva, Alfonso Siani, Frank Thies, Margarita Aguilera-Gómez, Francesco Cubadda, Thomas Frenzel, Marina Heinonen, Helle Katrine Knutsen, Harry J. McArdle, Monika Neuhäuser-Berthold, Morten Poulsen, Miguel Prieto Maradona, Josef Rudolf Schlatter, Alexandros Siskos, Henk van Loveren, Annamaria Rossi, Wolfgang Gelbmann, Ruth Roldán-Torres, Domenico Azzollini, Karen Ildico Hirsch-Ernst","doi":"10.2903/j.efsa.2025.9537","DOIUrl":null,"url":null,"abstract":"<p>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.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 8","pages":""},"PeriodicalIF":3.3000,"publicationDate":"2025-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9537","citationCount":"0","resultStr":"{\"title\":\"Safety of rhamnogalacturonan-I enriched carrot fibre (cRG-I) as a novel food pursuant to Regulation (EU) 2015/2283\",\"authors\":\"EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Dominique Turck, Torsten Bohn, Montaña Cámara, Jacqueline Castenmiller, Stefaan De Henauw, Ángeles Jos, Alexandre Maciuk, Inge Mangelsdorf, Breige McNulty, Androniki Naska, Kristina Pentieva, Alfonso Siani, Frank Thies, Margarita Aguilera-Gómez, Francesco Cubadda, Thomas Frenzel, Marina Heinonen, Helle Katrine Knutsen, Harry J. McArdle, Monika Neuhäuser-Berthold, Morten Poulsen, Miguel Prieto Maradona, Josef Rudolf Schlatter, Alexandros Siskos, Henk van Loveren, Annamaria Rossi, Wolfgang Gelbmann, Ruth Roldán-Torres, Domenico Azzollini, Karen Ildico Hirsch-Ernst\",\"doi\":\"10.2903/j.efsa.2025.9537\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p>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.</p>\",\"PeriodicalId\":11657,\"journal\":{\"name\":\"EFSA Journal\",\"volume\":\"23 8\",\"pages\":\"\"},\"PeriodicalIF\":3.3000,\"publicationDate\":\"2025-08-29\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9537\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"EFSA Journal\",\"FirstCategoryId\":\"97\",\"ListUrlMain\":\"https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2025.9537\",\"RegionNum\":3,\"RegionCategory\":\"农林科学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"FOOD SCIENCE & TECHNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"EFSA Journal","FirstCategoryId":"97","ListUrlMain":"https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2025.9537","RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"FOOD SCIENCE & TECHNOLOGY","Score":null,"Total":0}
Safety of rhamnogalacturonan-I enriched carrot fibre (cRG-I) as a novel food pursuant to Regulation (EU) 2015/2283
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.
期刊介绍:
The EFSA Journal covers methods of risk assessment, reports on data collected, and risk assessments in the individual areas of plant health, plant protection products and their residues, genetically modified organisms, additives and products or substances used in animal feed, animal health and welfare, biological hazards including BSE/TSE, contaminants in the food chain, food contact materials, enzymes, flavourings and processing aids, food additives and nutrient sources added to food, dietetic products, nutrition and allergies.