EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Dominique Turck, Torsten Bohn, Montaña Cámara, Jacqueline Castenmiller, Stefaan De Henauw, Ángeles Jos, Helle Katrine Knutsen, Alexandre Maciuk, Inge Mangelsdorf, Breige McNulty, Harry J. McArdle, Androniki Naska, Kristina Pentieva, Alfonso Siani, Frank Thies, Margarita Aguilera-Gómez, Francesco Cubadda, Thomas Frenzel, Marina Heinonen, Monika Neuhäuser-Berthold, Morten Poulsen, Miguel Prieto Maradona, Josef Rudolf Schlatter, Alexandros Siskos, Henk van Loveren, Emanuela Turla, Karen Ildico Hirsch-Ernst
{"title":"根据法规(EU) 2015/2283,含钾和镁矿物盐作为新型食品的安全性。","authors":"EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Dominique Turck, Torsten Bohn, Montaña Cámara, Jacqueline Castenmiller, Stefaan De Henauw, Ángeles Jos, Helle Katrine Knutsen, Alexandre Maciuk, Inge Mangelsdorf, Breige McNulty, Harry J. McArdle, Androniki Naska, Kristina Pentieva, Alfonso Siani, Frank Thies, Margarita Aguilera-Gómez, Francesco Cubadda, Thomas Frenzel, Marina Heinonen, Monika Neuhäuser-Berthold, Morten Poulsen, Miguel Prieto Maradona, Josef Rudolf Schlatter, Alexandros Siskos, Henk van Loveren, Emanuela Turla, Karen Ildico Hirsch-Ernst","doi":"10.2903/j.efsa.2025.9205","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 a mineral salt, containing potassium and magnesium, as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a mineral salt that consists mainly of magnesium potassium trichloride hexahydrate. The information provided on the composition is sufficient for characterising the NF and does not raise safety concerns. The production process is sufficiently described and does not raise safety concerns. The NF is intended to be added to meat, sausages and dishes based on pasta, rice and other cereals. Taking into account the composition of the NF and the proposed use and use levels, the Panel considers that the consumption of the NF is not nutritionally disadvantageous. Regarding the presence of bromide in the NF, the Panel notes that the combined daily intake of bromide from the NF and the background diet does not exceed the tolerable daily intake of bromide of 0.4 mg/kg body weight (bw) per day. Based on its physicochemical characteristics and solubility data, the NF is expected to be dissociated in the gastrointestinal tract. Taking into account the composition and the nature of the NF, the Panel considers that no toxicological studies with the NF are required. The Panel concludes that the NF (i.e. a mineral salt containing potassium and magnesium) is safe under the proposed conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 1","pages":""},"PeriodicalIF":3.3000,"publicationDate":"2025-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11733594/pdf/","citationCount":"0","resultStr":"{\"title\":\"Safety of mineral salt containing potassium and magnesium 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, Helle Katrine Knutsen, Alexandre Maciuk, Inge Mangelsdorf, Breige McNulty, Harry J. McArdle, Androniki Naska, Kristina Pentieva, Alfonso Siani, Frank Thies, Margarita Aguilera-Gómez, Francesco Cubadda, Thomas Frenzel, Marina Heinonen, Monika Neuhäuser-Berthold, Morten Poulsen, Miguel Prieto Maradona, Josef Rudolf Schlatter, Alexandros Siskos, Henk van Loveren, Emanuela Turla, Karen Ildico Hirsch-Ernst\",\"doi\":\"10.2903/j.efsa.2025.9205\",\"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 a mineral salt, containing potassium and magnesium, as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a mineral salt that consists mainly of magnesium potassium trichloride hexahydrate. The information provided on the composition is sufficient for characterising the NF and does not raise safety concerns. The production process is sufficiently described and does not raise safety concerns. The NF is intended to be added to meat, sausages and dishes based on pasta, rice and other cereals. Taking into account the composition of the NF and the proposed use and use levels, the Panel considers that the consumption of the NF is not nutritionally disadvantageous. Regarding the presence of bromide in the NF, the Panel notes that the combined daily intake of bromide from the NF and the background diet does not exceed the tolerable daily intake of bromide of 0.4 mg/kg body weight (bw) per day. Based on its physicochemical characteristics and solubility data, the NF is expected to be dissociated in the gastrointestinal tract. Taking into account the composition and the nature of the NF, the Panel considers that no toxicological studies with the NF are required. The Panel concludes that the NF (i.e. a mineral salt containing potassium and magnesium) is safe under the proposed conditions of use.</p>\",\"PeriodicalId\":11657,\"journal\":{\"name\":\"EFSA Journal\",\"volume\":\"23 1\",\"pages\":\"\"},\"PeriodicalIF\":3.3000,\"publicationDate\":\"2025-01-15\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11733594/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"EFSA Journal\",\"FirstCategoryId\":\"97\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2025.9205\",\"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://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2025.9205","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 mineral salt containing potassium and magnesium 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 a mineral salt, containing potassium and magnesium, as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a mineral salt that consists mainly of magnesium potassium trichloride hexahydrate. The information provided on the composition is sufficient for characterising the NF and does not raise safety concerns. The production process is sufficiently described and does not raise safety concerns. The NF is intended to be added to meat, sausages and dishes based on pasta, rice and other cereals. Taking into account the composition of the NF and the proposed use and use levels, the Panel considers that the consumption of the NF is not nutritionally disadvantageous. Regarding the presence of bromide in the NF, the Panel notes that the combined daily intake of bromide from the NF and the background diet does not exceed the tolerable daily intake of bromide of 0.4 mg/kg body weight (bw) per day. Based on its physicochemical characteristics and solubility data, the NF is expected to be dissociated in the gastrointestinal tract. Taking into account the composition and the nature of the NF, the Panel considers that no toxicological studies with the NF are required. The Panel concludes that the NF (i.e. a mineral salt containing potassium and magnesium) 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.