EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Dominique Turck, Montaña Cámara, Torsten Bohn, 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, Monika Neuhäuser-Berthold, Harry J. McArdle, Morten Poulsen, Miguel Prieto Maradona, Josef Rudolf Schlatter, Alexandros Siskos, Henk van Loveren, Reinhard Ackerl, Maria Glymenaki, Karen Ildico Hirsch-Ernst
{"title":"依据法规（EU） 2015/2283，莱茵衣藻THN 6干燥生物质粉末作为新型食品的安全性","authors":"EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Dominique Turck, Montaña Cámara, Torsten Bohn, 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, Monika Neuhäuser-Berthold, Harry J. McArdle, Morten Poulsen, Miguel Prieto Maradona, Josef Rudolf Schlatter, Alexandros Siskos, Henk van Loveren, Reinhard Ackerl, Maria Glymenaki, Karen Ildico Hirsch-Ernst","doi":"10.2903/j.efsa.2025.9413","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 dried biomass powder of <i>Chlamydomonas reinhardtii</i> THN 6 as a novel food (NF) pursuant to Regulation (EU) 2015/2283. During the risk assessment, the Panel identified a number of data gaps which needed to be addressed by the applicant. Therefore, an EFSA request for additional information was sent to the applicant. The requested data pertained to the identity, the production process, composition, specifications, history of use, proposed uses and use levels, nutritional information, genotoxicity and allergenicity of the NF. Despite being contacted several times, the applicant did not reply to EFSA's requests for additional data. The Panel concludes that, based on the available data, the safety of the NF, i.e. dried biomass powder of <i>C. reinhardtii</i> THN 6, cannot be established.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 4","pages":""},"PeriodicalIF":3.3000,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9413","citationCount":"0","resultStr":"{\"title\":\"Safety of dried biomass powder of Chlamydomonas reinhardtii THN 6 as a novel food pursuant to Regulation (EU) 2015/2283\",\"authors\":\"EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Dominique Turck, Montaña Cámara, Torsten Bohn, 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, Monika Neuhäuser-Berthold, Harry J. McArdle, Morten Poulsen, Miguel Prieto Maradona, Josef Rudolf Schlatter, Alexandros Siskos, Henk van Loveren, Reinhard Ackerl, Maria Glymenaki, Karen Ildico Hirsch-Ernst\",\"doi\":\"10.2903/j.efsa.2025.9413\",\"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 dried biomass powder of <i>Chlamydomonas reinhardtii</i> THN 6 as a novel food (NF) pursuant to Regulation (EU) 2015/2283. During the risk assessment, the Panel identified a number of data gaps which needed to be addressed by the applicant. Therefore, an EFSA request for additional information was sent to the applicant. The requested data pertained to the identity, the production process, composition, specifications, history of use, proposed uses and use levels, nutritional information, genotoxicity and allergenicity of the NF. Despite being contacted several times, the applicant did not reply to EFSA's requests for additional data. The Panel concludes that, based on the available data, the safety of the NF, i.e. dried biomass powder of <i>C. reinhardtii</i> THN 6, cannot be established.</p>\",\"PeriodicalId\":11657,\"journal\":{\"name\":\"EFSA Journal\",\"volume\":\"23 4\",\"pages\":\"\"},\"PeriodicalIF\":3.3000,\"publicationDate\":\"2025-04-30\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9413\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"EFSA Journal\",\"FirstCategoryId\":\"97\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2025.9413\",\"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.2025.9413","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 dried biomass powder of Chlamydomonas reinhardtii THN 6 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 dried biomass powder of Chlamydomonas reinhardtii THN 6 as a novel food (NF) pursuant to Regulation (EU) 2015/2283. During the risk assessment, the Panel identified a number of data gaps which needed to be addressed by the applicant. Therefore, an EFSA request for additional information was sent to the applicant. The requested data pertained to the identity, the production process, composition, specifications, history of use, proposed uses and use levels, nutritional information, genotoxicity and allergenicity of the NF. Despite being contacted several times, the applicant did not reply to EFSA's requests for additional data. The Panel concludes that, based on the available data, the safety of the NF, i.e. dried biomass powder of C. reinhardtii THN 6, cannot be established.
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.
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