Safety of paramylon as a novel food pursuant ...
Type de document :
Article dans une revue scientifique: Article original
DOI :
PMID :
URL permanente :
Titre :
Safety of paramylon as a novel food pursuant to Regulation (EU) 2015/2283.
Auteur(s) :
Turck, Dominique [Auteur]
Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286
Bohn, Torsten [Auteur]
Castenmiller, Jacqueline [Auteur]
De Henauw, Stefaan [Auteur]
Hirsch-Ernst, Karen Ildico [Auteur]
Maciuk, Alexandre [Auteur]
Mangelsdorf, Inge [Auteur]
Mcardle, Harry J. [Auteur]
Naska, Androniki [Auteur]
Pelaez, Carmen [Auteur]
Pentieva, Kristina [Auteur]
Siani, Alfonso [Auteur]
Thies, Frank [Auteur]
Tsabouri, Sophia [Auteur]
Vinceti, Marco [Auteur]
Aguilera-Gómez, Margarita [Auteur]
Cubadda, Francesco [Auteur]
Frenzel, Thomas [Auteur]
Heinonen, Marina [Auteur]
Prieto Maradona, Miguel [Auteur]
Marchelli, Rosangela [Auteur]
Neuhäuser-Berthold, Monika [Auteur]
Poulsen, Morten [Auteur]
Schlatter, Josef Rudolf [Auteur]
Van Loveren, Henk [Auteur]
Ackerl, Reinhard [Auteur]
Knutsen, Helle Katrine [Auteur]
Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286
Bohn, Torsten [Auteur]
Castenmiller, Jacqueline [Auteur]
De Henauw, Stefaan [Auteur]
Hirsch-Ernst, Karen Ildico [Auteur]
Maciuk, Alexandre [Auteur]
Mangelsdorf, Inge [Auteur]
Mcardle, Harry J. [Auteur]
Naska, Androniki [Auteur]
Pelaez, Carmen [Auteur]
Pentieva, Kristina [Auteur]
Siani, Alfonso [Auteur]
Thies, Frank [Auteur]
Tsabouri, Sophia [Auteur]
Vinceti, Marco [Auteur]
Aguilera-Gómez, Margarita [Auteur]
Cubadda, Francesco [Auteur]
Frenzel, Thomas [Auteur]
Heinonen, Marina [Auteur]
Prieto Maradona, Miguel [Auteur]
Marchelli, Rosangela [Auteur]
Neuhäuser-Berthold, Monika [Auteur]
Poulsen, Morten [Auteur]
Schlatter, Josef Rudolf [Auteur]
Van Loveren, Henk [Auteur]
Ackerl, Reinhard [Auteur]
Knutsen, Helle Katrine [Auteur]
Titre de la revue :
EFSA Journal
Nom court de la revue :
EFSA J
Numéro :
21
Pagination :
e07995
Date de publication :
2023-06-04
ISSN :
1831-4732
Mot(s)-clé(s) en anglais :
novel food
paramylon
algae
Euglena gracilis
beta-glucan
safety
paramylon
algae
Euglena gracilis
beta-glucan
safety
Résumé en anglais : [en]
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 paramylon as a novel food (NF) pursuant to Regulation (EU) 2015/2283. ...
Lire la suite >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 paramylon as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Paramylon is a linear, unbranched beta-1,3-ᴅ-glucan polymer that is isolated from the single-cell microalga Euglena gracilis. The NF consists of at least 95% beta-glucan and minor amounts of protein, fat, ash and moisture. The applicant proposed to use the NF in food supplements, as a food ingredient added to a number of food categories and in foods for total diet replacement for weight control. In 2019, E. gracilis was attributed the qualified presumption of safety (QPS) status with the qualification ‘for production purposes only’, which includes food products based on microbial biomass of the microalga. Based on the information provided, E. gracilis is not expected to survive the manufacturing process. The submitted toxicity studies did not raise safety concerns. No adverse effects were observed in the subchronic toxicity studies, up to the highest dose tested, i.e. 5,000 mg NF/kg body weight per day. In view of the QPS status of the source of the NF, supported by the manufacturing process, compositional data and lack of toxicity observed in the toxicity studies, the Panel has no safety concerns and concludes that the NF, i.e. paramylon, is safe under the proposed uses and use levels.Lire moins >
Lire la suite >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 paramylon as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Paramylon is a linear, unbranched beta-1,3-ᴅ-glucan polymer that is isolated from the single-cell microalga Euglena gracilis. The NF consists of at least 95% beta-glucan and minor amounts of protein, fat, ash and moisture. The applicant proposed to use the NF in food supplements, as a food ingredient added to a number of food categories and in foods for total diet replacement for weight control. In 2019, E. gracilis was attributed the qualified presumption of safety (QPS) status with the qualification ‘for production purposes only’, which includes food products based on microbial biomass of the microalga. Based on the information provided, E. gracilis is not expected to survive the manufacturing process. The submitted toxicity studies did not raise safety concerns. No adverse effects were observed in the subchronic toxicity studies, up to the highest dose tested, i.e. 5,000 mg NF/kg body weight per day. In view of the QPS status of the source of the NF, supported by the manufacturing process, compositional data and lack of toxicity observed in the toxicity studies, the Panel has no safety concerns and concludes that the NF, i.e. paramylon, is safe under the proposed uses and use levels.Lire moins >
Langue :
Anglais
Audience :
Internationale
Vulgarisation :
Non
Établissement(s) :
Université de Lille
Inserm
CHU Lille
Inserm
CHU Lille
Date de dépôt :
2024-02-03T22:34:51Z
2024-03-13T16:01:20Z
2024-03-13T16:01:20Z
Fichiers
- EFSA Journal - 2023 - - Safety of paramylon as a novel food pursuant to Regulation EU 2015 2283.pdf
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