Safety of Schizochytrium sp. oil as a novel ...
Type de document :
Article dans une revue scientifique: Article original
DOI :
PMID :
URL permanente :
Titre :
Safety of Schizochytrium sp. oil as a novel food pursuant to Regulation (EU) 2015/2283(a)
Auteur(s) :
Turck, Dominique [Auteur]
Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286
Castenmiller, Jacqueline [Auteur]
De Henauw, Stefaan [Auteur]
Hirsch-Ernst, Karen Ildico [Auteur]
Kearney, John [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]
Cubadda, Francesco [Auteur]
Engel, Karl-Heinz [Auteur]
Frenzel, Thomas [Auteur]
Heinonen, Marina [Auteur]
Marchelli, Rosangela [Auteur]
Neuhauser-Berthold, Monika [Auteur]
Poulsen, Morten [Auteur]
Sanz, Yolanda [Auteur]
Schlatter, Josef Rudolf [Auteur]
van Loveren, Henk [Auteur]
Ferreira, Lucien [Auteur]
Knutsen, Helle Katrine [Auteur]
Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286
Castenmiller, Jacqueline [Auteur]
De Henauw, Stefaan [Auteur]
Hirsch-Ernst, Karen Ildico [Auteur]
Kearney, John [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]
Cubadda, Francesco [Auteur]
Engel, Karl-Heinz [Auteur]
Frenzel, Thomas [Auteur]
Heinonen, Marina [Auteur]
Marchelli, Rosangela [Auteur]
Neuhauser-Berthold, Monika [Auteur]
Poulsen, Morten [Auteur]
Sanz, Yolanda [Auteur]
Schlatter, Josef Rudolf [Auteur]
van Loveren, Henk [Auteur]
Ferreira, Lucien [Auteur]
Knutsen, Helle Katrine [Auteur]
Titre de la revue :
EFSA Journal
Nom court de la revue :
EFSA J
Numéro :
18
Pagination :
e06242
Date de publication :
2020-10
ISSN :
1831-4732
Mot(s)-clé(s) :
Novel foods
safety
Schizochytrium limacinum
docosahexaenoic acid (DHA)
infant and young children
alga
fatty acid
safety
Schizochytrium limacinum
docosahexaenoic acid (DHA)
infant and young children
alga
fatty acid
Discipline(s) HAL :
Sciences du Vivant [q-bio]
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 the safety of Schizochytrium sp. oil as a novel food (NF) pursuant to ...
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 the safety of Schizochytrium sp. oil as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Schizochytrium sp. is a single-cell microalga. The strain WZU477, used by the applicant (Progress Biotech bv), was found to belong to the species Schizochytrium limacinum and was obtained in a marine environment from rotted mangrove forest leaves. The NF, an oil rich in docosahexaenoic acid (DHA), is isolated from the microalgae by mechanical extraction. The applicant proposed to use the NF in infant formulae (IF) and follow-on formulae (FOF). The use level defined by the applicant was derived from Regulation (EU) 2016/127, which states the mandatory addition of DHA to IF and FOF at the level of 20–50 mg/100 kcal. The intake of DHA resulting from the use of the NF in IF and FOF is not expected to pose safety concerns. The composition of the NF indicates the absence of marine biotoxins in the NF. Furthermore, Schizochytrium limacinum was attributed the qualified presumption of safety (QPS) status with the qualification ‘for production purposes only’. Based on the information provided, the microalga is not expected to survive the manufacturing process. Toxicological tests conducted with the NF were not performed. However, based on the available toxicological data on various forms of oils derived from Schizochytrium sp., the QPS status of the source of the NF, the production process and the composition of the NF, the Panel considers there are no concerns with regard to toxicity of the NF. The Panel concludes that the NF is safe under the proposed conditions of use.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 the safety of Schizochytrium sp. oil as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Schizochytrium sp. is a single-cell microalga. The strain WZU477, used by the applicant (Progress Biotech bv), was found to belong to the species Schizochytrium limacinum and was obtained in a marine environment from rotted mangrove forest leaves. The NF, an oil rich in docosahexaenoic acid (DHA), is isolated from the microalgae by mechanical extraction. The applicant proposed to use the NF in infant formulae (IF) and follow-on formulae (FOF). The use level defined by the applicant was derived from Regulation (EU) 2016/127, which states the mandatory addition of DHA to IF and FOF at the level of 20–50 mg/100 kcal. The intake of DHA resulting from the use of the NF in IF and FOF is not expected to pose safety concerns. The composition of the NF indicates the absence of marine biotoxins in the NF. Furthermore, Schizochytrium limacinum was attributed the qualified presumption of safety (QPS) status with the qualification ‘for production purposes only’. Based on the information provided, the microalga is not expected to survive the manufacturing process. Toxicological tests conducted with the NF were not performed. However, based on the available toxicological data on various forms of oils derived from Schizochytrium sp., the QPS status of the source of the NF, the production process and the composition of the NF, the Panel considers there are no concerns with regard to toxicity of the NF. The Panel concludes that the NF is safe under the proposed conditions of use.Lire moins >
Langue :
Anglais
Audience :
Internationale
Vulgarisation :
Non
Établissement(s) :
CHU Lille
Inserm
Université de Lille
Inserm
Université de Lille
Date de dépôt :
2021-07-06T12:48:25Z
2024-01-15T10:28:11Z
2024-01-15T10:28:11Z
Fichiers
- EFSA Journal - 2020 - - Safety of Schizochytrium sp oil as a novel food pursuant to Regulation EU 2015 2283 a.pdf
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