Titre :

Safety of oil from <i>Schizochytrium</i> sp. (strain CABIO-A-2) for use in infant and follow-on formula as a novel food pursuant to Regulation (EU) 2015/2283.

Auteur(s) :

Turck, Dominique [Auteur]
Institute for Translational Research in Inflammation - U 1286 [INFINITE]
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]
Siskos, Alexandros [Auteur]
Van Loveren, Henk [Auteur]
Turla, Emanuela [Auteur]
Knutsen, Helle Katrine [Auteur]

Titre de la revue :

EFSA Journal

Nom court de la revue :

EFSA J

Numéro :

21

Pagination :

e8415

Date de publication :

2023-12-19

ISSN :

1831-4732

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. (strain CABIO-A-2) oil as a novel food ...
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. (strain CABIO-A-2) oil as a novel food (NF) pursuant to Regulation (EU) 2015/2283. S. sp. is a single-cell microalga. The NF is a mixture of triglycerides in which docosahexaenoic acid (DHA) represents 38%–44% of fatty acids. The applicant proposed to use the NF in infant formulae (IF) and follow-on formulae (FOF). The use levels proposed by the applicant were 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 evidence provided demonstrated that the strain S. sp. CABIO-A-2 is phylogenetically closely related to the strain S. sp. ATCC 20888. The assessment of some already authorised S. sp. oils in the Union list were also based on similarities with the strain ATCC 20888. The applicant provided a 90-day repeated dose toxicity study in rats with the NF. No adverse effects were observed up to the highest dose tested, i.e. 10.2 g/kg body weight (bw) per day. Taking into account the toxicity studies performed with the NF and with DHA-oils derived from strains belonging to the genus Schizochytrium, its phylogenetical profile, the production process, the composition of the NF and the absence of marine biotoxins and viable cells in the NF, the Panel considers that there are no concerns with regard to the 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) :

Université de Lille
Inserm
CHU Lille

Collections :

• Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286

Date de dépôt :

2024-02-03T22:04:05Z
2024-03-15T09:37:24Z