Safety of Schizochytrium sp. oil as a novel food pursuant to Regulation (EU) 2015/2283(a) - Université de Lille
Article Dans Une Revue EFSA Journal Année : 2020

Safety of Schizochytrium sp. oil as a novel food pursuant to Regulation (EU) 2015/2283(a)

Jacqueline Castenmiller
  • Fonction : Auteur
Stefaan de Henauw
  • Fonction : Auteur
Karen Ildico Hirsch-Ernst
  • Fonction : Auteur
John Kearney
  • Fonction : Auteur
Alexandre Maciuk
  • Fonction : Auteur
Inge Mangelsdorf
  • Fonction : Auteur
Harry J. Mcardle
  • Fonction : Auteur
Androniki Naska
  • Fonction : Auteur
Carmen Pelaez
  • Fonction : Auteur
Kristina Pentieva
  • Fonction : Auteur
Alfonso Siani
  • Fonction : Auteur
Frank Thies
  • Fonction : Auteur
Sophia Tsabouri
  • Fonction : Auteur
Marco Vinceti
  • Fonction : Auteur
Francesco Cubadda
  • Fonction : Auteur
Karl-Heinz Engel
  • Fonction : Auteur
Thomas Frenzel
  • Fonction : Auteur
Marina Heinonen
  • Fonction : Auteur
Rosangela Marchelli
  • Fonction : Auteur
Monika Neuhauser-Berthold
  • Fonction : Auteur
Morten Poulsen
  • Fonction : Auteur
Yolanda Sanz
  • Fonction : Auteur
Josef Rudolf Schlatter
  • Fonction : Auteur
Henk van Loveren
  • Fonction : Auteur
Lucien Ferreira
  • Fonction : Auteur
Helle Katrine Knutsen
  • Fonction : Auteur

Résumé

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.
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Dates et versions

hal-04394185 , version 1 (15-01-2024)

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Dominique Turck, Jacqueline Castenmiller, Stefaan de Henauw, Karen Ildico Hirsch-Ernst, John Kearney, et al.. Safety of Schizochytrium sp. oil as a novel food pursuant to Regulation (EU) 2015/2283(a). EFSA Journal, 2020, EFSA Journal, 18, pp.e06242. ⟨10.2903/j.efsa.2020.6242⟩. ⟨hal-04394185⟩

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