Safety of oil from schizochytrium limacinum (strain fcc-3204) for use in food supplements as a novel food pursuant to regulation (eu) 2015/2283 - Université de Lille Accéder directement au contenu
Article Dans Une Revue EFSA Journal Année : 2021

Safety of oil from schizochytrium limacinum (strain fcc-3204) for use in food supplements as a novel food pursuant to regulation (eu) 2015/2283

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
Thomas Frenzel
  • Fonction : Auteur
Marina Heinonen
  • Fonction : Auteur
Rosangela Marchelli
  • Fonction : Auteur
Monika Neuhauser-Berthold
  • Fonction : Auteur
Morten Poulsen
  • Fonction : Auteur
Miguel Prieto Maradona
  • Fonction : Auteur
Josef Rudolf Schlatter
  • Fonction : Auteur
Henk van Loveren
  • Fonction : Auteur
Emanuela Turla
  • 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 FCC-3204, used by the applicant (Fermentalg), belongs to the species Schizochytrium limacinum. The NF, an oil rich in docosahexaenoic acid (DHA), is obtained from microalgae after enzymatic lysis. The applicant proposed to increase the use level of the NF as a food supplement, from 250 mg DHA/day (currently authorised for the general population, excluding pregnant and lactating women) to 3 g DHA/day for adults, excluding pregnant and lactating women. S. limacinum was attributed the qualified presumption of safety (QPS) status with the qualification ‘for production purposes only’. Data provided by the applicant demonstrated the absence of viable cells in the NF. No toxicological studies were performed with the NF. However, based on the available toxicological data on oils derived from Schizochytrium sp., the QPS status of the source of the NF, the production process, the composition of the NF and the absence of viable cells in the NF, the Panel considers there are no concerns with regard to toxicity of the NF. The Panel considers that the data provided by the applicant are not sufficient to conclude on the safety of the NF at the proposed uses (3 g DHA/day as a food supplement) in adults. However, in 2012, the Panel concluded that supplemental intakes of DHA alone up to about 1 g/day do not raise safety concerns for the general population. The Panel concludes that the NF is safe for the use in food supplements at the maximum intake level of 1 g DHA/day for the target population (adults, excluding pregnant and lactating women).
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hal-04387971 , version 1 (11-01-2024)

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Dominique Turck, Jacqueline Castenmiller, Stefaan de Henauw, Karen Ildico Hirsch-Ernst, John Kearney, et al.. Safety of oil from schizochytrium limacinum (strain fcc-3204) for use in food supplements as a novel food pursuant to regulation (eu) 2015/2283. EFSA Journal, 2021, EFSA Journal, 19, pp.e06345. ⟨10.2903/j.efsa.2021.6345⟩. ⟨hal-04387971⟩

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