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Article Dans Une Revue EFSA Journal Année : 2021

Safety of water extract of cistanche tubulosa stems 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
Wolfgang Gelbmann
  • 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 water extract of Cistanche tubulosa stems as a novel food (NF) for its use in food supplements (FS) and foods for special medical purposes (FSMP). The target population is the general adult population excluding pregnant and lactating women. The applicant proposes a maximum daily intake of 2 g for FS and a maximum use level of 10% in FSMP. The characteristic components of the extract are phenylethanoid glycosides (at least 70% of the NF), in particular, echinacoside (25-45% of the NF). The NF has been authorised as a prescription drug in China in 2005 for the treatment of vascular dementia. The Panel notes that an integrated analysis of three studies covering 1,076 patients with vascular dementia treated with the proposed NF at a daily dose of 1,800 mg, reported that 12 adverse events (AEs) were classified to be 'definitely', 'probably' or 'possibly related' to the exposure to the NF. Two of these AE were classified as severe (cerebral haemorrhage and epilepsy). The Panel considers that the reported AEs raise safety concerns. The Panel also notes the limitations of the provided toxicological studies, in particular the non-compliance with the EFSA approach on the genotoxicity testing strategy and the non-compliance with good laboratory practice (GLP) and the respective OECD Guidance documents of the repeated dose toxicity studies. In view of the AEs in the human studies, the Panel considers that additional toxicological studies, following testing guidelines would not be able to overcome the concerns raised from the human studies. The Panel concludes that the safety of the NF has not been established.
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Dates et versions

hal-04387989 , 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 water extract of cistanche tubulosa stems as a novel food pursuant to regulation (eu) 2015/2283. EFSA Journal, 2021, EFSA Journal, 19, pp.e06346. ⟨10.2903/j.efsa.2021.6346⟩. ⟨hal-04387989⟩

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