Safety of hot water extract of fruits and peduncles of Hovenia dulcis as a novel food pursuant to Regulation 1(EU) 2015/2283 - Université de Lille Accéder directement au contenu
Article Dans Une Revue EFSA Journal Année : 2020

Safety of hot water extract of fruits and peduncles of Hovenia dulcis as a novel food pursuant to Regulation 1(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
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 the safety of ‘Hovenia dulcis fruit extract’ as a novel food (NF) for its use in food supplements. The NF concerns a hot water extract of sliced and dried fruits and peduncles of Hovenia dulcis Thun. The production process is described in sufficient detail but contains contradictory information regarding the mixing with another ingredient of the NF. The NF is comprised of mostly carbohydrates (about 90%), about 2% proteins, 5% moisture, less than 1% fat and about 2% ash. In addition, the NF contains small amounts of flavonoids such as dihydromyricetin, myricetin and quercetin. The Panel notes limitations of the data provided from the batch testing regarding proximate analyses and plant secondary metabolites. Given these limitations, the Panel considers that the data provided by the applicant do not demonstrate that different batches produced with the described production process meet the proposed specifications. The target population is the general adult population excluding pregnant and lactating women and people with a chronic disease, such as liver malfunction. Limited information was provided on a history of consumption of Hovenia dulcis fruits and on an extract approved in South Korea. A number of toxicological studies were performed. However, the study reports did not allow to verify that the test item was representative of the NF. The same applied to a human study provided by the applicant. The Panel concludes that the safety of the NF has not been established.
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Dates et versions

hal-04387888 , 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 hot water extract of fruits and peduncles of Hovenia dulcis as a novel food pursuant to Regulation 1(EU) 2015/2283. EFSA Journal, 2020, EFSA Journal, 18, pp.e06196. ⟨10.2903/j.efsa.2020.6196⟩. ⟨hal-04387888⟩

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