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Article Dans Une Revue EFSA Journal Année : 2018

Safety of D-ribose as a novel food pursuant to Regulation (EU) 2015/2283

Jean-Louis Bresson
  • Fonction : Auteur
Barbara Burlingame
  • Fonction : Auteur
Tara Dean
  • Fonction : Auteur
Susan Fairweather-Tait
  • Fonction : Auteur
Marina Heinonen
  • Fonction : Auteur
Karen-Ildico Hirsch-Ernst
  • Fonction : Auteur
Inge Mangelsdorf
  • Fonction : Auteur
Harry J. Mcardle
  • Fonction : Auteur
Androniki Naska
  • Fonction : Auteur
Monika Neuhauser-Berthold
  • Fonction : Auteur
Grazyna Nowicka
  • Fonction : Auteur
Kristina Pentieva
  • Fonction : Auteur
Yolanda Sanz
  • Fonction : Auteur
Alfonso Siani
  • Fonction : Auteur
Anders Sjodin
  • Fonction : Auteur
Martin Stern
  • Fonction : Auteur
Daniel Tome
  • Fonction : Auteur
Marco Vinceti
  • Fonction : Auteur
Peter Willatts
  • Fonction : Auteur
Karl-Heinz Engel
  • Fonction : Auteur
Rosangela Marchelli
  • Fonction : Auteur
Annette Poting
  • Fonction : Auteur
Morten Poulsen
  • Fonction : Auteur
Josef Rudolf Schlatter
  • Fonction : Auteur
Andrea Germini
  • Fonction : Auteur
Henk van Loveren
  • Fonction : Auteur

Résumé

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on D-ribose as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The applicant intends to market the NF as ingredient in a variety of foods, food supplements and in certain foods for specific groups. The NF is produced by fermentation using a transketolase-deficient strain of Bacillus subtilis and marketed as Bioenergy Ribose™. The information provided on the batch-to-batch variability, specifications, stability, production process and history of the organism used as a source of the NF is sufficient and does not raise safety concerns. The Panel considers that the effects observed in a subchronic toxicity study in rats could be the consequence of nutritional imbalances, but toxicological effects could not be ruled out; from this study, the Panel derived a No observed adverse effect level (NOAEL) of 3.6 g/kg body weight (bw) per day. From the human studies indicating a potential decrease in glucose levels and/or the occurrence of transient symptomatic hypoglycaemia at intakes of 10 g of d-ribose, the Panel defined 70 mg/kg bw per day as the NOAEL with respect to hypoglycaemia that can be considered applicable for adults. For children, the Panel acknowledges the lack of human data directly relevant for this population group. Based on the NOAEL derived from the subchronic toxicity study in rats, an acceptable level of intake of 36 mg/kg bw per day was defined that would also take into account the potentially increased sensitivity of certain population groups to hypoglycaemia. The Panel concludes that the NF is safe for the general population at intake levels up to 36 mg/kg bw per day and considers that the safety of the NF at the intended uses and use levels as proposed by the applicant has not been established.
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Dates et versions

hal-04318470 , version 1 (01-12-2023)

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Dominique Turck, Jean-Louis Bresson, Barbara Burlingame, Tara Dean, Susan Fairweather-Tait, et al.. Safety of D-ribose as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal, 2018, EFSA Journal, 16, ⟨10.2903/j.efsa.2018.5265⟩. ⟨hal-04318470⟩

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