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

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dc.citation.issue5
dc.citation.volume16
dc.contributor.authorEFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)
dc.contributor.authorTurck D
dc.contributor.authorBresson J-L
dc.contributor.authorBurlingame B
dc.contributor.authorDean T
dc.contributor.authorFairweather-Tait S
dc.contributor.authorHeinonen M
dc.contributor.authorHirsch-Ernst KI
dc.contributor.authorMangelsdorf I
dc.contributor.authorMcArdle H
dc.contributor.authorNaska A
dc.contributor.authorNeuhäuser-Berthold M
dc.contributor.authorNowicka G
dc.contributor.authorPentieva K
dc.contributor.authorSanz Y
dc.contributor.authorSiani A
dc.contributor.authorSjödin A
dc.contributor.authorStern M
dc.contributor.authorTomé D
dc.contributor.authorVinceti M
dc.contributor.authorWillatts P
dc.contributor.authorEngel K-H
dc.contributor.authorMarchelli R
dc.contributor.authorPöting A
dc.contributor.authorPoulsen M
dc.contributor.authorSchlatter JR
dc.contributor.authorGermini A
dc.contributor.authorVan Loveren H
dc.coverage.spatialUnited States
dc.date.accessioned2023-07-10T02:58:12Z
dc.date.accessioned2023-09-04T01:40:34Z
dc.date.available2018-04-18
dc.date.available2023-07-10T02:58:12Z
dc.date.available2023-09-04T01:40:34Z
dc.date.issued2018-05-31
dc.date.updated2023-07-09T21:23:24Z
dc.description.abstractFollowing 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.
dc.description.confidentialfalse
dc.edition.editionMay 2018
dc.format.extente05265-
dc.identifierARTN 5265
dc.identifierEFS25265
dc.identifierhttps://www.ncbi.nlm.nih.gov/pubmed/32625902
dc.identifier.citationEFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) , Turck D, Bresson J-L, Burlingame B, Dean T, Fairweather-Tait S, Heinonen M, Hirsch-Ernst KI, Mangelsdorf I, McArdle H, Naska A, Neuhäuser-Berthold M, Nowicka G, Pentieva K, Sanz Y, Siani A, Sjödin A, Stern M, Tomé D, Vinceti M, Willatts P, Engel K-H, Marchelli R, Pöting A, Poulsen M, Schlatter JR, Germini A, Van Loveren H. (2018). Safety of d-ribose as a novel food pursuant to Regulation (EU) 2015/2283.. EFSA J. 16. 5. (pp. e05265-).
dc.identifier.doi10.2903/j.efsa.2018.5265
dc.identifier.eissn1831-4732
dc.identifier.elements-typejournal-article
dc.identifier.harvestedMassey_Dark
dc.identifier.issn1831-4732
dc.identifier.urihttp://hdl.handle.net/10179/19850
dc.languageeng
dc.publisherohn Wiley and Sons Ltd on behalf of European Food Safety Authority
dc.publisher.urihttps://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2018.5265
dc.relation.isPartOfEFSA J
dc.rightsCC BY
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/
dc.subjectd‐ribose
dc.subjectingredient
dc.subjectnovel food
dc.subjectribose
dc.subjectsafety
dc.titleSafety of d-ribose as a novel food pursuant to Regulation (EU) 2015/2283
dc.typeJournal article
pubs.elements-id444557
pubs.organisational-groupOther
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