Dataset Information

Re-evaluation of neohesperidine dihydrochalcone (E 959) as a food additive.

ABSTRACT: The present opinion deals with the re-evaluation of neohesperidine dihydrochalcone (E 959) when used as a food additive. It is obtained by catalytic hydrogenation of a flavanone - neohesperidine - which is naturally occurring and thus isolated by alcohol extraction in bitter oranges (Citrus aurantium). Based on in vivo data in rat, neohesperidine dihydrochalcone is likely to be absorbed, also in humans, and to become systemically available. It does not raise a concern regarding genotoxicity. The toxicity data set consisted of studies on subchronic and prenatal developmental toxicity. No human studies were available. The data set was considered sufficient to derive a new acceptable daily intake (ADI). Based on the weight of evidence (WoE) analysis, the Panel considered unlikely that neohesperidine dihydrochalcone would lead to adverse effects on health in animals in the dose ranges tested. The Panel also considered that a carcinogenicity study was not warranted and that the lack of human data did not affect the overall confidence in the body of evidence. The Panel derived an ADI of 20 mg/kg bodyweight (bw) per day based on a no observed adverse effect level (NOAEL) of 4,000 mg/kg bw per day from a 13-week study in rat, applying the standard default factors of 100 for inter- and intraspecies differences and of 2 for extrapolation from subchronic to chronic exposure. For the refined brand-loyal exposure assessment scenario, considered to be the most appropriate for the risk assessment, the exposure estimates at the mean ranged from < 0.01 to 0.09 mg/kg bw per day and at the 95th percentile (P95) from 0.01 to 0.24 mg/kg bw per day. Considering the derived ADI of 20 mg/kg bw per day, the exposure estimates were below the reference value in all age groups. Therefore, the Panel concluded that dietary exposure to the food additive neohesperidine dihydrochalcone (E 959) at the reported uses and use levels would not raise a safety concern.

SUBMITTER: EFSA Panel on Food Additives and Flavourings (FAF)

PROVIDER: S-EPMC9669802 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature

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Re-evaluation of neohesperidine dihydrochalcone (E 959) as a food additive.

Younes Maged M Aquilina Gabriele G Castle Laurence L Degen Gisela G Engel Karl-Heinz KH Fowler Paul J PJ Frutos Fernandez Maria José MJ Fürst Peter P Gundert-Remy Ursula U Gürtler Rainer R Husøy Trine T Manco Melania M Mennes Wim W Moldeus Peter P Passamonti Sabina S Shah Romina R Waalkens-Berendsen Ine I Wright Matthew M Batke Monika M Boon Polly P Bruzell Ellen E Chipman James J Crebelli Riccardo R FitzGerald Rex R Fortes Cristina C Halldorsson Thorhallur T LeBlanc Jean-Charles JC Lindtner Oliver O Mortensen Alicja A Ntzani Evangelia E Wallace Heather H Cascio Claudia C Civitella Consuelo C Horvath Zsuzsanna Z Lodi Federica F Mech Agnieszka A Tard Alexandra A Vianello Giorgia G

EFSA journal. European Food Safety Authority 20221117 11

The present opinion deals with the re-evaluation of neohesperidine dihydrochalcone (E 959) when used as a food additive. It is obtained by catalytic hydrogenation of a flavanone - neohesperidine - which is naturally occurring and thus isolated by alcohol extraction in bitter oranges (<i>Citrus aurantium</i>). Based on <i>in vivo</i> data in rat, neohesperidine dihydrochalcone is likely to be absorbed, also in humans, and to become systemically available. It does not raise a concern regarding gen ...[more]

PMID: 36406883

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Project description:This opinion deals with the re-evaluation of polydextrose (E 1200) when used as a food additive. The Panel followed the conceptual framework for the risk assessment of certain additives and considered that: adequate exposure estimates were available; the margin of safety (MOS)/margin of exposure (MOE) for arsenic was between 0.5-14 and 8.5 for lead; the exhaustions of the tolerable weekly intake (TWI) for cadmium would be 165%, 10% for mercury, whereas the exhaustion of the tolerable daily intake (TDI) for nickel would be 9%; the absorption is limited and part of polydextrose is fermented in the large intestine into short-chain fatty acids (SCFA); adequate toxicity data were available; there is no concern with respect to genotoxicity; no adverse effects were reported in subchronic studies in rats, dogs or monkeys nor in chronic or carcinogenicity studies in mice and rats at the highest doses tested of up 12,500 mg/kg body weight (bw) per day and 15,000 mg/kg bw per day, respectively; the nephrocalcinosis in dogs given high doses of polydextrose was considered to be a treatment-related but a secondary effect related to diarrhoea, and hence not relevant for the risk assessment; no adverse effects were reported in reproductive or developmental toxicity studies in rats administered up to 10,000 mg polydextrose/kg bw per day, or in a developmental toxicity study in rabbits up to 1,818 mg/kg bw per day (the highest dose tested). Therefore, the Panel concluded that there is no need for numerical acceptable daily intake (ADI) for polydextrose (E 1200), and that there is no safety concern for the reported uses and use levels of polydextrose as a food additive. The Panel recommended that European Commission considers to lower the maximum limit for lead and to introduce limits for arsenic, cadmium and mercury in the EU specifications for polydextrose (E 1200), and to verify that polydextrose-N as a food additive (E 1200) is no longer marketed in the EU.

Dataset Information

Re-evaluation of neohesperidine dihydrochalcone (E 959) as a food additive.

Publications

Re-evaluation of neohesperidine dihydrochalcone (E 959) as a food additive.

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