Re‐evaluation of neohesperidine dihydrochalcone (E 959) as a food additive
EFSA Panel on Food Additives and Flavourings (FAF), Maged Younes, Gabriele Aquilina, Laurence Castle, Gisela H. Degen, Karl‐Heinz Engel, Paul J Fowler, María José Frutos Fernández, Peter Fürst, Ursula Gundert‐Remy, Rainer Gürtler, Trine Husøy, Melania Manco, Wim Mennes, Peter Moldéus, Sabina Passamonti, Romina Shah, Ine Waalkens‐Berendsen, Matthew Wright, Monika Batke, Polly Boon, Ellen Bruzell, James Kevin Chipman, Riccardo Crebelli, Rex FitzGerald, Cristina Fortes, Þórhallur I. Halldórsson, Jean‐Charles Leblanc, Oliver Lindtner, Alicja Mortensen, Evangelia Ntzani, Heather Wallace, Claudia Cascio, Consuelo Civitella, Zsuzsanna Bagó-Horváth, Federica Lodi, Agnieszka Mech, Alexandra Tard, Giorgia Vianello
Abstract
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.