ArticleEFSA journal. European Food Safety Authority2024
Flavouring group evaluation 420 (FGE.420): Hesperetin dihydrochalcone.
Article in EFSA journal. European Food Safety Authority, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
1 citing paper in PubMed.
- Flavouring group evaluation 420 (FGE.420): Hesperetin dihydrochalcone.EFSA journal. European Food Safety Authority · 2024Article
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PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
27 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of hesperetin dihydrochalcone [FL-no: 16.137] as a new flavouring substance, in accordance with Regulation (EC) No 1331/2008. The substance is structurally related to the group of flavonoids evaluated in FGE.32 and is the aglycone of neohesperidine dihydrochalcone. Based on the data provided for [FL-no: 16.137], the Panel considered that a read-across between hesperetin dihydrochalcone and the substances in FGE.32 is not needed. Nevertheless, the flavonoids evaluated in FGE.32 were considered in a cumulative exposure assessment. The information provided on the manufacturing process, the composition and the stability of [FL-no: 16.137] was considered sufficient. The Panel concluded that there is no concern with respect to genotoxicity. No absorption, distribution, metabolism and excretion (ADME) studies on [FL-no: 16.137] were provided, but studies investigating the ADME of neohesperidine dihydrochalcone were submitted. The Panel noted that [FL-no: 16.137] has the same fate in the organism, as that of neohesperidine dihydrochalcone and considered that [FL-no: 16.137] can be anticipated to be metabolised to innocuous products only. In a prenatal developmental toxicity study, no maternal or foetal toxicity was observed. In a 90-day toxicity study, indications were obtained that the substance affects thyroid hormone levels at all doses tested (100-1000 mg/kg bw per day). Since these changes were not accompanied by apical findings indicative of hypothyroidism, the Panel considered these hormonal effects as not adverse. Using 1000 mg/kg bodyweight (bw) per day as reference point, adequate margins of exposure were calculated for adults and children, when considering the chronic added portions exposure technique (APET) dietary exposure estimates. Cumulative chronic exposure estimates to [FL-no: 16.137] and the four structurally related substances evaluated in FGE.32 do not raise a safety concern. The use of [FL-no: 16.137] as food flavouring, under the proposed conditions of use, does not raise a safety concern.
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