EU Food Safety Authority: Hesperetin Dihydrochalcone Flavoring Safe for 90 Days

On December 4, the European Food Safety Authority (EFSA) released a scientific opinion on the safety of hesperetin dihydrochalcone as a food flavoring. After a thorough evaluation, the EFSA's Food Additives and Flavorings (FAF) panel concluded that under the recommended usage conditions, hesperetin dihydrochalcone is safe as a food flavoring. According to Regulation (EC) No 1331/2008, the EFSA’s FAF panel is responsible for assessing the safety of hesperetin dihydrochalcone as a new flavoring substance. This substance is structurally related to flavonoid groups evaluated in FGE.32 and is the aglycone of new hesperidin dihydrochalcone.

Based on the data provided under [FL-no: 16.137], the assessment group deemed it unnecessary to cross-interpret hesperetin dihydrochalcone and the substances in FGE.32. However, the flavonoid compounds evaluated in FGE.32 are considered in cumulative exposure assessments. The information regarding the manufacturing process, composition, and stability of [FL-no: 16.137] was deemed sufficient. The assessment group concluded that there are no concerns regarding genotoxicity. Studies on the absorption, distribution, metabolism, and excretion (ADME) of [FL-no: 16.137] were not observed, but ADME studies for new hesperidin dihydrochalcone have been reported. The group noted that [FL-no: 16.137] behaves similarly in organisms as new hesperidin dihydrochalcone and is expected to be metabolized only into harmless products.

In a prenatal developmental toxicity study, no maternal or fetal toxicity was observed. In a 90-day toxicity study, indications showed that this substance affects thyroid hormone levels at all tested doses (100-1000 mg/kg body weight per day). Since these changes were not accompanied by clinical signs of thyroid dysfunction, the expert group considered these hormonal effects not adverse. When considering chronic dietary exposure estimates, an appropriate exposure level for adults and children was calculated based on a reference point of 1000 mg/kg body weight. Cumulative chronic exposure estimates for [FL-no: 16.137] and four structurally related substances evaluated in FGE.32 did not raise safety concerns. Under the recommended usage conditions, using [FL-no: 16.137] as a food flavoring poses no safety issues.