Flavouring group evaluation 420 (FGE.420): Hesperetin dihydrochalcone

Area of Science:

• Food Science and Technology
• Toxicology
• Chemical Safety Assessment

Background:

• Hesperetin dihydrochalcone [FL-no: 16.137] is a novel flavouring substance.
• It is structurally related to other evaluated flavonoids.

Purpose of the Study:

• To evaluate the safety of hesperetin dihydrochalcone as a food flavouring.
• To assess potential risks according to Regulation (EC) No 1331/2008.

Main Methods:

• Review of manufacturing process, composition, and stability data.
• Assessment of genotoxicity, metabolism, and toxicity studies.
• Evaluation of prenatal developmental and 90-day toxicity studies.
• Calculation of margins of exposure (MOE) using chronic added portions exposure technique (APET).

Main Results:

• No genotoxicity concerns identified.
• Hesperetin dihydrochalcone is anticipated to be metabolized to innocuous products.
• No maternal or foetal toxicity observed in developmental studies.
• Thyroid hormone level changes in toxicity studies were deemed not adverse.
• Adequate margins of exposure calculated for adults and children.
• Cumulative exposure to related substances does not raise safety concerns.

Conclusions:

• The use of hesperetin dihydrochalcone [FL-no: 16.137] as a food flavouring is considered safe under proposed conditions.
• No safety concerns arise from its use or cumulative exposure with related flavouring substances.