Flavouring Group Evaluation 413 (FGE.413): Naringenin

Area of Science:

• Food Science
• Toxicology
• Chemical Safety

Background:

• Naringenin (FL-no: 16.132) was evaluated as a new flavouring substance under Regulation (EC) No 1331/2008.
• No suitable structural analogues were identified for read-across assessment.

Purpose of the Study:

• To assess the safety of naringenin as a flavouring substance.
• To investigate potential genotoxicity, drug interactions, and endocrine-disrupting activity.

Main Methods:

• Evaluation of manufacturing process, composition, and stability.
• Genotoxicity studies and assessment of drug interaction potential.
• Extended one-generation toxicity study in rodents to determine the no observed adverse effect level (NOAEL).

Main Results:

• Naringenin showed no genotoxicity concerns.
• Unlikely risk of drug interaction at anticipated exposure levels.
• NOAEL established at 1320 mg/kg body weight/day based on developmental effects in the F2 generation.

Conclusions:

• Margins of exposure (MoE) for adults (1590) and children (630) were calculated using the NOAEL.
• The use of naringenin as a flavouring substance does not raise safety concerns at estimated exposure levels.