Background

The Norwegian Food Safety Authority has asked the Norwegian Scientific Committee for Food and Environment (VKM) to assess whether daily intake of hesperidin in dietary supplements (in doses of 2, 25 and 60 mg) may pose a health risk for adults over the age of 18.

The background for the assessment stems from applications for the addition of hesperidin from orange extract (Citrus sinensis) and bitter orange extract (Citrus aurantium) to food supplements. VKM was asked to identify harmful health effects and describe the doses at which they occur. VKM was also asked to characterize the health risks associated with exposure to the substance.

Hesperidin belongs to the group "other substances". These are substances that have a nutritional or physiological effect and are not vitamins or minerals.

Method

VKM has estimated the intake of hesperidin from citrus fruit and orange juice in the diet based on data from a Norwegian dietary survey (Norkost 3).

VKM has conducted its own literature searches for research articles on hesperidin in several areas: metabolism in the body (absorption, distribution, metabolism, and excretion), the possibility of damage to the genetic material (genotoxicity) or reproductive function (reproductive toxicity), and whether other signs of negative health effects have been found in clinical trials (with randomized controlled trial design) in humans.

VKM has reviewed and assessed the quality of both previous systematic reviews and primary studies.

Result

Research literature does not indicate that hesperidin can damage genetic material or reproductive function. Other negative health effects or side effects were also not found in the literature. The doses given were between 200-1000 mg/day, and the studies lasted up to 12 weeks.

Dietary intake is estimated at 20 mg per day (median value) among those who consume citrus and/or drink orange juice, while high intake of orange juice alone can contribute up to 196 mg/day.

The doses applied for (2, 25 and 60 mg) correspond to 0.02-1.15 mg per kg of body weight, per day.

Conclusion

The doses applied for (2, 25 and 60 mg) are within safe limits.

VKM has not identified negative health effects or side effects associated with the intake of hesperidin in the doses applied for, nor together with a high intake of citrus from the diet.

Knowledge gaps

VKM found no studies in which pregnant or breastfeeding women had received hesperidin as a dietary supplement.

Studies lasting more than 12 weeks are necessary to conclude on health effects after long-term use.

Larger studies with more participants are needed to conclude on potentially rare side effects.

The risk assessment is approved by VKM's Scientific Panel on Plant Protection Products.