Re-evaluation of β-cyclodextrin (E 459) as a food additive.

Area of Science:

• Food Additive Safety
• Toxicology
• Nutritional Science

Background:

• β-Cyclodextrin (E 459) is a cyclic oligosaccharide used as a food additive.
• The Scientific Committee on Food (SCF) previously set an ADI of 5 mg/kg bw/day in 1996.
• β-Cyclodextrin is poorly absorbed and metabolized in the gut.

Purpose of the Study:

• To re-evaluate the safety of β-cyclodextrin (E 459) as a food additive.
• To determine if the current Acceptable Daily Intake (ADI) requires revision.
• To assess exposure levels in various population groups.

Main Methods:

• Review of toxicological data, including acute, short-term, subchronic, chronic toxicity, genotoxicity, and carcinogenicity studies.
• Analysis of available reported use and consumption levels.
• Calculation of exposure estimates for different population groups under a 'brand-loyal scenario'.

Main Results:

• β-Cyclodextrin exhibits low acute oral toxicity.
• No Observed Adverse Effect Levels (NOAELs) were identified in rat and dog studies (ranging from 466 mg/kg bw/day to 864 mg/kg bw/day).
• No evidence of genotoxicity or carcinogenicity was found.
• The ADI of 5 mg/kg bw/day was considered appropriate based on the toxicological database.
• Calculated exposure exceeded the ADI in most population groups in the refined 'brand-loyal scenario'.

Conclusions:

• There is no scientific reason to revise the established ADI of 5 mg/kg bw/day for β-cyclodextrin.
• Current estimated dietary intake of β-cyclodextrin exceeds the ADI for most population groups, indicating a potential concern.
• Further monitoring of usage and consumption levels may be warranted.