Re-evaluation of karaya gum (E 416) as a food additive

Area of Science:

• Food Science
• Toxicology
• Regulatory Science

Background:

• Karaya gum (E 416) is an authorized food additive in the EU, derived from plant exudates.
• Previous assessments by JECFA and SCF established different acceptable daily intakes (ADIs).

Purpose of the Study:

• To re-evaluate the safety of karaya gum (E 416) as a food additive.
• To establish a scientific opinion on its use and potential exposure limits.

Main Methods:

• Review of existing toxicological data, including genotoxicity and animal studies.
• Assessment of human tolerance and exposure levels.
• Evaluation of Karaya gum's metabolic fate in the human body.

Main Results:

• Karaya gum is largely undigested and minimally absorbed, with no genotoxicity concerns.
• Animal studies showed no toxic effects up to 1,250 mg/kg bw/day.
• Human studies indicated good tolerance at approximately 100 mg/kg bw/day.

Conclusions:

• No safety concerns were identified for karaya gum (E 416) at refined exposure levels.
• A numerical ADI is not required for karaya gum.
• Adult exposure should not exceed 7,000 mg/person/day to prevent potential abdominal discomfort.