Re-evaluation of tragacanth (E 413) as a food additive

Area of Science:

• Food Science
• Toxicology
• Regulatory Science

Background:

• Tragacanth (E 413) is a food additive previously assessed by SCF and JECFA, with an 'ADI not specified'.
• Re-evaluation followed the framework in Commission Regulation (EU) No 257/2010.

Purpose of the Study:

• To re-evaluate the safety of tragacanth (E 413) as a food additive.
• To determine if a numerical acceptable daily intake (ADI) is necessary.

Main Methods:

• Review of available exposure and toxicity data, including carcinogenicity and genotoxicity studies.
• Analysis of human tolerance studies involving high oral intake levels.

Main Results:

• Tragacanth (E 413) is poorly absorbed and partially fermented by gut microbiota.
• No adverse effects were observed in carcinogenicity or genotoxicity studies.
• Human studies showed high daily intake (up to 9,900 mg/person/day) was well tolerated for 21 days.

Conclusions:

• No numerical ADI is required for tragacanth (E 413).
• No safety concerns exist for the general population at current uses and levels.