Re-evaluation of polydextrose (E 1200) as a food additive

Area of Science:

• Food Additive Safety
• Toxicology
• Risk Assessment

Background:

• Polydextrose (E 1200) is a widely used food additive.
• Previous safety assessments may require re-evaluation based on updated scientific frameworks.
• Concerns regarding potential contaminants and toxicological endpoints necessitate a thorough review.

Purpose of the Study:

• To re-evaluate the safety of polydextrose (E 1200) as a food additive.
• To assess exposure estimates, margins of safety/exposure, and tolerable intake levels for contaminants.
• To review available toxicity data, including genotoxicity, subchronic, chronic, carcinogenicity, reproductive, and developmental studies.

Main Methods:

• Followed the conceptual framework for risk assessment of food additives.
• Evaluated exposure estimates and calculated margins of safety (MOS)/exposure (MOE) for arsenic and lead.
• Assessed the exhaustion of tolerable weekly intake (TWI) for cadmium and mercury, and tolerable daily intake (TDI) for nickel.
• Reviewed data on polydextrose absorption, fermentation, and various toxicity studies (genotoxicity, subchronic, chronic, carcinogenicity, reproductive, developmental).

Main Results:

• Adequate exposure estimates were available, with specific MOS/MOE values for arsenic and lead.
• Exhaustion percentages for TWI/TDI of cadmium, mercury, and nickel were calculated.
• Limited absorption and fermentation of polydextrose into short-chain fatty acids were noted.
• No genotoxicity concerns were identified.
• No adverse effects were observed in subchronic, chronic, carcinogenicity, reproductive, or developmental toxicity studies up to the highest doses tested.
• Nephrocalcinosis in dogs was deemed a secondary effect of diarrhea, not relevant for risk assessment.
• No numerical acceptable daily intake (ADI) is needed for polydextrose (E 1200).

Conclusions:

• Polydextrose (E 1200) poses no safety concern at reported uses and levels as a food additive.
• Recommendations include lowering lead limits and introducing limits for arsenic, cadmium, and mercury in EU specifications.
• Verification that polydextrose-N is no longer marketed in the EU is advised.