This opinion deals with the re-evaluation of polydextrose (E 1200) when used as a food additive. The
Panel followed the conceptual framework for the risk assessment of certain additives and considered
that: adequate exposure estimates were available; the margin of safety (MOS)/margin of exposure
(MOE) for arsenic was between 0.5-14 and 8.5 for lead; the exhaustions of the tolerable weekly intake
(TWI) for cadmium would be 165%, 10% for mercury, whereas the exhaustion of the tolerable daily
intake (TDI) for nickel would be 9%; the absorption is limited and part of polydextrose is fermented in
the large intestine into short-chain fatty acids (SCFA); adequate toxicity data were available; there is no
concern with respect to genotoxicity; no adverse effects were reported in subchronic studies in rats, dogs
or monkeys nor in chronic or carcinogenicity studies in mice and rats at the highest doses tested of up
12,500 mg/kg body weight (bw) per day and 15,000 mg/kg bw per day, respectively; the
nephrocalcinosis in dogs given high doses of polydextrose was considered to be a treatment-related but
a secondary effect related to diarrhoea, and hence not relevant for the risk assessment; no adverse
effects were reported in reproductive or developmental toxicity studies in rats administered up to 10,000
mg polydextrose/kg bw per day, or in a developmental toxicity study in rabbits up to 1,818 mg/kg bw per
day (the highest dose tested). Therefore, the Panel concluded that there is no need for numerical
acceptable daily intake (ADI) for polydextrose (E 1200), and that there is no safety concern for the
reported uses and use levels of polydextrose as a food additive. The Panel recommended that European
Commission considers to lower the maximum limit for lead and to introduce limits for arsenic, cadmium
and mercury in the EU specifications for polydextrose (E 1200), and to verify that polydextrose-N as a
food additive (E 1200) is no longer marketed in the EU.
