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.