经过评估,专家小组认为报告的葡聚糖(E1200)用作食品添加剂的用途和使用水平没有安全问题。部分原文报道如下:
This opinion deals with the re‐e
valuation of polydextrose (E 1200) when used as a food additive. The Panel followed the co
nceptual f
ramework for the risk assessment of certain additives and co
nsidered that: adequate exposure estimates were available; the margin of safety (MOS)/margin of exposure (MOE) for arsenic was between 0.5?4 and 8.5 for lead; the exhaustions of the tolerable weekly intake (TWI) for cadmium would be 165%, 10% for mercury, wheras 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 co
ncern with respect to genotoxicity; no adverse effects were reported in subchro
nic studies in rats, dogs or mo
nkeys nor in chro
nic 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 co
nsidered to be a treatment‐related but a seco
ndary 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 co
ncluded that there is no need for numerical acceptable daily intake (ADI) for polydextrose (E 1200), and that there is no safety co
ncern for the reported uses and use levels of polydextrose as a food additive. The Panel recommended that European Commission co
nsiders 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 lo
nger marketed in the EU.
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