RESUMO
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.
RESUMO
The serum concentrations of perfluorooctanesulfonate (PFOS) and perfluorooctanoic acid (PFOA) were determined in 230 subjects of the Italian general population. Participants were enrolled in 2008 in two Italian towns (Brescia, Northern Italy, and Rome, Central Italy) and belonged to the three age ranges: 20-35 years, 36-50 years, and 51-65 years. PFOS and PFOA were quantified by HPLC interfaced to a mass spectrometer operating in the electrospray negative mode. Data were acquired using multiple reaction monitoring (MRM). The isotope dilution technique was applied throughout. The median serum concentrations of all participants were 6.31 ng g(-1) and 3.59 ng g(-1) for PFOS and PFOA, respectively, and the pertinent 90th percentiles were 12.38 and 6.92. Men had higher concentrations of PFOS and PFOA than women, regardless of age. The differences were statistically significant in the 20-35 and 36-50 years groups, but not in the 51-65 group. An increase of PFOS and PFOA serum concentrations with age was observed. The Median test showed a statistically significant difference (p<<0.01) between the three age groups for both PFOS and PFOA when applied to the entire dataset (males and females). When the test was applied to the groups of males and females separately, a significant difference was observed for females (p<<0.005) but not for males (p>0.1). The observed strong correlation between PFOS and PFOA concentrations suggests same or similar exposure routes.
