Re‐evaluation of dimethyl polysiloxane (E 900) as a food additive

The Panel on Food Additives and Flavourings (FAF) provided a scientific opinion re‐evaluating the safety of dimethyl polysiloxane (E 900) as a food additive. E 900 was evaluated by the Scientific Committee on Food (SCF) in 1990 and agreed with the Acceptable Daily Intake (ADI) of 1.5 mg/kg body weight (bw) per day previously established by Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1974. Dimethyl polysiloxane was only absorbed to a very limited extent from the gastrointestinal tract following oral administration and the vast majority was excreted unchanged in the faeces. Corneal opacities and other effects on cornea were observed in studies in rats. These effects are considered to be caused by direct contact with the test substance in the feed and/or with the test substance in the faeces and not due to systemic exposure. The Panel considered that oral exposure of dimethyl polysiloxane did not result in any systemic adverse effects in any species and dose tested and there is no concern with respect to genotoxicity of dimethyl polysiloxane (E 900). From a 26‐month toxicity study in rats, a No Observed Adverse Effect Level (NOAEL) of 1,742 and 2,055 mg dimethyl polysiloxane/kg bw per day for female and male, respectively, was identified. Using the NOAEL 1,742 mg/kg bw per day, the Panel established an ADI of 17 mg/kg bw per day for E 900 by applying an uncertainty factor of 100. Accordingly, the ADI for dimethyl polysiloxane (E 900) of 1.5 mg/kg bw per day, established by SCF in 1990, is withdrawn. The exposure estimates for the different population groups of all exposure scenarios did not exceed the ADI of 17 mg/kg bw per day for E 900. The Panel concluded that there is not a safety concern at the reported uses and use levels for dimethyl polysiloxane (E 900). The Panel also proposed a number of recommendations for the EU specifications to be amended.