Safety of the proposed amendment of the specifications for the food additive polyvinyl alcohol‐polyethylene glycol‐graft‐co‐polymer (E 1209)

摘要

The European Commission asked to provide a scientific opinion on the request for a modification of the specifications for polyvinyl alcohol‐polyethylene glycol‐ ‐co‐polymer ( ‐ ‐co‐polymer) (E 1209) and its possible impact on the safety. In accordance with Annex to Regulation ( ) No 1333/2008, ‐ ‐co‐polymer (E 1209) has a single authorisation for use as a food additive in the , in the food category food supplements in solid form. According to the current specifications, ethylene glycol and diethylene glycol can be present as impurities in other food additives authorised in the , namely in polysorbates (E 432–436) and polyethylene glycol (E 1521). The exposure to ethylene glycol and diethylene glycol from their presence in E 1209 and in the other food additives was estimated considering the maximum limit permitted according to the specifications and the new proposed maximum limit in E 1209 of 620 mg/kg for the ethylene glycol individually or in combination with diethylene glycol in E 1209. This proposed request would result in a total exposure from food additive uses below the group tolerable daily intake ( ) of 0.5 mg/kg body weight (bw) per day allocated by the Scientific Committee on Food ( ) for these contaminants. Therefore, the Panel concluded that the requested amendment of the specifications for E 1209 would not result in a safety concern. The Panel noted that the analytical results provided were consistently and considerably lower (up to 360 mg/kg) than the proposed level of 620 mg/kg for ethylene glycol individually or in combination with diethylene glycol in the specifications for E 1209.