Scientific Opinion on the re‐evaluation of oxidised polyethylene wax (E 914) as a food additive

Abstract

The EFSA ANS Panel delivered a scientific opinion re-evaluating the safety of oxidised polyethylene wax (OPEW) (E 914) as a food additive. E 914 is authorised at quantum satis only for the surface treatment of some fruits. The Scientific Committee on Food (SCF) evaluated the use of OPEW as a food additive but could not allocate an ADI and as an additive in food contact materials. The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) evaluated OPEW as a food contact material and established a TDI of 1 mg/kg bw/day. The ANS Panel considered that OPEW-an oxidised form of long-chain acids, alcohols and esters with a low epoxide and peroxide content-is stable in food matrices. Various 90-day studies in rats and a 90-day study in dogs reported no evidence of accumulation. In one rat study, at the highest dose, statistically significant increases in serum glucose and serum alkaline phosphatase and fatty livers were observed without other abnormalities. The lowest no observed adverse effect level (NOAEL) was considered 800 mg/kg bw/day. OPEW is not genotoxic. Owing to the lack of chronic toxicity and carcinogenicity studies, the limitations of the reprotoxicity study and the unavailability of the key 90-day study, the Panel considered that the overall toxicity database was insufficient to derive an ADI. Mean intake estimates of OPEW ranged from 0.001-0.03 mg/kg bw/day and high intake estimates ranged from 0.03-0.18 mg/kg bw/day across all population groups. Considering the NOAEL of 800 mg/kg bw/day, the calculated margin of safety (MoS) at the highest intake level of 0.18 mg/kg bw/day was 4 400. The Panel concluded that the exposure estimates of E 914 from its use at the maximum reported use level resulted in a sufficient MoS and that, despite the limitations in the database, E 914 is of no safety concern at the maximum reported use level in its currently authorised use. SUMMARYFollowing a request from the European Commission, the Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion on oxidised polyethylene wax (E 914) when used as a food additive.The Panel was not provided with a newly submitted dossier and based its evaluation on previous evaluations, additional literature that has become available since then and the data available following an EFSA call for data. The Panel noted that not all original studies on which previous evaluations were based were available to the Panel.Oxidised polyethylene wax (E 914) is a food additive authorised in the European Union (EU) only for the surface treatment of citrus fruit, melon, papaya, mango, avocado and pineapple. For most of these fruits, the peel is not consumed. Based on the available data on subchronic toxicity and taking into account the fact that longterm/carcinogenicity data were missing, the CEF Panel established a tolerable daily intake (TDI) of 1 mg/kg body weight (bw). The Panel noted that, in the EC specifications (Commission Regulation (EU) No 231/2012), oxidised po...