Following 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.
Oxidised polyethylene wax was evaluated by the Scientific Committee on Food (SCF) as a food additive (SCF, 1992) and as an additive in plastics for food contact (SCF, 2001). The Panel noted that, in 2009, the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) also evaluated oxidised polyethylene wax as a polymeric additive for food contact materials. Based on the available data on subchronic toxicity and taking into account the fact that long-term/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 polyethylene wax (E 914) is described in very general terms. As proposed by the European Wax Federation, the Panel agreed that a minimum weight average molecular weight (Mw) of 2 500 g/mol could be inserted in the EC specifications for oxidised polyethylene wax (E 914).
The Panel also noted that, if metals are used as catalysts in the manufacturing process of oxidised polyethylene wax as a food additive, the maximum residual level for each metal should be specified in the EC specifications, as is currently the case for chromium. In particular, the Panel noted that the presence of chromium(VI) should be avoided. The Panel also considered that the maximum limit for lead in the EC specification for oxidised polyethylene wax (E 914) should be revised in order to ascertain that oxidised polyethylene wax (E 914) as a food additive will not be a significant source of exposure to lead in food.
The Panel considered that, as oxidised polyethylene wax (E 914) is an oxidised form of long-chain acids, alcohols and esters with a low epoxide and peroxide content, it is expected to generally be stable in food matrices and, therefore, it is unlikely that degradation or reaction with food components will take place to any significant extent.
From data obtained in rats and dogs, the Panel considered that, when orally administered, the absorption of oxidised polyethylene waxes would be negligible (not more than 0.5 %).
Several 90-day studies in rats and a 90-day study in dogs did not find any evidence that accumulation of oxidised polyethylene wax might occur. In one rat study, in the highest dose group, statistically significant increases in serum glucose and serum alkaline phosphatase and fatty livers were observed, but no other abnormalities were found. Therefore, considering these effects, the Panel considered 800 mg/kg bw/day to be the lowest no observed adverse effect level (NOAEL) in these studies. The Panel noted that the 90-day study in which the NOAEL was identified was not available to the Panel and the reporting information from the available data was limited.
No acute oral toxicity, chronic toxicity or carcinogenicity studies were available.
The Panel considered that, based on the available data on genotoxicity, oxidised polyethylene wax was not genotoxic.
From a reproduction/developmental toxicity screening study in rats, the Panel identified a NOAEL of 1 000 mg/kg bw/day.
Exposure estimates of oxidised polyethylene wax (E 914) were based on the reported use level of 140 mg/kg fruit and mean estimates ranged from 0.001 to 0.03 mg/kg bw/day across all population groups. Estimates based on the high percentile of consumers only (95th percentile) ranged from 0.03 to 0.18 mg/kg bw/day across all population groups.
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 acceptable daily intake (ADI). Nevertheless, taking into consideration the information from all of the 90-day studies, the Panel considered that the NOAEL of 800 mg/kg bw/day was sufficiently reliable to calculate the margin of safety (MoS). At the highest intake level of 0.18 mg/kg bw/day (children and toddlers), the resulting lowest MoS was 4 400.
The Panel concluded that the exposure estimates of oxidised polyethylene wax (E 914) from its use at the maximum reported use level and using conservative assumptions for the consumption of the peel of citrus fruits resulted in a sufficient MoS compared with the NOAEL and that, despite the limitations in the database, oxidised polyethylene wax (E 914) is of no safety concern at the maximum reported use level in its currently authorised use.