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

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Article
Panel on Food Additives and Nutrient Sources Added to Food
EFSA Journal
EFSA Journal 2015;13(6):4145 [23 pp.].
doi
10.2903/j.efsa.2015.4145
Panel members at the time of adoption
Fernando Aguilar, Riccardo Crebelli, Alessandro Di Domenico, Birgit Dusemund, Maria Jose Frutos, Pierre Galtier, David Gott, Ursula Gundert-Remy, Claude Lambré, Jean-Charles Leblanc, Oliver Lindtner, Peter Moldeus, Alicja Mortensen, Pasquale Mosesso, Dominique Parent-Massin, Agneta Oskarsson, Ivan Stankovic, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright and Maged Younes.
Acknowledgements

The Panel wishes to thank the members of the former Working Group “A” Food Additives and Nutrient Sources (2011–2014) and the members of the Standing Working Group on the re-evaluation of food additives other than gums and colours: Polly Ester Boon, Dimitrios Chrysafidis, Birgit Dusemund, David Gott, Rainer Gürtler, Ursula Gundert-Remy, Claude Lambré, Jean-Charles Leblanc, Daniel Marzin, Peter Moldeus, Pasquale Mosesso, Dominique Parent-Massin, Ivan Stankovic, Paul Tobback, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen and Matthew Wright for the preparatory work on this scientific opinion and EFSA staff members: Ana Rincon and Alexandra Tard for the support provided to this scientific opinion. The ANS Panel wishes to acknowledge the organisations that provided data for this scientific output.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2011-00709
Adopted
11 June 2015
Published
2 July 2015
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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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.

Summary

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.

Keywords
oxidised polyethylene wax, CAS No 68441-17-8, OPEW, food additive, E 914
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Number of Pages
23