Scientific Opinion on the re-evaluation of candelilla wax (E 902) as a food additive

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Acknowledgements

The Panel wishes to thank the members of the Working Group B on Food Additives and Nutrient Sources added to Food: Fernando Aguilar, Martine Bakker, Riccardo Crebelli, Birgit Dusemund, David Gott, Torben Hallas-Møller, Jürgen König, Daniel Marzin, Inge Meyland, Alicja Mortensen, Iona Pratt, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen for the preparatory work on this scientific opinion.

Panel on Food Additives and Nutrient Sources Added to Food
EFSA Journal
EFSA Journal 2012; 10(11):2946 [27 pp.].
doi
10.2903/j.efsa.2012.2946
Panel members at the time of adoption
Fernando Aguilar, Riccardo Crebelli, Birgit Dusemund, Pierre Galtier, David Gott, Ursula Gundert-Remy,Jürgen König, Claude Lambré, Jean-Charles Leblanc, Alicja Mortensen, Pasquale Mosesso, Dominique Parent-Massin, Ivan Stankovic, Paul Tobback, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright
Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2011-00704
Adopted
24 October 2012
Published
16 November 2012
Last Updated
28 January 2013. This version replaces the previous one/s.
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

The Panel on Food Additives and Nutrient Sources added to Food (ANS) delivers a scientific opinion re-evaluating the safety of candelilla wax (E 902). Candelilla wax (E 902) is authorised in the EU as a food additive as a glazing agent. It has been evaluated by the Scientific Committee on Food (SCF) and by the Joint FAO/WHO Expert Committee on Food Additives (JECFA). The JECFA and the SCF did not establish an Acceptable Daily Intake (ADI) but considered the use of candelilla wax as a glazing agent acceptable. Candelilla wax is obtained from leaves of candelilla plants Euphorbia antisyphilitica found in semi-desert regions. It is a complex mixture composed of wax hydrocarbons, wax, resin esters, lactones, free wax resin alcohols, and free wax resin acids. The Panel considered that absorption of candelilla wax is expected to be low, and that upon absorption the components would be incorporated into normal metabolic pathways. The Panel noted that there were limited data comparing the composition of the candelilla wax tested with the specification of the food additive. However the Panel considered that the materials tested were likely to be broadly similar in composition to the food additive. Overall, the Panel considered that the available data suggest that candelilla wax is not genotoxic. The Panel considered that long-term toxicity data on candelilla wax were lacking and therefore did not establish an ADI. However, the Panel noted that available toxicity studies consistently reported no findings associated with intake of the main components constituting candelilla wax. Furthermore, consideration of the exposure estimates to candelilla wax, using the Maximum Permitted Level (MPL) of carnauba wax, indicated sufficient margins of safety. This allowed the Panel to conclude that the use of candelilla wax as a food additive with the currently authorised uses would not be of safety concern.

Keywords
Candelilla wax, INS No. 902, CAS Registry Number 8006-44-8, EINECS 232-347-0
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Number of Pages
27