Scientific Opinion on the re-evaluation of microcrystalline wax (E 905) as a food additive

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Article
Panel on Food Additives and Nutrient Sources Added to Food
Acknowledgements

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

EFSA Journal
EFSA Journal 2013;11(4):3146 [32 pp.].
doi
10.2903/j.efsa.2013.3146
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, Agneta Oskarsson, Dominique Parent-Massin, Martin Rose, Ivan Stankovic, Paul Tobback, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen and Matthew Wright.
Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2011-00706
Adopted
13 March 2013
Published
4 April 2013
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

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 microcrystalline wax (E 905) when used as a food additive. Microcrystalline wax (E 905) is authorised quantum satis as a surface treatment agent on non-chocolate confectionery, chewing gum and decorations, coatings and fillings, except fruit based fillings. It is also permitted as a surface treatment of melons, papaya, mango and avocado. The substance was evaluated by the Scientific Committee on Food (SCF) in 1990 and 1995 and by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), the latest in 1995. The JECFA established a group ADI of 20 mg/kg bw/day for mineral oils, paraffins and microcrystalline waxes. The Panel noted that all mineral oil products accumulated in tissues in a dose- and time-dependent manner with the exception of microcrystalline waxes. The Panel concluded that there is no concern for genotoxicity from microcrystalline wax (E 905). The Panel also considered that the available toxicity studies with mineral hydrocarbons, closely related from a chemical point of view with microcrystalline waxes, consistently reported no effects of concern associated with the intake of microcrystalline wax. The Panel further concluded that since no long-term toxicity and carcinogenicity studies with microcrystalline wax E 905 were available, no ADI could be established. The Panel also concluded that the conservative exposure estimates to microcrystalline wax (E 905) from its use at maximum permitted level (following quantum satis rules), resulted in a sufficient margin of safety compared to the NOAEL established by the Panel for the closely related high viscosity mineral oils, and therefore the use microcrystalline wax (E 905) as a food additive with the currently authorised uses would not be of safety concern.

Keywords
Petroleum wax, microcrystalline, CAS Registry Number 63231-60-7; Microcrystalline paraffin waxes and hydrocarbon waxes
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Number of Pages
32