Scientific Opinion on the re-evaluation of montan acid esters (E 912) as a food additive

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Article
Panel on Food Additives and Nutrient Sources Added to Food
EFSA Journal
EFSA Journal 2013;11(6):3236 [21 pp.].
doi
10.2903/j.efsa.2013.3236
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
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.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2011-00708
Adopted
16 May 2013
Published
7 June 2013
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

Following a request from the European Commission, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion re-evaluating the safety of montan acid esters (E 912) when used as a food additive. Montan acids are extracted from oxidised montan wax and esterified with ethylene glycol, 1,3-butanediol or triols, to form montan acid esters. Montan acid esters are authorised only for the surface treatment of fresh fruits. No data, specifically for montan acid esters, on toxicokinetics and reproductive and developmental toxicity were available. The available data on short-term and subchronic toxicity, genotoxicity and chronic toxicity and carcinogenicity were limited. Important deficiencies in the available studies on chronic toxicity and carcinogenicity were noticed. The data requested in the 1990s (i.e. chromosomal aberration in vitro, reproduction and teratogenicity studies, material characteristics, impurities, presence of PAHs) were not submitted. Furthermore no data were submitted following an EFSA public call for data in 2012. The Panel identified some summary data in the European Chemicals Agency database (ECHA) on registered substances that might have been relevant for the assessment of montan acid esters but the original study reports were not made available to EFSA. Based on these limitations in the toxicological database the Panel concluded that montan acid esters as a food additive could not be evaluated.

Summary

Following a request from the European Commission, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion on the re-evaluation of montan acid esters (E 912) as a food additive.

The Panel was not provided with a newly submitted dossier on montan acid esters and no new data were submitted following a public call for data. The present evaluation is based on previous evaluations and on additional literature that became available since then. Not all original studies on which previous evaluations were based were available for re-evaluation but the Panel had access to information submitted to the EU Scientific Committee on Food (SCF).

Montan acid esters (E 912) are waxes of various chemical compositions. Montan acids are isolated from montan wax, a bituminous product extracted from lignite, and then esterified with diols such as ethylene glycol and 1,3-butylene glycol or with triols such as glycerol.

The Panel noted that benzene is used as solvent in the manufacturing process. Benzene is genotoxic and is classified by the International Agency for Research on Cancer (IARC) and EU as a human carcinogen.

The Panel recommended that benzene should not be used for the manufacturing of montan acid esters.

The Panel noted that the specifications did not include properties such as melting point and solubility, which would help identify the substance. The Panel considered that the starting materials for the production of the montan acid esters would justify either a requirement for limits for poly-aromatic hydrocarbons (PAHs), or proof that the extraction procedure and the subsequent oxidation steps in the manufacturing process would prevent any residual contamination with such substances.

No data on absorption, distribution, metabolism, and excretion (ADME) of montan acid esters were available for the present evaluation.

Feeding studies in the dog and the rat have been performed with different types of test mixtures that fall within the definition of montan acid esters, E 912. In a 90-day study in the rat and in two 90-day studies in the dog no treatment related effects were found at doses up to 1660 mg/kg bw/day for the dog and up to about 4000 mg/kg bw/day for the rat.

The Panel considered that the two 2-year studies on montan acid esters (Wax E and Wax KPS) were not suitable for risk assessment due to the limitations in the studies or the material tested. Two types of commercial montan acid esters (Wax E and WE4) gave negative results in the Ames test.

No reproductive and developmental toxicity studies are available.

The Panel noted that:

  • no data on toxicokinetics and reproductive and developmental toxicity of montan acid esters were available,
  • the available data on short-term and subchronic toxicity, genotoxicity and chronic toxicity and carcinogenicity were limited,
  • the data requested by the SCF in the late 1990s (i.e. chromosomal aberration study in vitro, reproduction and teratogenicity studies, description of the material, including impurities, absence of PAHs and/or a specification) have not been submitted,
  • No data were submitted following an EFSA public call for data in 2012. The Panel identified some summary data in the European Chemicals Agency (ECHA) database on registered substances that might have been relevant for the assessment of montan acid esters but the original study reports were not made available to EFSA.

Based on these limitations in the toxicological database the Panel concluded that montan acid esters as a food additive could not be evaluated.

The Panel noted that benzene is reported to be used as solvent in the manufacturing process. Benzene is not authorised as an extraction solvent in the production of foodstuffs and ingredients (EU Directive No 2009/32/EU),. Benzene is genotoxic and is classified by IARC and EU as a human carcinogen and therefore it should not be used for the manufacturing of montan acid esters.

Keywords
Fatty acid, montan wax; montan acid wax; waxes, montan fatty acids; fatty acids, montan-wax, ethylene esters; glyceryl montanate; montan wax acid, butylene glycol montanate; 1,3-butanediol diester
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Number of Pages
21