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

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. © European Food Safety Authority, 2013 KEY WORDSFatty 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. SUMMARYFollowing 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 ...