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.