The European Food Safety Authority (EFSA) has found that methyloxolane is safe to be used as a solvent for vegetable oil extraction, the organisation announced on 15 March.

Methyloxolane’s uses include processes applying hexane, in particular to extract lipids from oil-rich and protein-rich biomass such as corn, rapeseed, soyabeans and sunflowerseeds. It is also used to extract natural aroma, flavours, antioxidants and colorants, particularly the lipophilic ones currently extracted with hexane such as annatto, carotenoids and chlorophylls.

The European Commission (EC) asked EFSA to provide a scientific opinion on the safety of the use of 2-methyloxolane as an extraction solvent following an application for the amendment of Annex I to Directive 2009/32/EC to authorise the use of 2-methyloxolane as an extraction solvent for the use in the production of a range of foodstuffs and food ingredients, EFSA said.

2-Methyloxolane is produced from lignocellulose biomass, more specifically, from pentosans (hemicelluloses). Pentosans are found in plant agricultural by-products, such as corn cobs, oat hulls and almond husks. According to the applicant, the produced 2-methyloxolane meets the proposed specifications regardless of the raw material source.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of 2‐methyloxolane as an extraction solvent under the intended conditions of use and the maximum residue limits (MRLs) proposed by the applicant.

The Panel calculated the dietary exposure with the highest potential maximum (95th percentile) for toddlers as 0.32 mg/kg body weight (bw)/day.

Based on the available toxicological data, the panel concluded that 2‐methyloxolane was rapidly metabolised with a low bio-accumulation potential and does not raise a concern for genotoxicity, according to the report.

In further tests, the panel found no observed adverse effect levels (NOAELs) in a sub-chronic oral toxicity study in rats, an oral developmental toxicity study and an extended one‐generation reproductive toxicity study.

The panel concluded that the extraction solvent 2‐methyloxolane does not raise a safety concern when used according to the intended conditions and at the proposed MRLs in the extracted food or food ingredients, including the fractionation of fat, oil or butter (with an MRL of 1mg/kg).