P12-10 EFSA's assessment of the need to re-evaluate the safety of hexane as an extraction solvent in food and food ingredient production

‘Technical hexane’ is an extraction solvent permitted for use in the production of foodstuffs and food ingredients under Directive 2009/32/EC, based on an assessment of the Scientific Committee on Food (SCF) in 1996. In response to a request from the European Commission, EFSA evaluated whether a re-assessment of its safety was necessary. EFSA reviewed the SCF evaluation, considered more recent studies from a scoping literature search and performed an exposure assessment based on current regulatory limits for use. In the Directive, technical hexane is defined as a commercial product primarily composed of acyclic saturated hydrocarbons containing six carbon atoms, with a boiling range between 64°C and 70°C. The identities and the proportions of the constituents are not further defined. n-Hexane is the main component. Impurities may be of concern, as they could be transferred to the extracted food, depending on their chemical properties and the extraction process. Based on the review of information available prior to and after the SCF opinion, EFSA confirmed that genotoxicity was not of concern. The 90-day rat study evaluated by the SCF was no longer deemed adequate for a comprehensive conclusion. Additionally, since n-hexane is absorbed by humans after oral exposure, further toxicity studies examining additional endpoints may be necessary. A scoping literature search identified recent toxicological data on the safety of hexane. Exposure assessment based on current regulatory limits (which is conservative) indicates that the exposure of infants, toddlers and children may be higher than calculated by the SCF. Therefore, EFSA concluded that a re-evaluation of the safety of using technical hexane as an extraction solvent in food production is needed.