Technical Report on the need for re‐evaluation of the safety of hexane used as an extraction solvent in the production of foodstuffs and food ingredients

Abstract Hexane (called ‘technical hexane’ in this report) is authorised for use as an extraction solvent in the production of foodstuffs and food ingredients under Directive 2009/32/EC. Following a request from the European Commission, EFSA assessed the need for a re‐evaluation of its safety, which was addressed by the Scientific Committee on Food (SCF) in 1996. To this end, EFSA focused on the composition of technical hexane, its established and potential toxicological adverse effects and the potential exposure of consumers. Technical hexane is defined in the Directive as ‘a commercial product consisting essentially of acyclic saturated hydrocarbons containing six carbon atoms and distilling between 64°C and 70°C’. Specifications, including the identity and fraction of constituents, are not defined. n‐Hexane is reported to be the main constituent. Impurities may be of concern, as they may be transferred to the extracted food, depending on their physicochemical properties and the extraction procedure. An exposure assessment based on regulatory limits showed that the exposure of infants, toddlers and other children may be higher than that considered by the SCF. Regarding genotoxicity, EFSA reiterated the absence of concern. The information provided by the 90‐day study in rats considered by the SCF was no longer considered sufficient to adequately conclude on the safety of technical hexane. Moreover, as n‐hexane is absorbed in humans, additional toxicity studies exploring more end points may be needed. A scoping literature search showed that recent toxicological information on the safety of technical hexane is available, although its relevance was not appraised during this activity. EFSA concluded that there is a need for a re‐evaluation of the safety of the use of technical hexane as an extraction solvent in the production of foodstuffs and food ingredients.