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Title: EDIBLE OIL EXTRACTION SOLVENTS: FDA REGULATORY CONSIDERATIONS

Author
item WAKELYN, PHILLIP - NATL. COTTON COUNCIL
item Wan, Peter

Submitted to: Inform
Publication Type: Review Article
Publication Acceptance Date: 12/1/2003
Publication Date: 1/1/2004
Citation: Wakelyn, P.J., Wan, P.J. 2004. Edible oil extraction solvents: fda regulatory considerations. Inform. 15(1):22-23

Interpretive Summary: The extraction efficiency, cost and availability of petroleum based solvent are the primary factors that commercial hexane has been chosen to extract edible oil from oil bearing materials since the 1940's. The main component of hexane, n-hexane, is now regulated as a Hazardous Air Pollutant (HAP) in the United States. Isohexane, isomers of n-hexane, is not a HAP and was recently demonstrated by several oil mills to perform adequately as an alternative solvent to replace hexane. Besides a slight energy savings and less regulation pressure, isohexane could also make some of the oilseed extraction operations easier than hexane. One of the major concerns for the existing users of hexane to convert to isohexane is the regulatory requirement. This article covers the various approaches a company can take when it chooses to use isohexane. These options include GRAS (Generally Regarded as Safe) Affirmation, FEMA (Flavor Extract Manufacturers' Association) GRAS, GRAS Self Determination and GRAS notification.

Technical Abstract: When a solvent is used to extract edible oil from oil bearing materials in the United States, federal and state workplace, environmental, and food safety regulations have to be complied with. Hexane has been the solvent of choice to extract edible oils since 1940's. The main component of hexane, n-hexane, is now regulated as a Hazardous Air Pollutant (HAP). Isohexane, which is not a HAP, was recently demonstrated by several oil mills to perform adequately as an alternative solvent to replace hexane. This article covers the various approaches a company can take when it chooses to use isohexane. These options include GRAS (Generally Regarded as Safe) Affirmation, FEMA (Flavor Extract Manufacturers' Association) GRAS, GRAS Self Determination and GRAS notification.