124

Handbook of Functional Lipids

contain any (0 to <100 ppb) of the extraction solvent, if proper manufacturing
practices are followed.

Commercial hexane, containing about 50 to 85% n-hexane (the rest are the hexane

isomers, which make up commercial isohexane), has been in major use since the 1940s
as an oilseed extraction solvent on the determination that it is GRAS and it may also
be subject to a prior sanction. Like many other food-processing substances, there is
no U.S. FDA regulation specifically listing n-hexane as GRAS or prior sanctioned.
However, under FDA regulations hexane has been cleared as a solvent (residue not
more than 5 to 25 ppm) for use in many products [47,48]. Isohexane/hexane isomers
also are not specifically listed as GRAS or prior sanctioned.

In Europe, the maximum residue limit (MRL) for n-hexane in vegetable oils has

been established as 5 ppm n-hexane (European Union [EU], 1988, Community
Directive 88/344/EECC of June 13, 1988; Official J. Eur. Commun. L 157, 24 June
24, 1988, pp. 0028–0033). There is no MRL for isohexane/hexane isomers.

In summary, extraction solvents can be considered incidental additives/process-

ing aids that are exempt from label declaration. GRAS status may be determined
by a company or an industry (“GRAS self-determination” [49] or “GRAS notification”
[April 17, 1997; 62 FR 18938]), an independent scientific organization (e.g., “FEMA
GRAS” [50]), or the U.S. FDA (GRAS affirmation [21 CFR 170.35]). The FFDCA
(21 U.S. Code 321 et seq.) does not provide for the U.S. FDA to approve all
ingredients used in food, and the U.S. FDA explicitly recognizes that its published
GRAS list is not meant to be a complete listing of all substances that are in fact
GRAS food substances. Although there is no requirement to inform the U.S. FDA
of a GRAS self-determination or to request FDA review or approval on the matter,
the U.S. FDA has established a voluntary GRAS affirmation program under which
such advice will be provided by the agency. Solvents that do not have prior sanction,
a GRAS determination of some kind, or a tolerance set probably should be evaluated
for compliance under food safety requirements, if a facility is considering changing
its extracting solvent.

5.4.3.2 trans Fat Labeling

In Europe trans fatty acid labeling of retail foods is required. In July 2003, the U.S.
FDA published a final rule requiring manufacturers to list trans fats on the nutrition
facts panel of food and some dietary supplements sold at retail stores (68 FR 41434;
July 11, 2003; 21 CFR 101). This rule, which goes into effect on January 1, 2006,
requires all foods containing at least 0.5 g per serving of trans fat to declare the
amount of trans fat per serving on the nutrition facts panel; products containing
<0.5 g per serving are required to express trans fat content as “0.”

5.5 FUTURE TRENDS

In the future, there most likely will be new demands for highly specialized extraction
solvents as newly domesticated species that make useful novel oils [51] and other
products. New or altered biological products with enhanced nutritional and industrial

2162_C005.fm Page 124 Monday, June 20, 2005 12:28 PM

http://yz.job1001.com