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CONFIDENTIAL<br />
Regulatory Affairs &<br />
Nutrition Communication – AJ/Se<br />
28 May 2008<br />
Page 2 of 16<br />
1. Isomaltulose - What it is!<br />
Isomaltulose is a carbohydrate which occurs in minor amounts naturally in honey and sugar<br />
cane juice (Siddiqui and Furgala 1967; Eggleston and Grisham 2003). In 1957,<br />
SÜDZUCKER discovered and described isomaltulose for the first time (Weidenhagen and<br />
Lorenz 1957). This was the basis for the commercial, large scale production of<br />
isomaltulose, which takes place in Offstein, Germany. An enzyme (non-GMO) transfers the<br />
α-1,2 linkage in sucrose to an α-1,6 linkage. This glucose-fructose combination is<br />
isomaltulose (6-O-α-D-glucopyranosyl-D-fructofuranose) (Figure 1).<br />
HO<br />
HO<br />
Sucrose<br />
OH<br />
O<br />
OH<br />
1 O<br />
OH<br />
1<br />
O<br />
2 HO<br />
OH<br />
[glucose] [fructose]<br />
OH<br />
6<br />
Enzyme<br />
HO<br />
HO<br />
PalatinoseTM PalatinoseTM OH<br />
O<br />
OH<br />
[glucose]<br />
1<br />
6<br />
O<br />
(isomaltulose)<br />
OH<br />
OH<br />
OH<br />
O<br />
OH<br />
2<br />
1<br />
[fructose]<br />
Figure 1: Enzymatic rearrangement of sucrose to isomaltulose (Palatinose).<br />
Isomaltulose is a food / food ingredient (like e.g. sugar, starch or maltodextrin). It has been<br />
used as such in Japan and other Asian countries since 1985. Its food status was confirmed<br />
in the European Union as well after undergoing the novel food approval process.<br />
SÜDZUCKER / PALATINIT’s Isomaltulose was approved as a novel food / novel food<br />
ingredient for use in food in the EU by Commission Decision 2005/251/EC of 25 th July<br />
2005. And it received GRAS status by FDA acknowledgement in March 2006 (FDA 2006).<br />
Compared to sucrose, isomaltulose has different key physiological properties, though:<br />
• It is hydrolysed by the same enzyme complex as is necessary for sucrose hydrolysis<br />
in the small intestine, but hydrolysis takes place at a much lower rate.<br />
• It is fully digested (as sucrose) yet slowly (and thus is not a low digestible but a SLOW<br />
digestible carbohydrate).<br />
• Its characteristic stable bond (α-1,6) is well known from starch, rather than from<br />
sugars.<br />
• Isomaltulose provides the same amount of energy yet in a more constant flow and<br />
within a lower insulin profile. Isomaltulose has a low effect on blood glucose and<br />
insulin levels.<br />
• Extreme blood glucose fluctuations and in particular a drastic fall below fasting<br />
glucose concentrations into the so-called relative hypoglycaemia, physiological