Palatinose gets GRAS Green Light in US

This new regulatory status will provide manufacturers with complete assurance in Palatinose for use in food and beverage products as well as an added marketing advantage.

19/04/06 Palatinit, a subsidiary of the world’s largest sugar producer, Südzucker AG, has achieved GRAS notification from the US Food and Drug Administration (FDA) for its new sugar Palatinose.

Palatinose was first self-affirmed as a substance Generally Recognised as Safe. Full FDA GRAS registration was granted in March 2006 and comes following an evaluation of the file submitted by Südzucker/PALATINIT. The GRAS notification is linked to the manufacturing process of Südzucker/PALATINIT to produce Palatinose, which effectively means the sugar can only be claimed as GRAS-registered if sourced from Palatinit. This new regulatory status will provide manufacturers with complete assurance in Palatinose for use in food and beverage products as well as an added marketing advantage.

Palatinose (generic name: isomaltulose) is a disaccharide derived from sucrose, and a natural constituent of e.g. honey and sugar cane. It has a smooth sweetness profile similar to that of sugar, but has more scope for flavour development. Interestingly, it provides the body with long-lasting energy in the form of glucose and is therefore highly suitable for use in energy-, sports- and wellness drinks as well as in cereal- and nutritional bars; it has the same calorie content as sugar, is tooth-friendly and has a low glycemic effect.

The FDA’s ‘letter of no objection’ paves the way for Palatinose™ from Palatinit to be used in a wide range of food and beverage products, including ready-to-drink and instant beverages, snack bars, dairy products as well as energy-reduced, wellness and sports foods and meal replacements.

As part of its consideration of Palatinose for GRAS status, the FDA reviewed in vivo and in vitro studies which demonstrated, that isomaltulose is completely hydrolysed and absorbed in the small intestine as glucose and fructose. Biological data, toxicological and metabolic studies as well as research into gastrointestinal tolerance concluded, that the use of Palatinose™ presents no health concerns.

In July 2005, Palatinose was authorised as a novel food or food ingredient in the EU and it has been used as a food ingredient in Japan since 1985.  This latest full GRAS classification means manufacturers can be confident in using Palatinose from Südzucker/PALATINIT in a wide variety of formulations globally.