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Labeling & Regulatory - Litesse®

The below information is intended to help you define the labeling requirements for Litesse®

However, as legislation can differ greatly between different markets, we always recommend the information provided below is reviewed in line with local labeling legislation.

How is Litesse® listed in the ingredient statement and the nutrition data?

In general Litesse® should be labeled as "polydextrose" or "E1200" within the ingredient statement for food and beverage products.

In some countries, a description of the technological function being performed by the polydextrose in the finished product is also required (e.g. "Bulking agent: polydextrose" or "Humectant: polydextrose").

In many countries, Litesse® polydextrose can be counted toward the amount of fiber listed in the nutritional data. It is important that local legislation concerning the labeling of polydextrose and its use as a fiber is evaluated prior to any final labeling decisions.

What are the regulatory and labeling guidelines for Litesse®?

Following a thorough review of the available data, no maximum usage levels for polydextrose were recommended by the FAO/WHO Joint Expert Committee on Food Additives (JECFA).

Similarly, no maximum use levels have been established in legislation for polydextrose in the USA, EU and most other countries worldwide and, as such, usage levels are only restricted by good manufacturing practices (GMP) which limit the quantity used to the amount necessary to achieve the intended effect (please refer to our regulatory section for details).

In the USA, the Food and Drug Administration has approved the use of polydextrose in all foods with the exception of meat, poultry, baby food and infant formula.

In the EU, polydextrose is approved under the Food Additives Regulation (1333/2008) - Annex II – as a Group I additive, permitting the use of polydextrose in virtually all foodstuffs following the quantum satis principle. In general, Litesse® can be labeled as ‘polydextrose’ or ‘E1200'.  

International Regulatory Status of Litesse®

Numerous national and supranational expert groups have assessed the safety in use of polydextrose in food applications, and have universally concluded that polydextrose is safe for human consumption.

Both the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and the European Union (EU) Scientific Committee on Food (SCF) have assigned polydextrose an acceptable daily intake (ADI) of “not specified” in 1987 and 1990 respectively, which is the safest categorization available. As such, usage levels of polydextrose are only restricted by good manufacturing practices (GMP) which limit the quantity used to the amount necessary to achieve the intended effect.

To date, polydextrose is approved for use in food in over 60 countries, the vast majority of whom permit the use of the 1 kcal/g energy value for the purposes of labeling.

Litesse® can generally be labeled as "polydextrose" or "E1200" within the ingredient declaration. In many countries, Litesse® polydextrose can also be counted toward the amount of fiber listed in the nutritional data.

In this case, an alternative labeling option would include "polydextrose (fiber)". It is important that local legislation concerning the labeling of polydextrose and its use as a fiber is evaluated prior to any final labeling decisions.

Our regulatory team can help advise you on what individual markets permit. DuPont Nutrition & Health’s global regulatory experts are located in all major regions and provide you with access to a critical resource our competitors just can’t match.

The above is provided for informational purposes only and does not constitute legal advice or counsel. Customers are advised to review the regulatory status of polydextrose with their legal counsel, and are advised that regulations are constantly being modified and updated.

Find out more

You are welcome to contact us for more information.