Global Regulatory Status of Polydextrose

 

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.

 

To date, polydextrose is approved for use in food in over 57 countries and regions, 56 of whom permit the use of the 1 kcal/g energy value for the purposes of labeling.

 

Australia/New Zealand

 

Polydextrose is regulated in the Australia New Zealand Food Standards Code (FSC) as both a food additive, when added to food to provide technological function/s, and as a food in its own right, when it constitutes a significant part of the final food, for example when used to replace sugar, starches or fat. Polydextrose is assigned an energy factor of 5kJ/g.

 

Polydextrose is regulated under Schedule 2 as a miscellaneous additive and can be added at GMP levels to a wide range of foods. When polydextrose is used as a food additive, there is a declaration requirement in the food label ‘ingredient list’; the required format is ‘functional class’ followed by ‘polydextrose’ or the INS number in brackets. e.g ‘humectant (polydextrose)’ or ‘humectant (1200)’. When Polydextrose constitutes a significant part of the final food, for example when it is used to replace sugar, starches or fat, it is regarded as a food in its own right. It is not considered as a bulking agent. As a food/ingredient, it is required to be listed in the food label ‘Ingredient List’, simply as ‘polydextrose’, and subject to following conditions and requirements, declared in the Nutrition Information Panel (NIP).

 

When Polydextrose is present in a food at 25g/100g or greater (or at that level or greater in combination with erythritol, isomalt or sorbitol) or at 10g/100g or greater (or at that level or greater in combination with lactitol, maltitol/syrup, mannitol, or xylitol) the food label must include an advisory statement to the effect that excess consumption may have a laxative effect.

 

Following approval/gazettal of “Application A495 – Polydextrose as a Specifically Named Fibre” in May 2004, nutrient claims for Polydextrose as dietary fibre will be permitted.

 

Europe

 

In the European Union, polydextrose is approved for use as a food additive under Annex I of the Miscellaneous Additives Directive. This approval permits the use of polydextrose at quantum satis in almost all food and beverage categories. In the EU, polydextrose may be labelled as “polydextrose” or “E1200”. Whilst a single caloric value for polydextrose is not currently published/approved at the EU level, the value of 1 kcal/g is accepted throughout the EU.

 

A number of other European countries including Switzerland and Norway have also approved the use of polydextrose in food under the same conditions.

 

Indonesia

 

Polydextrose is regulated as a food additive in the Indonesian Food Codex.  As per the Indonesia Food Codex, polydextrose can be used for the technological functions as bulking agent, formulation aid, humectant and texturizer in food products. In June 2004,  the National Agency of Drug and Food Control Indonesia (Badan Pengawas Obat dan Makanan – Badan POM) recognised polydextrose as a dietary fibre in food and it was subsequentlylisted under Chapter IV (Functional Food Components) in Guideline On Functional Food, 2005.  There is a requirement to list polydextrose in the ingredient list of packaging. Polydextrose has a reduced caloric content (1kcal/g).

 

Japan

 

In Japan the Ministry of Health and Welfare (MOHW) considers polydextrose to be a food, rather than a food additive. The MOHW has confirmed that Polydextrose has 1 kcal/g and conforms to the generally accepted Japanese definition of dietary fibre.

 

Malaysia

 

Polydextrose is a “permitted food conditioner”, listed under Table I of the 11th Schedule, regulation 25. In March 2005, the Ministry of Health recognised polydextrose as a dietary fibre and it was subsequently listed under Table I of the 12th Schedule as a nutrient and dietary fiber. Caloric value is 1 kcal/g as proposed. In 2007 the Ministry of Health approved the use of two nutrient function claims: “Polydextrose is bifidogenic” & “Polydextrose helps increase intestinal bifidobacteria and helps maintain a good intestinal microfloral” with the condition that at least 1.25g/serving was provided.

 

Philippines

 

Polydextrose is listed as a food additive in Table 2 (Additives Permitted for Use in Food in General) under BFAD Regulations.  It is further described in Table 3 (Additives Permitted for Use Under Specified Conditions in Certain Food Categories or Individual Food Items) as a bulking agent, humectant, stabilizer & thickener in specified food categories in accordance with GMP. In July 2005, polydextrose was recognized as a dietary fibre source in Philippines by BFAD.  Declaration of fibre content claims on the label of products with the presence of polydextrose is allowed, subjected to the access compliant with BFAD regulation.  It is required to be labeled as polydextrose in the ingredient list of packaging.  Polydextrose has a reduced caloric content of 1kcal/g.

 

Singapore

 

Polydextrose is a “permitted general purpose food additive”, listed under the 8th Schedule and is recognised as a dietary fiber. Caloric value is 1 kcal/g as proposed.

 

Taiwan

 

Polydextrose is approved as a food additive and recognized as a dietary fibre. Laxative advisory statement is required if the amount of polydextrose in product is > 15g/serving. Caloric value is 1 kcal/g.

 

Thailand

 

Polydextrose is approved as a food additive. In July 2006, polydextrose was recognised as a dietary fibre in food by the Thai Food and Drug Administration. There is a requirement to label polydextrose or ‘dextrose polymer’ in the ingredient list of packaging. Polydextrose has a reduced caloric content (1kcal/g).

 

United States

 

The United States Food and Drug Administration (FDA) has approved polydextrose for general use as a bulking agent, humectant, texturizer and formulation aid in all foods except for meat, poultry, baby food and infant formula under 21 CFR 172.841. No maximum use levels have been established for polydextrose, as current good manufacturing practices (cGMP) limit the quantity used to the amount necessary to achieve the intended effect. Foods containing more than 15 grams of polydextrose per serving must bear the label statement "Sensitive individuals may experience a laxative effect from excessive consumption of this product. " The US FDA has also reviewed the metabolism of polydextrose and approved a caloric value of 1 kcal/g for purposes of nutritional labelling.

 

Vietnam

 

Polydextrose was approved as a food additive and dietary fibre in 2005. Caloric value is 1 kcal/g as proposed.