National Organic Standards Board

Handling Subcommittee Petitioned Material Discussion

Pullulan

June 5, 2018

Summary of Petition: 

A petition has been submitted to add pullulan to the National List at §205.605(a) as an allowed nonagricultural, non-synthetic ingredient used in tablets and capsules for dietary supplements labeled 

“made with organic”. The petition was submitted by the Organic Trade Association (OTA) on behalf of its 

National List Innovation Working Group. The OTA states that the purpose of the petition is two-fold: to 

protect the continued production and availability of USDA-NOP certified dietary supplements and to 

support the commercial development of certified organic pullulan. 

For dietary supplements, the capsule is considered an “ingredient” and must either be “certified organic” 

or made up of ingredients compliant with the National Organic Program’s (NOP) National List of Allowed 

and Prohibited Substances. Since the early 2000s accredited certifying agents have classified pullulan as 

agricultural and it was allowed in encapsulated dietary supplements certified in the “made with organic” 

category. Since the release in late 2016 of the NOP’s Classification of Materials guidance document (NOP 

5033), certifying agents are in general agreement that pullulan should be classified as a non-agricultural 

and non-synthetic substance. Under this classification, pullulan would need to appear on the National 

List in order for it to be included in certified organic products. 

There are no other NOP compliant vegetarian options available for producing organic encapsulated 

supplements. Organic pullulan is currently not commercially available in the United States. According to 

the petition, Capsugel is the owner of US patents covering pullulan capsules, and they are in the process 

of developing organic pullulan. 

The only alternative practice for supplement manufacturers would be to use gelatin capsules. Gelatin is 

listed at §205.606 of the National List, but its use is problematic for consumers looking for a vegetarian, 

kosher, or halah product. Otherwise, to continue producing vegetarian products manufacturers would 

have to lose their organic certification. According to the petition, the 2018 forecast for pullulan capsules 

is approximately 2.5 billion capsules. They go on to calculate that a conservative estimate of $10 per 30 

count bottle would represent an economic value of over $825 million. 

In 2004, Capsugel submitted a petition to the NOSB to add pullulan to §205.605. The petition was put on 

hold and no recommendation was ever made. It is unclear why this is as no references to it were found 

in the NOSB meeting minutes. 

The manufacturing process of pullulan is described in the OTA’s petition, page 3: 

Pullulan is produced by mesophilic fermentation of A. pullulans in a suitable starch syrup. During 

fermentation, pullulan is secreted extracellularly by the organism into the culture medium from which it 

is then recovered and purified. At the completion of fermentation, the resulting broth consists of 

microbial cells and cellular debris, as well as the extracellular metabolites produced and excreted during 

the fermentation (e.g., pullulan). The microbial cells and cellular debris are first removed by 

microfiltration. The cell-free filtrate is heat sterilized and then purified by a deionization process. The 

deionized solution is concentrated to a solids content of about 12%, treated with activated carbon to 

remove pigments and other impurities, and filtered using diatomaceous earth. The filtrate is 

NOSB Oct 2018 proposals and discussion documents pg. 139 of 204
concentrated by evaporation to a solids content of about 30% and dried in a drum dryer. The dried 

pullulan is pulverized to a specified particle size and packaged. 

According to the petition, there are no known negative environmental impacts resulting from the use or 

disposal of pullulan. It is a biodegradable polysaccharide that is easily metabolized by many 

microorganisms found in nature. Furthermore, pullulan may be used as a base material in novel 

flocculants that have been developed for the removal of contaminants in wastewater (Ghimici & 

Constantin, 2011). 

The petition also cites a number of studies looking at the effects of pullulan on human health. The 

petition concludes that no adverse effects of toxicological significance have been observed for pullulan 

in a variety of assays. And that the safety of pullulan is supported by 30 years of human consumption in 

Japan and by the absence of adverse events in human trials at doses of 10g pullulan/day to evaluate 

metabolism and digestion. 

Summary of Review: 

In April 2018 the Handling Subcommittee found the petition for pullulan to be sufficient. A request for a 

technical report was submitted by the Subcommittee to the NOP. At this time, the technical report is 

under development. This petitioned material discussion document is being put forward with the intent 

of gathering public comment and allowing for discussion by the full Board at the Fall 2018 NOSB meeting. 

Questions:

1. If you are currently using pullulan in a certified organic encapsulated supplement, what effect 

would the disallowance of pullulan be on your product/business? 

2. Using the NOP’s Classification of Materials guidance document (NOP 5033), do you consider 

pullulan to be agricultural or not? Please explain your rationale. 

Subcommittee vote

Motion to accept the discussion document on Pullulan 

Motion by: Lisa de Lima 

Seconded by: Tom Chapman 

Yes: 7 No: 0 Abstain: 0 Absent: 0 Recuse: 0 

Approved by Lisa de Lima, Subcommittee Chair, to transmit to NOSB, August 24, 2018

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