Pullulan added to NOSB National List

Substance allowed in “made with organic” supplement tablets or capsules

July 1, 2021

In a final rule notice published June 25, U.S. Department of Agriculture's (USDA's) Agricultural Marketing Service announced the addition of pullulan to the National List of Allowed and Prohibited Substances (the National List). The rule, which enters effect on July 26, 2021, permits the continued use of pullulan in encapsulated herbs marketed as “made with organic [specified ingredients or food group(s)]”.

Pullulan is a natural extracellular polysaccharide excreted by the yeast-like fungus Aureobasidium pullulans, which has seen common use in the manufacture of dietary supplement tablets and capsules. Pullulan is also the only nonsynthetic substance available for vegetarian dietary supplement capsules certified under the USDA National Organic Program. AHPA had submitted October 2018 comments in support of the Organic Trade Association (OTA) petition that originally requested pullulan's addition to the National List. This final rule also follows the recommendations of the National Organic Standards Board, which concurred with the OTA petition in April of 2019.

The final rule notice states that pullulan will be added to the list of nonagricultural nonsynthetic substances at 7 C.F.R. § 205.605(a). AHPA notes that the approved “made with” labeling category is distinct from the “organic” and “100% organic” labeling categories under other USDA organic regulations at 7 C.F.R. § 205.301. As a result, products labeled “organic” or “100% organic” cannot contain nonorganic pullulan as an ingredient under the final rule. The rule also permits nonorganic pullulan only in tablets and capsules for dietary supplements.

The full final rule is available here.




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