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GRAS Notice 000099: Pullulan

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GRAS Notice 000099: Pullulan United States Department of Agriculture Agricultural Marketing Service | National Organic Program Document Cover Sheet https://www.ams.usda.gov/rules-regulations/organic/national-list/petitioned Document Type: ☒ National List Petition or Petition Update A petition is a request to amend the USDA National Organic Program’s National List of Allowed and Prohibited Substances (National List). Any person may submit a petition to have a substance evaluated by the National Organic Standards Board (7 CFR 205.607(a)). Guidelines for submitting a petition are available in the NOP Handbook as NOP 3011, National List Petition Guidelines. Petitions are posted for the public on the NOP website for Petitioned Substances. ☐ Technical Report A technical report is developed in response to a petition to amend the National List. Reports are also developed to assist in the review of substances that are already on the National List. Technical reports are completed by third-party contractors and are available to the public on the NOP website for Petitioned Substances. Contractor names and dates completed are available in the report. January 31, 2018 National List Manager USDA/AMS/NOP, Standards Division 1400 Independence Ave. SW Room 2648-So., Ag Stop 0268 Washington, DC 20250-0268 RE: Petition to add Pullulan to the National List at §205.605(a) as an allowed nonsynthetic ingredient in tablets and capsules for dietary supplements labeled “made with organic (specified ingredients or food group(s)).” Dear National List Manager: The Organic Trade Association1 is filing the attached petition on behalf of its National List Innovation Working Group to add Pullulan to the National List at §205.605(a) as an allowed non-agricultural, non-synthetic ingredient used in tablets and capsules for dietary supplements labeled “made with organic (specified ingredients or food group(s)).” The purpose of submitting this petition is to protect the continued production and availability of USDA-NOP certified encapsulated dietary supplements and to support the commercial development of certified organic Pullulan. Pullulan is a natural extracellular polysaccharide excreted by the yeast-like fungus Aureobasidium pullulans. It is not genetically modified and it is commercially produced by a non-pathogenic and non- toxigenic strain of the organism using a liquid starch syrup as the fermentation substrate. Pullulan can be made into very thin films with high tensile strength and stability over a range of temperatures, making it an ideal material to be used in the manufacture of empty capsules for the purpose of encapsulating dietary supplements or as a coating for dietary supplement tablets. Encapsulated vegetarian dietary supplements certified under USDA’s National Organic Program (NOP) rely on the use of Pullulan as the primary ingredient in the capsule. For dietary supplements, the capsule is considered an “ingredient” and must either be “certified organic,” or comprised of ingredients compliant with the National List of Allowed and Prohibited Substances. Since the early 2000s, accredited certifying agents have classified Pullulan as “agricultural” and allowed its use only in encapsulated dietary supplements certified to the “made with” product category. This allowance has significantly contributed to the growth of NOP certified dietary supplements. Currently, certified organic Pullulan is commercially unavailable in North America and there are no other NOP compliant vegetarian options available. Gelatin capsules, while allowed under NOP, present consumer acceptance and GMO challenges. 1 The Organic Trade Association (OTA) is the membership-based business association for organic agriculture and products in North America. OTA is the leading voice for the organic trade in the United States, representing over 9,500 organic businesses across 50 states. Our members include growers, shippers, processors, certifiers, farmers' associations, distributors, importers, exporters, consultants, retailers and others. OTA's mission is to promote and protect organic with a unifying voice that serves and engages its diverse members from farm to marketplace. 1 Headquarters - The Hall of the States, 444 N. Capitol St. NW, Suite 445-A, Washington, D.C., 20001 • (202) 403-8513 Member Services - 28 Vernon St., Suite 413, Brattleboro VT 05301 • (202) 403-8630 www.OTA.com In late 2016, NOP released a guidance document (NOP 5033) on the Classification of Materials. This document assists the National Organic Standards Board (NOSB), accredited certifying agents, and the organic industry in making ‘Agricultural’ vs. ‘Non-agricultural’ and ‘Synthetic’ vs. ‘Non-synthetic’ determinations. Given the information contained in the NOP guidance document, accredited certifying agents are now in general agreement that Pullulan should be classified as a “non-agricultural, non- synthetic” substance and accordingly must appear on the National List at §205.605 to be allowed in NOP certified products. In response to this new interpretation, we are requesting that Pullulan be added to the National List so that it may continue to be allowed as an ingredient in capsules for dietary supplements labeled “made with organic (specified ingredients or food group(s)).” Without its continued allowance, and without an alternative option, we estimate the economic impact to the organic dietary supplement sector would be over $825 million. Please note that we are intentionally limiting the allowance of non-organic Pullulan to dietary supplements certified to the “made with” category. Any encapsulated dietary supplement sold or labeled as “certified organic (95%+) will need to use certified organic Pullulan. Although organic Pullulan based capsules are not commercially available in North America, development is underway and they should be available in the future. In summary, adding Pullulan to the National List will: • Quickly address a new interpretation made by several accredited certifying agents in response to NOP’s Classification of Materials Guidance (NOP 5033); • Prevent widespread disruption and economically significant damage to the organic supplements sector; • Bring the allowance of non-organic Pullulan under strict review of NOSB and the National List Sunset process; • Support the commercial development of certified organic Pullulan. Thank you for your assistance in putting this petition before NOSB. If you need any additional information, please contact me via e-mail or telephone: [email protected] or (503) 798-3294. Respectfully submitted, Gwendolyn Wyard Vice President, Regulatory and Technical Affairs Organic Trade Association cc: Laura Batcha Executive Director/CEO Organic Trade Association 2 Headquarters - The Hall of the States, 444 N. Capitol St. NW, Suite 445-A, Washington, D.C., 20001 • (202) 403-8513 Member Services - 28 Vernon St., Suite 413, Brattleboro VT 05301 • (202) 403-8630 www.OTA.com Pullulan Petition 1/31/2018 Item A This petition seeks inclusion of Pullulan as an ingredient in tablets and capsules for dietary supplements labeled in the “made with organic (specified ingredients or food group(s))” category on the National List at §205.605(a). Item B 1. Substance Name. Common Name: Pullulan Chemical Name: Poly[6)-α-D-glucopyranosyl-(1→4)-α-D-glucopyranosyl-(1→4)-α-D-glucopyranosyl-(1→] CAS Number: 9057-02-7 EC / EINECS Number: 232-945-1 Empirical Formula: (C6H10O5) n where n=300 to 3000 Pullulan is a natural extracellular polysaccharide excreted by the yeast-like fungus Aureobasidium pullulans (formerly known as Pullularia pullulans). It is not genetically modified and it is commercially produced by a non-pathogenic and non-toxigenic strain of the organism using a liquid starch syrup as the fermentation substrate. Pullulan is a linear glucan consisting of repeating units of maltotriose joined by α-D-(1→6) linkages. 2. Petitioner and Manufacturer Information. Petitioner: Organic Trade Association 444 N. Capitol St. NW, Suite 445A Washington, DC 20001 Contact Person: Gwendolyn Wyard Title: Vice President of Regulatory & Technical Affairs Phone: (503) 798-3294 Email: [email protected] Manufacturer: Hayashibara Co., Ltd. Nihon-Seimei Okayama Bldg. II Shinkan 1-1-3 Shimoishii, Kita-ku, Okayama, 700-0907 Japan Phone: +81-86-224-4312 Page 1 of 15 3. Intended or Current Use. Pullulan can be made into very thin films with high tensile strength and stability over a range of temperatures. Pullulan films have a low oxygen permeability, are oil and grease resistant and dissolve rapidly in water. These films may be shaped using rapid evaporation of water, compression molding or extrusion at high temperatures, making it an ideal material to be used in the manufacture of empty capsules for the purpose of encapsulating dietary supplements or as a coating for dietary supplement tablets. Non-animal capsules and tablets are suitable for a variety of cultural and dietary requirements, including those of vegetarians, diabetics, and people with restricted diets for health or religious reasons. The danger from animal plagues such as mad cow disease and foot-and-mouth disease raised concerns about raw materials of animal origin being used in foods. Questions surrounding the GMO status of animal feed have also been pervasive in the natural products industry. The requests for raw materials of plant origin for use in foods, cosmetics and the medical fields have been increasing. Pullulan is produced from starch and, therefore, demand for pullulan capsules has grown significantly, as evidenced by the more than 42% growth in sales
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