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Low Acyl Gellan Gum for Inclusion on the National List of Substances Allowed in Organic Production and Handling (7 CFR 205.605 (B)

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Low Acyl Gellan Gum for Inclusion on the National List of Substances Allowed in Organic Production and Handling (7 CFR 205.605 (B) Petition for Evaluation of Low Acyl Gellan Gum for Inclusion on the National List of Substances Allowed in Organic Production and Handling (7 CFR 205.605 (b) Submitted by: CP Kelco U.S., Inc. 3100 Cumberland Blvd., Suite 600 Atlanta, GA 30339 Date: 08 August 2019 CP Kelco U.S., Inc. 08 August 2019 National Organic List Petiion Low Acyl Gellan Gum Table of Contents Item A.1 — Section of National List ........................................................................................................... 4 Item A.2 — OFPA Category - Crop and Livestock Materials .................................................................... 4 Item A.3 — Inert Ingredients ....................................................................................................................... 4 1. Substance Name ................................................................................................................................... 5 2. Petitioner and Manufacturer Information ............................................................................................. 5 2.1. Corporate Headquarters ................................................................................................................5 2.2. Manufacturing/Processing Facility ...............................................................................................5 2.3. Contact for USDA Correspondence .............................................................................................5 3. Intended or Current Use .......................................................................................................................5 4. Intended Activities and Application Rate ............................................................................................ 6 4.1. Food uses ...................................................................................................................................... 6 4.2. Animal and Canned Pet Food ....................................................................................................... 6 4.3. Consumer products, Cosmetics and Personal Care ...................................................................... 6 5. Manufacturing Process ......................................................................................................................... 7 5.1. Manufacturing Process ................................................................................................................. 7 5.1.1 Seed Development ..................................................................................................................... 7 5.1.2 Fermentation .............................................................................................................................. 8 5.1.3 Deacylation (for production of deacylation type product) ........................................................ 8 5.1.4 Clarification (for production of clarified type product) ............................................................. 8 5.1.5 Recovery .................................................................................................................................... 8 5.1.6 Testing ....................................................................................................................................... 8 5.1.7 Packaging ................................................................................................................................... 8 6. Ancillary Substances ............................................................................................................................ 9 7. Previous Reviews ................................................................................................................................. 9 8. Regulatory Authority ........................................................................................................................... 9 9. Chemical Abstracts Service (CAS) Number and Product Labels .......................................................10 10. Physical and Chemical Properties ....................................................................................................... 11 10.1. Chemical interactions with other substances, especially substances used in organic production........................................................................................................... 11 10.2. Toxicity and environmental persistence ..................................................................................... 12 10.3. Environmental impacts from its use and/or manufacture ........................................................... 12 10.4. Effects on human health ............................................................................................................. 12 10.5. Effects on soil organisms, crops, or livestock. ........................................................................... 12 11. Safety Information.............................................................................................................................. 12 12. Research Information ......................................................................................................................... 13 13. Petition Justification Statement...........................................................................................................13 Page 2 CP Kelco U.S., Inc. 08 August 2019 National Organic List Petiion Low Acyl Gellan Gum List of Appendices Appendix 1 – 21 CFR 172.665 .................................................................................................................. 16 Appendix 2a – Organic Products Application Use Levels ........................................................................ 19 Appendix 2b - Customer Letters………………………………………………………………………….22 Capsugel Letter .............................................................................................................................. 23 Ferrara Pan Letter .......................................................................................................................... 24 Appendix 3a – Low Acyl Gum Chemistry ................................................................................................ 25 Appendix 3b - Manufacturing Flow Chart ...…………………………………………………………….31 Appendix 4 – Food Chemicals Codex 10 (2016) ...................................................................................... 34 Appendix 5 – Agriculture Marketing Service – National List .................................................................. 38 Appendix 6 – 40 CFR 180 ......................................................................................................................... 46 Appendix 7 – Dietary Food Additive Intake EU ....................................................................................... 53 Appendix 8 – JECFA Evaluations ............................................................................................................. 81 Appendix 9 – Standards for Fermented Milk ............................................................................................ 89 FAO/CODEX Standards for Fermented Milk ............................................................................... 90 FAO/WHO Additives Listing for Fermented Milk ....................................................................... 101 Appendix 10 – Standards for Dairy Spread ............................................................................................... 130 CODEX Standard for Dairy Spread .............................................................................................. 131 FAO/WHO Dairy Spread .............................................................................................................. 137 Appendix 11 – Standards for Milk Products ............................................................................................. 146 Codex Standards for Milk Products ............................................................................................... 147 Codex Standard for Cream Cheese ................................................................................................ 154 Appendix 12 – Product Labeling Information ...........................................................................................161 Appendix 13 – Safety Studies .................................................................................................................... 166 Appendix 14 – Safety Data Sheet .............................................................................................................. 173 Appendix 15 – Literature Search ............................................................................................................... 183 Page 3 CP Kelco U.S., Inc. 08 August 2019 National Organic List Petiion Low Acyl Gellan Gum Item A.1 — Section of National List CP Kelco U.S., Inc. is petitioning to have Gellan Gum (low acyl) added to the National List per § 205.605(b): Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as ‘‘organic’’ or ‘‘made with organic (specified ingredients or food group(s)).’’ Item A.2 — OFPA Category - Crop and Livestock Materials The OFPA categories referenced in 7 U.S.C. § 6517(c)(1)(B)(i) do not apply to materials petitioned for use in organic handling or processing. Item A.3 — Inert Ingredients This section does not apply to this petition. Page 4 CP Kelco U.S., Inc. 08 August 2019 National Organic List Petiion Low Acyl Gellan Gum The purpose of
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