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