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Annatto extract  GMPIn-house validated method 21 CFR Section73.302,Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm ftp://ftp.fao.org/codex/ccmas23/ma01_09e.pdf ma01_09e.pdf Investigations Operations Manual Investigations Operations Manual
Dehydrated beets (beet powder)  GMPIn-house validated method 21 CFR Section73.403,Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm ftp://ftp.fao.org/codex/ccmas23/ma01_09e.pdf ma01_09e.pdf Investigations Operations Manual Investigations Operations Manual
Canthaxanthin30mg/lbof solid or semisolid food or per pint of liquid foodOFFICIAL ANALYTICAL PROTOCOL p. 20 21 CFR Section73.754,Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm http://www.fda.gov/ohrms/dockets/dockets/95s0316/95s-0316-rpt0237-07-Tab-E-vol172.pdf OFFICIAL ANALYTICAL PROTOCOL p. 20 Investigations Operations Manual Investigations Operations Manual
Caramel  GMPIn-house validated method 21 CFR Section73.855,Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm ftp://ftp.fao.org/codex/ccmas23/ma01_09e.pdf ma01_09e.pdf Investigations Operations Manual Investigations Operations Manual
B-Apo-8'-carotenal15 mg/lb of solid , 15 mg/pt liquid  AOAC 941.15 21 CFR Section73.906,Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm http://www.codexalimentarius.net/web/standard_list.jsp CXS_234e[1].pdf Investigations Operations Manual Investigations Operations Manual
Vegetable juice  GMPAcceptability determination 21 CFR Section73.26017,Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm UNITED STATES DEPARTMENT OF FOOD SAFETY AND INSPECTION SERVICEAGRICULTURE WASHINGTON, DC,FSIS Directive 7120.1, Amendment 21 Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
Carrot oil  GMPIn-house validated method 21 CFR Section73.30018,Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm ftp://ftp.fao.org/codex/ccmas23/ma01_09e.pdf ma01_09e.pdf Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
Paprika  GMPIn-house validated method 21 CFR Section73.34019,Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm ftp://ftp.fao.org/codex/ccmas23/ma01_09e.pdf ma01_09e.pdf Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
Paprika oleoresin  GMPIn-house validated method 21 CFR Section73.3452,Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm ftp://ftp.fao.org/codex/ccmas23/ma01_09e.pdf ma01_09e.pdf Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
Riboflavin  GMPAOAC 970.65 21 CFR Section73.45022,Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm http://www.codexalimentarius.net/web/standard_list.jsp CXS_234e[1].pdf Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
FD&C Yellow  GMPAOAC 966.21, AOAC 988.13 21 CFR Section74.70636Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm http://www.eoma.aoac.org/ Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
3-chloro-1,2-propanediol (3-MCPD)1ppmGMPPesticide Analytical Manual (PAM) vol.I (section 304) CPG Sec. 500.500 Guidance Levels for 3-MCPD(3-chloro-1,2-propanediol) in Acid-Hydrolyzed Protein and Asian-Style Sauces (http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074419.htm) Pesticide Analytical Manual (PAM) vol.I (section 304) Pesticide Analytical Manual (PAM)Vol. I (section 102) Pesticide Analytical Manual (PAM)Vol. I (section 102)
Histamine500 ppm set based on toxicity; 50 ppm set as defect action level, because histamine is generally not uniformly distributed in a decomposed fish; therefore, if 50 ppm is found possibility that other units may exceed 500 ppm  Fish and Fishery Products Hazards and Controls Guide. 2nd edn.,p 91-92 Compliance Policy Guide Section 540.525 (Fish and Fisheries Products Hazards and Controls Guidance Third Edition,Appendix 5 - FDA & EPA Safety Levels in Regulations and Guidance ; http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDoc Fish and Fishery Products Hazards and Controls Guide. 2nd edn.,p 91-92 Bacteriological Analytical Manual, Edition 8, Revision A, 1998. Chapter 1. Bacteriological Analytical Manual, Edition 8, Revision A, 1998. Chapter 1.
Acephate0.1ppm Pesticide Analytical Manual (PAM) vol.I (section 304) Index to Pesticide Chemical Names,Part 180 Tolerance Information, and Food and Feed Commodities Pesticide Analytical Manual (PAM) vol.I (section 304) Pesticide Analytical Manual (PAM)Vol. I (section 102) Pesticide Analytical Manual (PAM)Vol. I (section 102)
Saffron  GMPAcceptability determination 21 CFR Section73.50023,Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm UNITED STATES DEPARTMENT OF FOOD SAFETY AND INSPECTION SERVICEAGRICULTURE WASHINGTON, DC,FSIS Directive 7120.1, Amendment 21 Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
Titanium dioxide≤ 1.0%by wt. of foodIn-house validated method 21 CFR Section73.57524,Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm ftp://ftp.fao.org/codex/ccmas23/ma01_09e.pdf ma01_09e.pdf Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
Tomato lycopene extract; tomato lycopene concentrate  GMPAcceptability determination 21 CFR Section73.58525,Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm UNITED STATES DEPARTMENT OF FOOD SAFETY AND INSPECTION SERVICEAGRICULTURE WASHINGTON, DC,FSIS Directive 7120.1, Amendment 21 Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
Turmeric  GMPIn-house validated method 21 CFR Section73.60026,Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm ftp://ftp.fao.org/codex/ccmas23/ma01_09e.pdf ma01_09e.pdf Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
B-Carotene  GMPAOAC 941.15 21 CFR Section73.957,Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm http://www.codexalimentarius.net/web/standard_list.jsp CXS_234e[1].pdf Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
Cochineal extract  GMPAcceptability determination 21 CFR Section73.1008,Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm UNITED STATES DEPARTMENT OF FOOD SAFETY AND INSPECTION SERVICEAGRICULTURE WASHINGTON, DC,FSIS Directive 7120.1, Amendment 21 Investigations Operations Manual Investigations Operations Manual
Toasted partially defatted cooked cottonseed flour  GMPAcceptability determination 21 CFR Section73.1401,Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm UNITED STATES DEPARTMENT OF FOOD SAFETY AND INSPECTION SERVICEAGRICULTURE WASHINGTON, DC,FSIS Directive 7120.1, Amendment 21 Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
Fruit juice  GMPAcceptability determination 21 CFR Section73.25016,Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm UNITED STATES DEPARTMENT OF FOOD SAFETY AND INSPECTION SERVICEAGRICULTURE WASHINGTON, DC,FSIS Directive 7120.1, Amendment 21 Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
Enterotoxigenic Escherichia coli1x 10³ ETEC/g, LT or ST positive presence of pathogenic organismBacteriological Analytical Manual, 8th Edition, Revision A, 1998. Chapter 4. Compliance Programme 7303.842 (Fish and Fisheries Products Hazards and Controls Guidance Third Edition,Appendix 5 - FDA & EPA Safety Levels in Regulations and Guidance ; http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Sea http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/default.htm Bacteriological Analytical Manual, Edition 8, Revision A, 1998. Chapter 1. http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/default.htm
Listeria monocytogenes  presence of pathogenic organismBacteriological Analytical Manual, Edition 8, Revision A, 1998. Chapter 10 and 11. Compliance Programme 7303.842 (Fish and Fisheries Products Hazards and Controls Guidance Third Edition,Appendix 5 - FDA & EPA Safety Levels in Regulations and Guidance ; http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Sea http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/default.htm Bacteriological Analytical Manual, Edition 8, Revision A, 1998. Chapter 1. http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/default.htm
Turmeric oleoresin  GMPIn-house validated method 21 CFR Section73.61527,Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm ftp://ftp.fao.org/codex/ccmas23/ma01_09e.pdf ma01_09e.pdf Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
Salmonella species  presence of pathogenic organismBacteriological Analytical Manual, 8th Edition, Revision A, 1998. Chapter 5. Compliance Policy Guide Section 555.300 (Fish and Fisheries Products Hazards and Controls Guidance Third Edition,Appendix 5 - FDA & EPA Safety Levels in Regulations and Guidance ; http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDoc http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/default.htm Bacteriological Analytical Manual, Edition 8, Revision A, 1998. Chapter 1. http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/default.htm
Staphylococcus aureuspositive for staphylococcal enterotoxin, or level ³ 104/g (MPN)  Bacteriological Analytical Manual, 8th Edition, Revision A, 1998. Chapter 12. FDA/EPA guidance levels in seafoods (Fish and Fisheries Products Hazards and Controls Guidance Third Edition,Appendix 5 - FDA & EPA Safety Levels in Regulations and Guidance ; http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocumen http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/default.htm Bacteriological Analytical Manual, Edition 8, Revision A, 1998. Chapter 1. http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/default.htm
Clostridium botulinum  Presence of viable spores or vegetative cells in products that will support their growth; or Presence of toxinBacteriological Analytical Manual, 8th Edition, Revision A, 1998. Chapter 17. Compliance Programme 7303.842 (Fish and Fisheries Products Hazards and Controls Guidance Third Edition,Appendix 5 - FDA & EPA Safety Levels in Regulations and Guidance ; http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Sea http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/default.htm Bacteriological Analytical Manual, Edition 8, Revision A, 1998. Chapter 1. http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/default.htm
Vibrio cholearaepresence of toxigenic 01 or non-01  Bacteriological Analytical Manual, Edition 8, Revision A, 1998. Chapter 9. Compliance Programme 7303.842(Fish and Fisheries Products Hazards and Controls Guidance Third Edition,Appendix 5 - FDA & EPA Safety Levels in Regulations and Guidance ; http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seaf http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/default.htm Bacteriological Analytical Manual, Edition 8, Revision A, 1998. Chapter 1. http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/default.htm
Vibrio parahaemolyticuslevel ³ 1 x 104/g (Kanagawa positive or negative)  Bacteriological Analytical Manual, Edition 8, Revision A, 1998. Chapter 9. Compliance Programme 7303.842 (Fish and Fisheries Products Hazards and Controls Guidance Third Edition,Appendix 5 - FDA & EPA Safety Levels in Regulations and Guidance ; http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Sea http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/default.htm Bacteriological Analytical Manual, Edition 8, Revision A, 1998. Chapter 1. http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/default.htm
Vibrio vulnificus  presence of pathogenic organismBacteriological Analytical Manual, Edition 8, Revision A, 1998. Chapter 9. Compliance Programme 7303.842 (Fish and Fisheries Products Hazards and Controls Guidance Third Edition,Appendix 5 - FDA & EPA Safety Levels in Regulations and Guidance ; http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Sea http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/default.htm Bacteriological Analytical Manual, Edition 8, Revision A, 1998. Chapter 1. http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/default.htm
FD&C Blue  GMPAOAC 966.21, AOAC 988.13 21 CFR Section74.10128Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm http://www.eoma.aoac.org/ Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
FD&C Blue  GMPAOAC 966.21, AOAC 988.13 21 CFR Section74.10229Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm http://www.eoma.aoac.org/ Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
FD&C Green  GMPAOAC 966.21, AOAC 988.13 21 CFR Section74.20330Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm http://www.eoma.aoac.org/ Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
FD&C Red  GMPAOAC 966.21, AOAC 988.13 21 CFR Section74.34034Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm http://www.eoma.aoac.org/ Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
FD&C Yellow  GMPAOAC 966.21, AOAC 988.13 21 CFR Section74.70535Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices, http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm http://www.eoma.aoac.org/ Investigations Operations Manual http://www.fda.gov/ICECI/Inspections/IOM/default.htm
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