Annatto extract | | | GMP | In-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) | | | GMP | In-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
| | |
Canthaxanthin | 30 | mg/lb | of solid or semisolid food or per pint of liquid food | OFFICIAL 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 | | | GMP | In-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'-carotenal | 15 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 | | | GMP | Acceptability 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 | | | GMP | In-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 | | | GMP | In-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 | | | GMP | In-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 | | | GMP | AOAC 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 | | | GMP | AOAC 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) | 1 | ppm | GMP | Pesticide 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)
| | |
Histamine | 500 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.
| | |
Acephate | 0.1 | ppm | | 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 | | | GMP | Acceptability 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 food | In-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 | | | GMP | Acceptability 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 | | | GMP | In-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 | | | GMP | AOAC 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 | | | GMP | Acceptability 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 | | | GMP | Acceptability 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 | | | GMP | Acceptability 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 coli | 1x 10³ ETEC/g, LT or ST positive | | presence of pathogenic organism | Bacteriological 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 organism | Bacteriological 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 | | | GMP | In-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 organism | Bacteriological 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 aureus | positive 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 toxin | Bacteriological 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 cholearae | presence 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 parahaemolyticus | level 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 organism | 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
| | |
FD&C Blue | | | GMP | AOAC 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 | | | GMP | AOAC 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 | | | GMP | AOAC 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 | | | GMP | AOAC 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 | | | GMP | AOAC 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
| | |