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CFSAN/Office of Food Additive Safety
August 2007

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COLOR ADDITIVE STATUS LIST

Formerly called Appendix A of the Investigations Operations Manual (IOM); New items are highlighted in yellow. If you are using an older web browser and you do not see the highlighting, you may download this document in PDF (77 KB) for printing.

Food Additive Status List
List 1 | List 2 | List 3 | List 4 | List 5 | List 6 | List 7 |

Preface

This status list provides current information concerning color additives, and will enable you to determine the status and limitations of most color additives likely to be encountered in a food, drug, device, or cosmetic establishment.

To maintain concise form, this list is limited in many respects involving certification, regulations, labeling, etc. For specific details concerning these matters, please refer to the source documents, Code of Federal Regulations (CFR, Title 21, Parts 70 to 82) and to the Federal Food, Drug, and Cosmetic Act, as amended, Sections 601(e), 602(e), 706, [21 U.S.C. 361(e), 362(e), 376] and as it pertains to Sections 201(s)(3) and (t), 402(c), 403(m), 501(a), and 502(m) [21 U.S.C 321(s)(3), and (t), 342(c), 343(m), 351(a), and 352(m)].

Any color additives not included in this listing and found in the possession of manufacturers or processors where they may be used in foods, drugs, devices, or cosmetics should be referred to your district for consideration. Your Servicing Laboratory for color analysis is also a good reference source.

LAKES: Color additive lakes are provisionally listed under 21 CFR 81.1. Part 82 of 21 CFR explains how lakes may be manufactured and named and lists the color additives that may be used to manufacture lakes. All lakes are subject to certification.

Examples of nomenclature of lakes:

NOTE: You are cautioned that this Exhibit is condensed and should be used for screening and guidance only. When you encounter situations involving possible violations of color additive regulations check the latest basic document as indicated in the second paragraph of this preface. Be certain of the complete status and report the facts. It is the district responsibility to instigate appropriate action, not yours. Do not advise firms to destroy stocks of possible suspect merchandise or institute recalls without district clearance.

LIST 1

Color additives subject to certification and permanently listed (unless otherwise indicated) for use in FOOD. Most are also listed for use in DRUGS AND COSMETICS as noted. (None of these colors may be used in products that are for use in the area of the eye, unless otherwise indicated).

Use of the following color additives is no longer authorized or has been restricted:

LIST 2

Color additives subject to certification and permanently listed (unless otherwise indicated) for DRUG AND COSMETIC use. (None of these colors may be used in products that are for use in the area of the eye unless otherwise indicated)

Use of the following color additives is no longer authorized or has been restricted:

 

LIST 3

Color Additives subject to certification and permanently listed (unless otherwise indicated) for use in EXTERNALLY APPLIED DRUGS & COSMETICS. (None of these colors may be used in products that are for use in the area of the eye)

Use of the following color additives is no longer authorized:

LIST 4

Color additives exempt from certification and permanently listed for FOOD use.

Use of the following color additives is no longer authorized:

LIST 5

Color additives exempt from certification and permanently listed for DRUG use. (None of these color additives may be used in products that are for use in the area of the eye, unless otherwise indicated.).

Use of the following color additives is no longer authorized:

LIST 6

Color additives exempt from certification and permanently listed for COSMETIC use. (None of these colors may be used in products that are for use in the area of the eye, unless otherwise indicated)

Use of the following color additives is no longer authorized:

LIST 7

Color additives exempt from certification (unless otherwise indicated) and permanently listed for use in MEDICAL DEVICES

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Hypertext updated by emw August 7, 2007