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Author Topic: FOOD ADDITIVE STATUS LIST  (Read 3703 times)
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« on: May 24, 2007, 09:27:18 AM »


This Food Additives Status List organizes additives found in many parts of 21 CFR into one alphabetized list. Additives included are those specified in the regulations promulgated under the FD&C Act, under Sections 401 (Food Standards), and 409 (Food Additives). The list also includes selected pesticide chemicals from 40 CFR 180 for which EPA has set tolerances in food. FDA enforces those tolerances. Within the space available, the Food Additives Status List includes use limitations and permitted tolerances for each additive. For complete information on its use limitations, refer to the specific regulation for each substance. New regulations and revisions are published in current issues of the Federal Register as promulgated. Also refer to the CFSAN website on Food Additives and Premarket Approval to review several FDA databases of additive categories. For example, EAFUS (Everything Added to Food in the United States) is a helpful reference within the limitations described at the beginning of the database.

The Food Additive Status List omits certain categories of additives. Here are the omissions:
  • Obviously safe substances not cited in a regulation as Generally Recognized as Safe (GRAS). You may find such substances on an FDA web site, which contains GRAS notifications received from companies since 1998, and FDA's response.
  • Synthetic flavoring substances in 21CFR 172.515. The CFR does not contain a complete list of permissible flavorings. Certain trade groups such as the Flavor Extract Manufacturers Association have established expert panels to evaluate and make determinations on the GRAS status of their products. If you need help in determining the acceptability of a flavoring after consulting 21 CFR 172.515, contact CFSAN Office of Food Additive Safety (HFS-200) at (301) 436-1200.
  • Those pending administrative determination.
  • Substances granted prior sanction for specific use prior to enactment of the Food Additives Amendment. For additional information on these substances, contact the CFSAN Office of Food Additive Safety (HFS-200) at (301) 436-1200.
  • Indirect food additives, 21 CFR Parts 175, 176, 177, & Part 178 (except that sanitizing agents for food processing equipment as listed in 178.1010 are included in the Food Additives list.) Be aware that as a result of the Food Quality Protection Act of 1996 and Antimicrobial Regulation Technical Corrections Act of 1998, EPA now has jurisdiction over sanitizing solutions applied to permanent or semi-permanent food contact surfaces, other than food packaging. To look up indirect food additives in Parts 175, 176, 177 and 178 go to FDA's "List of Indirect Additives Used in Food Contact Substances". Use it to locate the regulation in which its use is fully described. FDA has recently implemented a new way to market, called "Premarket Notification", for certain food contact substances. These notifications are effective only for the manufacturer or supplier identified in the notification. A list of effective notifications is available on the FDA website.
  • Color additives, 21 CFR Parts 70, 71, 73, 74, 80 & 82. Go to the Color Additives Status List following the Food Additives Status list in Appendix A.

NOTE: The Food Additives Status List is provided only as a quick look-up on the use limitations for a food additive or pesticide chemical. It is possible that mistakes or omissions could have occurred. Additionally, there may be cases where the agency has offered interpretations concerning specific provisions of the regulations. For example, in the case of boiler water additives or other minor ingredients, processing aids, or indirect additives, FDA has not objected, in certain cases, to the substitution of ammonium, calcium, magnesium, potassium, or sodium salts for each other when only one is listed in a regulation. The Food Additive Status list is updated annually, so it may not reflect the latest information. For all these reasons, take care before advising a firm that a use of a particular food additive is prohibited or otherwise limited. Read the actual regulation. If there are any doubts or if a particular situation is unclear, you or your supervisor should consult with the CFSAN, Office of Food Additive Safety (HFS-200) at (301) 436-1200, or the Division of Petition Review (HFS-265) at (301) 436-1264, or the Division of Food Contact Substance Notification Review HFS-275 at (301) 436-1162, or the Division of Biotechnology and GRAS Notice Review HFS-255 at (301) 436-1221.

Please send corrections or additions to the list to Harold Woodall, FDA/CFSAN Office of Food Additive Safety (HFS-206), 5100 Paint Branch Parkway, College Park, Maryland 20740 or e-mail them to

This is a GRASSROOTS MOVEMENT to put the human and pet food manufacturer's of America on alert, that we will not tolerate vague labeling of our foods, any longer.

We want full disclosure of ingredients, source/country-of-origin, place of manufacturing & place of distribution, including a toll-free number.

Oh, by-the-way -- STOP POISONING OUR FOOD!!!
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