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CFSAN/Office of Food Additive Safety
July 2006

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FOOD 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 (270 KB) for printing.
 
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A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
  

FOREWORD

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:

  1. 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.
  2. 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.
  3. Those pending administrative determination.
  4. 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.
  5. 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.
  6. 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 harold.woodall@fda.hhs.gov.

ABBREVIATIONS USED

Technical Effects
Type Kind, effect or use of additive Type Kind, effect or use of additive
AC Anticaking agent AF Antifoaming (or defoaming) agent
AOX Antioxidant BC Boiler compound
BL Bleaching agent or flour-maturing agent B&N Buffer and neutralizing agent
CTG Component or coating for fruits & vegetables DS Dietary supplement
EMUL Emulsifier ENZ Enzyme
ESO Essential oil and/or oleoresin (solvent free) FEED Substances under the Food Additives Amendment added directly to feed
FLAV Natural flavoring agent FL/ADJ Substance used in conjunction with flavors
FUM Fumigant FUNG Fungicide
HERB Herbicide HOR Hormone
INH Inhibitor MISC Miscellaneous
NAT Natural substances and extractives NNS Non-nutritive sweetener
NUTR Nutrient NUTRS Nutritive Sweetener
PEST Pesticide other than fumigant PRES Chemical preservative
SANI Sanitizing agent for food processing equipment SDA Solubilizing and dispersing agent
SEQ Sequestrant SOLV Solvent
SP Spices, other natural seasonings & flavorings SP/ADJ Spray adjuvant
STAB Stabilizer SY/FL Synthetic flavor
VET Veterinary drug, which may leave residue in edible tissues of animals or in edible animal products

 

Status
Type Kind, effect or use of additive Type Kind, effect or use of additive
BAN Substances banned prior to the Food Additives Amendment (FAA) because of toxicity. These substances are bolded and italicized. FS Substances permitted as optional ingredient in a standardized food
GRAS Generally recognized as safe. Substances in this category are by definition, under Sec. 201(s) of the FD&C Act, not food additives. Most GRAS substances have no quantitative restrictions as to use, although their use must conform to good manufacturing practices. Some GRAS substances, such as sodium benzoate, do have a quantitative limit for use in foods. GRAS/FS Substances generally recognized as safe in foods but limited in standardized foods where the standard provides for its use.
ILL Substances used or proposed for use as direct additives in foods without required clearance under the FAA. Their use is illegal. These substances are bolded and italicized. PD Substances for which a petition has been filed but denied because of lack of proof of safety. Substances in this category are illegal and may not be used in foods.
PS Substances for which prior sanction has been granted by FDA for specific uses. There are a number of substances in this category not listed herein because they have not been published in the FEDERAL REGISTER. REG Food additives for which a petition has been filed and a regulation issued.
REG/FS Food additives regulated under the FAA and included in a specific food standard.

 

Other
Type Kind, effect or use of additive Type Kind, effect or use of additive
& and amt amount
art artificially avg average
ca about, approximately calc calculated
CFR Code of Federal Regulations cnd canned
cond conditions comb. w/ in combination with; combined with
comp component ctg coating for fruits, vegetables, tablets
do Same CFR reference as appears earlier in paragraph dr dried
F.R. Federal Register g gram(s)
GMP In accordance with good manufacturing practices; or sufficient for purpose; or quantity not greater than required incl including
mfr manufacture mg milligram(s)
min mineral ml milliliter
nonstdzd nonstandardized Part Refers to Part number under Title 21 CFR
pdt product pdtn production
pest pesticide pkg packaging
ppm parts per million prepns preparations
res residue sp special dietary
suppl supplement sw sweetened
tabs tablets temp temporary
veg vegetable(s) w/ with
w/o without wt weight
X-ref cross reference < less than
≤ less than or equal to > greater than
≥ greater than or equal to + plus

A