Appendix A - FOOD ADDITIVE STATUS LIST

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. To access 21 CFR, see http://www.access.gpo.gov/nara/cfr/index.html. To access 40 CFR 180, "Tolerances and Exemptions from Tolerances for Pesticide Chemicals in Food", see http://www.access.gpo.gov/nara/cfr/waisidx_01/40cfr180_01.html. New regulations and revisions are published in current issues of the Federal Register as promulgated. To access the Federal Register, see http://www.access.gpo.gov/su_docs/aces/aces140.html. Also refer to the CFSAN website on Food Additives and Premarket Approval to review several FDA databases of additive categories. See http://www.cfsan.fda.gov/~lrd/foodadd.html. 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, see http://www.cfsan.fda.gov/~rdb/opa-gras.html. It 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 (202) 418-3100.
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 (202) 418-3100.
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" See http://www.cfsan.fda.gov/~dms/opa-indt.html. 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. See http://www.cfsan.fda.gov/~dms/opa-fcn.html.

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 (202) 418-3100, or the Division of Petition Review (HFS-265) at (202) 418-3042, or the Division of Food Contact Substance Notification Review HFS-275 at (202) 418-3080, or the Division of Biotechnology and GRAS Notice Review HFS-255 at (202) 418-3090.

Please send corrections or additions to the list, to Alan Gion FDA/Division of Field Investigations (DFI) (HFC-130), 5600 Fishers Lane, Rockville, Maryland 20857 or e-mail them to IOM@ORA.FDA.GOV.

ABBREVIATIONS USED

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

BAN - Substances banned prior to the Food Additives Amendment (FAA) because of toxicity. These substances are bolded and italicized.

FS - Substance 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 - Substance 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 - Substance 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 additive for which a petition has been filed and a regulation issued.

REG/FS - Food additive regulated under the FAA and included in a specific food standard.

Other

& - 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 - diet 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

³ - greater than or equal to

+ - plus