A list of Effective Food Contact Substance (FCS) Notifications is available on the FDA web site. These notifications are effective only for the manufacturer or supplier identified in the notification.
In 1997, FDA implemented a new Food Contact Notification program for certain food contact substances. Use it to locate the regulation in which its use is fully described. To look up indirect food additives in Parts 175, 176, 177 and 178 go to FDA's Indirect Additives Used in Food Contact Substances. 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.For additional information on these substances, contact the CFSAN Office of Food Additive Safety (HFS-200) at (240) 402-1200. Substances granted prior sanction for specific use prior to enactment of the Food Additives Amendment.
Those pending administrative determination.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 (240) 402-1200. 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. The CFR does not contain a complete list of permissible flavorings. Synthetic flavoring substances in 21 CFR 172.515.This site contains notices received from companies since 1998, and FDA's response. You may find such substances in the GRAS Notice Inventory on the FDA web site. Obviously safe substances not cited in a regulation as Generally Recognized as Safe (GRAS).The Food Additive Status List omits certain categories of additives. NOTE: Pesticide chemicals from 40 CFR 180 for which EPA has set tolerances in food that are enforced by FDA have been removed from this list. For example, Substances Added to Food is a helpful reference within the limitations described at the beginning of the database. Also refer to the Food Ingredient and Packaging inventories in the Foods section of the FDA web site to review several FDA databases of additive categories. New regulations and revisions are published in current issues of the Federal Register as promulgated. For complete information on its use limitations, refer to the specific regulation for each substance. The Food Additives Status List includes short notations on use limitations for each additive. Additives included are those specified in the regulations promulgated under the FD&C Act, under Sections 401 (Food Standards), and 409 (Food Additives).
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This Food Additives Status List, formerly called Appendix A of the Investigations Operations Manual (IOM), organizes additives found in many parts of 21 CFR into one alphabetized list. Īdditives: 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
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 (240) 402-1200, or the Division of Petition Review (HFS-265) at (240) 402-1264, or the Division of Food Contact Substance Notification Review HFS-275 at (240) 402-1162, or the Division of Biotechnology and GRAS Notice Review HFS-255 at (240) 402-1221. For all these reasons, take care before advising a firm that a use of a particular food additive is prohibited or otherwise limited. The Food Additive Status list is updated at regular intervals, so it may not reflect the latest information. 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. Additionally, there may be cases where the agency has offered interpretations concerning specific provisions of the regulations. It is possible that mistakes or omissions could have occurred. NOTE: The Food Additives Status List is provided only as a quick look-up on the use limitations for a food additive.
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