U. S. Food and Drug Administration
Center for Food Safety & Applied Nutrition
Office of Food Additive Safety
Inventory of GRAS Notices
April 2007

GRAS Notices Received in 1999

Information about the Notifier, the Intended Use, and the Basis for the GRAS Determination

A substance that will be added to food is subject to premarket approval by FDA unless its use is generally recognized as safe (GRAS) by qualified experts.(1) On April 17, 1997, FDA issued a proposed rule (the GRAS proposal; 62 FR 18938) that would establish a notification procedure whereby any person may notify FDA of a determination by that person that a particular use of a substance is GRAS. Although the proposed notification procedure is not yet final, FDA has already received several notices. As described in the GRAS proposal, the agency is evaluating whether each submitted notice provides a sufficient basis for a GRAS determination and whether information in the notice or otherwise available to FDA raises issues that lead the agency to question whether use of the substance is GRAS. Following this evaluation, FDA replies to the notifier by letter.

In general, FDA's response has been in one of three categories:

  1. The agency does not question the basis for the notifier's GRAS determination;
  2. The agency concludes that the notice does not provide a sufficient basis for a GRAS determination (e.g., because the notice does not include appropriate data and information or because the available data and information raise questions about the safety of the notified substance); or
  3. The response letter states that the agency has, at the notifier's request, ceased to evaluate the GRAS notice.

In the GRAS proposal, FDA announced its intention to maintain an inventory of GRAS notices and the agency's response to those notices. The main page of the Inventory of GRAS Notices lists all notices that FDA has received, describes FDA's response as one of the three general categories described above, and provides a hyperlink to the actual response letter. The table below, which is a separate part of the Inventory of GRAS Notices, lists the notices that FDA received in the year 1999.

List of GRAS Notices Received in 1999

This yearly table:

This table is current as of March 30, 2007. Because all notices in this table have come to closure, FDA does not expect to update this table on a regular basis.

GRN No. Notifier Substance Intended Use GRP # Basis Receipt Closure
35 Consolidated Growers and Processors, Inc. Hempseed oil Use in food as a flavoring agent, adjuvant solvent, vehicle, stabilizer, thickener, emulsifier, or texturizer at the minimum required to produce the intended technical effect   Common use in food Nov. 17, 1999 Aug. 24, 2000
34 Novo Nordisk Aspartic proteinase derived from Aspergillus oryzae carrying a gene encoding aspartic proteinase from Rhizomucor miehei Use in meat as a tenderizing agent at minimum levels necessary to accomplish the intended technical effect in accordance with current good manufacturing practices   Scientific procedures Nov. 17, 1999 Apr. 19, 2000
33 Canola Council of Canada Low erucic acid oil derived from Brassica juncea Use in food processing, in the manufacture of margarines and shortenings, and as a salad and frying oil   Scientific procedures Oct. 22, 1999 Jan. 27, 2000
32 Rohm Enzyme GmbH Pectin lyase derived from Trichoderma reesei carrying a gene encoding pectin lyase from Aspergillus niger Use in the preparation of fruit and vegetable juices, purees, and concentrates as a processing aid at levels ranging from 5 to 100 parts per million to accomplish the intended technical effect in accordance with current good manufacturing practices   Scientific procedures Oct. 14, 1999 Apr. 20, 2000
31 Safe Foods Corporation Cetylpyridinium chloride Use on raw and fully cooked foods including, poultry, red meat, fish and shellfish, eggs, fruits, vegetables, cereal grains, nutmeats, and dairy products as an antimicrobial agent at levels not to exceed 1.0 percent   Scientific procedures Sept. 20, 1999 Jan. 10, 2000
30 ShanStar Biotech, Inc. Crospovidone-cranberry juice extract Ingredient in foods and beverages   Scientific procedures Aug. 3, 1999 Closure: Dec. 20, 1999
Additional correspondence that does not provide a basis for a GRAS determination: Feb. 20, 2001
29 Ajinomoto USA Transglutaminase from Streptoverticillium mobaraense Use in processed cheeses, natural hard cheeses (domestic), cream cheese, refrigerated yogurt, frozen desserts, and vegetable protein dishes/vegeburgers/meat substitutes as a crosslinking agent at varying levels   Scientific procedures July 28, 1999 Dec. 29, 1999
28 Marigot Ltd./Celtic Sea Minerals Seaweed-derived calcium Use in foods in general as a source of dietary calcium for food enrichment and fortification purposes at various levels that range up to 4.0 percent   Scientific procedures July 28, 1999 Closure: Apr. 21, 2000
Additional correspondence about intended uses: Mar. 27, 2007
27 Sankyo Co., Ltd. Dextranase from Chaetomium gracile Use in cane and beet sugar as a processing aid 6G0420 Scientific procedures July 14, 1999 Dec. 16, 1999
26 Manildra Group Isolated wheat protein Use in powdered shortenings in baked goods, milk-like beverages, beverage whiteners, cheese analogues, meat and fish products, cooked meats, soups, sauces and marinades, mousses and meringues, edible films and coatings for various technical effects at levels ranging from 1 to 50 grams per kilogram   Scientific procedures July 8, 1999 Dec. 16, 1999
25 Pharaoh Palmier Extract of Garcinia kola seed ("bitter cola") Use in an alcoholic beverage as a flavor enhancer   Scientific procedures June 25, 1999 Oct. 12, 1999
24 Novo Nordisk alpha-Amylase derived from Bacillus licheniformis carrying a gene encoding alpha-amylase from Bacillus stearothermophilus Use in the starch industry (for the liquefaction of starch in the production of syrups) and in the alcohol industry (for the thinning of starch in distilling mashes) as a processing aid at minimum levels necessary to accomplish the intended technical effect in accordance with current good manufacturing practices   Scientific procedures June 7, 1999 May 15, 2000
23 Desanguination Products, LLC Protein preparation from animal blood Use in foods in general, including meat products, to provide protein nutritional value   Scientific procedures June 4, 1999 Aug. 2, 1999
22 Novo Nordisk alpha-Amylase derived from Bacillus licheniformis carrying a gene encoding a modified alpha-amylase derived from Bacillus lichenformis and Bacillus amyloliquefaciens Use in the starch industry (for the liquefaction of starch in the production of syrups), and in the alcohol industry (for the thinning of starch in distilling mashes) as a processing aid at minimum levels necessary to accomplish the intended technical effect in accordance with current good manufacturing practices   Scientific procedures May 24, 1999 Dec. 29, 1999
21 AMPC, Inc. Pork collagen Use in meat products as a binder and purge reducing agent at levels of 1.0 to 3.5 percent   Scientific procedures Apr. 26, 1999 July 29, 1999
20 Enzyme Bio-Systems Ltd. Pullulanase derived from Bacillus subtilis carrying a gene encoding pullulanase from Bacillus naganoensis Use in hydrolyzing starch and starch-related compounds in the production of corn sweeteners, baked goods, and alcoholic beverages at minimum levels necessary to accomplish the intended effect in accordance with current good manufacturing practices   Scientific procedures Apr. 22, 1999 Sept. 30, 1999
19 Albion Laboratories, Inc. Ferrous bisglycinate chelate Use in foods in general as a source of dietary iron for food enrichment and fortification purposes consistent with iron supplementation guidelines   Scientific procedures Apr. 22, 1999 Sept. 30, 1999
18 Givaudan Roure Flavors Mesquite (Prosopis spp.) wood alcoholic extract Use in distilled spirits as a flavor at a use level of one pound per 400 wine gallons   Scientific procedures Mar. 12, 1999 May 12, 1999
17 Larex, Inc. Arabinogalactan Use in foods in general for multiple technical effects   Scientific procedures Mar. 11, 1999 Apr. 11, 2000
16 BASF Corporation Menhaden oil Use in a variety of foods as a source of fat at levels ranging from 0.5 to 12 percent by weight   Scientific procedures Mar. 11, 1999 June 8, 1999
15 Hawaii International Seafood Inc. Tasteless smoke Use in raw tuna, before it is frozen, to preserve its taste, aroma, texture and color at levels sufficient to accomplish this purpose   Scientific procedures Mar. 17, 1999 Mar. 10, 2000
14 Basic Vegetable Products Hydrogen peroxide Use in the manufacture of dehydrated onions as a processing aid to extend their shelf life   Scientific procedures Feb. 17, 1999 May 26, 1999
13 Vitasoy International Holdings Ltd. Nine Botanicals: Chrysanthemum; Licorice; Honeysuckle; Lophatherum; Jellywort; Mulberry leaf; Frangipani; Selfheal; Sophora flower bud Use in herbal tea as a flavor   Common use in food Jan. 11, 1999 June 2, 1999


(1)In addition, a substance that is used in accordance with a sanction granted prior to September 6, 1958 is not subject to premarket approval.

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