U. S. Food and Drug Administration Center for Food Safety & Applied Nutrition Office of Food Additive Safety Inventory of GRAS Notices July 2007 |
GRAS Notices Received in 2000
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:
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 2000. Importantly, the table below lists all GRAS notices received in the year 2000, regardless of whether the notice is pending at FDA or has come to closure.
The table below:
This table is current as of December 30, 2005. 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 |
---|---|---|---|---|---|---|---|
65 | Rhodia, Inc. | Nisin | Use on casings for frankfurters and on cooked meat and poultry products as an antimicrobial agent | Scientific procedures | Dec. 20, 2000 | Apr. 20, 2001 | |
64 | Rhodia, Inc. | Egg white lysozyme | Use on casings for frankfurters and on cooked meat and poultry products as an antimicrobial agent | Scientific procedures | Dec. 20, 2000 | Apr. 2, 2001 | |
63 | Rhodia, Inc. | Hops beta acids | Use on casings for frankfurters and on cooked meat and poultry products as an antimicrobial agent | Scientific procedures | Dec. 20, 2000 | Mar. 15, 2001 | |
62 | Bernard Technologies, Inc. | Chlorine dioxide generated from particles (<30µm) composed of sodium polyphosphate, magnesium sulfate, sodium silicate and sodium chlorite that are incorporated into low density polyethylene (LDPE) food-packaging films, at levels not exceeding 17.5 µg chlorite/in2 of finished package film | Use for packaging meats, poultry and seafood that will be cooked prior to being consumed, and for packaging fresh fruits and vegetables and foods in transit or storage from producers to processors, or institutional users, that will be washed with a potable water rinse and further processed before being consumed, to extend the shelf life and extend the freshness of the contained foods; Use for fresh pasta products that will be cooked prior to being consumed, and for preparaed dough products that will be baked, or otherwise cooked, prior to being consumed | Scientific procedures | Dec. 4, 2000 | June 19, 2001 | |
Additional correspondence about intended uses: Aug. 20, 2003 | |||||||
61 | Archer Daniels Midland Company | Plant sterols/Plant sterol esters | Plant sterols as an ingredient in vegetable oil spreads, dressings for salad, health drinks, health bars, yogurt-type products at a level of 1 gram per serving; and as a raw material in the manufacture of plant sterol esters for use as an ingredient in the same foods at a level of 1.65 grams (i.e., 1 gram sterol equivalent) per serving | Scientific procedures | Nov. 27, 2000 | Apr. 18, 2001 | |
60 | Jones-Hamilton Company | Potassium bisulfate | Use in cake mixes as a pH control agent and leavening agent at a level of 0.1 to 1.0 percent by weight; use in foods in general as a pH control agent and processing aid at levels not to exceed good manufacturing practices | Scientific procedures | Oct. 31, 2000 | Jan. 19, 2001 | |
59 | Grain Processing Corporation | Hydrogenated starch hydrolysate | Use in foods in general as a flavoring agent, adjuvant, formulation aid, humectant, processing aid, stabilizer, thickener, surface-finishing agent, or texturizer at levels not to exceed good manufacturing practice | Scientific procedures | Oct. 4, 2000 | Sept. 24, 2001 | |
58 | Kerry Ingredients | Gum arabic | Use in creamers for alcoholic beverages as a thickener, emulsifier or stabilizer at levels not to exceed 20 percent by weight of the alcoholic beverage | 3G0287 | Scientific procedures | Sept. 25, 2000 | Sept. 10, 2001 |
57 | Permafresh Corporation | Argon gas | Use in wines, fruit juices and vegetable juices to replace the normal air atmosphere in sealed containers | Scientific procedures | Sept. 8, 2000 | Nov 2, 2000 | |
56 | Kao Corporation | Diacylglycerol oil | Substitute for vegetable oils | Scientific procedures | Aug. 11, 2000 | Dec. 4, 2000 | |
55 | Ajinomoto USA | Transglutaminase from Streptoverticillium mobaraense | Use in pasta, bread, pastries, ready to eat cereal products, pizza dough, and grain mixtures as a crosslinking agent at varying levels | Scientific procedures | Aug. 8, 2000 | Jan. 30, 2001 | |
54 | Novo Nordisk | Xylanase derived from Fusarium venenatum carrying a gene encoding xylanase from Thermomyces lanuginosus | Use in the baking industry as a processing aid at minimum levels necessary in accordance with good manufacturing practices | Scientific procedures | July 28, 2000 | Feb. 23, 2001 | |
53 | Procter & Gamble Company | Phytosterol esters | Ingredient in vegetable oil, at a level up to 13.3 percent by weight, for home use applications such as baking, frying, and salad dressings | Scientific procedures | July 24, 2000 | Dec. 20, 2000 | |
52 | Glanbia Ingredients, Inc. | Whey mineral concentrate | Use in beverages, foods, and dairy products as a source of calcium at levels consistent with current calcium supplementation guidelines | Scientific procedures | June 27, 2000 | Jan. 30, 2001 | |
51 | B.F. Goodrich | Cassia gum from Cassia tora/obtusifolia | Use in foods in general in accordance with good manufacturing practice | Scientific procedures | June 23, 2000 | Feb. 27, 2001 | |
50 | Fuji Oil Co., Ltd. | Bohenin | Use in chocolate and chocolate coatings as a tempering aid and anti-bloom agent at a level not to exceed 5 percent by weight of the total fat | 4GO407 | Scientific procedures | June 20, 2000 | Aug. 31, 2000 |
49 | Nestle USA | Bifidobacterium lactis strain Bb12 and Streptococcus thermophilus strain Th4 | Ingredients in milk-based infant formula that is intended for consumption by infants four months and older, at levels not to exceed good manufacturing practice | Scientific procedures | June 14, 2000 | Closure: Mar. 19, 2002 | |
Additional correspondence clarifying new information on B. lactis strain Bb12: Nov. 28, 2005 | |||||||
48 | Cargill Inc. | Vegetable oil phytosterol esters | Ingredient in vegetable oil spread, dressings for salad, bars, and yogurt | Scientific procedures | June 2, 2000 | Nov. 27, 2000 | |
47 | Larex Inc. | Arabinogalactan from Larix occidentalis | Use in foods in general, including meat products, for multiple technical effects | Scientific procedures | May 30, 2000 | Jun. 6, 2000 | |
46 | Wacker Biochem Corp. | Gamma cyclodextrin | Use in bread spreads, frozen dairy desserts, ready-to-eat dairy desserts, desserts prepared from dry mixes, fruit fillings, cheese and cream fillings, and chewing gum as a stabilizer, emulsifier, carrier and formulation aid at varying levels | Scientific procedures | May 22, 2000 | Sept. 22, 2000 | |
45 | Hayashibara International Inc. | Trehalose | Use in foods in general, including meat products, for multiple technical effects at levels in accordance with good manufacturing practice | Scientific procedures | May 17, 2000 | Oct. 5, 2000 | |
44 | GTC Nutrition Company | Fructooligosaccharide | Use as a bulking agent in acidophilus milk, nutritional bars, baby food, nutritional beverages, biscuits, cakes, confectionery, cookies, crackers, flavored and unflavored milks, hard candy, ice cream and frozen yogurt, jams and jellies, muffins, ready-to-eat cereals, sorbet, soup and yogurt at varying levels | Scientific procedures | May 2, 2000 | Closure: Nov. 22, 2000 | |
Additional correspondence about intended uses: June 1, 2007 | |||||||
43 | Novo Nordisk | Lipase derived from Aspergillus oryzae carrying a gene encoding lipase from Thermomyces lanuginosus | Use in dough, baked goods, and the fats and oil industry as a processing aid for the interesterification or hydrolysis of glycerides at minimum levels necessary to achieve the desired effect | Scientific procedures | Apr. 28, 2000 | Sept. 22, 2000 | |
42 | DMV International | Milk-derived lactoferrin | Ingredient in sports and functional foods | Scientific procedures | Apr. 10, 2000 | Closure: Mar. 26, 2001 | |
Additional correspondence clarifying the appropriate mechanism to "supplement" a notice after FDA has responded to that notice: Apr. 23, 2001 | |||||||
41 | Martek Biosciences Corporation | DHASCO (docosahexaenoic acid-rich single-cell oil) and ARASCO (arachidonic acid-rich single-cell oil) | Provide DHASCO (as a source of docosahexaenoic acid) and ARASCO (as a source of arachidonic acid) in term infant formula, at a maximum level of 1.25 percent each of the total dietary fat and at a ratio ranging from 1:1 to 1:2 (DHASCO:ARASCO) | Scientific procedures | Mar. 01, 2000 | May 17, 2001 | |
40 | American Ingredients Company | Mineral oil | Use on food processing equipment as a sprayed release agent resulting in a presence on food at no more than 5 parts per million | Common use in food | Feb. 28, 2000 | Dec. 11, 2000 | |
39 | Novartis Consumer Health, Inc. | Tall oil phytosterols | Ingredient in vegetable oil spreads at a level up to 12 percent free phytosterols | Scientific procedures | Jan. 28, 2000 | Closure: Apr. 24, 2000 | |
Additional correspondence clarifying intended use: Nov. 2, 2000 | |||||||
38 | Safe Foods Corporation | Cetylpyridinium chloride | Use on the outside surface of raw and fully cooked meat and poultry products as an antimicrobial agent at a level not to exceed 1.0 percent | Scientific procedures | Jan. 17, 2000 | Feb. 29, 2000 | |
37 | American Dairy Products Institute | Whey protein isolate and dairy product solids | Whey protein isolate - use in foods in general, including meat, for multiple technical effects; dairy product solids - use in foods in general, including alcohol, for multiple technical effects | 1G0371 | Scientific procedures | Jan. 14, 2000 | Closure: Apr. 21, 2000 |
Additional correspondence clarifying the term "dairy product solids": Jan. 30, 2001 | |||||||
36 | Vancol Industries, Inc. | Chromium picolinate; Ginkgo biloba leaf extract; and Ginseng extract | Ingredients in non-carbonated beverage or tea | Scientific procedures | Jan. 3, 2000 | Apr. 10, 2000 |
(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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Content last updated by pmg on 2007-JUL-31
Hypertext updated by pmg/rxm/emw on 2007-AUG-22