U. S. Food and Drug Administration Center for Food Safety & Applied Nutrition Office of Food Additive Safety Inventory of GRAS Notices February 2008 |
GRAS Notices Received in 2002
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 2002. Importantly, the table below lists all GRAS notices received in the year 2002, regardless of whether the notice is pending at FDA or has come to closure.
The table below:
This table is current as of January 31, 2008. 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 | Date of filing | Closure |
---|---|---|---|---|---|---|---|
119 | BASF Corporation | Synthetic lycopene | Ingredient in food in general, except meat and poultry products | Scientific procedures | Nov. 27, 2002 | May 22, 2003 Corrected letter issued Apr. 7, 2005 | |
118 | Imperial-Sensus, LLC | Inulin | Use in food in general, including meat and poultry products, as a bulking agent | Scientific procedures | Nov. 14, 2002 | Closure:May 5, 2003 | |
Additional correspondence about intended uses: Jan. 16, 2008 | |||||||
117 | Unilever (Good Humor - Breyers) | Ice structuring protein preparation | Use in frozen novelty products as a texturizer at a maximum level of 0.01 percent by weight | Scientific procedures | Oct. 30, 2002 | Apr. 17, 2003 | |
116 | Wm. Bolthouse Farms, Inc. | Carrot fiber | Use in baked goods as a texturizer at a maximum level of 5 percent by weight of flour; use in meat substitutes (e.g., meatless sausages and meatless patties) at a maximum level of 5 percent; use in meat and poultry products as a binder/extender and to reduce water purging/gelling at a maximum level of 5 percent | Scientific procedures | Oct. 3, 2002 | Mar. 20, 2003 | |
115 | ADM Kao L.L.C. | Diacylglycerol oil | Use as a substitute for vegetable oils in bakery products, salad dressings, mayonnaise, pizza, breakfast/snack/power bars, soups and gravies, meal replacements, and frozen dinner entrees | Scientific procedures | Sept. 5, 2002 | Feb. 24, 2003 | |
114 | Japan Cellfoods Co., Ltd. | Pectate lyase enzyme preparation from Bacillus subtilis | Use in fruit and vegetable purees and concentrates as an enzyme | Scientific procedures | Sept. 5, 2002 | Jan. 27, 2003 | |
113 | Enzyme Technical Association | Lipase enzyme preparation from Aspergillus oryzae | Use in dairy-based flavoring preparations, cheeses, liquid and dried egg white, bread, flour, unstandardized bakery products, modified triglycerides, hydrolyzed lecithin, edible fats and oils, and modified egg yolk as an enzyme | 3G0016 | Scientific procedures | Aug. 21, 2002 | Jan. 27, 2003 |
112 | Teriaka Ltd. | Phytosterols | Ingredient in vegetable spread, yogurt, milk-based juice beverages, ice cream, cream cheese, snack bars, salad dressings, and white bread products | Scientific procedures | Aug. 19, 2002 | Feb. 4, 2003 | |
111 | Enzyme Technical Association | Lipase enzyme preparation from Aspergillus niger | Use in dairy-based flavoring preparations, cheeses, liquid and dried egg white, bread, flour, unstandardized bakery products, modified triglycerides, hydrolyzed lecithin, edible fats and oils, and modified egg yolk as an enzyme | 3G0016 | Scientific procedures | Aug. 16, 2002 | Dec. 20, 2002 |
110 | Cognis Corporation | Lutein esters | Ingredient in baked goods and baking mixes, soy milk, beverages and beverage powders, frozen dairy desserts and mixes, processed fruit and vegetable products, egg products and egg substitutes, breakfast cereals (ready-to-eat and hot), fats and oils, hard candy, fruit snacks, dairy products, and medical foods intended as the sole item of the diet | Scientific procedures | July 25, 2002 | Jan. 21, 2003 | |
109 | Clover Corporation Limited | Tuna oil | Use in the food categories listed in 21 CFR 184.1472(a)(3) as a direct food ingredient at levels that are no more than 62 percent of the levels specified in 21 CFR 184.1472(a)(3) | Scientific procedures | July 11, 2002 | Dec. 4, 2002 | |
108 | T&R Chemicals, Inc. | Glycerol ester of gum rosin | Use in citrus oils that are added to beverages to increase the density of the citrus oil and to act as an emulsifier at a maximum level of 100 parts per million | Scientific procedures | June 28, 2002 | Dec. 20, 2002 | |
107 | Danisco Cultor America | Polydextrose | Use in non-sweet baked goods, breading and batter coatings, flavor bits on crackers, snack chips, ready-to-eat breakfast cereals, surimi (minced fish and meat), ready-to-drink nutritional beverages, noncarbonated beverages and dry beverage mixes for multiple technical effects at varying levels | Scientific procedures | May 1, 2002 | Oct. 17, 2002 | |
106 | Novozymes North America, Inc. | Glucose oxidase enzyme preparation from Aspergillus oryzae carrying a gene encoding a glucose oxidase from Aspergillus niger | Use as an enzyme in baking applications and (in combination with a catalyze enzyme preparation) in the manufacture of foods such as cheese, beer, carbonated beverages, and fruit juice | Scientific procedures | Apr. 29, 2002 | Oct. 3, 2002 | |
105 | Unilever United States, Inc. | Fish oil concentrate | Use as an ingredient in the foods described in FDA's proposed rule for the use of menhaden oil (67 FR 8744; Feb. 26, 2002) at a level that is approximately 57 percent of the levels listed in that proposed rule | Scientific procedures | Apr. 19, 2002 | Oct. 15, 2002 | |
104 | Eastman Chemical Company | Sucrose acetate isobutyrate | Use as a stabilizer of emulsions of flavoring oils in alcoholic beverages | Scientific procedures | Apr. 17, 2002 | Aug. 16, 2002 | |
103 | Novozymes North America, Inc.; | Lipase enzyme preparation from Aspergillus oryzae carrying a gene constructed from a modified Thermomyces lanuginosus lipase gene and a portion of the Fusarium oxysporum lipase gene | Use in bakery products, egg yolks, whole eggs, and fats and oils as an enzyme at minimum levels necessary in accordance with good manufacturing practice | Scientific procedures | Apr. 4, 2002 | Aug. 19, 2002 | |
102 | Jedwards International | Small planktivorous pelagic fish body oil | Use in food as described in 21 CFR 184.1472(a)(3) with respect to food categories listed | Scientific procedures | Apr. 4, 2002 | Sept. 3, 2002 | |
101 | Cyanotech Corporation AND Earthrise Nutritionals, Inc. |
Spirulina | Ingredient in foods such as bars, powdered nutritional drink mixes, and as a condiment in salads and pasta, at levels ranging from 0.5 to 3 grams per serving size | Scientific procedures | Mar. 21, 2002 | May 28, 2002 | |
100 | Bioenergy, Inc. | D-Ribose | Use in food in general, including meat and poultry products, for multiple technical effects | Scientific procedures | Mar. 14, 2002 | Sept. 3, 2002 | |
99 | Hayashibara International | Pullulan | Use in food in general, including meat products, for multiple technical effects | Scientific procedures | Mar. 1, 2002 | Aug. 1, 2002 | |
98 | Jedwards International | Small planktivorous pelagic fish body oil | Use in food as described in 21 CFR 184.1472(a)(3) with respect to food categories and the level of use in those food categories | Scientific procedures | Feb. 12, 2002 | Mar. 25, 2002 | |
97 | Clover Corporation Limited | Tuna oil | Use in food as described in 21 CFR 184.1472(a)(3) with respect to food categories and the level of use in those food categories | Scientific proceodures | Jan. 25, 2002 | June 24, 2002 | |
96 | The New Silk Road, Inc. | Silk protein food powder | Use in food as a source of protein | Scientific procedures | Jan. 3, 2002 | May 20, 2002 | |
95 | Ajinomoto USA | Transglutaminase from Streptoverticillium mobaraense | Use in food in general as a crosslinking agent | Scientific procedures | Jan. 3, 2002 | July 3, 2002 | |
94 | Ross Products Division, Abbott Laboratories | Docosahexaenoic acid-rich oil from tuna (DHA-rich tuna oil) and arachidonic acid-rich oil from Mortierella alpina (AA-rich fungal oil) | Provide arachidonic acid (AA) at a mean level of 0.4 percent of total fatty acids and docosahexaenoic acid (DHA) at a mean level of 0.25 percent of total fatty acids in preterm infant formula used by hospitalized premature infants; AA at a mean level of 0.4 percent of total fatty acids and DHA at a mean level of 0.15 percent of total fatty acids in preterm infant formula used by post-discharge premature infants; and AA at a mean level of 0.4 percent of total fatty acids and DHA at a mean level of 0.15 percent of total fatty acids in term infant formula | Scientific procedures | Jan. 2, 2002 | April 18, 2006 |
(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.