U. S. Food and Drug Administration Center for Food Safety & Applied Nutrition Office of Food Additive Safety Inventory of GRAS Notices July 2001 |
GRAS Notices Received in 1998
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 1998.
This yearly table:
This table is current as of June 29, 2001. 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 |
---|---|---|---|---|---|---|---|
12 | Givaudan Roure Flavors | Mesquite wood alcoholic extract | Use in several food categories, including alcoholic beverages, as a flavor | Common use in food | Dec. 30, 1998 | Mar. 11, 1999 | |
11 | Bonlac Foods Limited | Calcium casein peptone-calcium phosphate | Use in chewing gum as a texturizer at a use level of up to 5 percent wt/wt | Scientific procedures | Nov. 2, 1998 | Jan. 29, 1999 | |
10 | Rohm Enzyme Finland Oy | Exopeptidase derived from Aspergillus oryzae carrying a gene encoding a leucine aminopeptidase from Aspergillus sojae | Use as a food processing aid at a level ranging from 0.2 to 0.8 percent | Scientific procedures | Oct. 28, 1998 | Jan. 29, 1999 | |
9 | Quest International | Polyglycerol polyricinoleic acid | Use in chocolate as an emulsifier at a level up to 0.3 percent | Scientific procedures | Oct. 22, 1998 | Mar. 2, 1999 | |
8 | Novo Nordisk | Pectin esterase derived from Aspergillus oryzae carrying a gene encoding pectin esterase from Aspergillus aculeatus | Use in fruit and vegetable products as a processing aid at minimal level needed to accomplish the intended technical effect | Scientific procedures | Oct. 14, 1998 | Mar. 2, 1999 | |
7 | Wyeth Nutritionals International | ARASCO (arachidonic acid-rich single-cell oil) and DHASCO (docosahexaenoic acid-rich single-cell oil) as sources of the fatty acids ARA (arachidonic acid) and DHA (docosahexaenoic acid) | ARASCO as a source of ARA and DHASCO as a source of DHA in infant formula | Scientific procedures | Sept. 1, 1998 | Mar. 4, 1999 | |
6 | Cytec Industries, Inc. | Dioctyl sodium sulfosuccinate | Use in carbonated and non-carbonated soft drinks as a wetting agent or solubilizer for flavor emulsion stabilizers at levels up to 10 parts per million of the finished beverage | Scientific procedures | Jul. 21, 1998 | Dec. 28, 1998 | |
5 | Hawaii International Seafood Inc. | Tasteless smoke | Use in red-meat seafoods such as tuna and salmon to preserve the taste, aroma, and color | Common use in food | Apr. 29, 1998 | Nov. 9, 1998 | |
4 | Ajinomoto USA | Transglutaminase from Streptoverticillium mobaraense | Use in processed seafood as a crosslinking agent at levels not to exceed 65 parts per million | Scientific procedures | Mar. 4, 1998 | June 22, 1998 | |
3 | Jones Hamilton Co. | Sodium bisulfate | Use in cake mixes as a pH control agent and a 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 | Feb. 26, 1998 | June 5, 1998 | |
2 | United Grain Growers Ltd. | Solin oil (low linolenic acid flaxseed oil or low linolenic acid linseed oil) | Use as a general purpose cooking, frying, and salad oil; and as an ingredient in margarines, shortenings, and other food products | 5G0416 | Scientific procedures | Feb. 11, 1998 | May 27, 1998 |
1 | Archer Daniels Midland Company | Soy isoflavone extract | Ingredient in performance bars, mature adult meal replacements, and beverages at a level of 25 milligrams per serving | Scientific procedures | Feb. 10, 1998 | Nov. 3, 1998 |
(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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