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CFSAN/Office of Food Additive Safety
December 2008
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 2005. Importantly, the table below lists all GRAS notices received in the year 2005, regardless of whether the notice is pending at FDA or has come to closure.
The table below:
This table is current as of December 17, 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 |
---|---|---|---|---|---|---|---|
188 | Tyson Foods, Inc. | Carbon monoxide | In modified atmosphere packing (MAP) for red meat products at levels of 5.5 milligrams/pound (12 milligrams/kilogram) of packaged meat | Scientific procedures | Dec. 28, 2005 | Nov. 5, 2008 | |
187 | S & G Resources, Inc AND Changmao Biochemical Engineering Co. |
L(+) Tartaric acid (alternative method of manufacture) | As described in 21 CFR 184.1099 | Scientific procedures | Dec. 15, 2005 | Mar. 20, 2006 | |
186 | Lipogen Products (9000) Ltd. | Soy lecithin enzymatically modified to have increased phosphatidylserine | Ingredient in food in general, except meat and poultry | Scientific procedures | Dec. 14, 2005 | July 20, 2006 | |
185 | San-Ei Gen F.F.I., Inc. | Concentrated tomato lycopene extract | Ingredient in non-alcoholic beverages up to a maximum level of 20 parts per million | Scientific procedures | Nov. 30, 2005 | May 30, 2006 | |
184 | SUDZUCKER AG Mannheim/Ochsenfurt | Isomaltulose | Nutrative sweetener in a variety of food categories and beverages | Scientific procedures | Nov. 4, 2005 | Mar. 20, 2006 | |
183 | DSM Food Specialties | Phospholipase A2 enzyme preparation from Aspergillus niger expressing a gene encoding a porcine phospholipase A2 | Use as an enzyme to hydrolyze phospholipids in bread dough, fine bakery wares, and egg yolk-based products | Scientific procedures | Nov. 2, 2005 | May 11, 2006 | |
182 | Martin Vialatte | Hydrolyzed wheat gluten isolate; pea protein isolate | Fining agent in wine making | Scientific procedures | Oct. 27, 2005 | June 27, 2006 | |
181 | Michael Foods, Inc. | Phytosterols | Ingredient in egg products including egg whites and egg substitutes | Scientific procedures | Aug. 23, 2005 | Mar. 16, 2006 | |
180 | Mitsubishi-Kagaku Foods Corporation | Allyl isothiocyanate | For use as an anitimicrobial agent (in packaged foods) | Scientific procedures | Aug. 16, 2005 | Mar. 16, 2006 | |
179 | Stepan Company | Polyglycerol polyricinoleic acid | Emulsifier in margarines, low fat margarines, spreads, creamers and dairy analogs at levels no greater than 1.0 percent | Scientific procedures | July 25, 2005 | Jan. 20, 2006 | |
178 | Akzo Nobel Chemicals | Sodium iron EDTA | Iron fortification of soy, fish, hoisin and teriyaki sauces at an iron level of 0.024 percent; and of sweet and sour sauce at an iron level of 0.012 percent | Scientific procedures | July 21, 2005 | Jan. 11, 2006 | |
177 | Heart Blend Foods LLC | Plant sterol esters | Ingredient in ground coffee at a level of 1.0 gram per 8 ounce serving of brewed coffee | Scientific procedures | July 20, 2005 | Dec. 20, 2005 | |
176 | Archer Daniels Midland Company | Plant sterols and plant sterol esters from vegetable oils or sterols/stanols from tall oil | Ingredient in margarines and vegetable oil spreads, dressings for salads, beverages, snack bars, dairy analogs (including soy milk, ice cream and cream substitutes), cheese and cream, baked foods, ready-to-eat breakfast cereals, mayonnaise, pasta and noodles, sauces, salty snacks, processed soups, puddings, yogurt, confections, vegetarian meat analogs at a level up to 0.4 gram (g) sterol equivalents per serving; in fruit/vegetable juices at a level up to 1 g sterol equivalents per serving; and in edible vegetable oils, including diacylglycerol oil as a replacement, at a level up to 4 g/100g sterol equivalents per serving | Scientific procedures | July 14, 2005 | Jan. 13, 2006 | |
175 | First Venture Technologies Corp. | Saccharomyces cerevisiae strain ECMo01 with enhanced expression of urea amidolyase | Reduction of ethyl carbamate in fermented beverages | Scientific procedures | July 12, 2005 | Jan. 6, 2006 | |
174 | Ventria Bioscience | Lysozyme (human) enzyme preparation from rice | Antimicrobial agent in cheese, processed meats, beer production, and winemaking; ingredient in meal replacements, frozen dairy desserts, yogurt, snack bars, sports beverages, and medical foods | Scientific procedures | June 27, 2005 | Sept. 13, 2005 | |
173 | Vitatene S.A. | Lycopene from Blakeslea trispora | Ingredient in foods in general, except meat and poultry, at levels ranging from 5-575 parts per million | Scientific procedures | June 22, 2005 | Dec. 1, 2005 | |
172 | BioNeutra, Inc. | Isomalto-oligosaccharide | Ingredient in foods in general, except meat and poultry | Scientific procedures | June 21, 2005 | Oct. 17, 2005 | |
171 | Nutrition Physiology Corporation | Lactobacillus acidophilus, Lactobacillus lactis, and Pediococcus acidilactici | Antimicrobial to control pathogenic bacteria in meat and poultry products | Scientific procedures | June 10, 2005 | Closure: Dec. 7, 2005 | |
Additional correspondence about intended use: Sept. 13, 2006 | |||||||
170 | Primex ehf | Shrimp-derived chitosan | Ingredient in food including meat and poultry products | Scientific procedures | June 3, 2005 | Oct. 31, 2005 | |
169 | Proliant, Inc. | Bovine globulin | Ingredient in dairy products, juices/beverages, nutritional bars, snack foods and sports nutrition protein supplements | Scientific procedures | May 24, 2005 | July 19, 2005 | |
168 | Proteus Industries, Inc. | Poultry protein | Use as a protein source in finished poultry products of the same species as the extracted protein | Scientific procedures | May 24, 2005 | Nov. 18, 2005 | |
167 | Tyson Foods, Inc. | Carbon monoxide | Use in modified atmosphere packing for red meat products | Scientific procedures | Apr. 5, 2005 | Sept. 29, 2005 | |
166 | Freezing Machines, Inc. | Carbon monoxide | Use in water-based brine or marinade for modified atmosphere packaging for red meat products | Scientific procedures | Mar. 10, 2005 | Sept. 29, 2005 | |
165 | American Beverage Association | Quillaia extract type 1 | Foaming agent in semi-frozen carbonated and non-carbonated beverages at levels not to exceed 500 milligrams dry weight per killogram beverage | Scientific procedures | Mar. 10, 2005 | Nov. 9, 2005 | |
164 | Laboratorios Miret, S.A. (LAMIRSA) | Lauramide arginine ethyl ester | Antimicrobial ingredient added directly to food, including meat and poultry | Scientific procedures | Mar. 8, 2005 | Closure: Sept. 1, 2005 | |
Additional correspondence about intended use: July 25, 2006 | |||||||
163 | LycoRed Natural Products Industries, Ltd. | Tomato pulp powder | Ingredient in in baked goods, ground meat products, meat analogs, dairy products, soups, and sauces | Scientific procedures | Feb. 14, 2005 | Closure: Aug. 8, 2005 | |
Additional correspondence about intended use: Jan. 26, 2007 |
(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.