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CFSAN/Office of Food Additive Safety
June 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 2006. Importantly, the table below lists all GRAS notices received in the year 2006, regardless of whether the notice is pending at FDA or has come to closure.
The table below:
This table is current as of May 31, 2008, and therefore does not show any new notices filed by FDA, or response letters issued by FDA, after that date. This table will be updated approximately monthly.
| GRN No. | Notifier | Substance | Intended Use | GRP # | Basis | Date of filing | Closure |
|---|---|---|---|---|---|---|---|
| 218 | EBI Food Safety B.V. | Bacteriophage P100 Preparation from Listeria innocua | For control of L. monocytogenes in foods in general, including meat and poultry products, at levels up to 109 plaque forming units per gram | Scientific procedures | Dec. 27, 2006 | June 22, 2007 | |
| 217 | The Nisshin OilliO Group USA, Inc. | Tailored triglycerides containing approximatly 12% medium-chain fatty acids | Oil used in cooking, salad dressings, vegetable oil spreads, and frozen dinners | Scientific procedures | Dec. 21, 2006 | Aug. 20, 2007 | |
| 216 | Amano Enzyme Inc. | Lipase enzyme preparation from Rhizopus oryzae | As an enzyme to produce tailored triglycerides for use in infant formula | Scientific procedures | Nov. 27, 2006 | May 18, 2007 | |
| 215 | Efficas, Inc. | Actinidia arguta extract | Ingredient in a variety of food categories | Scientific procedures | Oct. 30, 2006 | Aug. 16, 2007 | |
| 214 | DSM Food Specialties | Asparaginase enzyme preparation from Aspergillus niger expressing the asparaginase gene from A. niger | As an enzyme to lower free L-asparagine levels in breads, cereal-based products, potato-based products, and reaction flavors | Scientific procedures | Oct. 11, 2006 | Mar. 12, 2007 | |
| 213 | The Dow Chemical Company | Hydroxypropyl methylcellulose - expanded substitution pattern (HPMC-ESP) | Use in food in general, including meat products | Scientific procedures | Sept. 27, 2006 | Mar. 27, 2007 | |
| 212 | Nagase ChemteX Corporation | Phospholipase A2 enzyme preparation from Streptomyces violaceruber expressing a gene encoding phospholipase A2 from the same species | Use as a enzyme to hydrolyze soy and egg yolk lecithins | Scientific procedures | Sept. 5, 2006 | Mar. 22, 2007 | |
| 211 | CP Kelco | Xanthan gum (reduced pyruvate) | Use in foods in general, excluding meat and poultry products | Scientific procedures | Aug. 30, 2006 | Apr. 11, 2007 | |
| 210 | Provexis plc | Water soluble tomato concentrate | Ingredient in yogurt drinks, fruit juices, and fruit flavored drints at 3 grams per serving | Scientific procedures | Aug. 15, 2006 | Feb. 8, 2007 | |
| 209 | Taiyo International, Inc. | L-theanine | Ingredient in several food categories up to 250 milligrams per serving | Scientific procedures | Aug. 9, 2006 | Feb. 5, 2007 | |
| 208 | Mitsubishi Kagaku-Foods Corporation | Erythritol | Use in bakery fillings, cakes and cookies, chewing gum, dairy drinks, fat-based cream used in modified fat/calorie cookies, pastries, hard candies, frozen dairy desserts, puddings, reduced and low-calorie beverages, soft candies, sugar substitutes and yogurt as a flavor enhancer, formulation aid, humectant, nutritive sweetener, stabilizer and thickener, sequestrant, and texturizer at varying levels | Scientific procedures | Aug. 3, 2006 | Jan. 25, 2007 Corrected letter issued Nov. 20, 2007 | |
| 207 | Cargill Inc. | Barley fiber | Use in food in general, except for infant formula and meat and poultry products | Scientific procedures | June 23, 2006 | Dec. 19, 2006 | |
| 206 | Enzymotec Ltd. | Phytosterol esters and diglycerides resulting from transesterification of vegetable oils/fats with soy phytosterols | Ingredient in baked goods and baking mixes; fats and oils; frozen dairy desserts and mixes; gelatins, puddings, and fillings; grain products and pastas; gravies and sauces; hard candy; milk and milk products; soft candy, soups and soup mixes; and snack foods at a level of 0.65 gram phytosterol esters per serving | Scientific procedures | June 14, 2006 | Dec. 7, 2006 | |
| 205 | Novozymes North America Inc. | Pullulanase enzyme preparation from Bacillus subtilis expressing the pullulanase gene from B. acidopullulyticus | As an enzyme in the brewing industry (to hydrolyze 1-6- alpha-D-glucosidic linkages in pullulan, amylopectin, and glycogen) | Scientific procedures | June 9, 2006 | Dec. 4, 2006 | |
| 204 | Diversa Corporation | Phospholipase C enzyme preparation from Pichia pastoris expressing a heterologous Phospholipase C gene | As an enzyme in degumming vegetable oils for food use | Scientific procedures | June 9, 2006 | Dec. 5, 2006 | |
| 203 | Stepan Company | Erythritol fatty acid esters | As a surface active agent or microencapsulant in certain foods at the minimum level required to achieve the intended technical effect | Scientific procedures | June 9, 2006 | Nov. 15, 2006 | |
| 202 | Zymes LLC | Polyoxyethanyl-alpha-tocopheryl sebacate (PTS) | As a solubilizer for the dietary ingredient coenzyme Q10 in dietary supplements | Scientific procedures | June 5, 2006 | Dec. 6, 2006 | |
| 201 | Novozymes North America Inc. | Asparaginase enzyme preparation from Aspergillus oryzae expressing the asparaginase gene from A. oryzae | As an enzyme for use in reducing asparagine levels in wheat dough-based products such as cookies and crackers, fabricated potato chips, and cut or sliced potato products | Scientific procedures | June 5, 2006 | Nov. 24, 2006 | |
| 200 | Twin Rivers Technologies | Tailored triglycerides enriched in omega-3 fatty acids from fish oil | As a direct food ingredient in the food categories listed in 21 CFR 184.1472(a)(3) at levels that are no more than 36 percent of the levels specified in 21 CFR 184.1472(a)(3) | Scientific procedures | June 1, 2006 | Nov. 24, 2006 | |
| 199 | Calpis Co. Ltd. | Concentrated hydrolyzed milk protein | Ingredient in orange juice, yogurt (including yogurt drinks), nutrition bars and margarine spread | Scientific procedures | May 9, 2006 | May 11, 2007 | |
| 198 | EBI Food Safety B.V. | Bacteriophage P100 Preparation from Listeria innocua | Antimicrobial to control L. monocytogenes in brie, cheddar, Swiss, and other cheeses that are normally aged and ripened | Scientific procedures | Apr. 20, 2006 | Oct. 17, 2006 | |
| 197 | Degussa Food Ingredients GmbH | Phosphatidylserine | Ingredient in yogurt (excluding fat-free yogurts), powdered milk, ready to drink soymilk, meal replacements, cereal bars, powdered beverage mixes, chewing gum, and breakfast cereals at 20 milligrams per serving | Scientific procedures | Mar. 24, 2006 | Sept. 20, 2006 | |
| 196 | Snow Brand Milk Products Co., Ltd., AND IAS Co., Ltd. |
Bovine milk basic protein fraction | Ingredient in certain foods and beverages at 10 - 40 milligrams per serving | Scientific procedures | Mar. 8, 2006 | Sept. 1, 2006 | |
| 195 | Novozymes North America, Inc. | Mixed beta-Glucanase and xylanase enzyme preparation from Humicola insolens | Use in the brewing industry as an enzyme for clarifying beer | Scientific procedures | Mar. 3, 2006 | Sept. 21, 2006 | |
| 194 | Freezing Machines, Inc. | Carbon monoxide | Use in brine and modified atmospheric packaging for red meat products | Scientific procedures | Mar. 2, 2006 | ||
| 193 | Peluva Biotech | Fish oil (predominantly sardine and anchovy); tuna oil | Use as direct food ingredients in the food categories listed in 21 CFR 184.1472(a)(3) at levels that are no more than 67 percent of the levels specified in 21 CFR 184.1472(a)(3) | Scientific procedures | Feb. 7, 2006 | Aug. 3, 2006 | |
| 192 | Enzymotec Ltd. | High 2-palmitic vegetable oil | Use in term infant and pre-term infant formulas; in baby and toddler foods, including meat and poultry products; and in food in general, excluding meat and poultry products | Scientific procedures | Feb. 6, 2006 | Aug. 3, 2006 | |
| 191 | Ventria Bioscience | Lysozyme (human) purified from rice | Ingredient in term infant formulas at levels up to 0.6 grams/liter, in pre-term infant formulas and fortifiers at levels up to 0.3 grams/liter, and in pediatric oral rehydration solutions at levels up to 2 milligrams/milliliter | Scientific procedures | Jan. 26, 2006 | ||
| 190 | The Dow Chemical Company | Hydroxypropyl methylcellulose | Use in food in general including meat products | Scientific procedures | Jan. 17, 2006 | April 6, 2006 | |
| 189 | Pharming Group, N.V. | Lactoferrin (human) purified from bovine milk | Ingredient in meal replacements, yogurt, popsicles, sports beverages, snack bars, frozen diary desserts and mixes | Scientific procedures | Jan. 3, 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.
