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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 2007. Importantly, the table below lists all GRAS notices received in the year 2007, 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, 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 |
|---|---|---|---|---|---|---|---|
| 238 | Genencor, a Danisco Division | Lipase enzyme preparation derived from Hansenula polymorpha expressing a gene encoding a lipase from Fusarium heterosporum | As an enzyme to modify lipids in dough for bakery and noodle applications, in egg yolks for bakery applications and mayonnaise production, and in the refining process of soy bean oil | Scientific procedures | Dec. 27, 2007 | July 28, 2008 | |
| 237 | Cognis Corporation | Alkyl polyglycosides | Use in the cleaning of foods, including fruits, vegetables, meat, and poultry products | Scientific procedures | Dec. 19, 2007 | Oct. 14, 2008 | |
| 236 | Friesland Foods Domo | Galacto-oligosaccharides | Ingredient in term infant formula at a level of 5 grams (g) per liter, and in bars, yogurt, frozen dairy desserts, fruit drinks and energy drinks, fitness water and thirst quenchers, fruit pie filling, fruit preparation, jelly and jam, baby juice, baby yogurt drink, baby dessert, baby snack, milk, milk drinks, syrup flavorings for milk, meal replacement drinks, meal replacement drinks for children, and milk substitutes at levels ranging from 1 to 7.5 g per serving | Scientific procedures | Nov. 7, 2007 | July 28, 2008 | |
| 235 | Ventria BioScience | Lactoferrin (human) purified from rice | Ingredient in oral rehydration solutions at levels not to exceed 1.0 milligrams per milliliter | Scientific procedures | Oct. 19, 2007 | ||
| 234 | Proliant Health Ingredients Inc. | Bovine globulin | Ingredient in dairy foods, juices, snack foods, beverages and meal replacements at maximum levels of 5 per cent of the finished product | Scientific procedures | Sept. 17, 2007 | Feb. 14, 2008 | |
| 233 | Mead Johnson & Company | Galactooligosaccharides and polydextrose | Ingredients in milk-based term infant formulas, at levels not to exceed 5.0 grams per liter (g/l) and 2.5 g/l, respectively | Scientific procedures | Sept. 5, 2007 | ||
| 232 | Lipid Nutrition B.V. AND Cognis GmbH |
Conjugated linoleic acid isomers | Ingredient in certain specified foods within the general categories of soy milk, meal replacement beverages and bars, milk products and fruit juices at levels not to exceed 1.5 grams per serving | Scientific procedures | Aug. 13, 2007 | July 11, 2008 | |
| 231 | Mead Johnson & Company | Lactobacillus casei subsp. rhamnosus strain GG | Ingredient in term infant formula, at levels not to exceed 108 colony forming units per gram of powdered formula | Scientific procedures | Aug. 9, 2007 | May 29, 2008 | |
| 230 | Genencor, A Danisco Division | Chymosin enzyme preparation from Trichoderma reesei expressing the bovine prochymosin B gene | As an enzyme for milk coagulation during cheese making | Scientific procedures | July 27, 2007 | Feb. 19, 2008 | |
| 229 | Bergstrom Nutrition | Methylsulfonylmethane | Ingredient in meal supplement and meal replacement foods, fruit smoothie-type drinks and fruit-flavored thirst quencher-type beverages at levels up to 4000 milligrams per kilogram (mg/kg); and in food bars such as granola bars and energy-type bars at levels up to 30,000 mg/kg | Scientific procedures | July 25, 2007 | Feb. 18, 2008 | |
| 228 | Bemis Company, Inc | Sodium nitrite | Addition to the surface of raw beef via migration from packaging film to maintain the characteristic color of raw beef at a maximum level of 113 miligrams per square meter | Scientific procedures | July 10, 2007 | ||
| 227 | The Procter & Gamble Company | Olestra | Use as a total replacement for fats and oils in pre-packaged, ready-to-eat cookies | Scientific procedures | June 27, 2007 | Oct. 9, 2008 | |
| 226 | Enzymotec Ltd. | Lecithin derived from krill | Ingredient in breakfast bars at a level of 3.8 per cent, dairy product analogs (soy products) and milk-based beverages at a level of 0.6 per cent, fat spreads at a level of 10 per cent, yogurt at a level of 0.7 per cent, and soft candy at a level of 3.3 per cent | Scientific procedures | May 31, 2007 | Jan. 3, 2008 | |
| 225 | Kao Corporation | Catechins from green tea extract | Ingredient in beverages, including bottled teas, sport drinks, carbonated soft drinks and juice, at levels according to current good manufacturing practices | Scientific procedures | May 24, 2007 | Nov. 26, 2007 | |
| 224 | ATLA Holdings, LLC | trans-Resveratrol | Ingredient in bottled water products at levels up to 10 milligrams per liter | Scientific procedures | May 22, 2007 | Aug. 1, 2007 | |
| 223 | Enzymotec Ltd. | Phosphatidylserine | Ingredient in milk, flavored milk, milk drinks (excluding milk, fluid), milk imitation (soy milk), milk-based meal replacement , yogurt, breakfast bars, and fruit flavored drink at levels of 100 milligrams (mg) phosphatidylserine per serving and in breakfast cereals and milk, fluid at 50 mg/serving | Scientific procedures | May 22, 2007 | Dec. 20, 2007 | |
| 222 | Laboratorios Miret S.A. (LAMIRSA) | Citric acid esters of mono- and diglycerides | As an emulsifier in combination with lauramide ethyl ester in food in general, including meat and poultry | Scientific procedures | May 1, 2007 | Dec. 20, 2007 | |
| 221 | Kemin Health, L.C. | Suspended lutein | Ingredient in term infant formula at a maximum level of 250 micrograms/liter | Scientific procedures | Apr. 11, 2007 | Oct. 23, 2007 | |
| 220 | San-Ei Gen F.F.I., Inc. | alpha-Glycosyl isoquercitrin | As an antioxidant in multiple food categories at 150 milligrams per kilogram (mg/kg) and in chewing gum at 1500 mg/kg | Scientific procedures | Apr. 4, 2007 | Nov. 19, 2007 | |
| 219 | Palsgaard A/S | Ammonium phosphatide | As an emulsifier in chocolate and vegetable fat coatings at levels up to 0.7% | Scientific procedures | Jan. 3, 2007 | June 29, 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.
