|
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 2008. Importantly, the table below lists all GRAS notices received in the year 2008, 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 |
|---|---|---|---|---|---|---|---|
| 271 | Nestle USA, Inc. | Ferrous ammonium phosphate | Use in foods in general as a source of dietary iron for food enrichment and fortification purposes consistent with iron supplementation guidelines | Scientific procedures | Dec. 12, 2008 | ||
| 270 | Stephan Co. | Polyglycerol polyricinoleic acid | As an emulsifier in the formulation of color additives | Scientific procedures | Dec. 3, 2008 | ||
| 269 | Taiyo-Kagaku Co., Ltd. | Polyglycerol fatty acid esters | As an emulsifier within the meaning of 21 CFR 170.3 (n)(8) at levels ranging from 0.05-0.5 percent in food, including zinc- or iron- providing dietary supplements and as cloud inhibitors within the meaning of 21 CFR 170.3(n)(24) at levels ranging 0.05-0.5 percent in vegetable oils and salad oil | Scientific procedures | Nov. 25, 2008 | ||
| 268 | Morinaga Milk Industry Co., Ltd | Bifidobacterium longum BB536 | As a food ingredient in a variety of foods at a maximum level of 1 x 1010 colony forming units per serving | Scientific procedures | Nov. 21, 2008 | ||
| 267 | Amano Enzyme, Inc. | Protein-glutaminase enzyme preparation derived from Chryseobacterium proteolyticum | To enhance the functionality of proteins (casein, whey, protein, dried egg white, soy, and wheat protein) at levels of 0.49% by weight of the protein ingredient or as a food ingredient in foods such as breads, noodles, tofu, fish and meat-derived products, cheese, certain beverages, and seasonings at a rate of 0.09% of the protein content of the food | Scientific procedures | Nov. 14, 2008 | ||
| 266 | Palsgaard A/S | Polyglycerol polyricinoleate | As an emulsifier in vegetable fat coatings at levels of 0.1 - 0.3% to achieve the desired effect and in accordance with good manufacturing practice | Scientific procedures | Nov. 14, 2008 | ||
| 265 | Genencor, a Danisco Division | Glycerophospholipid cholesterol acyltransferase (GCAT) enzyme preparation produced by Bacillus licheniformis expressing the gene encoding GCAT enzyme from Aeromonas salmonicida subsp. salmonicida | To modify phospholipids to lyso-phospholipids and cholesterol ester in egg yolk, improve the emulsification of processed meat products and contribute to better consistency and reduce cooking loss, for the degumming of vegetable oils, increase yield in milk products like cheese, to give a softer and more tender crumb in bakery products containing eggs. The enzyme will be used at minimum levels to achieve the desired effect and according to good manufacturing practices | Scientific procedures | Nov. 7, 2008 | ||
| 264 | George Weston Foods Ltd. | Sweet lupin flour | Ingredient in baked goods and baking mixes and grain products and pastas at a maximum level of 25 per cent | Scientific procedures | Oct. 8, 2008 | ||
| 263 | George Weston Foods Ltd. | Sweet lupin fiber | Ingredient in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, jams and jellies, processed fruits and fruit juices and soft candy at levels ranging from 1 to 20 per cent | Scientific procedures | Oct. 8, 2008 | ||
| 262 | George Weston Foods Ltd. | Sweet lupin protein | Ingredient in baked goods and baking mixes, dairy product analogs, frozen dairy desserts and mixes, gelatins, puddings, and fillings, jams and jellies, meat products, milk products and soft candy at levels ranging from 1 to 20 per cent | Scientific procedures | Oct. 8, 2008 | ||
| 261 | Grain Millers, Inc. | Oat hull fiber | Ingredient in bread, pizza crust, cookies, crackers, bars, cereal, baby food cereal, and snacks | Scientific procedures | Sept. 22, 2008 | ||
| 260 | Cypress Systems, Inc. | High-selenium yeast | As a source of selenium in baked products, non-alcoholic beverages, breakfast cereals, grain products and pastas, milk products, processed fruits and fruit juices, processed vegetables and vegetable juices, commercial soups and soup mixes and medical foods at levels yielding 5 micrograms of selenium per serving | Scientific procedures | Sept. 12, 2008 | ||
| 259 | Kao Corporation | Catechins from green tea extract | Ingredient in bottled teas, sport drinks, carbonated soft drinks and juices at levels up to 540 milligrams per serving | Scientific procedures | Sept. 8, 2008 | ||
| 258 | Cargill, Inc. | Sucromalt | As a nutritive sweetener in baked goods, non-alcoholic beverages, alcoholic beverages, breakfast cereals, chewing gum, condiments and relishes, confectionery and frostings, frozen dairy, fruit ices, gelatins and puddings, hard candy, dairy products, non-dairy analogs, jams and jellies, milk, milk products, processed fruits and fruit juices, snack foods, soft candy, sweet sauce, and salad dressings at use levels of 1.5% to 85% | Scientific procedures | Sept. 8, 2008 | ||
| 257 | Pharma Foods International Co., Ltd. | gamma-Amino butyric acid | Ingredient in beverages and beverage bases, chewing gum, ready-to-drink coffee and tea products, and candy at levels ranging from 0.04% to 4% | Scientific procedures | Aug. 11, 2008 | ||
| 256 | Polar Foods, Inc. | Flaxseed oil | Ingredient in a variety of categories | Scientific procedures | June 10, 2008 | ||
| 255 | 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 | June 9, 2008 | ||
| 254 | BioGaia AB | Lactobacillus reuteri strain DSM 17938 | Ingredient in processed cheeses, yogurt, ice cream, fruit juices, fruit drinks, processed vegetables, processed vegetable drinks, beverage bases, energy bars, energy drinks, and chewing gum at a level up to 109 colony forming units (cfu) per serving, and in a drinking straw at a level of 109 cfu per straw | Scientific procedures | May 29, 2008 | Nov. 18, 2008 | |
| 253 | Cargill, Inc. | Rebaudioside A purified from Stevia rebaudiana (Bertoni) Bertoni | As a general-purpose sweetener in foods, excluding meat and poultry products, provided that food standards of identity do not preclude such use, at levels determined by current good manufacturing practices | Scientific procedures | May 20, 2008 | Dec. 17, 2008 | |
| 252 | Whole Earth Sweetener Company LLC (a wholly owned subsidiary of Merisant Company) | Rebaudioside A purified from Stevia rebaudiana (Bertoni) Bertoni | As a sweetener in a variety of food categories, and as a table top sweetener, formulated to provide 30 milligrams of rebaudioside A per gram of finished product | Scientific procedures | May 13, 2008 | Dec. 17, 2008 | |
| 251 | Vincent Mercogliano | Carbon monoxide | 0.4% carbon monoxide in a modified atmosphere of helium for treatment of fresh red meat prior to vacuum packaging for retail | Scientific procedures | May 8, 2008 | ||
| 250 | Arboris LLC | Pine tree phytosterols | For the existing uses of phytosterols in margarine and vegetable based spreads; yogurt and yogurt like products; milk-based juice beverages; ice cream and non-standardized ice cream products; cream cheese and cream cheese-like products; snack bars; salad dressing; standardized and non-standardized bread products; baked foods; beverages; dairy analogs; cheese and cream; breakfast cereal; mayonnaise; pasta and noodles; sauces; salty snacks; processed soups; puddings; confections; vegetarian meat analogs; fruit/vegetable juice; vegetable oils; egg products, including egg whites and substitute egg products | Scientific procedures | May 5, 2008 | ||
| 249 | SRA International Inc. | Capsiate | Ingredient in a variety of food categories to provide 1 milligram of capsiate per standard serving | Scientific procedures | Apr. 22, 2008 | ||
| 248 | Compass Foods Pte Ltd | Sucrose fatty acid esters (i.e., sucrose monoesters of lauric acid, palmitic acid, and stearic acid) manufactured by reaction of sucrose with vinyl esters of lauric, palmitic, and stearic acids | Use as emulsifiers in fruit-flavored beverages and beverage concentrates, at levels up to 50 milligrams per Liter as consumed | Scientific procedures | Apr. 10, 2008 | Oct. 24, 2008 | |
| 247 | TIC Gums, Inc. | Modified gum acacia | Use as an emulsifier in icings, salad dressings, sauces, pure fruit juices (100 percent), select fruit flavored drinks, select beverages, select breads (whole grain and high fiber breads), and select cereals (low fat, low sugar and high fiber health foods) at levels from 350 to 10,000 milligrams per kilogram | Scientific procedures | Apr. 9, 2008 | Oct. 7, 2008 | |
| 246 | BioNeutra Inc. | Isomalto-oligosaccharides | As a sweetener in conventional foods at levels ranging from 1.5 to 15 grams per serving | Scientific procedures | Apr. 4, 2008 | ||
| 245 | NattoPharma ASA | Menaquinone-7 | As a nutrient supplement in dairy products, margarine substitutes, and dairy products including yoghurt, cottage cheese, hard cheeses, milk drinks and substitute products at levels up to 50 micrograms per day | Scientific procedures | Apr. 2, 2008 | June 2, 2008 | |
| 244 | Kohjin Co., Ltd. | Glutathione | Ingredient in several food categories, including meat products, at levels ranging from 5 to 300 milligrams per serving; and in milk- and soy-based infant formula at levels up to 0.167 grams per 100 milliliters | Scientific procedures | Feb. 14, 2008 | May 9, 2008 | |
| 243 | Bioenergy, Inc. | D-Ribose | Ingredient in several food categories provided that D-ribose is used in conjunction with an additional carbohydrate energy source | Scientific procedures | Feb. 8, 2008 | Nov. 10, 2008 | |
| 242 | Neptune Technologies and Bioressources | Krill oil | Use as a direct food ingredient in breakfast cereals, cheese, beverages (nonalcoholic), fruit juices, frozen dairy desserts, milk products, and medical foods at levels up to 500 milligrams per serving | Scientific procedures | Feb. 4, 2008 | Oct. 14, 2008 | |
| 241 | Cypress Systems, Inc. | High-selenium yeast | Ingredient in baked products, non-alcoholic beverages, breakfast cereals, grain products and pastas, milk products, processed fruits/fruit juices, processed vegetables/ vegetables juices, commercial soups and soup mixes and medical foods as a source of selenium at levels yielding 5 micrograms selenium per serving | Scientific procedures | Jan. 30, 2008 | Apr. 9, 2008 | |
| 240 | PURAC | Corn, cane, or beet sugar cultured with Lactobacillus paracasei subsp. paracasei, Bacillus coagulans LA-1, or Propionibacterium freudenreichii subsp. shermanii, or mixtures of these microorganisms | Use as an antimicrobial agent in meat and poultry products at a level of 4.8 percent | Scientific procedures | Jan. 28, 2008 | Oct. 24, 2008 | |
| 239 | Biothera, Inc. | Bakers yeast beta-glucan | Ingredient in a variety of food products including baked goods and baking mixes, beverages and beverage bases, cereals and cereal products, dairy product analogs, milk and milk products, plant protein products, processed fruits and fruit juices, soft candy, soups and soup mixes at a level of up to 200 milligrams per serving | Scientific procedures | Jan. 24, 2008 | July 22, 2008 |
(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.
