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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 2004. Importantly, the table below lists all GRAS notices received in the year 2004, 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 |
|---|---|---|---|---|---|---|---|
| 162 | Ventria Bioscience | Lactoferrin (human) purified from rice | Ingredient in foods and beverages at levels not to exceed 1000 milligrams (mg)/serving and in medical foods at levels not to exceed 1 mg/milliliter | Scientific procedures | Dec. 22, 2004 | Nov. 16, 2006 | |
| 161 | Englehard Corporation | Chlorine dioxide, generated using sodium chlorite in calcined or sulfated kaolin clay | Used in packaging materials for fresh fruits and vegetables | Scientific procedures | Dec. 15, 2004 | Apr. 4, 2005 | |
| 160 | Nutrinova Nutrition Specialities & Food Ingredients GmbH | Micro-algal oil (Ulkenia sp.) | For use as a direct food ingredient in the food categories listed in 21 CFR 184.1472(a)(3) at levels that are no more than 40 percent of the levels specified in 21 CFR 184.1472(a)(3) and not to be combined with any other added oil that is a significant source of EPA or DHA | Scientific procedures | Nov. 19, 2004 | Apr. 1, 2005 | |
| 159 | Griffith Laboratories | Carnobacterium maltaromaticum strain CB1 | Used to inhibit the growth of Listeria monocytogenes in ready-to-eat meat products | Scientific procedures | Oct. 20, 2004 | May 27, 2005 | |
| 158 | Novozymes North America Inc. | Lipase preparation from Aspergillus niger expressing a gene encoding a lipase from Candida antartica | Use as an enzyme in the production of triglyceride products | Scientific procedures | Oct. 13, 2004 | Mar. 16, 2005 | |
| 157 | Solutia Inc. | Calcium propionate (alternative method of manufacture) | Described in 21 CFR 184.1221 | Scientific procedures | Aug. 13, 2004 | Dec. 13, 2004 | |
| 156 | LycoRed Natural Products Industries, Ltd. | Tomato lycopene extract 6 percent, tomato lycopene extract 1.5 percent, and crystallized tomato lycopene extract | Ingredients in baked goods, breakfast cereals, cheeses, condiments and relishes, confections, dairy product analogs, frozen dairy desserts, gelatins, puddings and fillings, grain products, gravies and sauces, jams and jellies, meat products, milk products, processed vegetables and vegetable juices, snack foods, soft candies, and soups and soup mixes at a maximum final concentration of lycopene in food of 10 milligrams/kilogram | Scientific procedures | Aug. 11, 2004 | Feb. 7, 2005 | |
| 155 | Wacker Chemical Corporation | alpha-Cyclodextrin | Use in selected foods, except meat and poultry, for fiber supplementation, as a carrier or stabilizer for flavors (flavor adjuvant), as a carrier or stabilizer for colors, vitamins and fatty acids and to improve mouthfeel in beverages | Scientific procedures | Jun. 30, 2004 | Dec. 22, 2004 | |
| 154 | Fiberstar, Inc. | Dried orange pulp | Use in baked goods, pastas, salad dressings, confectionery, processed cheese spreads, non-carbonated beverages and fruit drinks, frozen food entrees, such as frozen doughs, frozen meat products, frozen baked goods, frozen desserts, and frozen dairy products, and meat and poultry products at a maximum use level of 5 percent | Scientific procedures | Jun. 21, 2004 | Dec. 13, 2004 | |
| 153 | Cognis Corporation | Conjugated linoleic acid | Ingredient in yogurt, meal replacement beverages, meal replacement bars, fruit juices, milk-based fruit drinks, and milk-based beverages at a level of 1680 milligram per serving; in liquid cream substitute, powdered cream substitute, and milk chocolate at a level of 400 milligram per serving | Scientific procedures | Jun. 15, 2004 | Aug. 16, 2004 | |
| 152 | Kraft Foods Global | Sodium iron EDTA | Use in iron fortification of powdered soft drinks in areas of the world with a high prevalence of iron deficiency at a level of 2.5 milligram iron/200 milliliter of reconstituted beverage | Scientific procedures | Jun. 15, 2004 | Dec. 9, 2004 | |
| 151 | Frito-Lay, Inc. | Ethanol (ethyl alcohol) | Use as a preservative in the filling used in shelf-stable croissants at a concentration of 3000 ppm | Scientific procedures | May 14, 2004 | Oct. 29, 2004 | |
| 150 | Cargill, Inc. | Glucosamine hydrochloride prepared from chitin obtained from Aspergillus niger | Use in certain beverages at 0.75 g glucosamine hydrochloride per 8 ounce serving | Scientific procedures | Apr. 13, 2004 | Sept. 9, 2004 | |
| 149 | Novozymes North America Inc. | Beta-glucanase enzyme preparation from Trichoderma harzianum | Use as an enzyme to improve the clarification and filtration of wines | Scientific procedures | Mar. 31, 2004 | Sept. 27, 2004 | |
| 148 | Loders Croklaan B. V. | Vegetable oil conjugated linoleic acid preparation | Ingredient in yogurt, milk-based meal replacements, frozen or shelf-stable plate meals (with meat, poultry, or fish as the major ingredient), bars (e.g., protein, breakfast, meal replacement, granola, power), and low-calorie and reduced calorie salad dressings (and similar non-standardized versions of standardized foods), at levels ranging from 0.3 to 3.0 percent conjugated linoleic acid | Scientific procedures | Mar. 16, 2004 | Aug. 31, 2004 | |
| 147 | Proteus Industries, Inc. | Extracted "seafood species" protein | Use as a protein source in finished seafood products of the same species as the extracted seafood protein | Scientific procedures | Mar. 10, 2004 | Aug. 26 , 2004 | |
| Additional correspondence clarifying the subject of the notice: Nov. 14, 2008 | |||||||
| Use in fresh or frozen seafood (1) as a protein coating (only) by dip; (2) applied as a portion of the batter (only); or; (3) as a portion of the batter and coating (together), added to seafood of the same species or to a secondary processed seafood product of a different species, and identified as "(species) protein" on the finished product label | Additional correspondence about intended uses: Nov. 21, 2008 | ||||||
| 146 | Jedwards International | Salmon oil | For use as a direct food ingredient in the food categories listed in 21 CFR 184.1472(a)(3) and not to be combined or augmented with any other food ingredient containing EPA and DHA | Scientific procedures | Feb. 20, 2004 | Aug. 17, 2004 | |
| 145 | Genencor International, Inc. | Phospholipase A2 enzyme preparation from Streptomyces violaceoruber | Use as a enzyme to hydrolyze soy and egg yolk lechithins | Scientific procedures | Feb. 11, 2004 | Jul. 29, 2004 | |
| 144 | Linguagen Corp. | Adenosine 5'-monophosphoric acid and its monosodium and disodium salts | Use as a flavor enhancer in chewing gum, coffee and tea, snack foods, novelty snacks, soups and soup mixes (including meat and poultry), and sugar substitutes (as defined by those food categories in 21 CFR 170.3(n)(6), (7), (37), (40), and (42), respectively), and salt substitutes | Scientific procedures | Feb. 6, 2004 | Jul. 29, 2004 | |
| 143 | Precept Foods, LLC. | Carbon monoxide | Use as a component of a modified atmosphere packaging (MAP) system for case-ready fresh beef and pork | Scientific procedures | Jan. 12, 2004 | Jul. 29, 2004 |
(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.
