GRAS Notices Received in 2005

Information about the Notifier, the Intended Use, and the Basis for the GRAS Determination

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:

1. The agency does not question the basis for the notifier's GRAS determination;
2. The agency concludes that the notice does not provide a sufficient basis for a GRAS determination (e.g., because the notice does not include appropriate data and information or because the available data and information raise questions about the safety of the notified substance); or
3. The response letter states that the agency has, at the notifier's request, ceased to evaluate the GRAS notice.

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:

• Identifies each GRAS notice by a number (GRN No.);
• Identifies the name of the person who made the GRAS determination (notifier), with a hyperlink to the notifier's address;
• Identifies the substance that is the subject of each notice;
• Describes the intended use of the substance;
• Includes the petition number if the substance was originally the subject of a GRAS petition;
• Identifies the statutory basis for the GRAS determination;
• Identifies the date when FDA received the notice;
• Includes the date when the evaluation process came to closure, with a hyperlink to the agency's response to the notice; and
• When applicable, provides a hyperlink to additional correspondence that FDA has issued regarding the GRAS notice.

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.

List of GRAS Notices Received in 2005

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.