Summary of All GRAS Notices

The summary tables that are immediately below provide the following information about GRAS notices received within each year since 1998, when FDA received its first GRAS notice:

• The name of the substance
• The file number (GRN No.) that FDA has assigned to the notice
• A hyperlink to the letter that FDA sent in response to the notice

Within the summary table for each year, there is a hyperlink to a table that provides more details about the GRAS notices received in that year. This "detailed table" includes:

• The name of the notifier
• The intended conditions of use

Within the detailed table for each year, there is a hyperlink to the address of the notifier

These tables are current as of August 31, 2004, and therefore, do not show any new notices filed by FDA, or response letters issued by FDA, after that date. These tables will be updated approximately monthly.

For further information about the GRAS notification program, telephone Dr. Paulette Gaynor at (202) 418-3079 or send a question by electronic mail to premarkt@cfsan.fda.gov.

List of the substances that are the subject of each GRAS Notice and
the file number that FDA has assigned to the notice (GRN No.).

GRAS Notices Received in 2004

Details about Notices Received in 2004 (GRN No. 143-156)
GRN No.	Substance	FDA's Letter
156	Tomato lycopene extract	Pending
155	alpha-Cyclodextrin	Pending
154	Dried orange pulp	Pending
153	Conjugated linoleic acid	Pending
152	Sodium iron EDTA	Pending
151	Ethanol (ethyl alcohol)	Pending
150	Glucosamine hydrochloride prepared from chitin obtained from Aspergillus niger	Pending
149	Beta-glucanase enzyme preparation from Trichoderma harzianum	Pending
148	Vegetable oil conjugated linoleic acid preparation	Pending
147	Fish protein	FDA has no questions
146	Salmon oil	FDA has no questions
145	Phospholipase A2 enzyme preparation from Streptomyces violaceoruber	FDA has no questions
144	Adenosine 5'-monophosphoric acid and its monosodium and disodium salts	FDA has no questions
143	Carbon monoxide	FDA has no questions

GRAS Notices Received in 2003

Details about Notices Received in 2003 (GRN Nos. 120 - 142)
GRN No.	Substance	FDA's Letter
142	Phospholipase enzyme preparation from Aspergillus oryzae expressing the gene encoding a phospholipase A1 from Fusarium venenatum	FDA has no questions
141	Polyvinyl alcohol	FDA has no questions
140	Crystalline lutein	FDA has no questions; some uses may require a color additive listing
139	Cassia gum	At notifier's request, FDA ceased to evaluate the notice.
138	Fish oil	FDA has no questions
137	Algal oil (Schizochytrium sp.)	FDA has no questions
136	Calcium gluconate	FDA has no questions
135	ε-Polylysine	FDA has no questions
134	Soy protein hydrolyzate with enzyme-modified lecithin	FDA has no questions
133	Volatile oil of mustard	FDA has no questions
132	Lactase enzyme preparation from Aspergillus niger	FDA has no questions
131	High 2-palmitic vegetable oil	FDA has no questions
		Additional correspondence
130	Bovine milk-derived lactoferrin	FDA has no questions
		Additional correspondence
129	Sucrose fatty acid esters	FDA has no questions
128	Skim milk or dextrose cultured with Propionibacterium freudenreichii subsp. shermanii	FDA has no questions
127	Spirulina, the dried biomass of Arthrospira platensis	FDA has no questions; some uses may require a color additive listing
126	Alpha-amylase enzyme preparation from Pseudomonas fluorescens Biovar I expressing a gene encoding a hybrid alpha-amylase derived from three microorganisms within the order Thermococcales	FDA has no questions
125	Grape seed extract and grape pomace extract	FDA has no questions; some uses may require a color additive listing
124	Grape seed extract	FDA has no questions
123	Laminaria japonica broth and extract powder	FDA has no questions
122	Laccase enzyme preparation produced by Aspergillus oryzae expressing the gene encoding a laccase from Myceliophthora thermophila	FDA has no questions
121	Xanthan gum	FDA has no questions
120	Saccharomyces cerevisiae strain ML01 carrying a gene encoding the malolactic enzyme from Oenococcus oeni and a gene encoding malate permease from Schizosaccharomyces pombe	FDA has no questions

GRAS Notices Received in 2002

Details about Notices Received in 2002 (GRN Nos. 94 - 119)
GRN No.	Substance	FDA's Letter
119	Synthetic lycopene	FDA has no questions; some uses may require a color additive listing
118	Inulin	FDA has no questions
117	Ice structuring protein preparation	FDA has no questions
116	Carrot fiber	FDA has no questions
115	Diacylglycerol oil	FDA has no questions
114	Pectate lyase enzyme preparation from Bacillus subtilis	FDA has no questions
113	Lipase enzyme preparation from Aspergillus oryzae	FDA has no questions
112	Phytosterols	FDA has no questions
111	Lipase enzyme preparation from Aspergillus niger	FDA has no questions
110	Lutein esters	FDA has no questions; some uses may require a color additive listing
109	Tuna oil	FDA has no questions
108	Glycerol ester of gum rosin	Notice does not provide a basis for a GRAS determination
107	Polydextrose	At notifier's request, FDA ceased to evaluate the notice
106	Glucose oxidase enzyme preparation from Aspergillus oryzae carrying a gene encoding a glucose oxidase from Aspergillus niger	FDA has no questions
105	Fish oil concentrate	FDA has no questions
104	Sucrose acetate isobutyrate	FDA has no questions
103	Lipase enzyme preparation from Aspergillus oryzae carrying a gene constructed from a modified Thermomyces lanuginosus lipase gene and a portion of the Fusarium oxysporum lipase gene	FDA has no questions
102	Small planktivorous pelagic fish body oil	FDA has no questions
101	Spirulina	At notifier's request, FDA ceased to evaluate the notice. Resubmitted as GRN No. 127
100	D-Ribose	Notice does not provide a basis for a GRAS determination
99	Pullulan	FDA has no questions
98	Small planktivorous pelagic fish body oil	At notifier's request, FDA ceased to evaluate the notice. Resubmitted as GRN No. 102
97	Tuna oil	At notifier's request, FDA ceased to evaluate the notice. Resubmitted as GRN No. 109
96	Silk protein food powder	Notice does not provide a basis for a GRAS determination
95	Transglutaminase from Streptoverticillium mobaraense	FDA has no questions
94	Docosahexaenoic acid-rich oil from tuna (DHA-rich tuna oil) and arachidonic acid-rich oil from Mortierella alpina (AA-rich fungal oil)	Pending

GRAS Notices Received in 2001

Details about Notices Received in 2001 (GRN Nos. 66 - 93)
GRN No.	Substance	FDA's Letter
93	Grape seed extract and grape skin extract	Notice does not provide a basis for a GRAS determination. Resubmitted as GRN No. 125
92	Sucrose fatty acid esters	Notice does not provide a basis for a GRAS determination. Follow-up submitted as GRN No. 129
91	Mycoprotein	FDA has no questions
90	Carbohydrase enzyme preparation from Aspergillus oryzae, protease enzyme preparation from Aspergillus oryzae, and carbohydrase enzyme preparation from Rhizopus oryzae	FDA has no questions
		Additional correspondence
89	Five enzyme preparations from Aspergillus niger: Carbohydrase enzyme preparation, catalase enzyme preparation, glucose oxidase enzyme preparation, pectinase enzyme preparation, and protease enzyme preparation	FDA has no questions
		Additional correspondence
88	Invertase enzyme preparation from Saccharomyces cerevisiae and lactase enzyme preparation from Kluyveromyces marxianus	FDA has no questions
87	Composite filtration media (diatomaceous earth and perlite)	FDA has no questions
86	Coagulated potato protein, hydrolyzed potato protein, or clarified hydrolyzed potato protein	FDA has no questions
85	Isoamylase from Pseudomonas amyloderamosa	FDA has no questions
84	Arabinogalactan from Eastern Larch (Larix laricina)	FDA has no questions
83	Carbon monoxide	FDA has no questions
82	1,1,1,2-Tetrafluoroethane (HFC-134a)	FDA has no questions
81	Lipase from Candida rugosa	FDA has no questions
80	ARASCO (arachidonic acid-rich single-cell oil)	FDA has no questions
79	Alpha-amylase derived from Bacillus licheniformis carrying a gene encoding a modified alpha-amylase from Bacillus licheniformis	FDA has no questions
78	D-Tagatose	FDA has no questions
77	Milk-derived lactoferrin	FDA has no questions
76	Erythritol	FDA has no questions
75	Lipase derived from Aspergillus oryzae carrying a gene encoding lipase from Fusarium oxysporum	FDA has no questions
74	Beta-cyclodextrin	FDA has no questions
73	Shrimp-derived chitosan	At notifier's request, FDA ceased to evaluate the notice
72	Pullulanase derived from Bacillus licheniformis carrying a gene encoding pullulanase from B. deramificans	FDA has no questions
71	White mineral oil, USP (viscosity ISO 100 )	FDA has no questions
70	Stearyl alcohol	FDA has no questions
69	Behenic acid	FDA has no questions
68	Lipase from Penicillium camembertii	FDA has no questions
67	Milk-derived lactoferrin	FDA has no questions
66	Milk thistle extract	Notice does not provide a basis for a GRAS determination

GRAS Notices Received in 2000

Details about Notices Received in 2000 (GRN Nos. 36 - 65)
GRN No.	Substance	FDA's Letter
65	Nisin	FDA has no questions
64	Egg white lysozyme	FDA has no questions
63	Hops beta acids	FDA has no questions
62	Chlorine dioxide generated from particles (<30µm) composed of sodium polyphosphate, magnesium sulfate, sodium silicate and sodium chlorite that are incorporated into low density polyethylene (LDPE) food-packaging films, at levels not exceeding 17.5 µg chlorite/in2 of finished package film	FDA has no questions
		Additional correspondence about intended uses
61	Plant sterols/Plant sterol esters	FDA has no questions
60	Potassium bisulfate	FDA has no questions
59	Hydrogenated starch hydrolysate	At notifier's request, FDA ceased to evaluate the notice
58	Gum arabic	At notifier's request, FDA ceased to evaluate the notice
57	Argon gas	FDA has no questions
56	Diacylglycerol oil	FDA has no questions
55	Transglutaminase from Streptoverticillium mobaraense	FDA has no questions
54	Xylanase derived from Fusarium venenatum carrying a gene encoding xylanase from Thermomyces lanuginosus	FDA has no questions
53	Phytosterol esters	FDA has no questions
52	Whey mineral concentrate	FDA has no questions
51	Cassia gum from Cassia tora/obtusifolia	At notifier's request, FDA ceased to evaluate the notice. Resubmitted as GRN No. 139
50	Bohenin	FDA has no questions
49	Bifidobacterium lactis strain Bb12 and Streptococcus thermophilus strain Th4	FDA has no questions
48	Vegetable oil phytosterol esters	FDA has no questions
47	Arabinogalactan from Larix occidentalis	FDA has no questions
46	Gamma cyclodextrin	FDA has no questions
45	Trehalose	FDA has no questions
44	Fructooligosaccharide	FDA has no questions
43	Lipase derived from Aspergillus oryzae carrying a gene encoding lipase from Thermomyces lanuginosus	FDA has no questions
42	Milk-derived lactoferrin	Notice does not provide a basis for a GRAS determination. Resubmitted as GRN No. 77
		Additional correspondence clarifying the appropriate mechanism to "supplement" a notice after FDA has responded to that notice
41	DHASCO (docosahexaenoic acid-rich single-cell oil) and ARASCO (arachidonic acid-rich single-cell oil)	FDA has no questions
40	Mineral oil	Notice does not provide a basis for a GRAS determination. Resubmitted as GRN No. 71
39	Tall oil phytosterols	FDA has no questions
		Additional correspondence clarifying intended use
38	Cetylpyridinium chloride	Notice does not provide a basis for a GRAS determination
37	Whey protein isolate and dairy product solids	FDA has no questions
		Additional correspondence clarifying the term "dairy product solids"
36	Chromium picolinate; Ginkgo biloba leaf extract; and Ginseng extract	At notifier's request, FDA ceased to evaluate the notice

GRAS Notices Received in 1999

Details about Notices Received in 1999 (GRN Nos. 13 - 35)
GRN No.	Substance	FDA's Letter
35	Hempseed oil	Notice does not provide a basis for a GRAS determination
34	Aspartic proteinase derived from Aspergillus oryzae carrying a gene encoding aspartic proteinase from Rhizomucor miehei	FDA has no questions
33	Low erucic acid oil derived from Brassica juncea	FDA has no questions
32	Pectin lyase derived from Trichoderma reesei carrying a gene encoding pectin lyase from Aspergillus niger	FDA has no questions
31	Cetylpyridinium chloride	At notifier's request, FDA ceased to evaluate the notice. Resubmitted as GRN No. 38
30	Crospovidone-cranberry juice extract	Notice does not provide a basis for a GRAS determination
		Additional correspondence that does not provide a basis for a GRAS determination
29	Transglutaminase from Streptoverticillium mobaraense	FDA has no questions
28	Seaweed-derived calcium	FDA has no questions
27	Dextranase from Chaetomium gracile	FDA has no questions
26	Isolated wheat protein	FDA has no questions
25	Extract of Garcinia kola seed ("bitter cola")	Notice does not provide a basis for a GRAS determination
24	alpha-Amylase derived from Bacillus licheniformis carrying a gene encoding alpha-amylase from Bacillus stearothermophilus	FDA has no questions
23	Protein preparation from animal blood	At notifier's request, FDA ceased to evaluate the notice
22	alpha-Amylase derived from Bacillus licheniformis carrying a gene encoding a modified alpha-amylase derived from Bacillus lichenformis and Bacillus amyloliquefaciens	FDA has no questions
21	Pork collagen	FDA has no questions
20	Pullulanase derived from Bacillus subtilis carrying a gene encoding pullulanase from Bacillus naganoensis	FDA has no questions
19	Ferrous bisglycinate chelate	FDA has no questions
18	Mesquite (Prosopis spp.) wood alcoholic extract	FDA has no questions
17	Arabinogalactan	At notifier's request, FDA ceased to evaluate the notice. Resubmitted as GRN No. 47
16	Menhaden oil	At notifier's request, FDA ceased to evaluate the notice
15	Tasteless smoke	FDA has no questions
14	Hydrogen peroxide	Notice does not provide a basis for a GRAS determination
13	Botanicals: Chrysanthemum; Licorice; Jellywort	FDA has no questions
	Botanicals: Honeysuckle; Lophatherum; Mulberry leaf; Frangipani; Selfheal; Sophora flower bud	Notice does not provide a basis for a GRAS determination

GRAS Notices Received in 1998

Details about Notices Received in 1998 (GRN Nos. 1 - 12)
GRN No.	Substance	FDA's Letter
12	Mesquite wood alcoholic extract	At notifier's request, FDA ceased to evaluate the notice. Resubmitted as GRN No. 18
11	Calcium casein peptone-calcium phosphate	FDA has no questions
10	Exopeptidase derived from Aspergillus oryzae carrying a gene encoding a leucine aminopeptidase from Aspergillus sojae	Notice does not provide a basis for a GRAS determination
9	Polyglycerol polyricinoleic acid	FDA has no questions
8	Pectin esterase derived from Aspergillus oryzae carrying a gene encoding pectin esterase from Aspergillus aculeatus	FDA has no questions
7	ARASCO (arachidonic acid-rich single-cell oil) and DHASCO (docosahexaenoic acid-rich single-cell oil) as sources of the fatty acids ARA (arachidonic acid) and DHA (docosahexaenoic acid)	Notice does not provide a basis for a GRAS determination. Resubmitted as GRN No. 41
6	Dioctyl sodium sulfosuccinate	FDA has no questions
5	Tasteless smoke	At notifier's request, FDA ceased to evaluate the notice. Resubmitted as GRN No. 15
4	Transglutaminase from Streptoverticillium mobaraense	FDA has no questions
3	Sodium bisulfate	FDA has no questions
2	Solin oil (low linolenic acid flaxseed oil or low linolenic acid linseed oil)	FDA has no questions
1	Soy isoflavone extract	At notifier's request, FDA ceased to evaluate the notice

⁽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.