FDA Logo U.S. Food and Drug AdministrationCenter for Food Safety and Applied Nutrition
U.S. Department of Health and Human Services
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CFSAN/Office of Food Additive Safety
December 2008

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Alphabetical Listing of GRAS Notices

The summary tables that are immediately below provide the following information about GRAS notices:

More detailed information about the GRAS notices is available from the Numerical Listing of GRAS Notices page. For further information about the GRAS notification program, telephone Dr. Paulette Gaynor at (301) 436-1192 or send a question by electronic mail to .

A B C D E F G H I K L M N O P Q R S T V W X

GRN No. Substance FDA's Letter
A
215 Actinidia arguta extract FDA has no questions
144 Adenosine 5'-monophosphoric acid and its monosodium and disodium salts FDA has no questions
137 Algal oil (Schizochytrium sp.) FDA has no questions
237 Alkyl polyglycosides FDA has no questions
180 Allyl isothiocyanate FDA has no questions
257 gamma-Amino butyric acid Pending
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
79 alpha-Amylase derived from Bacillus licheniformis carrying a gene encoding a modified alpha-amylase from Bacillus licheniformis FDA has no questions
24 alpha-Amylase derived from Bacillus licheniformis carrying a gene encoding alpha-amylase from Bacillus stearothermophilus FDA has no questions
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
219 Ammonium phosphatide FDA has no questions
17 Arabinogalactan At notifier's request, FDA ceased to evaluate the notice.
Resubmitted as GRN No. 47
84 Arabinogalactan from Eastern Larch (Larix laricina) FDA has no questions
47 Arabinogalactan from Larix occidentalis FDA has no questions
80 ARASCO (arachidonic acid-rich single-cell oil) 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
57 Argon gas FDA has no questions
214 Asparaginase enzyme preparation from Aspergillus niger expressing the asparaginase gene from A. niger FDA has no questions
201 Asparaginase enzyme preparation from Aspergillus oryzae expressing the asparaginase gene from A. oryzae FDA has no questions
34 Aspartic proteinase derived from Aspergillus oryzae carrying a gene encoding aspartic proteinase from Rhizomucor miehei FDA has no questions
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
B
218 Bacteriophage P100 preparation from Listeria innocua FDA has no questions
198 Bacteriophage P100 Preparation from Listeria innocua FDA has no questions
239 Bakers yeast beta-glucan FDA has no questions
207 Barley fiber FDA has no questions
69 Behenic acid FDA has no questions
149 beta-Glucanase enzyme preparation from Trichoderma harzianum FDA has no questions
49 Bifidobacterium lactis strain Bb12 and Streptococcus thermophilus strain Th4 FDA has no questions
Additional correspondence regarding new information about B. lactis strain Bb12
50 Bohenin FDA has no questions
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
169 Bovine globulin At notifier's request, FDA ceased to evaluate the notice.
Resubmitted as GRN No. 234
234 Bovine globulin At notifier's request, FDA ceased to evaluate the notice.
Resubmitted as GRN No. 255
255 Bovine globulin Pending
196 Bovine milk basic protein fraction FDA has no questions
130 Bovine milk-derived lactoferrin FDA has no questions
Additional correspondence
C
11 Calcium casein peptone-calcium phosphate FDA has no questions
136 Calcium gluconate FDA has no questions
157 Calcium propionate (alternative method of manufacture) FDA has no questions
249 Capsiate Pending
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
251 Carbon monoxide Pending
194 Carbon monoxide Pending
188 Carbon monoxide At notifier's request, FDA ceased to evaluate the notice.
166 Carbon monoxide At notifier's request, FDA ceased to evaluate the notice.
167 Carbon monoxide FDA has no questions
143 Carbon monoxide FDA has no questions
83 Carbon monoxide FDA has no questions
159 Carnobacterium maltaromaticum strain CB1 FDA has no questions
116 Carrot fiber FDA has no questions
139 Cassia gum At notifier's request, FDA ceased to evaluate the notice.
51 Cassia gum from Cassia tora/obtusifolia At notifier's request, FDA ceased to evaluate the notice.
Resubmitted as GRN No. 139
259 Catechins from green tea extract Pending
225 Catechins from green tea extract At notifier's request, FDA ceased to evaluate the notice.
Resubmitted as GRN No. 259
31 Cetylpyridinium chloride At notifier's request, FDA ceased to evaluate the notice.
Resubmitted as GRN No. 38
38 Cetylpyridinium chloride Notice does not provide a basis for a GRAS determination
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
161 Chlorine dioxide, generated using sodium chlorite in calcined or sulfated kaolin clay FDA has no questions
36 Chromium picolinate; Ginkgo biloba leaf extract; and Ginseng extract At notifier's request, FDA ceased to evaluate the notice
230 Chymosin enzyme preparation from Trichoderma reesei expressing the bovine prochymosin B gene FDA has no questions
222 Citric acid esters of mono- and diglycerides FDA has no questions
86 Coagulated potato protein, hydrolyzed potato protein, or clarified hydrolyzed potato protein FDA has no questions
87 Composite filtration media (diatomaceous earth and perlite) FDA has no questions
199 Concentrated hydrolyzed milk protein FDA has no questions
Additional correspondence about intended uses
185 Concentrated tomato lycopene extract FDA has no questions
153 Conjugated linoleic acid At notifier's request, FDA ceased to evaluate the notice.
Resubmitted as GRN No. 232
232 Conjugated linoleic acid isomers FDA has no questions
240 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 FDA has no questions
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
140 Crystalline lutein FDA has no questions;
some uses may require a color additive listing
155 alpha-Cyclodextrin FDA has no questions
74 beta-Cyclodextrin FDA has no questions
46 Gamma cyclodextrin FDA has no questions
D
27 Dextranase from Chaetomium gracile FDA has no questions
41 DHASCO (docosahexaenoic acid-rich single-cell oil) and ARASCO (arachidonic acid-rich single-cell oil) FDA has no questions
115 Diacylglycerol oil FDA has no questions
56 Diacylglycerol oil FDA has no questions
6 Dioctyl sodium sulfosuccinate 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) FDA has no questions
154 Dried orange pulp FDA has no questions
E
64 Egg white lysozyme FDA has no questions
76 Erythritol FDA has no questions
208 Erythritol FDA has no questions
Corrected letter issued Nov. 20, 2007
203 Erythritol fatty acid esters At notifier's request, FDA ceased to evaluate the notice.
151 Ethanol (ethyl alcohol) 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
25 Extract of Garcinia kola seed ("bitter cola") Notice does not provide a basis for a GRAS determination
147 Extracted "seafood species" protein FDA has no questions
Additional correspondence clarifying the subject of the notice
Additional correspondence about intended uses
F
19 Ferrous bisglycinate chelate FDA has no questions
138 Fish oil FDA has no questions
193 Fish oil (predominantly sardine and anchovy); tuna oil FDA has no questions
105 Fish oil concentrate FDA has no questions
256 Flaxseed oil Pending
44 Fructooligosaccharide FDA has no questions
Additional correspondence about intended uses
G
236 Galacto-oligosaccharides FDA has no questions
233 Galactooligosaccharides and polydextrose Pending
150 Glucosamine hydrochloride prepared from chitin obtained from Aspergillus niger 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
244 Glutathione At notifier's request, FDA ceased to evaluate the notice
108 Glycerol ester of gum rosin Notice does not provide a basis for a GRAS determination
220 alpha-Glycosyl isoquercitrin FDA has no questions
124 Grape seed extract FDA has no questions
125 Grape seed extract and grape pomace extract FDA has no questions;
some uses may require a color additive listing
93 Grape seed extract and grape skin extract Notice does not provide a basis for a GRAS determination.
Resubmitted as GRN No. 125
58 Gum arabic At notifier's request, FDA ceased to evaluate the notice
H
35 Hempseed oil Notice does not provide a basis for a GRAS determination
192 High 2-palmitic vegetable oil FDA has no questions
131 High 2-palmitic vegetable oil FDA has no questions
Additional correspondence
260 High-selenium yeast Pending
241 High-selenium yeast At notifier's request, FDA ceased to evaluate the notice
Resubmitted as GRN No. 260
63 Hops beta acids FDA has no questions
14 Hydrogen peroxide Notice does not provide a basis for a GRAS determination
59 Hydrogenated starch hydrolysate At notifier's request, FDA ceased to evaluate the notice
182 Hydrolyzed wheat gluten isolate; pea protein isolate FDA has no questions
190 Hydroxypropyl methylcellulose At notifier's request, FDA ceased to evaluate the notice.
Resubmitted as GRN No. 213
213 Hydroxypropyl methylcellulose - expanded substitution pattern (HPMC-ESP) FDA has no questions
I
117 Ice structuring protein preparation FDA has no questions
118 Inulin FDA has no questions
Additional correspondence about intended uses
88 Invertase enzyme preparation from Saccharomyces cerevisiae and lactase enzyme preparation from Kluyveromyces marxianus FDA has no questions
85 Isoamylase from Pseudomonas amyloderamosa FDA has no questions
26 Isolated wheat protein FDA has no questions
246 Isomalto-oligosaccharide Pending
172 Isomalto-oligosaccharide At notifier's request, FDA ceased to evaluate the notice.
Resubmitted as GRN No. 246
184 Isomaltulose FDA has no questions
K
242 Krill oil FDA has no questions
L
122 Laccase enzyme preparation produced by Aspergillus oryzae expressing the gene encoding a laccase from Myceliophthora thermophila FDA has no questions
132 Lactase enzyme preparation from Aspergillus niger FDA has no questions
171 Lactobacillus acidophilus, Lactobacillus lactis, and Pediococcus acidilactici FDA has no questions
Additional correspondence about intended uses
231 Lactobacillus casei subsp. rhamnosus strain GG FDA has no questions
254 Lactobacillus reuteri strain DSM 17938 FDA has no questions
189 Lactoferrin (human) purified from bovine milk Pending
162 Lactoferrin (human) purified from rice At notifier's request, FDA ceased to evaluate the notice.
235 Lactoferrin (human) purified from rice Pending
123 Laminaria japonica broth and extract powder FDA has no questions
164 Lauramide arginine ethyl ester FDA has no questions
Additional correspondence about intended uses
226 Lecithin derived from krill FDA has no questions
75 Lipase derived from Aspergillus oryzae carrying a gene encoding lipase from Fusarium oxysporum FDA has no questions
43 Lipase derived from Aspergillus oryzae carrying a gene encoding lipase from Thermomyces lanuginosus FDA has no questions
111 Lipase enzyme preparation from Aspergillus niger FDA has no questions
113 Lipase enzyme preparation from Aspergillus oryzae 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
238 Lipase enzyme preparation derived from Hansenula polymorpha expressing a gene encoding a lipase from Fusarium heterosporum FDA has no questions
216 Lipase enzyme preparation from Rhizopus oryzae FDA has no questions
81 Lipase from Candida rugosa FDA has no questions
68 Lipase from Penicillium camembertii FDA has no questions
158 Lipase preparation from Aspergillus niger expressing a gene encoding a lipase from Candida antartica FDA has no questions
33 Low erucic acid oil derived from Brassica juncea FDA has no questions
110 Lutein esters FDA has no questions;
some uses may require a color additive listing
173 Lycopene from Blakeslea trispora FDA has no questions;
some uses may require a color additive listing
174 Lysozyme (human) enzyme preparation from rice At notifier's request, FDA ceased to evaluate the notice.
191 Lysozyme (human) purified from rice Pending
M
245 Menaquinone-7 At notifier's request, FDA ceased to evaluate the notice
16 Menhaden oil At notifier's request, FDA ceased to evaluate the notice
18 Mesquite (Prosopis spp.) wood alcoholic extract FDA has no questions
12 Mesquite wood alcoholic extract At notifier's request, FDA ceased to evaluate the notice.
Resubmitted as GRN No. 18
229 Methylsulfonylmethane FDA has no questions
160 Micro-algal oil (Ulkenia sp.) At notifier's request, FDA ceased to evaluate the notice.
66 Milk thistle extract Notice does not provide a basis for a GRAS determination
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
67 Milk-derived lactoferrin FDA has no questions
77 Milk-derived lactoferrin FDA has no questions
40 Mineral oil Notice does not provide a basis for a GRAS determination.
Resubmitted as GRN No. 71
195 Mixed beta-Glucanase and xylanase enzyme preparation from Humicola insolens FDA has no questions
247 Modified gum acacia FDA has no questions
91 Mycoprotein FDA has no questions
N
65 Nisin FDA has no questions
O
227 Olestra FDA has no questions
261 Oat hull fiber Pending
P
114 Pectate lyase enzyme preparation from Bacillus subtilis FDA has no questions
8 Pectin esterase derived from Aspergillus oryzae carrying a gene encoding pectin esterase from Aspergillus aculeatus FDA has no questions
32 Pectin lyase derived from Trichoderma reesei carrying a gene encoding pectin lyase from Aspergillus niger FDA has no questions
197 Phosphatidylserine FDA has no questions
223 Phosphatidylserine FDA has no questions
183 Phospholipase A2 enzyme preparation from Aspergillus niger expressing a gene encoding a porcine phospholipase A2 FDA has no questions
145 Phospholipase A2 enzyme preparation from Streptomyces violaceoruber FDA has no questions
212 Phospholipase A2 enzyme preparation from Streptomyces violaceruber expressing a gene encoding phospholipase A2 from the same species FDA has no questions
204 Phospholipase C enzyme preparation from Pichia pastoris expressing a heterologous phospholipase C gene FDA has no questions
142 Phospholipase enzyme preparation from Aspergillus oryzae expressing the gene encoding a phospholipase A1 from Fusarium venenatum FDA has no questions
53 Phytosterol esters FDA has no questions
206 Phytosterol esters and diglycerides resulting from transesterification of vegetable oils/fats with soy phytosterols FDA has no questions
181 Phytosterols FDA has no questions
112 Phytosterols FDA has no questions
250 Pine tree phytosterol Pending
177 Plant sterol esters FDA has no questions
176 Plant sterols and plant sterol esters from vegetable oils or sterols/stanols from tall oil FDA has no questions
61 Plant sterols/Plant sterol esters FDA has no questions
107 Polydextrose At notifier's request, FDA ceased to evaluate the notice
9 Polyglycerol polyricinoleic acid FDA has no questions
179 Polyglycerol polyricinoleic acid FDA has no questions
135 ε-Polylysine FDA has no questions
202 Polyoxyethanyl-alpha-tocopheryl sebacate (PTS) FDA has no questions
141 Polyvinyl alcohol FDA has no questions
21 Pork collagen FDA has no questions
60 Potassium bisulfate FDA has no questions
168 Poultry protein FDA has no questions
23 Protein preparation from animal blood At notifier's request, FDA ceased to evaluate the notice
99 Pullulan FDA has no questions
72 Pullulanase derived from Bacillus licheniformis carrying a gene encoding pullulanase from B. deramificans FDA has no questions
20 Pullulanase derived from Bacillus subtilis carrying a gene encoding pullulanase from Bacillus naganoensis FDA has no questions
205 Pullulanase enzyme preparation from Bacillus subtilis expressing the pullulanase gene from B. acidopullulyticus FDA has no questions
Q
165 Quillaia extract type 1 FDA has no questions
R
252 Rebaudioside A purified from Stevia rebaudiana (Bertoni) Bertoni FDA has no questions
253 Rebaudioside A purified from Stevia rebaudiana (Bertoni) Bertoni FDA has no questions
100 D-Ribose Notice does not provide a basis for a GRAS determination
Resubmitted as GRN No. 243
243 D-Ribose FDA has no questions
S
175 Saccharomyces cerevisiae strain ECMo01 with enhanced expression of urea amidolyase 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
146 Salmon oil FDA has no questions
28 Seaweed-derived calcium FDA has no questions
Additional correspondence about intended uses
73 Shrimp-derived chitosan At notifier's request, FDA ceased to evaluate the notice
170 Shrimp-derived chitosan At notifier's request, FDA ceased to evaluate the notice.
96 Silk protein food powder Notice does not provide a basis for a GRAS determination
128 Skim milk or dextrose cultured with Propionibacterium freudenreichii subsp. shermanii FDA has no questions
102 Small planktivorous pelagic fish body oil 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
3 Sodium bisulfate FDA has no questions
152 Sodium iron EDTA FDA has no questions
178 Sodium iron EDTA FDA has no questions
228 Sodium nitrite Pending
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
186 Soy lecithin enzymatically modified to have increased phosphatidylserine FDA has no questions
134 Soy protein hydrolyzate with enzyme-modified lecithin FDA has no questions
101 Spirulina At notifier's request, FDA ceased to evaluate the notice.
Resubmitted as GRN No. 127
127 Spirulina, the dried biomass of Arthrospira platensis FDA has no questions;
some uses may require a color additive listing
70 Stearyl alcohol FDA has no questions
258 Sucromalt Pending
104 Sucrose acetate isobutyrate FDA has no questions
248 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 FDA has no questions
129 Sucrose fatty acid esters FDA has no questions
92 Sucrose fatty acid esters Notice does not provide a basis for a GRAS determination.
Follow-up submitted as GRN No. 129
221 Suspended lutein FDA has no questions
263 Sweet lupin fiber Pending
264 Sweet lupin flour Pending
262 Sweet lupin protein Pending
119 Synthetic lycopene FDA has no questions;
some uses may require a color additive listing

Corrected letter issued April 7, 2005
T
78 D-Tagatose FDA has no questions
200 Tailored triglycerides enriched in omega-3 fatty acids from fish oil FDA has no questions
217 Tailored tryglycerides containing approximately 12 percent medium-chain fatty acids FDA has no questions
39 Tall oil phytosterols FDA has no questions
Additional correspondence clarifying intended use
187 L(+) Tartaric acid (alternative method of manufacture) FDA has no questions
5 Tasteless smoke At notifier's request, FDA ceased to evaluate the notice.
Resubmitted as GRN No. 15
15 Tasteless smoke FDA has no questions
82 1,1,1,2-Tetrafluoroethane (HFC-134a) FDA has no questions
209 L-theanine FDA has no questions
156 Tomato lycopene extract 6 percent, tomato lycopene extract 1.5 percent, and crystallized tomato lycopene extract FDA has no questions;
some uses may require a color additive listing
163 Tomato pulp powder FDA has no questions
Additional correspondence about intended uses
29 Transglutaminase from Streptoverticillium mobaraense FDA has no questions
95 Transglutaminase from Streptoverticillium mobaraense FDA has no questions
4 Transglutaminase from Streptoverticillium mobaraense FDA has no questions
55 Transglutaminase from Streptoverticillium mobaraense FDA has no questions
224 trans-Resveratrol At notifier's request, FDA ceased to evaluate the notice.
45 Trehalose FDA has no questions
97 Tuna oil At notifier's request, FDA ceased to evaluate the notice.
Resubmitted as GRN No. 109
109 Tuna oil FDA has no questions
V
148 Vegetable oil conjugated linoleic acid preparation At notifier's request, FDA ceased to evaluate the notice.
Resubmitted as GRN No. 232
48 Vegetable oil phytosterol esters FDA has no questions
133 Volatile oil of mustard FDA has no questions
W
210 Water soluble tomato concentrate FDA has no questions;
some uses may require a color additive listing
52 Whey mineral concentrate FDA has no questions
37 Whey protein isolate and dairy product solids FDA has no questions
Additional correspondence clarifying the term "dairy product solids"
71 White mineral oil, USP (viscosity ISO 100 ) FDA has no questions
X
121 Xanthan gum FDA has no questions
211 Xanthan gum (reduced pyruvate) FDA has no questions
54 Xylanase derived from Fusarium venenatum carrying a gene encoding xylanase from Thermomyces lanuginosus FDA has no questions


 

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