US FDA/CFSAN - Inventory of GRAS Notices: Summary of all GRAS Notices
`JUN AUG SEP
`
`http://www.cfsan.fda.gov:80/~rdb/opa-gras.html
`
`Go
`
`⍰❎
`f 🐦
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`▾ About this capture
`
`05
`
`2006 2007 2008
`
`7/17/2017
`
`182 captures
`4 Apr 2001 - 23 Oct 2011
`
`CFSAN/Office of Food Additive Safety
`July 2007
`
`FDA Home Page | CFSAN Home | Search/Subject Index | Q & A | Help
`
`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, the first row provides a hyperlink to a table that provides more details about the GRAS notices received in that year. That table lists the information in
`the notice corresponding to the proposed "GRAS exemption claim" (proposed 21 CFR 170.36(c)(1)), including the following information, which we proposed to make readily accessible to
`the public:
`
`The name of the notifier and a hyperlink to the notifier's address
`The intended conditions of use
`The basis for the GRAS determination
`
`Persons interested in obtaining additional data and information in the notice may obtain a copy of those data and information that are disclosable by requesting the information under the
`Freedom of Information Act (see FDA's document entitled "How to Request Information or Make a Freedom of Information Request").
`
`These tables are current as of June 29, 2007, 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 (301) 436-1192 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.).
`
`GRN No.
`227
`226
`225
`224
`
`Olestra
`Krill-derived lecithin
`Catechins from green tea extract
`trans-Resveratrol
`
`GRAS Notices Received in 2007
`Details about Notices Received in 2007
`(GRN No. 219-227)
`
`Substance
`
`FDA's Letter
`Pending
`Pending
`Pending
`Pending
`
`https://web.archive.org/web/20070805011458/http://www.cfsan.fda.gov:80/~rdb/opa-gras.html
`
`RIMFROST EXHIBIT 1052 page 0001
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`1/11
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`

`US FDA/CFSAN - Inventory of GRAS Notices: Summary of all GRAS Notices
`Pending
`JUN AUG SEP
`Pending
`2006 2007 2008
`Pending
`Pending
`FDA has no questions
`
`Go
`
`05
`
`Phosphatidylserine
`http://www.cfsan.fda.gov:80/~rdb/opa-gras.html
`Citric acid esters of mono- and diglycerides
`182 captures
`4 Apr 2001 - 23 Oct 2011
`Lutein
`alpha-Glycosyl isoquercitrin
`Ammonium phosphatide
`
`GRAS Notices Received in 2006
`Details about Notices Received in 2006
`(GRN No. 189-218)
`
`7/17/2017
`
`223
`222
`221
`220
`219
`
`GRN No.
`218
`217
`216
`215
`
`214
`
`213
`
`212
`
`211
`210
`209
`208
`207
`
`206
`
`205
`
`204
`
`203
`202
`
`201
`
`200
`199
`198
`197
`
`Substance
`Bacteriophage P100 preparation from Listeria innocua
`Tailored tryglycerides containing approximately 12 percent medium-chain fatty acids
`Lipase enzyme preparation from Rhizopus oryzae
`Actinidia arguta extract
`Asparaginase enzyme preparation from Aspergillus niger expressing the asparaginase gene
`from A. niger
`Hydroxypropyl methylcellulose - expanded substitution pattern (HPMC-ESP)
`Phospholipase A2 enzyme preparation from Streptomyces violaceruber expressing a gene
`encoding phospholipase A2 from the same species
`Xanthan gum (reduced pyruvate)
`Water soluble tomato concentrate
`L-theanine
`Erythritol
`Barley fiber
`Phytosterol esters and diglycerides resulting from transesterification of vegetable oils/fats
`with soy phytosterols
`Pullulanase enzyme preparation from Bacillus subtilis expressing the pullulanase gene from
`B. acidopullulyticus
`Phospholipase C enzyme preparation from Pichia pastoris expressing a heterologous
`phospholipase C gene
`Erythritol fatty acid esters
`Polyoxyethanyl-alpha-tocopheryl sebacate (PTS)
`Asparaginase enzyme preparation from Aspergillus oryzae expressing the asparaginase gene
`from A. oryzae
`Tailored triglycerides enriched in omega-3 fatty acids from fish oil
`Concentrated hydrolyzed milk protein
`Bacteriophage P100 Preparation from Listeria innocua
`Phosphatidylserine
`
`FDA's Letter
`FDA has no questions
`Pending
`FDA has no questions
`Pending
`
`FDA has no questions
`
`FDA has no questions
`
`FDA has no questions
`
`FDA has no questions
`FDA has no questions
`FDA has no questions
`FDA has no questions
`FDA has no questions
`
`FDA has no questions
`
`FDA has no questions
`
`FDA has no questions
`
`At notifier's request, FDA ceased to evaluate the notice.
`FDA has no questions
`
`FDA has no questions
`
`FDA has no questions
`FDA has no questions
`FDA has no questions
`FDA has no questions
`
`https://web.archive.org/web/20070805011458/http://www.cfsan.fda.gov:80/~rdb/opa-gras.html
`
`RIMFROST EXHIBIT 1052 page 0002
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`2/11
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`

`

`US FDA/CFSAN - Inventory of GRAS Notices: Summary of all GRAS Notices
`FDA has no questions
`JUN AUG SEP
`05
`FDA has no questions
`2006 2007 2008
`Pending
`FDA has no questions
`FDA has no questions
`Pending
`At notifier's request, FDA ceased to evaluate the notice.
`Resubmitted as GRN No. 213
`Pending
`
`Bovine milk basic protein fraction
`http://www.cfsan.fda.gov:80/~rdb/opa-gras.html
`Mixed beta-Glucanase and xylanase enzyme preparation from Humicola insolens
`182 captures
`4 Apr 2001 - 23 Oct 2011
`Carbon monoxide
`Fish oil (predominantly sardine and anchovy); tuna oil
`High 2-palmitic vegetable oil
`Lysozyme (human) purified from rice
`
`Go
`
`Hydroxypropyl methylcellulose
`
`Lactoferrin (human) purified from bovine milk
`GRAS Notices Received in 2005
`Details about Notices Received in 2005
`(GRN No. 163-188)
`
`7/17/2017
`
`196
`195
`194
`193
`192
`191
`
`190
`
`189
`
`GRN No.
`188
`187
`186
`185
`184
`
`183
`
`182
`181
`180
`179
`178
`177
`176
`175
`174
`
`173
`
`172
`
`171
`
`170
`169
`
`Substance
`
`Carbon monoxide
`L(+) Tartaric acid (alternative method of manufacture)
`Soy lecithin enzymatically modified to have increased phosphatidylserine
`Concentrated tomato lycopene extract
`Isomaltulose
`Phospholipase A2 enzyme preparation from Aspergillus niger expressing a gene encoding a
`porcine phospholipase A2
`Hydrolyzed wheat gluten isolate; pea protein isolate
`Phytosterols
`Allyl isothiocyanate
`Polyglycerol polyricinoleic acid
`Sodium iron EDTA
`Plant sterol esters
`Plant sterols and plant sterol esters from vegetable oils or sterols/stanols from tall oil
`Saccharomyces cerevisiae strain ECMo01 with enhanced expression of urea amidolyase
`Lysozyme (human) enzyme preparation from rice
`
`Lycopene from Blakeslea trispora
`
`Isomalto-oligosaccharide
`
`Lactobacillus acidophilus, Lactobacillus lactis, and Pediococcus acidilactici
`
`Shrimp-derived chitosan
`Bovine globulin
`
`FDA's Letter
`Pending
`FDA has no questions
`FDA has no questions
`FDA has no questions
`FDA has no questions
`
`FDA has no questions
`
`FDA has no questions
`FDA has no questions
`FDA has no questions
`FDA has no questions
`FDA has no questions
`FDA has no questions
`FDA has no questions
`FDA has no questions
`At notifier's request, FDA ceased to evaluate the notice.
`FDA has no questions;
`some uses may require a color additive listing
`At notifier's request, FDA ceased to evaluate the notice.
`FDA has no questions
`Additional correspondence about intended uses
`At notifier's request, FDA ceased to evaluate the notice.
`At notifier's request, FDA ceased to evaluate the notice.
`
`https://web.archive.org/web/20070805011458/http://www.cfsan.fda.gov:80/~rdb/opa-gras.html
`
`RIMFROST EXHIBIT 1052 page 0003
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`3/11
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`

`

`7/17/2017
`
`168
`167
`166
`165
`
`164
`
`163
`
`GRN No.
`162
`161
`160
`159
`
`158
`
`157
`
`156
`
`155
`154
`153
`152
`151
`150
`149
`148
`147
`146
`145
`144
`143
`
`http://www.cfsan.fda.gov:80/~rdb/opa-gras.html
`
`Go
`
`Poultry protein
`Carbon monoxide
`182 captures
`4 Apr 2001 - 23 Oct 2011
`Carbon monoxide
`Quillaia extract type 1
`
`Lauramide arginine ethyl ester
`
`Tomato pulp powder
`
`US FDA/CFSAN - Inventory of GRAS Notices: Summary of all GRAS Notices
`FDA has no questions
`JUN AUG SEP
`05
`FDA has no questions
`2006 2007 2008
`At notifier's request, FDA ceased to evaluate the notice.
`FDA has no questions
`FDA has no questions
`Additional correspondence about intended uses
`FDA has no questions
`Additional correspondence about intended uses
`
`GRAS Notices Received in 2004
`Details about Notices Received in 2004
`(GRN No. 143-162)
`
`Substance
`
`Lactoferrin (human) purified from rice
`Chlorine dioxide, generated using sodium chlorite in calcined or sulfated kaolin clay
`Micro-algal oil (Ulkenia sp.)
`Carnobacterium maltaromaticum strain CB1
`Lipase preparation from Aspergillus niger expressing a gene encoding a lipase from Candida
`antartica
`Calcium propionate (alternative method of manufacture)
`Tomato lycopene extract 6 percent, tomato lycopene extract 1.5 percent, and crystallized
`tomato lycopene extract
`alpha-Cyclodextrin
`Dried orange pulp
`Conjugated linoleic acid
`Sodium iron EDTA
`Ethanol (ethyl alcohol)
`Glucosamine hydrochloride prepared from chitin obtained from Aspergillus niger
`Beta-glucanase enzyme preparation from Trichoderma harzianum
`Vegetable oil conjugated linoleic acid preparation
`Fish protein
`Salmon oil
`Phospholipase A2 enzyme preparation from Streptomyces violaceoruber
`Adenosine 5'-monophosphoric acid and its monosodium and disodium salts
`Carbon monoxide
`
`GRAS Notices Received in 2003
`
`FDA's Letter
`At notifier's request, FDA ceased to evaluate the notice.
`FDA has no questions
`At notifier's request, FDA ceased to evaluate the notice.
`FDA has no questions
`
`FDA has no questions
`
`FDA has no questions
`FDA has no questions;
`some uses may require a color additive listing
`FDA has no questions
`FDA has no questions
`At notifier's request, FDA ceased to evaluate the notice.
`FDA has no questions
`FDA has no questions
`At notifier's request, FDA ceased to evaluate the notice.
`FDA has no questions
`At notifier's request, FDA ceased to evaluate the notice.
`FDA has no questions
`FDA has no questions
`FDA has no questions
`FDA has no questions
`FDA has no questions
`
`https://web.archive.org/web/20070805011458/http://www.cfsan.fda.gov:80/~rdb/opa-gras.html
`
`RIMFROST EXHIBIT 1052 page 0004
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`4/11
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`

`

`7/17/2017
`
`GRN No.
`
`142
`
`141
`
`140
`
`139
`138
`137
`136
`135
`134
`133
`132
`
`131
`
`130
`
`129
`128
`
`127
`
`126
`
`125
`
`182 captures
`4 Apr 2001 - 23 Oct 2011
`
`Substance
`Phospholipase enzyme preparation from Aspergillus oryzae expressing the gene encoding a
`phospholipase A1 from Fusarium venenatum
`Polyvinyl alcohol
`
`Crystalline lutein
`
`Cassia gum
`Fish oil
`Algal oil (Schizochytrium sp.)
`Calcium gluconate
`ε-Polylysine
`Soy protein hydrolyzate with enzyme-modified lecithin
`Volatile oil of mustard
`Lactase enzyme preparation from Aspergillus niger
`
`High 2-palmitic vegetable oil
`
`Bovine milk-derived lactoferrin
`
`Sucrose fatty acid esters
`Skim milk or dextrose cultured with Propionibacterium freudenreichii subsp. shermanii
`
`Spirulina, the dried biomass of Arthrospira platensis
`
`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
`
`Grape seed extract and grape pomace extract
`
`US FDA/CFSAN - Inventory of GRAS Notices: Summary of all GRAS Notices
`Details about Notices Received in 2003
`JUN AUG SEP
`http://www.cfsan.fda.gov:80/~rdb/opa-gras.html
`Go
`(GRN Nos. 120 - 142)
`
`05
`
`2006 2007 2008
`FDA's Letter
`
`FDA has no questions
`
`FDA has no questions
`FDA has no questions;
`some uses may require a color additive listing
`At notifier's request, FDA ceased to evaluate the notice.
`FDA has no questions
`FDA has no questions
`FDA has no questions
`FDA has no questions
`FDA has no questions
`FDA has no questions
`FDA has no questions
`FDA has no questions
`Additional correspondence
`FDA has no questions
`Additional correspondence
`FDA has no questions
`FDA has no questions
`FDA has no questions;
`some uses may require a color additive listing
`
`FDA has no questions
`
`FDA has no questions;
`some uses may require a color additive listing
`FDA has no questions
`FDA has no questions
`
`FDA has no questions
`
`FDA has no questions
`
`FDA has no questions
`
`RIMFROST EXHIBIT 1052 page 0005
`
`5/11
`
`124
`123
`
`122
`
`Grape seed extract
`Laminaria japonica broth and extract powder
`Laccase enzyme preparation produced by Aspergillus oryzae expressing the gene encoding a
`laccase from Myceliophthora thermophila
`Xanthan gum
`Saccharomyces cerevisiae strain ML01 carrying a gene encoding the malolactic enzyme from
`Oenococcus oeni and a gene encoding malate permease from Schizosaccharomyces pombe
`GRAS Notices Received in 2002
`Details about Notices Received in 2002
`https://web.archive.org/web/20070805011458/http://www.cfsan.fda.gov:80/~rdb/opa-gras.html
`
`121
`
`120
`
`

`

`7/17/2017
`
`GRN No.
`
`182 captures
`4 Apr 2001 - 23 Oct 2011
`
`Synthetic lycopene
`
`Go
`
`05
`
`US FDA/CFSAN - Inventory of GRAS Notices: Summary of all GRAS Notices
`(GRN Nos. 94 - 119)
`JUN AUG SEP
`http://www.cfsan.fda.gov:80/~rdb/opa-gras.html
`Substance
`FDA's Letter
`2006 2007 2008
`FDA has no questions;
`some uses may require a color additive listing
`Corrected letter issued April 7, 2005
`FDA has no questions
`FDA has no questions
`FDA has no questions
`FDA has no questions
`FDA has no questions
`FDA has no questions
`FDA has no questions
`FDA has no questions
`FDA has no questions;
`some uses may require a color additive listing
`FDA has no questions
`Notice does not provide a basis for a GRAS determination
`At notifier's request, FDA ceased to evaluate the notice
`
`119
`
`118
`117
`116
`115
`114
`113
`112
`111
`
`110
`
`109
`108
`107
`
`106
`
`105
`104
`
`103
`
`102
`
`101
`
`100
`99
`
`98
`
`97
`
`96
`95
`
`94
`
`Inulin
`Ice structuring protein preparation
`Carrot fiber
`Diacylglycerol oil
`Pectate lyase enzyme preparation from Bacillus subtilis
`Lipase enzyme preparation from Aspergillus oryzae
`Phytosterols
`Lipase enzyme preparation from Aspergillus niger
`
`Lutein esters
`
`Tuna oil
`Glycerol ester of gum rosin
`Polydextrose
`Glucose oxidase enzyme preparation from Aspergillus oryzae carrying a gene encoding a
`glucose oxidase from Aspergillus niger
`Fish oil concentrate
`Sucrose acetate isobutyrate
`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
`Small planktivorous pelagic fish body oil
`
`Spirulina
`
`D-Ribose
`Pullulan
`
`Small planktivorous pelagic fish body oil
`
`Tuna oil
`
`Silk protein food powder
`Transglutaminase from Streptoverticillium mobaraense
`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
`
`FDA has no questions
`FDA has no questions
`
`FDA has no questions
`
`FDA has no questions
`At notifier's request, FDA ceased to evaluate the notice.
`Resubmitted as GRN No. 127
`Notice does not provide a basis for a GRAS determination
`FDA has no questions
`At notifier's request, FDA ceased to evaluate the notice.
`Resubmitted as GRN No. 102
`At notifier's request, FDA ceased to evaluate the notice.
`Resubmitted as GRN No. 109
`Notice does not provide a basis for a GRAS determination
`FDA has no questions
`
`FDA has no questions
`
`https://web.archive.org/web/20070805011458/http://www.cfsan.fda.gov:80/~rdb/opa-gras.html
`
`RIMFROST EXHIBIT 1052 page 0006
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`6/11
`
`

`

`7/17/2017
`
`182 captures
`4 Apr 2001 - 23 Oct 2011
`
`US FDA/CFSAN - Inventory of GRAS Notices: Summary of all GRAS Notices
`GRAS Notices Received in 2001
`JUN AUG SEP
`http://www.cfsan.fda.gov:80/~rdb/opa-gras.html
`Go
`Details about Notices Received in 2001
`(GRN Nos. 66 - 93)
`
`2006 2007 2008
`
`05
`
`GRN No.
`
`Substance
`
`93
`
`92
`
`91
`
`90
`
`Grape seed extract and grape skin extract
`
`Sucrose fatty acid esters
`
`Mycoprotein
`
`Carbohydrase enzyme preparation from Aspergillus oryzae, protease enzyme preparation
`from Aspergillus oryzae, and carbohydrase enzyme preparation from Rhizopus oryzae
`
`FDA's Letter
`Notice does not provide a basis for a GRAS determination.
`Resubmitted as GRN No. 125
`Notice does not provide a basis for a GRAS determination.
`Follow-up submitted as GRN No. 129
`FDA has no questions
`FDA has no questions
`Additional correspondence
`FDA has no questions
`Additional correspondence
`
`FDA has no questions
`
`FDA has no questions
`FDA has no questions
`FDA has no questions
`FDA has no questions
`FDA has no questions
`FDA has no questions
`FDA has no questions
`FDA has no questions
`
`FDA has no questions
`
`FDA has no questions
`FDA has no questions
`FDA has no questions
`
`FDA has no questions
`
`FDA has no questions
`At notifier's request, FDA ceased to evaluate the notice
`
`FDA has no questions
`
`FDA has no questions
`FDA has no questions
`FDA has no questions
`
`RIMFROST EXHIBIT 1052 page 0007
`
`7/11
`
`89
`
`88
`
`87
`86
`85
`84
`83
`82
`81
`80
`
`79
`
`Five enzyme preparations from Aspergillus niger: Carbohydrase enzyme preparation,
`catalase enzyme preparation, glucose oxidase enzyme preparation, pectinase enzyme
`preparation, and protease enzyme preparation
`Invertase enzyme preparation from Saccharomyces cerevisiae and lactase enzyme
`preparation from Kluyveromyces marxianus
`Composite filtration media (diatomaceous earth and perlite)
`Coagulated potato protein, hydrolyzed potato protein, or clarified hydrolyzed potato protein
`Isoamylase from Pseudomonas amyloderamosa
`Arabinogalactan from Eastern Larch (Larix laricina)
`Carbon monoxide
`1,1,1,2-Tetrafluoroethane (HFC-134a)
`Lipase from Candida rugosa
`ARASCO (arachidonic acid-rich single-cell oil)
`Alpha-amylase derived from Bacillus licheniformis carrying a gene encoding a modified
`alpha-amylase from Bacillus licheniformis
`D-Tagatose
`Milk-derived lactoferrin
`Erythritol
`Lipase derived from Aspergillus oryzae carrying a gene encoding lipase from Fusarium
`oxysporum
`Beta-cyclodextrin
`Shrimp-derived chitosan
`Pullulanase derived from Bacillus licheniformis carrying a gene encoding pullulanase from
`B. deramificans
`White mineral oil, USP (viscosity ISO 100 )
`71
`Stearyl alcohol
`70
`Behenic acid
`69
`https://web.archive.org/web/20070805011458/http://www.cfsan.fda.gov:80/~rdb/opa-gras.html
`
`78
`77
`76
`
`75
`
`74
`73
`
`72
`
`

`

`7/17/2017
`
`68
`67
`66
`
`GRN No.
`65
`64
`63
`
`62
`
`61
`60
`59
`58
`57
`56
`55
`
`54
`
`53
`52
`
`51
`
`50
`
`49
`
`48
`47
`46
`45
`44
`
`Lipase from Penicillium camembertii
`http://www.cfsan.fda.gov:80/~rdb/opa-gras.html
`Milk-derived lactoferrin
`182 captures
`4 Apr 2001 - 23 Oct 2011
`Milk thistle extract
`
`Go
`
`US FDA/CFSAN - Inventory of GRAS Notices: Summary of all GRAS Notices
`FDA has no questions
`JUN AUG SEP
`05
`FDA has no questions
`2006 2007 2008
`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)
`
`Substance
`
`Nisin
`Egg white lysozyme
`Hops beta acids
`Chlorine dioxide generated from particles (<30�m) 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 �g
`chlorite/in2 of finished package film
`Plant sterols/Plant sterol esters
`Potassium bisulfate
`Hydrogenated starch hydrolysate
`Gum arabic
`Argon gas
`Diacylglycerol oil
`Transglutaminase from Streptoverticillium mobaraense
`Xylanase derived from Fusarium venenatum carrying a gene encoding xylanase from
`Thermomyces lanuginosus
`Phytosterol esters
`Whey mineral concentrate
`
`Cassia gum from Cassia tora/obtusifolia
`
`Bohenin
`
`Bifidobacterium lactis strain Bb12 and Streptococcus thermophilus strain Th4
`
`Vegetable oil phytosterol esters
`Arabinogalactan from Larix occidentalis
`Gamma cyclodextrin
`Trehalose
`Fructooligosaccharide
`
`FDA's Letter
`FDA has no questions
`FDA has no questions
`FDA has no questions
`
`FDA has no questions
`
`Additional correspondence about intended uses
`
`FDA has no questions
`FDA has no questions
`At notifier's request, FDA ceased to evaluate the notice
`At notifier's request, FDA ceased to evaluate the notice
`FDA has no questions
`FDA has no questions
`FDA has no questions
`
`FDA has no questions
`
`FDA has no questions
`FDA has no questions
`At notifier's request, FDA ceased to evaluate the notice.
`Resubmitted as GRN No. 139
`FDA has no questions
`FDA has no questions
`Additional correspondence regarding new information about B. lactis
`strain Bb12
`FDA has no questions
`FDA has no questions
`FDA has no questions
`FDA has no questions
`FDA has no questions
`Additional correspondence about intended uses
`
`https://web.archive.org/web/20070805011458/http://www.cfsan.fda.gov:80/~rdb/opa-gras.html
`
`RIMFROST EXHIBIT 1052 page 0008
`
`8/11
`
`

`

`7/17/2017
`
`43
`
`42
`
`41
`
`40
`
`39
`
`38
`
`37
`
`36
`
`GRN No.
`35
`
`34
`
`33
`
`32
`
`31
`
`30
`
`29
`
`28
`
`27
`26
`25
`24
`
`Lipase derived from Aspergillus oryzae carrying a gene encoding lipase from Thermomyces
`http://www.cfsan.fda.gov:80/~rdb/opa-gras.html
`lanuginosus
`182 captures
`4 Apr 2001 - 23 Oct 2011
`
`Milk-derived lactoferrin
`
`US FDA/CFSAN - Inventory of GRAS Notices: Summary of all GRAS Notices
`JUN AUG SEP
`05
`FDA has no questions
`2006 2007 2008
`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
`
`Go
`
`DHASCO (docosahexaenoic acid-rich single-cell oil) and ARASCO (arachidonic acid-rich
`single-cell oil)
`
`FDA has no questions
`
`Mineral oil
`
`Tall oil phytosterols
`
`Cetylpyridinium chloride
`
`Whey protein isolate and dairy product solids
`
`Notice does not provide a basis for a GRAS determination.
`Resubmitted as GRN No. 71
`FDA has no questions
`Additional correspondence clarifying intended use
`Notice does not provide a basis for a GRAS determination
`FDA has no questions
`Additional correspondence clarifying the term "dairy product solids"
`At notifier's request, FDA ceased to evaluate the notice
`
`Chromium picolinate; Ginkgo biloba leaf extract; and Ginseng extract
`GRAS Notices Received in 1999
`Details about Notices Received in 1999
`(GRN Nos. 13 - 35)
`
`Substance
`
`Hempseed oil
`Aspartic proteinase derived from Aspergillus oryzae carrying a gene encoding aspartic
`proteinase from Rhizomucor miehei
`Low erucic acid oil derived from Brassica juncea
`Pectin lyase derived from Trichoderma reesei carrying a gene encoding pectin lyase from
`Aspergillus niger
`
`Cetylpyridinium chloride
`
`Crospovidone-cranberry juice extract
`
`Transglutaminase from Streptoverticillium mobaraense
`
`Seaweed-derived calcium
`
`Dextranase from Chaetomium gracile
`Isolated wheat protein
`Extract of Garcinia kola seed ("bitter cola")
`alpha-Amylase derived from Bacillus licheniformis carrying a gene encoding alpha-amylase
`
`FDA's Letter
`Notice does not provide a basis for a GRAS determination
`
`FDA has no questions
`
`FDA has no questions
`
`FDA has no questions
`
`At notifier's request, FDA ceased to evaluate the notice.
`Resubmitted as GRN No. 38
`Notice does not provide a basis for a GRAS determination
`Additional correspondence that does not provide a basis for a GRAS
`determination
`FDA has no questions
`FDA has no questions
`Additional correspondence about intended uses
`FDA has no questions
`FDA has no questions
`Notice does not provide a basis for a GRAS determination
`FDA has no questions
`
`https://web.archive.org/web/20070805011458/http://www.cfsan.fda.gov:80/~rdb/opa-gras.html
`
`RIMFROST EXHIBIT 1052 page 0009
`
`9/11
`
`

`

`7/17/2017
`
`23
`
`22
`
`21
`
`20
`
`19
`18
`
`17
`
`16
`15
`14
`
`13
`
`US FDA/CFSAN - Inventory of GRAS Notices: Summary of all GRAS Notices
`JUN AUG SEP
`05
`At notifier's request, FDA ceased to evaluate the notice
`2006 2007 2008
`FDA has no questions
`
`Go
`
`from Bacillus stearothermophilus
`http://www.cfsan.fda.gov:80/~rdb/opa-gras.html
`Protein preparation from animal blood
`182 captures
`4 Apr 2001 - 23 Oct 2011
`alpha-Amylase derived from Bacillus licheniformis carrying a gene encoding a modified
`alpha-amylase derived from Bacillus lichenformis and Bacillus amyloliquefaciens
`Pork collagen
`Pullulanase derived from Bacillus subtilis carrying a gene encoding pullulanase from
`Bacillus naganoensis
`Ferrous bisglycinate chelate
`Mesquite (Prosopis spp.) wood alcoholic extract
`
`Arabinogalactan
`
`FDA has no questions
`
`FDA has no questions
`
`FDA has no questions
`FDA has no questions
`At notifier's request, FDA ceased to evaluate the notice.
`Resubmitted as GRN No. 47
`At notifier's request, FDA ceased to evaluate the notice
`FDA has no questions
`Notice does not provide a basis for a GRAS determination
`FDA has no questions
`
`Menhaden oil
`Tasteless smoke
`Hydrogen peroxide
`Botanicals: Chrysanthemum; Licorice; Jellywort
`Botanicals: Honeysuckle; Lophatherum; Mulberry leaf; Frangipani; Selfheal; Sophora flower
`Notice does not provide a basis for a GRAS determination
`bud
`GRAS Notices Received in 1998
`Details about Notices Received in 1998
`(GRN Nos. 1 - 12)
`
`GRN No.
`
`Substance
`
`12
`
`11
`
`10
`
`9
`
`8
`
`7
`
`6
`
`5
`
`Mesquite wood alcoholic extract
`
`Calcium casein peptone-calcium phosphate
`Exopeptidase derived from Aspergillus oryzae carrying a gene encoding a leucine
`aminopeptidase from Aspergillus sojae
`Polyglycerol polyricinoleic acid
`Pectin esterase derived from Aspergillus oryzae carrying a gene encoding pectin esterase
`from Aspergillus aculeatus
`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)
`Dioctyl sodium sulfosuccinate
`
`Tasteless smoke
`
`Transglutaminase from Streptoverticillium mobaraense
`4
`Sodium bisulfate
`3
`Solin oil (low linolenic acid flaxseed oil or low linolenic acid linseed oil)
`2
`1
`Soy isoflavone extract
`https://web.archive.org/web/20070805011458/http://www.cfsan.fda.gov:80/~rdb/opa-gras.html
`
`FDA's Letter
`At notifier's request, FDA ceased to evaluate the notice.
`Resubmitted as GRN No. 18
`FDA has no questions
`
`Notice does not provide a basis for a GRAS determination
`
`FDA has no questions
`
`FDA has no questions
`
`Notice does not provide a basis for a GRAS determination.
`Resubmitted as GRN No. 41
`
`FDA has no questions
`At notifier's request, FDA ceased to evaluate the notice.
`Resubmitted as GRN No. 15
`FDA has no questions
`FDA has no questions
`FDA has no questions
`At notifier's request, FDA ceased to evaluate the notice
`
`RIMFROST EXHIBIT 1052 page 0010
`
`10/11
`
`

`

`US FDA/CFSAN - Inventory of GRAS Notices: Summary of all GRAS Notices
`JUN AUG SEP
`
`http://www.cfsan.fda.gov:80/~rdb/opa-gras.html
`
`Go
`
`05
`
`7/17/2017
`
`
`
`
`
`
`182 captures
`4 Apr 2001 - 23 Oct 2011
`
`2006 2007 2008
`
`Food Ingredients and Packaging | GRAS Notification Program
`
`CFSAN Home | CFSAN Search/Subject Index | CFSAN Disclaimers & Privacy Policy | CFSAN Accessibility/Help
`FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA
`
`FDA/Center for Food Safety & Applied Nutrition
`Hypertext updated by pmg July31, 2007
`
`https://web.archive.org/web/20070805011458/http://www.cfsan.fda.gov:80/~rdb/opa-gras.html
`
`RIMFROST EXHIBIT 1052 page 0011
`
`11/11
`
`