`
`
`wwwarchivevrg
`415.561.6767
`413840—0391 e-fax
`
`Internet Archive
`300 Funston Avenue
`
`San Francisco, CA 94118
`
`AFFIDAVIT OF CHRISTOPHER BUTLER
`
`l. I am the Office Manager at the Internet Archive, located in San Francisco,
`California. I make this declaration of my own personal knowledge.
`2. The Internet Archive is a website that provides access to a digital library of
`Internet sites and other cultural artifacts in digital form. Like a paper library, we provide
`free access to researchers, historians, scholars, and the general public. The Internet
`Archive has partnered with and receives support from various institutions, including the
`Library of Congress.
`3. The Internet Archive has created a service known as the Wayback Machine. The
`Wayback Machine makes it possible to surf more than 450 billion pages stored in the
`Internet Archive's web archive. Visitors to the Wayback Machine can search archives
`by URL (i.e., a website address). If archived records for a URL are available, the Visitor
`will be presented with a list of available dates. The visitor may select one of those
`dates, and then begin surfing on an archived version of the Web. The links on the
`archived files, when served by the Wayback Machine, point to other archived files
`(whether HTML pages or images). If a visitor clicks on a link on an archived page, the
`Wayback Machine will serve the archived file with the closest available date to the page
`upon which the link appeared and was clicked.
`4. The archived data made viewable and browseable by the Wayback Machine is
`compiled using software programs known as crawlers, which surf the Web and
`automatically store copies of web files, preserving these files as they exist at the point of
`time of capture.
`'
`5. The Internet Archive assigns a URL on its site to the archived files in the format
`http://web.archive.org/web/[Year in yyyy][M0nth in mm][Day in dd] [Time code in
`hh:mm:ss]/ [Archived URL]. Thus, the Internet Archive URL
`http://web.archive.org/web/l 9970126045828/http://www.archive.org/ would be the
`URL for the record of the Internet Archive home page HTML file
`(http://www.archive.org/) archived on January 26, 1997 at 4:58 am. and 28 seconds
`(1997/01/26 at 04:58:28). A web browser may be set such that a printout from it will
`display the URL of a web page in the printout’s footer. The date assigned by the Internet
`Archive applies to the HTML file but not to image files linked therein. Thus images that
`appear on a page may not have been archived on the same date as the HTML file.
`Likewise, if a website is designed with "frames," the date assigned by the Internet
`Archive applies to the frameset as a whole, and not the individual pages within each
`frame.
`
`6. Attached hereto as Exhibit A are true and accurate copies of printouts of the
`Internet Archive's records of the HTML files for the URLs and the dates specified in the
`footer of the printout.
`7. I declare under penalty of perjury that the foregoing is true and correct.
`
`.
`
`DATE: 139/712!” WV
`
`"T ”W,
`
`Christoph‘er Butler
`
`RIMFROST EXHIBIT 1061
`
`RIMFROST EXHIBIT 1061 page 0001
`
`page 0001
`
`

`

`Exhibit A
`
`RIMFROST EXHIBIT 1061
`
`RIMFROST EXHIBIT 1061 page 0002
`
`page 0002
`
`

`

`US FDA/CFSAN - Inventory of GRAS Notices: Summary of all
`
`1 of 12
`
`Ll;-
`
`Vi ""1‘ H" 'U ‘5ii lii‘:“It-13ml
`CBNTER FOR FOOD SAFETY AND APPLIED NUTRITION
`
`FDA Home Page I CFSAN Home | Search/Sub‘ect Indexl Q & A | H_e2
`
`CFSAN/Office of Food Additive Safety
`July 2007
`
`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
`
`0 The file number (GRN No.) that FDA has assigned to the notice
`0 A hyperlink to the letter that FDA sent in response to the notice
`
`Wthin 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
`0 The intended conditions of use
`0 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.).
`
`GRAS Notices Received in 2007
`
`
`
`FDA's Letter
`
`
`
`1
`I
`
`
`!
`Pending
`,|
`
`I
`Pending
`|
`Pending
`I
`Pending
`Pending
`
`224
`223
`
`.i trans—Resveratrol
`l Phosphatidylsenne
`
`RIMFROST EXHIBIT 1061
`https://web.archive.org/web/2007080501 1458/http://www.cfsan.fdagov:80/~rdb/opa—gras.html
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`page 0003
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`US FDA/CFSAN - Inventory of GRAS Notices: Summary of all
`
`2 of 12
`
`r—Wr—Wr—I
`
`TWfi—F‘WF—
`
`WWW“
`[Z—W—l—W
`GRAS Notices Received"In 2006
`
`
`
`
`
`Details about Notices Received in 2006
`1 9-218
`
`[BacteriophageP100preparationfromListeria'mnocua
`[:
`[LipaseenzymepreparationfromRhizopusoryzae
`[:
`[Actinidiaargutaextract
`[:
`[214[
`
`Tailored tryglycerides containing approximately 12
`percent medium-chain fatty acids
`
`Asparaginase enzyme preparation from Aspergillus niger
`expressing the asparaginase gene from A. niger
`
`
`
`[
`
`FDA___l_1_q________asno uestions
`[
`
`FDA_h_q_____asno uestions
`[
`Pending
`__£L__._
`
`Pending
`
`
`
`FDA has nouestions
`
`213
`
`212
`
`[2
`[2
`[2
`[2
`[2
`
`206
`
`205
`
`204
`
`.
`Hydroxypropyl methylcellulose - expanded substitution
`,
`FDA has no uestions
`pattern (HPMC-ESP)
`
`
`Phospholipase A2 enzyme preparation from Streptomyces
`violaceruber expressing a gene encoding phospholipase
`FDA has no Questions
`
`A2 from the same species
`[ nouestions
`[Xanthan gum (reduced pyruvate)
`[
`
`FDA has no______qu___estions
`[Water soluble tomato concentrate
`[
`
`FDA has no___qu___estions
`[L-theanine
`[
`
`FDA____h__q___asno uestions
`[Erythritol
`[
`FDA has no questions
`[Barley fiber
`
`
`Phytosterol esters and diglycerides resulting from
`transesterification of vegetable oils/fats with soy
`FDA has no Questions
`
`phytosterols
`
`Pullulanase enzyme preparatlon from Baczlius subt1l1s-
`expressmg the pullulanase gene from B. aczdopullulytzcus
`
`Phosphohpase C enzyme preparat1on from P1ch1a
`pastorzs expressmg a heterologous phosphohpase C gene
`.
`.
`
`[O2032[Erythr1tolfattyac1desters
`[:
`[Polyoxyethanyl-a—lpha—tocopheryl sebacate (PTS)
`
`Asparaginase enzyme preparation from Asperg1llus
`oryzae expressing the asparaginase gene from A. oryzae
`
`FDA has no uestions
`_—g_
`
`FDA has no uestions
`____q______
`
`.
`
`‘
`
`V
`
`
`
`t________henot1ce.
`
`[ Atnotlfiersrequest,FDAceasedtoevaluate
`[
`
`FDA hasno_____g_u_estions
`
`
`
`FDA has no uest1on
`
`Tailored triglycerides enriched1n omega- 3 fatty acids
`from fish oil
`
`[1
`
`[Concentrated hydrolyzed milk protein
`
`[
`
`
`
`FDA___h___q_asno uestions
`
`RIMFROST EXHIBIT 1061
`https://web.archive.org/web/2007080501 1458/http://Www.cfsan.fda.gov:80/~rdb/opa-gras.html
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`US FDA/CFSAN - Inventory of GRAS Notices: Summary of all
`
`3 of 12
`
`I198
`
`197
`196
`
`IBacteriophage P100 Preparation from Listeria innocua
`IPhosphatidylserine
`IBovine milk basic protein fraction
`
`
`
`FDA has no Questions
`FDA has no questions
`FDA has no Questions
`
`Pending
`
`
`
`
`
`
`
`
`
`195
`
`190
`
`
`189
`
`Mixed beta—Glucanase and xylanase enzyme preparation
`FDA ha no ues 1 us
`from Humicola insolens
`" ""
`1
`WWW—
`—193' WWI—W—questions
`192W FDA has no questions
`191
`_WWI—WE;—
`
`
`At notifier's reguest, FDA ceased to evaluate
`the notice.
`Hydroxypropyl methylcellulose
`
`Resubmitted as GRN No. 213
`I
`IILactoferrin (human) purified from bovine milk
`GRAS Notices Received in 2005
`
`I
`
`(N).
`
`Details about Notices Received in 2005
`GRNNo. 163- 188
`
`I1 81I Carbon monoxide
`I17IIL(+) Tartaric acid (alternative method of manufacture)
`.Soy lecithin enzymatically modified to have increased
`phosphatidylserine
`
`IConcentratedtomato lycopeneextract
`
`I“:
`
`I
`I
`
`I
`
`Pending
`FDA has no Questions
`FDA has no uestions
`_________q_,__
`
`
`
`FD______g_Ahasno uestions
`
`183
`
`I
`FDAhas no uestions
`
`
`FDA has no questions
`
`I1 “Ilsomaltulose
`
`Phospholipase A2 enzyme preparation from Aspergillus
`niger expressing a gene encoding a porcine
`phospholipase A2
`I—‘WI—HW
`Tim—W
`WWI—W—
`film—WW—
`WWW—T?—
`fmI—m—
`176
`Plant sterols and plant sterol esters from vegetable oils or
`.
`.
`W115
`_ sterols/stanols from tall 011
`
`175
`
`174
`
`no u sti ns
`FDA h
`Saccharomyces cerevzsiae stram ECMoOl W1th enhanced
`express1on of urea amldolyase M
`
`.
`.
`Lysozyme (human) enzyme preparatlon from rlce
`
`At notifier's request, FDA ceased to evaluate
`.We;
`
`RIMFROST EXHIBIT 1061
`https://web.archive.org/web/2007080501145S/http://www.cfsan.fda.gov:80/~rdb/opa—gras.html
`
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`US FDA/CFSAN - Inventory of GRAS Notices: Summary of all
`
`4 of 12
`
`Lycopene from Blakeslea trispora
`
`Isomalto-oli gosaccharide
`
`Lactobacillus acidophilus, Laclobacillus lactis, and
`Pediococcus acidilactici
`
`171
`
`
`
`Shrimp-derived chitosan
`
`FDA has“nouestions
`
`
`me uses ma readditivelistincolor
`
`
`At notifiers re uest FDA ceased toevaluate
`
`the_n_otice
`
`FDA____h_q___asno uestions
`
`-- '
`Additional correspondence about intended
`
`At notifier‘5 re uest FDA ceased toevaluate
`
`
`t___henotice.
`
`1;:I
`I1
`
`'iI
`
`Bovine globulin
`
`IPoultryprotein
`ICarbon monoxide
`Carbon monoxide
`
`IQuillaiaextracttype 1
`
`I
`
`I
`
`At notifier‘ 5 re uest FDA ceased toevaluate
`
`
`t_____henotice.
`
`Ahanouestion
`
`FDA has nouestions
`At notifier'5 re uest FDA 0sedto evaluate
`then—otice.
`
`
`
`FDAhasnouestions
`
`
`
`
`
`164
`
`163
`
`
`
`
`I
`FDAhas11
`Lauramide arginine ethyl ester
`Additional correspondence about intended
`uses
`
`
`
`FDA has no questions
`Tomato pulp powder
`Additional correspondence about intended
`
`
`
`
`m
`
`
`
`GRAS Notices Received in 2004"
`
`Details about Notices Received in 2004
`
`1GRN No. 143-1621
`
`
`
`No.
`
`Chlorine dioxide, generated using sodium chlorite1n
`calcined or sulfated kaolin clay
`
`
`
`_the_n__.otice
`FDAhasno uest1on
`
`
`
`Lipase preparation from Aspergillus niger expressing a
`gene encoding a lipase from Candida antartica
`I
`ICalcium propionate (alternative method of manufacture)
`
`
`Tomato lycopene extract 6 percent, tomato lycopene
`FDA has no questions;
`extract 1.5 percent, and crystallized tomato lycopene
`
`
`.l. .
`. extract
`Ialpha-Cyclodextrin
`IDried orange pulp
`
`I1
`
`156
`
`I1
`I1
`
`I
`I
`
`FDA has nouestions
`
`
`
`FDAh no u i
`
`RIMFROST EXHIBIT 1061
`https://web.archive.org/web/20070805011458/http://www.cfsan.fda.gov:80/~rdb/opa—gras.html
`
`RIMFROST EXHIBIT 1061 page 0006
`
`page 0006
`
`I__CL__,______IAtnotifier’3re uest FDAceasedtoevaluate
`
`
`LI?ILactoferrin(human)purifiedfromrice
`
`IEO:fIMicro-algaloil(Ulkem'aSp.) WWIthe_n_otice
`{I
`ICarnobacteriummaltaromalzcumstrainCB1
`I
`FDA hasnoue ti ns
`
`
`
`FDA has nouestions
`
`

`

`US FDA/CFSAN - Inventory of GRAS Notices: Summary of all
`
`5 of 12
`
`Conjugated linoleic acid
`
`I1 ISodiumironEDTA
`
`Atnotifier'5 re uest FDA ceased to evaluate
`
`thenoice
`
`FDAhasno uestions
`
`I
`
`
`
`
`
`
`
`
`
`
`FDAhas no uestions
`I
`|_151m__IEthan01 (ethyl alcohol)
`
`Glucosamine hydrochloride prepared from chitin Atnotifier's re uest FDA ceased to evaluate
`
`obtained from Aspergillus niger
`
`t_____henotice.
`
` harzianumu
`
`
`
`FDAha______s___q__no uestions
`
`I
`
`
`I At____g___,__—notifierSreu::—_£—:‘:—5326063568toevaluate
`I
`FDAhasno u stions
`
`I
`
`
`
`FDA__h____g___asno uestions
`
`FDAhas no uestions
`
`I1
`
`IIFish protein
`
`IPhospholipase A2 enzyme preparation from Streptomyces
`Iviolacearuber
`
`III-5'9I Beta-glucanaseenzymepreparationfromTrichoderma
`I;148
`IIVegetableoilconjugatedlinoleicacidpreparation
`I146:IIIISalmonoil
`
`iI“:—MICarbonmonoxide
`
`Adenosine 5 -m0nophosphoric acid and its monosodium FDA has no uestions
`and disodium salts
`
`I
`
`
`
`
`
`FDAh n e tions
`
`GRAS Notices Received'In 2003
` Details about Notices Received in 2003
`GRNNos. 120- 142
`
` I Phospholipase enzyme preparation from Aspergillus
`
`FDA has no Questions
`I oryzae expressing the gene encoding a phospholipase A1
`I from Fusarzum venenalum
`
`142
`
`If: PIIPolyvinyl alcohol
`ICrystalline lutein
`
`I
`
`FDAhasno uestions
`
`FDAha no 5 i n
`
`some uses may require a color additive listing
`
`At notifier‘ s request, FDA ceased to evaluate
`t—henotice.
`TWT—W
`TWT—
`FTWTI—MT
`I—IW—TFW
`I
`134
`IISoy protein hydrolyzatewith Ienzyme——modified lecithin I FDAhas no uestions
`I
`133
`IIVolatile oil of mustard
`I
`
`_Fl_)____q_Ahas no uestions
`I ILactase enzyme preparation from Aspergillus niger
`
`I High 2—palmitic vegetable oil
`131
`I1 OIIBovine milk-derived lactoferrin
`
`I I
`
`FDA_l1___q_asno uestions
`
`I Aditi11
`I FDAhas no uestions
`
`Cassia gum
`
`RIMFROST EXHIBIT 1061
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`

`US FDA/CFSAN - Inventory of GRAS Notices: Summary of all
`
`6 of 12
`
`I1
`
`ISucrose fatty acid esters
`
`Skim milk or dextrose cultured with Propionibacterium
`eudenreichii subsp. shermanii
`
`
`
`Spirulina, the dried biomass of Arthraspira platensis
`
`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
`
`
`
`I
`I
`
`Additional corresondence
`
`FDAhasno uesti n
`
`FDA hasnouestions
`
`ti ns
`3
`FD
`
`A ha no___gu_zes0
`
`some uses ma re uire a coloradditivelistin
`
`
`
`
`
`FDA has no Questions
`
`
`FDA hasnouestions
`some uses muirea clorditive li tin
`
`I1
`I1
`
`122
`
`121
`
`I
`
`Grape seed extract and grape pomace extract
`IIGrape seed extract
`ILaminariajapom'ca broth and extract powder
`
`Laccase enzyme preparation produced by Aspergillus
`oryzae expressing the gene encoding a laccase from
`
`Myceliophthora thermophila
`IXanthan gum
`Saccharomyces cerevisiae strain MLOl carrying a gene
`
`encoding the malolactic enzyme from Oenococcus oem'
`
`
`120
`FDA has no Questions
`and a gene encoding malate permease from
`
`Schizosaccharomyces pombe
`
`GRAS Notices Received in 2002
`
`
`I
`FDA has_n__g_ouestions
`I
`
`FDA has no_____qu____estions
`
`
`
`
`
`
`I
`FDA has no guestions
`
`FDA has no questions
`
`
`
`Details about Notices Received in 2002
`
`GRNNos. 94- 119
`
`.
`
`119
`
`
`FDA has no questions;
`some uses may require a color additive listing
`Synthetic lycopene
`Corrected letter issued April 7, 2005
`
`
`
`I1
`
`ILipase enzyme preparation from Aspergillus niger
`
`Lutein esters
`
`I
`
`ITuna oil
`
`I
`
`FDA has no____g_1_1____estions
`
`FDAhasno uesti n
`
`
`some uses ma re uire a coloradditivelistin
`I
`
`FDA has noue________q__s___tions
`
`RIMFROST EXHIBIT 1061
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`
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`

`US FDA/CFSAN - Inventory of GRAS Notices: Summary of all
`
`7 of 12
`
`.
`Glycerol ester of gum rosm
`
`: Notice does not provide a basis for a GRAS
`.
`.
`determmatl n
`
`Polydextrose
`
`I
`
`Spirulina
`
`.
`
`
`
`
`
`
`D—Rlbose
`
`rov1de albas1s for a GRAS
`Not1ce does not
`deterrnmatlon
`
`
`
`
`
`
`
`
`
`
`A“...
`At notifier s re uest FDA ceased to evaluate
`the not1ce
`
`I
`Glucose oxidase enzyme preparation from Aspergillus
`
`FDA has no Questions
`oryzae carrying a gene encoding a glucose oxidase from ‘
`Aspergillus niger
`
`I
`FDA has no Questions
`)
`IFish oil concentrate
`I
`FDA has no questions
`I Sucrose acetate isobutyrate
`
`
`Lipase enzyme preparation from Aspergillus oryzae
`
`carrying a gene constructed from a modified
`
`FDA has no questions
`Thermomyces lanuginosus lipase gene and a portion of
`
`_ the Fusarium oxysporum lipase gene
`ISmall planktivorous pelagic fish body oil
`FDA has no questions
`At notifier's reguest, FDA ceased to evaluate
`m
`Resubmitted as GRN No. 127
`
`108
`
`107
`
`106
`
`105
`104
`
`103
`
`102
`
`101
`
`100
`
`99
`
`98
`
`I
`
`
`
`'
`
`________Q___—_
`-
`I
`FDA has no guestions
`.I Pullulan
`
`' At notifier‘s reguest, FDA ceased to evaluate
`mm;
`Small planktivorous pelagic fish body oil
`
`Resubmitted as GRN N0. 102
` At notifier's reguest, FDA ceased to evaluate
`the notice.
`
`Resubmitted as GRN No. 109
`
`
`Tuna oil
`Silk protein food powder
`I:65—"I_—
`I
`.ITransglutaminase from Streptoverticillium mobaraense
`I
`FDAhas no uestions
`
`: Docosahexaenoic acid-rich oil from tuna (DHA-rich tuna
`
`
`oil) and arachidonic acid-rich oil from Mortierella alpina
`FDA has no Questions
`
`(AA-rich fungal oil)
`
`_______
`GRAS Notices Received in 2001
`
`
`
`
`
`Noticedoesnot rovide a asis for a GRAS
`
`I_—P____D______—d—_etermination
`
`
`
`
`
`'
`
`
`
`Details about Notices Received in 2001
`
`GRNNos. 66- 93
`
`- N
`
`
`
`
`
`
`__________n—_oticedoes not rovide a basis for a GRAS
`
`
`determination.
`
`
`Grape seed extract and grape skin extract
`Resubmitted as GRN N0. 125
`
`
`91-"-:IIMycoprotein
`I
`
`Notice does not provide a basis for a GRAS
`l
`.
`.
`Followup submitted as GRN N0 129
`
`
`
`FDA______h______q_asno uestions
`
`RIMFROST EXHIBIT 1061
`https: //Webarchive .org/web/2007080501 1458/http://wwwcfsan ..fdagov: 80/~rdb/opa— gras.html
`
`RIMFROST EXHIBIT 1061 page 0009
`
`page 0009
`
`

`

`
`
`
`
`
`
`Invertase enzyme preparation from Saccharomyces
`cerevisiae and lactase enzyme preparation from
`Kluyveromyces marxianus
`
`FDA has no questions
`
`Composne filtrat1on med1a(d1atomaeeous earth and
`perlite)
`
`FDA has no uestions
`____g_—
`
`
`
`
`
`
`Coagulated potato protem, hydrolyzed potato protem, or
`FDA has no uestions
`clarlfied hydrolyzed potato proteln
`*4—
`WWI—1m—
`r—WWW
`WWI—Fm—guestlons
`WWI—W—questions
`
`IT‘WI—W—questions
`
`WWWsno questions
`
`
`
`Alpha—amylase derived from Bacillus lichem'formis
`carrying a gene encoding a modified alpha-amylase from
`Bacillus licheniformis
`I
`
`I
`I
`
`
`
`
`
`I
`I
`
`.
`;
`
`90
`89
`
`88
`
`87
`
`86
`
`
`
`US FDA/CFSAN - Inventory of GRAS Notices: Summary of all
`
`8 of 12
`
`
` Carbohydrase enzyme preparatlon trom Asperglllus
`.
`.
`oryzae, protease enzyme preparauon from Aspergzllus
`oryzae, and carbohydrase enzyme preparation from
`Rhizopus oryzae
`
`
`.
`Five enzyme preparations from Aspergillus niger:
`Carbohydrase enzyme preparation, catalase enzyme W
`preparation, glucose oxidase enzyme preparation,
`pectinase enzyme preparation, and protease enzyme
`preparation
`
`FDA has no questions
`
`__
`
`‘
`.
`Add1tlonal correspondence
`
`Additional correspondence
`
`FDA has no questions
`
`
`_F______q__DAhas nouestions
`
`ID--Tagatose
`FDA has nouestin
`IMilk-derived lactoferrin
`FDA has no questions
`;I Erythritol
`FDA h
`no ue ti n
`: L1pase derived from Asperg1llus oryzae carrymg a gene
`encoding llpase from Fusarmm oxysporum M
`IBeta-cyclodextrin
`I
`FDA hasnouestions
`
`79
`
`:HW'77I
`I
`I
`
`75
`
`I
`
`Shrimp-der1ved chitosan
`
`:Pullulanase derived from Bacillus licheniformis carrying
`a gene encoding pullulanase from B. deramificans
`IWhite mineral oil USP (viscosity ISO 100)
`IStearyl alcohol
`IBehenic acid
`IL1pase from Penicillium camembertii
`IMilk—derived lactoferrin
`
`67
`
`I:68IM11kth1stleextract
`
`I
`I
`I
`I
`I
`
`
`
`At notifier'rceasedVluate
`
`t___henotice
`
`
`
`FDAha 11 ue i n
`
`I
`I
`I
`I
`I
`
`FDA has no____qu____estions
`
`FDAhasno uesi n
`
`FDA_h___q___asno uestions
`
`FDA has no_____qu__estions
`FDA has no questions
`
`I Not1cedoesnotprovrdeabasrsforaGRAS
`
`determinatlon
`
`
`
`RIMFROST EXHIBIT 1061
`https://web .archive.org/web/2007080501 l458/http://www.cfsan.fda.gov:80/~rdb/opa— gras .html
`
`RIMFROST EXHIBIT 1061 page 0010
`
`page 0010
`
`

`

`US FDA/CFSAN ~ Inventory of GRAS Notices: Summary of all
`
`9 of 12
`
`GRAS Notices Received in 2000
`
`Details about Notices Received in 2000
`
`RNNos. 36- 65
`
`
`
`
`
`fi'N—isin FDA'h—asl—questionsno
`
`j-
`
`
`'—Eggwhitelysozyme ‘
`
`
`FDA hasnoquestions
`
`'
`
`
`0‘1DJ
`
`
`G\ ,_.11?GO
`U1 \0W
`
`
`
`I
`
`H_ops beta ac_ids
`Chlorine dioxidegenerated from particles (<300m)
`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 0g chlorite/in2 of
`finished pac_kage film
`'Plant sterols/Plant sterol esters
`'Potassium bisulfate
`
`Hydrogenated starch hydrolysate
`
`FDA has no questions
`
`3'
`2
`}
`
`FDA has no questions
`
`
`Additional correspondence about intended
`w
`
`I
`I
`
`FDA has no questions
`FDA has no questions
`4—...4—
`At notlfier 5 re uest FDA ceased to eva uate
`W
`
`_
`
`WW
`
`I'Argon gas1
`56
`55
`54
`
`'
`
`
`Diacylglycerol oil
`'Transglutaminase from Streptoverticz’llium mobaraense
`- Xylanase derlved from Fusarzum venenamm carrying a
`. gene encoding xylanase from Thermomyces lanugmosus
`'Phytosterol esters
`'Whey mineral concentrate
`
`l
`'
`
`S3
`52
`
`Cassia gum from Cassia tom/obtusifolia
`
`:' Bohenin
`I
`
`
`Bifidobacterium lactis strain Bb12 and Streptococcus
`thermophilus strain Th4
`
`FDA has no questions
`FDA has no questions
`FDA has no questions
`FDA has no uestions
`_ —C;
`'
`FDA has no questions
`FDA has no questions
`
`At notifier's request, FDA ceased to evaluate
`the qotiqqi
`
`Resubmitted as GRN No. 139
`
`
`
`FDA has no questions
`FDA has no questions
`
`Additional correspondence regarding new
`.
`E
`.
`l
`E
`l
`.
`. E! l 2
`
`'
`
`FDA has no questions
`'Vegetable oil phytosterol esters
`FDA has no questions
`; Arabinogalactan from Larix occidentalz's
`FDA has no questions
`'Gamma cyclodextrin
`E'Trehalose
`FDA has no questions
`
`Fructooligosaccharide
`3 Additional correspondence about intended
`3
`uses
`
`44
`
`RIMFROST EXHIBIT 1061
`https: //Web.archive.org/web/2007080501 l458/http: //www .cfsan .fd.agov. 80/~rdb/opa-gras.html
`
`RIMFROST EXHIBIT 1061 page 0011
`
`page 0011
`
`
`
`
`
`
`

`

`US FDA/CFSAN - Inventory of GRAS Notices: Summary of all
`
`10 of 12
`
`L
`lpase derived from Aspergillus oryzae carrying a gene
`encoding lipase from Thermomyces [anuginosus
`
`
`
`FDA has no____q___t_ionuess
`
`Noticedoes not rov1de abasisforaGRAé
`
`W
`
`
`Resubmitted as GRN No. 77
`— '
`
`
`
`Additional correspondence clarifying the
`appropriate mechanism 19 "supplement" a
`
`
`notice after FDA has responded to that notice
`
`—.§_QM
`
`
`
`.FDA ha no ue tion
`
`Notice does not provide a basis for a GRAS
`r
`’
`tio .
`Resubmitted as GRN No. 71
`
`FDA has no questions
`
`I -_
`_
`_
`Additional correspondence clarifying
`
`in___tendeduse
`
`
`
`42
`
`Milk-derived lactoferrin
`
`
`
`
`
`
`
`I—7DHASCO (docosahexaenoic acid—rich single-cell oil) andI—7ARASCO (arachidonic acid-rich single-cell oil)
`
`
`
`-Mineral oil
`
`
`
`
`
`39
`
`I—38
`
`37
`
`
`
`Tall oil pliytuslei'ols
`
`
`ICetylpyridiniumchloride
`
`I Whey protein isolate and dairy product solids
`
`Notice dpps pot provide a basis £91 a GRAS
`
`determination
`I W
`Additional correspondence clarifying the term
`
`"dairr_oductsolids"
`Chromium picolinate; Ginkgo biloba leaf extract; and— At notifier'5 re uest FDA ceasedtoevaluate
`Ginseng extract
`then___(_)_tice
`
`
`
`
`
`
`
`:
`
`
`
`
`
`No.
`
`’35
`
`34
`
`I”
`
`GRAS Notices Received'In 1999
`
`Details about Notices Received in 1999
`GRNNos. 13 35
`
`ll‘l)/\IS llelttll-
`
`Notlce does not provide a basis for a GRAS
`determmation
`
`.
`
`.
`
`1
`
`‘
`
`Hem seed oil
`p
`Aspartic proteinase derived from Aspergzllus oryzae
`
`carrying a gene encoding aspartic proteinase from
`
`Rhizomucor miehei
`
`“ILow erucic acid oil derived from BrassicaJuncea
`Pectin lyase derived from Trichoderma reesei carrying a
`'gene encoding pectin lyase from Aspergillus mger
`
`
`
`I
`
`FDhn
`
`i
`
`I
`
`FDA has noestions
`
`FDAhasno uestions
`
`An fi
`the notice.
`Resubmitted as GRN No. 38
`
`31
`
`3 Cetylpyridinium chloride
`
`3O
`
`
`
`Crospovidone—cranberry juice extract
`II Wm'
`
`rovide abasisfor a GRAS determination
`
`I
`
`FDA has no___gu___estions
`ITransglutaminase from Srreptoverticillmm mobaraense
`
`i
`
`-
`
`_
`
`.
`
`Notice does not provide a basis for a GRAS -
`We
`
`RIMFROST EXHIBIT 1061
`https://web.archive.org/web/2007080501 1458/http://www.cfsan .fda.gov:80/~rdb/opa— gras .html
`
`RIMFROST EXHIBIT 1061 page 0012
`
`page 0012
`
`

`

`I F_____g________DAhas no uestions
`
`I
`
`F—q_DAhas no uestions
`
`
`
`
`
`IHINo____t________p______________icedoesnot:-_’L‘____;?:aiiba8isforaGRAS
`
`
`
`
`_
`
`
`
`
`
`
`
`
`
`
`
`
`US FDA/CFSAN - Inventory of GRAS Notices: Summary of all
`
`11 of 12
`
` I
`Seaweed-derived calcium
`
`28
`
`FDA has no Questions
`u in nd
`Additi n l orr
`on en e
`uses
`
`I
`I
`
`ll Dextranase from Chaetomium gracile
`IIIIsolated wheat protein
`
`,2I:E IExtractofGarciniakolaseed("bittercola")
`
`24
`
`23
`
`22
`
`21
`20
`
`«
`
`I
`T
`
`I
` _|
`
`
`I alpha-Amylase derived from Bacillus licheniformis
`carrying a gene encoding alpha-amylase from Bacillus
`I stearothermophilus
`
`FDA has no questions
`
`n
`e
`o
`Protein preparatlon from animal blood
`
`I
`
`:
`
`.
`'
`
`—‘““'J—‘——-Atnotifier S re uest FDA ceased to evaluate
`mm
`
`
`
`alpha-Amylase derived from Bacillus licheniformis
`carrying a gene encoding a modified alpha-amylase
`
`derived from Bacillus lichenformis and Bacillus
`1 amyloliquefaciens
`IIPork collagen
`Pullulanase derlved from Baczllus subnlzs carrymg a gene
`encoding pullulanase from BaCillus naganoenszs
`IFerrous bisglycinate chelate
`IMesquite (Prosopis spp.) wood alcoholic extract
`
`I
`
`FDA has no questions
`
`FDA has no questions
`FDA has no uestions
`*4—
`I FDAhas no uestions
`I
`FDAhas no uestions
`
`Atnotifiersreuest FDA cea e to evaluate
`the notice.
`Resubmitted as GRN No.47
`
`
`
`Arabinogalactan
`
`Menhaden oil
`
`Atnotifier‘s re uest FDA ceased to evaluate
`
`t_henotice
`
`I_
`
`IEITa_steless smoke
`
`Hydrogen peroxide
`
`I
`
`FDAha 11 uestions
`
`
`
`Noticedoes not rovide a basis for a GRAS
`d______etemlination
`Botanicals: Chrysanthemum; Licorice; Jellywort
`FDAhasnouestions
`
`
`
`
` Botanicals: Honeysuckle; Lophatherum; Mulberry leaf;
`Notice does not provide a basis for a GRAS
`determination
`Frangipani; Selfheal; Sophora flower bud
`
`GRAS Notices Received in 1998
`
`
`
`
`Details about Notices Received in 1998
`GRN Nos. 1 - 12
`
`
`
`FDA '5 Letter
`
`At notifier‘s reguest, FDA ceased to evaluate
`them
`Resubmitted as GRN No. 18
`
`I
`
`11
`
`1
`
`0
`
`II Calcium casein peptone-calcium phosphate
`Exopeptidase derived from Aspergillus oryzae carrying a
`.
`.
`_
`.
`
`gene encoding a leucme amlnopeptidase from Aspergillus
`
`FDA has no Questions
`
`Notice does not provide a basis for a GRAS
`.
`.
`(hate—magma
`
`I
`
`RIMFROST EXHIBIT 1061 page 0013
`
`RIMFROST EXHIBIT 1061
`https://web.archive.0rg/web/20070805011458/http://www.cfsan.fdagov:80/~rdb/opa—gras.html
`
`page 0013
`
`

`

`US FDA/CFSAN - Inventory of GRAS Notices: Summary of all
`
`12 of 12
`
`
`
`FDA has no Questions
`
`
`I
`Isoyae
`
`_-I_ noue_tin
`IIPolyglycerol polyricinoleic acid
`
`
`
`Pectin esterase derived from Aspergillus oryzae carrying
`
`a gene encoding pectin esterase from Aspergillus
`I aculeatus
`
`Notice does not
`rovide a basis for a GRAS i
`ARASCO (arachidonic acid-rich single——cell oil) and
`
`
`
`
`. DHASCO (docosahexaenoic acid-rich single——cell 011) as _—"“"L—‘—"—"..
`'
`
`
`
`determinatlon.
`
`
`. sources of the fatty acids ARA (arachidonic acid) and
`Resubmitted as GRN No. 41
`
`! DHA (docosahexaenoic acid)
`
`FDA hasnouestions
`I
`IDioctyl sodium sulfosuccinate
`
`
`: At notifier's reguest, FDA ceased to evaluate I
`Tasteless smoke
`the notice,
`I
`
`Resubmitted as GRN No.15
`;_I FDAhas no uestions
`
`
`FDA hasn________oq__uestions
`
`I
`I
`
`I
`
`I
`I
`
`8
`
`7
`
`U‘i
`
`3
`
`ITransglutaminase from Strepto—verticilliummobaraense
`ISodium bisulfate
`
`ISolin oil (low linolenic acid flaxseed oil or low linolenic
`acid linseed oil)
`
`Il2IIS
`
`
`
`oy isoflavone extract
`
`
`
`
`
`
`I
`
`
`
`
`FDA has nestions
`
`
`
`
`
`—t_l_1__en_otice
`
`
`
`I___q_,_Atnotifier’—3re uest FDA—ceasedtoevaluate
`
`
`
`
`Eood Ingredients and Packaging | GRAS Notification Prggrgm
`
`CFSAN Home | CFSAN Search/Sub'ect Index | CFSAN Disclaimers & Privacy Policy | CFSAN Accessibility/Hem
`FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA
`
`FDA/Center for Food Safety & Applied Nutrition
`Hypertext updated by 9mg July31, 2007
`
`RIMFROST EXHIBIT 1061
`https://web.archive.0rg/web/2007080501 1458/http://www.cfsan .fda. gov:80/~rdb/opa— gras .html
`
`RIMFROST EXHIBIT 1061 page 0014
`
`page 0014
`
`

`

`Enzymotec 1 Development and Marketing of Innovative BioFuncti...
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`RIMFROST EXHIBIT 1061
`https://web .archivc .org/web/20070925024350/http: //WWW .enzymotec .Com/Pagelndex .asp?cc=0 1 020403
`
`RIMFROST EXHIBIT 1061 page 0015
`
`page 0015
`
`

`

`Enzymotec | Development and Marketing of Innovative BioFuncti...
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`
`Enzymotec takes
`advantage of its
`technology platform to
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