RX-0135
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`
`DEPARTMENT OF HEALTH & HUMAN SERVICES
`
`Public Health Service
`—
`
`Memorandum
`
`DOCKETS TRANSMITTAL MEMO
`Date:
`2 3 2003
`
`0 4 1 3
`
`'03 JAN 27 P 2 :03
`—
`
`F'°m3
`
`Consumer Safety Officer, Division of Standards and Labeling Regulations, Office
`of Nutritional Products, Labeling and Dietary Supplements, HFS-821
`
`Subject‘
`
`75-Day Premarket Notification of New Dietary Ingredients
`
`T05
`
`Dockets Management Branch, HFA-305
`
`Firm: Neptune Technologies & Bioressources
`
`Date Received by FDA: 5-15-02
`
`90-Day Date: 8-13-02
`
`In accordance with the requirements of section 413(a) of the Federal Food, Drug, and
`
`Cosmetic Act, the attached 75-day premarket notification and related correspondence for the
`
`aforementioned substance should be placed on public display in docket number 95 S-0316 as
`
`soon possible since it is past the 90-day date. Thank you for your assistance.
`
`
`
`Gloria Chang, R.Ph./Inte
`
`sciplinary Scientist
`
`Attachments
`
`Q5/5 - cs/e
`
`/<4/07‘/W
`
`1
`
`1
`
`AKER877|TC00057906
`AKBM 1107
`
`AKBM 1107
`
`RX-0135.0001
`
`

`
`‘
`
`Y’
`
`;-»"":-..,
` ' , DEPARTMENT OF HEALTH 8: HUMAN SERVICES Public Health service
`
`
`
`
`
`
`%..,~__
`
`Food and Drug Administration
`Washington. Dc 20204
`
`OUT
`
`A 2032
`
`Tina Sampalis, M.D., Ph.D
`Vice President of Research
`Neptune Technologies _& _Bior_'§ssou£ces Inc.
`"566 §t7s71fli17FWdE‘West “‘~‘_ ‘"7 7 “
`Laval, Quebec
`H7W 3J8,€anada
`
`e-
`
`'
`-V ‘-
`
`-
`
`~
`
`—-
`
`Dear Dr. Sampalis:
`
`This is to inform you that your notification, dated February 17, 2002 was originally filed with
`the Food and Drug Administration (FDA) on February 28, 2002. Your original notification
`contained three separate notifications concerning three new dietary ingredients that were
`identified as: Neptune Krill Oil" (Krill oil), Neptune Aquatvinen‘ (Krill-based protein
`concentrate powder of the dry residue from the extraction of oil), and Neptune Ly0-Kn'll""
`(freeze-dried Krill). You indicated that the primary source oi all three ingredients is Krill, a
`shrimp-like crustacean identified as Antarctic Krill (species known as Euphausia superba). In
`~ a telephone conversation with you on April 8, 2002, we informed you that your notification
`was incomplete in that it did not supply all of the information as required in Title 21 of the
`Code of Federal Regulations (21 CPR) _90.6.
`
`Your amended notification, dated April 26, 2002, containing the additional information was
`received by FDA on May 15, 2002, which was the revised filing date for the three ingredients
`cited above. We note that in the amended notification you included a new notification for an
`ingredient described as Neptune Krill Enzyme'"‘. Subsequently, in telephone conversations
`with you on June 17 and July 15, 2002, we requested additional information on this ingredient
`and indicated that the new filing date for Neptune Krill Enzyme?“ would be the date that we
`receive this information. The new filing date for the notification on Neptune Krill Enzyme”
`was July 19, 2002. Further, on July 18, 2002 you notified us ‘via electronic mail that you
`changed the tradename fi-om Neptune Krill Enzyme“ to Neptune Krill Euphausial“. Hence,
`we will be using the new tradename for the rest of this letter. FDA considered the notification
`for Neptune Krill Euphausiam separately fi'om the other threc notifications. Nonetheless, this
`letter addresses the four notifications for the following ingredients: Neptune Krill Oil” (Krill
`oil), Neptune Aquateine““ (Krill-based protein concentrate powder of the dry residue from the
`extraction of oil), Neptune Ly0-Krilll“ (freeze-dried Krill), and Neptune Krill Euphausial“)
`(a blend of Neptune Krill Aquateinem and Neptune Lyo-Krill”).
`
`In your amended notification, you indicated that the serving levels and daily servings are:
`Neptune Krill Oil'"" (1 gram of oil per geleap with a reeornmended daily serving of 1 to 3
`gelcaps per day); Neptune Aquateine"'” (300 mg per sac with a recommended daily serving
`of l to 3 sacs per day), Neptune LyO-Krill“ (300 mg per capsule with a recommended daily
`
`2
`
`AKER877|TC00057907
`
`RX-0135.0002
`
`

`
`\
`
`Dr. Sampalis-Neptune Page 2
`
`serving of l to 3 capsules per day) and Neptune Krill Euphausirfl“ (300 mg per capsule with a
`recommended daily serving of 1 to 3 capsules. You also stated that there was no limitation in
`the duration of use for any of the four ingredients and that the only subpopulations excluded
`from using these ingredients are persons with seafood allergies and those taking
`anticoagulants.
`
`In accordance with 21 C.F.R 190.6 (c), FDA must acknowledge its receipt of a notification for
`a new dietary ingredient. For 75 days alter the filing dates, you must not introduce or deliver
`for introduction into interstate commerce any dietary supplement that contains Neptune Krill
`Oil“ (Krill oil), Neptune Aquateine'“‘ (Krill-based protein concentrate powder ofthe dry
`residue from the extraction of oil), Neptune Ly0-Krill“ (freeze-dried Krill) or Neptune Krill
`Euphausiam (a blend ofNeptune Krill Aquateine“‘ and Neptune Lyo-Krill“).
`
`Please note that acceptance ofthis notification for filing is a procedural matter and, thus, does
`not constitute a finding by FDA that the new dietary ingredient or supplement that contains
`the new dietary ingredient is safe or is not adulterated under 21 USC. 342. Irnportantly, new
`dietary ingredients for use in dietary supplements that FDA has reviewed through the
`premarket notification process are not "approved" or “authorised” by the agency.
`
`Although we are not finding at this time that the basis on which you concluded that a dietary
`supplement containing either Neptune Krill Oil“, Neptune Aquateine", Neptune Ly0-
`Krill“ and Neptune Krill Euphausial" will reasonably be expected to be safe is inadequate,
`' FDA is not precluded from taking action in the firture against 4 dietary supplement containing
`any ofthese ingredients if it is found to be adulterated or misbtanded. It is the manufacturer's
`or distributor-’s responsibility to ensure that any dietary ingredient or a dietary supplement
`marketed in the United States is safe and complies with all applicable requirements of the
`Federal Food, Dmg and Cosmetic Act and implementing regulations in Title 21 of the Code
`ofFederal Regulations as well as any other applicable Federal laws and regulations.
`
`Your notifications for Neptune Krill Oil“ (Krill oil), Neptune Aquateinem (Krill-based
`protein concentrate powder ofthe dry residue fi'om the extraction of oil),
`Neptune Ly0-Krill“ (freeze-dried Krill) and Neptune Krill Euphausiam (a blend ofNeptune
`Krill Aquateine“ and Neptune Lyo-Krilll”) will be kept confidential for 90 days from the
`date of their receipt. Therefore, your notifications for Neptune Krill Oil“, Neptune
`Aquateine“, and Neptune LyO-Krill?“ and your notification for Neptune Krill Euphausia“‘
`will be placed on public display at FDA's Dockets Management Branch in docket number
`955-0316 afier August 13, 2002 and October 16, 2002, respectively. However, any trade
`secret or otherwise confid_ential commercial information in the notifications will not be ._
`disclosed to the public.
`
`Prior to October 16, 2002, you may wish to identify in writing specifically what information
`you believe is proprietary in the notification for Neptune Krill §3uphausia“‘ for FDA's
`consideration. Nevertheless, our Centers Freedom of Information Officer has the authority to
`make the final decision about what information in the notifications should be redacted before
`it is posted at Dockets.
`
`3
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`AKER877|TC00057908
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`RX-0135.0003
`
`

`
`Dr. Sampalis-Neptune Page 3
`
`For your information, the following FDA Internet sites and their corresponding links may be
`useful:
`http://www.cfsan.fda.gov/:g_n1s/supglmnthhnl
`http://w-ww.cf§an.fda.ggv/~lrd/fr9722;e.1;m1 (21 CFR 190.6)
`http://www.cfsan.fda.gov/~d1ns/ds-info.htm1
`http://www.cfsan.fda.gov/~dms/ds-indhfl
`hwr//
`http://www.cfsan.fda.gov/~lrd/§7223b.hgg
`http://www.cf§an.fda.gov/~dms/ds-1&1.htmI#structure
`
`http://w/ww.fic. ov/bc lconlinel ub . b di
`
`
`Please contact me at (301)436-2371, if you have any questions concerning this matter.
`
`Sincerely yours,
`
`Gloria Chang R.Ph
`Interdisciplinary Scienti:-1:
`HFS-821
`Division of Standards
`
`and Labeling Regulations
`Ofiice ofNutritional Products, Labeling
`and Dietary Supplements
`Center for Food Safety
`and Applied Nuuition
`
`4
`
`AKER877|TC00057909
`
`RX-0135.0004
`
`

`
`‘ @ NEPTUNE
`
`tec/mologies G bIO7‘€SSOl/!l’(‘€\‘
`
`500 St—Manin Blvd.West
`Suits‘ 550
`Laval (Quebec)
`Canada H7M 3Y2
`
`Telepimne ’-S50» 9726291
`Toll free 1. 888 564-9166
`Fax 1450) 972-635’;
`www nmminebiorech com
`
`Ms. Gloria Chang
`Acting Team Leader
`Dietary Supplement Team
`Division of Standards and Labeling
`HFS-821,
`CFSAN,—
`2OO C Street, SW
`
`Washington, DC 20204
`Telephone No. 301-436-1853
`
`April 26, 2002
`
`Re: ITPN 79419
`
`Dear Ms. Chang,
`
`Please contact me if further information is required at:
`tel.: 450-972~6291
`cell: 514-865-9917
`e—mai1:tinas ne tunebiotech.com
`
`Best Regards
`
`7/"
`
`:2:
`
`Vice President Research
`
`E
`EaG.#I‘AA
`
`/.119
`
`5
`
`AKER877|TC00057910
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`RX-0135.0005
`
`

`
`
` APPENDIX A: Photostatic copies or reprints of
`full—published references,
`
`
`APPENDIX B: Neptune Krill Oil TM
`
`serving and daily dos:
`
`the
`
`APPENDIX C:Neptune Aquateine TM serving and daily dose
`
`
`
`
`APPENDIX D : Ly0—Kri1l daily serving and dose
`
`APPENDIX E : Neptune Krill Enzymes TM serving and daily
`dose
`
`APPENDIX F: Scientific Report
`
`APPENDIX H Krill additive by Nippon Suisan
`
`CR213-8PD
`
`6
`
`AKER877|TC00057911
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`RX-0135.0006
`
`

`
`Neptune Technologies & Bioressources Inc.
`Information Package
`
`Table of Contents
`
`1. General information requested
`
`2. Appendix A : Photostatic copies or reprints of the full-published references,
`
`citations, and articles in English:
`
`a Krill
`
`b. Cardiovascular disease
`
`c.
`
`Inflammatory disease
`
`d. Phospholipids
`
`e. Astaxanthin
`
`Appendix B : Neptune Krill Oilm serving and daily dose
`
`Appendix C : Neptune Aquateinem serving and daily dose
`
`Appendix D : LyO-Krill daily serving and dose
`
`Appendix E: Neptune Krill Enzymesm serving and daily dose
`
`Appendix F: Scientific Report
`
`9°.\'.°‘S":“.‘*’
`
`a. —& Neptune Aquateinem
`
`b. LyO-Krill
`
`9. Appendix H: Krill additive by Nippon Suisan
`
`7
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`AKER877|TC00057912
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`RX-0135.0007
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`

`
`SUPPLEMENTARY INFORMATION
`
`I informed her that we needed photostatic copies
`> The references included abstracts.
`or reprints of the full-published references, citations, and articles in English.
`0 Please refer to “Appendix A”
`
`I ask if there was
`> The specific species of Krill was not identified in the notification.
`a specific species that was to be marketed. Dr. Sampalis stated that there was, and
`that she would provide that information to us.
`0 The krill species used is: Antarctic Krill Eup/zasia superba fished in the
`Antarctic ocean near the South Georgia and Sandwich Islands
`
`> The notification was unclear as to what form of the Krill was to be orally ingested,
`there were 3 forms:
`the oil extract, the dry fraction, and the freeze—dried form. Dr.
`Sampalis stated that all three forms were to be marketed for oral ingestion. I asked
`her to indicate this in her response.
`0 All three forms are meant for oral ingestion:
`I Neptune Krill Oilm : gel caps (1 gram of oil per gel cap)
`I Aquateinem (dry fraction): powder
`I LyO-Krill (freeze dried): capsules (300mg per capsule)
`
`> The notification was unclear as to the specific levels or concentration of Krill
`per serving dose for each form (i.e., the oil extract, the dry fraction, and the
`freeze-dried Krill) and the total daily serving intake and I asked Dr. Sampalis
`to provide information for all three forms. I also requested if there was any
`limitation or duration of use and frequency of serving doses (e.g., how many
`times a day it is taken), if so, to please indicate, if not to also state this.
`o Neptune Krill Oilm : gel caps
`I
`1 gram of oil per gel cap
`I
`recommended dose = 1 — 3 gel caps per day
`I Daily dose: Appendix B
`
`o Aquateinem (dry fraction): powder
`I
`300mg per sac
`I
`recommended dose = 1 — 3 sacs per day
`I Daily dose: Appendix C
`
`o LyO-Krill (freeze dried): capsules
`I
`300mg per capsule
`I
`recommended dose = 1 — 3 capsules per day
`I Daily dose: Appendix D
`
`0 Limitations:
`I No limitation in the duration of use
`
`8
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`AKER877|TC00057913
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`RX-0135.0008
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`

`
`)> Because the target population was not clear or missing, to provide the target
`population that the NDI would be used. If there is no target population, to
`please indicate that. To also provide information if there is any excluded
`populations such as pregnant/lactating women, the elderly, children or infants
`(state age range if any) or other populations with specific disease or medical
`conditions. If so, to specify, if not also state this.
`0 There is no target population
`o Excluded populations:
`'
`Seafood allergy
`- Anticoagulant use
`
`> I also asked Dr. Sampalis to submit the requested complete information
`in triplicate.
`0 Three copies enclosed
`
`> Also please make sure that the complete processing information for all three
`forms, if not in original submission notification, are included in the submission,
`(i.e., the processing technique used, the chemicals, compounds, or other
`ingredients used in processing if any, the drying and freezing techniques, etc.)
`o Please refer to “Appendix E”
`
`> If there are any other ingredients in the various serving (dosage) forms such as
`excipients, flavors, coloring, preservatives, stabilizers, etc, also please identify
`and indicate levels.
`
`0 The company that fishes the raw material (krill) in the Antarctic add
`“sodium hydrogen sulfite (NaHSO3)” as an additive upon freezing. The
`amount of NaHSO3 in krill is approximately 100 ppm.
`0 There are no other ingredients included in any of the serving forms
`
`9
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`AKER877|TC00057914
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`RX-0135.0009
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`

`
`APPENDIX A
`
`10
`10
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`AKER877|TC00057915
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`RX-0135.0010
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`

`
`_)r'1|1_c_)_c(1)g_
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`MATERIAL SAFETY DATA SHEET .
`-.......—--5--——-........_...__-_.____-_..._.._.._._.......__........_—..-..._....
`__........-..._.—-—........_....._...._-__.....____.__.____.___.._-...__-_....._.__.__._.....
`
`SECTION I - PRODUCT IDENTIFICATION
`=————“=—"—"Z='.1.._."""'—==;'=—"=='3...-"""..-."'=.'.=’—-'=—.'—"'....-"—'—‘—'="——"‘-1=="—==
`
`Product Name: Marine Oil
`
`Product Use: Dietary supplement
`
`WHMIS Class: Not Controlled
`
`TDG classification: Not Regulated
`
`Manufacturerlsupplierz
`Address:
`
`Telephone:
`
`Neptune Technologies 8: Bioresources
`500 boul Saint—Mar1in Guest
`Bureau 550
`450 — 972-8291519
`
`——-u
`
`-..'—
`
`
`SECTION II - HAflRDOU$ INGREDIENTS———.—
`
`-¢—-.-—-»——==
`——————=.
`_.-.-.-=
`
`ingredients
`
`OAS13 WI% OSI-IA-PEL ACGII-I-TLV
`
`L050 I.Dso
`
`None by WHMISIOSHA criteria.
`=-"='.'.'=:‘.====:====:=='-==:=‘=".£==3======"-—===“—1-°===i==='-
`
`SECTION III - PHYSICAL DATA
`£5323:ii====%======i==i==.1..."='.::..":===:
`
`Specific Gravity («r20 = 1): Not available
`Boiling Point ("(3): Not available
`% Volatile (Wt 56): Not avaiable
`Vapour Pressure (mm Hg): Not available
`Evaporation Rate (Ether = 1): Not availau
`Vapour Density (Air = 1): Not available
`oil (100%): Not available
`Solubility in Water: Insoluble
`Viscosity: VISCOUS
`Physical State: Liquid
`Odour Threshold (ppm): Not available
`Appearance: Brown
`=c_ro='uvrv—q-u.—w—--—-=-:3-coop-uvp_-;=up-.o-go-—:_-_—_—-_.._=__:‘._..==.__...::_..
`
`SECTION IV - FIRE AND EXPLOSION DATA
`==:==‘”¥“‘_.*Z'.1‘:==:2“__:=:‘.~“::=‘*" "”‘“3‘-‘———"’——-
`
`Flammability: Not flammable by WHMISIOSHA
`UEL: Not applicable
`Flash Point ('0. rec): None
`LEL: Not applicable
`Hazardous combustion Products: May include and are not limited to oxides of carbo
`Autoignition Temperature P0): Not appmble
`Means of Extinction: Treat for surrounding material
`special Fire Hazards: Firefighters should wear self-contained breathing apparatus.
`
`PAGE lbs 3
`
`11
`11
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`AKER877|TC00057916
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`RX-0135.0011
`
`

`
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`-—__.--- —-———_—_———-—.....——————_.———-——____..__...-
`-............__:__—-.—_...._.-..................._—.._..—..__......._-_..__.__..._
`
`SECTION V - REACTIVITY DATA
`============== =%. “======——====:======
`
`Conditions for Chemical Instability: Stable.
`incompatible Materials: None known.
`Reactivity. and Under What Conditions: Not available.
`Hazardous Decomposition Products: May include and are not limited to oxides of rbon when
`heated to
`Decomposition
`
`.. -....__....__..__.-_..-_.._-_.._-_....._..__-...._............._.....--..
`..:........___._.____-___.._-___.__-__...__-__._._-_._-..-_.-....-..
`
`SECTION VI - TOXICOLOGICAL PROPERTIES
`
`—:_. _==‘;: .2:22::—..': —._‘‘‘'_——_===__'..._'”.._._-nu-o'-.—og-c-—"-.—¢—c——"-"'=—"—‘_——'
`
`Route of Entry: Eye, Skin contact, Inhalation. Ingestion.
`
`EFFECTS OF ACUTE EXPOSURE:
`Eye: May cause irritation upon direct contact.
`Skin: May cause irritation upon direct contact.
`inhalation: May cause respiratory tract irritation.
`Ingestion: May cause stomach distress, nausea or vomiting if ‘ngcsted in large quantities.
`
`EFFECTS OF CHRONIC EXPOSURE:
`
`Skin: Prolonged or repeated exposure can cause drying. defatting and dermatitis.
`lrritancy: Non-hazardous by Wl-lMlSlO$HA criteria.
`Respiratory Tract sensitization: No data available.
`carcinogenicity: Non-hazardous by WHMISIOSHA criteria.
`Tcratogenicity. lllutagenicity, Reproductive Effects: No data available.
`Synergistic Materials: Not available.
`
`%—————-o-""'-—-...-o—==‘3==="—-u-"o===—“"———""=="'—=-'—‘==—‘«—--‘====:
`
`SECTION VII- PREVENTATIVE MEASURES
`Q-.——-.—-—up~—
`————-——----———
`"~=%——-.—.—..——___—.':==='.==—-——-_.—'.‘=‘J2=i_..__t_____.__
`
`-
`Gloves: No requirements beyond standard industrial hygiene practices.
`Eye Protection: No requirements beyond standard industrial hygiene practices.
`Respiratory Protection: Not normally required ifgood ventilation is maintained.
`other Protective Equipment: As required by employer code.
`Engineering controls: General ventilation normally adequate.
`Look and Split Procedure: Before attempting clean up. refer to hazard data given above. Small
`spills may be absorbed
`with non-reactive absorbent and placed in suitable, covered. labelled containers. Prevent large
`spills from entering sewers or
`.
`waterways. Contact emergency services and supplier for advice.
`Waste Disposal: Review federal. statelprovincial. and local government requirements prior to
`disposal.
`Storage and Handling Requirements: Keep out of reach of children. Store ‘n a closed contaher
`away from incompatible
`»
`materials.
`
`PAGE 2 OF 3
`
`12
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`AKER877|TC00057917
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`RX-0135.0012
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`

`
`JHN.cfD.CUU¢'.’
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`1U354I'I'|
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`(
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`.:
`
`=33.“-"...--—-~----2:-=2:::=._'-:'*‘.._::::::t-.::::::::::‘.::-:-:
`
`SECTION VIII - FIRST AID
`—__—.....—___...—.._—-..—...—_..—___..—..——....-_—____.._——_——_____.
`--———————-.——.._.————-—u———-————..———-‘—__....————._._—..—_-. ——
`
`Eye: Flush with cool water. Remove contact lenses. if appticabte. and continue flushing. Obtain
`medical attention if
`persists.
`Skin: Flush with cool water. Wash with soap and water. Obtain medical attention if initation
`persists.
`Inhalation: If symptoms develop move victim to fresh ait. If symptoms persist. obtain medicat
`attention
`
`Ingestion: Do not induce vomiting. Rinse mouth with water then drink one or two glasses of
`water. Obtain medical attention.
`Never give anything by mouth if victim is unconscious. or is oonvutsing.
`
`—-——-——==="—:'~‘=====——=‘“-======:='::::==::=:‘=.==$8==3‘-3‘&’2
`
`SECTION IX - PREPARATION INFORMATION
`
`MSDS Prepared by: KGK SYNERGIZE INC.
`Date: 2oo2Io1I24
`-—-——.---..—--a--1;-—c-.—.——--g.
`-v-————-—-———-_— __ «-
`Telephone: 1 —- 51 9- 438-9374
`—————__-—..-_——-..—.—_—-..-—.———..—-'—'—.—..~___:_._._—=-._=_:
`
`Disclaimer
`Imawmbnbrmbmamwukydahmeumsouaindfiomswmecmnddwwbdxmawamnbamrebue
`WhiteeveryefforthasbeenmadOtoenwmIuIdsdo$0Ndn0ducIhazams,msmIecasesdahisrmwaflobIemdb
`sostawd.SheocondlolxsofacmalptounxnnearebeymiaoonuoIonhesuppiev.itlsassuunedtt\atuaoIsofthIs
`maufidMwbembwvdnedawor6mwmmUuabwwmhumnhdwHMls.mmnaw.awruudwhp5e¢
`Blmmawnmplnmlruuhbbwmubughwuummmmfiddamuswuwmayvwwfiwfluuisd
`uneuaoceonanyinfomiafionuontatraedtnttitsfoim.lfuserrwaiasiideneiidentisicxmaiouimiwguedievivabittisorany
`olhormatatlatwereonrrunend wnhctwimmeCanadianCenwoforOocupaflma|HoatmandSafoty(cooHs)m
`Hamilton, Ontario (1—905-572-4400) or CSST in Montreal. Quebec (514-873-3990).
`
`PAGE 3 OF 3
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`AKER877|TC00057918
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`RX-0135.0013
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`1414
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`AKER877|TC00057919
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`RX-0135.0014
`
`

`
`JI'I‘1.CD.CUUC
`
`1U‘J‘4I'I'I
`
`l\bI‘\ DIINLKULLL U1.
`
`l1U.DlJ.
`
`F.D
`
`MATERIAL SAFETY DATA SHEET
`—.——-.-—_.._.q.-—-_-.—..——._——._..
`_.._...__..__...__.-_...._.__
`———-.-.—_——...-—u-..——¢.——<.——c._——.——_..—-.—.--.....-—_.__ ___..._ _
`
`SECTION I - PRODUCT IDENTIFICATION
`
`Product Name: Krill Protein
`
`Product Use: Dietary supplement
`
`WI-Illlls Class: Not Controlled
`
`TD6 Classification: Not Regulated
`
`Manulacturerlsupplier:
`Address:
`
`Telephone:
`
`an...
`...._....-pg
`
`Neptune Technologies 8. Bioresources
`500 boul Saint-Martin Guest
`Bureau 550
`Laval. Quebec. H7M 3Y2
`450 — 972-6291
`—%-"===:=-'¥'—’==m=====l=:_‘i=333
`
`SECTION II — HAZARDOUS INGREDIENTS
`=== =%===$=:-':==‘—="—=.:.¥¥=——”':==;“::::=::22:
`
`Ingredients. 95% Wfle
`
`fitiflfifl
`
`A.Q.G_l_|J:IL¥
`
`L__.C50
`
`_.LD___50
`
`None by WHMISIOSHA
`
` —~..‘“:=:=:%==:=:=i¢——.*
`.———-—-nu--:3‘:
`
`SECTION III - PHYSICAL DATA
`
`Specific Gravity (H20 = 1 ): Not available
`Boiling Point (“(2): Not applicable
`96 Volatile (wt 95): Not available
`Vapour Pnssuro (mm Hg): Not applicable
`Evaporation Rate (Ether = 1): Not applicable
`Vapour Density (Air :3 1): Nol applicable
`pH (100%): Not available
`solubility In Water: Not available
`Viscosity: Not applicable
`Physical State: Solid
`Odour Threshold (ppm): Not available
`Appearance: oil-white powder
`-v..—
`——-n—-
`-._.....__.....-...-upa-u-—-.-
`_-_:._ nuns
`_____.-:_........._...-.._.....m====.--——-..——-.__.._.--...——-..-
`
`SECTION IV - FIRE AND EXPLOSION DATA
`... ..
`_ --...___...-...__-..—-—....
`....__...._...
`—..._=:..._==_‘:..-...___.__.._.........—--p---.-n-"""'=-—===~..__-.._...._
`
`Flammability: Not flammable by WHMISIOSI-IA criteria.
`UEL: Not applicable
`Flash Point ('0. TOG’): None
`LEL: Not applicable
`Hazardous combustion Products: May include and are not linited to oxides of carbon.
`Autoignition Tomporaturo ('C): Not applicable
`Means of Extinction: Treat for surrounding material.
`special Firo Hazards: Firefighters should wear self-contained breathing apparatus.
`
`PAGE 1 OF3
`
`15
`15
`
`AKER877|TC00057920
`
`RX-0135.0015
`
`

`
`Jl"i‘$.fiC).Ct9K)C.
`
`J.U‘J‘-§I1I'l
`
`l’\\)l'\ Z>II1LRK)1LL Alix.
`
`..v...,r
`
`.._.._.—__—_—_—-_.—__-_-._——__..——._.—_..———__——._.._——_—..——.
`_.._...._.._....__.._...—....—_-.-.._ —_——..__.-—_—__.—.....—-..._ __._.-—.——...
`
`SECTION V - REACTIVITY DATA
`——.-——..--.————-..—_————-.——..——_——_—_-——————..------—_-—-
`_————-— --.----—..—»-_..—.———_.—-up-—.—-.—————-.-—.———.———
`
`Conditions for chemical instability: Stable.
`Incompatible Materials: None known.
`Reactivity. and Under What Conditions: Not available.
`Hazardous Decomposition Products: May include and are not limited to oxides of carbon when
`heated to decomposition.
`_..:__.........-..........._—_....-.._.._...——_.—-e.-—-—...—~
`__._____.___..__..._._...__._...__._..-_....._...-..-m_—-up.-p-—u---.--——u—..
`
`SECTION VI - TOXICOLOGICAL PROPERTIES
` "‘"""""‘——.¢-""“"—’."’-————.’—""'¢-——“-up.-“"‘£=--"'.-""."—--"—’—:=’’—_..:.'=-—-——
`
`Route of Entry: Eye. Skin contact. Inhalation, ingestion.
`
`EFFECTS OF ACUTE EXPOSURE:
`
`Eye: May cause irritation upon direct contact.
`inhalation: May cause respiratory tract irritation.
`ingestion: May cause stomach distress. nausea or vomiting if ingested in large quantities.
`
`EFFECTS OF CHRONIC EXPOSURE:
`Skin: Prolonged or repeated exposure can cause drying. defatting and
`Irritancy: Non-hazardous by WHMISIOSHA criteria.
`Respiratory Tract Sensitization: No data avaiable.
`carcinogenicity: Non—hazardous by WHMISIOSHA criteria.
`Teratogenicity. Mutagenicity, Reproductive Effects: No data available.
`synergistic Materials: Not available.
`.—.._—.._...—-.....--
`_-.——_—o-———-o—-
`—..———a-
`
`.......——-———-.--————u-pc —-—--————-—w.-on-.=——___.__._...__......
`
`SECTION VII- PREVENTATIVE MEASURES
` ~——_—._-___________.:._._——_—__¢—
`-————-¢-u--—-up—..-.—-—.-.—_—--.__.._..___......_~_.-a——-———-—-
`
`Gloves: No requirements beyond standard industrial hygiene practices.
`Eye Protection: No requirements beyond standard industrial hygiene practices.
`Respiratory Protection: Not normally required if good venmation is maintained.
`other Protective Equipment: As required by employer code.
`Engineering controls: General ventilation normally adequate.
`Look and spill Procedure: Before attempting clean up, refer to hazard data given above. Use
`broom or dry vacuum to
`collect material for proper disposal without raising dust. Rinse area with water. Prevent large
`spills from entering sewers or
`vmterways. Contact emergency services and supplier for advice.
`Waste Disposal: Review federal. state/provincial, and local govemment requirements prior to
`disposal.
`Storage and Handling Requirements: Keep out of reach of children. Store in a closed container
`away from incompatbie
`materials.
`
`PAGE 2 OF 3
`
`16
`16
`
`AKER877|TC00057921
`
`RX-0135.0016
`
`

`
`-JPIV.C.D.CUUC
`
`1K)'JDf“l‘|
`
`l\K:!l'\ DIIVLKULLL LIVK.
`
`l\U.Jl1
`
`I
`
`.LU
`
`_....—.________..._._.____..__=_..a--==
`
`_-.-—————..————u----
`
`SECTION VII! - FIRST AID
`
`Eye: Flush with cool water. Remove contact lenses, if applicable, and continue flushing. Obtain
`medics! attention if irritation
`
`persists.
`Skin: Bmsh away excess of dry material. Flush with water. Obtain medical attention if irritation
`persists.
`Inhalation: If symptoms develop move victim to fresh air. If symptoms persist, obtain medical
`attention.
`Ingestion: Do not induce vomiting. Rinse mouth with water then drink one or two giasses of
`water. Obtain medical attention.
`
`1
`
`Never give anything by mouth if victim is unconscious. or is oonvuising.
`.....____.-...._-.._.....__._.-..—-....——..—— up.-.-—
`— ..__.._-__..
`..-.-..._______..........__.._..-so.
`—-==
`""'-‘=-=..c——-—-———-—
`
`SECTION IX - PREPARATION INFORMATDN
`
`‘ "".....—=""—.—==3B===833'—'3=33:==:B=S===:2-T“""‘——="-—=""--='—=-1::
`
`ulsos Prepared by: KGK SYNERGIZE mc.
`Date: 2002/01/24
`._...._.,...__.._.___.._______—_—.——.———.a—————-—————————
`Teicpnono: 1 - 519 -438~9374
`-_______..__..__---__._.....--—-——s¢-——————-—-.;____......_....
`
`Disclaimer
`Informationtumknamrialnfewdamsheuwawhmdfiomswrmswuwaedwdmialyaocuabamdabh.
`wnileeveryeiiorthasbeenmadebwsuomldisdmndmodmhazams.hsomocasesdataisnmavaihbbmdis
`sostated.SinuwM|fimsda1adummdmeuebeymflcmIddVnwpHhf,IhuamwdhutweIsdHs
`mhrflhawbemuwwnwamordmbmomanubqmmkamibdwuwsuomnmmaoiesswuhmud,
`isrmdeaftdsuppliervflnmbehbbfuuiylossesjwibsuwnsequmiddamuesflfldtmayresmfimlmetaed
`anfimwmmylmanubnmnbmedhfisfmmflmanqmnskflowmafihhunfimmhgeienahhkuay
`othamatenaI,werecmmnendoontactMdWooCmadIanCenueforOewpafionalHeaithandSa1ety(Cc0Hs)in
`Hamilton. Ontario (1-905-572-4400)or CSST inMontn:a|. Quebec (514-873-3990).
`
`PAGE 3 OF 3
`
`1
`17
`
`7
`
`AKER877|TC00057922
`
`RX-0135.0017
`
`

`
`1818
`
`AKER877|TC00057923
`
`RX-0135.0018
`
`

`
`Jl'I1vLJ-LI'JL)L
`
`.lKJ'_X_l"II
`
`T\§J'\ Jl|\L.[\UL{_L L|‘\.-
`
`"V"" ‘
`
`MATERIAL SAFETY DATA SHEET
`--—--———-——----——:-—-.9-——-.—_—--—-_.._.%_ ___..__.__....———
`—_....._—._..———.____.__ _ _-_-——-—-.-—_—-___ _ __.__._——_-—.-———
`
`SECTION I - PRODUCT IDENTIFICATION
`=3=======:‘::::========:==::j:::i=========::
`
`Product Name: Freeze Dried Krill
`
`Product Use: Dietary supplement
`
`WHMIS Class: Not Comrolled
`
`TDG classification: Not Regulated
`
`Manufacturerlsuppller:
`Address:
`
`Neptune Technologies & Bloresources
`500 boul saint-Martin Ouest
`.
`Bureau 550
`Laval, Quebec, H7M 3Y2
`450 — 972-6291
`
`::=======%:%—~——-—=:::i“==T%—=2====%=
`
`Telephone:
`
`SECTION ll - HAZARDOUS INGREDIENTS
`
`lggredients CAS#
`
`Wl:%
`
`OSI-IA‘-‘PEI.
`
`ACGII-I-TLV
`
`LC 50
`
`LD 50
`
`None by WHMISIOSI-IA criteria.
`
`'"""""""s'£érT6»TnT.‘£fi?'s?éRI.'53?i“""""’
`====:=%S:==:=======¥~*——‘=%=‘- ”;:::
`
`Specific Gravity (H20 = 1): Not avaflable
`Boiling Point (°C): Not applicable
`56 Volatile (Wt 96): Not available
`Vapour Pressure (mm Hg): Not applicable
`Evaporation Rate (Ether = 1): Not applicable
`Vapour Density (Air = 1): Not applicable
`pl! (100%): Not available
`Solubility in Water:_Not available
`Viscosity: Not applicable
`Physlcal State: Solld
`Odour Threshold (ppm): Not availaale
`Appearance: Off-white powder
`_..-.._____.—._......¢p—-————u-nu-——-cc-.————-....____.._
`——...._.._..._..____——.-____————————-pc-—...——————..—____._.
`
`SECTION IV - FIRE AND EXPLOSION DATA
`-9-.-__
`.._......._._....-...._.... _.........
`=-4-——————--————-~..=--—--..=
`—..——-—-—-.....___._
`
`Flammabilityz Not flammable by WHMISIOSHA criteria.
`UEL: Not applicable
`Flash Point (-0, rec): None
`LEL: Not applicable
`Hazardous Combustion Products: Mayindudeandarenotlmitedtooxidesofcarbon.
`Autolgnltlon Temperature (re): Not applicable
`Ileana of Extinction: Treat for surrounding material.
`special Fire Hazards: Firefighters should wear self-contained breathing apparatus.
`
`PAGE 1 OF 3
`
`19
`
`19
`
`AKER877|TC00057924
`
`RX-0135.0019
`
`

`
`JF1l\.L..I.l_|'_IL}L
`
`Lu-_2i_rni
`
`l\\.It\ ‘r..._.
`
`..,-___
`
`-
`
`~
`
`..___.._.._.__.___....__.____._.—..: —......_.—___-..__._-___.—.
`—_.._.._.........__________ *1_ —_———.-.___.-1—x—
`
`SECTION V - REACTIVITY DATA
`_—_
`—
`—
`—— __—._....a_.._-..._.._._._.___._.____.._.—..__
`—.=‘%—::--....:.=‘_"===_—=...__.__......__.-__..._..___.___._._-_........._
`
`conditions for Chemical Instability: Stable.
`Incompatible Materials: None known.
`Reactivity, and Under What Conditions: Not available.
`Hazardous Decomposition Products: May include and are not limited to oxides of carbon when
`heated to decomposition.
`_...__........_.__.____.____..__.___.__...._._..w—.-.a——..——_..........—-—..——
`..___.___........__...___..._—.-—.-—.———-—.-—¢->—-—--——o—-—-—————.-
`
`_— c.—...-—__-__...._._.—__—_...._.-___.._._.._....__...__..... _
`3=‘_‘_.._'.==_...._..._.%_.__.....__—__.-..__.--—__-——..—i..—_.—-——_.=—=
`
`Route of Entry: Eye. Skin contact, inhalation, ingestion.
`
`EFFECTS OF ACUTE EXPOSURE:
`Eye: May cause irritation upon direct contact.
`Inhalation: May cause respiratory tract irritation.
`Ingestion: May cause stomach distress. nausea or vomiting if ingested in large
`
`EFFECTS OF CHRONIC EXPOSURE:
`
`Skin: Prolonged or repeated exposure can cause drying, defatling and dermatitis.
`lrritancy: Non-hazardous by WHMISIOSHA criteria.
`Respiratory Tract Sensitization: No data available.
`carcinogenicity: Nonhazardous by WHMIS/OSHA
`Teratogenicity, Mutagenicity, Reproductive Effects: No data available.
`synergistic Materials: Not available.
`----.~.——¢——--u--o-....._....__:.___...__.._.__..-_—_....-..-...____..
`u-—-———.-—-—-——..—_....-...____._...__.._._._.__._._.._...__.....-.._.....:_.__
`
`SECTION VlI- PREVENTATNE MEASURES
`=‘_*—‘—T—=:::===—_:===::=::=::=:7—:"."====T_‘.:_—‘:£==i:—‘:.=:”.:i
`
`Gloves: No requirements beyond standard industrial hygiene practices.
`Eye Protection: No requirements beyond standard industrial hygiene practices.
`Respiratory Protection: Not normally required if good ventilation is maintained.
`other Protective Equipment: As required by employer code.
`Engineering Controls: General ventilation normally adequate.
`Leak and spill Procedure: Before attempting clean up. refer to hazard data given above. Use
`broom or dry vacuum to
`collect material forproperdisposalwilhoutraisingdust. Rinseareawithwater. Preventlarge
`spills from entering sewers or
`waterways. Contact emergency services and supplier for advice.
`waste Disposal: Review federal. statelprovincial. and local government requirements prior to
`disposal.
`storage and Handing Requirements: Keep out of reach of children. store in a closed container
`away from incompatible
`materials.
`
`PAGE 2 OF 3
`
`20
`
`20
`
`AKER877|TC00057925
`
`RX-0135.0020
`
`

`
`_;ffi|1_(__;_{_§;L;¢_
`
`ALJ'.J_)T\¢|
`
`l\\)I\
`
`.JiI!;I\\)A1_n_ ‘In,
`
`-_..._..__..._____.____—....._—-—.—o—oo..——-.up——_-nu.--—-.—.-—
`
`SECTION VIII - FIRST AID
`==2===2**.—='—.-====’.==:=2===$ ======2
`
`" Eye: Flush with cool water. Remove contact lenses. if applicabte. and continue flushing. Obtain
`medical attention if irritation
`persists.
`Skin: Bmsh away excess of dry material. Ftush with water. Obtain medical attention if
`persists.
`Inhalation: If symptoms deveiop move victim to fresh air. If symptoms persist, obtain medical
`attention.
`Ingestion: Do not induce vomiting. Rinse mouth with water then drink one or two glasses of
`water. Obtain medical attention.
`Never give anything by mouth if victim is unconscious, or is convulsing.
`==-7======'—=======8=3S=3=8= ==2=3
`
`.
`
`——-u.
`
`SECTION IX - PREPARATION INFORMATION
`--..--a-_...._...___._____..._._._-__._....____._.—_...._._
`
`MSDS Prepared by: KGK SYNERGIZE INC.
`Date: 2002l01I24
`—-——.....——__...._..:.—-——— ———_o——
`Telephone: 1 — 519 -438-9374
`
`--——_..--u———--——_.-c-.¢-——“ —..p-———————
`
`Iniorrrlationiorthiamabliat satetydahsheetwuobuficdtrunsmlcesomsiduedhduicallyaountemflmi