2550 El Presidio St. • Long Beach, CA 90810 – 1193 • Phone: 310-669-2100 • Fax: 310-637-3644 • www.botanicals.com Rev 05-07-15
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PRODUCT REGULATORY INFORMATION DATASHEET Botanical Dietary Ingredient
I - PRODUCT INFORMATION
PRODUCT NAME & CODE: Psyllium Blonde Seed Husk 40M (S) - FP667093
COMMON or USUAL NAME of BOTANICAL (per current Herbs of Commerce):
Psyllium Blonde Seed Husk
SCOPE of DOCUMENT: Product Information
GENERAL PRODUCT INFORMATION: Botanical Powder
II - MANUFACTURING INFORMATION NAME & ADDRESS of MANUFACTURING SITE:
BI Nutraceuticals Inc. 2550 EL Presidio St., Long Beach, CA90810
AGRICULTURAL PROCESS (ex: sustainably-wildcrafted, or cultivation method, identification,
harvest, handling,etc.) Cultivated
POST-HARVEST PROCESSING: (Identify type) Dried, milled, sieved, and steamed
IDENTIFICATION METHOD: TLC
MODE OF MANUFACTURING: (Provide flow chart if applicable)
Flowchart attached
GMP COMPLIANT? Compliant
STERILIZATION or FUMIGATION METHOD(S): Steam treated
KNOWN or POTENTIAL IMPURITIES (including solvents) :
None known to BI
III - PHSYSICAL AND CHEMICAL PROPERTIES
INGREDIENT LIST (include Carriers and Excipient(s):
COMMON or USUAL NAME (per current Herbs of
Commerce):
LATIN BINOMIAL (and authority, per
ICBN):
PART PLANT USED:
COUNTRY OF
ORIGIN:
HARVEST AGE/
SEASON:
CAS#: COMPOSITION (%):
Psyllium Blonde Seed Husk Plantago ovata Forssk. Husks India Annually N/A 100%
NON BOTANICAL INGREDIENTS (if any):
COMMON or USUAL NAME: ORIGIN*:
FOR EXTRACTS ONLY:
EXTRACTION RATIO: N/A
SOLVENT(S) NAME: SOLVENT PERCENT: PERCENT LEFT AT EXTRACTION:
None
2550 El Presidio St. • Long Beach, CA 90810 – 1193 • Phone: 310-669-2100 • Fax: 310-637-3644 • www.botanicals.com Rev 05-07-15
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CURRENT PRODUCT SPECIFICATION SHEET ATTACHED: Yes
BIO ASSAY METHOD: N/A
IV - REGULATORY INFORMATION
PATENT COVERAGE: None
COMPENDIAL GRADE (USP/NF, FCC, PhEur, etc.): Food Grade
IS THIS PRODUCT GRAS AFFIRMED? GRAS per Phytochemical Constituents of GRAS Herbs and Other Economic Plants; James A. Duke, 2001, page 472.
BSE/ TSE FREE? Yes
AFLATOXIN Tested based on history
MELAMINE Not Applicable
VEGETARIAN STATUS: Suitable
VEGAN STATUS: (any animal derived ingredient would not be suitable – specify type) Suitable
FREE OF PRO-HORMONES? Not known, nor added at BI
FREE OF SEWAGE SLUDGE USE? Yes
GELATIN FREE?: Yes
ANIMAL MATERIAL FREE?: Yes
CLONED ANIMALS ORINGREDIENTS DERIVED FROM CLONED ANIMALS USED?
No
NON-GMO: PCR testing done: Traceability documents available:
Yes No Yes
TARIFF CODE for IMPORT or EXPORT (HTS#) 1211.90.9120
KOSHER STATUS Include certifying agency/authority: Kosher (Circle K)
HALAL STATUS Include certifying agency/authority: Halal (Crescent M)
ORGANIC STATUS Include certifying agency/authority: Non-Organic
V. ALLERGENS/ HYPERSENSITIVITES:
Artificial flavor No
Buckwheat No
Caffeine No
Celery (not seed) No
Colorants / Artificial color No
Corn No
Egg or egg derivatives No
Fish (ex: bass, flounder, cod or tuna) No
Gluten (including wheat, rye, barley, oats and their derivatives) No
Grapefruit No
Kamut No
Lactose No
Lupin No
Milk/Dairy (includes butter, casein, cheese, curds, whey, lactose, margarine, cream, custard, nougat, pudding, sodium caseinate, sour cream, yogurt)
No
MSG No
Mustard No
Peanuts (includes peanut butter, peanut flour, protein, groundnuts, monkey nuts) No
Porcine (pork / pig) No
2550 El Presidio St. • Long Beach, CA 90810 – 1193 • Phone: 310-669-2100 • Fax: 310-637-3644 • www.botanicals.com Rev 05-07-15
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Preservatives (artificial or other) No
Seeds (sunflower, cottonseed, poppy) No
Sesame (includes sesame butter, sesame seed, protein) No
Shellfish /Mollusks (crustaceans and mollusks to include shrimp, crab, lobster, clam, scallop, crayfish, prawns, mussels, oysters, octopus, squid)
No
Soy (includes tofu, soy beans, soy derivatives) No
Spelt No
Sugar Alcohols No
Sulfur Dioxide, Sulfites, Sorbates No
Tree Nuts or Derivatives (includes almond, beech nut, brazil nut, butternut, cashew, chestnut
(Chinese, American, European, Sequin), chinquapin, coconut, filbert/hazelnut, ginkgo nut, hickory, lychee, macadamia, bush nut, pecan, pine/pinon nut, pili nut, pistachio, shea nut, walnut)
No
Yeast or yeast derivatives No
Any other allergen not listed (as applicable) No
VI - MISCELLANEOUS PRODUCT INFORMATION
LOT NUMBERING SYSTEM:
Lot numbers contains seven (7) alphanumeric characters a) The first two (2) digits: one (1) letter with one (1) number represents the year. b) The following two (2) numbers represent the month. c) The last three (3) numbers represent the sequential number within each type of material.
LOT DEFINITION: Continuous production of the same material.
EXPIRATION DATING: Three (3) years from the date of manufacture
RECOMMENDED STORAGE CONDITIONS: Store in tightly closed containers, protected from light, moisture and heat.
PACKAGE SIZE OPTIONS: 25kg corrugated boxes
RECYCLED PACKAGING MATERIALS: No
SUGGESTED PRODUCT CLAIMS (including supporting documentation & dosage)
Not known to BI
OTHER PRODUCT SAFETY INFORMATION: Refer to MSDS
VII - REVISIONS
REVISION DATE: 07/25/2012 REVISION LEVEL: 2
VII - CONTACT INFORMATION
COMPANY NAME: BI Nutraceuticals
CONTACT NAME: Nely Fernando TITLE: Regulatory Compliance Coordinator
CONTACT SIGNATURE: DATE: 05/18/2015
CONTACT PHONE: 310-669-2155 FAX NUMBER: 310-669-8248
2550 El Presidio St. • Long Beach, CA 90810 – 1193 • Phone: 310-669-2100 • Fax: 310-637-3644 • www.botanicals.com Rev 05-07-15
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ADDITIONAL SUPPORTING DOCUMENTS
SPECIFICATION SHEET / PRODUCT DATA SHEET: Attached
MSDS: Attached
CERTIFIATE OF ANALYSIS (typical) Attached
NUTRITIONAL DATA (if available): Attached
PRODUCTION PROCESS FLOW CHART: Attached
CONTINUING GUARANTEE STATEMENT: Attached
KOSHER CERTIFICATE (if applicable): Attached
HALAL CERTIFICATE (if applicable): Attached
ORGANIC CERTIFICATE (if applicable): N/A
ADDITIONAL DOCUMENTS: N/A
Product # FP667093 Psyllium Blonde Seed Husk 40M (S) Powder
Revised 08/27/13 Supercedes Date 08/27/13
Product Characteristics SpecificationBotanical Name Plantago ovata Forssk.Plant Part Husks of P. ovata
Appearance TanComposition 100% Husks of P. ovata
Preservatives NoneCertifications Kosher (Circle K); Halal (Crescent M)Treatment Steam (Product has not been ETO-treated or Irradiated)Country of Origin IndiaHarvest CultivatedProduct Testing Performed on an "as-is" basis
Physical Profile Method SpecificationQC-0014Particle Analysis >95.0% through 40 meshQC-0014 Report Only through 60 meshQC-0014 Report Only through 80 meshQC-0014 Report Only through 100 meshQC-0014 Report Only through 200 meshQC-0021Loose Density Report OnlyQC-0020Tapped Density @ 300 taps Report Only
Product ProfileID-0001Identification Comply to StandardQC-0001Total Ash <4.0%QC-0002Acid Insoluble Ash <1.0%QC-0005Loss On Drying <12.0%QC-0138Total Heavy Metals Report Only (ppm)QC-0016Light Extraneous Matter <15.0 %QC-0006Swell Volume >40.0 ml/gQC-0017Insect Infestation/25g <400
Microbiological ProfileMIC-0002Total Aerobic Plate Count <50,000 CFU/gMIC-0006Yeast & Mold Count <300 CFU/gMIC-0009Total Coliforms (MPN/g) Report OnlyMIC-0024E.Coli None Detected in 10gMIC-0024Salmonella None Detected in 10gMIC-0022Staphylococcus Aureus None Detected in 10gMIC-0031Enterobacteria <1,000 /g
Supplemental InformationQC-0125Organochloride Pesticides (GC-MS) Meets USP/EP RequirementsQC-0125Organophosphorus Pesticides(GC-MS) Meets USP/EP RequirementsQC-0125Pyrethyroid Pesticides (GC-MS) Meets USP/EP RequirementsQC-0120Arsenic (ICP-MS) Report Only (ppm)QC-0120Cadmium (ICP-MS) Report Only (ppm)QC-0120Lead (ICP-MS) Report Only (ppm)QC-0120Mercury (ICP-MS) Report Only (ppm)
Packaging and StoragePackaged in a polyethylene lined fiber drum with appropriate labeling. Store in tight containers, protected from light,moisture and heat.
08/27/13
Material Safety Data Sheet U.S. Department of Labor(meets Commission Regulation (EU) No 453/2010)
May be used to comply with Occupational Safety and Health Administration
OSHA's Hazard Communication Standard, (Non-Mandatory Form)
29 CFR 1910.1200. Standard must be Form Approved
consulted for specific requirements. OMB No. 1218-0072
Section I -- Identity InformationIDENTITY (As Used on Label and List) Note: Blank spaces are not permitted. If any item is not applicable,
or no information is available, the space must be marked to indicate that.
Manufacturer's Name Emergency Telephone Number
BI Nutraceuticals 310-669-2100Address (Number and Street) Telephone Number for Information
2550 El Presidio Street N/A(City, State, and Zip Code)
Long Beach, CA 90810
Section II -- Hazard(s) Identification
Hazardous Components (Specific Chemical Identity; Common Name(s)) OSHA PEL ACGIH TLV Other Limits Recommended % (optional)
None known to BI Nutraceuticals
Health Hazards (Acute and Chronic):
None known to BI Nutraceuticals
Hazardous Decomposition or Byproducts
None known to BI Nutraceuticals
Section III -- Composition/Information on Ingredients
100% Husks of Plantago ovata
Section IV -- First Aid MeasuresSigns and Symptoms of Exposure
None known to BI NutraceuticalsMedical Conditions (Generally Aggravated by Exposure)
No data foundEmergency and First Aid Procedures
Eye Contact: Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at least 15 minutes.
Get medical attention if irritation occurs.
Skin Contact: Wash with soap and water. Cover the irritated skin with an emollient. Get medical attention if irritation develops.
Inhalation: If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen.
Ingestion: Do not induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconscious person.
Loosen tight clothing such as a collar, tie, belt or waistband. Get medical attention if symptoms appear.
Section V -- Fire Fighting Measures
Flash Point (Method Used) Flammable Limits Flammable Limits
N/A LEL: No data found UEL: No data foundExtinguishing Media
Use media proper to primary cause of fire such as: Water, Fog, Foam, CO2, and/or Dry ChemicalsSpecial Fire Fighting Procedures
None known to BIUnusual Fire and Explosion Hazards
None known to BI
Psyllium Blonde Seed Husk 40M (S)
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BI Nutraceuticals 2550 El Presidio Street, Long Beach CA 90810 310-637-9566 310-637-3644 (fax)
Section VI -- Accidental Release MeasureSteps to be taken in case material is released or spilled:
Clean up spills immediately by scoop, absorb material and/or vacuum area then place the material into an appropriate disposal container.
Flush the area with water to remove residue.Protective Gloves Eye Protection
Wear appropriate protective gloves to prevent skin exposure. Safety glasses/gogglesOther Protective Clothing or Equipment
Wear appropriate protective clothing to prevent skin exposure.
Section VII -- Safe Handling and Storage InformationIncompatibility (Materials to Avoid)
None known to BI NutraceuticalsPrecautions to be taken in handling and storing:
Keep in normal dry storage, protected against light, heat, moisture and insect infestation.Other Precautions:
Use only in well ventilated area.
Section VIII -- Exposure Controls / Personal ProtectionRespiratory Protection (Specify Type)
Avoid breathing dust or wear dust mask/respirator where dusting cannot be avoided.
Ventilation Local Exhaust Special
Dust Adequate to keep airborne concentrations low. N/A
Control Mechanical (General) Other
Adequate to keep airborne concentrations low. N/AProtective Gloves Eye Protection
Wear appropriate protective gloves to prevent skin exposure. Safety glasses/gogglesOther Protective Clothing or Equipment
Wear appropriate protective clothing to prevent skin exposure.Work/Hygienic Practices
Observe general measures of personal hygiene
Section IX -- Physical and Chemical PropertiesBoiling Point Specific Gravity (H2O = 1)
N/A No data foundVapor Pressure (mm Hg.) Melting Point
No data found No data foundVapor Density (Air = 1) Evaporation Rate (Butyl Acetate = 1)
No data found No data foundSolubility in Water
No data foundAppearance and Odor
Section X -- Stability and ReactivityStability Unstable Conditions to Avoid
Stable Conditions to Avoid
X
Hazardous May Occur Conditions to Avoid
Polymerization
Will Not Occur Conditions to Avoid
X None known to BI NutraceuticalsHazardous Decomposition or Byproducts
None known to BI Nutraceuticals
Section XI -- Toxicological InformationRoute(s) of Entry: Eyes? Inhalation? Skin? Ingestion?
X X X X
Carcinogenicity: NTP? IARC Monographs? OSHA Regulated?
N/A N/A N/A N/ASigns and Symptoms of Exposure
None known to BI NutraceuticalsHealth Hazards (Acute and Chronic):
None known to BI Nutraceuticals
Protected from heat and strong light.
Tan powder with characteristic odor.
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BI Nutraceuticals 2550 El Presidio Street, Long Beach CA 90810 310-637-9566 310-637-3644 (fax)
Section XII -- Ecological InformationEcotoxicity:
Not availableProducts of Biodegradation:
None known to BI NutraceuticalsToxicity of Products of Biodegradation:
Not known to BI Nutraceuticals
Section XIII -- Waste DisposalWaste Disposal Method
This material is not regulated as hazardous. Dispose of the material in an approved landfill in accordance with federal, state and local regulations.
Section XIV -- Transport InformationDOT Classification:
Not a DOT controlled materialIdentification:
N/ASpecial Provisions for Transport
N/A
Section XV -- Regulatory InformationFederal and State Regulations:
Not in TSCA inventoryOther Regulations:
Not availableOther Classifications:
Not available
Protective Equipment:
Refer to Section VIII -- Exposure Controls / Personal Protection
Section XVI -- Other Information
References: Previous eight section MSDS for this product.
Date Created 8/23/2012
Last Updated: 5/18/2015
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BI Nutraceuticals 2550 El Presidio Street, Long Beach CA 90810 310-637-9566 310-637-3644 (fax)
Product # FP667093 Psyllium Blonde Seed Husk 40M (S) Powder
Lot No. B411549 Release Date 11/24/14
Product Characteristics SpecificationBotanical Name Plantago ovata Forssk.Plant Part Husks of P. ovata
Appearance TanComposition 100% Husks of P. ovata
Preservatives NoneCertifications Kosher (Circle K); Halal (Crescent M)Treatment Steam (Product has not been ETO-treated or Irradiated)Country of Origin IndiaHarvest Cultivated
Physical Profile Method Specification ResultQC-0014Particle Analysis 100.0%>95.0% through 40 meshQC-0014 78.8%Report Only through 60 meshQC-0014 45.9%Report Only through 80 meshQC-0014 30.6%Report Only through 100 meshQC-0014 6.95%Report Only through 200 meshQC-0021Loose Density 0.55g/mlReport OnlyQC-0020Tapped Density @ 300 taps 0.67g/mlReport Only
Product ProfileID-0001Identification CompliesComply to StandardQC-0001Total Ash 2.7<4.0%QC-0002Acid Insoluble Ash 0.3<1.0%QC-0005Loss On Drying 9.9<12.0%QC-0138Total Heavy Metals <10Report Only (ppm)QC-0016Light Extraneous Matter 10.5<15.0 %QC-0006Swell Volume 41.1>40.0 ml/gQC-0017Insect Infestation/25g 4<400
Microbiological ProfileMIC-0002Total Aerobic Plate Count <2500<50,000 CFU/gMIC-0006Yeast & Mold Count <100<300 CFU/gMIC-0009Total Coliforms (MPN/g) <3/gReport OnlyMIC-0024E.Coli None DetectedNone Detected in 10gMIC-0024Salmonella None DetectedNone Detected in 10gMIC-0022Staphylococcus Aureus None DetectedNone Detected in 10gMIC-0031Enterobacteria <10<1,000 /g
Supplemental InformationQC-0125Organochloride Pesticides (GC-MS) Complies (See Attached)Meets USP/EP RequirementsQC-0125Organophosphorus Pesticides(GC-MS) Complies (See Attached)Meets USP/EP RequirementsQC-0125Pyrethyroid Pesticides (GC-MS) Complies (See Attached)Meets USP/EP RequirementsQC-0120Arsenic (ICP-MS) <0.10Report Only (ppm)QC-0120Cadmium (ICP-MS) <0.10Report Only (ppm)QC-0120Lead (ICP-MS) 0.35Report Only (ppm)QC-0120Mercury (ICP-MS) <0.02Report Only (ppm)
Packaging and StoragePackaged in a polyethylene lined fiber drum with appropriate labeling. Store in tight containers, protected from light,moisture and heat.
Manufactured Date: 11/24/14 Expiration Date: 11/24/17
11/24/14
5/18/15
2550 El Presidio Street Long Beach, CA 90810 Phone: 310-637-9566 Fax: 310-637-3644 www.botanicals.com
Psyllium Blonde Seed Husk 95% 40 Mesh (S)
NUTRITIONAL PROFILE (Per 100 gm)
Analysis Range
Ash (total) 2.3 – 2.6 g
Calcium 166 – 212 mg
Calories 294 - 306
Calories from Fat 2.1 – 4.5
Carbohydrates 83.61 – 86.10 g
Cholesterol < 1.0 mg
Dietary Fiber 84.4 – 88.3 g
Soluble Fiber 70.2 – 75.4 g
Insoluble Fiber 11.0 – 14.2 g
Iron 13.9 – 39.1 mg
Saturated Fat 0.049 – 0.109 g
Protein 1.6 – 2.0 g
Sodium 40.5 – 79.6 mg
Sugars < 1.0 g
Reference: The data was based on nutritional analysis of five data points obtained through third party testing.
02/12/2014
2550 El Presidio Street Long Beach, CA 90810 Phone: 310-669-2100 Fax: 310-637-3644 www.botanicals.com
BI Process Flow Diagram
Steam Treated Whole Herb Processing
Raw Material is sorted,
cleaned, packed and
fumigated at origin (if
necessary)
Raw Material received at
BI, sorted by lot
If material is packed in
permeable bags, it is taken
directly to steam treatment
If material is not in permeable
bags, it is processed by machine
into special polypropylene bags
suitable for steam treatment
Steam Sanitizing
Milled into powder form
Blending – if needed Finished product
packaging and labeling
Starting QA
samples
collected
Finish
product QC
testing
In process
Sample
Testing
Inventory storage or shipment
following QC release
2550 El Presidio Street Long Beach, CA 90810-1193 Phone: 310-637-9566 Fax: 310-637-3644 www.botanicals.com
CONTINUING GUARANTEE LETTER
BI Nutraceuticals is a manufacturer of dietary supplement ingredients.
BI Nutraceuticals certifies that the methods used in, and the facilities and controls used for,
the manufacturing, processing, packaging, and holding of the dietary supplement ingredients
are in conformity with Current Good Manufacturing Practices according to Part 110 of Title
21 of the Code of Federal Regulations.
Standard Operating Procedures are followed in the manufacturing, processing, and handling
of products to assure that all lots conform to the approved specification.
BI Nutraceuticals guarantees and warrants each shipment of food or ingredients has been
properly packaged to preclude, avoid and prevent adulteration and contamination in
accordance with applicable federal, state, and local laws and acceptable good commercial
practices. All labels affixed to the package shall correctly describe the contents as required
by law, and in accordance with instruction from the buyer.
BI Nutraceuticals further guarantees and warrants that the packaging materials used for the
product for each shipment, as of the date of the shipment not to be adulterated, or misbranded
within the meaning of the Federal Food, Drug and Cosmetic Act as revised and amended.
Date: January 1, 2015
Rupa Das
Vice President of Global Quality & Compliance