PRODUCT REGULATORY INFORMATION DATASHEET Botanical …nasc.cc/wp-content/uploads/2015/09/BInutra... · PRODUCT REGULATORY INFORMATION DATASHEET Botanical Dietary Ingredient I

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


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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


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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


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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):


Hazardous Decomposition or Byproducts


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


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):


Protected from heat and strong light.

Tan powder with characteristic odor.

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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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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

Documents

PRODUCT REGULATORY INFORMATION DATASHEET Botanical …nasc.cc/wp-content/uploads/2015/09/BInutra... · PRODUCT REGULATORY INFORMATION DATASHEET Botanical Dietary Ingredient I