PRODUCT TECHNICAL DOSSIER K-PURE COPPER BIS-GLYCINATE

Transcription

1 PRODUCT TECHNICAL DOSSIER K-PURE COPPER BIS-GLYCINATE Product Code: P03482 Raw Material Full Name: K-Pure Copper Bis-Glycinate This material is Food Grade: Kosher Status: Kosher Certified Limit/Range/Specification: Cu Content: 10.0%-12.5% CAS Number: Molecular Formula for the raw material: Cu (C 2 H 4 NO 2 ) 2 Average Molecular weight: g/mol Particle Size: 40 Mesh Percentage passed through: Min 90% Tapped Density: Report Loss on Drying: Max 5% Country of Origin: USA Country of Origin of the Manufacture: USA Product Code: P03482 Version: 2 Page 1 of 14

2 Base Source/Start Material: L-Glycine (Derived from Sodium Glyconate) Copper Carbonate (Mined), Maltrodextrin (Corn Starch), Silicon Dioxide (Mined) Origin of Product Synthetic, Plant, Mineral, Animal, Fish or Fermented: Synthetic Synthetic: What are the starting materials of the synthesis and their sources? L-Glycine (Derived from Sodium Glyconate) Copper Carbonate (Mined), Maltrodextrin (Corn Starch), Silicon Dioxide (Mined) Material is: 100% Shelf Life from Date of Manufacture: Min 3 Years Storage Conditions: Store in a cool and dry location Appearance: Powder Colour: Light Blue to Blue Flavour/Taste: Characteristic Odour: Characteristic Do any of the parameters change in different seasons? No Product Code: P03482 Version: 2 Page 2 of 14

3 Microbiological Test Total Viable Count: Max 3,000 cfu/g Yeast & Moulds: Max 300 cfu/g E.Coli: Negative Salmonella: Negative/25g Coliforms: Negative Staphylococcus aureus: Negative Metals Lead (Pb): Max 2ppm Cadmium (Cd): Max 1ppm Mercury (Hg): Max 0.1ppm Arsenic (As): Max 1ppm There are no nuts in this recipe; however we cannot guarantee that the raw materials entering the site are nut free. Please note that surveillance testing may mean that not all the parameters stated on this specification are tested for every batch. Product Code: P03482 Version: 2 Page 3 of 14

4 ALLERGENS Product Contains YES/NO Listed Item on Site at Manufacturer YES/NO Peanuts and Peanut Derivatives (There are no nuts in this recipe, however CCL cannot guarantee that the raw materials entering the site are nut free.) NO NO Other Nut and Nut Derivatives Almond (Amygdalus communis L.), Hazelnut (Corylus avellana), Walnut (Juglans regia), Cashew (Anacardium occidentale), Pecan nut (Carya illinoiesis (Wangenh.) K. Koch), Brazil nut (Bertholletia excelsa), Pistachio nut (Pistacia vera), Macadamia nut and Queensland NO NO nut (Macadamia ternifolia) (There are no nuts in this recipe, however CCL cannot guarantee that the raw materials entering the site are nut free.) Sesame Seeds and Sesame Seed Derivatives NO NO Other Seeds and Seed Derivatives (Poppy Seeds, Cotton Seeds, Sunflower Seeds) NO NO Milk and Milk Derivatives (including lactose) NO NO Egg and Egg Derivatives NO NO Cereals and Derivatives containing OR POTENTIALLY CONTAMINATED WITH Gluten (wheat, wheatgrass, faro, freekeh, spelt, kamut, rye, oats, barley, barley grass) NO NO Soya and Soya Derivatives NO NO Lupin and Lupin Derivatives NO NO Mustard and Mustard Derivatives NO NO Celery or Celery Derivatives (including Celeriac) NO NO Fish and Fish Derivatives NO NO Molluscs and their Derivatives NO NO Crustaceans and their Derivatives NO NO Sulphur Dioxide and Sulphites (E220, E228) at levels > 10mg/kg or 10mg/litre NO NO If YES, Please Comment Product Code: P03482 Version: 2 Page 4 of 14

5 ADDITIVES / CONTAMINANTS / DIETARY REQUIREMENTS Product Contains YES/NO Listed Item on Site at Manufacturer YES/NO Additives NO NO Antioxidants NO NO Ethylene Oxide NO NO Gelatine NO NO Flavourings (Artificial / Nature Identical / Natural / Smoked) NO NO Maize / Corn and any Derivatives YES YES Legumes / Pulses NO NO Rice and Rice Derivatives NO NO Added Salt NO NO Added Sugar / artificial or natural sweeteners NO NO Aspartame NO NO BHA / BHT (E320 / E321) NO NO Caffeine NO NO Colours (Artificial / Nature Identical / Natural / Smoked) NO NO Dextrose NO NO Dioxins NO NO MSG (Added and Naturally Occurring E621) or Glutamates (E620 to E625) NO NO Nucleotides (E627, E630, E631, E635) NO NO Polyols (sugar alcohols) NO NO Benzoates (E210 / E219) NO NO Sorbic Acid (E200, E203) NO NO Any other Preservatives NO NO Ethanol NO NO Honey NO NO Lactose NO NO Yeast and Yeast Derivatives NO NO All Animal Products (Beef, Pork, Poultry or other) and Derivatives (which may include growth/yield hormones, antibiotics etc.) NO NO Bovine Products or Derivatives (which may include growth/yield hormones, antibiotics etc.) NO NO If YES, Please Comment Contains Maltodextrin from Corn Product Code: P03482 Version: 2 Page 5 of 14

6 PRODUCTION FLOW CHART Raw Materials are inspected and weighed. Raw Materials are mixed to a liquid state and allowed to react. The product is spray dried. The product is sampled, tested, and packaged. Product Code: P03482 Version: 2 Page 6 of 14

7 CONFIRMATION OF BSE/TSE STATUS This is to certify that this product complies with all relevant current UK and EU Legislative requirements in regard to Transmissible Spongiform Encephalopathies (TSE) and Bovine Spongiform Encephalopathy (BSE) for human food, and so is free of TSE/BSE. This is also to certify that, during the course of their manufacture, the above-mentioned product did not come into contact with any materials, which could be derived from TSE/BSE risk materials. CONFIRMATION OF GM STATUS This is to certify that this product is not manufactured from GM raw materials and is therefore not subject to labelling under regulations 1829/2003/EC and 1830/2003/EC. CONFIRMATION OF NON IRRADIATION STATUS This is to certify that this product, whole or in part, has not been subjected to Ionising Radiation as per European Directives 1999/3/EC. CONFIRMATION OF NANDROLONE STATUS This is to certify that this product, whole or in part, has not come into contact with Nandrolone or any of its precursors in any way. CONFIRMATION OF IOC PRODUCT STATUS This is to certify that this product, whole or in part, has not come into contact with any product/s, which is banned by the IOC (International Olympics Committee) and or WADA. CONFIRMATION OF ANIMAL TESTING STATUS This is to certify that all the products sold by Cambridge Commodities have not been tested on animals in any part of its manufacture in accordance with regulation 86/609/EEC. CONFIRMATION OF PESTICIDES STATUS This is to certify that the above-mentioned product complies with the regulation (EC) No.396/2005 of 23rd February 2005 and commission Regulation (EU) No. 559/2011 of 7th June 2011 amending annexes II and III of the above Regulation. CONFIRMATION OF NANOPARTICLE STATUS This is to certify that unless otherwise stated, the above-mentioned product is free of nanoparticles. Commission Recommendation 2011/696/EU, defines as follows: "'Nanomaterial' means a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an Agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm nm". Product Code: P03482 Version: 2 Page 7 of 14

8 MATERIAL SAFETY DATA SHEET Section 1 Identification of the Substance/Mixture and of the Company/Undertaking Product Name: K-Pure Copper Bis-Glycinate Product Code: P03482 Molecular Formula Cu (C 2 H 4 NO 2 ) 2 Supplier: Cambridge Commodities Limited Lancaster Way, Ely, Cambridgeshire, CB6 3NX Tel: qa@c-c-l.com Section 2 Hazards Identification Components CAS Number Copper Carbonate L-Glycine Silicon Dioxide Maltodextrin N/A Section 3 Composition/Information on Ingredients Emergency Overview: Fine, light green, free flowing powder. Avoid contact with eyes, skin and clothing. Harmful if swallowed. Potential Health Effects: Skin: May cause skin irritation. Eyes: May cause irritation. Inhalation: May cause irritation to the respiratory tract. Ingestion: Nausea, vomiting, gastrointestinal pain. Chronic Effects: Kidney damage, liver damage. Carcinogenicity: Not listed under OSHA, IARC, or NTP. Emergency Overview: May be harmful by inhalation, in contact with skin and if swallowed. Product dust may be irritating to eyes, skin and respiratory system. It is white, crystalline, solid and odourless. Eyes: Contact with eyes may cause irritation Stinging, tears, redness and swelling. Avoid contact. Skin: May be harmful by skin contact. Substance ay cause slight skin irritation. Avoid contact with skin. Inhalation: May be harmful by inhalation. May cause irritation to the mucous membranes. May cause irritation of the respiratory tract. Ingestion: May be harmful if swallowed. Ingestion of large amounts may cause gastrointestinal irritation. Product Code: P03482 Version: 2 Page 8 of 14

9 Silicon Dioxide: Emergency Overview: Dust may be irritating to respiratory tract. Potential Health Effects: Eye Contact: Possibly irritating. Skin Contact: May cause drying of the skin. Inhalation: Temporary discomfort to upper respiratory tract may occur due to mechanical irritation when exposures are above occupational exposure limits. Ingestion: No hazard expected in normal use. General: Medical conditions which may be aggravated by exposure to this include: Conjunctivitis of the eyes, dermatitis of the skin, asthma and respiratory diseases. HMIS Ratings: Health 1 Flammability 0 Reactivity 0 Rating Key: 4 = Highest Standard, 0 = Lower Standard, * = Chronic Health Hazard, N=No rating for powders NFPA Rating: Health - 1 Flammability 0 Reactivity 0 Rating Key: 4= Highest Standard, 0= Lower Standard, N=No rating for powders Section 4 Emergency and First Aid Procedures General Advice: Eyes Contact: Skin Contact: Swallowing: Inhalation: Ingestion: Notes to Physician: Protection to First-Aiders: Show this safety data sheet to the doctor in attendance. Rinse thoroughly with plenty of water, also under the eye lids. Consults a physician. Wash off immediately with soap and plenty of water removing all contaminated clothes and shoes. Wash contaminated clothing before reuse. Consult a physician. Wash out mouth and drink water if conscious. Never give anything by mouth to an unconscious person. Seek medical attention if irritation persists. Move to fresh air. If not breathing, give artificial respiration. If breathing is difficult, administer oxygen. Consult a physician. Rinse mouth. Never give anything by mouth to an unconscious person. Consult a physician. Treat symptomatically. Use personal protective equipment. Avoid contact with skin, eyes and clothing. Section 5 Fire and Explosion Data Extinguishing Media: Use media appropriate to treat surrounding fire. Special Fire Fighting Procedures: Use firefighting procedures that is appropriate to the surrounding fire. All fire fighters should us selfcontained breathing apparatus and full firefighting turnout gear. Product Code: P03482 Version: 2 Page 9 of 14

10 Silicon Dioxide: Maltodextrin: Flammable Properties: Dust may form explosive mixture in air. Suitable Extinguishing Media: Water spray, carbon dioxide, dry powder, foam. Hazardous Combustion Products: Thermal decomposition or combustion may produce hazardous gases and/or materials. Specific Hazards Arising from the Chemical: Keep product and empty container away from heat and sources of ignition. Protective Equipment and Precautions form Fire Fighters: AS in any fire, wear a self-contained breathing apparatus pressure- demand, MSHA/NIOSH (approved or equivalent) and full protective gear. NFPA: Health: 1 Flammability: 0 Instability: 0 Extinguishing Media: Use water spray or fog, foam, dry chemicals or CO2. Fire Fighting Procedures: Firefighting must wear positive pressure self-contained breathing apparatus and full positive clothing. Extinguishing Media: Water Special Fire-fighting Procedures: Use water spray to prevent dust air mixtures. Unusual Fire and Explosion Hazards: Maltodextrin becomes flammable dust when finely divided and suspended in air. Keep away from sources of ignition, sparks and open flame. Use only in well-ventilated areas. Provide adequate dust control. Section 6 Accidental release measures Silicon Dioxide: Isolate hazard area and deny entry to unnecessary or unprotected personnel. Contain spill, sweep up, collect and place in a disposal container. Avoid runoff into storm sewers and ditches which lead to waterways. Method of Cleaning Up: Evacuate personnel to safe areas. Sweep up and shovel in to suitable container for disposal. Avoid dust formation. Clean contaminated surface thoroughly. Personal Precautions: Evacuate personnel to safe areas. Ensure adequate ventilation. Use personal protective equipment. Avoid contact with skin, eyes and clothing. In insufficient ventilation, wear suitable respiratory equipment. Environmental Precautions: Local authorities should be advised if significant spillages cannot be contained. Steps to be taken if this Material is Release or Spilled: Obey relevant local, state, provincial and federal laws and regulations. Do not contaminate any lakes, streams, pounds, groundwater or soil. Use personal protective equipment as described in section 8. Shovel spilled material into a suitable container. Product Code: P03482 Version: 2 Page 10 of 14

11 Maltodextrin: Steps to be Taken In Case of Release or Spilled: Sweep up and/or flush clear with water; avoid production of dust. Eliminate all ignition sources. Section 7 Handling and Storage Silicon Dioxide: Maltodextrin: Handling: Avoid contact with skin, eyes and clothing. Use with adequate ventilation. Avoid breathing dust. Use normal personal hygiene and housekeeping. Storage: Store in a cool, dry area away from other incompatible materials. Product is slightly hygroscopic and should be store in a dry area to prevent moisture pick up and caking. Handling: Use only in an area equipped with a safety shower. Ensure that eyewash and safety shower are close to workstation location. Ensure adequate ventilation. Do not breathe vapours/ dust. Avoid consult with skin, eyes and clothing. Avoid repeated exposure. Storage: Keep container tightly closed. Keep in properly labelled containers. Handling: Wash thoroughly after handling. Use with adequate ventilation. Follow all MSDS/label precautions even after container is emptied because it may retain product residues. Take precautionary measures against static discharges. Storage: Store in a cool, dry place. Keep container closed when not in use. Precautions to be taken in Handling and Storage: Store in dry area. Avoid handling procedures that produce dust. Section 8 Control Methods/Personal Protection Respiratory Protection: Use NIOSH/MSHA approved respirators. Ventilation Requirements: Ventilate as necessary to eliminate dust from the work area. Skin and Eye Protection: Use rubber or neoprene gloves, chemical goggles and clothing sufficient to protect skin from dust. Exposure Limits: 1mg/m 3 (OSHA-PEL) 1mg/m 3 (ACGIH-TLV) Exposure Guidelines: This product does not contain any hazardous materials with occupational exposure limits established by the region specific respiratory bodies. Engineering Controls: Ensure adequate ventilation, especially in confined areas. Eyes/Face Protection: Tightly fitted safety goggles. Skin Protection: Wear protective gloves/clothing. Respiratory Protection: In case of insufficient ventilation wear suitable respiratory equipment. Product Code: P03482 Version: 2 Page 11 of 14

12 Silicon Dioxide: Exposure Limits: Values: Limit: Reference: Silicon Dioxide 6 mg/m 3 TWA OSHA Amorphous, fumed 10mg/m3 TWA ACGIH Crystalline free N.E STEL OSHA/ACGIH Engineering Controls: Use adequate ventilation. Respiratory Protection: A respiratory protection program that meets OSHA and ANSIZ88.2 or applicable federal/provincial requirements must be followed whenever workplace conditions warrant respirator use NIOSH s Respirator Decision Logic may be useful in determining the suitability of various types of respirator. Eye Protection: Wear safety glasses with side shields. Skin Protection: Use impermeable gloves. Other Protective Equipment: A safety shower and eye wash fountain should be readily available. To identify additional Personal Equipment requirements, it is recommended that a hazard assessment to conducted before using this product. Maltodextrin: Product is GRAS for human consumption 21CFR Section 9 Physical and Chemical Properties Physical state and Appearance: Colour: Odour: Solubility: Powder White to Off White Characteristic Partial Section 10 Stability and Reactivity Stability: Hazardous Decomposition Products: Incompatibility with Various Substances: Conditions to Avoid: Stable under normal conditions. Oxides of carbon. Strong acids, strong oxidants. Sources of ignition, sparks, open flame. Section 11 Toxicological Information Silicon Dioxide: Maltodextrin: Acute Oral Toxicity LD50 Rat: Dose 1,385 mg/kg Acute Toxicity LD50 Oral = 7930 mg/kg Oral LD50 Rat Carcinogenicity: There are no known carcinogenic chemicals in this product. Product Toxicological Information Oral LD50 (rat) : >10000 mg/kg Dermal LD50 (rabbit): >5000 mg/kg N/A Product Code: P03482 Version: 2 Page 12 of 14

13 Section 12 Ecological Information Silicon Dioxide: Maltodextrin: N/A Eco toxicity: Contains no substance known to be hazardous to the environment or not degradable in waste water treatment plants. No data available. N/A Section 13 Disposal Considerations Waste must be dispose of in accordance with federal, state and local environmental control regulations. Section 14 Transport Information Silicon Dioxide: Maltodextrin: D.O.T. Shipping Name: Not required. Not required US DOT Transport Information: Not required. Not available. Section 15 Regulatory Information OSHA Status: Not listed. TSCA Status: Listed. CERCLA Reportable Requirements: Contains copper RQ 5000 lbs. Section 302 Extremely Hazardous Substances: Unlisted. Section 313 Toxic Chemicals: Listed contains copper. Section 311/312 Hazard Category: immediate (acute) Health Hazard, Delayed (chronic). USA (TSCA): Complies. Canada (DSL): Complies. EU (ELINCS): Does not comply. Japan (ENCS): Complies. China: Complies. Korea (KECL): Complies. Philippines (PICCS): Complies. Australia (AICS): Complies. USA: SARA 313: Section 313 of Title III of the Superfund Amendments and Reauthorization Act of 1986 (SARA). This product does not contain any chemicals which are subject to the reporting requirements of the Act and Title 40 of the Code of Federal Regulations, Part 372. Product Code: P03482 Version: 2 Page 13 of 14

14 Silicon Dioxide: Maltodextrin: SARA 311/312 Hazardous Categorization: Acute Health= No Chronic Health= No Fire Hazard= No Reactive Hazard= No Sudden Release of Pressure Hazard= No Clean Air Act, Section 112 Hazardous Air Pollutants (HAPs)(see 40 CFR 61) This product does not contain HAPs. Chemical Name: Glycine CAS No.: VOCs: Present California Proposition 65: This product does not contain any Proposition 65 chemicals. Canada: This product has been classified in accordance with the hazard article of the Controlled Products Regulations (CPR) and the MSDS contains all information required by the CPR. WHMIS Hazard Class: Not determined. Not regulated. Not regulated. Section 16 Other Information This advice is given by Cambridge Commodities Ltd who accepts no legal liability for it. The information contained herein is based on the present state of our knowledge and is intended to describe our products from the point of view of safety requirements. It should not therefore be construed as guaranteeing specific properties. Individuals working with chemicals should consider all chemicals to be potentially hazardous even if their individual hazards may be uncharacterised or unknown. This Information provided in this document is subject to change and the batch specific Certificate of Analysis should always be referenced. To be used as per local legislation. Change History Version Change Customer Notification required Yes / No 1 First Issue N/A 2 Kosher Status and Logo have been added No Document Approval Originator Job Title QC Technician Approver Job Title QC Technician Adam Mulcahy Adam Mulcahy (Mar 16, 2016) Harry Selby Harry Selby (Mar 16, 2016) Product Code: P03482 Version: 2 Page 14 of 14

15 P03482-K-Pure Copper Bis- Glycinate-Technical Dossier Adobe Document Cloud Document History 3/16/16 Created: 3/16/16 By: Status: Transaction ID: Adam Mulcahy SIGNED CBJCHBCAABAAfGWjOiNPfMqmXXDAE3T_r0gO2NIfLgop P03482-K-Pure Copper Bis-Glycinate-Technical Dossier History Document uploaded by Adam Mulcahy from Reader 3/16/16-3:29:40 PDT - IP address: Document signed in Reader by Adam Mulcahy (adam.mulcahy@c-c-l.com) Signature Date: 3/16/16-3:30:02 PDT - Time Source: server - IP address: Document ed to Harry Selby (harry.selby@c-c-l.com) for signature 3/16/16-3:30:03 PDT Document viewed by Harry Selby (harry.selby@c-c-l.com) 3/16/16-3:32:07 PDT - IP address: Document e-signed by Harry Selby (harry.selby@c-c-l.com) Signature Date: 3/16/16-3:32:26 PDT - Time Source: server - IP address: Signed document ed to Adam Mulcahy (adam.mulcahy@c-c-l.com) and Harry Selby (harry.selby@c-cl.com) 3/16/16-3:32:26 PDT