PRODUCT TECHNICAL DOSSIER VITAMIN B12 (CYANOCOBALAMIN)

Transcription

1 PRODUCT TECHNICAL DOSSIER VITAMIN B12 (CYANOCOBALAMIN) Product Code: P2208 Raw Material Full Name: Cyanocobalamin Raw Material Full Botanical/Chemical/Latin/Trade Name/Synonyms: Co α [α (5,6-Dimethyibenzimi-dazoly)]-Co β-cyanocobamide Assay: 96.0% % CAS Number: Molecular Formula for the raw material: C 63H 88CoN 14O 14P Average Molecular weight: Solubility in Water: Sparingly Soluble in Water Solubility in Alcohol: Slightly Soluble in Ethanol Loss on Drying: Max 12% Country of Origin: China Country of Origin of the Manufacture: China Base Source/Start Material: Cyanocobalamin (VB12) is produced by fermentation. The strain for production of VB12 is Pseudomonas denitrificans Product Code: P2208 Version: 5 Page 1 of 15

2 Origin of Product Synthetic, Plant, Mineral, Animal, Fish or Fermented: Fermented Synthetic: What are the starting materials of the synthesis and their sources? Cyanocobalamin Material is: 100% Compound Ingredients: None Shelf Life from Date of Manufacture: Min 4 Years (batch specific) Storage Conditions: This material is to be stored in a tightly sealed bag/container and to be kept in a cool place away from moisture and direct sunlight Appearance: Crystals or Crystalline Powder Colour: Dark Red Flavour/Taste: Characteristic Texture: Crystals or Crystalline Powder Odour: Characteristic Microbiological Test Total Viable Count: <10 5 Yeast & Moulds: <10 2 E.Coli: Negative in 25g Product Code: P2208 Version: 5 Page 2 of 15

3 Salmonella: Negative in 25g Metals Heavy Metals: Max 10ppm Lead (Pb): Max 3ppm Cadmium (Cd): Max 1ppm Mercury (Hg): Max 0.1ppm This Product Complied with the Specifications of: USP34 and Ph.Eur.7.0 There are no nuts in this recipe and are no nuts on site, however we cannot guarantee that the raw materials entering the site are nut free. Not all parameters are tested every batch (only routinely), therefore may not appear on certificates of analysis. Product Code: P2208 Version: 5 Page 3 of 15

4 INTOLERANCE DATA If No please give details Free from All Animal Products (Beef, Pork, Poultry or other) Free from Bovine Products or Derivatives by using hormones to increase milk yield in cows Free from Bone Meal Free from Peanuts and Peanut Derivatives (including possible cross contamination) Free from other Nut and Nut Derivatives Free from Nut Derived Oil Free from Sesame Seeds and Sesame Seed Derivatives Free from Poppy Seeds and Poppy Seed Derivatives Free from Sunflower Seeds and Sunflower Seeds Derivatives Free from other Seeds and Seed Derivatives Free from Milk and Milk Derivatives (including lactose) Free from Egg and Egg Derivatives Free from Cereals containing Gluten (wheat / rye / oats / barley/ spelt/ kamut or their hybridised strains) and Derivatives Free from Soya and Soya Derivatives Free from Maize and Maize Derivatives Free from Corn and Corn Derivatives Free from Lupin and Lupin Derivatives Free from Yeast and Yeast Derivatives Free from Cotton Seeds (Flour) and Cotton Seed Derivatives Free from Rice and Rice Derivatives Free from Mustard and Mustard Derivatives Free from Celery or Celery Derivatives Free from Celeriac or Celeriac Derivatives Free from Fruit and Fruit Derivatives Free from Vegetable and Vegetable Derivatives Free from Carrot and Carrot Derivatives Free from Legumes / Pulses Free from Fish and Fish Derivatives Free from Crustaceans / Molluscs and their Derivatives Free from Additives Free from Added Salt Free from Added Sugar Free from Antioxidants Free from Artificial Glutamates Free from Aspartame Free from Azo and Coal Tar Dyes Free from Benzoates (E210 / E219) Free from BHA / BHT (E320 / E321) Free from Caffeine Free from Cinnamon Free from Cocoa Free from Colours (Artificial / Nature Identical / Natural / Smoked) Free from Dextrose Free from Dioxins Free from Ethanol NO <0.5% Product Code: P2208 Version: 5 Page 4 of 15

5 INTOLERANCE DATA Free from Ethylene Oxide Free from Flavourings (Artificial / Nature Identical / Natural / Smoked) Free from Garlic Free from Gelatine Free from Glutamates (E620 to E625) Free from Histamine Free from Hickory Free from Honey Free from Lactose Free from Latex Free from MSG (Added and Naturally Occurring E621) Free from Nucleotides (E627, E630, E631, E635) Free from Polyols Free from Preservatives Free from Starch Products (Including Maltodextrin) Free from Sorbic Acid (E200, E203) Free from Sulphur Dioxide and Sulphites at levels above 10mg/kg or 10mg/litre expressed as SO 2 Free from Sulphites (E220, E228) Free from Sweeteners Free from Vannillin Suitable for Diabetics Suitable for Coeliacs Suitable for Ovo-Lacto Vegetarians Suitable for Vegans Kosher Certified Halal Certified If No please give details NO NO Product Code: P2208 Version: 5 Page 5 of 15

6 PRODUCT FLOW CHART Lyophilized tube (WCB) Seed culture in slant Seed culture in mother bottle culture Primary seed culture Second seed culture Fermentation Fermentation broth primary acidification Continuous lysis Ultra-filtration Adsorption on IRC-50 aberlite column Eluate vacuum concentration Product Code: P2208 Version: 5 Page 6 of 15

7 PRODUCT FLOW CHART Continued Transformation concentration eluate collection Adsorption on XAD-2 aberlite column Eluate vacuum concentration Purification on IRC-900 aberlite column Vacuum concentration Crystallization Vacuum drying and homogenized Filling, packing, labeling Finished product Product Code: P2208 Version: 5 Page 7 of 15

8 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: P2208 Version: 5 Page 8 of 15

9 MATERIAL SAFETY DATA SHEET Section 1 Identification of the Substance/Mixture and of the Company/Undertaking Product Name: Product Code: Supplier: Vitamin B12 (Cyanocobalamin) P2208 Cambridge Commodities Limited 203 Lancaster Way, Ely, Cambridgeshire, CB6 1NX. Tel: qc@c-c-l.com Section 2 Hazards Identification EMERGENCY OVERVIEW Appearance: dark red crystalline powder. Caution! May cause eye, skin, and respiratory tract irritation. Light sensitive. Hygroscopic (absorbs moisture from the air). This is expected to be a low hazard for usual industrial handling. Target Organs: None. Potential Health Effects Eye: Skin: Ingestion: Inhalation: Chronic: Contact may cause transient eye irritation. May cause skin irritation. Although allergic reactions to vitamin B12 have generally been attributed to impurities in the preparation, a few patients have reacted positively to skin testing with purified cyanocobalamin. May cause gastrointestinal irritation with nausea, vomiting and diarrhea. Ingestion of large amounts may cause convulsions, tremors, muscular contractions or spasticity, diarrhea, or fever. May cause respiratory tract irritation. Not available. Available evidence suggests that cobalt is not likely to cause cancer in humans except under uncommon or unlikely routes or levels of exposure. Cobalt is an essential element for humans. It forms part of the molecule of cyanocobalamin. The absence of cyanocobalamin is associated with a variety of deficiency-disease states notably dealing with proper erythropoiesis. Section 3 Composition/Information on Ingredients Components % in Product CAS Number Formula EINECS Number Vitamin B % % C 63H 88CoN 14O 14P Product Code: P2208 Version: 5 Page 9 of 15

10 Section 4 Emergency and First Aid Procedures Eyes: Skin: Ingestion: Inhalation: In case of contact, immediately flush eyes with plenty of water for a t least 15 minutes. Get medical aid. In case of contact, flush skin with plenty of water. Remove contaminated clothing and shoes. Get medical aid if irritation develops and persists. Wash clothing before reuse. If swallowed, do not induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconscious person. Get medical aid. If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical aid. Notes to Physician: Treat symptomatically and supportively. Section 5 Fire-Fighting Measures General Information: As in any fire, wear a self-contained breathing apparatus in pressure-demand, MSHA/NIOSH (approved or equivalent), and full protective gear. During a fire, irritating and highly toxic gases may be generated by thermal decomposition or combustion. Extinguishing Media: For small fires, use water spray, dry chemical, carbon dioxide or chemical foam. Flash Point: Not applicable. Auto-ignition Temperature: Not applicable. Explosion Limits, Lower: Not available. Upper: Not available. NFPA Rating: (estimated) Health: 1; Flammability: 1; Instability: 0 Section 6 Accidental Release Measures General Information: Use proper personal protective equipment as indicated in Section 8. Spills/Leaks: Vacuum or sweep up material and place into a suitable disposal container. Clean up spills immediately, observing precautions in the Protective Equipment section. Avoid generating dusty conditions. Provide ventilation. Section 7 Handling and Storage Handling: Wash thoroughly after handling. Use with adequate ventilation. Minimize dust generation and accumulation. Avoid contact with eyes, skin, and clothing. Avoid breathing dust. Storage: Stored in an airtight container, protected from light. Product Code: P2208 Version: 5 Page 10 of 15

11 Section 8 Control Methods/Personal Protection Engineering Controls: Facilities storing or utilizing this material should be equipped with an eyewash facility and a safety shower. Use adequate ventilation to keep airborne concentrations low. Exposure Limits: Chemical Name ACGIH NIOSH OSHA - Final PELs Cyanocobalamin None listed None listed None listed OSHA Vacated PELs: Cyanocobalamin: No OSHA Vacated PELs are listed for this chemical. Personal Protective Equipment Eyes: Wear appropriate protective eyeglasses or chemical safety goggles as described by OSHA's eye and face protection regulations in 29 CFR or European Standard EN166. Skin: Wear appropriate protective gloves to prevent skin exposure. Clothing: Wear appropriate protective clothing to minimize contact with skin. Respirators: Follow the OSHA respirator regulations found in 29 CFR or European Standard EN 149. Use a NIOSH/MSHA or European Standard EN 149 approved respirator if exposure limits are exceeded or if irritation or other symptoms are experienced. Section 9 Physical and Chemical Properties Physical State: Crystalline powder Appearance: Dark red Odor: Odorless ph: aq solns are neutral Vapor Pressure: Negligible Vapor Density: Not available Evaporation Rate: Negligible Viscosity: Not available Boiling Point: > 300 deg C Freezing/Melting Point:> 300 deg C Solubility: Moderately soluble in water Molecular Formula: C 63H 88CoN 14O 14P Molecular Weight: Decomposition Temperature: Not available Product Code: P2208 Version: 5 Page 11 of 15

12 Section 10 Stability and Reactivity Chemical Stability: Stable under normal temperatures and pressures. May decompose when exposed to light. Darkens at Conditions to Avoid: Light, dust generation, excess heat. Incompatibilities with Other Materials: Strong oxidizers, strong acids. Hazardous Decomposition Products: Carbon monoxide, oxides of nitrogen, oxides of phosphorus, carbon dioxide, oxides of cobalt. Hazardous Polymerization: Will not occur. Section 11 Toxicological Information RTECS#: CAS# : GG LD50/LC50: Not available. Carcinogenicity: CAS# : ACGIH: Not listed. California: Not listed. NTP: Not listed. IARC: Group 2B carcinogen (listed as Cobalt compounds). Epidemiology: No information available. Teratogenicity: See actual entry in RTECS for complete information. Reproductive Effects: See actual entry in RTECS for complete information. Mutagenicity: Please refer to RTECS# GG for specific information. Neurotoxicity: No information available. Section 12 Ecological Information No information available Section 13 Disposal Considerations Chemical waste generators must determine whether a discarded chemical is classified as a hazardous waste. US EPA guidelines for the classification determination are listed in 40 CFR Parts Additionally, waste generators must consult state and local hazardous waste regulations to ensure complete and accurate classification. RCRA P-Series: None listed. RCRA U-Series: None listed. Product Code: P2208 Version: 5 Page 12 of 15

13 Section 14 Transport Information US DOT Shipping Name: Not regulated as a hazardous material Canada TDG Shipping Name: No information available. Section 15 Regulatory Information US FEDERAL TSCA CAS# is listed on the TSCA inventory. Health & Safety Reporting List None of the chemicals are on the Health & Safety Reporting List. Chemical Test Rules: None of the chemicals in this product are under a Chemical Test Rule. Section 12b None of the chemicals are listed under TSCA Section 12b. TSCA Significant New Use Rule None of the chemicals in this material have a SNUR under TSCA. CERCLA Hazardous Substances and corresponding RQs None of the chemicals in this material have an RQ. SARA Section 302 Extremely Hazardous Substances None of the chemicals in this product have a TPQ. Section 313 This material contains Cyanocobalamin (listed as Cobalt compounds), >96%, (CAS# ) which is subject to the reporting requirements of Section 313 of SARA Title III and 40 CFR Part 373. Clean Air Act: CAS# (listed as Cobalt compounds) is listed as a hazardous air pollutant (HAP). This material does not contain any Class 1 Ozone depletors. This material does not contain any Class 2 Ozone depletors. Clean Water Act: None of the chemicals in this product are listed as Hazardous Substances under the CWA. None of the chemicals in this product are listed as Priority Pollutants under the CWA. None of the chemicals in this product are listed as Toxic Pollutants under the CWA. OSHA: None of the chemicals in this product are considered highly hazardous by OSHA. Product Code: P2208 Version: 5 Page 13 of 15

14 STATE CAS# can be found on the following state right to know lists: Pennsylvania, (listed as Cobalt compounds). California Prop 65 California No Significant Risk Level: None of the chemicals in this product are listed. European/International Regulations European Labeling in Accordance with EC Directives Hazard Symbols: Not available. Risk Phrases: Not available Safety Phrases: S 24/25 Avoid contact with skin and eyes. WGK (Water Danger/Protection) CAS# : No information available. Canada - DSL/NDSL CAS# is listed on Canada's DSL List. Canada - WHMIS not available. This product has been classified in accordance with the hazard criteria of the Controlled Products Regulations and the MSDS contains all of the information required by those regulations. Canadian Ingredient Disclosure List CAS# is not listed on the Canadian Ingredient Disclosure List. 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. Product Code: P2208 Version: 5 Page 14 of 15

15 Change History Version Change Customer Notification required Yes / No 1 First Issue N/A 2 Updated to new format. Amendment of assay tolerance from 96.0% - Yes 102.0% to 96.0% % in accordance with the compliance statement to both USP34 and Ph.Eur MSDS has been updated. Yes 4 Added statement: Not all parameters are tested every batch (only No routinely), therefore will not appear on certificates of analysis. 5 Origin of product from synthetic to fermented due to a change in process No Document Approval Originator Job Title Quality Specialist Approver Job Title Quality Specialist Lucia Valle (Nov 9, 2016) Shannon McKenna (Nov 9, 2016) Product Code: P2208 Version: 5 Page 15 of 15

16 P Vitamin B12 - Technic al Dossier V5 Adobe Sign Document History 11/09/2016 Created: 11/09/2016 By: Status: Transaction ID: Shannon McKenna (shannon.mckenna@c-c-l.com) Signed CBJCHBCAABAA7Ekon0h0OddfJ4aDs5QTPGxQVpOlvgY7 "P Vitamin B12 - Technical Dossier V5" History Document uploaded by Shannon McKenna (shannon.mckenna@c-c-l.com) from Acrobat 11/09/2016-7:10:25 AM PST- IP address: Document signed in Acrobat by Shannon McKenna (shannon.mckenna@c-c-l.com) Signature Date: 11/09/2016-7:10:49 AM PST - Time Source: server- IP address: Document ed to Lucia Valle (lucia.valle@c-c-l.com) for signature 11/09/2016-7:10:50 AM PST Document viewed by Lucia Valle (lucia.valle@c-c-l.com) 11/09/2016-7:11:06 AM PST- IP address: Document e-signed by Lucia Valle (lucia.valle@c-c-l.com) Signature Date: 11/09/2016-7:16:25 AM PST - Time Source: server- IP address: Signed document ed to Lucia Valle (lucia.valle@c-c-l.com) and Shannon McKenna (shannon.mckenna@c-c-l.com) 11/09/2016-7:16:25 AM PST