PRODUCT TECHNICAL DOSSIER RAW MATERIAL Product Code: P0902 Raw Material Full Name: Inositol Raw Material Full Botanical/Chemical/Latin/Trade Name/Synonyms: Meso-imositol,myo-inositol,1,2,3,4,5,6-hexahydroxycyclohexane This material is Food Grade: Yes Vegan / Vegetarian Status: Suitable for both Limit/Range/Specification: 97-101% CAS Number: 87-89-8 EC/EINECS Number: 201-781-2 Molecular Formula for the raw material: C 6H 12O 6 Average Molecular weight: 180.16 Solubility in Water: One gram is soluble in 6 ml of water Solubility in Alcohol: Slightly soluble in alcohol Particle Size: 60 Mesh Product Code: P0902 Version: 2 Page 1 of 13
Percentage passed through: 100% Bulk Density: 0.45g/ml Tapped Density: 0.71g/ml ph: 5-6 Loss on Drying: Max 0.5% Residue on Ignition: Max 0.1% Country of Origin: China Country of Origin of the Manufacture: China Base Source/Start Material: Phytin from Corn Origin of Product Synthetic, Plant, Mineral, Animal, Fish or Fermented: Plant Material is: 100% Compound Ingredients Origin, Function and Percentages: None Shelf Life from Date of Manufacture: Minimum 3 Years Storage Conditions: Store in a well closed container at room temperature in a dry place Appearance (Fine/Crystals/Crystalline/Hygroscopic): Free Flowing Crystalline Powder Product Code: P0902 Version: 2 Page 2 of 13
Colour: White/Off White Flavour/Taste: Sweet Flavour Odour: Odourless Do any of the parameters change in different seasons? No Microbiological Test Total Viable Count: Max 10,000cfu/g Yeast & Moulds: Max 1,000cfu/g E.Coli: Negative/25g Salmonella: Negative/25g Max Heavy Metals: 10ppm Iron (Fe): Max 5ppm Sulphate: Max 60ppm Chloride: Max 50ppm Pharmacopeia Standard Used: FCCV1 & NF12 There are no nuts in this recipe; however we cannot guarantee that the raw materials entering the site are nut free. Product Code: P0902 Version: 2 Page 3 of 13
Please note that surveillance testing may mean that not all the parameters stated on this specification are tested for every batch. ALLERGENS Product Free From YES/NO Listed Item on Site at Manufacturer YES/NO Free from Peanuts and Peanut Derivatives (including possible cross contamination) Yes No Free from other Nut and Nut Derivatives Yes No 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 nut (Macadamia ternifolia) Free from Sesame Seeds and Sesame Seed Derivatives Yes No Free from other Seeds and Seed Derivatives (Poppy Seeds, Cotton Seeds, Sunflower Yes No Seeds) Free from Milk and Milk Derivatives (including lactose) Yes No Free from Egg and Egg Derivatives Yes No Free from Cereals and Derivatives containing OR POTENTIALLY CONTAMINATED WITH Yes No Gluten (wheat, wheatgrass, faro, freekeh, spelt, kamut, rye, oats, barley, barley grass) Free from Soya and Soya Derivatives Yes No Free from Lupin and Lupin Derivatives Yes No Free from Mustard and Mustard Derivatives Yes No Free from Celery or Celery Derivatives (including Celeriac) Yes No Free from Fish and Fish Derivatives Yes No Free from Molluscs and their Derivatives Yes No Free from Crustaceans and their Derivatives Yes No Free from Sulphur Dioxide and Sulphites (E220, E228) at levels > 10mg/kg or 10mg/litre Yes No If YES, Please Comment Product Code: P0902 Version: 2 Page 4 of 13
ADDITIVES / CONTAMINANTS / DIETARY REQUIREMENTS Product Free From YES/NO Listed Item on Site at Manufacturer YES/NO Free from Additives Yes No Free from Antioxidants Yes No Free from Ethylene Oxide Yes No Free from Gelatine Yes No Free from Flavourings (Artificial / Nature Identical / Natural / Smoked) Yes No Free from Maize / Corn and any Derivatives No Yes Free from Legumes / Pulses Yes No Free from Rice and Rice Derivatives Yes No Free from Added Salt Yes No Free from Added Sugar / artificial or natural sweeteners Yes No Free from Aspartame Yes No Free from BHA / BHT (E320 / E321) Yes No Free from Caffeine Yes No Free from Colours (Artificial / Nature Identical / Natural / Smoked) Yes No Free from Dextrose Yes No Free from Dioxins Yes No Free from MSG (Added and Naturally Occurring E621) or Glutamates (E620 to E625) Yes No Free from Nucleotides (E627, E630, E631, E635) Yes No Free from Polyols (sugar alcohols) Yes No Free from Benzoates (E210 / E219) Yes No Free from Sorbic Acid (E200, E203) Yes No Free from any other Preservatives Yes No Free from Ethanol Yes No Free from Honey Yes No Free from Lactose Yes No Free from Yeast and Yeast Derivatives Yes No Free from All Animal Products (Beef, Pork, Poultry or other) and Derivatives (which may Yes No include growth/yield hormones, antibiotics etc.) Free from Bovine Products or Derivatives (which may include growth/yield hormones, antibiotics etc.) Yes No If YES, Please Comment Source of the Phytin Product Code: P0902 Version: 2 Page 5 of 13
PRODUCTION FLOW CHART Corn/Maize Starch Hydrolyse Neutralise Pressure Filtration Vacuum Concentrate Second Concentrate Cooling Down Crystalline Crude Products Decolour Filter Centrifugation Drying Crush Packing Product Code: P0902 Version: 2 Page 6 of 13
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 - 100 nm". Product Code: P0902 Version: 2 Page 7 of 13
MATERIAL SAFETY DATA SHEET Section 1 Identification of the Substance/Mixture and of the Company/Undertaking Product name: Inositol Chemical formula: C 6H 12O 6 Company: Cambridge Commodities Limited Lancaster Way, Ely, Cambridgeshire, CB6 3NX Tel: 01353 667258. Email: qa@c-c-l.com Section 2 Hazards Identification Not hazardous according to directive (EC) No 1272/2008. If contact or inhale the powder/dust, may cause eyes, skin or respiratory system irritation. The toxicological properties of this material have not been fully investigated. UN Hazard Class None GHS Classification None GHS label Elements None CLP in Accordance with EC None Directives Section 3 Composition/Information on Ingredients Components % in Product CAS Number Formula EINECS Number Inositol 100 87-89-8 C6H12O6 201-781-2 Section 4 Emergency and First Aid Measures Eyes Skin Inhalation Do not allow victim to rub eyes. In case of contact, immediately flush eyes with water for at least 15 minutes, occasionally lifting the upper and lower eyelids. Check for and remove and contact lenses if easily possible. Get medical aid if symptoms occur If a reaction with skin contact occurs, remove the contaminated clothing. Wash the affected area. Wash clothing before reuse. Seek medical attention if irritation persists If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Seek medical attention if cough and other symptoms appear Product Code: P0902 Version: 2 Page 8 of 13
Ingestion Note to Physicians Seek medical help if symptoms occur. If a large amount is swallowed induce vomiting under the guidance of a professional doctor. If the injured is full conscious wash mouth out with water, and then give 2 4 cupful s of milk or water. Never give anything by mouth to an unconscious person. Treat symptomatically and supportively Section 5 Fire-fighting measures Extinguishing Media Specific Hazards Specific Extinguishing Methods Protective Equipment Use water spray, dry chemical, carbon dioxide, or appropriate foam Non-flammable. In case of fire, oxides of carbon, hydrocarbons, fumes, and smoke may be generated by thermal decomposition If appropriate, reduce airborne dust and prevent scattering by moistening with water spray. Approach fire from upwind to avoid vapours and toxic fumes. Run off water from fire control should be contained to avoid pollution As in any fire, wear a self-contained breathing apparatus in pressuredemand, MSHA/NIOSH (approved or equivalent), and full protective gear. Section 6 Accidental Release Measures Personal Precautions Environmental Protection Ventilate closed spaces before entering. Review section 5 and 7 before proceeding with clean-up. Use proper personal protective equipment as indicated in section 8 DO NOT let the chemical enter the environment Measures for Cleaning/Collecting Remove all sources of ignition. Stop leak if possible without personal risk. Sweep up material carefully, and then place into a suitable disposal container for disposal. Avoid generating dusty conditions. If appropriate, moisten first to prevent dusting. Contaminated floor may be flushed with water to chemical sewer Section 7 Handling and Storage General Information This product should be stored, handled and used in accordance with good industrial hygiene practices and in conformity with any legal regulations. Smoking should be prohibited in areas where this material is handled, stored and processed. Wash hands thoroughly after handling chemical products Product Code: P0902 Version: 2 Page 9 of 13
Storage Store in a tightly closed container. Store in a cool, dry, well-ventilated area away from incompatible substances, sources of ignition or heat, food, drink direct sunlight and dust/impurities. Protect from humidity and water. Inspect regularly for deficiencies such as damage or leaks. Treat carefully, avoid physical damage to containers Handling Ensure good local exhaust ventilation. Handle and open containers with care. Keep containers tightly closed and away from incompatible substances, sources of ignition or heat, food, drink, direct sunlight and dust/impurities. Protect from humidity and water. Minimize dust generation and accumulation. Avoid dust contact with eyes, skin and clothing and shoes. Remove any contaminated clothing and wash before reuse. Empty containers retain product residue. Section 8 Exposure Controls/Personal Protection Exposure Limit No exposure limit is listed for this product. But nuisance dust limits can be used for this product. Composition Nuisance Dust -TLV-TWA 10 mg/m 3 (ACGIH, total) -TLV-TWA 3 mg/m 3 (ACGIH, respirable fraction) -PEL-TWA 15 mg/m 3 (OSHA, total) -PEL-TWA 5 mg/m 3 (OSHA, respirable fraction) Monitoring Methods No information found Engineering Methods Use adequate ventilation to keep airborne concentrations low. Facilities storing or utilizing this material should be equipped with an eyewash facility and safety shower Personal Protective Equipment Eyes: Dust service goggles should be worn to prevent mechanical injury or other irritation to eyes due to airborne particles which may result from handling product Skin & Clothing: Wear appropriate protective clothing, and gloves to prevent skin contact Respirators: An appropriate respirator or mask should be used whenever work place conditions warrant a respirators use. A full face positive pressure supplied-air respirator or a self-contained breathing apparatus should be used when large spill or fire Other Protection: To maintain good health habits. Smoking should be prohibited in areas where the material is handled, stored and processed. Wash hands thoroughly after handling chemical products Product Code: P0902 Version: 2 Page 10 of 13
Section 9 Physical and Chemical Properties Physical state Odour Initial Melting Point Ignition Temperature Explosion Limits Decomposition Temperature Flammability Solubility in Water White powder Weak odour At approx. 226 o C Approx. 800 o C N/A N/A The preliminary screening test for readily combustible solids is conducted in accordance with the regulation (recommendations on the transport of dangerous goods manual of tests and criteria), so the product does not belongs to flammability solid Approx. 1g/6ml at 25 o C, i.e. highly soluble Section 10 Stability and Reactivity Chemical Stability Conditions to Avoid Incompatibilities Other Materials Hazardous Decomposition Products Hazardous Polymerization Stable under normal storage and handling conditions. Incompatible material, sources of ignition or heat, dust generation, excess heat, moisture. Strong oxidizing agents Decomposition will not occur if handled and stored properly. In case of a fire, oxides of carbon, hydrocarbons, fumes, and smoke may be generated by thermal decomposition. Will not occur Section 11 Toxicological Information Toxicological Information Composition: CAS# 87-89-8 -RTECS # NM7520800 -LD50: 10g/kg (Oral, mouse) Sensitisation Rate: Not available Carcinogenicity: Composition: CAS# 87-89-8 -Not listed as a carcinogen by ACGIH, IARC, NTP or CA Prop 65. Potential Health Effects: -Eye: Contact with powder/dust may cause eyes irritation -Skin: Prolonged or repeated contact with powder/dust may cause skin irritation -Ingestion: May cause gastrointestinal irritation if taken in large quantities -Inhalation: If inhaled powder/dust, may cause respiratory tract irritation -Other Information: The toxicological properties of this material have not been fully investigated Product Code: P0902 Version: 2 Page 11 of 13
Section 12 Ecological Information No Data Available Section 13 Disposal Considerations The generation of waste should be avoided or minimised wherever possible. Chemical waste generators must be determine whether a discarded chemical is classified as a hazardous waste. Additionally, waste generators must consult state local hazardous waste regulations to ensure complete and accurate classification. Contaminated packaging material should be treated equivalent to residual chemical. Clean packaging material should be subject to waste management schemes (recovery recycling, reuse) according to local legislation. RCRA P-Series: None listed RCRA U-Series: None listed Section 14 Transport Information Transport classification: Not classified as dangerous for any mode of UK or International transport. Section 15 Regulatory Information TSCA: TSCA Section 12b SARA Section 302 SARA Section 313 DSL OSHA California Prop 65 IECSC CAS# 87-89-8 is Listed CAS# 87-89-8 is unlisted CAS# 87-89-8 is unlisted CAS# 87-89-8 is unlisted CAS# 87-89-8 is listed CAS# 87-89-8 is unlisted CAS# 87-89-8 is unlisted CAS# 87-89-8 is listed US: This substance is not listed in OSHA hazard communication standard (29CFR 1910.1200, List of Highly Hazardous Chemicals, Toxics and Reactives) EU: There is no information in ESIS for this substance with respect to the BPD This substance is not listed in the Annex I of Regulation (EC) No 689/2008 (Export & Import of Dangerous Chemicals This substance is not listed in the European Priority Lists and Risk Assessment (Council Regulation (EEC) No 793/93) Product Code: P0902 Version: 2 Page 12 of 13
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 Updated shelf life from date of manufacture from 3 years to minimum 3 years to conform to the supplier s specification. Updated format. No Document Approval Originator Job Title QC Technician Approver Job Title QC Technician Ash Bean Ash Bean (Jun 6, 2016) Adam Mulcahy Adam Mulcahy (Jun 6, 2016) Product Code: P0902 Version: 2 Page 13 of 13
P0902-Inositol-Technical Dossier Adobe Sign Document History 06/06/2016 Created: 06/06/2016 By: Status: Transaction ID: Ash Bean (ash.bean@c-c-l.com) SIGNED CBJCHBCAABAAolyAaDS-h-YLxwiZCZLmvsm9W3saNh_U P0902-Inositol-Technical Dossier History Document uploaded by Ash Bean (ash.bean@c-c-l.com) from Reader 06/06/2016-9:12:13 PDT - IP address: 81.145.42.226 Document signed in Reader by Ash Bean (ash.bean@c-c-l.com) Signature Date: 06/06/2016-9:12:37 PDT - Time Source: server - IP address: 81.145.42.226 Document emailed to Adam Mulcahy (adam.mulcahy@c-c-l.com) for signature 06/06/2016-9:12:38 PDT Document viewed by Adam Mulcahy (adam.mulcahy@c-c-l.com) 06/06/2016-9:13:11 PDT - IP address: 81.145.42.226 Document e-signed by Adam Mulcahy (adam.mulcahy@c-c-l.com) Signature Date: 06/06/2016-9:13:54 PDT - Time Source: server - IP address: 81.145.42.226 Signed document emailed to Ash Bean (ash.bean@c-c-l.com) and Adam Mulcahy (adam.mulcahy@c-cl.com) 06/06/2016-9:13:54 PDT