PRODUCT TECHNICAL DOSSIER L-TAURINE 0.5% SILICON DIOXIDE

Transcription

1 PRODUCT TECHNICAL DOSSIER L-TAURINE 0.5% SILICON DIOXIDE Product Code: P20030 Raw Material Full Name: L-Taurine Raw Material Full Botanical/Chemical/Latin/Trade Name/Synonyms: 2-Aminoethylsulfonic Acid This material is Food Grade: Vegan / Vegetarian Status: FEMAS Status: Assured Identification: Positive Limit/Range/Specification: Min 98.0% CAS Number: Molecular Formula for the raw material: C 2H 7NSO 3 Average Molecular weight: Solubility in Water: 10g (20 C) Particle Size: 40 Mesh Product Code: P20030 Version: 5 Page 1 of 19

2 Percentage passed through: ~95% Bulk Density: g/ml Chloride (Cl): Max 0.02% Sulphate (SO 4): Max 0.02% Loss on Drying: Max 0.2% Residue on Ignition: Max 0.6% Ammonium Salt (NH 4): Max 0.02% ph: Country of Origin: China Country of Origin of the Manufacture: China Base Source/Start Material: Chemicals Origin of Product Synthetic, Plant, Mineral, Animal, Fish or Fermented: Synthetic Synthetic: What are the starting materials of the synthesis and their sources? Sodium bisulphite, Ethylene oxide, Liquid ammonia, Sulphuric Acid. Compound Ingredients Origin, Function and Percentages: 0.5% Silicon Dioxide Product Code: P20030 Version: 5 Page 2 of 19

3 Shelf Life from Date of Manufacture: Min 2 Years 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 (Fine/Crystals/Crystalline/Hygroscopic): Free Flowing Crystal/Crystalline Powder Colour: White to Off White Flavour/Taste: Characteristic Odour: Characteristic Do any of the parameters change in different seasons? No Microbiological Test Total Viable Count: Max 1,000cfu/g Yeast & Moulds: Max 100cfu/g Coliforms: Negative E. Coli: Negative Salmonella: Negative Product Code: P20030 Version: 5 Page 3 of 19

4 Heavy Metals Heavy Metals: Max 10ppm Iron (Fe): Max 10ppm Lead (Pb): Max 3ppm Cadmium (Cd): Max 1ppm Mercury (Hg): Max 0.1ppm Arsenic (As): Max 1ppm Pharmacopeia Standard Used: CP 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: P20030 Version: 5 Page 4 of 19

5 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 Almond (Amygdalus communis L.), Hazelnut (Corylus avellana), Walnut (Juglans regia), Cashew (Anacardium occidentale), Pecan nut (Carya illinoiesis (Wangenh.) K. Koch), YES NO 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 Seeds) YES NO 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 Gluten (wheat, wheatgrass, faro, freekeh, spelt, kamut, rye, oats, barley, barley grass) YES NO 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: P20030 Version: 5 Page 5 of 19

6 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 YES NO 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 include growth/yield hormones, antibiotics etc.) YES NO Free from Bovine Products or Derivatives (which may include growth/yield hormones, antibiotics etc.) YES NO If YES, Please Comment Product Code: P20030 Version: 5 Page 6 of 19

7 NUTRITIONAL DATA Test Calculated Value per 100gm Energy KJ / Kcal 0KJ / 0Kcal Fat 0g - Of which saturates 0g Carbohydrate 0g - Of which sugars 0g Fibre 0g Protein 0g Salt 0g Product Code: P20030 Version: 5 Page 7 of 19

8 PRODUCTION FLOW CHART Product Code: P20030 Version: 5 Page 8 of 19

9 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: P20030 Version: 5 Page 9 of 19

10 MATERIAL SAFETY DATA SHEET Section 1 Identification of the Substance/Mixture and of the Company/Undertaking 1.1 Product Identifier Product Name: Product Code: L-Taurine P Relevant identified uses of the substance or mixture and uses advised against N/A 1.3 Details of the supplier of the safety data sheet Company: Cambridge Commodities Limited Lancaster Way, Ely, Cambridgeshire, CB6 3NX Tel: qa@c-c-l.com 1.4 Emergency Telephone Number Section 2 Hazards Identification 2.1 Classification of the substance or mixture In compliance with EC regulation No. 1272/2008 and its amendments: Skin irritation, Category 2. Eye irritation, Category 2. Specific target organ toxicity (single exposure) Category 3. This substance does not present a physical hazard. Refer to the recommendations regarding the other products present on site. This substance does not present an environmental hazard. No known or foreseeable environmental damage under standard conditions of use. In compliance with directives 67/548/EEC and their amendments: Possibility of irritation to the eyes, by inhalation and skin. This substance does not present a physical hazard. Refer to the recommendations regarding the other products present on the site. This substance does not present an environmental hazard. No known foreseeable environmental damage under standard conditions of use. Product Code: P20030 Version: 5 Page 10 of 19

11 2.2 Label elements In compliance with EC regulation No. 1272/2008 and its amendments: Hazard pictograms: In compliance with directives 76/548/EEC, 1999/45/EC and their Amendments: GHS07 Signal Word: Warning Product identifiers: EC : TAURINE Hazards statements: H315: Causes skin irritation, H319: Causes serious eye irritation, H335: May cause respiratory irritation Precautionary statements Prevention: P261: Avoid breathing dust/fume/gas/mist/vapours/spray Precautionary statements Response: P305 + P351 + P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Hazard symbols: IRRITANT Risk phrase: R 36/37/38: Irritating to eyes, respiratory system and skin Safety phrase: S 26: In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S 36: Wear suitable protective clothing. 2.3 Other hazards In use, may form flammable/explosive dust-air mixture. Product Code: P20030 Version: 5 Page 11 of 19

12 Section 3 Composition/Information on Ingredients 3.1 Substances Identification Name Classification Percent INDEX: CAS: EC: TAURINE GHS07, Wng Xi H: R: 36/37/ % 3.2 Mixtures No substances fulfil the criteria set forth in annexe II section A of the REACH regulations (EC) no 1907/2006. Section 4 Emergency and First Aid Measures 4.1 Description of first aid measures General: As a general rule, in case of doubt or if symptoms persist, always call a doctor. NEVER induce swallowing by an unconscious person. In the event of exposure by inhalation: In the event of massive inhalation of dust, remove the person exposed to fresh air. Keep warm and at rest. If the person is unconscious, place in recovery position. Notify a doctor in all events, to ascertain whether observation and supportive hospital care will be necessary. If breathing is irregular or has stopped, effect mouthto-mouth resuscitation and call a doctor. In the event of contact with eyes: Wash thoroughly with soft, clean water for 15 minutes holding eyelids open. If there is any redness, pain or visual impairment, consult an ophthalmologist. In the event of contact with skin: Remove contaminated clothing and wash the skin thoroughly with soap and water or a recognised cleaner. Watch out for any remaining product between the skin and clothing, watches, shoes, etc. If the contaminated area is widespread and/or there is damage to the skin, a doctor must be consulted or the patient transferred to hospital. In the event of swallowing: Do not give patient anything orally. In the event of swallowing, if the quantity is small (no more than one mouthful) rinse mouth with water and consult a doctor. Seek medical attention immediately, showing the label. 4.2 Most important symptoms and effects, both acute and delayed Product Code: P20030 Version: 5 Page 12 of 19

13 4.3 Indication of any immediate medical attention and special treatment needed Section 5 Fire-fighting measures 5.1 Extinguishing media Non-flammable. 5.2 Special hazards arising from the substance or mixture A fire will often produce a thick black smoke. Exposure to decomposition products may be hazardous to health. Do not breathe smoke. In the event of a fire, the following may be formed: -carbon monoxide (CO) -carbon dioxide (CO2) 5.3 Advice for firefighters Section 6 Accidental Release Measures 6.1 Personal precautions, protective equipment and emergence procedures Consult the safety measures listed under headings 7 & 8. For non-fire-fighters: avoid any contact with the skin and eyes, avoid inhaling dust, if a large quantity has been split, evacuate all personal and only allow intervention by trained operators equipped with safety apparatus. For fire-fighters: fire-fighters will be equipped with suitable personal protective equipment (see section 8). 6.2 Environmental precautions Prevent any material from entering drains or waterways. 6.3 Methods and material for containment and cleaning up Retrieve the product by mechanical means (sweeping/vacuuming): do not generate dust. 6.4 Reference to other sections Product Code: P20030 Version: 5 Page 13 of 19

14 Section 7 Handling and Storage 7.1 Precautions for safe handling Precautions: Fire prevention: Recommended equipment and Procedures: Requirements relating to storage premises apply to all facilities where the substance is handled. Always wash hands after handling. Remove and wash contaminated clothing before re-using. Handle in well-ventilated areas. Prevent access by unauthorised personal. For personal protection, see section 8. Observe precautions stated on label and also industry safety regulations. Avoid inhaling dust. Also provide breathing apparatus for certain short tasks of an exceptional nature and for emergency interventions. In all cases, recover emissions at source. Avoid skin and eye contact with this substance. Prohibited equipment and procedures: No smoking, eating or drinking in areas where the substance is used. 7.2 Conditions for safe storage, including any incompatibilities Storage: Packaging: Keep container tightly closed in a dry, well-ventilated place Always keep in packaging made of an identical material to the original. 7.3 Specific end use(s) Section 8 Exposure Controls/Personal Protection 8.1 Control parameters Product Code: P20030 Version: 5 Page 14 of 19

15 8.2 Exposure controls Personal protection measures, such as personal protective equipment: Pictogram (s) indicating the obligation of wearing personal protective equipment (PPE) Eye/Face Protection: Hand protection: Body protection: Use personal protective equipment that is clean and has been properly maintained. Store personal protective equipment in a clean place, away from the work area. Never eat, drink or smoke during use. Remove and wash contaminated clothing before reusing. Ensure that there is adequate ventilation especially in confined areas. Avoid contact with eyes. Before handling powders or dust emissions, wear mask and goggles in accordance with standard EN166. Prescriptions glasses are not considered protection. Provide eyewash stations in facilities where the product is to be handled. Wear suitable protective gloves in the event of prolonged or repeated skin contact. Use suitable protective gloves that are resistant to chemical agents in accordance with standard EN374. Gloves must be selected according to the application and duration of use at the workstation. Protection gloves need to be selected according to their suitability for the workstation in question, other chemical products that may be handled necessary physical protections (cutting, pricking, heat protection), level of dexterity required. Recommendations properties are impervious gloves in accordance with standard EN374. Avoid skin contact. Wear suitable protective clothing. These clothes shall be chosen to ensure there is no inflammation or irritation of the skin at the neck and wrist by contact with the powder. Wear protective clothing against solid chemicals and particles suspended in the air (type 5) in accordance with standard EN to prevent skin contact. Work clothing worn by personal shall be laundered regularly. After contact with the product, all parts of the body that have been soiled must be washed. Product Code: P20030 Version: 5 Page 15 of 19

16 Respiratory protection: Avoid breathing dust. If the ventilation is insufficient, wear appropriate breathing apparatus. When workers are confronted with concentrations that are above occupational exposure limits they must wear suitable clothing, approved respirator device. Wear a disposable half-mask dust filter in accordance with standard EN149, Category FFP1, with Anti-gas and vapour filter (s) (combined filters) in accordance with standard EN149 A1 (brown). Section 9 Physical and Chemical Properties 9.1 Information on basis physical and chemical properties Physical state: Powder of dust ph of the substance or preparation: Not relevant ph (aqueous solution): C Boiling point: Not relevant Flash point: Not relevant Vapour pressure: Not relevant Density: Not stated Water solubility: Soluble Melting point: Not relevant Self-ignition temp: Not relevant Decomposition point/decomposition range: Not relevant 9.2 Other information Section 10 Stability and Reactivity 10.1 Reactivity 10.2 Chemical stability This substance is stable under the recommended handling and storage conditions section Possibility of hazardous reactions Product Code: P20030 Version: 5 Page 16 of 19

17 10.4 Conditions to avoid Heating, heat, formations of dust. Dusts can form explosive mixtures in the air Incompatible materials Keep away from, combustible materials Hazardous decomposition products The thermal decomposition may release/form: carbon monoxide (CO) and carbon dioxide (CO 2). Section 11 Toxicological Information 11.1 Information on toxicological effects May cause irreversible damage to the skin, namely inflammation of the skin or the formation of erythema and eschar or oedema following exposure up to four hours. Repeated or prolonged exposure with the substance may cause removal of natural oils from the skin resulting in non-allergic contact dermatitis and absorption through the skin. May have reversible effects on the skin eyes, such as eye irritation which is totally reversible by the end of observations at 21 days. Respiratory tract irritation may occur, together with symptoms such as coughing, choking and breathing difficulties. Oral route: DL50>5000mg/kg: Species: RAT (recommended by the CLP). Section 12 Ecological Information 12.1 Toxicity Substances: No aquatic toxicity data available for the substance Persistence and degradability 12.3 Bio accumulative potential 12.4 Mobility in soil Product Code: P20030 Version: 5 Page 17 of 19

18 12.5 Results of PBT and vpvb assessment 12.6 Other adverse effects No data available Section 13 Disposal Considerations 13.1 Waste treatment methods General: Waste: Soiled packaging: Proper waste management of the substance and/or its container must be determined in accordance with Directive 2008/98/EC. Do not pour in to drains or waterways. Waste management is carried out without endangering human health, without harming the environment and, in particular without risk to water, air, soil, plants or animals. Recycle or dispose of waste in compliance with current legislation, preferably via a certified collector or company. Do not contaminate the ground or water with waste, do not dispose of waste into the environment Empty container completely. Keep label(s) on container. Give to a certified disposal contractor. Section 14 Transport Information 14.1 Transport Information Exempt from transport classification and labelling. Transport product in compliance with provisions of the ADR for road, RID for rail, IMDG for sea and ICAO/IATA for air transport (ADR IMDG ICAO/IATA 2011). Section 15 Regulatory Information Safety, health and environmental regulations/legislation specific for the substance or mixture Particular provisions: Chemical safety assessment Product Code: P20030 Version: 5 Page 18 of 19

19 Section 16 Other Information 16.1 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 1-2 Pre Change History N/A 3 The following has been updated, due to the supplier updating their specification: No - Format has been updated - Nutritional Data has been added - Production Flow Chart has been added - Shelf Life from Date of Manufacture has been updated from 2 Years to Min 2 Years 4 Added mesh information and bulk density No 5 Changed specifications for chloride (Cl) & sulphate (SO4) from max 0.01% each to max 0.02% each and sieve analysis from 65% to 70% passed through mesh size to ~95% pass 40 mesh. Updated MSDS section 3 to state that this material is not 100% Taurine. Yes Document Approval Originator Job Title QC Team Leader Approver Job Title Quality Specialist Ash Bean Ash Bean (Jun 28, 2017) Casey White Casey White (Jun 28, 2017) Product Code: P20030 Version: 5 Page 19 of 19

20 P20030-L-Taurine 0.5% Silicon Dioxide-Technical Dossier Adobe Sign Document History 06/28/2017 Created: 06/28/2017 By: Status: Transaction ID: Casey White Signed CBJCHBCAABAAf701x9c7L--G72ZCz gxats6tgbsbko "P20030-L-Taurine 0.5% Silicon Dioxide-Technical Dossier" H istory Document uploaded by Casey White (casey.white@c-c-l.com) from Acrobat 06/28/2017-0:01:45 AM PDT- IP address: Document signed in Acrobat by Casey White (casey.white@c-c-l.com) Signature Date: 06/28/2017-0:02:04 AM PDT - Time Source: server- IP address: Document ed to Ash Bean (ash.bean@c-c-l.com) for signature 06/28/2017-0:02:05 AM PDT Document viewed by Ash Bean (ash.bean@c-c-l.com) 06/28/2017-1:08:34 AM PDT- IP address: Document e-signed by Ash Bean (ash.bean@c-c-l.com) Signature Date: 06/28/2017-1:09:15 AM PDT - Time Source: server- IP address: Signed document ed to Ash Bean (ash.bean@c-c-l.com) and Casey White (casey.white@c-c-l.com) 06/28/2017-1:09:15 AM PDT