PRODUCT TECHNICAL DOSSIER STEVIA EXTRACT STEVIOSIDES RA 97

Transcription

1 PRODUCT TECHNICAL DOSSIER STEVIA EXTRACT STEVIOSIDES RA 97 Product Code: P19241 Raw Material Full Name: Steviosides Raw Material Full Botanical/Chemical/Latin/Trade Name/Synonyms: Stevia, Steviosides, Steviosin, Rebaudiosides A This material is Food Grade: Yes Food Grade Packaging: Yes Total Steviol Glycosides %: >98.00 Rebaudioside A%: >97.00 Vegan / Vegetarian Status: Suitable for Both CAS Number: Stevioside Rebaudioside A Molecular Formula for the raw material: C 44H 70O 23 Average Molecular weight: Particle Size: 60 Mesh & 80 Mesh Percentage passed through: 100% & 90% Respectively Product Code: P19241 Version: 2 Page 1 of 12

2 Bulk Density: 0.45g/cm3-0.7g/cm3 ph: Loss on Drying: Max 6% Residue on Ignition: Max 1% Country of Origin: China Country of Origin of the Manufacture: China Base Source/Start Material: Stevia Leaves Origin of Product Synthetic, Plant, Mineral, Animal, Fish or Fermented: Plant Solvents used: Water & Ethanol What is the extraction/processing used? What solvents are used and at what ratio s? Water & Ethanol 3:7 Alcohol Residual: Max 5,000mg/kg Material is: 100% Compound Ingredients Origin, Function and Percentages: None Shelf Life from Date of Manufacture: 2 Years Product Code: P19241 Version: 2 Page 2 of 12

3 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): Powder Colour: White to Off White Flavour/Taste: Characteristic Odour: Characteristic Microbiological Test Total Viable Count: Max 1,000cfu/g Heavy Metals Lead (Pb): Max 1ppm Cadmium (Cd): Max 1ppm Mercury (Hg): Max 0.1ppm Arsenic (As): Max 1ppm Pharmacopeia Standard Used: CP2010 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: P19241 Version: 2 Page 3 of 12

4 ALLERGENS Product Contains YES/NO Listed Item on Site at Manufacturer YES/NO Peanuts and Peanut Derivatives (including possible cross contamination) 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), No No Brazil nut (Bertholletia excelsa), Pistachio nut (Pistacia vera), Macadamia nut and Queensland nut (Macadamia ternifolia) 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: P19241 Version: 2 Page 4 of 12

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 No 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 Yes Yes 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 No risk of cross contamination. Used as solvent, residual solvent meets EU regulations. Product Code: P19241 Version: 2 Page 5 of 12

6 NUTRITIONAL DATA Test Calculated Value per 100gm Energy KJ / Kcal 28 KJ / 7 Kcal Fat 0.03g - Of which saturates 0.02g Carbohydrate 1.5g - Of which sugars <0.25g Protein <0.1g Salt Trace Product Code: P19241 Version: 2 Page 6 of 12

7 PRODUCTION FLOW CHART Preparation of raw material (Select & Abandon impurities) Extract by water Absorbed by Resin A, and eluted by ethanol & recycle ethanol Absorbed by Resin B, eluted by ethanol & Recycle solvent Concentration Spray drying Smash Screen Mix Packaging Inner bag: Food grade PE bag, Outer package: Paper drum, 25KG/Drum Inspect Finished Product Product Code: P19241 Version: 2 Page 7 of 12

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: P19241 Version: 2 Page 8 of 12

9 MATERIAL SAFETY DATA SHEET Section 1 Identification of the Substance/Mixture and of the Company/Undertaking Product name: Stevia Extract Steviosides RA 97 Chemical formula: C 44H 70O 23 Company: Cambridge Commodities Limited Lancaster Way, Ely, Cambridgeshire, CB6 3NX Tel: qa@c-c-l.com Section 2 Hazards Identification 100% Stevia Extract Powder Section 3 Composition/Information on Ingredients Potential Acute Health Effects: Slightly hazardous in case of skin contact (Irritant), of eye contact (Irritant), of ingestion, of inhalation. Repeated or prolonged exposure is not known to aggravate medical condition. Section 4 Emergency and First Aid Measures Ingestion: Wash out mouth with water provided person is conscious. Never give anything by mouth to an unconscious person. Get medical help. Inhalation: If inhaled remove to fresh air, if not breathing give artificial respiration or give oxygen by trained personnel. Get immediate medical attention. Skin Contact: Immediately wash skin with soap and plenty of water. Remove contaminated clothing. Get medical attention if symptoms occur wash clothing before reuse. Eye Contact: Hold eyelids apart and flush with plenty of water. After initial flushing remove contact lenses and continue flushing for at least 20mins. Have eyes examined and tested by medical personnel. Section 5 Fire-fighting measures General Information: Deal with as the ordinary powder material fire if applicable. Extinguishing Media: Using the water, dry fire extinguishing media, water spray-jet, alcohol resistant foam and carbon dioxide if applicable. Unusual Fire/Explosion Hazard: N/A Product Code: P19241 Version: 2 Page 9 of 12

10 Section 6 Accidental Release Measures Personnel Precautions: No special precautions required. Environmental Precautions: See item 8. Methods for Cleaning Up: Clean up with sweeping brushes and lots of water. Section 7 Handling and Storage General Information: Deal with as the ordinary powder material for handling and storage. Handling: Keep to sterility condition, avoid to mixture microorganisms. Avoid contact with eyes. Storage: Store in a dry, ventilated and clean area, keep away from strong light and heat, in the carton container or the similar with sealed double - layer PE bag. Avoid contact with any poisonous, harmful, easily spoiled or pollutant things. Spills & Disposal: Vacuum or sweep up material into a suitable disposal container, avoid generating dusty conditions Section 8 Exposure Controls/Personal Protection Engineering Measures: Provide sufficient mechanical (general and/or local exhaust) ventilation to maintain exposure below level of overexposure. Respiratory Protection: Avoid inhalation and wear respirator if needed. 3M Dust Respirator No or 9900 is recommended, or a NIOSH/MSHA jointly approved dust respirator. Hand/Body Protection: Avoid contact and prolonged or repeated exposure. Wear resistant gloves. Wash thoroughly after handling. Protective clothing recommended. Eye Protection: Wear safety glasses in compliance with OSHA regulations if needed. Section 9 Physical and Chemical Properties Physical state: Powder Colour: White to off white Odour: Characteristic Section 10 Stability and Reactivity Stability: Stable under the recommended storage and handling conditions (see section 7). Hazardous Decomposition Products: N/A Section 11 Toxicological Information Steviol glycosides is safe as sweetener or food additive in a broad range of food categories. Product Code: P19241 Version: 2 Page 10 of 12

11 Section 12 Ecological Information No Data Available. Section 13 Disposal Considerations Take notice of regulations. Section 14 Transport Information Transport classification: Not classified as dangerous for any mode of UK or International transport. Section 15 Regulatory Information European Regulation: This product is not classified according to the EU regulations. Reviews, Standards and Regulations: Health & Safety at work act 1974, COSHH Regulations (1994) & EH40 Occupational exposure limits. 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: P19241 Version: 2 Page 11 of 12

12 Change History Version Change Customer Notification required Yes / No 1 First Issue N/A 2 Added statement confirming this product has food grade packaging, CAS number for rebaudioside a, ethanol as a solvent used, nutritional information, that maize/corn and any derivatives are on site at manufacturer and confirmation of nanoparticle status. Removed methanol residue as this is no longer used. Changed pharmacopeia standard used from FCC to CP2010. Updated production flowchart and sections 2 and 3 of the MSDS. Yes Document Approval Originator Job Title QC Team Leader Approver Job Title Quality Specialist Ash Bean Ash Bean (Apr 21, 2017) Shannon McKenna (Apr 21, 2017) Product Code: P19241 Version: 2 Page 12 of 12

13 P19241-Stevia Extract Steviosi des RA 97-Technical Dossier Adobe Sign Document History 04/21/2017 Created: 04/21/2017 By: Status: Transaction ID: Ash Bean Signed CBJCHBCAABAAiS5KgSuKc4_ANioZxvn5g He0t1ncB5 "P19241-Stevia Extract Steviosides RA 97-Technical Dossier" History Document uploaded by Ash Bean from Acrobat 04/21/2017-0:57:54 AM PDT- IP address: Document signed in Acrobat by Ash Bean Signature Date: 04/21/2017-0:58:22 AM PDT - Time Source: server- IP address: Document ed to Shannon McKenna (shannon.mckenna@c-c-l.com) for signature 04/21/2017-0:58:22 AM PDT Document viewed by Shannon McKenna (shannon.mckenna@c-c-l.com) 04/21/2017-1:05:47 AM PDT- IP address: Document e-signed by Shannon McKenna (shannon.mckenna@c-c-l.com) Signature Date: 04/21/2017-1:19:19 AM PDT - Time Source: server- IP address: Signed document ed to Shannon McKenna (shannon.mckenna@c-c-l.com) and Ash Bean (ash.bean@c-c-l.com) 04/21/2017-1:19:19 AM PDT