PRODUCT TECHNICAL DOSSIER SUCRALOSE FCC Product Code: P19283 Raw Material Full Name: Sucralose This material is Food Grade: Yes Vegan / Vegetarian Status: Suitable for Both Limit/Range/Specification: Min 98.0% CAS Number: 56038-13-2 Molecular Formula for the raw material: C 12H 19Cl 3O 8 Average Molecular weight: 397.64 Solubility in Water: Dissolves easily in water Particle Size: 60-80 Mesh Percentage passed through: Min 80% Loss on Drying: Max 2.0% Residue on Ignition: Max 0.7% Product Code: P19283 Version: 4 Page 1 of 11
Specific Optical Rotation: +84.0 - +87.5 ph of 10% Aqueous Solution: 5.0-7.0 Methanol: Max 0.1% Hydrolysis Products (Chlorinated Monosaccharides): Max 0.1% Triphenylphosphine Oxide: 150mg/kg Related Substances (Other Chlorinated Disaccharides): Max 0.5% Country of Origin: China Country of Origin of the Manufacture: China Base Source/Start Material: Sucrose Origin of Product Synthetic, Plant, Mineral, Animal, Fish or Fermented: Synthetic Material is: 100% Compound Ingredients Origin, Function and Percentages: None 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. Product Code: P19283 Version: 4 Page 2 of 11
Appearance (Fine/Crystals/Crystalline/Hygroscopic): Powder Colour: White to Off-White Flavour/Taste: Characteristic Odour: Characteristic Microbiological Test Total Viable Count: Max 250cfu/g Yeast & Moulds: Max 50cfu/g E. coli: Negative Salmonella: Negative Pharmacopeia Standard Used: FCC/USP 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: P19283 Version: 4 Page 3 of 11
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: P19283 Version: 4 Page 4 of 11
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 No Legumes / Pulses No No Rice and Rice Derivatives No No Added Salt No No Added Sugar / artificial or natural sweeteners Yes Yes 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 Product is an artificial sweetener Product Code: P19283 Version: 4 Page 5 of 11
PRODUCTION FLOW CHART Product Code: P19283 Version: 4 Page 6 of 11
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: P19283 Version: 4 Page 7 of 11
MATERIAL SAFETY DATA SHEET Section 1 Identification of the Substance/Mixture and of the Company/Undertaking Product name: Sucralose FCC Chemical formula: C 12H 19Cl 3O 8 Company: Cambridge Commodities Limited Lancaster Way, Ely, Cambridgeshire, CB6 3NX Tel: 01353 667258. Email: qa@c-c-l.com Section 2 Hazards Identification No effects expected Section 3 Composition/Information on Ingredients Components % in Product CAS Number Formula EINECS Number Sucralose 100 56038-13-2 C 12H 19Cl 3O 8 N/A Section 4 Emergency and First Aid Measures Eyes: Flush eyes with plenty of water. Skin: Wash with plenty of water. No treatment necessary under normal circumstances. If redness or irritation develop, seek medical attention. Remove grossly contaminated clothing and wash before re-use. Swallowing: No special treatment necessary. In extreme cases seek medical attention. Inhalation: Remove to fresh air. In severe cases obtain medical attention. Note to Physicians: Material is non-toxic food ingredient in the form of an intensely sweet crystalline solid. Exposure to high airborne concentration may cause mild irritation. Section 5 Fire-fighting measures Flammability Class (Fire train method): Not highly flammable. Fire Fighting Media: Use any media suitable for the surrounding fire. Special Fire Fighting Procedures: Wear self-contained breathing apparatus and full protective gear. Section 6 Accidental Release Measures No special clean-up is necessary. Avoid creating dusty conditions. Carefully sweep or vacuum up into waste container. Wash site of spillage thoroughly with water. Product Code: P19283 Version: 4 Page 8 of 11
Section 7 Handling and Storage Handling: Normal work/hygienic practices. Avoid creating dusty conditions Storage: It is recommended that sucralose powder is stored in manufactures supplied packaging at 21 C or below and away from odoriferous materials. The store should be dry and the product kept in closed containers away from direct sunlight. Section 8 Exposure Controls/Personal Protection Exposure Limits: No threshold limit (TLV) assigned by American Conference of Government Industrial Hygienists (ACGIH). Personal Protection: General Protection Use good industrial hygiene practices. Eye Protection: Not required (but recommended). Safety goggles or face shield in emergency or non-routine situations. Protective Clothing: Food manufacturing plant or laboratory clothing should normally be sufficient. Gloves may be used to avoid skin contact. Respiratory Protection: Not required under normal circumstances. Dusk mask or respirator for dusty conditions. Plant and Engineering Factors: It is recommended that all dust control equipment and material transport systems to be engineered to prevent conditions contributing to dust explosions. Section 9 Physical and Chemical Properties Physical state: Powder Colour: White to Off-White Odour: Characteristic Solubility 25.7g/100g at 20 C Section 10 Stability and Reactivity Stable under normal conditions. When burned, the combustion product was identified as carbon dioxide, hydrogen, hydrogen chloride, methane and organics as both low molecular and aromatic hydrocarbons. Heavy concentrations of sucralose dust may result in the formation of explosive air/dust mixtures. Appropriate measures should be employed to minimize the potential for dust explosions. It is recommended that all dust control equipment and material transport systems are engineered to prevent conditions contributing to dust explosions. Dust Hazard Classification Maximal Explosion Pressure P: 6-7 barg Dust Class: ST-2 Kst: 225 bar.m.sec-1 Minimum Explosive Concentration for Dust (MEC): 115gm3 Minimum Ignition Energy (MIE): 200-300 mj Minimum Ignition Temperature (MIT): 390 C Product Code: P19283 Version: 4 Page 9 of 11
Stability: Stable under normal conditions. Incompatibility (Materials to Avoid): None known. Hazardous Decomposition Products: If subjected to elevated temperatures in storage or processing, sucralose in its pure form will break down with the release of volatile organic compounds and hydrogen chloride. Hazardous Polymerisation: Will not occur. Conditions to Avoid: Excessive hot storage and processing conditions. Creating high concentrations of dust. Section 11 Toxicological Information Oral rat LD50>10g/Kg: Oral mouse LD50>16g/Kg. (No mortality at the highest tested doses). Material is a non-toxic food ingredient. Eye Contact: No special effects expected. High airborne concentration may cause mild irritation. Skin Contact: No effects expected. Ingestion: Material is a non-toxic food ingredient. Inhalation: No effect expected. Material is an intensely sweet, crystalline solid. Expose to high airborne concentration may cause mild respiratory irritation. Medical Conditions Aggravated by Exposure: None known. Section 12 Ecological Information Eco-toxicity: No Data Available. Air pollution: Observe local/national regulations. Section 13 Disposal Considerations May be disposed of as land fill (subject to local regulations) or by incineration. Small quantities may be flushed down drains with excess water. Disposal of Container: Wash out with water and dispose of as general household waste. 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. US Federal Regulations Not known. Product Code: P19283 Version: 4 Page 10 of 11
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 & 2 First Issues N/A 3 Changed name of product to Sucralose FCC, residue on ignition from Yes max 0.2% to max 0.7% and shelf life from 2 years to min 2 years. Removed the word granular from the products description and the specifications for moisture and ignited residue. Added production flowchart. 4 The ph parameter and the additives table were modified. Yes Document Approval Originator Job Title Quality Specialist Approver Job Title Assistant Quality Manager Product Code: P19283 Version: 4 Page 11 of 11
P19283 - Sucralose FCC - Technical Dossier Adobe Sign Document History 12/07/2017 Created: 12/07/2017 By: Status: Transaction ID: Matthew Vincent (Matthew.Vincent@c-c-l.com) Signed CBJCHBCAABAAiCJJdn9ikxTvWAI9LxAc4pYbAEi3RTue "P19283 - Sucralose FCC - Technical Dossier" History Document uploaded by Matthew Vincent (Matthew.Vincent@c-c-l.com) from Acrobat 12/07/2017-5:00:40 AM PST- IP address: 81.145.42.226 Document e-signed by Matthew Vincent (Matthew.Vincent@c-c-l.com) Signature Date: 12/07/2017-5:01:25 AM PST - Time Source: server- IP address: 81.145.42.226 Document emailed to Richard Cecil (Richard.Cecil@c-c-l.com) for signature 12/07/2017-5:01:26 AM PST Document viewed by Richard Cecil (Richard.Cecil@c-c-l.com) 12/07/2017-5:01:51 AM PST- IP address: 185.122.131.164 Document e-signed by Richard Cecil (Richard.Cecil@c-c-l.com) Signature Date: 12/07/2017-5:04:50 AM PST - Time Source: server- IP address: 81.145.42.226