PRODUCT TECHNICAL DOSSIER ASCORBYL PALMITATE Product Code: P22158 Raw Material Full Name: Ascorbyl Palmitate Raw Material Full Botanical/Chemical/Latin/Trade Name/Synonyms: 6-Palmitoyl-L-Ascorbic Acid This material is Food Grade: Limit/Range/Specification: Min 95% Ratio of Material: Ascorbyl Palmitate 100% CAS Number: 137-66-6 EC/EINECS Number: 205-305-4 Molecular Formula for the raw material: C22H38O7 Average Molecular weight: 414.54g/mol Solubility in Water: Insoluble in Water Solubility in Alcohol: Soluble in Alcohol Product Code: P22158 Version: 1 Page 1 of 17
Bulk Density: 0.15-0.25 g/ml Tapped Density: 0.40-0.50 g/ml Loss on Drying: Max 2.0% Residue on Ignition: Max 0.1% Country of Origin: China Country of Origin of the Manufacture: China Base Source/Start Material: Ascorbic Acid, Palmitic Acid Origin of Product Synthetic, Plant, Mineral, Animal, Fish or Fermented: Synthetic Synthetic: What are the starting materials of the synthesis and their sources? Ascorbic Acid: Fermented Palmitic Acid: Plant Compound Ingredients Origin, Function and Percentages: Ascorbyl Palmitate 100% Shelf Life from Date of Manufacture: Minimum 2 Years Storage Conditions: Preserve in airtight containers, protected from light, at a temperature of 8 C to 15 C Product Code: P22158 Version: 1 Page 2 of 17
Appearance (Fine/Crystals/Crystalline/Hygroscopic): Powder Colour: White to Yellowish Odour: Almost odourless Do any of the parameters change in different seasons? No Microbiological Test Total Viable Count: Max 100cfu/g Yeast & Moulds: Max 10cfu/g E.Coli: Negative Salmonella: Negative Heavy Metals Lead (Pb): Max 3ppm Cadmium (Cd): Max 1ppm Mercury (Hg): Max 0.1ppm Arsenic (As): Max 1ppm Product Code: P22158 Version: 1 Page 3 of 17
Pharmacopeia Standard Used: FCC8 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: P22158 Version: 1 Page 4 of 17
ALLERGENS Free from Peanuts and Peanut Derivatives (including possible cross contamination) 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), Brazil nut (Bertholletia excelsa), Pistachio nut (Pistacia vera), Macadamia nut and Queensland nut (Macadamia ternifolia) Free from Sesame Seeds and Sesame Seed Derivatives Free from other Seeds and Seed Derivatives (Poppy Seeds, Cotton Seeds, Sunflower Seeds) Free from Milk and Milk Derivatives (including lactose) Free from Egg and Egg Derivatives Free from Cereals and Derivatives containing OR POTENTIALLY CONTAMINATED WITH Gluten (wheat, wheatgrass, faro, freekeh, spelt, kamut, rye, oats, barley, barley grass) Free from Soya and Soya Derivatives Free from Lupin and Lupin Derivatives Free from Mustard and Mustard Derivatives Free from Celery or Celery Derivatives (including Celeriac) Free from Fish and Fish Derivatives Free from Molluscs and their Derivatives Free from Crustaceans and their Derivatives Free from Sulphur Dioxide and Sulphites (E220, E228) at levels > 10mg/kg or 10mg/litre Product Free From YES/NO Listed Item on Site at Manufacturer YES/NO If YES, Please Comment Product Code: P22158 Version: 1 Page 5 of 17
ADDITIVES / CONTAMINANTS / DIETARY REQUIREMENTS Free from Additives Free from Antioxidants Free from Ethylene Oxide Free from Gelatine Free from Flavourings (Artificial / Nature Identical / Natural / Smoked) Free from Maize / Corn and any Derivatives Free from Legumes / Pulses Free from Rice and Rice Derivatives Free from Added Salt Free from Added Sugar / artificial or natural sweeteners Free from Aspartame Free from BHA / BHT (E320 / E321) Free from Caffeine Free from Colours (Artificial / Nature Identical / Natural / Smoked) Free from Dextrose Free from Dioxins Free from MSG (Added and Naturally Occurring E621) or Glutamates (E620 to E625) Free from Nucleotides (E627, E630, E631, E635) Free from Polyols (sugar alcohols) Free from Benzoates (E210 / E219) Free from Sorbic Acid (E200, E203) Free from any other Preservatives Free from Ethanol Free from Honey Free from Lactose Free from Yeast and Yeast Derivatives Free from All Animal Products (Beef, Pork, Poultry or other) and Derivatives (which may include growth/yield hormones, antibiotics etc.) Free from Bovine Products or Derivatives (which may include growth/yield hormones, antibiotics etc.) Product Free From YES/NO No No Listed Item on Site at Manufacturer YES/NO If YES, Please Comment This product is a food additive This product is an antioxidant Product Code: P22158 Version: 1 Page 6 of 17
PRODUCTION FLOW CHART Ascorbic Acid Palmitic Acid Catalyst Esterification Hydrolysis Extraction Decolouration Crystallisation Filtration Drying Packaging Product Code: P22158 Version: 1 Page 7 of 17
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: P22158 Version: 1 Page 8 of 17
Section 1 Identification of the substance/preparation MATERIAL SAFETY DATA SHEET Product name: Product code: Chemical formula: Company: Ascorbyl Palmitate P22158 C22H38O7 Cambridge Commodities Limited Lancaster Way, Ely, Cambridgeshire, CB6 3NX. Tel: 01353 667258. Email: qa@c-c-l.com Section 2 Ingredients/Identity Information Substance / Mixture: Ingredient(s): Substance Chemical Name Registration No. CAS No. EC No. Concentration Ascorbyl Palmitate N/A 137-66-6 205-305-4 98% Section 3 Possible Hazards Classification: The substance is classified as following according to 67/548/EEC and REGULATION (EC) No. 1272/2008: REGULATION (EC) No. 1272/2008 Hazard classes / Hazard categories Hazard statement N/A N/A 67/548/EEC Hazards characteristics N/A R-Phrases N/A The most important adverse effects: Most important adverse physicochemical effects: Not applicable. The most important adverse human health effects: Not applicable. The most important adverse environmental effects: Not applicable. Label elements: Hazard Pictograms: No hazard pictograms. Signal Word(s): No signal words. Hazard Statement: Not applicable. Precautionary Statement: Not applicable. Other hazards: (PBT, vpvb, Substance is an endocrine disruptor etc.) Product Code: P22158 Version: 1 Page 9 of 17
Section 4 Emergency and First Aid Procedures Description of first aid measures: In case of inhalation: In case of skin contact: In case of eyes contact: In case of ingestion: Most important symptoms and effects, both acute and delayed: Indication of any immediate medical attention and special treatment needed: In all cases of doubt, or when symptoms persist, consult a physician. Remove the casualty to fresh air and keep him/her calm. Consult a physician. Flush skin with soap and plenty of water for at least 15 minutes while removing contaminated clothing and shoes. Wash clothing before reuse. Immediately flush thoroughly with water for at least 15 minutes, occasionally lifting the upper and lower eyelids. Consult a physician. Never give anything by mouth to an unconscious person. If conscious and alert, rinse mouth with water. Consult a physician. The material is not expected to be harmful. As a precaution, get medical advice / attention. Treat symptomatically and supportively Section 5 Fire and Hazard Data Extinguishing media: Unsuitable extinguishing media: Special hazards arising from the substance or mixture: Advice for fire-fighters: Suitable extinguishing media: Use water spray jet, dry powder, carbon dioxide, or appropriate foam. Emits toxic fumes under fire conditions. Wear self-contained breathing apparatus and protective clothing to prevent contact with skin and eyes. Product Code: P22158 Version: 1 Page 10 of 17
Section 6 Accidental release measures For non-emergency personnel: For emergency responders: Environmental Precautions: Methods for Containment and Cleaning up: Reference to other sections: Additional information: Remove ignition sources. Provide adequate ventilation. Avoid inhalation of vapour or dust. Avoid skin and eye contact. Wear protective gloves / protective clothing / eye protection / face protection. Wear an appropriate NIOSH/MSHA approved respirator if mist, vapour or dust is generated. Avoid disposing into drainage / sewer system or directly into the aquatic environment. Keep away from drains, surface-and groundwater and soil. Sweep up, place in a bag and hold for waste disposal. Avoid raising dust. Ventilate area and wash spill site after material pickup is complete. See Section 7 for information on safe handling. See Section 8 for information on personal protection equipment. See Section 13 for information on disposal. In case of small amount, washes with water, In case of large amount, fences by non-flammable material and recovers. Section 7 Storage & Handling Protective measures: Advice on general occupational hygiene: Conditions for safe storage, including any incompatibilities: Specific end use(s): Wash thoroughly after handling. Remove contaminated clothing and wash before reuse. Minimize dust generation and accumulation. Use with adequate ventilation. Wash clothing before reuse. Avoid contact with eyes, skin, and clothing. Avoid ingestion and inhalation. Avoid prolonged, or repeated, skin contact. Preserve in airtight containers, protected from light, preferably at 8 to 15 ºC. Keep the container closed when not in use and away from incompatible substances. Not applicable. Product Code: P22158 Version: 1 Page 11 of 17
Section 8 Control Methods/Personal Protection Occupational exposure limits: Additional exposure limits under the conditions of use: DNEL/DMEL and PNEC-Values: Appropriate engineering controls: Individual protection measures, such as personal protective equipment: Not listed... 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. Eye / face protection: Wear appropriate protective eyeglasses or chemical safety goggles as described by OSHA's eye and face protection regulations in 29 CFR 1910.133 or European Standard EN166. Hand protection: Wear appropriate protective gloves to prevent skin exposure. Body protection: Wear appropriate protective clothing to minimize contact with skin. Respiratory protection: Follow the OSHA respirator regulations found in 29 CFR 1910.134 or European Standard EN149. Always use a NIOSH or European Standard EN 149 approved respirator when necessary. Thermal hazards: Wear appropriate protective clothing to minimize contact with skin. Environmental exposure controls: According to local regulations, Federal and official regulations. Product Code: P22158 Version: 1 Page 12 of 17
Section 9 Physical and Chemical Properties Appearance: White to yellowish powder Colour: White to yellowish Odour: Almost odourless Odour threshold: ph: Melting point / range ( C): 107 ~ 117 ºC Boiling point / range ( C): Flash point ( C): Evaporation rate: Not applicable Flammability (solid, gas): Not flammable Ignition temperature ( C): Upper / lower flammability/ explosive limits: Not determined Vapour pressure (20 C): Not determined Vapour density: Not applicable Relative Density (25 C): Not determined Bulk density (kg/m3): 0.15 ~ 0.25 g/cm3 Solubility Insoluble in water, soluble in vegetable oils and ethanol. n-octanol/water (log Po/w): Not determined Auto-ignition temperature: Decomposition temperature: Viscosity, dynamic (mpa s): Not determined Explosive properties: Not determined Oxidising properties: Not applicable Fat solubility (solvent-oil to be specified) etc: Surface tension: Dissociation constant in water (pka): Oxidation-reduction Potential: Section 10 Stability and Reactivity Reactivity: Chemical stability: The substance does not react vigorously with reducing agent, so it does not belong to oxidizing substances. Under normal conditions, the product is stable. No hazardous reaction when handled and stored according to provisions. Hazardous reactions are not known. Product Code: P22158 Version: 1 Page 13 of 17
Possibility of hazardous reactions: Conditions to avoid: Incompatible materials: Under normal conditions, not hazardous reactions will occur. Incompatible materials, light, dust generation, excess heat, strong oxidants, and humidity. Strong oxidizing agents. Hazardous decomposition products:. Section 11 Toxicological Information Non-human toxicological data: Method: Dosis: Routes of administration: Results: Absorption: Distribution: Metabolism: Excretion: Acute toxicity: Skin corrosion / Irritation: Serious eye damage / irritation: Respiratory or skin sensitization: Germ cell mutagenicity: Carcinogenicity: Reproductive toxicity: STOT- single exposure: STOT-repeated exposure: Aspiration hazard: LD50 (Oral, Rat): >10 g/kg LD50 (Oral, Mouse): >20 g/kg No irritating. No irritating. No sensitizing. Not classified Not classified Not classified Not classified Not classified Not classified Section 12 Ecological Information Ecotoxicity: Bioaccumulative potential: Mobility in soil: Results of PBT&vPvB assessment: Other adverse effects: Moderately toxic for fish (suspension) (rainbow trout) LC50 (96 h) 51 mg/l LC100 (96 h) 100 mg/l LC0 (96 h) 25 mg/l.. Not applicable. Not applicable. Product Code: P22158 Version: 1 Page 14 of 17
Section 13 Disposal Considerations Waste treatment methods: Product / Packaging disposal: Offer surplus and non-recyclable solutions to a licensed disposal company. Contact a licensed professional waste disposal service to dispose of this material. Dissolve or mix the material with a combustible solvent and burn in a chemical incinerator equipped with an afterburner and scrubber. If empty container retains product residues, all label precautions must be observed. Section 14 Transport Information Land transport (ADR/RID) Sea transport (IMDG) Air transport (ICAO/IATA) UN-Number: Not Regulated Not Regulated Not Regulated UN Proper shipping name: Not Regulated Not Regulated Not Regulated Transport hazard Class: Not Regulated Not Regulated Not Regulated Packaging group: Not Regulated Not Regulated Not Regulated Environmental hazards: Not Regulated Not Regulated Not Regulated Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code: Not Regulated Not Regulated Not Regulated Product Code: P22158 Version: 1 Page 15 of 17
Section 15 Regulatory Information Relevant information regarding authorization: Relevant information regarding restriction: Other EU regulations: Other National regulations: Chemical Safety Assessment has been carried out: Not applicable. Not applicable. Employment restrictions concerning young person must be observed. For use only by technically qualified individuals. Not applicable No 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: P22158 Version: 1 Page 16 of 17
Change History Version Change Customer Notification required / No 1 First Issue N/A Document Approval Task Role Name Sign Date Amended By QC Assistant Adam Mulcahy 21.07.2015 Approver Quality Specialist Shannon McKenna 23.07.2015 Product Code: P22158 Version: 1 Page 17 of 17