PRODUCT TECHNICAL DOSSIER BORAGE OIL - REFINED Product Code: P0213 Raw Material Full Name: Borage Oil, refined Raw Material Full Botanical/Chemical/Latin/Trade Name/Synonyms: Borago officinalis Seed Oil CAS Number: 225234-12-8 This Material is Food Grade: Yes FEMAS (Feed Materials Assurance Scheme) Status: Assured Solubility in Water: Insoluble Colour (Lovibond 5.25 Cell): Max 20 y, 3r Colour (Gardner): N/S Specific Gravity at 20 o C: 0.910 0.920 Refracted Index at 20 o C: 1.461 1.480 Free Fatty Acid (% as Oleic): Max 0.3% Iodine Value (Calc): 125 160 Product Code: P0213 Version: 4 Page 1 of 12
Peroxide Value (MegO 2/kg): Max 5.0 Saponification Value: 170 215 Unsaponifiable Matter: Max 2.0 Acid Value (Mg/KOH/GR): Max 0.6 Moisture & Volatile Content (%): Max 0.1 Pyrrolizidine Alkaloids (UG/KG): Max 1.0 (Tested annually) Fatty Acid Profile Range C-Chain Palmitic 9 12 C16:0 Palmitoleic 0.3 0.5 C16:1 Stearic 2.5 5.0 C18:0 Oleic 14.0 22.0 C18:1 Linoleic 34.0 45.0 C18:2 Gamma Linoleic Min 20.0 C18:3 Alpha Linoleic Max 1.0 C18:3 Icosanoic Max 0.5 C20:0 Icosenoic 2.0 6.0 C20:1 Tetracosanoic Max 2.0 C24:0 Country of Origin: Europe Country of Origin of the Manufacture: Europe Base Source/Start Material: Borago officinalis seed oil is a fixed oil obtained from the seeds of the Borago Officinalis, Boraginaceae Origin of Product Synthetic, Plant, Mineral, Animal, Fish or Fermented: Plant Product Code: P0213 Version: 4 Page 2 of 12
What is the extraction/processing used? What solvents are used and at what ratio s? Refined/Hexane Material is: 100% Borage Oil Compound Ingredients: None Shelf Life from Date of Manufacture: 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: Liquid Colour: Clear Pale Yellow Microbiological Test (Tested Annually) Total Viable Count: Max 1,000cfu/g Yeast & Moulds: Max 100cfu/g E.Coli: Max 1cfu/g Salmonella: Absent Product Code: P0213 Version: 4 Page 3 of 12
Metals (Tested Annually) Lead (Pb): Max 3ppm Mercury (Hg): Max 0.1ppm Cadmium (Cd): Max 1ppm Arsenic (As): Max 1ppm Pharmacopeia Standard Used: EP There are no nuts in this recipe and are no nuts on site, however we cannot guarantee that the raw materials entering the site are nut free. Product Code: P0213 Version: 4 Page 4 of 12
INTOLERANCE DATA If No please give details Free from All Animal Products (Beef, Pork, Poultry or other) Free from Bovine Products or Derivatives by using hormones to increase milk yield in cows Free from Bone Meal Free from Peanuts and Peanut Derivatives (including possible cross contamination) Free from other Nut and Nut Derivatives Free from Nut Derived Oil Free from Sesame Seeds and Sesame Seed Derivatives Free from Poppy Seeds and Poppy Seed Derivatives Free from Sunflower Seeds and Sunflower Seeds Derivatives Free from other Seeds and Seed Derivatives NO Borago officinalis Free from Milk and Milk Derivatives (including lactose) Free from Egg and Egg Derivatives Free from Cereals containing Gluten (wheat / rye / oats / barley/ spelt/ kamut or their hybridised strains) and Derivatives Free from Soya and Soya Derivatives Free from Maize and Maize Derivatives Free from Corn and Corn Derivatives Free from Lupin and Lupin Derivatives Free from Yeast and Yeast Derivatives Free from Cotton Seeds (Flour) and Cotton Seed Derivatives Free from Rice and Rice Derivatives Free from Mustard and Mustard Derivatives Free from Celery or Celery Derivatives Free from Celeriac or Celeriac Derivatives Free from Fruit and Fruit Derivatives Free from Vegetable and Vegetable Derivatives Free from Carrot and Carrot Derivatives Free from Legumes / Pulses Free from Fish and Fish Derivatives Free from Crustaceans / Molluscs and their Derivatives Free from Additives Free from Added Salt Free from Added Sugar Free from Antioxidants Free from Artificial Glutamates Free from Aspartame Free from Azo and Coal Tar Dyes Free from Benzoates (E210 / E219) Free from BHA / BHT (E320 / E321) Free from Caffeine Free from Cinnamon Free from Cocoa Free from Colours (Artificial / Nature Identical / Natural / Smoked) Free from Dextrose Free from Dioxins Free from Ethanol Product Code: P0213 Version: 4 Page 5 of 12
INTOLERANCE DATA If No please give details Free from Ethylene Oxide Free from Flavourings (Artificial / Nature Identical / Natural / Smoked) Free from Garlic Free from Gelatine Free from Glutamates (E620 to E625) Free from Histamine Free from Hickory Free from Honey Free from Lactose Free from Latex Free from MSG (Added and Naturally Occurring E621) Free from Nucleotides (E627, E630, E631, E635) Free from Polyols Free from Preservatives Free from Starch Products (Including Maltodextrin) Free from Sorbic Acid (E200, E203) Free from Sulphur Dioxide and Sulphites at levels above 10mg/kg or 10mg/litre expressed as SO 2 Free from Sulphites (E220, E228) Free from Sweeteners Free from Vannillin Suitable for Diabetics Suitable for Coeliacs Suitable for Ovo-Lacto Vegetarians Suitable for Vegans Kosher Certified NO Not Certified Halal Certified NO Not Certified Product Code: P0213 Version: 4 Page 6 of 12
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: P0213 Version: 4 Page 7 of 12
MATERIAL SAFETY DATA SHEET Section 1 Description PRODUCT NAME: BORAGE OIL - REFINED PRODUCT CODE: P0213 CAS 225234-12-8 Supplier: Cambridge Commodities Limited 203 Lancaster Way, Ely, Cambridgeshire, CB6 3NX. Tel: 01353 667258. Email: QA@c-c-l.com Section 2 Ingredients/Identity Information Components % in Product CAS Number Formula EINECS Number Borage Oil 100 225234-12-8 Section 3 Possible Hazards Concentrated product. Do not ingest. Observe good housekeeping procedures. Section 4 Emergency and First Aid Procedures Inhalation Eye Contact Skin Contact Ingestion Other Remove from exposure site to fresh air. Keep at rest. Obtain medical attention Rinse immediately with plenty of water for at least 15mins. Contact a doctor if symptoms persist. Remove contaminated clothes. Wash thoroughly with soap and water, flush with plenty of water. If irritation persists seek medical advice. Rinse mouth out with water. Seek medical advice immediately. When assessing action take Risk & Safety Phrases into account (section 15). Product Code: P0213 Version: 4 Page 8 of 12
Section 5 Fire and Hazard Data Extinguishing Media Spraying Recommended Special Measures Extinguishing Procedures Use CO 2, dry powder or foam type extinguishers Extinguishing media to base of flames. Do not use direct water jet on burning material Avoid vapour inhalation. Keep away from sources of ignition. Do not smoke. Wear positive pressure self-contained breathing apparatus and protective clothing. Closed containers may build up pressure when exposed to heat and should be cooled with water spray. Section 6 Accidental release measures. Personal Precautions Environmental Precautions Cleaning up Methods Avoid inhalation and direct contact with skin and eyes. Use individual protective equipment (safety glasses, waterproof-boots, suitable protective clothing) in case of major spillages. Keep away from drains, soils, surfaces and ground waters. Remove all potential ignition sources. Contain spilled material. Cover with an inert or non-combustible inorganic absorbent material, sweep up and remove to an approved disposal container. Dispose according to UK/EU environmental regulations. Section 7 Storage & Handling Precautions in Handling Storage Conditions Fire Protection Apply good manufacturing practice and industrial hygiene practices, ensuring proper ventilation. Observe good personal hygiene, and do not eat, drink or smoke whilst handling. Store in tightly closed original container, in a cool dry and ventilated area away from heat sources and protect from light. Keep air contact to a minimum. Keep away from ignition sources and naked flames. Take avoid precautions to static discharges in working area. Product Code: P0213 Version: 4 Page 9 of 12
Section 8 Control Methods/Personal Protection Respiratory Protection Ventilation Hand Protection Eye Protection Work/Hygiene Practices Avoid breathing product vapour. Apply local ventilation where possible Ensure good ventilation of working area Avoid all skin contact. Use chemical resistant gloves if required Use safety glasses Wash hands with soap and water after handling Section 9 Physical and Chemical Properties Form Liquid at room temperature Odour Neutral Colour Very pale yellow, clear oily liquid ph Neutral Boiling Point >100 Density at 20 o C 0.910 0.920 Hydrosolubility Insoluble Liposolubility Soluble in vegetable oils Section 10 Stability and Reactivity Reactivity Decomposition It presents no significant reactivity hazards, by itself or in contact with water. Avoid contact with strong acids, alkali or oxidising agents. None Section 11 Toxicological Information Non-toxic product Section 12 Ecological Information Readily biodegradable Product Code: P0213 Version: 4 Page 10 of 12
Section 13 Disposal Considerations Residue For Disposal Waste Packing According to local regulations Observe local regulations Section 14 Transport Information Road (ADR/RID) Air (IATA) Sea (IMDG) CHIP See section 15 Section 15 Regulatory Information According to Directive 88/379/EEC Hazards Symbols Risk Phrases Safety Phrases Other information Cosmetics Directive 7 th Amendment: Not restricted 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. We confirm that the information above is sourced from the original manufacturers/suppliers Specification. To be used as per local legislation. Product Code: P0213 Version: 4 Page 11 of 12
Change History Version Change Customer Notification required Yes / No 1 First Issue 2 Refracted Index increased, Peroxide value increased, Tetracosanoic Yes (Fatty Acid) value increased, Ercuic Acid removed. 3 FEMAS status added No 4 FEMAS (Feed Materials Assurance Scheme) Status added. Updated to new format. No Document Approval Originator Job Title Quality Specialist Approver Job Title Quality Manager P Barnhill Shannon McKenna (Oct 11, 2016) P Barnhill (Oct 11, 2016) Product Code: P0213 Version: 4 Page 12 of 12
P0213 - Borage Oil (Refined) - Technical Dossier.. Adobe Sign Document History 10/11/2016 Created: 10/11/2016 By: Status: Transaction ID: Shannon McKenna (shannon.mckenna@c-c-l.com) Signed CBJCHBCAABAA_Pcp27tf2_xkLsS1fJxcwCwvIVUP-b_9 "P0213 - Borage Oil (Refined) - Technical Dossier.." History Document uploaded by Shannon McKenna (shannon.mckenna@c-c-l.com) from Acrobat 10/11/2016-2:15:04 AM PDT- IP address: 81.145.42.226 Document signed in Acrobat by Shannon McKenna (shannon.mckenna@c-c-l.com) Signature Date: 10/11/2016-2:15:47 AM PDT - Time Source: server- IP address: 81.145.42.226 Document emailed to P Barnhill (phil.barnhill@c-c-l.com) for signature 10/11/2016-2:15:48 AM PDT Document viewed by P Barnhill (phil.barnhill@c-c-l.com) 10/11/2016-2:16:21 AM PDT- IP address: 31.50.14.60 Document e-signed by P Barnhill (phil.barnhill@c-c-l.com) Signature Date: 10/11/2016-2:16:38 AM PDT - Time Source: server- IP address: 31.50.14.60 Signed document emailed to Shannon McKenna (shannon.mckenna@c-c-l.com) and P Barnhill (phil.barnhill@c-c-l.com) 10/11/2016-2:16:38 AM PDT