PRODUCT TECHNICAL DOSSIER PAPAIN Product Code: P16010 Raw Material Full Name: Papain 100TU/mg This material is Food Grade Limit/Range/Specification: 90 110 TU/mg CAS Number: 9001-73-4 EC/EINECS Number: 232-627-2 Solubility in Water: Soluble Particle Size: Min 99% Country of Origin: DR Congo Country of Origin of the Manufacture: UK Material is: Approx. 17.0% Compound Ingredients Origin, Function and Percentages: Maltodextrin from Potato Approx. 83.0% Shelf Life from Date of Manufacture: Minimum 6 Months (Batch Specific) Product Code: P16010 Version: 8 Page 1 of 11
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 50,000cfu/g E.Coli: Absent in 25g Salmonella: Absent 25g Coliforms: Max 30cfu/g Heavy Metals Lead (Pb): Max 3ppm Arsenic (As): Max 1ppm Pharmacopeia Standard Used: FCC/JECFA/WHO/FAO Product Code: P16010 Version: 8 Page 2 of 11
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. 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 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 NO Papaya Extract Free from Vegetable and Vegetable Derivatives NO Maltodextrin 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: P16010 Version: 8 Page 3 of 11
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) NO 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 NO Sodium Free from Sulphites (E220, E228) NO Metabisulphite Free from Sweeteners Free from Vannillin Suitable for Diabetics NO Unknown Suitable for Coeliacs NO Unknown Suitable for Ovo-Lacto Vegetarians Suitable for Vegans Kosher Certified NO Not Certified Halal Certified NO Not Certified Product Code: P16010 Version: 8 Page 4 of 11
PRODUCTION FLOW CHART Collection of latex Bulk Storage Homogenisation Sieve Permeate Solids Solids Solids Ultrafiltration Concentration Microfiltration Filtration Centrifuge Dilute to adjust total solids Spray dry Standardise with MaltodextrinPotato Mixed Packed and sealed Sieved We confirm that the information above is sourced from the original manufacturers/suppliers flow diagram. Product Code: P16010 Version: 8 Page 5 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: P16010 Version: 8 Page 6 of 11
1. Identification of the substance/preparation MATERIAL SAFETY DATA SHEET Product name: Product Code: Company: Papain P16010 Cambridge Commodities Limited Lancaster Way, Ely, Cambridgeshire, CB6 3NX. Tel: 01353 667258. Email: qa@c-c-l.com 2. Ingredients/Identity Information Components % in Product CAS Number EINECS Number Enzyme preparation 17.0% 900-73-4 232-627-2 Maltodextrin 83% 3. Hazards identification (Xi) R36/37/38; (Sens.) R42 4. Emergency and First Aid Procedures Eyes Skin Swallowing Inhalation If symptoms develop, rinse with plenty of water for at least 15 minutes while holding eyelids apart. Seek medical attention if irritation persists. Remove contaminated clothing. Wash with soap and copious amounts of water. Wash out mouth and drink water if conscious. Never give anything by mouth to an unconscious person. Seek medical attention if irritation persists. Remove to fresh air. If breathing is difficult, seek medical attention. 5. Fire and Hazard Data Exposure hazards Extinguishing Media Fire Fighting Instructions May cause allergic respiratory reaction Foam, water spray, carbon dioxide, dry chemical powder. Wear a self-contained breathing apparatus with a full-face piece operated in the positive pressure demand mode. Use chemical resistant personal protective equipment. Product Code: P16010 Version: 8 Page 7 of 11
6. Accidental release measures Procedures of personal precaution Cleaning up Methods Wear respirator, chemical safety goggles, rubber boots and heavy rubber gloves. 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. 7. Storage Handling Storage Avoid creating dust. Avoid contact with eyes, skin and clothing, avoid prolonged or repeated exposure. Keep containers tightly closed in a cool and dry place for quality reasons. Protect from humidity and light. 8. Control Methods/Personal Protection Engineering Measures Respiratory Protection Hand/Body Protection Eye Protection Provide sufficient mechanical (general and/or local exhaust) ventilation to maintain exposure below level of overexposure. Avoid inhalation. 3M Dust respirator No. 8710 or 9900 is recommended, or a NIOSH/MSHA jointly approved dust respirator. Avoid contact and prolonged or repeated exposure. Wear resistant gloves. Wash thoroughly after handling. Protective clothing recommended. Wear safety glasses in compliance with OSHA regulations. 9. Control Methods/Personal Protection Physical state Colour Odour Solubility Powder Off white to off White Distinctive Papain odour Soluble in water 10. Stability and Reactivity Chemical Stability Stable under conditions mentioned in section 7. May decompose when exposed to light. Conditions to avoid None known Incompatibility None known Hazardous Decomposition Products None known Product Code: P16010 Version: 8 Page 8 of 11
11. Toxicological Information See Registry of Toxic Effects of Chemical Substances (RTECS) for complete information. Acute effects Irritating to eyes, respiratory system and skin. Sensitisation May cause sensitisation by inhalation. 12. Ecological Information Persistence and degradability Bioaccumulative potential PBT identification Biodegradable No bioaccumulative potential This substance is not identified as a PBT substance 13. Disposal Considerations Waste from residues Dispose of in accordance with all applicable local and national regulations. 14. Transport Information Transport classification Not classified as dangerous for any mode of UK or International transport. 15. Regulatory Information Hazard symbols: Harmful Risk phrases Safety phrases R42 May cause sensitisation by inhalation R 36/37/38. Irritating to eyes, respiratory system and skin. S22 Do not breath dust. S24/25 Avoid contact with skin and eyes. S36/37 Wear suitable protective clothing and gloves. Product Code: P16010 Version: 8 Page 9 of 11
15. Regulatory Information Continued Hazard ingredients (Label): PAPAIN Reviews, Standards and Health & Safety at work act 1974. Regulations COSHH Regulations (1994). EH40 Occupational exposure limits. 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: P16010 Version: 8 Page 10 of 11
Change History Version Change Customer Notification required Yes / No 1 4 Pre change History N/A 5 Shelf Life updated to Minimum 6 Months from 6 Months. Also format No updated. 6 Updated format and vegetarian and vegan suitable NO 7 Lipase activity added No 8 Lipase activity removed due to correspondence with supplier. Yes. Document Approval Originator Job Title Quality Technician Approver Job Title Quality Specialist Lucia Valle (Jun 21, 2017) Product Code: P16010 Version: 8 Page 11 of 11
P16010-Papain-Technical Dossier 8 Adobe Sign Document History 06/21/2017 Created: 06/21/2017 By: Status: Transaction ID: Emma Dane (emma.dane@c-c-l.com) Signed CBJCHBCAABAAB_femIbAYkr6Kuvx-x1th60oKuJupCs_ "P16010-Papain-Technical Dossier 8" History Document uploaded by Emma Dane (emma.dane@c-c-l.com) from Acrobat 06/21/2017-2:31:59 AM PDT- IP address: 81.145.42.226 Document signed in Acrobat by Emma Dane (emma.dane@c-c-l.com) Signature Date: 06/21/2017-2:32:13 AM PDT - Time Source: server- IP address: 81.145.42.226 Document emailed to Lucia Valle (Lucia.Valle@c-c-l.com) for signature 06/21/2017-2:32:14 AM PDT Document viewed by Lucia Valle (Lucia.Valle@c-c-l.com) 06/21/2017-3:33:13 AM PDT- IP address: 81.145.42.226 Document e-signed by Lucia Valle (Lucia.Valle@c-c-l.com) Signature Date: 06/21/2017-3:34:06 AM PDT - Time Source: server- IP address: 81.145.42.226 Signed document emailed to Lucia Valle (Lucia.Valle@c-c-l.com) and Emma Dane (emma.dane@c-c-l.com) 06/21/2017-3:34:06 AM PDT