PRODUCT TECHNICAL DOSSIER PHYTOFARE R CATECHIN COMPLEX GREEN TEA POWDERED EXTRACT

Transcription

1 PRODUCT TECHNICAL DOSSIER PHYTOFARE R CATECHIN COMPLEX GREEN TEA POWDERED EXTRACT Product Code: P02252 Raw Material Full Name: Phytofare Catechin Complex Raw Material Full Botanical/Chemical/Latin/Trade Name/Synonyms: Camellia sinensis (L.) Kuntze This material is Food Grade: Yes Vegan / Vegetarian Status: Suitable Ratio of Material: Ratio of dried plant 26:1 Ratio of fresh plant 100:1 CAS Number: EC/EINECS Number: Molecular Formula for the raw material: C 22H 18O 11 Active ingredients Total Polyphenols >98% Caffeine >6% Epigallocatechin >16.5% Catechin >0.75% Epicatechin >8% Epigallocatechin Gallate >42% Gallocatechin Gallate >0.6% Epicatechin Gallate >6% Catechin Gallate >0.2% Gallocatechin >4.1% Product Code: P02252 Version: 4 Page 1 of 15

2 Solubility in Water: Yes Solubility in Alcohol: Yes Particle Size: 177 microns Percentage passed through: Min 75% Bulk Density: ~ g/cm³ Country of Origin: South Africa Country of Origin of the Manufacture: South Africa Base Source/Start Material: Green Tea Origin of Product Synthetic, Plant, Mineral, Animal, Fish or Fermented: Plant Plant: Camelia sinensis Part of the plant used: Top three leaves and the bud Solvents used: Ethyl Acetate (Sugar Based Ethanol and Acetic Acid) Shelf Life from Date of Manufacture: Minimum 2 years Storage Conditions: Cool temperatures Product Code: P02252 Version: 4 Page 2 of 15

3 Appearance (Fine/Crystals/Crystalline/Hygroscopic): Hygroscopic Colour: Green Flavour/Taste: Mild Odour: Aromatic Do any of the parameters change in different seasons? Percentages of catechins can change depending on the seasons Microbiological Test Total Viable Count: <100,000 cfu/g Yeast & Moulds: <1,000 cfu/g E.Coli: Negative/10g Salmonella: Negative/10g Heavy Metals Lead (Pb): < 3ppm Cadmium (Cd): <0.3ppm Mercury (Hg): <0.1ppm Arsenic (As): <1 ppm Product Code: P02252 Version: 4 Page 3 of 15

4 Aluminium (Al): information only* Pharmacopeia Standard Used: European and USDA The allergen information is supplied by the manufacturer, we have not tested for each individual allergen to ensure they are not present. The information given is based on a documented risk assessment and is accurate to the best of our knowledge. If you intend to make a voluntary free from claim on your pack, additional testing may need to be carried out. For technical and labelling guidance you should always speak to the competent authority for the market or member state in which the final products are placed. Please note that surveillance testing may mean that not all the parameters stated on this specification are tested for every batch. *Currently, there is no EU legislation on Aluminium content for the food products. Scientists at Europe s food safety watchdog (The EFSA Journal (2008) 754,1-34) have assessed the safety of aluminium from all sources in food and established a Tolerable Weekly Intake (TWI) of 1 milligram of aluminium per kilogram of body weight. So, for an adult person which weights 50 kg TWI = 50 mg Al and for person whose weight is 70 kg TWI = 70 mg Al. Therefore, we ask you to assess this product in relation to its intended usage. Product Code: P02252 Version: 4 Page 4 of 15

5 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 NO NO 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) 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 NO NO (wheat, wheatgrass, faro, freekeh, spelt, kamut, rye, oats, barley, barley grass) 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: P02252 Version: 4 Page 5 of 15

6 ADDITIVES / CONTAMINANTS / DIETARY REQUIREMENTS Product Contains YES/NO Listed Item on Site at Manufacturer YES/NO If YES, Please Comment 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 NO NO Aspartame NO NO BHA / BHT (E320 / E321) NO NO Caffeine NO YES Naturally occurred 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 YES Ethyl Acetate (Sugar Based Ethanol and Acetic Acid) used as solvent 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 NO NO growth/yield hormones, antibiotics etc.) Bovine Products or Derivatives (which may include growth/yield hormones, antibiotics etc.) NO NO Product Code: P02252 Version: 4 Page 6 of 15

7 PRODUCTION FLOW CHART Product Code: P02252 Version: 4 Page 7 of 15

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: P02252 Version: 4 Page 8 of 15

9 MATERIAL SAFETY DATA SHEET Section 1 Identification of the Substance/Mixture and of the Company/Undertaking Product name: Other names: Product code: Identified uses: Company: Phytofare Catechin Complex Green Tea extract P02252 Nutraceutical ingredient, Dietary supplement, Cosmetic ingredient Cambridge Commodities Limited Lancaster Way, Ely, Cambridgeshire, CB6 3NX Tel: qa@c-c-l.com Section 2 Hazards Identification Classification of the substance or mixture Classification (EC 1272/2008) Physical and Chemical Hazards: Not classified. Human health: Not classified. Environment: Not classified. Classification (1999/45/EEC): Not classified. Label elements CAS No Contains Polyphenols, catechins and flavanoids Label in Accordance with (EC) No. 1272/2008 Not classified. Other hazards May irritate eyes and respiratory system if inhaled Section 3 Composition/Information on Ingredients Mixtures Total Polyphenols: Min 98% (Contains total Catechins ( EC,ECG,EGCG) >80% ) Classification (EC 1272/2008): Not classified. Classification (67/548/EEC): Not classified. CAS-No.: Product Code: P02252 Version: 4 Page 9 of 15

10 Section 4 Emergency and First Aid Measures Description of first aid measures Inhalation: Move the exposed person to fresh air at once. Get medical attention if any discomfort continues. Ingestion Remove victim immediately from source of exposure. Skin contact: Wash skin thoroughly with soap and water. Eye contact: Immediately rinse with water for at least 15 minutes. Hold eyelids apart. Get medical attention if any discomfort continues. Most important symptoms and effects, both acute and delayed General information: The severity of the symptoms described will vary dependant of the concentration and the length of exposure. Inhalation: Dust may irritate respiratory system. Ingestion: May cause discomfort if swallowed. Skin contact: Skin irritation is not anticipated when used normally. Eye contact: May temporarily irritate eyes. Indication of any immediate medical attention and special treatment needed Treat symptoms. Section 5 Fire-fighting measures Extinguishing media Water spray, foam, dry powder or carbon dioxide. Special hazards arising from the substance or mixture Hazardous combustion products Fire or high temperatures create: Carbon dioxide (CO2). Carbon monoxide (CO). Advice for fire fighters Special Fire Fighting Procedures Water spray should be used to cool containers. Protective equipment for fire-fighters Self-contained breathing apparatus and full protective clothing must be worn in case of fire. Section 6 Accidental Release Measures Personal precautions, protective equipment and emergency procedures Product Code: P02252 Version: 4 Page 10 of 15

11 Ensure suitable personal protection (including respiratory protection) during removal of spillages in a confined area. In case of spills, beware of slippery floors and surfaces. Environmental precautions Avoid discharge into drains, water courses or onto the ground. Methods and material for containment and cleaning up Collect powder using special dust vacuum cleaner with particle filter or carefully sweep into closed container. Section 7 Handling and Storage Precautions for safe handling Avoid handling which leads to dust formation. Avoid inhalation of dust and contact with skin and eyes. Observe good chemical hygiene practices. Conditions for safe storage, including any incompatibilities Store in tightly closed original container in a dry, cool and well-ventilated place < 25 C. Avoid heat, flames and other sources of ignition. Avoid contact with strong oxidisers. Section 8 Exposure Controls/Personal Protection Ingredient Comments No exposure limits noted for ingredient(s). Exposure controls Protective equipment Process conditions Provide eyewash station. Engineering measures: Provide adequate ventilation with face velocity >60cfm. Respiratory equipment: If ventilation is insufficient, suitable respiratory protection must be provided. Hand protection: Wear protective gloves. Eye protection: Wear approved safety goggles. Other Protection: Wear suitable protective clothing. Hygiene measures: When using; do not eat, drink or smoke. Wash hands after handling. Wash contaminated clothing before reuse. Environmental Exposure Controls: Avoid discharge into drains, water courses or onto the ground. Product Code: P02252 Version: 4 Page 11 of 15

12 Section 9 Physical and Chemical Properties Information on basic physical and chemical properties Appearance - Powder Colour - Emerald Green Odour - Aromatic Solubility ug/ml Melting point - >200 C Viscosity (1% in water 25 C) - N.A. Particle size (mesh size) - 110nm Section 10 Stability and Reactivity Reactivity No reactivity issues associated with this substance Chemical stability Stable under the prescribed storage conditions. Possibility of hazardous reactions None Conditions to avoid Avoid heat, moisture, flames and other sources of ignition. Incompatible materials Materials to Avoid: Strong oxidising substances. Hazardous decomposition products Fire or high temperatures create: Carbon dioxide (CO2). Carbon monoxide (CO). Section 11 Toxicological Information Information on toxicological effects Acute Toxicity (Oral LD50) No information available. Inhalation: Dust may irritate respiratory system. Ingestion: None. Skin contact: Skin irritation is not anticipated when used normally. Eye contact: May irritate eyes. Product Code: P02252 Version: 4 Page 12 of 15

13 Section 12 Ecological Information Toxicity Acute Toxicity - Fish not available. Persistence and degradability Degradability - Fully biodegradable. Bio accumulative potential No bioaccumulation potential. Mobility in soil Mobility: Soluble in water. Results of PBT and vpvb assessment No data available. Section 13 Disposal Considerations General information Waste to be treated as controlled waste. Disposal to licensed waste disposal site in accordance with local Waste Disposal Authority. Waste treatment methods Dispose of waste and residues in accordance with local authority requirements. Section 14 Transport Information General - The product is not covered by international regulation on the transport of dangerous goods (IMDG, IATA, ADR/RID). UN number Not applicable. UN proper shipping name Not applicable. Transport hazard class (es) Transport Labels - No transport warning sign required. Packing group Not applicable. Product Code: P02252 Version: 4 Page 13 of 15

14 Environmental hazards Environmentally Hazardous Substance/Marine Pollutant - No. Special precautions for user - Not applicable. Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable. Section 15 Regulatory Information Safety, health and environmental regulations/legislation specific for the substance or mixture EU Legislation Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, including amendments. Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 with amendments. Chemical Safety Assessment No chemical safety assessment has been carried out. 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: P02252 Version: 4 Page 14 of 15

15 Change History Version Change Customer Notification required Yes / No 1 First Issue N/A 2 Format updated. Heavy Metals units and caffeine amended due a No clerical mistake. Flow chart format changed 3 The 2nd column on the additives table was changed from product contains to Product free from. Extract ratio for fresh plant 100:1 was added. The active ingredient levels were amended due supplier s specification was updated: Yes Catechin >2 to 0.75% Gallocatechin Gallate >1.3 to 0.6% Epicatechin Gallate >11.5 to 6% Salmonella and E.coli limits changed from Absent/10g to <10cfu/g due a clerical error. 4 Added aluminium results Updated active ingredients, micro results and TD format. Yes Document Approval Originator Job Title QC Technician Approver Job Title Assistant Quality Manager Product Code: P02252 Version: 4 Page 15 of 15

16 P02252 Phytofare R Catechin Complex Green Tea Powdered Extract Technical Dossierv41 Adobe Sign Document History 05/11/2018 Created: 05/10/2018 By: Status: Transaction ID: Alan Feetham (alan.feetham@c-c-l.com) Signed CBJCHBCAABAA8sN9GkkXVvoK-BfxH8bA7oPgj_Iqw-HP "P02252 Phytofare R Catechin Complex Green Tea Powdered Extract Technical Dossierv41" History Document uploaded by Alan Feetham (alan.feetham@c-c-l.com) from Acrobat 05/10/2018-8:01:08 AM PDT- IP address: Document e-signed by Alan Feetham (alan.feetham@c-c-l.com) Signature Date: 05/10/2018-8:02:05 AM PDT - Time Source: server- IP address: Document ed to Richard Cecil (Richard.Cecil@c-c-l.com) for signature 05/10/2018-8:02:05 AM PDT Document viewed by Richard Cecil (Richard.Cecil@c-c-l.com) 05/11/2018-1:20:53 AM PDT- IP address: Document e-signed by Richard Cecil (Richard.Cecil@c-c-l.com) Signature Date: 05/11/2018-1:21:19 AM PDT - Time Source: server- IP address: