Vitapherole® E-1000 Sunflower-OC Suitable for Organic Cosmetic
(High content in RRR-alpha tocopherol)
- Chemical Name: mixed tocopherols
- Antioxidant: E-306
- INCI Name: tocopherol
|Common Name||Empirical Formula||Molecular Weight||CAS|
- This product complies with current EP and USP-NF standards, FCC, JECFA and Regulation (EC) Nº 852/2004.
- Kosher (“Circle U”) and Halal certified. Produced under UNE EN ISO 9001: 2008 standard.
- Non GMO (IP). It is not subjected to be labelled under Regulations (EU) 1829/2003 and 1830/2003.
- This product does not contain allergens according to Regulation (EU) Nº1169/2011 so; it is not required labelling declaration as being potential allergen.
- Mixed tocopherols are generally recognized as safe (GRAS) by FDA (21 CFR Part 182, Sec.182.8890 and 182.3890).
- Suitable for organic cosmetic. This product can be used in the formulation of cosmetics certified according to the natural and organic ECOCERT and COSMOS standards.
GC method according to IT-02-L
|Natural Mixed Tocopherols:||671 mg/g min.||(67.1 %) min.|
|Alpha Tocopherol:||671 mg/g min.||(67.1 %) min.|
|Beta-Gamma Tocopherol:||0 – 100 mg/g||(0 – 10 %)|
|Delta Tocopherol:||0 – 50 mg/g||(0 – 5 %)|
|Organic vegetable oil (sunflower):||329 mg/g max.||(32.9 %) max.|
Quality Control Assay
(Parameters analyzed per batch)
Appearance: Clear, from amber to reddish viscous oil
Taste: Mild, characteristic
Odour: Typical vegetable oil
Colour: Max. 14 Gardner Units
Viscosity (60ºC): 90 – 180 cP
Specific gravity/Density (25ºC): 0.93 – 0.95 g/cm3
Potency: 1000 I.U/g (min)
Acidity: <1 ml KOH 0.1N /g (According to USP and ISO 660:2009)
Benzo (a) pyrene: < 2 ppb (As per EC Regulation (EU) 835/2011)
Sum of Benzo(a) pyrene, Benzo(a) anthracene, Benzo(b) fluoranthene and Chrysene: < 10 ppb (As per EC Regulation (EU) 835/2011)
(Parameters analyzed periodically based on statistical data)
Irradiation: This product has not been irradiated at any point during themanufacturing process.
Specific Rotation: ( ) D25. Min. + 20º (for 100% concentration)
(As per Commission Directive 2008/84/EC and Commission Regulation (EU) Nº 231/2012)
Heavy Metals: Pb: <0.1ppm Hg:<0.1ppm Cd: <1ppm As: <1ppm
(As per Commission Regulation (EC) Nº 629/2008, amending Regulation (EC) Nº 1881/2006). Complies also with Commission Regulation (EU) Nº 231/2012)
Microbiological Tests: E. Coli: None cfu/g (In compliance with EP and RD 3177/83)
- Salmonella: None cfu/25g
- Listeria Monocytogenes: None cfu/10 g
- Shigella: None cfu/10 g
- Clostridium Perfringens: None cfu/g
- Staphylococcus Aureus: None cfu/g
- Enterobacteriaceae: max 100 cfu/g
- Total Aerobic Count: max 1000 cfu/g
- Yeast & Moulds: max 100 cfu/g
Sulphated Ashes: < 0.1%
(In compliance with Directive 2008/84/EC and Commission Regulation (EU) Nº 231/2012)
Residual Solvents: In compliance with limits established in EP and USP for Class I solvents.
- Sum of dioxins (WHO-PCDD/F-TEQ) 0,75 pg/g fat
- Sum of dioxins and dioxin-like PCBS (WHO-PCDD/F-PCB-TEQ) 1, 25 pg/g fat
- Sum of PCB28, PCB52, PCB101, PCB138, PCB153 and PCB180 (ICES – 6) 40 ng/g fat
(In compliance with Commission Regulation (EU) Nº 1259/2011)
Pesticides: In compliance with Regulation (EC) Nº 396/2005, amending Council Directive 91/414/EEC and according to current European Pharmacopoeia (EP).
Properties and Conditions
Solubility: Insoluble in water. Soluble in ethanol, animal fats and vegetable oils, essential and mineraloils. Miscible with organic solvents.
Stability: Unstable to light, heat, alkali and oxidizing conditions.
Storage: Ambient temperature. Nitrogen blanketing and protection from light, moisture and air. Store in tightly closed containers.
Shelf Life: 36 months from packaging date (unopened).
Packaging: 20 and 190 kg containers are supplied for this product.
(In compliance with Commission Regulation (EU) Nº 10/2011 and FDA 21 CFR)
Labelling: All products produced using “Vitapherole® E-1000 sunflower-OC” may be labelled as“natural source Vitamin E”.
The product is in compliance with Regulation (EC) Nº 1223/2009 on cosmetic products (Art.19 Labelling).
Uses: “Vitapherole® E-1000 sunflower-OC” is a natural antioxidant widely used in cosmetic industries to avoid the negative effects of oxidation.
This product may be used in the manufacturing of cosmetics as per Regulation (EC) Nº 1223/2009.
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