Vitapherole® T-50 Non-GMO
(Mixed tocopherols concentrate)
- Chemical Name: mixed tocopherols
- Antioxidant: E-306
- INCI Name: tocopherol
Vitapherole T-50 Non-GMO is a clear brownish-red viscous oil which contains mixed tocopherols derived from Non-GMO, IP certified soybean oil. The mixed tocopherols are then diluted in sunflower oil. It is intended for use as an antioxidant in the food and dietary supplement industry.
|Common Names||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).
GC METHOD ACCORDING TO IT-02-L
|Natural Mixed Tocopherols*:||500 mg/g min.||(50 %) min.|
|Non alpha Tocopherol:||400 mg/g min.||(40 %) min.|
|Alpha Tocopherol:||0 – 100 mg/g||(0 –10 %)|
|Beta Tocopherol:||0 – 50 mg/g||(0 – 5 %)|
|Gamma Tocopherol:||250 – 350 mg/g||(25 – 35 %)|
|Delta Tocopherol:||50 – 150 mg/g||(5 – 15 %)|
*Derived from soybean oil
|Vegetable oil (sunflower):||500 mg/g max.||(50 %) max.|
Quality Control Assay
(Parameters analyzed per batch)
Appearance: Clear, brownish red viscous oil
Taste: Mild, characteristic
Odour: Typical vegetable oil
Colour: Max. 14 Gardner Units
Viscosity (60ºC): 90 - 110 cP
Specific gravity/Density (25ºC): 0.92 – 0.96 g/cm3
Acidity: < 0.35 ml KOH 0.1N /g (According to EP, 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)
Specific Rotation: ( ) D25. Min. + 20º (for 100% concentration)
(As per Commission Directive 2008/84/EC, Commission Regulation (EU) Nº 231/2012 and JECFA)
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) and JECFA limits).
Microbiological Tests: E. Coli: None cfu/g (In compliance with EP and RD 3177/83)
- Salmonella: None cfu/25gListeria
- 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% max.
(In compliance with Directive 2008/84/EC, Commission Regulation (EU) Nº 231/2012 and JECFA)
Residual Solvents: In compliance with limits established in EP and USP for Class I solvents. This product meets as well Directive 2009/32/EC.
- 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 mineral oils. 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® T-50 Non GMO” may be labelled as “natural source Vitamin E”.
The product is in compliance with Directive 2000/13/EC regarding labelling of foodstuffs and with Regulation (EC) Nº 1223/2009 on cosmetic products (Art.19 Labelling).
Uses: “Vitapherole® T-50 Non GMO” is a natural antioxidant widely used in food and cosmetic industries to avoid the negative effects of oxidation.
We recommend testing with several different amounts of “Vitapherole® T-50 Non GMO” between 300 and 2000 ppm, which is equivalent to 0.03 to 0.2 % based on the fat content.
This product is permitted as “food additive” under Regulation (EC) Nº 1333/2008 and Commission Regulation (EU) Nº 231/2012.
“Vitapherole® T-50 Non GMO” may be used in the manufacturing of food supplements according to Commission Regulation (EC) Nº 1170/2009 and cosmetics as per Regulation (EC) Nº 1223/2009.
This product has not been irradiated at any point during the manufacturing process.
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