Vitapherole® T-50-ORG Non-GMO Suitable for Organic Food
(Mixed tocopherols concentrate)

Common Names

  • Chemical Name: mixed tocopherols
  • Antioxidant: E-306
  • INCI Name: tocopherol

General Characterization

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 Organic sunflower oil. It is intended for use as an antioxidant in the food and dietary supplement industry.

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Additional Information

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Download: Vitapherole T- 50 ORG Non-GMO PDS (PDF, 445 KB)

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Identification

Common NameEmpirical FormulaMolecular WeightCAS
d-alpha tocopherolC29H50O2430.6959-02-9
d-beta tocopherolC28H48O2416.6616698-35-4
d-gamma tocopherolC28H48O2416.6654-28-4
d-delta tocopherolC27H46O2402.64119-13-1

Standards

  • 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).
  • Organic attestation: This product is suitable for use to Organic Farming according to Regulations (EC) Nº 834/2007 and 889/2008 and NOP Organic production.

Ingredients/Composition

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 %)
Organic vegetable oil (sunflower):500 mg/g max.(50 %) max.
*Derived from soybean oil  

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/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% 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.

Dioxins:
- 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-ORG Non GMO” may be labelled as “natural source Vitamin E”.
The product is in compliance with Directive 2000/13/EC regarding labelling of foodstuffs.

Uses: “Vitapherole® T-50-ORG Non GMO” is a natural antioxidant widely used in food industries to avoid the negative effects of oxidation.

This product has not been irradiated at any point during the manufacturing process.

Dosage Information

We recommend testing with several different amounts of “Vitapherole® T-50-ORG 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-ORG Non GMO” may be used in the manufacturing of food supplements according to Commission Regulation (EC) Nº 1170/2009.

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