Vitapherole® E-1000 Sunflower-Organic Suitable for Organic Food

(High content in RRR-alpha tocopherol)

Common Names

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

General Characterization

Vitapherole E-1000 Sunflower-Organic is a clear amber viscous oil containing mixed tocopherols, primarily alpha-tocopherol. It is produced from Non-GMO, IP certified sunflower oil through physical means. The mixed tocopherols are then diluted in organic sunflower oil. It is intended for use as Vitamin E/mixed tocopherol in the food and dietary supplement industry.

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Additional Information

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Download: Vitapherole E-1000 Sunflower Organic 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 USP-NF standard, 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*: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.
*Derived from sunflower oil  

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)

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%
(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 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. Storein 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-Organic” may be labelled as“natural source Vitamin E”.
The product is in compliance with Directive 2000/13/EC regarding labelling of foodstuffs.

Uses: “Vitapherole® E-1000 sunflower-Organic” is a natural antioxidant widely used in food industries to avoid the negative effects of oxidation.

This product is permitted as “food additive” under Regulation (EC) Nº 1333/2008 and Commission Regulation (EU) Nº 231/2012.

“Vitapherole® E-1000 sunflower-Organic” may be used in the manufacturing of food supplements according to Commission Regulation (EC) Nº 1170/2009.

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

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