Vitapherole® EP-500/GS-ORG Suitable for Organic Food

(Mixed tocopherols powder - high content in RRR-alpha tocopherol)

Common Names

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

General Characterization

Vitapherole® EP-500/GS-ORG is an off white/beige free flowing granular powder. The active ingredient, alpha-tocopherol, is derived from non-GMO, IP certified sunflower oil and is produced by physical and chemical means. It is then absorbed onto silicon dioxide. It is intended for use as Vitamin E in the food and dietary supplement industry.

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Additional Information

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Download: Vitapherole EP-500 GS-ORG Food PDS (PDF, 446 KB)

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Identification

Common NamesEmpirical FormulaMolecular WeightCAS
d-alpha tocopherolC29H50O2430.6959-02-9
d-beta tocopherolC28H48O416.6616698-35-4
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 and FSSC 22000 standards.
  • 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 under NOP Organic production.

Ingredients/Composition

GC method according to IT-02-L

Mixed tocopherols (high content in RRR-alpha tocopherol) from sunflower:335 mg/g min.(33.5 %) min.
Alpha Tocopherol:335 mg/g min.(33.5 %) min.
Beta-Gamma Tocopherol:0 – 50 mg/g(0 – 5 %)
Delta Tocopherol:0 – 25 mg/g(0 – 2.5 %)
Silicon Dioxide SiO2 Carrier (free flowing type) (E-551):500 mg/g max.(50 %) max.
Vegetable Oil (sunflower):165 mg/g max(16.5%) max.

Quality Control Assay

(Parameters analyzed per batch)

Appearance: Off-white to beige granular powder
Taste: Bland, characteristic
Odour: Bland to none
Specific gravity/Density (25ºC): 0.35 – 0.60 g/cm3

Potency: 500 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)
Loss of drying: < 5%

(Parameters analyzed periodically based on statistical data)
(These parameters are analyzed separately in the ingredients present in the product)

Particle Size: 90% ≥ 400 μm (40 mesh)

Specific Rotation (for mixed tocopherols): (  )D25. Min. + 20º (for 100% concentration)
(As per Commission Directive 2008/84/EC, Commission Regulation (EU) Nº 231/2012 and JECFA)

Heavy Metals (for mixed tocopherols): 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 withCommission Regulation (EU) Nº 231/2012 and JECFA limits.

Heavy Metals (for Silicon dioxide): Pb: <5ppm Hg:<1ppm Cd: <2ppm As: <3ppm
(As per Commission Regulation (EC) 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

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 and organic solvents.

Stability: Unstable to alkali and acid conditions. Stable to air.

Storage: Ambient temperature. Protection from light, moisture and air. Store in tightly closed bags.

Shelf Life: 12 months from packaging date (unopened).

Packaging: 20 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® EP-500/GS-ORG” may be labelled as “naturalsource Vitamin E”.
The product is in compliance with Directive 2000/13/EC regarding labelling of foodstuffs.

Uses: “Vitapherole® EP-500/GS-ORG” is a natural antioxidant widely used in food industries toavoid the negative effects of oxidation.

“Vitapherole® EP-500/GS-ORG” is may be added to foods and can be used in the manufacturing of food supplements (mainly hard gel capsules and multivitamins) according to Commission Regulation (EC) Nº1170/2009.

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

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