Vitapherole® TP-350 PA Non-GMO

(Mixed tocopherols concentrate powder)

Common Names

  • Chemical Name: mixed tocopherols
  • INCI Name: tocopherol

The raw material of “Vitapherole® TP-350 PA Non GMO” is the “Vitapherole®T-70 Non GMO” which specifications are available upon request.

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Additional Information

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Download: Vitapherole TP-350 Pa Non- GMO PDS (PDF, 513 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

  • “Vitapherole® TP-350 PA Non GMO” complies with 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).
  • Mixed tocopherols comply with current EP, USP, FCC and JECFA.

Ingredients/ Composition

GC method according to IT-02-L

Natural Mixed Tocopherols:(50%)(Total tocopherols content: 350 mg/g min)
Silicon Dioxide (compressing type):(30%) 
Ascorbyl Palmitate(20%) 

Quality Control Assay

(Parameters analyzed per batch)

Appearance: Clear, white to cream fine powder
Taste: Bland, characteristic
Odour: Bland to none
Specific gravity/Density (25ºC): 0.35 – 0. 60 g/cm3

Acidity: < 0.35 ml KOH 0.1N /g (According to EP, USP and ISO 660:2009)
(As mixed tocopherols)
Loss on drying: < 5 %
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)
(These parameters are analyzed separately in the ingredients present in the product)

Particle Size: D(50) = 50μm

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 with Commission Regulation (EU) Nº 231/2012)

Heavy Metals (for Ascorbyl palmitate): Pb: <2ppm Hg:<1ppm Cd: <1ppm As: <3ppm
(As per Commission Regulation (EU) Nº 231/2012)

Heavy Metals (for Silicon dioxide): Pb: <5ppm Hg:<1ppm Cd: <2ppm As: <3ppm
(As per 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 (for Mixed Tocopherols and Ascorbyl palmitate): 0.1% max.
(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. 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: Stable to air. Unstable to alkali and acid conditions.

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

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

Packaging: 25 kg carton drums with interior plastic bag are supplied for this product.
(Carton drum in compliance with Regulation (EC) Nº 1935/2004 and Plastic bag in compliance with Regulation (EC)Nº 1935/2004, Commission Directive 2002/72/EC and Commission Regulation (EC) Nº 1895/2005)

Labelling: All products produced using “Vitapherole® TP-350 PA 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® TP-350 PA Non GMO” 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® TP-350 PA Non GMO” 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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