Vitapherole® TP-350 PA Non-GMO
(Mixed tocopherols concentrate powder)
- 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.
|Common Name||Empirical Formula||Molecular Weight||CAS|
- “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.
GC method according to IT-02-L
|Natural Mixed Tocopherols:||(50%)||(Total tocopherols content: 350 mg/g min)|
|Silicon Dioxide (compressing type):||(30%)|
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.
- 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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