Tocopherol concentrate, mixed
Tocopherol concentrate, mixed · 307bINS 307b
Listed as an antioxidant by Codex.
Listed as antioxidants (Codex)
- Codex Alimentarius: Antioxidant — CXS 192-1995 Table One, INS 307b
Mixed tocopherol concentrate is a plant-derived vitamin E preparation, used as an antioxidant in oils and fatty foods and as a nutrient.
Where it is and isn’t permitted
| Jurisdiction | Status | Scope and limits | Citation |
|---|---|---|---|
| Australia and New Zealand | Permitted, with conditions | 5 food categories highest permitted level 300 mg/L Show every food category
| Food Standards Code, Schedule 15, S15—5and 4 further provisionsretrieved 2026-10-17 |
| Canada | No listing matchedHealth Canada’s lists name additives without E or INS numbers, so this site matches them by exact name. A substance listed there under a name this site does not recognise has no row here. | ||
| European Union | No listed food uses foundThis site has not matched this substance to any food use on this jurisdiction’s list of authorised food additives. A food additive may be used only in foods that list names. Flavourings, enzymes, processing aids and added nutrients are regulated separately and do not appear on it. | ||
| Great Britain | No listed food uses foundThis site has not matched this substance to any food use on this jurisdiction’s list of authorised food additives. A food additive may be used only in foods that list names. Flavourings, enzymes, processing aids and added nutrients are regulated separately and do not appear on it. | ||
| Japan | No listing matchedThis site imports only Japan’s list of designated additives (Appended Table 1 to the Regulations for Enforcement of the Food Sanitation Act), matched by English name. Existing additives, natural flavouring agents and ordinary foods used as additives are permitted outside that list and are not imported, so an empty row does not show that Japan does not permit the substance. | ||
| South Korea | Permitted, with conditions | Designated food additive: Standards and Specifications for Food Additives, Part III, 1. …Designated food additive: Standards and Specifications for Food Additives, Part III, 1. 일반식품첨가물 (general food additives), d-토코페롤(혼합형) (“d-Tocopherol Concentrate, Mixed”, the English the Code prints beside it); the Code marks it as also usable as a nutrient fortifier; 3. 영양강화제 (nutrient fortifiers), d-토코페롤(혼합형); nutrient: 비타민E; the Code marks it as also usable as a general food additive. Main use (주용도) of d-토코페롤(혼합형): 산화방지제. Standard for use (사용기준) of d-토코페롤(혼합형): (1) [to be used under the general standard for use in II. 2. 1), the minimum amount that achieves the technical effect, with no limit set for this additive in particular] “II. 2. 1)의 규정에 따라 사용하여야 한다.” The Korean is the standard as published. There is no official English translation of the current Code (the English version on MFDS’s website is the 2020 edition and has no legal effect); the English in square brackets is this site’s description of what each sentence does, not a translation of the foods or the levels. Compositional specifications (Part IV) are not imported, nor are the general standards in Part II, which apply to every additive. | Standards and Specifications for Food Additives (식품첨가물의 기준 및 규격), MFDS Notification, Part III (Standards for use, by item)retrieved 2026-10-18 |
| United States | Not listedDoes not appear on this jurisdiction’s permitted list. That is not the same as being prohibited. | ||
| Codex Alimentarius | Permitted, with conditions | 67 food categories highest permitted level 5,000 mg/kg Show every food category and its notes
| CXS 192-1995 Table One, INS 307band 66 further provisionsretrieved 2026-09-07 |
How much is permitted
A listing usually limits the quantity as well as the food. Only one of the forms that takes is a figure: quantum satis and good manufacturing practice permit the amount the technological effect requires and no more, which is a limit rather than the absence of one. Figures below are the range across every food category this page is listed in, and categories differ between regulators — see how much is permitted.
| Australia and New Zealand | 10 mg/kg – 300 mg/kg | 3 numeric limit, 2 GMP |
|---|---|---|
| South Korea | — | 1 no quantity stated |
| Codex Alimentarius | 5 mg/kg – 5,000 mg/kg | 67 numeric limit |
What it is made from
Concentrated from the distillate left over from refining vegetable oils, chiefly soya and sunflower.
- Vegan
- Vegetarian
Compare other additives on the dietary indexes.
How JECFA defines it
The international specification for identity and purity, prepared by the Joint FAO/WHO Expert Committee on Food Additives and published by FAO. It is a different document from any above, written by a different body and revised on its own cycle; it is advisory, and a country adopts it or does not.
INS 307b Tocopherol Concentrate, mixed
A form of Vitamin E obtained by the vacuum steam distillation of edible vegetable oil products, comprising concentrated tocopherols. It may contain an edible vegetable oil added to adjust the required amount of total tocopherols, and the tocopherol forms may be adjusted by suitable physical and chemical means.
Synonyms: Vitamin E, INS No 307b Vitamin E
Assay, identification and purity criteria
Description and assay
- Specification history
- Prepared at the 30th JECFA (1986), published in FNP 37 (1986) and in FNP 52 (1992). Metals and arsenic specifications revised at the 61st JECFA (2003). A group ADI of 0.15-2 mg/kg bw for dl- α -tocopherol and d- α -tocopherol, concentrate, singly or in combination, was established at the 30th JECFA (1986).
- Chemical names
- Mixed Tocopherol Concentrate contains tocopherols such as d-alpha-, d-ß-, d-gamma-, d-delta-tocopherols
- C.A.S. number
- No single definite C.A.S. number is for this substance. No. 59-02-9 is for vitamin E, 1406-18-4 is for alpha-tocopherol, 2074-53-5 is for all-rac-alpha-tocopherol, and 10191-40-0 is for racemic-alpha-tocopherol synthesized from natural phytol or its derivative.
- Assay
- Not less than 34% of total tocopherols
- DESCRIPTION
- Brownish red to red, clear, viscous oil having a mild, characteristic odour; may show a slight separation of waxlike constituents in microcrystalline form It oxidizes and darkens slowly in air and on exposure to light, particularly when in alkaline media.
- FUNCTIONAL USES
- Antioxidant
- METHOD OF ASSAY
- Gas Liquid Chromatographic Method Reagents and solutions: Internal Standard Solution: Transfer about 600 mg of hexadecyl hexadecanoate, accurately weighed, to a 200-ml volumetric flask, dissolve in a solution containing 2 parts of pyridine and 1 part of propionic anhydride, dilute to volume with the solution, and mix. Standard Preparations: Transfer 12-, 25-, 37-, and 50-mg portions of USP Alpha Tocopherol Reference Standard, accurately weighed, to separate 50-ml Erlenmeyer flasks having 19/38 standard-taper ground-glass necks. Pipet 25.0 ml of the Internal Standard Solution into each flask, mix, and reflux for 10 min. under water-cooled condensers. Assay Preparation: Transfer about 60 mg of the sample, accurately weighed, to another 50-ml Erlenmeyer flask, pipet 10.0 ml of the Internal Standard Solution into the flask, mix, and reflux for 10 min. under a water-cooled condenser. Chromatographic System Use a gas chromatograph equipped with a flame-ionization detector and a glass-lined sample-introduction system or on-column injection. Under typical conditions, the instrument contains a 2-m x 4-mm borosilicate glass column packed with 2% to 5% methylpolysiloxane gum on 80- to 100-mesh acid-base washed silinized chromatographic diatomaceous earth. The column is maintained isothermally between 240 o and 260 o , the injection port at about 290 o , and the detector block at about 300 o . The flow rate of dry carrier gas is adjusted to obtain a hexadecyl-hexadecanoate peak approximately 18 to 20 min. after sample introduction when a 2% column is used, or 30 to 32 min. when a 5% column is used. (NOTE: Cure and condition the column as necessary). System Suitability Chromatograph a suitable number of injections of the Assay Preparation, as directed under Calibration, to assure that the resolution factor, R, between the major peaks occurring at retention times of approximately 0.50 (delta-tocopherol propionate) and 0.63 (ß-plus gamma-tocopheryl propionates), relative of hexadecyl hexadecanoate at 1.00, is not less than 2.5. Calibration Chromatograph successive 2- to 5-μl portions of each Standard Preparation until the relative response factor, F, for each is constant (i.e. within a range of approximately 2%) for three consecutive injections. If graphic integration is used, adjust the instrument to obtain at least 70% maximum recorder response for the hexadecyl hexadecanoate peak. Measure the areas under the first (I-tocopheryl propionate) and second (hexadecyl hexadecanoate) major peaks (excluding the solvent peak), and record the values as As and A1, respectively. Calculate the factor, F, for each concentration of (As/A1) x C1/Cs), in which C1 and Cs are the exact concentrations, in mg per ml, of hexadecyl hexadecanoate and of USP Alpha Tocopherol Reference Standard in the Standard Preparation, respectively. Prepare a relative response factor curve by plotting area of alpha-tocopheryl propionate versus relative response factor. Procedure Inject a suitable portion (2 to 5 μl) of the Assay Preparation into the chromatograph, and record the chromatogram. Measure the areas under the four major peaks occurring at relative retention times of 0.50, 0.63, 0.76, and 1.00, and record the values as adelta, abeta+gamma, aalpha and a1, corresponding to delta-tocopheryl propionate, ß-plus gamma-tocopheryl propionates, alpha-tocopheryl propionate, and hexadecyl hexadecanoate, respectively. Calculate the weight, in mg, of each tocopherol form in the sample by the following formulas: delta-tocopherol = (10C1/F) x (adelta/a1); ß-plus gamma-tocopherols = (10C1/F) x (abeta+gamma/a1); alpha-tocopherol = (10C1/F) x (aalpha/a1), where F is obtained from the relative response factor curve (see Calibration) for each of the corresponding areas under the delta-, ß- plus gamma-, and alpha-tocopheryl propionate peaks produced by the Assay Preparation. (NOTE: The relative response factor for delta-tocopheryl propionate and for ß- plus gamma-tocopheryl propionates has been determined empirically to be the same as for alpha-tocopheryl propionate).
Identification
- Solubility (Vol. 4)
- Insoluble in water; soluble in ethanol; miscible in ether
- Chromatography
- The retention time of the third major peak (i.e. the peak occurring just before that of the internal standard) in the chromatogram of the Assay Preparation is the same as that of the Standard Preparation, both relative to the internal standard, as obtained in the Assay.
- Colour reaction
- Dissolve about 0.05 g of the sample in 10 ml of absolute ethanol. Add, with swirling, 2 ml of nitric acid and heat at about 75 o for 15 min. A bright red to orange colour develops
Purity criteria
- Specific rotation (Vol. 4)
- [alpha] 25, D: Not less than +20 o See description under TESTS
- Sulfated ash (Vol. 4)
- Not more than 0.1% Test 1 g of the sample (Method II)
- Acidity
- Dissolve 1 g of the sample in 25 ml of a mixture of equal volumes of ethanol and ether that has been neutralized to phenolphthalein TS with 0.1 N sodium hydroxide, add 0.5 ml of phenolphthalein TS, and titrate with 0.1 N sodium hydroxide until the solution remains faintly pink after shaking for 30 sec. Not more than 1.0 ml of 0.1 N sodium hydroxide is required.
- Lead (Vol. 4)
- Not more than 2 mg/kg Determine using an atomic absorption technique appropriate to the specified level. The selection of sample size and method of sample preparation may be based on the principles of the method described in Volume 4, “Instrumental Methods.”
- Test: Specific rotation
- Transfer an accurately weighed amount of sample, equivalent to about 100 mg of total tocopherols, to a separator, and dissolve it in 50 ml of ether. To the separator add 20 ml of a 10% solution of potassium ferricyanide in sodium hydroxide solution (1 in 125), and shake for 3 min. Wash the ether solution with four 50-ml portions of water, discard the washings, and dry over anhydrous sodium sulfate. Evaporate the dried ether solution on a water bath under reduced pressure or in an atmosphere of nitrogen until about 7 or 8 ml remain, and then complete the evaporation, removing the last traces of ether without the application of heat. Immediately dissolve the residue in 5 ml of isooctane, and determine the optical rotation. Calculate the specific rotation, using as c the concentration expressed as the number of g of total tocopherols, determined in the Assay, in 100 ml of the solution.
Every name it appears under
2 recorded names. A label may use any of them.
INS number
- 307b
Other names
- Tocopherol concentrate, mixed
Hazard reference values
No reference value for this substance in the sources we hold.
Evidence and how bodies read it
What assessing bodies concluded
Each conclusion is paraphrased in the body's own framing, from the published opinion linked beneath it. Where bodies differ, both stand; this site does not adjudicate between them or add a view of its own.
EFSA 2015
The ANS Panel considered the data too limited to establish an ADI for the tocopherols (E 306–E 309), and found no concern for genotoxicity or carcinogenicity. Taking into account that vitamin E is an essential nutrient and upper intake levels were not generally exceeded, it concluded that tocopherols are not of safety concern at the levels used in food.
Common questions
Assembled from what is above, in the words the questions are usually asked in. Each answer is the same statement the relevant section makes, with the same citations behind it.
- What is INS 307b?
- INS 307b is Tocopherol concentrate, mixed. Mixed tocopherol concentrate is a plant-derived vitamin E preparation, used as an antioxidant in oils and fatty foods and as a nutrient.
- What is Tocopherol concentrate, mixed used for in food?
- It is listed as an antioxidant — the role Codex assigns it. This page shows every function each regulator records, with the citation for each.
- Where is Tocopherol concentrate, mixed permitted?
- Of the seven regulators this site reads, Australia and New Zealand, South Korea and the Codex standard permit it. Each permission is for named foods at named levels, not a blanket one; the table on this page gives them with citations.
- Is Tocopherol concentrate, mixed vegan?
- Yes. Tocopherol concentrate, mixed is not derived from animals, and is suitable for vegetarians. This page says what it is made from and how.
Sources for this page
- anz retrieved 2026-10-17
- kr retrieved 2026-10-18
- gsfa retrieved 2026-09-07
- jecfaspecs retrieved 2026-09-23
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