Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
This standard replaces GB 19191-2003 Food Additive - Natural Vitamin E.
The following main changes have been made with respect to GB 19191-2003:
——The standard name is revised as National Food Safety Standard - Food Additive - Vitamin E;
——The types of tocopherols contained in vitamin E are modified;
——Refractive index requirements are added;
——Requirements of absorption coefficient indexes are added.
National Food Safety Standard
Food Additive - Vitamin E
1 Scope
This standard is applicable to products made from the natural vitamin E extracted from the by-products of natural edible vegetable oils or synthetic vitamin E by incorporating with edible vegetable oils. This standard is applicable vitamin E containing d-α-tocopherol, dl-α-tocopherol, d-α-tocopheryl acetate, dl-α-tocopheryl acetate, d-α-tocopheryl acid succinate, dl-α-tocopheryl acid succinate, d-α-tocopheryl acetate concentrate, and concentrate of mixed tocopherols.
2 Chemical Name, Molecular Formula, Structural Formula and Relative Molecular Mass
2.1 Chemical name
d-α-tocopherol: (+) 2,5,7,8-tetramethyl-2-(4,8,12-trimethyl-tridecyl)-6-benzopyran alcohol;
dl-α-tocopherol: (+) 2,5,7,8-tetramethyl-2-(4,8,12-trimethyl-tridecyl)-6-chromanol;
d-α-tocopheryl acetate:
(+)2,5,7,8-tetramethyl-2-(4,8,12-trimethyl-tridecyl) chromanol-6-acetate;
dl-α-tocopheryl acetate:
(+)2,5,7,8-tetramethyl-2-(4,8,12-trimethyl-tridecyl)-2H-1-benzopyran-6-ol acetate;
d-α-tocopheryl acid succinate:
(+)2,5,7,8-tetramethyl-2-(4,8,12-trimethyl-tridecyl) chromanol-6-succinate;
dl-α-tocopheryl acid succinate:
(+)2,5,7,8-tetramethyl-2-(4,8,12-trimethyl-tridecyl) chromanol-6-succinate.
2.2 Molecular formula
d-α-tocopherol: C29H50O2
dl-α-tocopherol: C29H50O2
d-α-tocopheryl acetate: C31H52O3
dl-α-tocopheryl acetate: C31H52O3
d-α-tocopheryl acid succinate: C33H54O5
dl-α-tocopheryl acid succinate: C33H54O5
2.3 Structural formula
The radical groups R1, R2, R3 and R4 corresponding to structural formulae of d-α-tocopherol, dl-α-tocopherol, d-α-tocopheryl acetate, dl-α-tocopheryl acetate, d-α-tocopheryl acid succinate, dl-α-tocopheryl acid succinate, d-α-tocopheryl acetate concentrate and concentrate of mixed tocopherols are as shown in Table 1.
Table 1
Type Substituting group R1 Substituting group R2 Substituting group R3 Substituting group R4
d-α-tocopherol CH3 CH3 CH3 H
d-β-tocopherol CH3 H CH3 H
d-γ-tocopherol H CH3 CH3 H
d-δ-tocopherol H H CH3 H
dl-α-tocopherol CH3 CH3 CH3 H
d-α-tocopheryl acetate CH3 CH3 CH3 CH3CO
dl-α-tocopheryl acetate CH3 CH3 CH3 CH3CO
d-α-tocopheryl acid succinate CH3 CH3 CH3 HOCO(CH3)2CO
dl-α-tocopheryl acid succinate CH3 CH3 CH3 HOCO(CH3)2CO
2.4 Relative molecular mass
d-α-tocopherol: 430.71 (as per 2013 international relative atomic mass);
dl-α-tocopherol: 430.71 (as per 2013 international relative atomic mass);
d-α-tocopheryl acetate: 472.75 (as per 2013 international relative atomic mass);
dl-α-tocopheryl acetate: 472.75 (as per 2013 international relative atomic mass);
d-α-tocopheryl acid succinate: 530.79 (as per 2013 international relative atomic mass);
dl-α-tocopheryl acid succinate: 530.79(as per 2013 international relative atomic mass).
3 Technical Requirements
3.1 Sensory requirements
Sensory requirements shall be in accordance with those specified in Table 2.
Table 2 Sensory Requirements
Item Requirements Inspection method
Color and lustre d-α-tocopherol: red brown to pale yellow Place a proper amount of specimen into a white porcelain dish or transparent beaker, and then observe its color and lustre as well as state under natural light.
d-α-tocopheryl acetate: colorless to yellow
d-α-tocopheryl acetate concentrate: light brown to pale yellow
d-α-tocopheryl acid succinate: white to off-white
dl-α-tocopheryl acid succinate: white to off-white
Concentrate of mixed tocopherols: red brown to pale yellow
Character d-α-tocopherol: clear oily liquid
d-α-tocopheryl acetate: clear viscous oily liquid, solidify when keeping still and melt at about 25℃
d-α-tocopheryl acetate concentrate: clear viscous oily liquid
d-α-tocopheryl acid succinate: crystalline powder, melt at about 75℃
dl-α-tocopheryl acid succinate: crystalline powder, melt at about 75℃
Concentrate of mixed tocopherols: clear oily liquid, allow the separation of tiny crystal
3.2 Physical and chemical indexes
Physical and chemical indexes shall be in accordance with those specified in Table 3.
Table 3 Physical and Chemical Indexes
Item Index Inspection method
d-α-tocopherol d-α-tocopheryl acetate concentrate d-α-tocopheryl acetate d-α-tocopheryl acid succinate dl-α-tocopheryl acid succinate Concentrate of mixed tocopherols
E50 type E70 type
Contenta, ω/% Total tocopherols ≥50.0 ≥70.0 ≥70.0 96.0 ~ 102.0. ≥50.0 A.3 of
Annex A
Where,
d-α-tocopherol ≥ 95.0 —
d-β-, d- γ- and d–ð-tocopherols — ≥ 80.0
pH/mL ≤ 1.0 ≤ 0.5 18.0 ~ 19.3 ≤ 1.0 A.4 of
Annex A
Specific rotation ≥ + 24° — + 20° A.5 of
Annex A
Absorption coefficient
(284nm) — 41.0~45.0 — A.6 of
Annex A
Refractive index
— 1.494~1.499 — GB/T 614
Heavy metal (calculated by Pb)/
(mg/kg) ≤ 10 GB/T 5009.74
Note 1: By taking vitamin E complying with this standard as raw material, commercial products of food additive vitamin E shall be made of food raw materials such as food additives complying with quality specification standard like antioxidant, emulsifier, thickener, anti-caking agent and (or) edible vegetable oils; among which, the content in d-α-tocopherol, d-α-tocopheryl acetate, d-α-tocopheryl acetate concentrate, d-α-tocopheryl acid succinate, dl-α-tocopheryl acid succinate, concentrate of mixed tocopherols shall conform to the marking values.
Note 2: Technical indexes of dl-α-tocopherol shall meet the relevant requirements of GB 29942, the technical indexes of dl-α-tocopheryl acetate shall meet the relevant requirements of GB 14756.
a The content may also be expressed in international unit (IU/g), 1mg d-α-tocopherol=1.49 IU, 1mg d-α-tocopheryl acetate=1.36 IU, 1mg d-α-tocopheryl acid succinate=1.21 IU.
Annex A
Inspection Methods
A.1 General requirements
Unless otherwise specified in this standard, the purity of the adopted reagents shall be above analytically pure; the adopted standard titration solutions, standard solutions for impurity determination, preparations and products shall be prepared according to the requirements of GB/T 601, GB/T 602 and GB/T 603; the test water shall be Grade 3 water specified in GB/T 6682. Solutions used in the test are all aqueous solution, unless other solvents are indicated to be used for preparation.
Foreword i
1 Scope
2 Chemical Name, Molecular Formula, Structural Formula and Relative Molecular Mass
3 Technical Requirements
Annex A Inspection Methods
Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
This standard replaces GB 19191-2003 Food Additive - Natural Vitamin E.
The following main changes have been made with respect to GB 19191-2003:
——The standard name is revised as National Food Safety Standard - Food Additive - Vitamin E;
——The types of tocopherols contained in vitamin E are modified;
——Refractive index requirements are added;
——Requirements of absorption coefficient indexes are added.
National Food Safety Standard
Food Additive - Vitamin E
1 Scope
This standard is applicable to products made from the natural vitamin E extracted from the by-products of natural edible vegetable oils or synthetic vitamin E by incorporating with edible vegetable oils. This standard is applicable vitamin E containing d-α-tocopherol, dl-α-tocopherol, d-α-tocopheryl acetate, dl-α-tocopheryl acetate, d-α-tocopheryl acid succinate, dl-α-tocopheryl acid succinate, d-α-tocopheryl acetate concentrate, and concentrate of mixed tocopherols.
2 Chemical Name, Molecular Formula, Structural Formula and Relative Molecular Mass
2.1 Chemical name
d-α-tocopherol: (+) 2,5,7,8-tetramethyl-2-(4,8,12-trimethyl-tridecyl)-6-benzopyran alcohol;
dl-α-tocopherol: (+) 2,5,7,8-tetramethyl-2-(4,8,12-trimethyl-tridecyl)-6-chromanol;
d-α-tocopheryl acetate:
(+)2,5,7,8-tetramethyl-2-(4,8,12-trimethyl-tridecyl) chromanol-6-acetate;
dl-α-tocopheryl acetate:
(+)2,5,7,8-tetramethyl-2-(4,8,12-trimethyl-tridecyl)-2H-1-benzopyran-6-ol acetate;
d-α-tocopheryl acid succinate:
(+)2,5,7,8-tetramethyl-2-(4,8,12-trimethyl-tridecyl) chromanol-6-succinate;
dl-α-tocopheryl acid succinate:
(+)2,5,7,8-tetramethyl-2-(4,8,12-trimethyl-tridecyl) chromanol-6-succinate.
2.2 Molecular formula
d-α-tocopherol: C29H50O2
dl-α-tocopherol: C29H50O2
d-α-tocopheryl acetate: C31H52O3
dl-α-tocopheryl acetate: C31H52O3
d-α-tocopheryl acid succinate: C33H54O5
dl-α-tocopheryl acid succinate: C33H54O5
2.3 Structural formula
The radical groups R1, R2, R3 and R4 corresponding to structural formulae of d-α-tocopherol, dl-α-tocopherol, d-α-tocopheryl acetate, dl-α-tocopheryl acetate, d-α-tocopheryl acid succinate, dl-α-tocopheryl acid succinate, d-α-tocopheryl acetate concentrate and concentrate of mixed tocopherols are as shown in Table 1.
Table 1
Type Substituting group R1 Substituting group R2 Substituting group R3 Substituting group R4
d-α-tocopherol CH3 CH3 CH3 H
d-β-tocopherol CH3 H CH3 H
d-γ-tocopherol H CH3 CH3 H
d-δ-tocopherol H H CH3 H
dl-α-tocopherol CH3 CH3 CH3 H
d-α-tocopheryl acetate CH3 CH3 CH3 CH3CO
dl-α-tocopheryl acetate CH3 CH3 CH3 CH3CO
d-α-tocopheryl acid succinate CH3 CH3 CH3 HOCO(CH3)2CO
dl-α-tocopheryl acid succinate CH3 CH3 CH3 HOCO(CH3)2CO
2.4 Relative molecular mass
d-α-tocopherol: 430.71 (as per 2013 international relative atomic mass);
dl-α-tocopherol: 430.71 (as per 2013 international relative atomic mass);
d-α-tocopheryl acetate: 472.75 (as per 2013 international relative atomic mass);
dl-α-tocopheryl acetate: 472.75 (as per 2013 international relative atomic mass);
d-α-tocopheryl acid succinate: 530.79 (as per 2013 international relative atomic mass);
dl-α-tocopheryl acid succinate: 530.79(as per 2013 international relative atomic mass).
3 Technical Requirements
3.1 Sensory requirements
Sensory requirements shall be in accordance with those specified in Table 2.
Table 2 Sensory Requirements
Item Requirements Inspection method
Color and lustre d-α-tocopherol: red brown to pale yellow Place a proper amount of specimen into a white porcelain dish or transparent beaker, and then observe its color and lustre as well as state under natural light.
d-α-tocopheryl acetate: colorless to yellow
d-α-tocopheryl acetate concentrate: light brown to pale yellow
d-α-tocopheryl acid succinate: white to off-white
dl-α-tocopheryl acid succinate: white to off-white
Concentrate of mixed tocopherols: red brown to pale yellow
Character d-α-tocopherol: clear oily liquid
d-α-tocopheryl acetate: clear viscous oily liquid, solidify when keeping still and melt at about 25℃
d-α-tocopheryl acetate concentrate: clear viscous oily liquid
d-α-tocopheryl acid succinate: crystalline powder, melt at about 75℃
dl-α-tocopheryl acid succinate: crystalline powder, melt at about 75℃
Concentrate of mixed tocopherols: clear oily liquid, allow the separation of tiny crystal
3.2 Physical and chemical indexes
Physical and chemical indexes shall be in accordance with those specified in Table 3.
Table 3 Physical and Chemical Indexes
Item Index Inspection method
d-α-tocopherol d-α-tocopheryl acetate concentrate d-α-tocopheryl acetate d-α-tocopheryl acid succinate dl-α-tocopheryl acid succinate Concentrate of mixed tocopherols
E50 type E70 type
Contenta, ω/% Total tocopherols ≥50.0 ≥70.0 ≥70.0 96.0 ~ 102.0. ≥50.0 A.3 of
Annex A
Where,
d-α-tocopherol ≥ 95.0 —
d-β-, d- γ- and d–ð-tocopherols — ≥ 80.0
pH/mL ≤ 1.0 ≤ 0.5 18.0 ~ 19.3 ≤ 1.0 A.4 of
Annex A
Specific rotation ≥ + 24° — + 20° A.5 of
Annex A
Absorption coefficient
(284nm) — 41.0~45.0 — A.6 of
Annex A
Refractive index
— 1.494~1.499 — GB/T 614
Heavy metal (calculated by Pb)/
(mg/kg) ≤ 10 GB/T 5009.74
Note 1: By taking vitamin E complying with this standard as raw material, commercial products of food additive vitamin E shall be made of food raw materials such as food additives complying with quality specification standard like antioxidant, emulsifier, thickener, anti-caking agent and (or) edible vegetable oils; among which, the content in d-α-tocopherol, d-α-tocopheryl acetate, d-α-tocopheryl acetate concentrate, d-α-tocopheryl acid succinate, dl-α-tocopheryl acid succinate, concentrate of mixed tocopherols shall conform to the marking values.
Note 2: Technical indexes of dl-α-tocopherol shall meet the relevant requirements of GB 29942, the technical indexes of dl-α-tocopheryl acetate shall meet the relevant requirements of GB 14756.
a The content may also be expressed in international unit (IU/g), 1mg d-α-tocopherol=1.49 IU, 1mg d-α-tocopheryl acetate=1.36 IU, 1mg d-α-tocopheryl acid succinate=1.21 IU.
Annex A
Inspection Methods
A.1 General requirements
Unless otherwise specified in this standard, the purity of the adopted reagents shall be above analytically pure; the adopted standard titration solutions, standard solutions for impurity determination, preparations and products shall be prepared according to the requirements of GB/T 601, GB/T 602 and GB/T 603; the test water shall be Grade 3 water specified in GB/T 6682. Solutions used in the test are all aqueous solution, unless other solvents are indicated to be used for preparation.
Contents of GB 1886.233-2016
Foreword i
1 Scope
2 Chemical Name, Molecular Formula, Structural Formula and Relative Molecular Mass
3 Technical Requirements
Annex A Inspection Methods