The Japan Food Chemical Research Foundation

Approval of New High-Intensity Sweetner :

Sucralose
Last update11/30/2006
Revision of t he Enf orcement Regulat ions under t he Food Sanit at ion Law and of t he
St andards and Specif icat ions f or Food and Food Addit ives, et c.*
(published in Of f icial Gazet t e, No. 2678, July 30, 1999)
July 30, 1999
The Ministry of Health and Welfare has revised the Enforcement Regulations(Ministry of Health and
Welfare Ordinance No.23, 1948), based on Article 6 and Article 11, Paragraph 1 of the Food Sanitation
Law (Law No. 233, 1947), and the Standards and Specifications for Food and Food Additives, etc. (Ministry
of Health and Welfare Announcement No. 370, December 1959), based on Article7-1 of the Food
Sanitation Law. These revisions have been based on Ministry of Health and Welfare Ordinance No.
75(Ministerial Ordinance to revise part of the Enforcement Regulations under the Food Sanitation Law)
and Ministry of Health and Welfare Announcement No. 167, which were published in Official Gazette, No.
2678, July 30, 1999.
Revision of t he Enf orcement Regulat ions
The substance given below has been added in a list of the additives designated as approved by Minister
of Health and Welfare,( Table 2 under Article 3 of the Ministerial Ordinance.)
No.168-2 Sucralose (Trichlorogalactosucrose)
Supplementary provision
This revision has come into effect on the date of publication.
Revision of t he St andards and Specif icat ions f or Food and Food Addit ives, et c.
The specifications and standards for components and standards for use, given below, have been added
in the specifications and standards for food and food additives based on Paragraph 7-1 and Paragraph 10.

Sucralose
Trichlorogalactosucrose

C12H19Cl3O8 Mol. Wt. 397.64

1,6-dichloro-1,6-dideoxy-beta-D-fructofuranosyl-4-chloro-4-deoxy-alpha-D-galactopyranoside
[56038-13-2]
Cont ent Sucralose, when calculated on the anhydrous basis, contains 98.0 - 102.0 % of Sucralose
(C12H19Cl3O 8).
Descript ion Sucralose occurs as a white to off-white crystalline powder. It is odorless and has a sweet
taste. It is freely soluble in water, in methanol, and in ethanol and slightly soluble in ethyl acetate.
Ident if icat ion T est s (1) Determine the infrated absorption spectrum of Sucralose as directed in the
Potassium Bromide Disk Method under the Infrated Spectrophotometry and compare the obtained
spectrum with the Reference Spectrum of Sucralose. Both spectra exhibit similar intensities of

spectrum with the Reference Spectrum of Sucralose. Both spectra exhibit similar intensities of
absorption at the same wave numbers.
(2) Dissolve 1.0g of Sucralose in 10ml of methanol, and used this solution as the test solution. Perform
Thin-Layer Chromatography on 5 l of the test solution, using a sodium chloride solution (dissolve 1g in a
solvent to make 20ml)-acetnitrile mixture (7:3) as the developing solvent. The Rf value of the spot is
from 0.4 to 0.6. For the thin layer plate, use octadecylsilanized silica gel for thin-layer chromatography.
Stop the development when the development solvent rises 15 cm, air-dry, remove the solvent, spray
with the 15 % Sulfuric acid-methanol TS, and heat at 125 C for 10 minutes to develop the color.
Purit y T est s (1) Clarity of solution Clear (1.0g, water 10ml)
(2) Specific rotation
(3) pH 3.0 - 6.0 (2.0 g, water 20 ml)
(4) Heavy metals Not more than 10 m g/g as Pb. (1.0 g, Method 2, Control solution Lead Standard Solution
1.0ml)
(5) Arsenic Not more than 4.0 mg/g as As2O 3.(0.50g, Method 2, Apparatus B)
(6) Other chlorinated disaccharides Not more than 0.5%
Test solution Dissolve 1.0 g of Sucralose in 10 ml of methanol.
Control solution Measure 0.5 ml of Test solution, add methanol to make 100 ml.
Procedure Perform Thin-Layer Chromatography on 5ml each of Test solution and Control solution, conduct
TLC assay of Identification Test (2). The spot in the Test Solution has no other spot which is more intense
than the spot in Control solution.
(7) Chlorinated monosaccharide Not more than 0.16 % as fructose
Test solution Weigh 2.5 g of Sucralose, add methanol to make exactly 10 ml.
Control solution A Weigh exactly 10.0 g of mannitol, add water to make exactly 100 ml.
Control solution B Weigh exactly 10.0 g of mannitol and 40 mg of fructose, add water to make exactly
100 ml.
Procedure Apply 1 ml of each of Test solutions, Control solution A and B onto the thin-layer
chromatography plate coated with a 0.25 mm thickness of silica gel, air-dry, and repeat this procedure
four times. Splay the p-anisidine-phthalic acid TS, and heat at 98 - 102 C for about 10 minutes to
develop the color. The spot from the Test Solution is not more colored than the spot from Control
solution B. When the mannitol spot from Control Solution A represent, a second plate should be
prepared, and repeat these procedure.
(8) Triphenylphosphine oxide Not more than 150 mg/g
Test solution Weigh accurately about 100 mg of Sucralose, dissolve a mixture of acetnitril-water(67:33)
to make exactly 10 ml.
Standard solution Weigh exactly 100 mg of triphenylphosphine oxide, dissolve a mixture of acetnitrilwater(67:33) to make exactly 10 ml. Measure exactly 1 ml of the resulting solution and add a mixture of
acetnitril-water(67:33) to make exactly 100 ml. Measure exactly 1 ml of the resulting solution and add a
mixture of acetnitril-water(67:33) to make exactly 100 ml.
Procedure Perform Liquid Chromatography on 25 ml each of the Test solution and Standard solution under
the conditions given below. Record the mean peak areas for the Standard and Test Solutions as As and
At respectively. Calculate the concentration of triphenylphosphine oxide (TPPO) in Sucralose from the
following formula.

Operating Conditions
Detector : Ultraviolet range absorption detector (measurement wavelength : 220 nm)
Column packing material :5mm octadecylsilanized silica gel.
Column tube :Stainless steel tube (length : 15 cm, internal diameter : 4.6 mm)
Column temperature :40 C
Mobile phase :acetonitrile - water (67:33)
Flow rate :1.5 ml/min.
(9) Methanol Not more than 0.1%
Test solution Weigh accurately about 2.0 g of Sucralose, add water to make exactly 10 ml, and mix.
Control solution Measure exactly 2 ml of methanol, add water to make exactly 100 ml, and mix.
Measure exactly 1 ml of this solution, add water to make exactly 100 ml, and mix.
Procedure Measure each 1ml of Test solution and Control solution, and perform Gas Chromatography
under the operating conditions given below. Measure the peak area of each solution, calculate SA and
AS, and calculated the content by the following formula:

CS is the concentration of methanol in the Control solution in percent.

C is the concentration of methanol in the Control solution in percent.

Operating conditions
Detector : Hydrogen flame ionization detector.
Column packing material : 150 180mm porous polymer for gas chromatography
Column tube : Glass tube (length : about 2 m, internal diameter : 2-4 mm)
Column temperature : Constant temperature of 140 - 160 C
Inlet temperature : 200 C
Detector temperature : 250 C
Carrier gas and flow rate : Use nitrogen or helium. Adjust the flow rate so that the retention time of
methanol is about 4 minutes.
Residue in Ignit ion Not more than 0.7%
Wat er Not more than 2.0% (1 g, direct titration).
Assay Weigh accurately about 1g of Sucralose, and dissolve in water to make exactly 100 ml. Measure
exactly 10 ml of this solution, added 10 ml of sodium hydroxide solution (dissolved 1g in a solvent to
make 10ml). Equip with reflex condenser, and gently heat for 30 minutes. Cool and neutralize with dilute
nitric acid, and titrate with 0.1mol/l silver nitrate. The end point is usually confirmed by using a
potentiometer (Indicator electrode : Silver electrode, expect that for silver-silver chloride electrode as
reference electrode is used.) Perform a blank test in the same manner, and make any necessary
correction and calculate on the dry basis.
1 ml of 0.1mol/l silver nitrate = 13.255mg C12H19Cl3O 8

St andards f or use of sucralose

Additives

Major use

Standards for use

Foods

Sucralose

Sweetener

Maximum Limit of use

Limitation of use

Confections

1.8g/kg

Chewing gum

2.6g/kg

Jam

1.0g/kg

The maximum limits

do not apply to foods
approved to be
labeled as "special
dietary use."

Lactic acid bacteria

drinks
Milk drinks
Miscellaneous
alcoholic beverages

0.40g/kg
(Applied to dilutions to the
case of concentrated
products)

Nonalcoholic
beverages
"Sake"(rice wine)
"Sake"(compounded)
Wine
Substitute for Sugar
Other foods

12g/kg
0.58g/kg

Note: This translation is an outline of Ministry of Health and Welfare Ordinance No.75 (Ministerial
Ordinance to revise part of the Enforcement Regulations under the Food Sanitation Law) and Ministry of
Health and Welfare Announcement No. 167. This is translated by The San-Ei Gen Foundation for Food
Chemical Research. If there is any discrepancy in this document, please refer to the Official Gazette in
Japanese, No. 2678, July 30, 1999.