DEAS  994: 2019  
ICS 67.220.20  
 
© EAC 2019                                                                                                                               First Edition 2019   
 DRAFT EAST AFRICAN STANDARD  
Food grade sucralose  — Specification   
EAST AFRICAN COMMUNITY  DEAS 994: 2019  
ii © EAC  2019  – All rights reserved  
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Reproduction for sales purposes may be subject to royalty payments or a licensing agreement.  
Violators may be prosecuted . DEAS 994: 2019  
© EAC 2019  – All rights reserved  iii 
 Contents  Page 
Foreword  ................................ ................................ ................................ ................................ ............................  iv 
1 Scope  ................................ ................................ ................................ ................................ ......................  1 
2 Normative references  ................................ ................................ ................................ ............................  1 
3 Terms and definitions  ................................ ................................ ................................ ...........................  1 
4 Requirements  ................................ ................................ ................................ ................................ .........  2 
4.1 General requirements  ................................ ................................ ................................ ...........................  2 
4.3 Infrared absorption  ................................ ................................ ................................ ................................  2 
5 Hygiene  ................................ ................................ ................................ ................................ ...................  2 
6 Contaminants  ................................ ................................ ................................ ................................ .........  2 
7 Packaging  ................................ ................................ ................................ ................................ ...............  2 
8 Weights and measures  ................................ ................................ ................................ .........................  3 
9 Labelling  ................................ ................................ ................................ ................................ .................  3 
10 Sampling  ................................ ................................ ................................ ................................ ................  3 
Annex  A (normative)  Infrared spectrum of sucralose  ................................ ................................ ...................  4 
Annex  B (normative)  Determination of chlorinated disaccha rides  ................................ ..............................  5 
Annex  C  (normative)   Test for chlorinated monosaccharides  ................................ ................................ ..... 6 
Annex  D (normative)  Assay: Percentage purity  ................................ ................................ .............................  7 
Annex  E (normative)  Loss on drying  ................................ ................................ ................................ ...............  9 
Annex  F (normative)  Determination of sulphated ash  ................................ ................................ .................  11 
Annex  G (normative)  Test for triphenylphosphine oxide  ................................ ................................ ............  12 
Annex  H (normative)  Test for methanol  ................................ ................................ ................................ ........  13 
Bibliography  ................................ ................................ ................................ ................................ ......................  15 
 
 
  DEAS 994: 2019  
iv © EAC  2019  – All rights reserved  
 Foreword  
Development of the East African Standards has been necessitated by the need for harmonizing requirements 
governing quality of products and services in the East African Community. It is envisaged that through 
harmonized standardization, trade barriers that are encountered when goods and services are exchanged 
within the Community will be removed.  
The Community has established an East African Standards Committee  (EASC)  mandated to develop and 
issue East African Standards  (EAS) . The Committee is composed of representatives of the National 
Standards Bodies in Partner States, together with the representatives from the public and private sector 
organizations  in the community .  
East African Standards are developed through  Techn ical Committees that are representative of key 
stakeholders including government, academia, consumer groups, private sector and other interested parties. 
Draft East African Standards are circulated to stakeholders through the National Standards Bodies in t he 
Partner States. The comments received are discussed and incorporated before finalization of standards, in 
accordance with the Principles and procedures for develop ment of East African Standards.  
East African Standards are subject to review, to keep pace  with technological advances. Users of the East 
African Standards are therefore expected to ensure that they always have the latest versions of the standards 
they are implementing .  
The committee responsible  for this document is Technical Committee EASC /TC 005 Food additives . 
Attention is drawn to the possibility that some of the elements of this document may be subject of patent 
rights. EAC shall not be held responsible for identifying any or all such patent rights.  DEAS 994: 2019  
© EAC 2019  – All rights reserved  v 
 Introduction  
Sucralose, (1,6 -dichloro -1,6-dideoxy -β-D-fructofuranosyl -4-chloro -4-deoxy -alpha -D-galactopyranoside) is a 
non-caloric artificial sweetener, approximately 650 times sweeter than sucrose (table sugar), twice as sweet 
as saccharin, and four times as sweet as aspartame. It has an Acceptable Daily Intake (ADI) of 15 mg/kg body 
weight.  
Its consumption has increased as result of the growing trends to consume low calorie foods with less impact 
on blood glucose than sucrose. It also has no effect on tooth decay and is commonly found in oral healt h 
products. It possesses the following sweetener characteristics: non -caloric, insipid and stability at high 
temperatures and in acidic medium. Its characteristics are preserved, even during pasteurisation, sterilisation 
and cooking at high temperatures. I n addition, it cannot be hydrolysed during digestion or metabolism due to 
the high stability of its carbon -chlorine bonds and it does not interact chemically with other foods.  
Sucralose -based products are found in a broad range of lower -calorie foods, inc luding, fizzy drinks, chewing 
gum, baking mixes, breakfast cereals and salad dressings.  
This standard has therefore been developed to prescribe requirements for  food grade  sucralose for use in 
food industry.  
 DEAS 994: 2019    
 
© EAC 2019  – All rights reserved  
  
 Food grade s ucralose  — Specification  
1 Scope  
This Draft East African Standard specifies requirements, sampling and test methods for sucralose intended  for 
use in food products . 
2 Normative references  
The following documents are referred to in the text in such a way that some or all of their content co nstitutes 
requirements of this document.  For dated references, only the edition cited applies. For undated references, 
the latest edition of the referenced document (including any amendments) applies.  
AOAC 972.25 , Lead in food. Atomic absorption spectropho tometric method  
CAC/GL 50 , General guidelines on sampling  
CODEX STAN 107, General standard for the labelling of food additives when sold as such  
EAS 39, Hygiene in the food and drink manufacturing industry — Code of practice  
3 Terms and definitions  
For the  purposes of this document, the following terms and definitions apply.  
ISO and IEC maintain terminological databases for use in standardization at the following addresses:  
— ISO Online browsing platform: available at http://www.iso.org/obp  
3.1 
food grade material  
material, made of substances that  are safe and suitable for their intended use and which will not impart any 
toxic substance or undesirable odour or flavour to the product  
3.2 
sucralose  
low calorie, artificial , derivative substance of chlorination of sucrose, used for sweetening food and drink  
3.3 
artificial sweetener  
synthetic substance used as a sugar substitute to sweeten food and drink  DEAS 994: 2019  
2 © EAC  2019  – All rights reserved  
 4 Requirements  
4.1 General  requirements  
Sucralose shall be;  
a) a white to o ff-white ;  
b) practically odourless crystalline powder ; 
c) freely soluble in  water, methanol and ethanol ; and 
d) slightly soluble in ethyl acetate . 
4.2 Specific requirements  
Sucralose shall comply with the specific requirements given in Table 1  when tested in acco rdance with the 
test methods  specified therein.  
Table 1 — Specific r equirements for sucralose  
S/N Characteristic  Requirement  Test method  
i) Chlorinated disaccharides* To pass the test  Annex B  
ii) Chlorinated monosaccharides  To pass the test  Annex C  
iii) Assay: percentage purity, % m/m  (dry basis ) 98 – 102 Annex D  
iv) Loss on drying , % m/m, max. 2 Annex E  
v) Sulphated ash, % m/m , max. 0.7 Annex F  
vi) Triphenylphosphine oxide, mg/kg, max. 150 Annex G  
vii) Methanol, % m/m , max. 0.1 Annex H  
* The mai n spot in the test solution shall have the same retardation factor ( Rf) as that of the main spot of Standard Solution 
A obtained in the test for other chlorinated disaccharides when tested using thin layer chromatography.  
4.3 Infrared absorption  
The infra red spectrum of a potassium bromide dispersion of a sucralose sample shall correspond with the 
reference infrared spectrum in Annex A.  
5 Hygiene  
Food grade s ucralose shall be manufactured and handled in accordance with EAS 39.  
6 Contaminants  
Lead  (as Pb), shall not exceed 1 mg/kg  when tested in accordance with AOAC 972.25.  
7 Pack aging  
Food grade sucralose  shall be securely packaged in containers made of food grade material s. The packages 
shall preserve the  safety and  quality of the product, prevent entry o f light and preclude contamination from the 
external environment . DEAS 994: 2019  
© EAC 2019  – All rights reserved  3 
 8 Weights and measures  
The products shall comply with the Weights and Measures Regulations of the respective Partner States . 
9 Labelling  
In addition to the requirements of CODEX STAN 107, th e product packages shall be legibly and indelibly labelled with the 
following information:  
a) name of the product  as “Food grade sucralose ”; 
b) name and physical address of the processor/packer/importer;  
c) date of manufacture;  
d) expiry date;  and 
e) net weight  of the pr oduct in metric  units . 
10 Sampling  
Representative samples of the product shall be drawn in accordance with CAC/GL 50.  
 DEAS 994: 2019  
4 © EAC  2019  – All rights reserved  
 Annex  A 
(normative)  
 
Infrared spectrum of sucralose  
 
Figure 1 — Reference i nfrared spectrum of a p otassium bromide dispersion of  sucralo se 
 DEAS 994: 2019  
© EAC 2019  – All rights reserved  5 
 Annex  B 
(normative)  
 
Determination of chlorinated disaccharides   
B.1  Appara tus 
TLC plates . Reverse phase thin layer chromatography plates coated with 0.2 mm layer of silica gel absorbent 
(for example, Whatman LKC 18) 
B.2  Reagents  
B.2.1  Mobile phase . Mix 7 volumes of a 5.0 % w/v aqueous solution of sodium chloride and 3 volumes of 
acetonitrile.  
B.2.2  Spray r eagent . Use 15 % v/v solution of concentrated sulphuric acid in methanol.  
B.2.3  Standard s olutions . Dissolve 1.0 g of sucralose reference standard in 10 ml of methanol (Solution 
A). Dilute 0.5 ml of Solution A with methanol to 100 ml (Solution B).  
B.2.4  Test s olution . Dissolve 1.0 g of sample in 10 ml of methanol.  
B.3  Procedure  
Apply 5 μl each of solution A, solution B and test solution to the bottom of the chromatographic plate. Place 
the plate in a suitable chromatography chamber containing freshly prepared mobile phase and allow the 
solvent front to ascend 15 cm. Remove the pl ate from the chamber, allow it to dry and spray with spray 
reagent. Heat the plate in an oven at 125 °C for 10 min.  
The sample is said to have passed the test when the main spot in the test solution has the same Rf value as 
the main in solution A and no o ther spot in the test solution is more intense than the 0.5 % spot in solution B.  DEAS 994: 2019  
6 © EAC  2019  – All rights reserved  
 Annex  C  
(normative)  
 
Test for chlorinated monosaccharides  
C.1  Apparatus  
TLC p lates  coated with 0.25 mm thickness of silica gel 60 or equivalent.  
C.2  Reagents  
C.2.1  Spray reagent . Dissolve 1.23 g p -anisidine and 1.66 g phthalic acid in 100 ml methanol. Store the 
solution in darkness and refrigerate to prevent it from becoming decolourised. Discard if solution becomes 
discoloured.  
NOTE  p-anisidine is toxic by skin absorption  and inhalation and should be used with due caution.  
C.2.2  Standard s olution A . Dissolve 10.0 g ± 0.001 g of mannitol in 40 ml of distilled water in a 100 ml 
volumetric flask. Dilute to volume using the water.  
C.2.3  Standard s olution B . Dissolve 10 g of ma nnitol and 40 mg of fructose (Analytical grade) in 25 ml of 
water in a 100 ml volumetric flask and make up to volume  with the water.  
C.2.4  Sample solution . Dissolve 2.5 g of sample in 5 ml of methanol in a 10 ml volumetric flask and make 
up to volume with methanol.  
C.3  Procedure  
Spot 5 μl of each of standard solutions A and B onto the TLC plate, applying the solution slowly in 1 μl aliquots 
and allowing the plate to dry between applications. Spot 5 μl of the sample solution onto the plate in a similar 
manner. The three spots shoul d be of similar size. Spray the plate with the spray reagent and heat at 100 °C ± 
2 °C for 15 min. View the plate against a dark background immediately after heating.  
The sample shall have passed the test when the spot from the sample solution is not more  coloured than the 
spot from solution B (equivalent to a limit of 0.1 % maximum total chlorinated monosaccharides).  
Darkening of the mannitol spot from standard solution A indicates that the plate has been held too long in the 
oven, and a second plate sho uld be prepared.  DEAS 994: 2019  
© EAC 2019  – All rights reserved  7 
 Annex  D 
(normative)  
 
Assay: Percentage purity  
D.1  Apparatus  
D.1.1  Chromatographic system  
Fit a high -pressure liquid chromatograph, operated at room temperature, with a radial compression m odule 
containing a 10 cm 5 μm C 18 reverse phase column. The mobile phase is maintained at a pressure and flow 
rate (typically 1.5 ml/min) capable of giving the required elution time (see D.5). An ultraviolet detector that 
monitors absorption at 190 nm, or a refractive index detector is used.  
D.1.2  Mobile phase  
Add 150 ml of acetonitrile (HPLC grade, far UV, filtered through a 0.45 μm millipore filter or equivalent) to 850 
ml of water (glass distilled, filtered through a 0.45 μm millipore filter or equivalen t). Mix and degas thoroughly.  
D.2  Standard solution  
Weigh accurately about 250 mg of sucralose reference standard into a 25 ml volumetric flask. Dissolve and 
make up to volume using the mobile phase. Filter the solution through a 0.45 μm millipore filter or equivalent. 
Record the mass of reference standard as Ws. 
D.3  Test solution  
Weigh accurately about 250 mg of sample into a 25 ml volumetric flask. Dissolve and make up to volume 
using the mobile phase. Filter the solution through a 0.45 μm millipore fil ter or equivalent. Record the mass of 
sample as Wt. 
D.4  System suitability test  
Inject duplicate 20 μl portions of standard solution into the chromatograph. The retention time of the sucralose 
should be approximately 9 min. The co -efficient of variation ( 100 x standard deviation divided by mean peak 
area) for the peak areas should not exceed 2 %.  
NOTE  The retention time quoted is appropriate for a 10 cm 5 μm Rad -Pak C 18 column. If a column of a different 
make or length is used it may be necessary to adjust  the proportion of acetonitrile in the eluent to obtain the required 
retention time.  
D.5  Procedure  
Analyse the test solution under the conditions described above, making duplicate 20 μl injections, and 
calculate the mean peak area.  
The percentage purity from the relative peak areas of the test ( At) and standard solutions ( As), expressed as 
percent, shall be calculated as follows:  
Purity =
100 x  x  x 
t ss t
W AW A  
 DEAS 994: 2019  
8 © EAC  2019  – All rights reserved  
 where  
 At is the percentage purity of the test solution;  
 Ws is the mass, in milligrams, of the  reference standard;  
 As is the percentage purity of the standard solution; and  
 Wt is the mass, in milligrams of the sample  
The percentage purity on a water -free and methanol -free basis shall be calculated using the values obtained 
in the tests for water  and methanol, respectively.  
 DEAS 994: 2019  
© EAC 2019  – All rights reserved  9 
 Annex  E 
(normative)  
 
Loss on drying  
E.1  Requirements  
E.1.1 Weighing bottle with a stopper  
E.1.2 Air oven  
E.1.3 Desiccator  
E.1.4 Weighing scale  
E.2  Sample preparation  
Weigh  1 to 2 g of sample (M 1). Tare a glass -stoppered, shallow weighing bottle that has been dried for 30 
minutes at 105 ºC. Transfer the sample into the bottle, replace the cover, and weigh the bottle and the sample 
(M2). Distribute the sample as evenly as pra cticable to a depth of about 5 mm, and not over 10 mm.  
E.3  Procedure  
Place the bottle with its contents in the drying chamber, removing the stopper and leaving it also in the 
chamber, and dry the sample at the 105 ºC for 2 hours. Upon opening the chambe r, close the bottle promptly 
and allow it to come to room temperature in a desiccator. Weigh the cool bottle and its contents (M 3).  
Calculate the loss on drying from the following equation:  
Loss on drying (%w/w) = 
  
where  
 M1 is the mass of s ample in grams;  
 M2 is the mass of sample and weighing bottle in grams before drying; and  
 M3 is the mass of sample and weighing bottle in grams after drying and cooling in a desiccator.  
If the sample melts at a temperature lower than 105 ºC, prepare the  sample as described above, then place it 
in a vacuum desiccator containing sulfuric acid. Evacuate the desiccator to 130 Pa (1 mm of mercury), 
maintain this vacuum for 24h, and then weigh the dried sample. Calculate the loss on drying using the same 
equat ion above.  
 DEAS 994: 2019  
10 © EAC  2019  – All rights reserved  
  DEAS 994: 2019  
© EAC 2019  – All rights reserved  11 
 Annex  F 
(normative)  
 
Determination of sulphated ash  
F.1  Apparatus  
F.1.1  Crucible   
F.1.2 Heating plate  
F.1.3 Desiccator  
F.1.2 Analytical balance  
F.2  Reagents  
Concentrated sulphuric acid (A. R. grade)  
F.3  Procedure  
Weigh accurately about 2 g of product in a tared crucible ( W2). Ignite, gently at first, until the material is 
thoroughly charred. Cool and moisten the residue with 1 ml of sulphuric acid and ignite gently till the carbon is 
comple tely consumed. Cool the crucible in a desiccator and weigh ( W1). 
NOTE  Carry out the ignition in a place protected from air  currents and use as low a temperature as possible to effect 
the combustion of carbon.  
Sulphated ash, expressed as percent by mass, sh all be calculated using the formula below:  
21
WW
X 100  
where  
W1 is the mass , in grams, of the residue ; and  
W2 is the mass, in grams, of the product tested. DEAS 994: 2019  
12 © EAC  2019  – All rights reserved  
 Annex  G 
(normative)  
 
Test for trip henylphosphine oxide  
G.1  Apparatus  
Chromatographic s ystem . Typically a high -pressure liquid chromatograph, operated at room temperature, is 
fitted with a radial compression module containing a 5 μm C 18 Rad-Pak reverse phase column (10 cm x 8 
mm). The mobi le phase is maintained at a pressure and flow rate (typically 1.5 ml/min) capable of giving the 
required elution time. The chromatograph is equipped with a UV detector (220 nm).  
G.2  Reagents  
G.2.1 Mobile p hase . Add 67 volumes of acetonitrile (HPLC grade, far UV, filtered through a 0.45 μm 
millipore filter or equivalent) to 33 volumes of water (glass distilled, filtered through a 0.45 μm millipore filter or 
equivalent). Mix and de -gas thoroughly.  
G.2.2 Standard  solution . Weigh accurately 100 mg of triphenyl phosphine oxide into a 10 ml volumetric 
flask. Dissolve and make up to volume using the mobile phase. Take 1.0 ml of the resulting solution and make 
up to 100 ml with mobile phase. From this solution, prepare a further 100 -fold dilution with mobile phase a nd 
use this as the standard solution. Filter through a 0.45 μm millipore filter or equivalent.  
G.2.3 Test s olution . Weigh accurately 100 mg of sample into a 10 ml volumetric flask. Dissolve and make 
up to volume with mobile phase. Filter through a 0.45 μm millipore filter or equivalent. Record the mass of 
sample as Wt in milligrams  
G.3  Procedure  
Inject duplicate 25 μl portions of the standard and test solutions into the chromatograph. Under the conditions 
stated above the retention time for triphenylphosph ine oxide is 6 min. Record the mean peak areas for the 
standard and test solutions as As and At respectively.  
The concentration of triphenylphosphine oxide (TPPO) in the sample, expressed in milligrams per kilogram, 
shall be calculated using the formula be low: 
TPPO (mg/kg) =
t st
W AA 10000 x  
where  
 At is the mean peak area for the standard solution ;  
 As is the mean peak area for the test solution; and 
 Wt is the mass, in milligrams, of the sample.  DEAS 994: 2019  
© EAC 2019  – All rights reserved  13 
 Annex  H 
(normative)  
 
Test for methanol  
H.1  Apparatus  
Use a suitable gas chromatograph equipped with a hydrogen flame ionization detector containing a 2.1 m x 
4.0 mm (id) glass column packed with Porapak PS 80 -100 mesh or equivalent materials.  
H.1.2 Operating conditions  
The operating conditions may vary depending upon the particular instrument used but a suitable 
chromatogram may be obtained by using the following conditions:  
 Column temperature: 150 °C (isothermal);  
 Inlet temperature: 200 °C;  
 Detector temperatu re: 250 °C; and  
 Carrier gas nitrogen: 20 ml/min.  
H.2  Reagents  
H.2.1 Standard s olutio n. Using a 2.0 ml class A  volumetric pipette, pipette 2.0 ml of methanol into a 100 ml 
volumetric flask, dilute to volume with pyridine, and mix. Transfer 1.0 ml of this s olution to a 100 ml volumetric 
flask, dilute to volume with pyridine, and mix.  
H.2.2 Sample s olution . Weigh accurately about 2 g of the sample ( Ws) into a 10 ml volumetric flask, dilute 
to volume with pyridine, and mix.  
H.3  Procedure  
Inject a 1 μl portion of the standard solution onto a gas chromatography column, obtain the chromatogram, 
and measure the area of the peak produced. The relative standard deviation for replicate injections should not 
be more than 2.0 %. Calculate the mean peak areas for the standard solution ( As). Similarly, inject a 1 μl 
portion of the sample solution ( Vs) into the gas chromatograph, and measure the areas of the peaks produced 
by methanol ( SA).  
Calculate the mean peak areas, and determine the methanol concentration,  expressed as a percentage, using 
the following formula:  
Methanol, percent = 
S SS S A
 x  x x 
W AC V S  
where  
 SA is the area for the sample;  
CS  is the percentage concentration of methanol in the standard (volume of methanol X dilution 
factor X density of so lvent equals 2 x 10–4 x 0.79 x 100);  
VS  is the volume of the sample solution;  DEAS 994: 2019  
14 © EAC  2019  – All rights reserved  
 AS  is the standard area; and  
WS  is the mass, in grams, of the sample.  
 DEAS 994: 2019  
© EAC 2019  – All rights reserved  15 
 Bibliography  
[1] IS 5345: 1996 (Reaffirmed in 2001) , Sodium saccharin  food grade — Specification  (Second  revision)  
[2] JECFA (2001), Saccharin monograph  
[3] Food chemicals Codex  (5th Edition)   
[4] JECFA (2006), Analytical methods, test procedures and laboratory solutions used by and  referenced in 
the food additive specifications, Volume 4.