ANNEX 2

SPECIFICATIONS AND TESTS FOR ACESULFAME POTASSIUM

Acesulfame potassium; Acesulfame K;

INS 950

ADI = 0 - 15 mg/kg bw

55589-62-3

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201,24

 Odourless, white crystalline powder

Sweetener, flavour enhancer

Freely soluble in water, very slightly soluble in ethanol.

Dissolve 10 mg of the sample in 1,000 ml of water. The solution shows an absorbance maximum at 227±2 nm

Passes test.

(Test the residue obtained by igniting 2 g of the sample).

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Not more than 1.0% (105^oC, 2 h).

5.5 - 7.5 (1% soln).

Passes test for 20 mg/kg of UV active components.

See description under Tests.

Not more than 3 mg/kg.

(Method III; using an appropriate sample size and appropriate volumes of the standard solution for construction of the calibration curve)

Not more than 1 mg/kg.

Not less than 99.0% and not more than 101.0% on the dried basis.

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Proceed as directed under the method for Chromatography (High Performance Liquid Chromatography, FNP 5) using the following conditions and using 4-hydroxybenzoic acid ethyl ester as the reference substance:

Column: 25 cm x 4.6 mm stainless steel

Stationary phase: Reversed phase (C18 silica gel, 3 - 5 µm)

Elution: Isocratic

Mobile phase: Acetonitrile/0.01 mol/l tetrabutyl ammonium hydrogen sulfate (TBAHS) in water; 40/60 v/v

Flow: About 1 ml/min

Detector type: UV or Diode array, 227 nm

Sample size: 20 µl of a 10 g/l solution of the sample in deionized water

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If peaks other than that due to acesulfame K appear within three times the elution time of acesulfame K, carry out a second run using 20 µl of a 0.2 mg/l solution of the sample.

The sum of the areas of all peaks eluted in the first run within 3 times the elution time of acesulfame K elution time, except for the acesulfame K peak, does not exceed the peak area of acesulfame K in the second run.

Tested under JECFA monograph 1 - Vol.4.