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MINISTRY OF HEALTH OF
VIETNAM
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THE SOCIALIST REPUBLIC
OF VIETNAM
Independence – Freedom – Happiness
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No. 18/2010/TT-BYT
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Hanoi, May 20, 2010
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CIRCULAR
PROMULGATING NATIONAL
TECHNICAL REGULATION ON FOOD ADDITIVE - FLAVOUR ENHANCER
THE MINISTER OF HEALTH
Pursuant to the Law on
Standards and Technical Regulations dated June 29, 2006 and the Government's
Decree No. 127/2007/ND-CP dated August 01, 2007 elaborating on some Articles of
the Law on Standards and Technical Regulations;
Pursuant to the Ordinance on Foods Safety dated August 07, 2003 and
Government’s Decree No. 163/2004/ND-CP dated September 07, 2004 elaborating on
some Articles of the Ordinance on Foods Safety;
Pursuant to the Government’s Decree No. 188/2007/ND-CP dated December 27, 2007
defining functions, tasks, rights and organizational structure of the Ministry
of Health;
At the request of the Director General of the Vietnam Food Administration, the
Director General of the Science and Education Department and the Director General
of the Department of Legal Affairs,
HEREBY DECIDES:
Article 1. Promulgated together with this Circular
is:
QCVN 4-1:2010/BYT - National technical
regulation on food additive - flavour enhancer.
Article 2. This Circular comes into force from
January 01, 2011.
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PP. THE MINISTER
THE DEPUTY MINISTER
Trinh Quan Huan
Foreword
QCVN 4-1 :2010/BYT is developed by the Drafting
Board for National technical regulation on food additives and food processing
aids, submitted by the Vietnam Food Administration for approval and
promulgated together with the Circular No. 18/2010/TT-BYT dated May 20, 2010 of
the Minister of Health.
NATIONAL TECHNICAL
REGULATION ON FOOD ADDITIVE – FLAVOUR ENHANCER
I. GENERAL
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This National technical regulation (hereinafter
referred to as “the Regulation”) provides for specifications and regulatory
requirements for quality, hygiene and safety of flavour enhancers used as food
additives.
2. Regulated entities
This Regulation applies to:
2.1. Importers, exporters, producers, traders
and users of flavour enhancers used as food additives (hereinafter referred to
as “entities”).
2.2. Relevant regulatory bodies.
3. Interpretation of terms and acronyms:
3.1. “flavour enhancer” refers to a food
additive used for the purpose of adding flavor to food products.
3.2. JECFA monograph 1 - Vol. 4 (JECFA
monographs 1 - Combined compendium of food additive specifications; Joint
FAO/WHO expert committee on food additives; Volume 4 - Analytical methods, test
procedures and laboratory solutions used by and referenced in the food additive
specifications; FAO, 2006) is developed by JECFA and was published by FAO
in 2006.
3.3. “C.A.S number” (Chemical Abstracts
Service) refers to registry numbers of chemical substances identified by the
American Chemical Society.
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3.5. “ADI” stands for Acceptable daily
intake.
3.6. “INS” stands for international
numbering system.
II. SPECIFICATIONS, TESTS AND SAMPLING
1. Specifications and tests for flavour enhancers specified
in the annexes to this Regulation:
Annex 1: Specifications and tests for L-glutamic
acid
1.2. Annex 2: Specifications and tests for
monosodium L-glutamate
1.3. Annex 3: Specifications and tests for
monopotassium L-glutamate
1.4. Annex 4: Specifications and tests for calcium
di-L-glutamate
1.5. Annex 5: Specifications and tests for 5’-guanylic
acid
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1.7. Annex 7: Specifications and tests for maltol
1.8. Annex 8: Specifications and tests for ethyl maltol
2. Specifications specified in this Regulation are
tested under JECFA monograph 1 - Vol. 4, except for some specific tests
described in the annexes. The tests provided in this Regulation are optional.
Other equivalent tests may be used.
3. Sampling adheres to the guidelines in the
Circular No. 16/2009/TT-BKHCN dated June 02, 2009 by the Ministry of Science
and Technology and relevant regulations of law.
III. REGULATORY
REQUIREMENTS
1. Declaration
of conformity
Conformity of flavour enhancers shall be
declared in accordance with the regulations set out in this Regulation.
1.2. Methods and procedures for declaration of
conformity shall comply with the Regulation on certification and declaration of
conformity with regulations and standards under the Decision No. 24/2007/QD-BKHCN
dated September 28, 2007 of the Minister of Science and Technology and
regulations of laws.
2. Inspection of flavour enhancers
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IV.
RESPONSIBILITIES OF ENTITIES
1. Entities
must declare conformity according to the specifications mentioned in this
Regulation, register their declarations of conformity at the Vietnam Food
Administration and ensure the quality, hygiene and safety as declared.
2. Entities
are only entitled to import, export, produce, sell and use flavour enhancers as
declared after their completion of registration of declarations of conformity
and their compliance with regulations of law on quality, hygiene, safety and
labeling.
V.
IMPLEMENTATION
1. The Vietnam Food Administration shall preside
over and cooperate with competent authorities concerned to provide guidance on
and organize the implementation of this Regulation.
2. The Vietnam Food Administration shall, according
to its managerial duties, suggest amendments to this Regulation to the Ministry
of Health.
3. In the cases where any of the international
guidelines for tests and regulations of law referred to in this Regulation is
amended or replaced, the newest one shall apply.
ANNEX 1
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1. Synonyms
L-glutamic acid,
Glutamic acid
INS 620
ADI “Not limited”
2. Definition
Chemical names
Acid L-glutamic; Acid
L-(+)-glutamic, acid L-2-amino-pentandioic; Acid L-alpha-aminoglutaric
C.A.S. number
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Chemical formula
C5H9NO4
Structural formula
Formula weight
147,13
3. Description
Colourless or white crystals or crystalline
powder.
4. Functional uses
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5. Specifications
5.1. Identification
Solubility
Sparingly soluble in water; practically
insoluble in ethanol or ether.
Test for glutamate
Passes test.
5.2. Purity
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Not more than 0.2%
(80 oC, 3 h).
pH
3.0 - 3.5 (saturated solution).
Specific rotation
[a]D20: Between +31.5 and
+32.2o (10%(w/v) soln in 2N hydrochloric acid)
Sulfated ash
Not more than 0.2%.
Chlorides
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Pyrrolidone carboxylic
acid
Passes test (described in “Tests”).
Arsenic
Not more than 3 mg/kg
Lead
Not more than 1 mg/kg.
5.3. C5H9NO4
content
Not less than 99.0% on the dried basis.
6. Tests
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Sulfated ash
Tested according to JECFA monograph 1 - Vol.4
- Method I, test 1 g of the sample
Chlorides
Tested according to JECFA monograph 1 - Vol.4
- Test 0.07 g of the sample as directed in the Limit Test using 0.4 ml of
0.01 N hydrochloric acid in the control.
Pyrrolidone carboxylic
acid
- Tested according to JECFA monograph 1 -
Vol.4 - Thin-layer chromatography.
- Sample: 2 μl of a 0.5 in solution of the
sample.
- Reference: 2 μl of a 0.5 in solution of
monosodium L-glutamate containing 2.5 mg of pyrrolidone carboxylic acid.
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- Adsorbent: Silica gel.
Potassium iodide-starch solution: Stir and
heat 0.5 g of starch in about 50 ml of water until it gelatinizes; after
cooling add 0.5 g of potassium iodide and water to make up to 100 ml.
- Proceed as directed under thin-layer
chromatography (analytical techniques). Stop the development when the solvent
front has advanced about 10 cm from the point of the application dry the
plate for 30 min in air.
- At the same time, prepare a similar chamber
to that used for developing; place a 50-ml beaker containing about 3 g of
sodium hypochlorite in the chamber; slowly add 1 ml of hydrochloric acid into
the beaker to generate chlorine gas; put on the lid and allow to stand for 30
sec to fill the chamber with chlorine. Place the dried plate in this chamber,
put on the lid and allow to stand for 20 min. Take out the plate, keep for 10
min in air and spray with ethanol. After drying, spray with potassium
iodide-starch solution and observe the plate under natural light immediately
after the standard spot has appeared.
Requirement: No spot corresponding to
pyrrolidone carboxylic acid standard is detected in the sample (sensitivity =
0.2%).
Arsenic
- Tested according to JECFA monograph 1 -
Vol.4, Method II.
Lead
- Tested according to JECFA monograph 1 -
Vol.4.
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6.2. Method of assay
Dissolve about 200 mg of the sample,
previously dried and weighed accurately, in 6 ml of formic acid, and add 100
ml of glacial acetic acid. Titrate with 0.1 N perchloric acid determining the
end-point potentiometrically. Run a blank determination in the same manner
and correct for the blank.
Each ml of 0.1 N perchloric acid is equivalent
to 14.713 mg of C5H9NO4.
ANNEX 2
SPECIFICATIONS AND TESTS
FOR MONOSODIUM L-GLUTAMATE
1. Synonyms
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INS 621
ADI “Not limited”
2. Definition
Chemical names
Monosodium L-glutamate
monohydrate, glutamic acid monosodium salt monohydrate
C.A.S. number
6106-04-3
Chemical formula
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Structural formula
Formula weight
187,13
3. Description
White, practically odourless crystals or
crystalline powder.
4. Functional uses
Flavour enhancer.
5. Specifications
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Solubility
Freely soluble in water; sparingly soluble in
ethanol; practically insoluble in ether.
Test for glutamate
Passes test.
Test for sodium
Passes test.
5.2. Purity
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Not more than 0.5% (98oC , 5 h).
pH
6.7 - 7.2 (1 in 20 soln).
Specific rotation
[a]D20: Between +24.8 and
+25.3o (10%(w/v) soln in 2N hydrochloric acid)
Chlorides
Not more than 0.2%.
Pyrrolidone carboxylic
acid
Passes test (described in “Tests”).
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Not more than 1 mg/kg.
5.3. C5H8NNaO4.H2O
content
Not less than 99.0% on the dried basis.
6. Tests
6.1. Purity
Chlorides
Tested according to JECFA monograph 1 - Vol.4
- Test 0.07 g of the sample as directed in the Limit Test using 0.4 ml of
0.01 N hydrochloric acid in the control.
Pyrrolidone carboxylic
acid
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- Sample: 2 μl of a 0.5 in solution of the
sample.
- Reference: 2 μl of a 0.5 in solution of
monosodium L-glutamate containing 2.5 mg of pyrrolidone carboxylic acid.
- Solvent: A mixture of 2 volumes of
n-butanol, 1 volume of glacial acetic acid and 1 volume of water.
- Adsorbent: Silica gel.
Potassium iodide-starch solution: Stir and
heat 0.5 g of starch in about 50 ml of water until it gelatinizes; after
cooling add 0.5 g of potassium iodide and water to make up to 100 ml.
- Proceed as directed under thin-layer
chromatography (analytical techniques). Stop the development when the solvent
front has advanced about 10 cm from the point of the application dry the
plate for 30 min in air.
- At the same time, prepare a similar chamber
to that used for developing; place a 50-ml beaker containing about 3 g of
sodium hypochlorite in the chamber; slowly add 1 ml of hydrochloric acid into
the beaker to generate chlorine gas; put on the lid and allow to stand for 30
sec to fill the chamber with chlorine. Place the dried plate in this chamber,
put on the lid and allow to stand for 20 min. Take out the plate, keep for 10
min in air and spray with ethanol. After drying, spray with potassium
iodide-starch solution and observe the plate under natural light immediately
after the standard spot has appeared.
Requirement: No spot corresponding to
pyrrolidone carboxylic acid standard is detected in the sample (sensitivity =
0.2%).
Lead
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- 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 JECFA monograph 1 - Volume 4, “Instrumental Methods.”
6.2. Method of assay
Dissolve about 200 mg of the sample,
previously dried and weighed accurately, in 6 ml of formic acid, and add 100
ml of glacial acetic acid. Titrate with 0.1 N perchloric acid determining the
end-point potentiometrically. Run a blank determination in the same manner
and correct for the blank.
Each ml of 0.1 N perchloric acid is equivalent
to 9.356 mg of C5H9NNaO4.H2O.
ANNEX 3
SPECIFICATIONS AND TESTS
FOR FOR MONOPOTASSIUM L-GLUTAMATE
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Monopotassium
L-glutamate, Potassium glutamate; MPG
INS 622
ADI “Not limited”
2. Definition
Chemical names
Monopotassium
L-glutamate monohydrate, glutamic acid monopotassium salt monohydrate
C.A.S. number
19473-49-5
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C5H8NKO4.H2O
Structural formula
Formula weight
203,24
3. Description
4. Functional uses
Flavour enhancer, salt
substitute.
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5.1. Identification
Solubility
Freely soluble in
water; slightly soluble in ethanol.
Test for glutamate
Passes test.
Potassium
Passes test.
5.2. Purity
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Loss on drying
Not more than 0.2% (80oC,
5 h).
pH
6.7 - 7.3 (1 in 50
soln).
Specific rotation
[a]D20: Between +22.5 and
+24.0o (10%(w/v) soln in 2N hydrochloric acid)
Chlorides
Not more than 0.2%.
Pyrrolidone carboxylic
acid
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Lead
Not more than 1 mg/kg.
5.3. C5H8NKO4.H2O
content
Not less than 99.0% on
the dried basis.
6. Tests
6.1. Purity
Chlorides
- Tested according to JECFA monograph 1 -
Vol.4.
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Pyrrolidone carboxylic
acid
- Tested according to JECFA monograph 1 -
Vol.4 - Thin-layer chromatography.
- Sample: 2 μl of a 0.5 in solution of the
sample.
- Reference: 2 μl of a 0.5 in solution of
monosodium L-glutamate containing 2.5 mg of pyrrolidone carboxylic acid.
- Solvent: A mixture of 2 volumes of
n-butanol, 1 volume of glacial acetic acid and 1 volume of water.
- Adsorbent: Silica gel.
Potassium iodide-starch solution: Stir and
heat 0.5 g of starch in about 50 ml of water until it gelatinizes; after
cooling add 0.5 g of potassium iodide and water to make up to 100 ml.
- Proceed as directed under thin-layer
chromatography (analytical techniques). Stop the development when the solvent
front has advanced about 10 cm from the point of the application dry the
plate for 30 min in air.
- At the same time, prepare a similar chamber
to that used for developing; place a 50-ml beaker containing about 3 g of
sodium hypochlorite in the chamber; slowly add 1 ml of hydrochloric acid into
the beaker to generate chlorine gas; put on the lid and allow to stand for 30
sec to fill the chamber with chlorine. Place the dried plate in this chamber,
put on the lid and allow to stand for 20 min. Take out the plate, keep for 10
min in air and spray with ethanol. After drying, spray with potassium
iodide-starch solution and observe the plate under natural light immediately
after the standard spot has appeared.
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Lead
- Tested according to JECFA monograph 1 - vol
4.
- 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 JECFA monograph 1 - Volume 4, “Instrumental Methods.”
6.2. Method of assay
Dissolve about 200 mg of the sample,
previously dried and weighed accurately, in 6 ml of formic acid, and add 100
ml of glacial acetic acid. Titrate with 0.1 N perchloric acid determining the
end-point potentiometrically. Run a blank determination in the same manner
and correct for the blank.
Each ml of 0.1 N perchloric acid is equivalent
to 10.162 mg of C5H8KNO4.H2O.
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SPECIFICATIONS AND TESTS
FOR FOR CALCIUM DI-L-GLUTAMATE
1. Synonyms
Monocalcium
di-L-glutamate, Calcium glutamate;
INS 623
ADI “Not limited”
2. Definition
Chemical names
Monocalcium
di-L-glutamate;
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19238-49-4
Chemical formula
C10H16CaN2O8
. xH2O (x = 0, 1, 2, 6 or 4)
Structural formula
Formula weight
332.32 (anhydrous)
3. Description
White, practically
odourless crystals or crystalline powder.
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Flavour enhancer, salt
substitute.
5. Specifications
5.1. Identification
Solubility
Freely soluble in
water.
Test for glutamate
Passes test.
Test for calcium
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5.2. Purity
Water
Not more than 19%
Specific rotation
[a]D20:
Between +27.4 and +29.2o (10%(w/v) soln in 2N hydrochloric acid)
Chlorides
Not more than 0.2%.
Pyrrolidone carboxylic
acid
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Lead
Not more than 1 mg/kg.
5.3. C10H16CaN2O8
content
Not less than 98.0%
and not more than 102.0 % on the anhydrous basis.
6. Tests
6.1. Purity
Water
- Tested according to JECFA monograph 1 -
Vol.4.
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Chlorides
- Tested according to JECFA monograph 1 -
Vol.4.
- Tested according to JECFA monograph 1 -
Vol.4 - Test 0.07 g of the sample as directed in the Limit Test using 0.4 ml
of 0.01 N hydrochloric acid in the control.
Pyrrolidone carboxylic
acid
- Tested according to JECFA monograph 1 -
Vol.4 - Thin-layer chromatography.
- Sample: 2 μl of a 0.5 in solution of the
sample.
- Reference: 2 μl of a 0.5 in solution of
monosodium L-glutamate containing 2.5 mg of pyrrolidone carboxylic acid.
- Solvent: A mixture of 2 volumes of
n-butanol, 1 volume of glacial acetic acid and 1 volume of water.
- Adsorbent: Silica gel.
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- Proceed as directed under thin-layer
chromatography (analytical techniques). Stop the development when the solvent
front has advanced about 10 cm from the point of the application dry the
plate for 30 min in air.
- At the same time, prepare a similar chamber
to that used for developing; place a 50-ml beaker containing about 3 g of
sodium hypochlorite in the chamber; slowly add 1 ml of hydrochloric acid into
the beaker to generate chlorine gas; put on the lid and allow to stand for 30
sec to fill the chamber with chlorine. Place the dried plate in this chamber,
put on the lid and allow to stand for 20 min. Take out the plate, keep for 10
min in air and spray with ethanol. After drying, spray with potassium
iodide-starch solution and observe the plate under natural light immediately
after the standard spot has appeared.
Requirement: No spot corresponding to
pyrrolidone carboxylic acid standard is detected in the sample (sensitivity =
0.2%).
Lead
- Tested according to JECFA monograph 1 -
Vol.4.
- 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 JECFA monograph 1 - Volume 4, “Instrumental Methods.”
6.2. Method of assay
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Each ml of 0.1 N perchloric acid is equivalent
to 8.308 mg of C10H16CaN2O8.
Calculate the content on the anhydrous basis.
ANNEX 5
SPECIFICATIONS
AND TESTS FOR 5’-GUANYLIC ACID
1. Synonyms
5’-Guanylic acid;
Guanylic acid; GMP
INS 626
ADI “Not limited”
2. Definition
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Chemical names
Guanosine-5'-monophosphoric
acid
C.A.S. number
85-32-5
Chemical formula
C10H14N5O8P
Structural formula
Formula weight
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3. Description
Odourless, colourless or white crystals, or a
white crystalline powder
4. Functional uses
Flavour enhancer
5. Specifications
5.1. Identification
Solubility
Slightly soluble in water; practically insoluble
in ethanol.
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A 1 in 50,000 solution of the sample in 0.01 N
hydrochloric acid exhibits an absorbance maximum at 256±2nm. The ratio A250/A260
is between 0.95 and 1.03, and the ratio A280/260
is between 0.63 and 0.71.
Test for ribose
Passes test.
Test for organic
phosphate
Passes test.
5.2. Purity
Loss on drying
Not more than 1.5% (120oC, 4 h)
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1.5 - 2.5 (1 in 400 soln).
Related foreign
substances
Chromatographically not detectable.
Lead
Not more than 1 mg/kg.
5.3. C10H14N5O8P
content
Not less than 97.0% and not more than 102.0%
of on the dried basis.
6. Tests
6.1. Identification
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Test for organic
phosphate
- Tested according to JECFA monograph 1 -
Vol.4.
- A 1 in 400 soln.
6.2. Purity
Related foreign
substances
- Tested according to JECFA monograph 1 -
Vol.4.
- Test 2 µl of a 1 in 400 soln.
Lead
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6.3. Method of assay
Weigh accurately about 0.5 g of the sample,
dissolve in and make to 1,000 ml with 0.01 N hydrochloric acid. Take 10 ml of
this solution and dilute with 0.01 N hydrochloric acid to 250 ml. Determine
the absorbance A of the solution in a 1-cm cell at the wave length of 260 nm
using 0.01 N hydrochloric acid as the reference.
Calculate the content of C10H14N5O8P,
in % in the sample by the formula:
ANNEX 6
SPECIFICATIONS AND TESTS
FOR 5’- INOSINIC ACID
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5’- Inosinic acid;
Inosinic acid; IMP
INS 630
ADI “Not limited”
2. Definition
Chemical names
Inosine-5'-monophosphoric
acid
C.A.S. number
131-99-7
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C10H13N4O8P
Structural formula
Formula weight
348.21
3. Description
Odourless, colourless or white crystals, or a
white crystalline powder
4. Functional uses
Flavour enhancer
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5.1. Identification
Solubility
Freely soluble in water; slightly soluble in
ethanol.
Spectrophotometry
A 1 in 50,000 solution of the sample in 0.01 N
hydrochloric acid exhibits an absorbance maximum at 250±2nm. The ratio A250/A260
is between 1.55 and 1.65, and the ratio A280/260 is
between 0.20 and 0.30.
Test for ribose
Passes test.
Test for organic
phosphate
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5.2. Purity
Loss on drying
Not more than 3.0% (120 oC , 4 h).
pH
1.0 - 2.0 (1 in 20 soln).
Related foreign
substances
Chromatographically not detectable.
Lead
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5.3. C10H13N4O8P
content
Not less than 97.0% and not more than 102.0%
of on the dried basis.
6. Tests
6.1. Identification
Test for organic
phosphate
- Tested according to JECFA monograph 1 -
Vol.4.
- A 1 in 400 soln.
6.2. Purity
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Related foreign
substances
- Tested according to JECFA monograph 1 -
Vol.4.
- Test 1 µl of a 1 in 200 soln.
Lead
- Tested according to JECFA monograph 1 -
Vol.4.
- 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 JECFA monograph 1 - Vol.4, “Instrumental Methods.”
6.3. Method of assay
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Calculate the content of C10H13N4O8P,
in % in the sample by the formula:
ANNEX 7
SPECIFICATIONS AND TESTS
FOR MALTOL
1. Synonyms
INS 636
ADI = 0 - 1 mg/kg bw
2. Definition
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Chemical names
3-Hydroxy-2-methyl-4-pyrone
C.A.S. number
118-71-8
Chemical formula
C6H6O3
Structural formula
Formula weight
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3. Description
White crystalline powder having a
characteristic caramel-butterscotch odour.
4. Functional uses
Flavour enhancer, flavouring agent.
5. Specifications
5.1. Identification
Solubility
Sparingly soluble in water, soluble in ethanol
and in propylene glycol.
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160o - 164o.
Ultraviolet absorption
The ultraviolet spectrum of a 10 mg/l solution
of the sample in 0.1 N hydrochloric acid shows an absorption maximum at about
274 nm.
5.2. Purity
Water
Not more than 0.5%
Sulfated ash
Not more than 0.2% (use 5 g sample).
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Not more than 1 mg/kg.
5.3. C6H6O3
content
Not less than 99.0%, calculated on the
anhydrous basis.
6. Tests
6.1. Purity
Water
- Tested according to JECFA monograph 1 -
Vol.4.
- Karl Fischer method.
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- Tested according to JECFA monograph 1 -
Vol.4.
- Use 5 g sample.
Lead
- Tested according to JECFA monograph 1 -
Vol.4.
- Determine using an AAS/ICP-AES technique
appropriate to the specified level. The selection of sample size and method
of sample preparation may be based on the principles of the methods described
in JECFA monograph 1 - Vol.4 under “General Methods, Metallic Impurities”.
6.2. Method of assay
Standard solution
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Assay solution
Transfer about 50 mg of the sample, accurately
weighed, into a 250-ml volumetric flask, dilute to volume with 0.1 N
hydrochloric acid, and mix. Pipet 5 ml of this solution into a 100-ml
volumetric flask, dilute to volume with 0.1 N hydrochloric acid, and mix.
Procedure
Determine the absorbance of each solution in a
1-cm quartz cell at the absorption maximum (about 274 nm) using 0.1 N
hydrochloric acid as the blank.
Calculate the percent of Maltol in the sample
by the formula:
% Maltol = 100 x WS x AA /
(AS x WA)
Where:
AA is the absorbance of the sample
solution
AS is the absorbance of the
standard solution
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WS is the weight in mg of the
reference standard in the standard solution
ANNEX 8
SPECIFICATIONS AND TESTS
FOR ETHYL MALTOL
1. Synonyms
INS 637
ADI = 0 - 2 mg/kg bw
2. Definition
Ethyl maltol is obtained by chemical synthesis
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2-Ethyl-3-hydroxy-4-pyrone
C.A.S. number
4940-11-8
Chemical formula
C7H8O3
Structural formula
Formula weight
140,14
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White, crystalline powder with a sweet,
fruit-like aroma.
4. Functional uses
Flavour enhancer, flavouring agent.
5. Specifications
5.1. Identification
Solubility
Sparingly soluble in water, soluble in ethanol
and in propylene glycol.
Melting range
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Ultraviolet absorption
The ultraviolet spectrum of a 10 mg/l solution
of the sample in 0.1 N hydrochloric acid shows an absorption maximum at about
276 nm.
5.2. Purity
Water
Not more than 0.5%.
Sulfated ash
Not more than 0.2%.
Lead
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5.3. C7H8O3
content
Not less than 99.0%, calculated on the
anhydrous basis.
6. Tests
6.1. Purity
Water
- Tested according to JECFA monograph 1 -
Vol.4.
- Karl Fischer method.
Sulfated ash
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- Use 5 g sample
Lead
- Tested according to JECFA monograph 1 -
Vol.4.
- Determine using an AAS/ICP-AES technique
appropriate to the specified level. The selection of sample size and method
of sample preparation may be based on the principles of the methods described
in JECFA monograph 1 - Vol.4 under “General Methods, Metallic Impurities”.
6.2. Method of assay
Standard solution
Transfer about 50 mg of Ethyl Maltol Reference
Standard, or equivalent, accurately weighed, into a 250-ml volumetric flask,
dilute to volume with 0.1 N hydrochloric acid, and mix. Pipet 5 ml of this
solution into a 100-ml volumetric flask, dilute to volume with 0.1 N
hydrochloric acid, and mix.
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Transfer about 50 mg of the sample, accurately
weighed, into a 250-ml volumetric flask, dilute to volume with 0.1 N
hydrochloric acid, and mix. Pipet 5 ml of this solution into a 100-ml
volumetric flask, dilute to volume with 0.1 N hydrochloric acid, and mix.
Procedure
Determine the absorbance of each solution in a
1-cm quartz cell at the absorption maximum (about 276 nm) using 0.1 N
hydrochloric acid as the blank.
Calculate the percent of Ethyl maltol in the
sample by the formula:
% Ethyl maltol = 100 x WS x AA
/ (AS x WA)
Where:
AA is the absorbance of the sample
solution
AS is the absorbance of the standard
solution
WA is the weight in mg of sample in
the sample solution
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