|
MINISTRY
OF HEALTH OF VIETNAM
-------
|
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
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|
|
No.
18/2010/TT-BYT
|
Hanoi,
May 20, 2010
|
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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