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 +32.2^o (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% (98^oC , 5 h).

pH

6.7 - 7.2 (1 in 20 soln).

Specific rotation

[a]^D₂₀: Between +24.8 and +25.3^o (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% (80^oC, 5 h).

pH

6.7 - 7.3 (1 in 50 soln).

Specific rotation

[a]^D₂₀: Between +22.5 and +24.0^o (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 +29.2^o (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% (120^oC, 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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160^o - 164^o.

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 W_S x A_A / (A_S x W_A)

Where:

A_A is the absorbance of the sample solution

A_S is the absorbance of the standard solution

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W_S 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 W_S x A_A / (A_S x W_A)

Where:

A_A is the absorbance of the sample solution

A_S is the absorbance of the standard solution

W_A is the weight in mg of sample in the sample solution

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Thông tư 18/2010/TT-BYT ban hành Quy chuẩn kỹ thuật quốc gia về phụ gia thực phẩm - Chất điều vị do Bộ trưởng Bộ Y tế ban hành