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MINISTRY OF HEALTH
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THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No. 44/2010/TT-BYT
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Hanoi, December 22, 2010
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CIRCULAR
PROMULGATING NATIONAL TECHNICAL
REGULATIONS ON FOOD ADDITIVES
THE MINISTER OF HEALTH
Pursuant to the Law on Standards and Technical Regulations dated
June 29, 2006 and Government's Decree No. 127/2007/ND-CP dated August 01, 2007 elaborating
some Articles of the Law on Standards and Technical Regulations;
Pursuant to the Ordinance on Food Safety dated August 07, 2003 and Government’s
Decree No. 163/2004/ND-CP dated September 07, 2004 elaborating some Articles of
the Ordinance on Food Safety;
Pursuant to the Government’s Decree No. 188/2007/ND-CP dated December 27, 2007
defining functions, tasks, powers 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, the Director General
of the Department of Legal Affairs,
HEREBY PRESCRIBES:
Article
1. Promulgated together with this
Circular are National technical regulations on food additives, including:
1. QCVN
4-12:2010/BYT - National technical regulation on food additives -
Preservatives;
2. QCVN
4-13:2010/BYT - National technical regulation on food additives - Stabilizers;
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4. QCVN
4-15:2010/BYT - National technical regulation on food additives - Flour
treatment agents;
5. QCVN
4-16:2010/BYT - National technical regulation on food additives - Bulking
agents;
6. QCVN
4-17:2010/BYT - National technical regulation on food additives - Propellants;
Article
2. This Circular comes into force
from July 01, 2011.
Article
3. Director General of Vietnam Food
Administration, heads of units owned by the Ministry of Health, heads of units
affiliated to the Ministry of Health, Directors of Departments of Health of
provinces and central-affiliated cities and relevant organizations and
individuals are responsible for the implementation of this Circular./.
PP. THE MINISTER
THE DEPUTY MINISTER
Trinh Quan Huan
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NATIONAL TECHNICAL REGULATION
QCVN 4-12:2010/BYT
NATIONAL TECHNICAL REGULATION ON
FOOD ADDITIVE - PRESERVATIVE
FOREWORD
QCVN 4-
: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.
44/2010/TT-BYT dated December 22, 2010 of the Minister of Health.
NATIONAL TECHNICAL REGULATION ON FOOD ADDITIVE - PRESERVATIVE
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 preservatives used as food additives.
2.
Regulated entities
This
Regulation applies to:
2.1.
Importers, exporters, producers, traders and users of preservatives used as
food additives (hereinafter referred to as “entities”).
2.2.
Relevant regulatory bodies.
3.
Interpretation of terms and acronyms:
3.1.
“preservative” refers to a food additive used for the purpose of extending the
shelf life of a product by preventing microbial spoilage.
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:
1.1.
Annex
1:
Specifications
and tests for acid sorbic
1.2.
Annex
2:
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1.3.
Annex
3:
Specifications
and tests for calcium sorbate
1.4.
Annex
4:
Specifications
and tests for benzoic acid
1.5.
Annex
5:
Specifications
and tests for sodium benzoate
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Annex
6:
Specifications
and tests for potassium benzoate
1.7.
Annex
7:
Specifications
and tests for calcium benzoate
1.8.
Annex
8:
Specifications
and tests for ethyl p-hydroxybenzoate
1.9
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Specifications
and tests for methyl p-hydroxybenzoate
1.10
Annex
10:
Specifications
and tests for sulfur dioxide
1.11
Annex
11:
Specifications
and tests for sodium sulfite
1.12
Annex
12:
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1.13
Annex
13:
Specifications
and tests for sodium metabisulfite
1.14
Annex
14:
Specifications
and tests for potassium metabisulfite
1.15
Annex
15:
Specifications
and tests for potassium sulfite
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Annex
16:
Specifications
and tests for nisin
1.17
Annex
17:
Specifications
and tests for hexamethylene tertramine
1.18
Annex
18:
Specifications
and tests for dimethyl dicarbonate
1.19
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Specifications
and tests for propionic acid
1.20
Annex
20:
Specifications
and tests for sodium propionate
1.21
Annex
21:
Specifications
and tests for sodium hyposulfite
2.
Specifications and tests for sodium nitrate and potassium nitrate used as
preservatives are specified in QCVN 4-5 :2010/BYT promulgated together with the
Circular No. 22/2010/TT-BYT dated May 20, 2010 of the Minister of Health.
3.
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.
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III.
REGULATORY REQUIREMENTS
1.
Declaration of conformity
1.1.
Conformity of preservatives 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/QĐ-BKHCN dated September 28, 2007 of
the Minister of Science and Technology and regulations of laws.
2. Inspection
of preservatives
The
quality, hygiene and safety of flavour enhancers must be inspected in
accordance with the regulations of law.
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.
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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
SPECIFICATIONS AND TESTS FOR ACID
SORBIC
1. Synonyms
Sorbic
acid
INS 200
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2. Definition
Chemical
names
Acid
sorbic; acid 2,4-hexadienoic; acid 2-propenylacrylic
C.A.S.
number
110-44-1
Chemical
formula
C6H8O2
Structural
formula
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Formula
weight
112.12
3.
Description
Colourless
needles or white free flowing powder, having a slight characteristic odour.
4.
Functional uses
Antimicrobial
preservative, fungistatic agent
5.
Specifications
5.1.
Identification
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Slightly
soluble in water, soluble in ethanol.
Melting
range
Between
132 and 135oC (the melting apparatus should be preheated to 125º
before introducing the sample).
Spectrophotometry
A 1 in
400,000 solution in isopropanol solution shows absorbance maximum at 254±2 nm
Test
for double bond
Passes
test.
5.2.
Purity
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Not
more than 0.5%.
Sulfated
ash
Not
more than 0.2%.
Aldehydes
Not
more than 0.1% (as formaldehyde).
Lead
Not
more than 2 mg/kg.
5.3.
C6H8O2 content
Not
less than 99.0% calculated on the anhydrous basis.
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6.1.
Identification
Test
for double bond
Shake
about 0.02 g of the sample with 1 ml bromine TS; the colour disappears
6.2.
Purity
Water
- Karl
Fischer Method.
-
Tested according to JECFA
monograph 1 - Vol.4.
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- Test
2 g of the sample.
-
Tested according to method I, JECFA monograph 1 - Vol.4.
Aldehydes
To 1 ml
of a saturated aqueous solution of the sample, add 0.5 ml of Schiff's reagent
TS and allow to stand for 10-15 min. Compare the colour with that produced by
1 ml of formaldehyde solution (containing 2 µg) with the same amount of
Schiff's reagent under the same conditions. The colour of the test solution
should not be more intense than that of the formaldehyde solution.
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 essay
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Dissolve
about 0.25 g of the sample, accurately weighed, in 50 ml of anhydrous
methanol previously neutralized with 0.1 N sodium hydroxide, add
phenolphthalein TS, and titrate with 0.1 N sodium hydroxide to the first pink
colour which persists for at least 30 sec.
Each ml
of 0.1 N sodium hydroxide is equivalent to 11.21 mg of C6H8O2.
ANNEX 2
SPECIFICATIONS AND TESTS FOR
POTASSIUM SORBATE
1.
Synonyms
Potassium
sorbate
INS 202
ADI = 0
– 25 mg/kg bw
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Chemical
names
Potassium
sorbate, potassium salt of trans, trans-2,4-hexadienoic acid
C.A.S.
number
24634-16-5
Chemical
formula
C6H7KO2
Structural
formula
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150.22
3.
Description
White
or yellowish-white crystals or crystalline powder or granules.
4.
Functional uses
Preservative
5.
Specifications
5.1.
Identification
Solubility
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Test
for potassium
Passes
test.
Melting
range of sorbic acid derived from the sample
132-135oC.
Test
for unsaturation
Passes
test.
5.2.
Purity
Loss on
drying
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Acidity
or alkalinity
Not
more than about 1% (as sorbic acid or potassium carbonate).
Aldehydes
Not
more than 0.1% (as formaldehyde).
Lead
Not
more than 2 mg/kg.
5.3.
C6H7KO2 content
Not
less than 98% and not more than 102% at the dried basis.
6.
Tests
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Test
for potassium
Tested
according to JECFA monograph 1 - Vol.4.
Melting
range of sorbic acid derived from the sample
Acidify
a solution of the sample with dilute hydrochloric acid TS. Collect the
precipitated sorbic acid on a filter paper, wash free of chloride with water
and dry under vacuum over sulfuric acid.
Test
for unsaturation
To 2 ml
of a 1 in 10 solution of the sample, add a few drops of bromine TS. The
colour of the bromine disappears.
6.2.
Purity
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Tested
according to JECFA monograph 1 - Vol. 4. (105º, 3 h).
Acidity
or alkalinity
Dissolve
1.1 g of the sample in 20 ml of water and add 3 drops of phenolphthalein TS.
If the solution is colourless, titrate with 0.1 N sodium hydroxide to a pink
colour that persists for 15 sec. Not more than 1.1 ml should be required.
If the
solution is pink in colour titrate with 0.1 N hydrochloric acid. Not more
than 0.8 ml should be required to discharge the pink colour.
Aldehydes
Prepare
a 0.3% solution of the sample, adjust the pH to 4 with 1N HCl and filter. To
5 ml of the filtrate add 2.5 ml of Schiff's reagent TS and allow to stand for
10 - 15 min. Compare the colour with that produced by 5 ml of a control
solution containing 15 µg of formaldehyde instead of the sample. The colour
of the test solution should not be more intense than that of the control
solution.
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.”
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Weigh,
to the nearest 0.1 mg, 0.25 g of the sample, previously dried at 105º for 3
h. Dissolve in 36 ml of glacial acetic acid and 4 ml acetic anhydride in a
250-ml glass-stoppered flask, warming to effect solution. Cool to room
temperature, add 2 drops of crystal violet TS and titrate with 0.1 N
perchloric acid in glacial acetic acid to a blue-green end point which
persists for at least 30 sec. Perform a blank determination and make any
necessary correction.
Each ml
of 0.1 N perchloric acid is equivalent to 15.02 mg of C6H7KO2.
ANNEX 3
SPECIFICATIONS AND TESTS FOR
CALCIUM SORBATE
1.
Synonyms
Calcium
sorbate
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ADI = 0
- 25 mg/kg bw
2.
Definition
Chemical
names
Calcium
sorbate; calcium salt of trans, trans-2,4-hexadienoic acid.
C.A.S.
number
7492-55-9
Chemical
formula
C12H14CaO4
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Formula
weight
262.32
3.
Description
Fine
white crystalline powder not showing any change in colour after heating at
105oC for 90 min.
4.
Functional uses
Preservative
5.
Specifications
5.1.
Identification
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Solubility
Soluble
in water; practically insoluble in ethanol.
Test
for calcium
Passes
test.
Melting
range of sorbic acid derived from the sample
132-135oC.
Test
for unsaturation
Passes
test.
5.2.
Purity
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Loss on
drying
Not
more than 3%.
Fluoride
Not
more than 10 mg/kg.
Aldehydes
Not
more than 0.1% (as formaldehyde).
Lead
Not
more than 2 mg/kg.
5.3.
C12H14CaO4 content
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6.
Tests
6.1.
Identification
Test
for calcium
Tested
according to JECFA monograph 1 - Vol.4.
Melting
range of sorbic acid derived from the sample
Acidify
a solution of the sample with dilute hydrochloric acid TS. Collect the
precipitated sorbic acid on a filter paper, wash free of chloride with water
and dry under vacuum over sulfuric acid.
Test
for unsaturation
To 2 ml
of a 1 in 10 solution of the sample, add a few drops of bromine TS. The
colour of the bromine disappears.
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Loss on
drying
Tested
according to JECFA monograph 1 - Vol. 4. (over sulfuric acid in vacuum, 4h).
Fluoride
Tested
according to method I, JECFA monograph 1 - Vol.4 (weigh 5 g of the sample to
the nearest mg and proceed as directed in the Fluoride Limit Test (Method I
or III).
Aldehydes
Prepare
a 0.3% solution of the sample, adjust the pH to 4 with 1N HCl and filter. To
5 ml of the filtrate add 2.5 ml of Schiff's reagent TS and allow to stand for
10 - 15 min. Compare the colour with that produced by 5 ml of a control
solution containing 15 µg of formaldehyde instead of the sample. The colour
of the test solution should not be more intense than that of the control
solution.
Lead
-
Tested according to JECFA monograph 1 - Vol.4.
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6.3.
Method of essay
Weigh
to the nearest mg, 0.25 g of the dried sample. Dissolve in 35 ml of glacial
acetic acid and 4 ml of acetic anhydride in a 250-ml glass-stoppered flask,
warming to effect solution. Cool to room temperature, add 2 drops of crystal
violet TS and titrate with 0.1 N perchloric acid in glacial acetic acid to a
blue-green end point which persists for at least 30 sec. Perform a blank
determination and make any necessary correction.
Each ml
of 0.1 N perchloric acid is equivalent to 13.12 mg of C12H14CaO4.
ANNEX 4
SPECIFICATIONS AND TESTS FOR
BENZOIC ACID
1.
Synonyms
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INS 210
ADI = 0
– 5 mg/kg bw
2.
Definition
Chemical
names
Benzoic
acid, benzenecarboxylic acid, phenylcarboxylic acid
C.A.S.
number
65-85-10
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C7H6O2
Structural
formula
Formula
weight
122.12
3.
Description
White
crystalline solid, usually in the form of scales or needles, having not more
than a faint characteristic odour.
4.
Functional uses
Antimicrobial
preservative
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5.1.
Identification
Solubility
Slightly
soluble in water, freely soluble in ethanol
Melting
range
121oC
-123oC
Test
for benzoate
Passes
test.
pH
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5.2.
Purity
Loss on
drying
Not
more than 0.5%.
Sublimation
test
Passes
test (described in “Tests”).
Sulfated
ash
Not
more than 0.05%.
Lead
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Readily
carbonizable substances
Passes
test (described in “Tests”).
Chlorinated
organic compounds
Not
more than 0.07% (as Cl2).
Readily
oxidizable substances
Passes
test (described in “Tests”).
5.3.
C7H6O2 content
Not
less than 99.5% on the dried basis.
6.
Tests
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Test
for benzoate
-
Tested according to JECFA monograph 1 - Vol.4.
- Use
0.1 g of the sample with 0.1 g of calcium carbonate and 5 ml of water.
6.2.
Purity
Loss on
drying
-
Tested according to JECFA monograph 1 - Vol.4.
- Over
sulfuric acid, 3 h.
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Place a
small amount of the sample in a dry test tube. Wrap the test tube about 4 cm
from the bottom with moistened filter paper. Heat the test tube over a low
flame. Benzoic acid sublimes and crystals deposit in the colder part of the
test tube leaving no residue at the bottom.
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.”
Readily
carbonizable substances
-
Tested according to JECFA monograph 1 - Vol.4.
-
Dissolve 0.5 g of the sample, weighed to the nearest mg, in 5 ml of sulfuric
acid TS. The colour produced should not be darker than a light pink (Matching
Fluid Q).
Chlorinated
organic compounds
Test
0.25 g of the sample dissolved in 10 ml of 0.1 N sodium hydroxide, using 0.5
ml of 0.01N hydrochloric acid in the control.
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Add 1.5
ml of sulfuric acid to 100 ml of water, heat to boiling and add 0.1N
potassium permanganate in drops, until the pink colour persists for 30 sec.
Dissolve 1 g of the sample, weighed to the nearest mg, in the heated
solution, and titrate with 0.1N potassium permanganate to a pink colour that
persists for 15 sec. Not more than 0.5 ml should be required.
6.3.
Method of essay
Weigh,
to the nearest mg, 2.5 g of the dried sample. Dissolve in 15 ml of warm
ethanol previously neutralized using phenol red TS as indicator. Add 20 ml of
water and titrate with 0.5N sodium hydroxide, using phenolphthalein TS as
indicator.
Each ml
0.5N sodium hydroxide is equivalent to 61.06 mg of C7H6O2.
ANNEX 5
SPECIFICATIONS AND TESTS FOR
SODIUM BENZOATE
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Sodium
benzoate;
INS 211
ADI = 0
- 5 mg/kg bw
2.
Definition
Chemical
names
Benzoic
acid, benzenecarboxylic acid, phenylcarboxylic acid
C.A.S.
number
532-32-1
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C7H5NaO2
Structural
formula
Formula
weight
144.11
3.
Description
White,
almost odourless, crystalline powder, flakes or granules
4.
Functional uses
Antimicrobial
preservative
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5.1.
Identification
Solubility
Freely
soluble in water, sparingly soluble in ethanol.
Test
for sodium
Passes
test.
Test
for benzoate
Passes
test.
5.2.
Purity
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Loss on
drying
Not
more than 1.5%.
Acidity
or alkalinity
Passes
test (described in “Tests”).
Readily
carbonizable substances
Passes
test (described in “Tests”).
Chlorinated
organic compounds
Not
more than 0.07% (as Cl2).
Readily
oxidizable substances
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Lead
Not
more than 2 mg/kg.
5.3.
C7H5NaO2 content
Not
less than 99.0% calculated on the anhydrous basis.
6.
Tests
6.1.
Identification
Test
for sodium
-
Tested according to JECFA monograph 1 - Vol.4.
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-
Tested according to JECFA monograph 1 - Vol.4.
- Use a
10% solution of the sample
6.2.
Purity
Loss on
drying
-
Tested according to JECFA monograph 1 - Vol. 4.
- 105oC,
4 h.
Acidity
or alkalinity
Dissolve
2 g of the sample, weighed to the nearest mg, in 20 ml of freshly boiled
water. Not more than 0.5 ml of either 0.1N sodium hydroxide or 0.1N
hydrochloric acid should be required for neutralization, using
phenolphthalein TS as indicator.
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Dissolve
0.5 g of the sample, weighed to the nearest mg, in 5 ml of sulfuric acid TS.
The colour produced should not be darker than a light pink ("Matching
Fluid Q") (Tested according to JECFA monograph 1 - Vol. 4).
Chlorinated
organic compounds
-
Tested according to JECFA monograph 1 - Vol.4.
- Test
0.25 g of the sample using 0.5 ml of 0.01N hydrochloric acid in the control.
Readily
oxidizable substances
Add 1.5
ml of sulfuric acid to 100 ml of water, heat to boiling and add 0.1N
potassium permanganate, dropwise, until the pink colour persists for 30 sec.
Dissolve 1 g of the sample, weighed to the nearest mg, in the heated
solution, and titrate with 0.1N potassium permanganate to a pink colour that
persists for 15 sec. Not more than 0.5 ml should be required.
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.”
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Weigh,
to the nearest mg, 3 g of the sample previously dried for 4 h at 105oC
and transfer to a 250-ml Erlenmeyer flask. Add 50 ml of water to dissolve the
sample. Neutralize the solution, if necessary, with 0.1N hydrochloric acid,
using phenolphthalein TS as indicator. Add 50 ml of ether and a few drops of
bromophenol blue TS, and titrate with 0.5N hydrochloric acid, shaking the
flask constantly, until the colour of the indicator begins to change.
Transfer the lower aqueous layer to another flask. Wash the ethereal layer
with 10 ml of water, and add the washing and an additional 20 ml of ether to
the separated aqueous layer. Complete the titration with the 0.5N
hydrochloric acid, shaking constantly the flask.
Each ml
of 0.5N hydrochloric acid is equivalent to 72.05 mg of C7H5NaO2.
ANNEX 6
SPECIFICATIONS AND TESTS FOR
POTASIUM BENZOATE
1.
Synonyms
Potasium
benzoate;
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ADI=0 -
5 mg/kg bw
2.
Definition
Chemical
names
Potassium
benzoate, potassium salt of benzenecarboxylic acid, potassium salt of
phenylcarboxylic acid
C.A.S.
number
582-25-2
(anhydrous)
Chemical
formula
C7H5KO2.3H2O
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Formula
weight
160.22
(anhydrous C7H5KO2)
214.27
(trihydrate C7H5KO2.3H2O)
3.
Description
White
crystalline powder
4.
Functional uses
Antimicrobial
preservative
5.
Specifications
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Solubility
Freely
soluble in water, soluble in ethanol.
Test
for potassium
Passes
test.
Test
for benzoate
Passes
test.
5.2.
Purity
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Not
more than 26.5%.
Acidity
or alkalinity
Passes
test (described in “Tests”).
Readily
carbonizable substances
Passes
test (described in “Tests”).
Chlorinated
organic compounds
Not
more than 0.07% (as Cl2).
Readily
oxidizable substances
Passes
test (described in “Tests”).
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Not
more than 2 mg/kg.
5.3.
C7H5KO2 content
Not
less than 99.0% calculated on the anhydrous basis.
6.
Tests
6.1.
Identification
Test
for potassium
-
Tested according to JECFA monograph 1 - Vol. 4.
- Use a
10% solution of the sample.
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-
Tested according to JECFA monograph 1 - Vol.4.
- Use a
10% solution of the sample.
6.2.
Purity
Loss on
drying
-
Tested according to JECFA monograph 1 - Vol. 4.
- 105oC,
4 h.
Acidity
or alkalinity
Dissolve
2 g of the sample, weighed to the nearest mg, in 20 ml of freshly boiled
water. Not more than 0.5 ml of either 0.1N sodium hydroxide or 0.1N
hydrochloric acid should be required for neutralization, using
phenolphthalein TS as indicator.
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-
Tested according to JECFA monograph 1 - Vol. 4.
-
Dissolve 0.5 g of the sample, weighed to the nearest mg, in 5 ml of sulfuric
acid TS. The colour produced should not be darker than a light pink (Matching
Fluid Q).
Chlorinated
organic compounds
-
Tested according to JECFA monograph 1 - Vol. 4.
- Test
0.25 g of the sample using 0.5 ml of 0.01N hydrochloric acid in the control.
Readily
oxidizable substances
Add 1.5
ml of sulfuric acid to 100 ml of water, heat to boiling and add 0.1N
potassium permanganate, dropwise, until the pink colour persists for 30 sec.
Dissolve 1 g of the sample, weighed to the nearest mg, in the heated
solution, and titrate with 0.1N potassium permanganate to a pink colour that
persists for 15 sec. Not more than 0.5 ml should be required.
Lead
-
Tested according to JECFA monograph 1 - Vol. 4.
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6.3.
Method of essay
Weigh
to the nearest 0.1 mg, 2.5 to 3 g of the dried sample, and transfer to a
250-ml Erlenmeyer flask. Add 50 ml of water to dissolve the sample.
Neutralize the solution, if necessary, with 0.1N hydrochloric acid, using
phenolphthalein TS as indicator. Add 50 ml of ether and a few drops of
bromophenol blue TS, and titrate with 0.5N hydrochloric acid, shaking the
flask constantly, until the colour of the indicator begins to change.
Transfer the lower aqueous layer to another flask. Wash the ethereal layer
with 10 ml of water, and add the washing and an additional 20 ml of ether to
the separated aqueous layer. Complete the titration with the 0.5N
hydrochloric acid, shaking constantly the flask.
Each ml
of 0.5N hydrochloric acid is equivalent to 80.11 mg of C7H5KO2.
ANNEX 7
SPECIFICATIONS AND TESTS FOR
CALCIUM BENZOATE
1.
Synonyms
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INS 213
ADI = 0
- 5 mg/kg bw
2.
Definition
Chemical
names
Calcium
benzoate
C.A.S.
number
2090-05-3
Chemical
formula
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Monohydrate:
C14H10CaO4.H2O
Trihydrate:
C14H10CaO4.3H2O
Structural
formula
Anhydrous
Formula
weight
Anhydrous:
282.31
Monohydrate:
300.32
Trihydrate:
336.36
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White
or colourless crystals, or white powder.
4.
Functional uses
Antimicrobial
preservative
5.
Specifications
5.1.
Identification
Solubility
Sparingly
soluble in water
Test
for calcium
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Test
for benzoate
Passes
test.
5.2.
Purity
Loss on
drying
Not
more than 17.5%.
Water
insoluble matter
Not
more than 0.3%.
Acidity
or alkalinity
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Fluoride
Not
more than 10 mg/kg.
Lead
Not
more than 2 mg/kg.
Chlorinated
organic compounds
Not
more than 0.07% (as Cl2).
Readily
oxidizable substances
Passes
test (described in “Tests”).
5.3.
C14H10CaO4 content
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6.
Tests
6.1.
Identification
Test
for calcium
Tested
according to JECFA monograph 1 - Vol.4.
Test
for benzoate
Tested
according to JECFA monograph 1 - Vol. 4.
6.2.
Purity
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-
Tested according to JECFA monograph 1 - Vol. 4.
- 105oC,
4 h.
Water
insoluble matter
Dissolve
10 g of the sample, weighed to the nearest mg, in 100 ml of hot water. Filter
through a Gooch crucible, tared to an accuracy of ±0.2 mg, and wash any
residue with hot water. Dry the crucible for 2 h at 105ºC. Cool, weigh and
calculate as percentage.
Acidity
or alkalinity
Dissolve
2 g of the sample, weighed to the nearest mg, in 20 ml of freshly boiled
water. Not more than 0.5 ml of either 0.1N sodium hydroxide or 0.1N
hydrochloric acid should be required for neutralization, using
phenolphthalein TS as indicator.
Fluoride
-
Tested according to JECFA monograph 1 - Vol. 4, Method I or III.
- Weigh
5 g of the sample to the nearest mg.
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-
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.”
Chlorinated
organic compounds
Test
0.25 g of the sample using 0.5 ml of 0.01N hydrochloric acid in the control.
Readily
oxidizable substances
Add 1.5
ml of sulfuric acid to 100 ml of water, heat to boiling and add 0.1N
potassium permanganate in drops, until the pink colour persists for 15 sec.
Dissolve 1 g of the sample, weighed to the nearest mg, in the heated
solution, and titrate with 0.1N potassium permanganate to a pink colour that
persists for 15 sec. Not more than 0.5 ml should be required.
6.3.
Method of essay
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Each ml
of 0.05M disodium ethylenediamine tetraacetate is equivalent to 14.116 mg of
C14H10CaO4.
ANNEX 8
SPECIFICATIONS AND TESTS FOR
ETHYL p-HYDROXYBENZOATE
1.
Synonyms
Ethyl
p-oxybenzoate; Ethylparaben
INS 214
ADI= 0
– 10 mg/kg bw
2.
Definition
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Chemical
names
Ethyl
p-hydroxybenzoate, ethyl ester of p-hydroxybenzoic acid
C.A.S.
number
120-47-8
Chemical
formula
C9H10O3
Structural
formula
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166.18
3.
Description
Almost
odourless, small, colourless crystals or a white, crystalline powder.
4.
Functional uses
Preservative
5.
Specifications
5.1.
Identification
Solubility
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Melting
range
115oC
-118oC.
Test
for p-hydroxybenzoate
Melting
range of p-hydroxybenzoic acid derived from the sample is 212- 217o.
5.2.
Purity
Loss on
drying
Not
more than 0.5%.
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Not
more than 0.05%.
Acidity
Passes
test (described in “Tests”).
p-Hydroxybenzoic
acid and salicylic acid
Passes
test (described in “Tests”).
Lead
Not
more than 2 mg/kg.
5.3.
C9H10O3 content
Not
less than 99.0% calculated on the anhydrous basis.
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6.1.
Identification
Test
for p-hydroxybenzoate
To 0.5
g of the sample add 10 ml of sodium hydroxide TS. Boil for 30 min and
concentrate to about 5 ml. Cool, acidify with dilute sulfuric acid TS,
collect the precipitate on a filter, and wash thoroughly with water. Dry in a
desiccator over sulfuric acid. Determine the melting range of phydroxybenzoic
acid so obtained.
6.2.
Purity
Loss on
drying
-
Tested according to JECFA monograph 1 - Vol. 4.
- Not
more than 0.5% (80º, 2 h).
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-
Tested according to JECFA monograph 1 - Vol. 4, Method I.
- Test
2 g of the sample.
Acidity
Heat
750 mg of the sample with 15 ml of water at 80o for 1 min, cool, and filter.
The filtrate should be acid or neutral to litmus. To 10 ml of the filtrate
add 0.2 ml of 0.1 N sodium hydroxide and 2 drops of methyl red TS. The
solution should be yellow without even a light cast of pink.
p-Hydroxybenzoic
acid and salicylic acid
Dissolve
0.5 g of the sample, accurately weighed, in 30 ml of ether, add 20 ml of a 1
in 100 sodium hydrogen carbonate solution, shake, and separate the water
layer. Wash the water layer with two 20 ml portions of ether, add 5 ml of
dilute sulfuric acid and 30 ml of ether, and shake. Separate the ether layer,
and shake with about 10 ml of water. Filter
the ether layer, and wash the vessel and the filter with a small amount of
ether. Combine the washings and the filtrate, evaporate ether on a water
bath, and dry the residue over sulfuric acid to constant weight. The weight
of the residue should not exceed 5 mg. Dissolve any residue in 25 ml of water,
heat to about 70o , filter, and add a few drops of dilute ferric chloride TS.
No violet to reddish violet colour should be produced.
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.”
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Weigh,
to the nearest mg, 2 g of the dried sample and transfer into a flask. Add 40
ml of N sodium hydroxide and rinse the sides of the flask with water. Cover
with a watch glass, boil gently for 1 h and cool. Add 5 drops of bromothymol
blue TS and titrate the excess sodium hydroxide with N sulfuric acid,
comparing the colour with a buffer solution (pH 6.5) containing the same
proportion of indicator. Perform a blank determination with the reagents and
make any necessary correction.
Each ml
of N sodium hydroxide is equivalent to 166.18 mg of C9H10O3.
ANNEX 9
SPECIFICATIONS AND TESTS FOR
METHYL p-HYDROXYBENZOATE
1.
Synonyms
Methyl
p-oxybenzoate; Methylparaben
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ADI = 0
- 10mg/kg bw
2.
Definition
Chemical
names
Methyl
p-hydroxybenzoate, methyl ester of p-hydroxybenzoic acid
C.A.S.
number
99-76-3
Chemical
formula
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Structural
formula
Formula
weight
152.15
3.
Description
Almost
odourless, small, colourless crystals or a white, crystalline powder.
4.
Functional uses
Preservative
5.
Specifications
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Solubility
Slightly
soluble in water; freely soluble in ethanol and propylene glycol; soluble in
ether.
Melting
range
125oC
-128oC.
Test
for p-hydroxybenzoate
Melting
range of p-hydroxybenzoic acid derived from the sample is 212- 217o.
5.2.
Purity
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Not
more than 0.5%.
Sulfated
ash
Not
more than 0.05%.
Acidity
Passes
test (described in “Tests”).
p-Hydroxybenzoic
acid and salicylic acid
Passes
test (described in “Tests”).
Lead
Not
more than 2 mg/kg.
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Not less
than 99.0% calculated on the anhydrous basis.
6.
Tests
6.1.
Identification
Test
for p-hydroxybenzoate
To 0.5
g of the sample add 10 ml of sodium hydroxide TS. Boil for 30 min and
concentrate to about 5 ml. Cool, acidify with dilute sulfuric acid TS, collect
the precipitate on a filter, and wash thoroughly with water. Dry in a
desiccator over sulfuric acid. Determine the melting range of phydroxybenzoic
acid so obtained.
6.2.
Purity
Loss on
drying
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- Over
silica gel, 5 h.
Sulfated
ash
Tested
according to JECFA monograph 1 - Vol. 4, Method I (Test 2 g of the sample).
Acidity
Heat
750 mg of the sample with 15 ml of water at 80o for 1 min, cool, and filter.
The filtrate should be acid or neutral to litmus. To 10 ml of the filtrate
add 0.2 ml of 0.1 N sodium hydroxide and 2 drops of methyl red TS. The
solution should be yellow without even a light cast of pink.
p-Hydroxybenzoic
acid and salicylic acid
Dissolve
0.5 g of the sample, accurately weighed, in 30 ml of ether, add 20 ml of a 1
in 100 sodium hydrogen carbonate solution, shake, and separate the water
layer.
Wash
the water layer with two 20 ml portions of ether, add 5 ml of dilute sulfuric
acid and 30 ml of ether, and shake. Separate the ether layer, and shake with
about 10 ml of water.Filter the ether layer, and wash the vessel and the
filter with a small amount of ether. Combine the washings and the filtrate,
evaporate ether on a water bath, and dry the residue over sulfuric acid to
constant weight. The weight of the residue should not exceed 5 mg. Dissolve
any residue in 25 ml of water, heat to about 70o , filter, and add a few
drops of dilute ferric chloride TS. No violet to reddish violet colour should
be produced.
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 - Vol.
4, “Instrumental Methods.”
6.3.
Method of essay
Weigh,
to the nearest mg, 2 g of the dried sample and transfer into a flask. Add 40
ml of N sodium hydroxide and rinse the sides of the flask with water. Cover
with a watch glass, boil gently for 1 h and cool. Add 5 drops of bromothymol
blue TS and titrate the excess sodium hydroxide with N sulfuric acid,
comparing the colour with a buffer solution TS (pH 6.5) containing the same
proportion of indicator. Perform a blank determination with the reagents and
make any necessary correction.
Each ml
of N sodium hydroxide is equivalent to 152.2 mg of C8H8O3.
ANNEX 10
SPECIFICATIONS AND TESTS FOR
SULFUR DIOXIDE
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INS 220
ADI = 0
- 0.7 mg/kg bw
2.
Definition
C.A.S.
number
7446-09-5
Structural
formula
SO2
Formula
weight
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3.
Description
Colourless,
non-flammable gas, with strong, pungent, suffocating odour. Its vapour
density is 2.26 times that of air at atmospheric pressure and 0oC.
The specific gravity of the liquid is about 1.436 at 0o/4oC.
At 20o the solubility is about 10 g of SO2 per 100 g of solution.
It is normally supplied under pressure in containers in which it is present
in both liquid and gaseous phases.
Caution:
Sulfur dioxide gas is intensely irritating to the eyes, throat, and upper
respiratory system. Liquid sulfur dioxide may cause skin burns, which result
from the freezing effect of the liquid on tissue. Safety precautions to be
observed in handling of the material are specified in technical brochures
from liquid sulfur dioxide manufacturers, suppliers or organizations of gas
manufacturers or suppliers.
4.
Functional uses
Preservative,
antibrowning agent, antioxidant.
5.
Specifications
5.1.
Identification
Solubility
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Test
for sulfurous substances
Passes
test.
Oxidizing
activity
Passes
test.
5.2.
Purity
Water
Not
more than 0.05%.
Non-volatile
residue
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Selenium
Not
more than 20 mg/kg.
Lead
Not
more than 5 mg/kg.
5.3.
SO2 content
Not
less than 99.9 % SO2 by weight.
6.
Tests
6.1.
Identification
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The
sample blackens filter paper moistened with mercurous nitrate TS.
Oxidizing
activity
Expose
a filter paper, treated with potassium iodate and starch TS, to the sample. A
blue colour is developed that fades on continued exposure.
6.2.
Purity
Water
-
Tested according to JECFA monograph 1 - Vol. 4.
-
Transfer about 50 ml of liquid sulfur dioxide into a Karl Fischer titration
jar, determine the weight of the sample taken, and determine the water
content by Karl Fischer Method.
Non-volatile
residue
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Selenium
- A
2.0-ml portion of the Sample Solution meets the requirements of the Selenium
Limit Test, Method II.
- For
sampling and sample preparation, see “Tests”.
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.
Sampling
Samples
of sulfur dioxide may be safely withdrawn from a tank or transfer lines, either
of which should be equipped with a 1-cm nozzle and valve. Samples should be
taken in bombs constructed of 316 stainless steel, designed to withstand 7
MPa (1000 psig) and equipped with 316 stainless steel needle valves on both
ends. To draw a sample, the bomb is first flushed with dry air to remove any
sulfur dioxide, remaining from previous sample drawings, and then attached to
the tank or transfer lines with a solid pipe connection. A hose is connected
to the other end of the bomb and submerged in either a weak caustic solution
or water. Any gas in the bomb is discharged into the caustic or water by
first opening the valve at the pipe end, followed by slowly opening at the
valve at the hose end. When all of the gas is dispelled and liquid sulfur dioxide
begins to emerge into the solution, the valve at the hose end is blocked off. The other valves are then tightly closed, and the bomb is
detached from the pipe connecting it to the tank or transfer line
Approximately 15% of the liquid sulfur dioxide in the bomb is then discharged
into the water or caustic solution. The
bomb is then capped at its end and transferred to the laboratory for
analysis.
Caution:
The bomb should never be stored with more than 85% of the total water
capacity of the bomb.
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Note:
The tests in which this solution is to be used will be accurate assuming a
144 g sample has been taken; if not, the weight of sample actually taken must
be considered in the calculations.
6.4.
Method of essay
Subtract
from 100 the percentages of non-volatile residue and of water, as determined
herein, to obtain the percentage of SO2.
ANNEX 11
SPECIFICATIONS AND TESTS FOR
SODIUM SULFITE
1.
Synonyms
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INS 221
ADI=0 –
0.7 mg/kg bw as SO2
2.
Definition
Chemical
names
Sodium
sulfite
C.A.S.
number
7757-83-7
Chemical
formula
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Formula
weight
126.04
3.
Description
White
powder with not more than a faint odour of sulfur dioxide.
4.
Functional uses
Antibrowning
agent, antioxidant, preservative
5.
Specifications
5.1.
Identification
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Freely
soluble in water; sparingly soluble in ethanol.
Test
for sodium
Passes
test.
Test
for sulfite
Passes
test.
5.2.
Purity
pH
8.5 -
10.0 (1 in 10 soln).
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Not more
than 0.1%.
Iron
Not
more than 10 mg/kg.
Lead
Not
more than 2 mg/kg.
Selenium
Not
more than 5 mg/kg.
5.3.
Na2SO3 content
Not
less than 95.0%.
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6.1.
Identification
Test
for sodium
-
Tested according to JECFA monograph 1 - Vol. 4.
Test
for sulfite
-
Tested according to JECFA monograph 1 - Vol. 4.
6.2.
Purity
Thiosulfate
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Iron
-
Tested according to JECFA monograph 1 - Vol. 4.
- Use
0.5 ml of Iron Standard Solution (5 µg Fe) in the control.
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.”
Selenium
Reagents:
Hydrochloric
acid, hydrazinium sulfate, standard selenium solution (100 µg Se/ml)
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Weigh
2.0 ± 0.1 g of sample and transfer to a 50-ml beaker. Add 10 ml water, 5 ml
hydrochloric acid and boil to remove SO2.
Into a
second beaker, weigh 1.0 ± 0.1 g of sample, add 0.05 ml standard selenium
solution and proceed as above.
To each
beaker add 2 g hydrazinium sulfate and warm to dissolve. Let stand for 5 min.
Dilute the contents of each beaker to 50 ml in a Nessler tube and compare the
colour of the two solutions. The sample should be less pink than the sample
with the added standard.
6.3.
Method of essay
Weigh
250 mg of the sample, add to 50.0 ml of 0.1 N iodine in a glassstoppered
flask, and stopper the flask. Allow to stand for 5 min, add 1 ml of
hydrochloric acid and titrate the excess iodine with 0.1 N sodium
thiosulfate, adding starch TS as the indicator.
Each ml
of 0.1 N iodine is equivalent to 6.302 mg of Na2SO3.
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SPECIFICATIONS AND TESTS FOR
SODIUM HYDROGEN SULFITE
1.
Synonyms
Sodium
hydrogen sulfite;
INS 222
ADI =0
- 0,7 mg/kg bw as SO2
2.
Definition
Chemical
names
Sodium
hydrogen sulfite, sodium bisulfite
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7631-90-5
Chemical
formula
NaHSO3
Formula
weight
104.06
3.
Description
White
crystals or granular powder having an odour of sulfur dioxide.
4.
Functional uses
Antibrowning
agent, antioxidant, preservative
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5.1.
Identification
Solubility
Freely
soluble in water; sparingly soluble in ethanol
Test
for sodium
Passes
test.
Test
for sulfite
Passes
test.
5.2.
Purity
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Water
insolubles
Passes
test (described in “Tests”).
pH
2.5 -
4.5 (1 in 10 soln).
Iron
Not
more than 10 mg/kg.
Lead
Not
more than 2 mg/kg.
Selenium
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5.3.
SO2 content
Not
less than 58.5% and not more than 67.4% of SO2
6.
Tests
6.1.
Identification
Test
for sodium
Tested
according to JECFA monograph 1 - Vol. 4.
Test
for sulfite
Tested
according to JECFA monograph 1 - Vol. 4.
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Water
insolubles
Dissolve
20 g of the sample in 200 ml of water. The solution should be clear with only
a trace of suspended matter.
Iron
-
Tested according to JECFA monograph 1 - Vol. 4.
- Use
0.5 ml of Iron Standard Solution (5 µg Fe) in the control.
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.”
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Reagents:
Hydrochloric
acid, hydrazinium sulfate, standard selenium solution (100 µg Se/ml)
Procedure:
Weigh
2.0 ± 0.1 g of sample and transfer to a 50-ml beaker. Add 10 ml water, 5 ml
hydrochloric acid and boil to remove SO2.
Into a
second beaker, weigh 1.0 ± 0.1 g of sample, add 0.05 ml standard selenium
solution and proceed as above.
To each
beaker add 2 g hydrazinium sulfate and warm to dissolve. Let stand for 5 min.
Let stand for 5 min. Dilute the contents of each beaker to 50 ml in a Nessler
tube and compare the colour of the two solutions. The sample should be less
pink than the sample with the added standard.
6.3.
Method of essay
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Each ml
of 0.1 N iodine is equivalent to 3.203 mg of SO2.
ANNEX 13
SPECIFICATIONS AND TESTS FOR SODIUM
METABISULFITE
1.
Synonyms
Sodium
metabisulfite;
INS 223
ADI = 0
- 0.7mg/kg bw as SO2
2.
Definition
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Chemical
names
Sodium
disulfite, disodium pentaoxodisulfate, disodium pyrosulfite
C.A.S.
number
7681-57-4
Chemical
formula
Na2S2O5
Formula
weight
190.11
3.
Description
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4. Functional
uses
Antibrowning
agent, antioxidant, flour treatment agent, preservative
5.
Specifications
5.1.
Identification
Solubility
Freely
soluble in water; sparingly soluble in ethanol.
Test
for sodium
Passes
test.
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Passes
test.
5.2.
Purity
Water
insolubles
Passes
test (described in “Tests”).
pH
4.0 -
4.5 (1 in 10 soln).
Thiosulfate
Not
more than 0.1%.
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Not
more than 10 mg/kg.
Lead
Not
more than 2 mg/kg.
Selenium
Not
more than 5 mg/kg.
5.3.
Na2S2O5 content
Not
less than 90.0%.
6.
Tests
6.1.
Identification
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Test
for sodium
-
Tested according to JECFA monograph 1 - Vol. 4.
Test
for sulfite
-
Tested according to JECFA monograph 1 - Vol. 4.
6.2.
Purity
Water
insolubles
Dissolve
20 g of the sample in 200 ml of water. The
solution should be clear with only a trace of suspended matter.
Thiosulfate
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Iron
-
Tested according to JECFA monograph 1 - Vol. 4.
- Use
0.5 ml of Iron Standard Solution (5 µg Fe) in the control.
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.”
Selenium
Reagents:
Hydrochloric
acid, hydrazinium sulfate, standard selenium solution (100 µg Se/ml)
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Weigh
2.0 ± 0.1 g of sample and transfer to a 50-ml beaker. Add 10ml ml water, 5 ml
hydrochloric acid and boil to remove SO2.
Into a
second beaker, weigh 1.0 ± 0.1 g of sample, add 0.05 ml standard selenium
solution and proceed as above.
To each
beaker add 2 g hydrazinium sulfate and warm to dissolve. Let stand for 5 min.
Let stand for 5 min. Dilute the contents of each beaker to 50 ml in a Nessler
tube and compare the colour of the two solutions. The sample should be less
pink than the sample with the added standard.
6.3.
Method of essay
Weigh
0.2 g of the sample, to the nearest mg, add 50.0 ml of 0.1 N iodine in a
glass-stoppered flask, and stopper the flask. Allow to stand for 5 min, add 1
ml of hydrochloric acid and titrate the excess iodine with 0.1 N sodium
thiosulfate, adding starch TS as the indicator.
Each ml
of 0.1 N iodine is equivalent to 4.753 mg of Na2S2O5.
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SPECIFICATIONS AND TESTS FOR
POTASSIUM METABISULFITE
1.
Synonyms
Potassium
metabisulfite;
INS 224
ADI=0 -
0.7 mg/kg bw as SO2
2.
Definition
Chemical
names
Potassium
disulfite, potassium pentaoxodisulfate, potassium pyrosulfite
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16731-55-8
Chemical
formula
K2S2O5
Formula
weight
222.33
3.
Description
Colourless
free-flowing crystals, crystalline powder, or granules, usually having an
odour of sulfur dioxide.
4.
Functional uses
Antibrowning
agent, antioxidant, preservative
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5.1.
Identification
Solubility
Soluble
in water; insoluble in ethanol.
Test
for potassium
Passes
test.
Test
for sulfite
Passes
test.
5.2.
Purity
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Water
insolubles
Passes
test (described in “Tests”).
Thiosulfate
Not
more than 0.1%.
Iron
Not
more than 10 mg/kg.
Lead
Not
more than 2 mg/kg.
Selenium
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5.3.
K2S2O5 content
Not
less than 90.0%.
6.
Tests
6.1.
Identification
Test
for potassium
Passes
test.
Test
for sulfite
Passes
test.
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Water
insolubles
Dissolve
20 g of the sample in 200 ml of water. The solution should be clear with only
a trace of suspended matter.
Thiosulfate
A 10%
solution of the sample should remain clear on acidification with sulfuric or
hydrochloric acid.
Iron
-
Tested according to JECFA monograph 1 - Vol. 4.
- Use
0.5 ml of Iron Standard Solution (5 µg Fe) in the control.
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 - Vol.
4, “Instrumental Methods.”
Selenium
Reagents:
Hydrochloric
acid, hydrazinium sulfate, standard selenium solution (100 µg Se/ml)
Procedure:
Weigh
2.0 ± 0.1 g of sample and transfer to a 50-ml beaker. Add 10 ml water, 5 ml
hydrochloric acid and boil to remove SO2.
Into a
second beaker, weigh 1.0 ± 0.1 g of sample, add 0.05 ml standard selenium
solution and proceed as above.
To each
beaker add 2 g hydrazinium sulfate and warm to dissolve. Let stand for 5 min.
Let stand for 5 min. Dilute the contents of each beaker to 50 ml in a Nessler
tube and compare the colour of the two solutions. The sample should be less
pink than the sample with the added standard.
6.3.
Method of essay
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Weigh
250 mg of the sample, add to 50.0 ml of 0.1 N iodine in a glass stoppered
flask, and stopper the flask. Allow to stand for 5 min, add 1 ml of dilute
hydrochloric acid TS and titrate the excess iodine with 0.1 N sodium
thiosulfate, using starch TS as the indicator.
Each ml
of 0.1 N iodine is equivalent to 5.558 mg of K2S2O5.
ANNEX 15
SPECIFICATIONS AND TESTS FOR
POTASSIUM SULFITE
1.
Synonyms
Potassium
sulfite;
INS 225
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2.
Definition
Chemical
names
Potassium
sulfite
C.A.S.
number
10117-38-1
Chemical
formula
K2SO3
Formula
weight
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3.
Description
White, odourless, granular powder.
4.
Functional uses
Antibrowning
agent, antioxidant, preservative
5.
Specifications
5.1.
Identification
Solubility
Freely
soluble in water; slightly soluble in ethanol.
...
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Passes
test.
Test
for sulfite
Passes
test.
5.2.
Purity
Alkalinity
Between
0.25 and 0.45% as K2CO3.
Iron
Not
more than 10 mg/kg.
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Not
more than 2 mg/kg.
Selenium
Not
more than 5 mg/kg.
5.3.
K2SO3 content
Not
less than 90.0%.
6.
Tests
6.1.
Identification
Test
for potassium
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Test
for sulfite
Tested
according to JECFA monograph 1 - Vol. 4.
6.2.
Purity
Alkalinity
Dissolve
1 g of the sample in 20 ml of water and add 25 ml of 3% hydrogen peroxide,
previously neutralized to methyl red TS. Mix thoroughly, cool to room
temperature, and titrate with 0.02 N hydrochloric acid. Perform a blank determination using 25 ml of neutralized
hydrogen peroxide solution. Each ml of 0.02 N hydrochloric acid is equivalent
to 1.38 mg of K2CO3.
Iron
-
Tested according to JECFA monograph 1 - Vol. 4.
- Use
0.5 ml of Iron Standard Solution (5 µg Fe) in the control.
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-
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.”
Selenium
Reagents:
Hydrochloric
acid, hydrazinium sulfate, standard selenium solution (100 µg Se/ml)
Procedure:
Weigh
2.0 ± 0.1 g of sample and transfer to a 50-ml beaker. Add 10 ml water, 5 ml
hydrochloric acid and boil to remove SO2.
Into a
second beaker, weigh 1.0 ± 0.1 g of sample, add 0.05 ml standard selenium
solution and proceed as above.
To each
beaker add 2 g hydrazinium sulfate and warm to dissolve. Let stand for 5 min.
Let stand for 5 min. Dilute the contents of each beaker to 50 ml in a Nessler
tube and compare the colour of the two solutions. The sample should be less
pink than the sample with the added standard.
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Weigh
accurately about 0.75 g of the sample and dissolve in a mixture of 100 ml of
0.1 N iodine and 5 ml of dilute hydrochloric acid TS. Titrate the excess
iodine with 0.1 N sodium thiosulfate, adding starch TS as the indicator.
Each ml
of 0.1 N iodine is equivalent to 7.912 mg of K2SO3.
ANNEX 16
SPECIFICATIONS AND TESTS FOR
NISIN
1.
Synonyms
INS 234
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Nisin
is a mixture of closely related antimicrobial polypeptides produced by
strains of Lactococcus lactis subsp. lactis under appropriate fermentation
conditions.
Nisin
preparation consists of nisin and sodium chloride with an activity of not
less than 900 units per mg. Nisin preparation is stable at ambient
temperatures and upon heating under acid conditions (maximum stability at pH
3).
C.A.S.
number
1414-45-5
Chemical
formula
C143H230N42O37S7
Structural
formula
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Dhb=dehydrobutyrine
Formula
weight
Ca.
3354
3.
Description
White to
light brown micronized powder
4.
Functional uses
Antimicrobial
preservative
5.
Specifications
5.1.
Identification
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Solubility
Soluble
in water and insoluble in non-polar solvents
Differentiation
from other antimicrobial substances
Passes
test.
5.2.
Purity
Loss on
drying
Not
more than 3.0% (105oC , 2 h)
Lead
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Microbiological
criteria
Salmonella
species: Absent in 25 g of sample
Total
coliforms: Not more than 30 per gram
Escherichia
coli: Absent in 25 g sample
5.3.
Content
Not
less than 900 IU of nisin per milligram and not less than 50% sodium chloride
6.
Tests
6.1.
Identification
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-
Stability to acid: Suspend a 100-mg sample in 0.02 N hydrochloric acid as
described in “Standard stock solution” under Method of Assay. Boil this
solution for 5 min.
Using
the method of assay described below, determine the nisin activity. No
significant loss of activity is noted following this heat treatment. The
calculated nisin concentration of the boiled sample is 100% +/- 5% of the
assay value. Adjust the pH of the nisin solution to 11.0 by adding 5N sodium
hydroxide. Heat the solution at 65° for 30 min, and then cool. Adjust the pH
to 2.0 by adding hydrochloric acid dropwise. Again determine the nisin
concentration using the assay method described below. Complete loss of the
antimicrobial activity of nisin is observed following this treatment.
-
Tolerance of Lactococcus lactis to high concentrations of nisin: Prepare
cultures of Lactococcus lactis (ATCC 11454, NCIMB 8586) in sterile skim m
(<1% fat) milk by incubating for 18 h at 30°. Prepare one or more flasks
containing 100 ml of litmus milk, and sterilize at 121° for 15 min. Suspend
0.1 g of sample in the sterilized litmus milk, and allow to stand at room
temperature for 2 h. Add 0.1 ml of the L. lactis culture, and incubate at
30° for 24 h. L. lactis will grow in this concentration of sample (about 1000
IU/ml); however, it will not grow in similar concentrations of other
antimicrobial substances. This test will not differentiate nisin from
subtilin.
6.2.
Purity
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.”
6.2.
Method of essay
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Determination
of nisin activity (Based on the method of Friedman and Epstein, J. Gen.
Microbiol. 5: 830, 1951)
Preparation
of the test organism:
Lactococcus
lactis sbsp .cremoris (ATCC 14365, NCDO 495) is subcultured daily in sterile
separated milk by transferring one loopful to a McCartney bottle of litmus
milk and incubating at 30o. Prepare inoculated milk for the assay
by inoculating a suitable quantity of sterile skim milk with 2 percent of a
24 h culture, and place it in a water-bath at 30o for 90 min. Use
immediately.
Standard
stock solution:
Dissolve
an accurately weighed quantity of standard nisin in 0.02N hydrochloric acid
to give a solution containing 5 000 units/ml. Immediately before use, dilute
the solution further with 0.02N hydrochloric acid to give 50 units/ml. (NOTE:
Nisin preparation containing 2.5 % nisin, minimum potency of 10 6 IU/g,
obtainable from Sigma, St Louis, USA or Fluka, Buchs, Switzerland, may be
used for the Standard Stock Preparation, as well as, the preparation under
the name of Nisaplin, available from Danisco, Copenhagen, Dennmark).
Sample
solution:
Weigh
an amount of sample sufficient to ensure that corresponding tubes of the
sample and standard series match, i.e. within close limits, the nisin content in the sample and standard is the same. Dilute the
sample solution in 0.02 N hydrochloric acid to give an estimated
concentration of 50 units of nisin per ml.
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Prepare
a 0.0125% solution of resazurin in water immediately before use.
Procedure:
Pipet
graded volumes (0.60, 0.55, 0.50, 0.45, 0.41, 0.38, 0.34, 0.31, 0.28, 0.26
ml) of the 50 unit per ml sample and standard solutions into rows of 10 dry
6-inches x 5/8-inch bacteriological test-tubes. Add 4.6 ml of the inoculated
milk to each by means of an automatic pipetting device. The addition of
inoculated milk is made in turn across each row of tubes containing the same
nominal concentration, not along each row of ten tubes. Place the tubes in a
water-bath at 30o for 15 min, then cool in an ice water bath while
adding 1 ml resazurin solution to each. The addition is made with an
automatic pipetting device, in the same order used for the addition of
inoculated milk. Thoroughly mix the contents of the tubes by shaking.
Continue incubation at 30o in a water-bath for a further 3-5 min.
Examine
the tubes under fluorescent light in a black matt-finish cabinet. The sample
tube of the highest concentration which shows the first clear difference in
colour (i.e. has changed from blue to mauve) is compared with tubes of the
standard row to find the nearest in colour. Make further matches at the next
two lower concentrations of the sample and standard. Interpolation of matches
may be made at half dilution steps. As the standard tubes contain known
amounts of nisin, calculate the concentration of nisin in the sample
solution. Obtain three readings of the solution and average them. Calculate
the activity in terms of IU per gram of preparation.
NaCl
Accurately
weigh about 100 mg of sample, and transfer to a porcelain casserole. Add 100
ml water, 2 ml 2% dextrin soln, and 1 ml 0.1% dichlorofluoroscein soln. Mix, and
titrate with 0.1 N silver nitrate soln until the silver chloride flocculates
and the mixture acquires a faint pink colour.
Sodium
chloride,% (w/w):
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Where:
V is
the volume of silver nitrate solution consumed (ml)
N is
the normality of the silver nitrate solution
58.5 is
the formula weight of sodium chloride, and
W is
the weight of the sample (mg).
ANNEX 17
SPECIFICATIONS AND TESTS FOR
HEXAMETHYLENE TERTRAMINE
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Hexamethylenetertramine;
Hexamine; Methenamine
INS 239
ADI = 0
- 0.15 mg/kg bw.
2.
Definition
Chemical
names
1,3,5,7-tetraazatricylo[3.3.1.13,7]-decan;
hexamethylen- tetramin
C.A.S.
number
100-97-0
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C6H12N4
Structural
formula
Formula
weight
140.19
3.
Description
Nearly
odourless, colourless lustrous crystals, or white crystalline powder.
4.
Functional uses
Antimicrobial
preservative
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5.1.
Identification
Solubility
Freely
soluble in water, soluble in ethanol.
Test
for formaldehyde
Passes
test.
Ammonium
Passes
test.
5.2.
Purity
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Loss on
drying
Not
more than 2.0%.
Sulfated
ash
Not
more than 0.05%.
Test
for ammonia
Passes
test (described in “Tests”).
Lead
Not
more than 2 mg/kg.
5.3.
C6H12N4 content
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6.
Tests
6.1.
Identification
Test
for formaldehyde
Heat a
1 in 10 solution of the sample with dilute sulfuric acid TS. Formaldehyde is
liberated, recognizable by its odour and by its darkening of paper moistened
with silver ammonium nitrate TS.
Ammonium
Tested
according to JECFA monograph 1 - Vol. 4.
6.2.
Purity
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Tested
according to JECFA monograph 1 - Vol. 4. (over P2O5, 4 h).
Sulfated
ash
Tested
according to JECFA monograph 1 - Vol. 4, Method I (Test 2 g of the sample).
Test
for ammonia
Add 1
ml of Nessler's reagent TS to 10 ml of a 5% solution of the sample. The
mixture should not be darker than a mixture of 1 ml of the reagent in 10 ml
of water.
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 essay
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Weigh,
to the nearest 0.1 mg, 1 g of the sample, previously dried for 4 h over
phosphorus pentoxide. Transfer into a beaker and add 40.00 ml of N sulfuric
acid. Boil gently adding water from
time to time, if necessary, until the odour of formaldehyde is no longer
perceptible. Cool, add 20 ml of water, and methyl red TS and titrate the
excess acid with N sodium hydroxide.
Each ml
of N sulfuric acid is equivalent to 35.05 mg of C6H12N4.
ANNEX 18
SPECIFICATIONS AND TESTS FOR
DIMETHYL DICARBONATE
1.
Synonyms
Dimethyl
dicarbonate; DMDC, dimethyl pyrocarbonate
INS 242
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Chemical
names
Dimethyl
dicarbonate
C.A.S.
number
004-525-33-1
Chemical
formula
C4H6O5
Structural
formula
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139.09
3.
Description
Colourless
liquid.
Caution:
Corrosive to eyes and skin and toxic by inhalation and ingestion; must be kept in a tightly sealed container to exclude moisture.
4.
Functional uses
Preservative
5.
Specifications
5.1.
Identification
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Soluble
in water with decomposition; miscible with toluene.
Infrared
absorption
The
infrared spectrum of the sample corresponds with the reference infrared
spectrum below.
5.2.
Purity
Dimethyl
dicarbonate
Not
more than 0.2%.
Lead
Not
more than 2 mg/kg.
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Not
less than 99.8%.
6.
Tests
6.1.
Purity
Dimethyl
dicarbonate
Apparatus:
Gas
chromatograph with a flame ionization detector, equipped for capillary gas
chromatography, and inlet part for the "on column" technique (e.g.,
Carlo Erba Fraktovap 4160, or Hewlett-Packard 5880 or 5792).
-
Capillary: 50 m SE 30-D (internal diameter: 0,3 mm).
-
Potentiometric recorder, 1 mV.
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Operating
conditions
Temperatures:
-
Injection block: Room temperature (approximately 25o)
-
Detector: 200o.
- Capillary
Tube: Initial temperature 30o; Preliminary phase 5 min, Rate of
ascent 40o/min; Final temperature 120o, Final phase 5
min.
Carrier
gas:
-
Preliminary pressure: 3.0 bar (Helium)
-
Capillary tubes: Approx. 11 ml/min
-
Make-up gas: 28 ml/min
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- Air:
300 ml/min
Recorder
feed: 1 cm/min
Reagents:
Methylisobutylketone,
purest grade.
Procedure:
Accurately
weigh about 10 g of the sample to the nearest mg (W1 mg) into a rolled rim
vial. Add in a quantity of dimethyl-isobutylketone (W2 mg), corresponding to
the anticipated dimethylcarbonate content. Seal the rolled rim vial, mix well
and inject 0.002 ml.
Retention
times:
dimethylcarbonate:
Approx. 2 min
methylisobutylketone:
Approx. 4.5 min
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Typical
Chromatogram in 7.2
Determine
the peak areas. Calculate the % of dimethyl carbonate from:
Where:
F1:
peak area of dimethylcarbonate
F2: peak area of the standard
K: a
Correction Factor for dimethylcarbonate
Remarks:
1. It
should be noted the DMDC is sensitive to moisture and heat.
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3. The
correction factor for dimethylcarbonate should be determined with
corresponding test solutions in DMDC which is to the greatest extent possible
free of dimethylcarbonate.
4. The
specimen mixed with the standard must be measured immediately
5.
Hamilton syringes with Metal needles can result in a partial decomposition of
the DMDC.
Lead
-
Tested according to JECFA monograph 1 - Vol. 4.
- 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.”
6.2.
Method of essay
Introduce
about 70 ml of pure acetone into a 150-ml glass beaker. Using a disposable 2
ml syringe weigh 1.0-1.3 g of the sample to an accuracy of ±0.1 mg into the
glass beaker. Pipette exactly 20 ml dibutyl amine solution (add chlorobenzene
to 120 g dibutyl amine until the 1 L mark is reached) while stirring. Titrate
the solution potentiometrically with 1N hydrochloric acid. Run a blank test.
Calculate
the % of dimethyldicarbonate from:
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Where:
V1 =
amount of hydrochloric acid used for titration of the sample (ml)
V2 =
amount of hydrochloric acid used for titration of the blank (ml)
t =
normality of hydrochloric acid
W =
weight of sample (g)
7.
Spectrum and chromatogram
7.1. Infrared spectrum
7.2. Typical chromatogram
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ANNEX 19
SPECIFICATIONS AND TESTS FOR
PROPIONIC ACID
1.
Synonyms
Propionic
acid; propanoic acid;
ethylformic acid; methylacetic acid
INS 280
ADI
“Not limited”
2.
Definition
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Propionic
acid
C.A.S.
number
79-09-4
Chemical
formula
C3H6O2
Structural
formula
Formula
weight
74.08
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An oily
liquid with a slightly pungent odour
4.
Functional uses
Preservative,
antimould, antirope agent, flavouring agent
5.
Specifications
5.1.
Identification
Solubility
Miscible
with water and ethanol.
Specific
gravity
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5.2.
Purity
Distillation
range
138.5 -
142.5o.
Non-volatile
residue
Not
more than 0.01% when dried at 140o to constant weight
Formic
acid
Not
more than 0.1%.
Aldehydes
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Lead
Not
more than 2 mg/kg.
5.3.
C3H6O2 content
Not
less than 99.5% on dried basis.
6.
Tests
6.1.
Purity
Formic
acid
Dissolve
15 g of sodium hydroxide in 50 ml of water, cool, add 6 ml of bromine,
stirring to effect complete solution, and dilute to 2,000 ml with water.
Transfer 25.0 ml of this solution, into a 250 ml, glass-stoppered Erlenmeyer
flask containing 100 ml of water, and add 10 ml of a 1 in 5 solution of
sodium acetate and 10.0 ml of the sample. Allow to stand for 15 min, add 5 ml
of a 1 in 4 solution of potassium iodide and 10 ml of hydrochloric acid, and
titrate with 0.1 N sodium thiosulfate just to the disappearance of the brown
colour.Perform a blank determination. The difference between the volume of
0.1 N sodium thiosulfate required for the blank and that required for the
sample is not more than 4.4 ml.
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Transfer
10.0 ml of the sample into a 250-ml glass-stoppered conical flask containing
50 ml of water and 10.0 ml of a 1 in 8 solution of sodium bisulfite. Stopper the flask, and shake vigorously. Perform a blank
determination. Allow the mixture to stand for 30 min, then titrate with 0.1N
iodine to the same brownish yellow end-point obtained with a blank treated
with the same quantities of the same reagents. The difference between the
volume of 0.1N iodine required for the blank and that required for the sample
is not more than 7 ml.
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.”
6.2.
Method of essay
Mix 3 g
of the sample, weighed to the nearest 0.1 mg, with 50 ml of water in a 250-ml
flask. Add phenolphthalein TS, and titrate with 1N sodium hydroxide to the
first appearance of a faint pink end-point which persists for at least 30
sec.
Each ml
of 1N sodium hydroxide is equivalent to 74.08 mg of C3H6O2.
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ANNEX 20
SPECIFICATIONS AND TESTS FOR
SODIUM PROPIONATE
1.
Synonyms
Sodium
propionate; Sodium propanoate;
INS 281
ADI
“Not limited”
2.
Definition
Chemical
names
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C.A.S.
number
137-40-6
Chemical
formula
C3H5NaO2
Structural
formula
Formula
weight
96.06
3.
Description
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4.
Functional uses
Preservative,
antimould and antirope agent.
5.
Specifications
5.1.
Identification
Solubility
Freely
soluble in water, soluble in ethanol.
Test
for sodium
Passes
test.
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Passes
test.
Test
for alkali salt of organic acid
Passes
test.
5.2.
Purity
Loss on
drying
Not
more than 4.0%.
pH
7.5 -
10.5 (1 in 10 soln).
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Not
more than 0.1%.
Iron
Not
more than 50.0 mg/kg.
Lead
Not
more than 5 mg/kg.
5.3.
C3H6NaO2 content
Not
less than 99.0% on the dried basis.
6.
Tests
6.1.
Identification
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Test
for sodium
Tested
according to JECFA monograph 1 - Vol. 4.
Test
for propionate
Warm
the sample with sulfuric acid. The propionic acid evolved may be recognized
by its odour.
Test
for alkali salt of organic acid
Ignite
the sample at a relatively low temperature. The alkaline residue effervesces
with acid.
6.2.
Purity
Loss on
drying
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Water-insoluble
matter
Weigh 5
g of the sample to the nearest mg, transfer into a 100-ml beaker and add 50
ml of water. Stir until all the sample appears to be completely dissolved. Filter through a Gooch crucible, tared to an accuracy
of ± 0.2 mg. Rinse the beaker with 20 ml of water. Dry the crucible with its
contents in a 60º oven to constant weight. Cool in a desiccator, weigh, and
calculate as percentage.
Iron
-
Tested according to JECFA monograph 1 - Vol. 4.
- Test
0.5 g of the sample as described in the Limit Test using 2.5 ml of Iron
Standard Solution (25 µg Fe) in the control.
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 essay
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Weigh,
to the nearest mg, 3 g of the sample previously dried at 105º for 1 h, into a
distillation flask and add 200 ml of 50% phosphoric acid. Boil for 2 h and
collect the distillate. During distillation keep the volume in the flask at
about 200 ml by adding water using a dropping funnel. Titrate with 1N sodium
hydroxide using phenolphthalein TS
as indicator to the first appearance of a faint pink end-point which persists
for at least 30 sec.
Each ml
of 1N sodium hydroxide corresponds to 96.06 mg of C3H5NaO2.
ANNEX 21
SPECIFICATIONS AND TESTS FOR
SODIUM HYPOSULFITE
1.
Synonyms
Sodium
hyposulfite;
INS 539
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2.
Definition
Chemical
names
Sodium
thiosulfate
C.A.S.
number
7772-98-7
Chemical
formula
Na2S2O3.5H2O
Formula
weight
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3.
Description
Colourless
crystals or coarse crystalline powder; deliquesces in moist air and
effloresces in dry air above 33o.
4.
Functional uses
Antibrowning
agent, antioxidant, sequestrant
5.
Specifications
5.1.
Identification
Solubility
Very
soluble in water; insoluble in ethanol
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Passes
test.
Test
for sodium
Passes
test.
Thiosulfate
Passes
test.
5.2.
Purity
Loss on
drying
32-37%
(40-45o , 16 h, under vacuum).
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Not
more than 10 mg/kg.
Selenium
Not
more than 5 mg/kg.
Lead
Not
more than 2 mg/kg.
5.3.
Na2S2O3 content
Not
less than 99.0% on the dried basis.
6.
Tests
6.1.
Identification
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Reducing
activity
To a 1
in 10 solution of the sample add a few drops of iodine TS; the colour is
discharged.
Test
for sodium
Tested
according to JECFA monograph 1 - Vol. 4.
Thiosulfate
Tested
according to JECFA monograph 1 - Vol. 4.
6.2.
Purity
Iron
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- Use
0.5 ml of Iron Standard Solution (5 µg Fe) in the control.
Selenium
Reagents
Hydrochloric
acid, hydrazinium sulfate, standard selenium solution (100 µg Se/ml).
Procedure
Weigh 2
± 0.1 g of sample and transfer to a 50-ml beaker.
Into a
second beaker, weigh 1.0 ± 0.1 g of sample, add 0.05 ml standard selenium
solution and proceed as above.
To each
beaker, add 10 ml water, 5 ml hydrochloric acid and boil to remove SO2; then
add 2 g hydrazinium sulfate and warm to dissolve. Dilute the contents of each
beaker to 50 ml in a Nessler tube and compare the colour of the two
solutions. The sample should be less pink than the sample with the added
standard.
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 - Vol.
4, “Instrumental Methods.”
6.3.
Method of essay
Dissolve
about 0.5 g of the dried sample, accurately weighed, in 30 ml of water and
titrate with 0.1 N iodine solution using starch TS as the indicator. Perform
a blank determination.
Each
ml of 0.1 N iodine is equivalent to 15.81 mg of Na2S2O3.
NATIONAL TECHNICAL REGULATION
QCVN 4-13:2010/BYT
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FOREWORD
QCVN 4-
: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.
44/2010/TT-BYT dated December 22, 2010 of the Minister of Health.
NATIONAL TECHNICAL REGULATION ON FOOD ADDITIVE - STABILIZER
I.
GENERAL
1. Scope
This
National technical regulation (hereinafter referred to as “the Regulation”)
provides for specifications and regulatory requirements for quality, hygiene
and safety of stabilizers used as food additives.
2.
Regulated entities
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2.1.
Importers, exporters, producers, traders and users of preservatives used as
stabilizers used as food additives (hereinafter referred to as “entities”).
2.2.
Relevant regulatory bodies.
3.
Interpretation of terms and acronyms:
3.1.
“stabilizer” refers to a food additive used for the purpose of maintaining the
dispersion of two or more ingredients in order to create uniformity of a
product.
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.
3.4. “TS”
stands for test solution.
3.5.
“ADI” stands for acceptable daily intake.
3.6.
“MTDI” stands for maximum tolerable daily intake.
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II.
SPECIFICATIONS, TESTS AND SAMPLING
1.
Specifications and tests for stabilizers are specified in the annexes to this
Regulation as follows:
1.1.
Annex
1:
Specifications
and tests for Polyvinylpyrrolidone
1.2.
Annex
2:
Specifications
and tests for calcium lactate
1.3.
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Specifications
and tests for potassium dihydrogen citrate
1.4.
Annex
4:
Specifications
and tests for disodium orthophosphate
1.5.
Annex
5:
Specifications
and tests for dispotasium orthophosphate
1.6.
Annex
6:
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1.7.
Annex
7:
Specifications
and tests for ammonium polyphosphate
1.8.
Annex
8:
Specifications
and tests for sodium hydrogen carbonate
1.9
Annex
9:
Specifications
and tests for potassium carbonate
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Annex
10:
Specifications
and tests for ammonium hydrogen carbonate
1.11
Annex
11:
Specifications
and tests for potassium chloride
1.12
Annex
12:
Specifications
and tests for monopotassium orthophosphate
2.
Specifications and tests for calcium lactate used as stabilizers are specified
in QCVN 3-4 :2010/BYT promulgated together with the Circular No. 17/TT-BYT
dated May 20, 2010 of the Minister of Health.
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4.
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
1.1. Stabilizers
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/QĐ-BKHCN dated September 28, 2007 of
the Minister of Science and Technology and regulations of laws.
2.
Inspection of stabilizers
The
quality, hygiene and safety of stabilizers must be inspected in accordance with
the regulations of law.
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.
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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
SPECIFICATIONS AND TESTS FOR
POLYVINYLPYRROLIDONE
1.
Synonyms
Povidone,
PVP, Polyvinylpyrrolidone
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ADI =
0-50 mg/kg
2.
Definition
Chemical
names
Polyvinylpyrolidone,
poly-[1-(2-oxo-1-pyrolidinyl)- ethylene]
C.A.S.
number
9003-39-8
Chemical
formula
(C6H9NO)n
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Formula
weight
Lower
molecular weight range product: about 40000.
Higher
molecular weight range product: about 360000.
3.
Description
White
to tan powder; supplied in two molecular weight forms; the molecular weight
value is an average molecular weight for the two forms.
4.
Functional uses
Clarifying
agent, stabilizer, bodying agent, tableting adjunct, dispersing agent
5.
Specifications
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Solubility
Soluble
in water, in ethanol and in chloroform; insoluble in ether
pH
3.0 -
7.0 (5% soln)
Precipitate
formation
Passes
test.
5.2.
Purity
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Not
more than 5%.
Relative
viscosity
Between
1.188 and 1.325 for lower molecular weight product, and between 3.225 and
5.662 for higher molecular weight product (See description under Tests).
Total
ash
Not
more than 0.02%.
Aldehydes
Not
more than 0.2% (as acetaldehyde)
Monomer
content
Not
more than 1% (as vinylpyrrolidone) (see description under Tests)
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Not
more than 1 mg/kg (see description under Tests).
Lead
Not
more than 2 mg/kg.
5.3.
Nitrogen content
Not
less than 12.2% and not more than 13.0% of Nitrogen (N) on the anhydrous
basis
6.
Tests
6.1.
Identification
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To 5 ml
of a 1 in 50 solution of the sample add 5 ml of dilute hydrochloric acid TS,
5 ml of water and 2 ml of 1 in 10 solution of potassium dichromate. A yellow
precipitate forms.
Add 5
ml of a 1 in 50 solution of the sample to 75 mg of cobalt nitrate and 0.3 g
of ammonium thiocyanate dissolved in 2 ml of water, mix and acidify with
dilute hydrochloric acid TS. A pale blue precipitate forms.
To 5 ml
of a 1 in 50 solution of the sample add 1 ml of 25% hydrochloric acid and 5
ml of 5% barium chloride solution and 1 ml of 5% phosphomolybdotungstic acid
solution. A voluminous white precipitate is formed which becomes gradually
blue on standing in daylight. (Note: The blue colouration on exposure to
light distinguishes polyvinylpyrrolidone from polyethylene oxide adducts
which give similar precipitates with the same reagents but which retain their
white colour in light).
6.2.
Purity
Water
-
Tested according to JECFA monograph 1 - Vol.4.
- Karl
Fischer Method.
Relative
viscosity
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Transfer
an accurately weighed portion of the sample, equivalent to 1 g of anhydrous
polyvinylpyrrolidone, into a 250 ml conical flask, and calculate the amount
of water to be added to make a 1% solution. Allow the mixture to stand at
room temperature, with occasional swirling, until solution is complete, and
then allow to stand for 1 h. longer. Filter through a dry sintered-glass
filter funnel of coarse porosity, then pipet 10 ml of the filtrate into a
Cannon-Fenske viscometer, or equivalent, and place the viscometer in a water
bath maintained at 25±0.05oC. After allowing the sample solution
and pipet to warm in the water bath for 10 min., draw the solution by means
of very gentle suction up through the capillary until the meniscus is formed
from 3 to 4 mm above the upper etched mark. Release the vacuum, and, when the
meniscus reaches the upper etched mark, begin timing the flow through the
capillary. Record the exact time when the meniscus reaches the lower etched
mark, and calculate the flow time to the nearest 0.1 sec. Repeat this operation
until at least three readings are obtained. The readings must agree within
0.3 sec.; if not, repeat the determination with additional 10 ml portions of
the sample solution after recleaning the viscosity pipet with sulfuric
acid-dichromate cleaning solution. Calculate the average flow time for the
sample solution, and then obtain the average flow time in similar manner for
10 ml of filtered water for the same viscosity pipet. Calculate the relative
viscosity of the sample by dividing the average flow time for the sample
solution by that of the water sample.
Total
ash
Test 10
g of the sample.
Tested
according to JECFA monograph 1 - Vol.4
Aldehydes
Transfer
about 10 g of the sample, accurately weighed and dissolved in 300 ml of
water, into a 1000 ml round-bottom flask containing 80 ml of 25% sulfuric
acid, reflux for about 45 min. under a water-cooled condenser, and then
distil about 100 ml into a receiver containing 20 ml of 1 N hydroxylamine
hydrochloride previously adjusted to pH 3.1. Titrate the contents of the
receiver with 0.1 N sodium hydroxide to a pH of 3.1, using a pH meter.
Perform a blank determination and make any necessary correction.
Each ml
of 0.1 N sodium hydroxide is equivalent to 4.405 mg of C2H4O.
Monomer
content
Dissolve
about 4 g of the sample, accurately weighed, in 30 ml of water in a 125 ml
round-bottom flask, add 0.5 g of sodium acetate, mix and begin titrating with
0.1 N iodine. When the iodine colour no longer fades, add additional 3.0 ml
of the titrant, and allow the solution to stand for 5 to 10 min. Add starch
TS, and titrate the excess iodine with 0.1 N sodium thiosulfate. Perform a
blank determination, using the same volume of 0.1 N iodine, accurately
measured, as was used for the sample.
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Hydrazine
Transfer
2.5 g of the sample into a 50-ml centrifuge tube, add 25 ml of a 1 in 20
solution of salicylaldehyde in methanol, swirl, and heat in a water bath at
60oC for 15 min. Allow to cool, add 2.0 ml of toluene, insert a
stopper in the tube, shake vigorously for 2 min, and centrifuge. On a
suitable thin-layer chromatographic plate, coated with a 0.25-mm layer of
dimethylsilanized chromatographic silica gel mixture, apply 10 µl of the
clear upper toluene layer in the centrifuge tube and 10 µl of a Standard
solution of salicylaldazine in toluene containing 9.38 µg per ml. Allow the
spots to dry, and develop the chromatogram in a solvent system of methanol
and water (2:1) until the solvent front has moved about three-fourths of the
length of the plate. Remove the plate from the developing chamber, mark the
solvent front, and allow the solvent to evaporate. Locate the spots on the
plate by examination under ultraviolet light at a wavelength of 365 nm:
salicylaldazine appears as a fluorescent spot having an Rf value of about
0.3, and the fluorescence of any salicylaldazine spot from the test specimen
is not more intense than that produced by the spot obtained from the Standard
solution (1 ppm of hydrazine).
Preparation
of Salicylaldazine Standard: Dissolve
300 mg of hydrazine sulfate in 5 ml of a freshly prepared 20% (v/v) solution
of salicylaldehyde in isopropyl alcohol, mix, and allow to stand until a
yellow precipitate forms. Extract the mixture with two 15-ml portions of
methylene chloride. Combine the methylene chloride extracts, and dry over
anhydrous sodium sulfate. Decant the methylene chloride solution, and
evaporate it to dryness. Recrystallize the residue of salicyclaldazine from a
mixture of warm toluene and methanol (60:40) with cooling; filter and dry the crystals
in vacuum. The crystals have a melting range of 213o C to 214o
C.
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 essay
Determine
as directed under Nitrogen Determination in Volume 4, using about 1 g of the
sample, accurately weighed.
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SPECIFICATIONS AND TESTS FOR
CALCIUM LACTATE
1.
Synonyms
INS 327
ADI
“Not limited”
2.
Definition
Chemical
names
Calcium
dilactate, calcium dilactate hydrate, 2-Hydroxypropanoic acid calcium salt
C.A.S.
number
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Chemical
formula
C6H10CaO6.xH2O
(x = 0 - 5)
Structural
formula
Formula
weight
218.22
(anhydrous)
3.
Description
White
to cream coloured, almost odourless, crystalline powder or granules. The
pentahydrate is somewhat efflorescent.
4.
Functional uses
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5.
Specifications
5.1.
Identification
Solubility
Soluble
in water; insoluble in ethanol.
Lactate
Passes
test.
Test
for calcium
Passes
test.
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Loss on
drying
Not
more than 30%
pH
6.0-8.0
(1 in 20 soln).
Acidity
Passes
test (described in “Tests”).
Magnesium
and alkali salts
Not
more than 1%.
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Not
more than 30 mg/kg.
Lead
Not
more than 2 mg/kg.
5.3.
C6H10CaO6 content
Not
less than 98.0% on the dried basis.
6.
Tests
6.1.
Identification
Lactate
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Test
for calcium
Tested
according to JECFA monograph 1 - Vol.4.
6.2.
Purity
Loss on
drying
-
Tested according to JECFA monograph 1 - Vol.4.
- 120o,
4 h.
Acidity
Dissolve
1 g of the sample in 20 ml of water, add 3 drops of phenolphthalein TS, and
titrate with 0.1 N sodium hydroxide. Not more than 0.5 ml should be required.
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Dissolve
1 g of the sample in 40 ml of water, add 0.5 g of ammonium chloride, boil,
and add about 20 ml of ammonium oxalate TS. Heat the solution on a water bath
for 1 h, cool, add water to 100 ml, and filter. To 50 ml of the filtrate, add
0.5 ml of sulfuric acid, evaporate to dryness, and ignite to constant weight.
Cool, weigh and calculate as percentage. The weight of the residue should not
exceed 5 mg.
Fluoride
-
Tested according to JECFA monograph 1 - Vol.4.
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 essay
Dissolve
about 350 mg of previously dried sample, accurately weighed, in 150 ml of
water containing 2 ml of dilute hydrochloric acid TS. While stirring,
preferably with a magnetic stirrer, add about 30 ml of 0.05 M disodium
ethylenediaminetetraacetate from a 50-ml buret. Then add 15 ml of sodium
hydroxide TS and 300 mg of hydroxy-naphthol blue indicator, and continue the
titration to a blue end-point.
Each ml
of 0.05 M disodium ethylenediaminetetraacetate is equivalent to 10.91 mg of
C6H10CaO6.
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ANNEX 3
SPECIFICATIONS AND TESTS FOR
POTASSIUM DIHYDROGEN CITRATE
1.
Synonyms
Monopotassium
citrate, potassium citrate monobasic
INS
332i
ADI
“Not limited”
2.
Definition
Chemical
names
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C.A.S.
number
866-83-1
Chemical
formula
C6H7KO7
Structural
formula
Formula
weight
230.21
3.
Description
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4.
Functional uses
Buffering
agent, sequestrant, yeast food.
5.
Specifications
5.1.
Identification
Solubility
Freely
soluble in water; very slightly soluble in ethanol.
pH
3.5 -
3.9 (1 in 10 soln).
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Passes
test.
Test
for potassium
Passes
test.
5.2.
Purity
Loss on
drying
Not
more than 0.5% (105º, 4 h).
Oxalate
Not
more than 0.04%.
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Not
more than 2 mg/kg.
5.3.
C6H7NaO7 content
Not
less than 99.0% and not more than the equivalent of 101.0% on the dried
basis.
6.
Tests
6.1.
Identification
Citrate
Tested
according to JECFA monograph 1 - Vol.4.
Test
for potassium
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6.2.
Purity
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 essay
Dissolve
about 180 mg of the dried sample, accurately weighed in 25 ml of water and
titrate with 0.1 N sodium hydroxide (potentiometric end-point determination).
Each ml
of 0.1 N sodium hydroxide is equivalent to 11.511 mg of C6H7KO7.
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SPECIFICATIONS AND TESTS FOR
POTASSIUM DIHYDROGEN PHOSPHATE
1.
Synonyms
Disodium
hydrogen phosphate; Disodium phosphate; Dibasic sodium phosphate; Disodium
acid phosphate; secondary sodium phosphate; Dinatri orthophosphate
INS
339ii
MTDI=70mg/kg
bw as phosphorus from all food sources
2.
Definition
Chemical
names
Disodium
hydrogen phosphate; disodium hydrogen orthophosphate; disodium hydrogen
monophosphate;
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7558-79-4
Chemical
formula
Anhydrous:
Na2HPO4
Hydrated:
Na2HPO4.xH2O
Formula
weight
141.98
(anhydrous)
3.
Description
Anhydrous:
White, hygroscopic, odourless powder.
Dihydrate:
White crystalline, odourless solid.
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Dodecahydrate:
White, efflorescent, odourless powder or crystals.
4.
Functional uses
Emulsifier,
texturizer, buffer
5.
Specifications
5.1.
Identification
Solubility
Freely
soluble in water; insoluble in ethanol.
pH
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Test
for sodium
Passes
test.
Test
for phosphate
Passes
test.
Test
for orthophosphate
Passes
test.
5.2.
Purity
Loss on
drying
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Dihydrate:
Not more than 22.0% (40oC, 3 h, then 105oC , 5 h)
Heptahydrate:
Not more than 50.0% (40oC , 3 h, then 105oC , 5 h)
Dodecahydrate:
Not more than 61.0% (40oC , 3 h, then 105oC , 5 h)
Water
insoluble matter
Not
more than 0.2%.
Fluoride
Not
more than 50.0 mg/kg.
Arsenic
Not
more than 3.0 mg/kg.
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Not
more than 4.0 mg/kg.
5.3.
Na2HPO4 content
Not
less than 98.0% on the dried basis.
6.
Tests
6.1.
Identification
Test
for sodium
Tested
according to JECFA monograph 1 - Vol.4.
Test
for phosphate
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Test
for orthophosphate
Dissolve
0.1 g of the sample in 10 ml water. Acidify slightly with dilute acetic acid
TS, and add 1 ml of silver nitrate TS. A yellow precipitate is formed.
6.2.
Purity
Fluoride
Tested
according to JECFA monograph 1 - Vol. Vol.4, Method I or III.
Arsenic
Tested
according to JECFA monograph 1 - Vol. Vol.4, Method II.
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 - Vol.4,
“Instrumental Methods.”
6.3.
Method of essay
Into a
250-ml beaker transfer about 6.5 g of the dried sample accurately weighed.
Add 50 ml of 1N hydrochloric acid and 50 ml of water, and stir until the
sample is completely dissolved. Place the electrodes of a suitable pH meter
in the solution and titrate the excess acid with 1N sodium hydroxide to the
inflection point occurring at about pH 4. Record the buret reading and
calculate the volume (A) of 1N hydrochloric acid consumed by the sample.
Continue the titration with 1N sodium hydroxide until the inflection point
occurring at about pH 8.8 is reached, record the buret reading, and calculate
the volume (B) of 1N sodium hydroxide required in the titration between the
two inflection points (pH 4 to pH 8.8).
When
(A) is equal to, or less than, (B), each ml of the volume (A) of 1N
hydrochloric acid is equivalent to 142.0 mg of Na2HPO4.
When
(A) is greater than (B), each ml of the volume 2(B) -(A) of 1N sodium
hydroxide is equivalent to 142.0 mg of Na2HPO4.
ANNEX 5
SPECIFICATIONS AND TESTS FOR
DIPOTASSIUM HYDROGEN PHOSPHATE
1.
Synonyms
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INS
340ii
MTDI =
70 mg/kg bw as phosphorus from all food sources
2.
Definition
Chemical
names
Dipotassium
hydrogenphosphate; dipotassium hydrogen orthophosphate; dipotassium hydrogen
monophosphate
C.A.S.
number
7758-11-4
Chemical
formula
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Formula
weight
174.18
3.
Description
Colourless
or white granular powder, crystals or masses; deliquescent
4.
Functional uses
Buffering
agent, sequestrant, yeast food
5.
Specifications
5.1.
Identification
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Freely
soluble in water; insoluble in ethanol.
pH
8.7-9.3
(1 in 100 soln).
Test
for potassium
Passes
test.
Test
for phosphate
Passes
test.
Test
for orthophosphate
Passes
test.
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Loss on
drying
Not
more than 5% (105oC , 4 h).
Water
insoluble matter
Not
more than 0.2%.
Fluoride
Not
more than 10 mg/kg.
Arsenic
Not
more than 3.0 mg/kg.
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Not
more than 4.0 mg/kg.
5.3.
K2HPO4 content
Not
less than 98.0% on the dried basis.
6.
Tests
6.1.
Identification
Test
for potassium
Tested
according to JECFA monograph 1 - Vol.4.
Test
for phosphate
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Test
for orthophosphate
Dissolve
0.1 g of the sample in 10 ml water, acidify slightly with dilute acetic acid
TS, and add 1 ml of silver nitrate TS. A yellow precipitate is formed.
6.2.
Purity
Fluoride
Place 5
g of the sample, 25 ml of water, 50 ml of perchloric acid, 5 drops of silver
nitrate solution (1 in 2), and a few glass beads in a 250-ml distilling flask
connected with a condenser and carrying a thermometer and a capillary tube,
both of which must extend into the liquid. Connect a small dropping funnel,
filled with water, or a steam generator, to the capillary tube. Support the
flask on an asbestos mat with a hole which exposes about one-third of the
flask to the flame. Distil into a 250-ml flask until the temperature reaches
135oC. Add water from the funnel or introduce steam through the
capillary to maintain the temperature between 135oC and 140oC.
Continue the distillation until 225-240 ml has been collected, then dilute to
250 ml with water, and mix. Place a 50-ml aliquot of this solution in a 100-ml
Nessler tube. In another similar Nessler tube place 50 ml of water as a
control. Add to each tube 0.1 ml of a filtered solution of sodium
alizarinsulfonate (1 in 1000) and 1 ml of freshly prepared hydroxylamine
solution (1 in 4000), and mix well. Add, drop wise, and with stirring, 0.05 N
sodium hydroxide to the tube containing the distillate until its colour just
matches that of the control, which is faintly pink. Then add to each tube
exactly 1 ml of 0.1 N hydrochloric acid, and mix well. From a buret, graduated
in 0.05 ml, add slowly to the tube containing the distillate enough thorium
nitrate solution (1 in 4000) so that, after mixing, the colour of the liquid
just changes to a faint pink. Then add to each tube exactly 1 ml of 0.1 N
hydrochloric acid, and mix well. Now add to the control sodium fluoride TS
(10 µg F per ml) from a buret to make the colours of the two tubes match
after dilution to the same volume. Mix well, and allow all air bubbles to
escape before making the final colour comparison. Check the end-point by
adding 1 or 2 drops of sodium fluoride TS to the control. A distinct change
in colour should take place. Note the volume of sodium fluoride added. The
volume of sodium fluoride TS required for the control solution should not
exceed 1 ml.
Arsenic
Tested
according to JECFA monograph 1 - Vol. Vol.4- Method II.
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 - Vol.4,
“Instrumental Methods.”
6.3.
Method of essay
Into a
250-ml beaker transfer about 6.5 g of the dried sample, accurately weighed.
Add 50 ml of 1 N hydrochloric acid and 50 ml of water, and stir until the
sample is completely dissolved. Place the electrodes of a suitable pH meter
in the solution and titrate the excess acid with 1N sodium hydroxide to the
inflection point occurring at about pH 4. Record
the buret reading and calculate the volume (A) of 1N hydrochloric acid
consumed by the sample. Continue the titration with 1N sodium hydroxide until
the inflection point occurring at about pH 8.8 is reached, record the buret
reading, and calculate the volume (B) of 1 N sodium hydroxide required in the
titration between the two inflection points (pH 4 to pH 8.8).
When
(A) is equal to, or less than, (B), each ml of the volume (A) of 1N
hydrochloric acid is equivalent to 174.2 mg of K2HPO4.
When
(A) is greater than (B), each ml of the volume 2(B) - (A) of 1N sodium
hydroxide is equivalent to 174.2 mg of K2HPO4.
ANNEX 6
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1.
Synonyms
Calcium
phosphate, tribasic; precipitated calcium phosphate;
INS
341iii
MTDI =
70 mg/kg bw as phosphorus from all food sources
2.
Definition
Consists
of a variable mixture of calcium phosphates having and approximate
composition of 10CaO.3P2O5.H2O. The article of commerce can be specified
further as to titration value.
3.
Description
White,
odourless powder which is stable in air.
4.
Functional uses
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5.
Specifications
5.1.
Identification
Solubility
Practically
insoluble in water; insoluble in ethanol, soluble in dilute hydrochloric and
nitric acid.
Test
for calcium
Passes
test.
Test
for phosphate
Passes
test.
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Loss on
ignition
Not
more than 10% after ignition at 825oC to constant weight.
Fluoride
Not
more than 50 mg/kg.
Lead
Not
more than 4 mg/kg.
5.3.
Ca3(PO4)2 content
Not
less than the equivalent of 90% of Ca3(PO4)2, calculated on the ignited
basis.
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6.1.
Identification
Test
for calcium
Dissolve
about 100 mg of the sample by warming with 5 ml of dilute hydrochloric acid
TS and 5 ml of water. Add 1 ml of ammonia TS, dropwise, with shaking, and
then add 5 ml of ammonium oxalate TS. A white precipitate is formed.
Test
for phosphate
To a
warm solution of the sample in a slight excess of nitric acid add ammonium
molybdate TS. A yellow precipitate forms.
6.2.
Purity
Fluoride
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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 - Vol.4,
“Instrumental Methods.”
6.3.
Method of essay
Weigh
200 mg of the sample to the nearest 0.1 mg and dissolve in a mixture of 25 ml
of water and 10 ml of dilute nitric acid TS. Filter, if necessary, wash any
precipitate, add sufficient ammonia TS to the filtrate to produce a slight
precipitate, then dissolve the precipitate with the addition of 1 ml of
dilute nitric acid TS. Adjust the temperature to about 50o, add 75
ml of ammonium molybdate TS, and maintain the temperature at about 50o
for 30 min, stirring occasionally. Wash the precipitate once or twice with
water by decantation, using from 30 to 40 ml each time. Transfer the precipitate
to a filter, and wash with a 1 in 100 potassium nitrate solution until the
last washing is not acid to litmus paper. Transfer the precipitate and filter
to the precipitation vessel, add 40.0 ml of N sodium hydroxide, agitate until
the precipitate is dissolved, add 3 drops of phenolphthalein TS, and then
titrate the excess alkali with N sulfuric acid.
Each ml
of N sodium hydroxide corresponds to 6.743 mg of Ca3(PO4)2.
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SPECIFICATIONS AND TESTS FOR
AMMONIUM POLYPHOSPHATE
1.
Synonyms
INS 452v
MTDI =
70 mg/kg bw as phosphorus from all food sources
2.
Definition
Chemical
names
Ammonium
polyphosphate
C.A.S.
number
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Chemical
formula
Heterogeneous
mixture of ammonium salts of linear condensed polyphosphoric acids of general
formula Hn+2PnO3n+1
3.
Description
Aqueous
solution
4.
Functional uses
Stabilizer,
sequestrant, emulsifier
5.
Specifications
5.1.
Identification
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Freely
soluble in water
pH
4.0 -
9.0 (1% soln)
Test
for ammonium
Passes
test.
Test
for phosphate
Passes
test.
5.2.
Purity
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Not
more than 8% calculated as P2O5 content
Fluoride
Not
more than 10 mg/kg
Arsenic
Not
more than 3 mg/kg
Lead
Not
more than 4 mg/kg.
5.3.
Content
Not
less than 55.0% and not more than 75.0% on an anhydrous basis, calculated as
P2O5
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6.1.
Identification
Ammonium
Tested
according to JECFA monograph 1 - Vol.4.
Test
for phosphate
- Test
a solution resulting from mixing 0.5 g of sample with 10 ml of nitric acid
and 50 ml of water, boiled for 30 min and cooled.
-
Tested according to JECFA monograph 1 - Vol.4.
6.2.
Purity
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Cyclic
phosphate
Tested
according to JECFA monograph 1 - Vol.4.
Fluoride
Tested
according to JECFA monograph 1 - Vol.4.
Arsenic
Tested
according to JECFA monograph 1 - Vol.4.
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.”
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Proceed
as directed under “Phosphate Determination as P2O5”, Method I, in Volume 4.
ANNEX 8
SPECIFICATIONS AND TESTS FOR
SODIUM HYDROGEN CARBONATE
1.
Synonyms
Baking
soda, bicarbonate of soda, sodium bicarbonate
INS
500(ii)
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2.
Definition
Chemical
names
Sodium
hydrogen carbonate, sodium acid carbonate
C.A.S.
number
144-55-8
Chemical
formula
NaHCO3
Formula
weight
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3.
Description
Colourless,
white, crystalline masses or crystalline powder
4.
Functional uses
Stabilizer,
alkali, raising agent, buffer, leavening agent
5.
Specifications
5.1.
Identification
Solubility
Soluble
in water; insoluble in ethanol.
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8.0 -
8.6 (1 in 100 soln of the sample in cold water without shaking)
Test
for sodium
Passes
test.
Test
for carbonate
Passes
test.
5.2.
Purity
Loss on
drying
Not
more than 0.25% (over silica gel, 4 h).
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Passes
test (described in “Tests”).
Ammonium
salts
Passes test
(described in “Tests”).
Lead
Not
more than 2 mg/kg.
5.3.
NaHCO3 content
Not
less than 99.0% after drying
6.
Tests
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Test
for sodium
Tested
according to JECFA monograph 1 - Vol.4.
Test
for carbonate
Tested
according to JECFA monograph 1 - Vol.4.
6.2.
Purity
Water
insoluble matter
1 g of
the sample dissolves completely in 20 ml of water and gives a clear solution.
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Heat 1
g of the sample in a test tube. No odour of ammonia is detected.
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 essay
Weigh
accurately about 3 g of the dried sample, add methyl orange TS and titrate
with 1 N sulfuric acid.
Each ml
of 1 N sulfuric acid is equivalent to 84.01 mg of NaHCO3.
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ANNEX 9
SPECIFICATIONS AND TESTS FOR
POTASSIUM CARBONATE
1.
Synonyms
INS
501(i)
ADI
“Not limited”
2.
Definition
Chemical
names
Potassium
carbonate, potassium salt of carbonic acid
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584-08-7
Chemical
formula
Anhydrous:
K2CO3
Hydrated:
K2CO3.1½H2O
Formula
weight
138,21
(anhydrous)
3.
Description
White,
odourless, very deliquescent powder. The hydrated form occurs as small,
white, translucent crystals or granules.
4.
Functional uses
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5.
Specifications
5.1.
Identification
Solubility
Very
soluble in water; insoluble in ethanol.
Test
for potassium
Passes
test.
Test
for carbonate
Passes
test.
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Loss on
drying
Anhydrous:
Not more than 5% (180o, 4 h)
Hydrated
forms: Between 10% and 18% (180o, 4 h)
Lead
Not
more than 2 mg/kg.
5.3.
K2CO3 content
Not
less than 99.0% after drying.
6.
Tests
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Test
for potassium
Tested
according to JECFA monograph 1 - Vol.4.
Test
for carbonate
Tested
according to JECFA monograph 1 - Vol.4.
6.2.
Purity
Lead
-
Tested according to JECFA monograph 1 - Vol.4.
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6.3.
Method of essay
Weigh
accurately about 1 g of the dried sample. Dissolve carefully in 50 ml of 1 N
sulfuric acid, add methyl orange TS and titrate the excess acid with 1 N
sodium hydroxide.
Each ml
of 1 N sulfuric acid is equivalent to 69.11 mg of K2CO3.
ANNEX 10
SPECIFICATIONS AND TESTS FOR
AMMONIUM HYDROGEN CARBONATE
1.
Synonyms
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INS
503(ii)
ADI
“Not limited”
2.
Definition
Chemical
names
Ammonium
hydrogen carbonate
C.A.S.
number
1066-33-7
Chemical
formula
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Structural
formula
NH4HCO3
Formula
weight
79.06
3.
Description
White
crystals or a crystalline powder with a slight odour of ammonia.
4.
Functional uses
Stabilizer,
raising agent.
5.
Specifications
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Solubility
Freely
soluble in water, insoluble in ethanol
pH
About 8
(1 in 20 soln).
Test
for carbonate
Passes
test.
Ammonium
Passes
test.
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When
heated, it volatilizes without charring and the vapour is alkaline to moist
litmus.
5.2.
Purity
Non-volatile
residue
Not
more than 500 mg/kg (Test 4 g of the sample in 10 ml of water)
Chlorides
Not
more than 30 mg/kg (see description under Tests).
Sulfates
Not
more than 70 mg/kg (see description under Tests).
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Not more
than 2 mg/kg (see description under Tests).
5.3.
NH4CO3 content
Not
less than 99.0%.
6.
Tests
6.1.
Identification
Test
for carbonate
Tested
according to JECFA monograph 1 - Vol.4.
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Tested
according to JECFA monograph 1 - Vol.4.
6.2. Purity
Chlorides
-
Tested according to JECFA monograph 1 - Vol.4.
-
Dissolve 500 mg of the sample in 10 ml of hot water, add about 5 mg of sodium
carbonate, and evaporate to dryness on a steam bath. Test the residue as
directed under the Limit Test. Any turbidity produced does not exceed that
shown in a control containing 15 µg of chloride ion (Cl- ).
Sulfates
Dissolve
4 g of the sample in 40 ml of water, add about 10mg of sodium carbonate and 1
ml of 30% hydrogen peroxide, and evaporate the solution to dryness on a steam
bath. Treat the residue as directed under the Limit Test. Any turbidity
produced does not exceed that shown in a control containing 280 µg of sulfate
ion (SO4 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 - Vol.4,
“Instrumental Methods.”
6.3.
Method of essay
Place
about 10 ml of water in a weighing bottle, tare the bottle and its contents,
add about 2 g of the sample and weigh accurately. Transfer the contents of
the bottle to a 250-ml flask and slowly add, with mixing, 50 ml of 1 N
sulfuric acid. When solution has been effected, wash down the sides of the
flask, add methyl orange TS, and titrate the excess acid with 1 N sodium
hydroxide.
Each ml
of 1 N sulfuric acid is equivalent to 79.06 mg of NH4HCO3.
ANNEX 11
SPECIFICATIONS AND TESTS FOR
POTASSIUM CHLORIDE
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Sylvite;
Sylvine
INS 508
ADI
“Not limited”
2.
Definition
Chemical
names
Potassium
chloride
C.A.S.
number
7447-40-7
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KCl
Formula
weight
74.56
3.
Description
Colourless,
elongated, prismatic, or cubital crystals, or white granular powder;
odourless.
4.
Functional uses
Stabilizer,
seasoning agent, gelling agent, yeast food
5.
Specifications
5.1.
Identification
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Solubility
Freely
soluble in water; insoluble in ethanol.
Test
for chloride
Passes
test.
Test
for potassium
Passes
test.
5.2.
Purity
Loss on
drying
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Acidity
or alkalinity
Passes
test (described in “Tests”).
Iodide
or bromide
Passes
test (described in “Tests”).
Test
for sodium
Negative
test (described in “Tests”).
Lead
Not
more than 2 mg/kg.
5.3.
KCl content
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6.
Tests
6.1.
Identification
Chlorides
Tested
according to JECFA monograph 1 - Vol.4.
Potassium
Tested
according to JECFA monograph 1 - Vol.4.
6.2.
Purity
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To a
solution of 5 g of the sample in 50 ml of recently boiled and cooled water
add 3 drops of phenolphthalein TS. No pink colour is produced. Then add 0.3
ml of 0.02 N sodium hydroxide. A pink
colour is produced.
Iodide
or bromide
Dissolve
2 g of the sample in 6 ml of water, add 1 ml of chloroform, and then add,
dropwise and with constant agitation, 5 ml of a mixture of equal parts of
chlorine TS and water. The chloroform is free from even a transient violet or
permanent orange colour.
Test for
sodium
Tested
according to JECFA monograph 1 - Vol.4.
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 essay
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Dissolve
about 250 mg of the dried sample, accurately weighed in 50 ml of water in a
glass-stoppered flask. Add, while agitating, 50 ml of 0.1 N silver nitrate, 3
ml of nitric acid, and 5 ml of nitrobenzene, shake vigorously, add 2 ml of
ferric ammonium sulfate TS, and titrate the excess silver nitrate with 0.1 N
ammonium thiocyanate.
Each ml
of 0.1 N silver nitrate is equivalent to 7.456 mg of KCl.
ANNEX 12
SPECIFICATIONS AND TESTS FOR
POTASSIUM DIHYDROGEN PHOSPHATE
1.
Synonyms
Potassium
dihydrogen phosphate; Monobasic potassium phosphate; Monopotassium
monophosphate; Potassium acid phosphate; Potassium biphosphate
INS
340i
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2.
Definition
Chemical
names
Potassium
dihydrogenphosphate, monopotassium dihydrogenorthophosphate, monopotassium
dihydrogen monophosphate
C.A.S.
number
7778-77-0
Chemical
formula
KH2PO4
Formula
weight
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3.
Description
Odourless,
colourless crystals or white granular or crystalline powder
4.
Functional uses
Stabilizer,
buffer, neutralizing agent, sequestrant, yeast food
5.
Specifications
5.1.
Identification
Solubility
Freely
soluble in water; insoluble in ethanol.
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4.2 -
4.7 (1 in 100 soln).
Test
for potassium
Passes
test.
Test
for phosphate
Passes
test.
Test
for orthophosphate
Passes
test.
5.2.
Purity
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Not
more than 2% (105o, 4 h).
Water
insoluble matter
Not
more than 0.2%.
Fluoride
Not
more than 10 mg/kg.
Arsenic
Not
more than 3.0 mg/kg.
Lead
Not
more than 4.0 mg/kg.
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Not
less than 98.0% on the dried basis.
6.
Tests
6.1.
Identification
Test
for potassium
Tested
according to JECFA monograph 1 - Vol.4.
Test
for phosphate
Tested
according to JECFA monograph 1 - Vol.4.
Test
for orthophosphate
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6.2.
Purity
Fluoride
Place 5
g of the sample, 25 ml of water, 50 ml of perchloric acid, 5 drops of silver
nitrate solution (1 in 2), and a few glass beads in a 250-ml distilling flask
connected with a condenser and carrying a thermometer and a capillary tube,
both of which must extend into the liquid.Support the flask on an asbestos
mat with a hole which exposes about one-third of the flask to the flame.
Distil into a 250-ml flask until the temperature reaches 135o. Add
water from the funnel or introduce steam through the capillary to maintain
the temperature between 135o and 140o. Continue the
distillation until 225-240 ml has been collected, then dilute to 250 ml with
water, and mix. Place a 50-ml aliquot of this solution in a 100-ml Nessler
tube. In another similar Nessler tube place 50 ml of water as a control. Add
to each tube 0.1 ml of a filtered solution of sodium alizarinsulfonate (1 in
1000) and 1 ml of freshly prepared hydroxylamine solution (1 in 4000), and
mix well. Add, dropwise, and with stirring, 0.05 N sodium hydroxide to the tube
containing the distillate until its colour just matches that of the control,
which is faintly pink. Then add to each tube exactly 1 ml of 0.1 N
hydrochloric acid, and mix well. From a buret, graduated in 0.05 ml, add
slowly to the tube containing the distillate enough thorium nitrate solution
(1 in 4000) so that, after mixing, the colour of the liquid just changes to a
faint pink. Then add to each tube exactly 1 ml of 0.1 N hydrochloric acid,
and mix well. Now add to the control sodium fluoride TS (10 µg F per ml) from
a buret to make the colours of the two tubes match after dilution to the same
volume. Mix well, and allow all air bubbles to escape before making the final
colour comparison. Check the end-point by adding 1 or 2 drops of sodium
fluoride TS to the control. A distinct change in colour should take place.
Note the volume of sodium fluoride added. A distinct change in colour should
take place. Note the volume of sodium fluoride added.
The
volume of sodium fluoride TS required for the control solution should not
exceed 1 ml.
Arsenic
Tested
according to JECFA monograph 1 - Vol. Vol.4, Method II.
Lead
-
Tested according to JECFA monograph 1 - Vol.4.
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6.3.
Method of essay
Transfer
about 5 g of the dried sample, accurately weighed, into a 250-ml beaker. Add
100 ml of water and 5 ml of 1 N hydrochloric acid, and stir until the sample
is completely dissolved. Place the electrodes of a suitable pH meter in the
solution, and slowly titrate the excess acid, stirring constantly, with 1 N
sodium hydroxide to the inflection point occurring at about pH 4. Record the
buret reading, and calculate the volume (A), if any, of 1 N hydrochloric acid
consumed by the sample. Continue the titration with 1 N sodium hydroxide
until the inflection point occurring at about pH 8.8 is reached, record the
buret reading, and calculate the volume (B) of 1 N sodium hydroxide required
in the titration between the two inflection points (pH 4 and pH 8.8).
Each ml
of the volume (B) - (A) of 1 N sodium hydroxide is equivalent to 136.1 mg of
KH2PO4.
ON FOOD ADDITIVE – PROPELLANT
Foreword
QCVN 4-
: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.
44/2010/TT-BYT dated December 22, 2010 of the Minister of Health.
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I.
GENERAL
1. Scope
This
National technical regulation (hereinafter referred to as “the Regulation”)
provides for specifications and regulatory requirements for quality, hygiene
and safety of sequestrants used as food additives.
2.
Regulated entities
This
Regulation applies to:
2.1.
Importers, exporters, producers, traders and users of preservatives used as
sequestrants used as food additives (hereinafter referred to as “entities”).
2.2.
Relevant regulatory bodies.
3.
Interpretation of terms and acronyms:
3.1.
“sequestrant” refers to a food additive used for the purpose of controlling the
availability of a cation in food.
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3.3.
“C.A.S number” (Chemical Abstracts Service) refers to registry numbers of
chemical substances identified by the American Chemical Society.
3.4. “TS”
stands for test solution.
3.5.
“ADI” stands for acceptable daily intake.
3.6.
“MTDI” stands for maximum tolerable daily intake.
3.7.
“INS” stands for international numbering system.
II.
SPECIFICATIONS, TESTS AND SAMPLING
1.
Specifications and tests for sequestrants are specified in the annexes to this
Regulation as follows:
1.1.
Annex
1:
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1.2.
Annex
2:
Specifications
and tests for calcium disodium ethylenediaminetetraacetate
1.3.
Annex
3:
Specifications
and tests for disodium ethylenediaminetetraacetate
1.4.
Annex
4:
Specifications
and tests for tetrasodium diphosphate
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Annex
5:
Specifications
and tests for tetrapotassium diphosphate
1.6.
Annex
6:
Specifications
and tests for pentasodium triphosphate
1.7.
Annex
7:
Specifications
and tests for pentapotassium triphosphate
1.8.
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Specifications
and tests for sodium polyphosphate
1.9
Annex
9:
Specifications
and tests for potassium polyphosphate
1.10
Annex
10:
Specifications
and tests for sodium calcium polyphosphate
1.11
Annex
11:
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1.12
Annex
12:
Specifications
and tests for potassium gluconate
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
1.1.
Sequestrants 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/QĐ-BKHCN dated September 28, 2007 of
the Minister of Science and Technology and regulations of laws.
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The
quality, hygiene and safety of sequestrants must be inspected in accordance
with the regulations of law.
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
sequestrants 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.
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SPECIFICATIONS AND TESTS FOR ISOPROPYL
CITRATE
1.
Synonyms
Isopropyl
citrate mixture
INS 384
ADI = 0
– 14 mg/kg bw
2.
Definition
Chemical
names
Citric
acid mixed ester of 2-propanol. The article of commerce, monoisopropyl
citrate mixture, is composed of approximately 38 parts by weight of isopropyl
citrate in 62 pars by weight of mono- and diglycerides.
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where R
is either hydrogen or a isopropyl group. The major component of the 38 parts
of isopropyl citrate mixture is monoisopropyl citrate (approximately 25 parts),
the remainder being diisopropyl citrate (approximately 9 parts) and
triisopropyl citrate (approximately 4 parts).
Approximate
composition:
Monoisopropyl
citrate - 27 parts by weigh
Diisopropyl
citrate - 9 parts by weight
Triisopropyl
citrate - 2 parts by weight
3.
Description
Oil
miscible semi-solid material. The commercial product, monoisopropyl citrate
mixture, is a viscous, colourless syrup exhibiting some crystallization upon
standing, and may be further specified as to saponification value, acid
value, citric acid and isopropyl content.
4.
Functional uses
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5.
Specifications
5.1.
Identification
Solubility
Soluble
in water and ethanol.
Test
for citrate
Passes
test.
Test
for isopropanol
Passes
test.
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Acids
other than citric acid
Should
be absent.
Alcohols
other than isopropanol
Should
be absent.
Sulfated
ash
Not
more than 0.3%.
Lead
Not
more than 2 mg/kg.
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6.1.
Identification
Citrate
Reflux
3 g of sample with 50 ml of sodium hydroxide TS for 1 h, and let stand to
cool. This solution is used for the following tests:
Neutralize
the solution with a (1 in 20) sulfuric acid solution, add an excess of
mercuric sulfate TS, heat to boil, and add potassium permanganate TS. The
permanganate colour of the solution disappears, and a white precipitate
forms.
Neutralize
the solution with hydrochloric acid, add an excess of calcium chloride TS,
and boil. A white crystalline precipitate is formed which is insoluble in
sodium hydroxide TS, but soluble in dilute hydrochloric acid TS.
Test
for isopropanol
Reflux
2 g of sample with 50 ml of sodium hydroxide TS for 1 h. Distil off 20 ml.
Place 8 g of chromic oxide in a flask, add 15 ml water and 2 ml concentrated
sulfuric acid. Provide the flask with a reflux condenser and add 5 ml
distillate slowly through the condenser. Reflux for 30 min, then cool and
distil off 2 ml. Add 3 ml water and 10 ml mercuric sulfate TS to the
distillate. Heat in a boiling water bath for 3 min. A white or yellow
precipitate within 3 min indicates the presence of isopropanol.
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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 - Vol.4,
“Instrumental Methods.”
ANNEX 2
SPECIFICATIONS AND TESTS FOR
CALCIUM DISODIUM ETHYLENEDIAMINETETRAACETATE
1.
Synonyms
Calcium
disodium ethylenediaminetetraacetate; calcium disodium EDTA; calcium disodium
edetate
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ADI = 0
– 2.5 mg/kg bw
2.
Definition
Chemical
names
N,N'-1,2-Ethanediylbis[N-(carboxymethyl)-glycinate](4-)-
N,N',O,O',ON,ON]calciate(2-)disodium;
Calcium
disodium ethylenediaminetetraacetate;
Calcium
disodium (ethylene-dinitrilo)- tetraacetate.
C.A.S.
number
662-33-9
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C10H12CaN2Na2O8.2H2O
Structural
formula
Formula
weight
410.31
3.
Description
White,
odourless crystalline granules or a white to nearly white powder; slightly
hygroscopic
4.
Functional uses
Sequestrant,
preservative.
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5.1.
Identification
Solubility
Freely
soluble in water; sparingly soluble in ethanol
Test
for calcium
Passes
test.
Test
for sodium
Passes
test.
Chelating
activity to metal ions
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5.2.
Purity
pH
6.5 -
7.5 (1 in 100 soln)
Magnesium
chelating substances
Passes
test (described in “Tests”).
Lead
Not
more than 2 mg/kg.
5.3.
C10H12CaN2Na2O8 content
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6.
Tests
6.1.
Identification
Test
for calcium
Tested
according to JECFA monograph 1 - Vol.4.
Test
for sodium
Tested
according to JECFA monograph 1 - Vol.4.
Chelating
activity to metal ions
To 5 ml
of water in a test tube add 2 drops of ammonium thiocyanate TS and 2 drops of
ferric chloride TS. A deep red solution develops. Add about 50 mg of the
sample and mix. The deep red colour disappears.
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Magnesium
chelating substances
Transfer
1 g of the sample, accurately weighed, to a small beaker, and dissolve it in
5 ml of water. Add 5 ml of buffer solution prepared by dissolving 67.5 g of
ammonium chloride in 200 ml of water, adding 570 ml of strong ammonia TS, and
diluting with water to 1000 ml. To the buffered solution add 5 drops of
eriochrome black TS, and titrate with 0.1 M magnesium acetate to the
appearance of a deep wine-red colour. Not more than 2.0 ml should be
required.
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 essay
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Each ml
of 0.1 M mercuric nitrate is equivalent to 37.43 mg of C10H12CaN2Na2O8.2H2O.
(*)
Mercuric nitrate solution:
Dissolve
about 35 g of mercuric nitrate Hg(NO3)2.H2O in a mixture of 5 ml of nitric
acid and 500 ml of water and dilute with water to 1000 ml. Standardize the
solution as follows: Transfer an accurately measured volume of about 20 ml of
the solution into an Erlenmeyer flask and add 2 ml of nitric acid and 2 ml of
ferric ammonium sulfuric TS. Cool to below 20o and titrate with 0.1 N
ammonium thiocyanate to the first appearance of a permanent brownish colour.
Calculate the molarity. (0.1 M=32.46g Hg(NO3)2/l).
ANNEX 3
SPECIFICATIONS AND TESTS FOR
DISODIUM ETHYLENEDIAMINETETRAACETATE
1.
Synonyms
Disodium
EDTA, disodium edetate;
Disodium
ethylenediaminetetraacetate;
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ADI = 0
– 2.5 mg/kg bw
2.
Definition
Chemical
names
Disodium
salt of N,N'-1,2-Ethanediylbis[N-(carboxymethyl)glycine]; disodium dihydrogen
ethylenediaminetetraacetate; disodium dihydrogen
(ethylene-dinitrilo)-tetraacetate
C.A.S.
number
139-33-3
Chemical
formula
C10H14N2Na2O8
· 2H2O
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Formula
weight
372.24
3.
Description
White,
odourless crystalline granules or a white to nearly white powder
4.
Functional uses
Sequestrant,
antioxidant synergist, preservative
5.
Specifications
5.1.
Identification
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Solubility
Freely
soluble in water, practically insoluble in ethanol.
Infrared
absorption
The
infrared spectrum of the sample corresponds with that of a reference standard
(a Reference standard may be obtained from the U.S. Pharmacopeia, 12601 Twin
Brook Parkway, Rockville, Maryland 20852)
Test
for sodium
Passes
test.
Chelating
activity to metal ions
Passes
test.
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pH
4.3 -
4.7 (1 in 100 soln)
Nitrilotriacetic
acid
Passes
test (described in “Tests”).
Lead
Not
more than 2 mg/kg.
5.3.
C10H14N2Na2O8 content
Not
less than 99.0%.
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6.1.
Identification
Test
for sodium
Tested
according to JECFA monograph 1 - Vol.4.
Chelating
activity to metal ions
To 5 ml
of water in a test tube add 2 drops of ammonium to thiocyanate TS and 2 drops
of ferric chloride TS. A deep red solution develops. Add about 50 mg of the
sample and mix. The deep red colour disappears.
6.1. Purity
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Stock
test solution
Transfer
10 g of the sample into a 100-ml volumetric flask, dissolve in 40 ml of a (1
in 10) potassium hydroxide solution, dilute to volume with water, and mix.
Diluted
stock test solution
Pipette
10 ml of the "stock test solution" into a 100-ml volumetric flask,
dilute to volume with water, and mix.
Test
preparation
Pipette
20 ml of the "diluted stock test solution" into a 150-ml beaker,
add 1 ml of a (1 in 10) potassium hydroxide solution, 2 ml of a (1 in 10)
ammonium nitrate solution, and about 50 mg of eriochrome black T indicator,
and titrate with a (3 in 100) cadmium nitrate solution to a red endpoint.
Record the volume, in ml, of the titrant required as V, and discard the
solution.
Pipette
20 ml of the "diluted stock test solution" into a 100-ml volumetric
flask, and add the volume V of the (3 in 100) cadmium nitrate solution
required in the initial titration, plus 0.05 ml in excess. Add 1.5 ml of a (1
in 10) potassium hydroxide solution, 10 ml of a (1 in 10) ammonium nitrate
solution, and 0.5 ml of methyl red TS, then dilute to volume with water and
mix.
Stock
standard solution
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Dilute
stock standard solution
Pipette
1 ml of the "stock standard solution" and 10 ml of the "stock
test solution" into a 100-ml volumetric flask, dilute to volume with
water, and mix.
Standard
preparation
Proceed
as directed under "test preparation", using "diluted stock
standard solution" where "diluted stock test solution" is
specified.
Polarographic
test: Rinse a polarographic cell with a portion of the "standard
preparation", then add a suitable volume to the cell, immerse it in a
constant-temperature bath maintained at 25 ± 0.5o , and de-aerate by bubbling
oxygen-free nitrogen through
the solution for 10 min. Insert the dropping mercury electrode of a suitable
polarograph, and record the polarogram from -0.6 to -1.2 volts at a
sensitivity of 0.006 microampere per mm, using a saturated calomel electrode
as the reference electrode. In the same manner, obtain a polarogram for a
portion of the "test preparation".
The diffusion current observed with the "test preparation"
is not greater than 10% of the difference between the diffusion currents
observed with the "standard preparation" and the "test
preparation", respectively. (Note: An extra polarographic wave appearing
ahead of the nitrilotriacetic acid-cadmium complex wave is probably due to
uncomplexed cadmium. This wave should be ignored in measuring the diffusion
current).
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.”
6.2.
Method of essay
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Transfer
about 5 g, accurately weighed, of the sample, into a 250-ml volumetric flask,
dissolve in water, dilute to volume and mix, to give the assay preparation.
Place about 200 mg, accurately weighed, of reagent grade calcium carbonate of
known purity in a 400-ml beaker, add 10 ml of water and swirl to form a slurry.
y. Cover the beaker with a watch glass and introduce 2 ml of dilute
hydrochloric acid TS from a pipette inserted between the lip of the beaker
and the edge of the watch glass. Swirl the contents of the beaker to dissolve
the calcium carbonate. Wash down the outer surface of the pipette, the watch
glass and the sides of the beaker, and dilute to about 100 ml with water.
While stirring the solution, preferably with a magnetic stirrer, add about 30
ml of the assay preparation from a 50- ml burette. Add 15 ml of sodium
hydroxide TS, 300 mg of hydroxynaphthol blue indicator and continue the
titration with the assay preparation to a blue end point. Calculate the
percentage of C10H14N2Na2O8.2H2O in the sample by the formula:
%
sodium EDTA = 
where
mCaCO3
= the weight in grams of calcium carbonate;
Vt =
the volume in ml of assay preparation; and
mt =
the weight in gram of the sample taken
ANNEX 4
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1.
Synonyms
Sodium
pyrophosphate, tetrasodium diphosphate
INS
450iii
MTDI =
70 mg/kg bw as phosphorus from all food sources
2.
Definition
Chemical
names
Tetrasodium
diphosphate, tetrasodium pyrophosphate
C.A.S.
number
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Chemical
formula
Anhydrous:
Na4P2O7
Decahydrate:
Na4P2O7.10H2O
Formula
weight
Anhydrous:
265.94
Decahydrate:
446.09
3.
Description
Colourless
or white crystals, or a white crystalline or granular powder; the decahydrate
effloresces slightly in dry air.
4.
Functional uses
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5.
Specifications
5.1.
Identification
Solubility
Soluble
in water; insoluble in ethanol.
pH
9.9 -
10.8 (1 in 100 soln).
Test
for sodium
Passes
test.
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Passes
test.
5.2.
Purity
Loss on
ignition
Not
more than 0.5% for anhydrous
38-42%
for decahydrate
(105º,
4h then 550º, 30 min).
Water
insoluble matter
Not
more than 0.2%.
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Not
more than 10 mg/kg.
Arsenic
Not
more than 3.0 mg/kg.
Lead
Not
more than 4.0 mg/kg.
5.3.
Na4P2O7 content
Not
less than 95.0% on the dried basis.
6.
Tests
6.1.
Identification
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Test
for sodium
Tested
according to JECFA monograph 1 - Vol.4.
Test
for phosphate
Tested
according to JECFA monograph 1 - Vol.4.
6.2.
Purity
Water
insoluble matter
Dissolve
10 g of the sample in 100 ml of hot water, and filter through a tared
filtering crucible. Wash the insoluble residue with hot water, dry at 105o
for 2 h, cool and weigh.
Fluoride
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Arsenic
Tested
according to JECFA monograph 1 - Vol..4, Method II.
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 essay
Dissolve
an accurately weighed quantity of the sample, equivalent to about 500 mg of
anhydrous Na4P2O7, in 100 ml of water in a 400-ml beaker. Adjust the pH of
the solution to 3.8 with hydrochloric acid, using a pH meter, then add 50 ml
of a 1 in 8 solution of zinc sulfate (125 g of ZnSO4.7H2O dissolved in water,
diluted to 1000 ml, filtered, and adjusted to pH 3.8) and allow to stand for
2 min.Titrate the liberated acid with 0.1 N sodium hydroxide until a pH of
3.8 is again reached. After each addition of sodium hydroxide near the
end-point, time should be allowed for any precipitated zinc hydroxide to
redissolve.
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ANNEX 5
SPECIFICATIONS AND TESTS FOR
TETRAPOTASSIUM DIPHOSPHATE
1.
Synonyms
Tetrapotassium
diphosphate; Potassium pyrophosphate.
INS
450v
MTDI =
70 mg/kg bw as phosphorus from all food sources
2.
Definition
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Tetrapotassium
diphosphate, tetrapotassium pyrophosphate, tetrapotassium salt of
diphosphoric acid
C.A.S.
number
7320-34-5
Chemical
formula
K4P2O7
Formula
weight
330.34
3.
Description
Colourless
or white crystals, or a white crystalline or granular powder, powder of
granular solid; hygroscopic
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Stabilizer,
emulsifier, sequestrant
5.
Specifications
5.1.
Identification
Solubility
Soluble
in water; insoluble in ethanol.
pH
10.0 -
10.7 (1 in 100 soln).
Test
for potassium
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Test
for phosphate
Passes
test.
5.2.
Purity
Loss on
ignition
Not
more than 2% (105o, 4 h; then 550o, 30 min)
Water
insoluble matter
Not
more than 0.2%.
Fluoride
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Arsenic
Not
more than 3.0 mg/kg.
Lead
Not more
than 4.0 mg/kg.
5.3.
K4P2O7 content
Not
less than 95% on the ignited basis
6.
Tests
6.1.
Identification
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Tested
according to JECFA monograph 1 - Vol.4.
Test
for phosphate
Tested
according to JECFA monograph 1 - Vol.4.
6.2.
Purity
Fluoride
Place 5
g of the sample, 25 ml of water, 50 ml of perchloric acid, 5 drops of silver
nitrate solution (1 in 2), and a few glass beads in a 250-ml distilling flask
connected with a condenser and carrying a thermometer and capillary tube,
both of which must extend into the liquid.Connect a small dropping funnel,
filled with water, or a steam generator, to the capillary tube. Support the
flask on an asbestos mat with a hole which exposes about one-third of the
flask to the flame. Distil into a 250-ml flask until the temperature reaches
135o. Add water from the funnel or introduce steam through the
capillary to maintain the temperature between 135o and 140o.
Continue the distillation until 225-240 ml has been collected, then dilute to
250 ml with water, and mix.
Place a
50-ml aliquot of this solution in a 100-ml Nessler tube. In another similar
Nessler tube place 50 ml of water as a control. Add to each tube 0.1 ml of a
filtered solution of sodium alizarinsulfonate (1 in 1000) and 1 ml of freshly
prepared hydroxylamine solution (1 in 4000), and mix well. Add, dropwise, and
with stirring, 0.05 N sodium hydroxide to the tube containing the distillate
until its colour just matches that of the control, which is faintly pink.
Then add to each tube exactly 1 ml of 0.1 N hydrochloric acid, and mix well.
From a buret, graduated in 0.05 ml, add slowly to the tube containing the
distillate enough thorium nitrate solution (1 in 4000) so that, after mixing,
the colour of the liquid just changes to a faint pink. Note the volume of the
solution added, add exactly the same volume to the control, and mix. Now add
to the control sodium fluoride TS (10 µg F per ml) from a buret to make the
colours of the two tubes match after dilution to the same volume. Mix well,
and allow all air bubbles to escape before making the final colour
comparison. Check the end-point by adding 1 or 2 drops of sodium fluoride TS
to the control. A distinct change in colour should take place. Note the
volume of sodium fluoride added.
The
volume of sodium fluoride TS required for the control solution should not
exceed 1.0 ml.
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Tested
according to JECFA monograph 1 - Vol..4, Method II.
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 essay
Dissolve
about 600 mg of the sample, accurately weighed, in 100 ml of water in 400-ml
beaker, and adjust the pH of the solution to exactly 3.8 with hydrochloric
acid, using a pH meter. Add 50 ml of a 1 in 8 solution of zinc sulfate (125 g
of ZnSO4 · 7H2O dissolved in water, diluted to 1000 ml, filtered, and
adjusted to pH 3.8) and allow to stand for 2 min. Titrate the liberated acid
with 0.1 N sodium hydroxide until a pH of 3.8 is again reached. After each
addition of sodium hydroxide near the end-point, time should be allowed for
any precipitated zinc hydroxide to redissolve.
Each ml
of 0.1 N sodium hydroxide is equivalent to 16.52 mg of K4P2O7.
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ANNEX 6
SPECIFICATIONS AND TESTS FOR
PENTASODIUM TRIPHOSPHATE
1.
Synonyms
Penta
sodium tripolyphosphate, sodium triphosphate,
sodium
tripolyphosphae, triphosphate;
INS
451i
2.
Definition
Chemical
names
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C.A.S.
number
7758-29-4
Chemical
formula
Na5O10P3.x
H2O (x = 0 or 6)
Structural
formula
Formula
weight
Anhydrous:
367.86
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3.
Description
White,
slightly hygroscopic granules or powder
4.
Functional uses
Sequestrant,
texturizer.
5.
Specifications
5.1.
Identification
Solubility
Freely
soluble in water; insoluble in ethanol
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9.1 -
10.1 (1 % soln)
Test
for phosphate
Passes
test.
Test
for sodium
Passes
test.
5.2.
Purity
Loss on
drying
Anhydrous:
not more than 0.7% (105o, 1 h).
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Hexahydrate:
not more than 23.5% (60o, 1 h, followed by 105o, 4 h).
Water-insoluble
matter
Not
more than 0.1%.
Higher
polyphosphates
Not
detectable (see description under Tests).
Fluoride
Not
more than 50 mg/kg (Method I or III)
Arsenic
Not
more than 3 mg/kg (Method II)
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Not
more than 4.0 mg/kg.
5.3.
Content
Anhydrous:
not less than 85.0% of Na5O10P3 and not less than 56.0% and not more than
58.0% of P2O5
Hexahydrate:
not less than 65.0% of Na5O10P3 and not less than 43.0% and not more than
45.0% of P2O5
6.
Tests
6.1.
Identification
Test
for phosphate
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Test
for sodium
Tested
according to JECFA monograph 1 - Vol.4.
6.2.
Purity
Higher
polyphosphates
-
Chromatographic solvent: Mix 75 ml of isopropanol, 10 ml of water, 20 ml of
20% trichloroacetic acid and 0.3 ml of 20% ammonia. Make fresh every week.
-
Chromatographic spray: Dissolve 1 g of ammonium molybdate in 85 ml of water,
10 ml of N hydrochloric acid and 5 ml of 60% perchloric acid.
-
Sample solution: Dissolve 1 g of the sample in 50 ml of water.
-
Reference solution: Dissolve 1 g of a standard sample of pentasodium
triphosphate in 50 ml of water.
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-
Procedure: Place 0.01 ml of the sample solution and 0.01 ml of reference
solution on the starting line of the chromatographic paper and allow to dry
in a stream of warm air. Use ascending chromatography at 18-20º until the
solvent has ascended about 25 cm from the starting line (12 - 15 h) Dry at
60° in an oven and spray with the chromatographic spray. . Place the paper
under an ultraviolet lamp and irradiate until the phosphates are visible as
blue spots (about 2 min).
Three
spots (one from the monophosphate (Rf = 0.69), a second from the diphosphate
(Rf = 0.44) and the third from the triphosphate (Rf = 0.29) are observed, and
no other spot is observed.
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 essay
Determination
of Na5O10P3:
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+
Potassium acetate buffer (pH 5.0): Dissolve 78.5 g of potassium acetate in 1000 ml of water and adjust the pH of the solution to 5.0
with acetic acid. Add a few mg of mercuric iodide to inhibit mould growth.
+ 0.3 M
Potassium chloride: Dissolve 22.35 g of potassium chloride in water, add 5 ml
of potassium acetate buffer, dilute with water to 1000 ml, and mix. Add a few
mg of mercuric iodide.
+ 0.6 M
Potassium chloride: Dissolve 44.7 g of potassium chloride in water, add 5 ml
of potassium acetate buffer, dilute with water to 1000 ml, and mix. Add a few
mg of mercuric iodide.
+ - 1 M
Potassium chloride: Dissolve 74.5 g of potassium chloride in water, add 5 ml
of potassium acetate buffer, dilute to 1000 ml with water, and mix. Add a few
mg of mercuric iodide.
-
Chromatographic Column: Use a standard chromatographic column 20 to 40 cm
length, 20 to 28 cm inside diameter, with a sealed-in, coarse porosity fritted
disk. If a stopcock is not provided, attach a stopcock.
-
Procedure: Close the column stopcock, fill the space between the fritted disk
and the stopcock with water, and connect a vacuum line to the stopcock.
Prepare a 1:1 water slurry of Dowex F x 8, or equivalent, chloride form,
100-200 or 200-400 mesh, styrenedivinylbenzene ion exchange resin, and decant
off any fine particles and any foam. Do this two or three times or until no
more finely suspended material or foaming is observed. Fill the column with
the slurry, and open the stopcock to allow the vacuum to pack the resin bed
until the water level is slightly above the top of the resin, then
immediately close the stopcock. Do not allow the liquid level to fall below
the resin level at any time. Repeat this procedure until the packed resin
column is 15 cm above the fritted disk. Place one circle of tightly fitting
fibre filter paper on top of the resin bed, then place a perforated
polyethylene disk on top of the paper. Alternatively, a loosely packed plug
of glass wool may be placed on top of the bed. Close the top of the column
with a rubber stopper in which a 7.6 cm length of capillary tubing (1.5 mm
i.d., 7 mm o.d.) has been inserted through the centre, so that about 12 mm of
the tubing extends through the bottom of the stopper. Connect the top of the
capillary tubing to the stem of a 500-ml separator with flexible vinyl
tubing, and clamp the separator to a ring stand above the column. Wash the
column by adding 100 ml of water to the separator with all stopcocks closed.
First open the separator stopcock, then open the column stopcock. The rate of
flow should be about 5 ml per min. When the separator is empty, close the
stopcock on the column then close the separator stopcock.
Transfer
about 500 mg of the sample (a), accurately weighed, into a 250 ml volumetric
flask, dissolve and dilute to volume with water, and mix. Transfer 10 ml of
this solution into the separator, open both stopcocks and allow the solution
to drain into the column, rinsing the separator with 20 ml of water. Discard
the eluate. Add 370 ml of 0.3 M Potassium Chloride to the separator, and
allow this solution to pass through the column, discarding the eluate. Add
250 ml of 0.6 M Potassium Chloride to the column, allow the solution to pass
through the column, and receive the eluate in a 400-ml beaker (To ensure a
clean column for the next run, pass 100 ml of 1 M Potassium Chloride through
the column, followed by 100 ml of water. Discard all washings.) To the beaker
add 15 ml of nitric acid, mix, and boil for 15
to 20 min. Add methyl orange TS, and neutralize the solution with stronger
ammonia TS. Add 1 g of ammonium nitrate crystals, stir to dissolve, and cool.
Add 15 ml of ammonium molybdate TS, with stirring, and stir vigorously for 3
min or allow to stand with occasional stirring for 10 to 15 min. Filter the
contents of the beaker with suction through a 6-7 mm paper pulp filter pad
supported in a 25 mm porcelain disk. After the contents of the beaker have
been transferred to the filter, wash the beaker with five 10 ml portions of a
1% solution of sodium or potassium nitrate, passing the washings through the
filter, then wash the filter with five 5-ml portions of the wash solution.
Return the filter pad and the precipitate to the beaker, wash the funnel
thoroughly with water into the beaker, and dilute to about 150 ml. Add 0.1 N
sodium hydroxide from a buret until the yellow precipitate is dissolved, then
add 5 to 8 ml in excess. Add phenolphthalein TS, and titrate the excess
alkali with 0.1 N nitric acid. Finally, titrate with 0.1 N sodium hydroxide
to the first appearance of the pink colour. The difference between the total
volume of 0.1 N sodium hydroxide added and the volume of nitric acid required
represents the volume, V, in ml, of 0.1 N sodium hydroxide consumed by the
phosphomolybdate complex.
Calculate
the Na5O10P3 content of the sample in % by the formula:
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a =
the weight of the sample (mg)
Determination
of P2O5:
Accurately
weigh about 20 mg of sample, and transfer to a porcelain casserole. Add 150
ml water and 20 ml concentrated nitric acid. Introduce anti-bumping granules,
cover the beaker with a watch glass and boil gently for 1 h. Cool to room
temperature. Quantitatively transfer the solution to a 500-ml volumetric flask,
dilute with water, mix well and dilute to the mark with water. Transfer 20.0
ml of the solution to a plastic beaker, dilute to about 50 ml with water and
place the beaker in an automatic titrator equipped with a pH meter. Adjust
the pH of the solution to between 2.5 and 2.8 with 5 mol/l sodium hydroxide.
Titrate the solution with 0.5 mol/l sodium hydroxide. Record the consumed
volumes at the inflection points at about pH 4 (V1) and about pH 9 (V2).
Calculate
the P2O5 content of the sample in % by the formula
% P2O5
= [(V2 – V1)/2000] x f x 70,97 x (500/20) x (100/w)
= [(V2
– V1)/w] x f x 88,71
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where:
w =
weight of the sample (g)
f =
factor of 0.5 mol/l sodium hydroxide (= actual molarity/0.5)
ANNEX 7
SPECIFICATIONS AND TESTS FOR
PENTAPOTASSIUM TRIPHOSPHATE
1.
Synonyms
Penta
potassium tripolyphosphate, potassium triphosphate,
potassium
tripolyphosphate;
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MTDI =
70 mg/kg bw as phosphorus from all food sources
2.
Definition
Chemical
names
Pentapotassium
triphosphate, pentapotassium tripolyphosphate
C.A.S.
number
13845-36-8
Chemical
formula
K5O10P3
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448.42
3.
Description
Hygroscopic
white granules or powder
4.
Functional uses
Sequestrant,
texturizer
5.
Specifications
5.1.
Identification
Solubility
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pH
9.2 -
10.1 (1 in 100 soln)
Test
for phosphate
Passes
test.
Test
for potassium
Passes
test.
5.2.
Purity
Water-insoluble
matter
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Loss on
ignition
Not
more than 0.4% after drying (105o, 4 h), followed by ignition at
550o for 30 min.
P2O5
Not
less than 46.5% and not more than 48.0% (using about 1.5 g of the dried
sample accurately weighed).
Fluoride
Not
more than 10 mg/kg (see description under Tests)
Arsenic
Not
more than 3 mg/kg (Method II)
Lead
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5.3.
K5O10P3 content
Not
less than 85% of K5O10P3 on the dried basis, the remainder being principally
other potassium phosphates.
6.
Tests
6.1.
Identification
Test
for phosphate
Tested
according to JECFA monograph 1 - Vol.4.
Test
for potassium
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6.2.
Purity
Fluoride
Place 5
g of the sample, 25 ml of water, 50 ml of perchloric acid, 5 drops of silver
nitrate solution (1 in 2), and a few glass beads in a 250-ml distilling flask
connected with a condenser and carrying a thermometer and a capillary tube,
both of which must extend into the liquid. Connect a small dropping funnel,
filled with water, or a steam generator to the capillary tube. Support the
flask on an asbestos mat with a hole which exposes about one-third of the
flask to the flame. Distil into a 250-ml flask until the temperature reaches
135o. Add water from the funnel or introduce steam through the
capillary to maintain the temperature between 135 and 140o.
Continue the distillation until 225-240 ml has been collected, then dilute to
250 ml with water, and mix. Place a 50-ml aliquot of this solution in a 100-
ml Nessler tube. In another similar Nessler tube place 50 ml of water as a
control. Add to each tube 0.1 ml of a filtered solution of sodium
alizarinsulfonate (1 in 1000) and 1 ml of freshly prepared hydroxylamine
hydrochloride solution (1 in 4000), and mix well. Add, dropwise, and with
stirring, 0.05 N sodium hydroxide to the tube containing the distillate until
its colour just matches that of the control, which is faintly pink. Then add
to each tube exactly 1 ml of 0.01 N hydrochloric acid, and mix well. From a
buret, graduated in 0.05 ml, add slowly to the tube containing the distillate
enough thorium nitrate solution (1 in 4000) so that, after mixing, the colour
of the liquid just changes to a faint pink. Note the volume of the solution
added, add exactly the same volume to the control, and mix. Now add to the
control sodium fluoride TS (10 µg, F per ml) from a buret to make the colours
of the two tubes match after dilution to the same volume. Mix well, and allow
all air bubbles to escape before making the final drops of sodium fluoride TS
to the control. A distant change in colour should take place. Note the volume
of sodium fluoride added. The volume of sodium fluoride TS required for the
control solution should not exceed 10 ml.
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 essay
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Reagents
and Solutions
-
Potassium acetate buffer (pH 5.0): Dissolve 78.5 g of potassium acetate in
1000 ml of water. and adjust the pH of the solution to 5.0 with acetic acid.
Add a few mg of mercuric iodide to inhibit mould growth.
- 0.3 M
Potassium chloride: Dissolve 22.35 g of potassium chloride in water, add 5 ml
of potassium acetate buffer, dilute with water to 1000 ml, and mix. Add a few
mg of mercuric iodide.
- 0.6 M
Potassium chloride: Dissolve 44.7 g of potassium chloride in water, add 5 ml
of potassium acetate buffer, dilute with water to 1000 ml, and mix. Add a few
mg of mercuric iodide.
- 1 M
Potassium chloride: Dissolve 74.5 g of potassium chloride in water, add 5 ml
of potassium acetate buffer, dilute to 1000 ml with water, and mix. Add a few
mg of mercuric iodide.
Chromatographic
Column:
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Use a
standard chromatographic column 20 to 40 cm in length, 20 to 28 cm in inside
diameter, with a sealed-in, coarse porosity fritted disk. If a stopcock is
not provided, attach a stopcock.
Procedure:
Close
the column stopcock, fill the space between the fritted disk and the stopcock
with water, and connect a vacuum line to the stopcock. Prepare a 1:1 water
slurry of Dowex F x 8, or equivalent, chloride form, 100-200 or 200-400 mesh,
styrenedivinylbenzene ion exchange resin, and decant off any fine particles
and any foam. Do this two or three times or until no more finely suspended
material or foaming is observed. Fill the column with the slurry, and open
the stopcock to allow the vacuum to pack the resin bed until the water level
is slightly above the top of the resin, then immediately close the stopcock.
Do not allow the liquid level to fall below the resin level at any time.
Repeat this procedure until the packed resin column is 15 cm above the
fritted disk. Place one circle of tightly fitting fiber filter paper on top
of the resin bed, then place a perforated polyethylene disk on top of the
paper. Alternatively, a loosely packed plug of glass wool may be placed on
top of the bed. Close the top of the column with a rubber stopper in which a
7.6 cm length of capillary tubing (1.5 mm i.d., 7 mm 0.d.) has been inserted
through the centre, so that about 12 mm of the tubing extends through the
bottom of the stopper. Connect the top of the capillary tubing to the stem of
a 500 ml separator with flexible vinyl tubing, and clamp the separator to a
ring stand above the column. Wash the column by adding 100 ml of water to the
separator with all stopcocks closed. First open the separator stopcock, then
open the column stopcock. The rate of flow should be about 5 ml per min. When
the separator is empty, close the stopcock on the column then close the
separator stopcock.
Transfer
about 500 mg of the sample previously dried at 105º for 4 h and accurately
weighed, into a 250 ml volumetric flask, dissolve and dilute to volume with
water, and mix. Transfer 10 ml of this solution into the separator, open both
stopcocks and allow the solution to drain into the column, rinsing the
separator with 20 ml of water. Discard the eluate. Add 370 ml of 0.3 M
Potassium Chloride to the separator, and allow this solution to pass through
the column, discarding the eluate. Add 250 ml of 0.6 M Potassium Chloride to
the column, allow the solution to pass through the column, and receive the
eluate in a 400 ml beaker. (To
ensure a clean column for the next run, pass 100 ml of 1 M Potassium Chloride
through the column, followed by 100 ml of water. Discard all washings). To
the beaker add 15 ml of nitric acid, mix, and boil for 15 to 20 min. Add
methyl orange TS, and neutralize the solution with stronger ammonia TS. Add 1
g of ammonium nitrate crystals, stir to dissolve, and cool. Add 15 ml of
ammonium molybdate TS, with stirring, and stir vigorously for 3 min or allow
to stand with occasional stirring for 10 to 15 min. Filter the contents of
the beaker with suction through a 6-7 mm paper pulp filter pad supported in a
25 mm porcelain disk. After the contents of the beaker have been transferred
to the filter, wash the beaker
with five 10 ml portions of a 1 in 100 solution of sodium or potassium
nitrate, passing the washings through the filter, then, wash the filter with
five 5-ml portions of the wash solution. Return the filter pad and the
precipitate to the beaker, wash the funnel thoroughly with water into the
beaker, and dilute to about 150 ml. Add 0.1 N sodium hydroxide from a buret
until the yellow precipitate is dissolved, then add 5 to 8 ml in excess. Add
phenolphthalein TS, and titrate the excess alkali with 0.1 N, nitric acid.
Finally, titrate with 0.1 N sodium hydroxide to the first appearance of the
pink colour. The difference between the total volume of 0.1 N sodium
hydroxide added and the volume of nitric acid required represents the volume,
V, in ml, of 0.1 N sodium hydroxide consumed by the phosphomolybdate complex.
Calculate
the quantity, in mg, of K5O10P3 in the sample taken by the formula 0.650 x
25V.
ANNEX 8
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1.
Synonyms
Sodium
hexametaphosphate, sodium tetrapolyphosphate, Graham's salt
INS
452i
MTDI =
70 mg/kg bw as phosphorus from all food sources
2.
Definition
Obtained
by fusion and subsequent chilling of sodium orthophosphates; a class of
compounds consisting of several amorphous, water-soluble polyphosphates
composed of linear chains of metaphosphate units.
Chemical
names
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C.A.S.
number
68915-31-1,
10124-56-8, 10361-03-2
Structural
formula
Where x
= 2 ; 4 ; 13 – 18, 20 – 100 or more
3.
Description
Colourless
or white, transparent platelets, granules, or powders
4. Functional
uses
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5.
Specifications
5.1.
Identification
Solubility
Very
soluble in water
Test
for sodium
A 1 in
20 solution passes test
Test
for orthophosphate
Passes
test.
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Loss on
ignition
Not
more than 1.0%.
Insoluble
substances
Not
more than 0.1%.
Fluoride
Not
more than 10 mg/kg (Method I or III)
Arsenic
Not
more than 3 mg/kg
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Not
more than 4 mg/kg.
5.3.
P2O5 content
Not
less than 60.0% and not more than 71.0% of P2O5
6.
Tests
6.1. Identification
Test
for orthophosphate
Dissolve
0.1 g of the sample in 5 ml of hot dilute nitric acid TS. Warm on a steam
bath for 10 min, and cool.Neutralize to litmus with sodium hydroxide TS, and
add silver nitrate TS. A yellow precipitate is formed which is soluble in
dilute nitric acid TS.
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Insoluble
substances
Dissolve
about 10 g of the sample, accurately weighed, in 100 ml of hot water, and
filter through a tared filtering crucible. Wash the insoluble residue with
hot water, dry at 105o for 2 h, and weigh.
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 essay
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ANNEX 9
SPECIFICATIONS AND TESTS FOR
POTASSIUM POLYPHOSPHATE
1.
Synonyms
Potassium
metaphosphate;
MTDI =
70 mg/kg bw as phosphorus from all food sources
INS
452ii
2.
Definition
A
heterogeneous mixture of potassium salts of linear condensed polyphosphoric
acids of general formula Hn+2PnO3n+1 where "n" is not less than 2.
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Potassium
metaphosphate, potassium polymetaphosphate, potassium polyphosphate
C.A.S.
number
7790-53-6
Chemical
formula
Hn+2PnO3n+1
where
n ≥ 2
3.
Description
Odourless,
colourless or white glassy masses, fragments, crystals or powder
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Emulsifier,
moisture-retaining agent, sequestrant, texturizer
5.
Specifications
5.1.
Identification
Solubility
1 g
dissolves in 100 ml of a 1 in 25 soln of sodium acetate
Gel
formation
Passes
test.
Test
for potassium
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Test
for phosphate
Passes
test.
5.2.
Purity
Loss on
ignition
Not
more than 2 % after drying (105o, 4 h) followed by ignition at
550o for 30 min
Cyclic
phosphate
Not
more than 8.0%
Fluoride
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Arsenic
Not
more than 3 mg/kg (Method II)
Lead
Not
more than 4 mg/kg.
5.3.
P2O5 content
Not
less than 53.5% and not more than 61.5% of P2O5 on the ignited basis
6.
Tests
6.1.
Identification
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Gel
formation
Finely
powder about 1 g of the sample, and add it slowly to 100 ml of a 1 in 50
solution of sodium chloride while stirring vigorously. A gelatinous mass is
formed.
Test
for potassium
Mix 0.5
g of the sample with 10 ml of nitric acid and 50 ml of water, boil for about
30 min, and cool. The resulting solution is used for the test.
Test
for phosphate
Mix 0.5
g of the sample with 10 ml of nitric acid and 50 ml of water, boil for about
30 min, and cool. The resulting solution is used for the test.
6.2.
Purity
Fluoride
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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 - Vol.4,
“Instrumental Methods.”
6.3.
Method of essay
Mix
about 300 mg of the sample, accurately weighed, with 15 ml of nitric acid and
30 ml of water, boil for 30 min, and dilute with water to about 100 ml. Heat
at 60o , add an excess of ammonium molybdate TS, and heat at 50o
for 30 min. Filter, and wash the precipitate with dilute nitric acid (1 in 36
soln), followed by potassium nitrate solution (1 in 100 soln) until the
filtrate is no longer acid to litmus. Dissolve the precipitate in 50 ml of 1
N sodium hydroxide, add phenolphthalein TS, and titrate the excess sodium
hydroxide with 1 N sulfuric acid. Each ml of 1 N sodium hydroxide is
equivalent to 3.086 mg of P2O5.
ANNEX 10
SPECIFICATIONS AND TESTS FOR
SODIUM CALCIUM POLYPHOSPHATE
1.
Synonyms
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INS
452iii
MTDI =
70 mg/kg bw as phosphorus from all food sources
2.
Definition
Chemical
names
Sodium
calcium polyphosphate
Chemical
formula
(NaPO3)n_CaO
where n is typically 5
3.
Description
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4.
Functional uses
Sequestrant,
stabilizer, leavening agent, emulsifier, nutrient
5.
Specifications
5.1. Identification
Test
for sodium
Passes
test.
Test
for phosphate
Passes
test.
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Passes
test.
5.2.
Purity
Fluoride
Not
more than 10 mg/kg.
Arsenic
Not
more than 3.0 mg/kg.
Lead
Not
more than 4 mg/kg.
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Not
less than 61% and not more than 69 % expressed as P2 O5 on dried basis.
6.
Tests
6.1.
Identification
Test
for sodium
Tested
according to JECFA monograph 1 - Vol.4.
Test
for phosphate
Tested
according to JECFA monograph 1 - Vol.4.
Test
for calcium
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6.2.
Purity
Fluoride
Tested
according to JECFA monograph 1 - Vol..4, Method 3; use an appropriate sample
size and appropriate volumes of standard solution for construction of the
calibration curve.
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 essay
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Weigh
accurately about 200 mg of the sample, dissolve in 25 ml of water and 10 ml
of diluted nitric acid TS and boil for 30 min.
Filter if necessary, and wash any precipitate, then dissolve the
precipitate by the addition of 1 ml diluted nitric acid TS. Adjust the
temperature to about 50o, add 75 ml of ammonium molybdate TS, and
maintain the temperature at about 50o for 30 min, stirring
occasionally. Allow to stand for 16 h or overnight at room temperature.
Decant the supernate, through a filter paper, wash the precipitate once or
twice with water by decantation using 30 to 40 ml each time, and pour the
washings through the same filter. Transfer
the precipitate to the same filter, and wash with potassium nitrate solution
(1 in 100) until the filtrate is no longer acid to litmus paper. Transfer
the precipitate with filter paper to the original precipitation vessel, add
50.0 ml of 1N sodium hydroxide, agitate until the precipitate is dissolved,
add 3 drops of phenolphthalein TS and titrate the excess alkali with 1N
sulfuric acid.
Each ml
of 1N sodium hydroxide consumed is equivalent to 3.088 mg of P2O5.
ANNEX 11
SPECIFICATIONS AND TESTS FOR
SODIUM GLUCONATE
1.
Synonyms
Sodium
gluconate
INS 576
ADI
“Not limited”
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Chemical
names
Sodium
D-gluconate
C.A.S.
number
527-07-1
Chemical
formula
C6H11NaO7
Structural
formula
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218.14
3.
Description
White
to tan, granular to fine, crystalline powder.
4.
Functional uses
Sequestrant,
yeast food
5.
Specifications
5.1.
Identification
Solubility
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Test
for sodium
Passes
test.
Test
for gluconate
Passes
test.
5.2.
Purity
Reducing
substances
Not
more than 1.0% calculated as D-glucose.)
Lead
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5.3.
C6H11NaO7 content
Not
less than 98.0%.
6.
Tests
6.1.
Identification
Test
for sodium
Tested
according to JECFA monograph 1 - Vol.4.
Test
for gluconate
Tested
according to JECFA monograph 1 - Vol.4.
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Reducing
substances
Tested
according to JECFA monograph 1 - Vol.4 - Method I.
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 essay
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Each ml
of 0.1 N perchloric acid is equivalent to 21.81 mg of C6H11NaO7.
ANNEX 12
SPECIFICATIONS AND TESTS FOR
POTASSIUM GLUCONATE
1.
Synonyms
Potassium
gluconate, Potassium D-gluconate
INS 577
ADI
“Not limited”
2.
Definition
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Chemical
names
Potassium
D-gluconate
C.A.S.
number
Anhydrous:
299-27-4
Monohydrate:
35398-15-3
Chemical
formula
C6H11KO7
Structural
formula
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Anhydrous:
234.25
Monohydrate:
252.26
3.
Description
Odourless,
free flowing white to yellowish white, crystalline powder or granules.
4.
Functional uses
Sequestrant,
acidity regulator, nutrient supplement, yeast food
5.
Specifications
5.1.
Identification
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Passes
test.
Test
for gluconate
Passes
test.
5.2.
Purity
Loss on
drying
Anhydrous:
Not more than 3%
Monohydrate:
Not less than 6% and not more than 7.5%.
(105o,
4 h, under vacuum).
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Not
more than 1.0% calculated as D-glucose.
Lead
Not
more than 2 mg/kg.
5.3.
C6H11KO7 content
Not
less than 97.0% and not more than 103.0% on dried basis.
6. Tests
6.1.
Identification
Test
for potassium
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Test
for gluconate
Tested
according to JECFA monograph 1 - Vol.4.
6.2.
Purity
Reducing
substances
Tested
according to JECFA monograph 1 - Vol.4 - Method I.
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.”
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Transfer
about 175 mg of the sample, accurately weighed, into a clean, dry 200-ml
Erlenmeyer flask, add 75 ml of glacial acetic acid and dissolve by heating on
a hot plate. Cool, add quinaldine red TS, and titrate with 0.1 N perchloric
acid in glacial acetic acid, using a 10-ml microburet, to a colourless end
point.
Each ml
of 0.1 N perchloric acid is equivalent to 23.42 mg of C6H11KO7.
ON FOOD ADDITIVE – FLOUR TREATMENT AGENT
Foreword
QCVN 4-
: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.
44/2010/TT-BYT dated December 22, 2010 of the Minister of Health.
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I.
GENERAL
1. Scope
This
National technical regulation (hereinafter referred to as “the Regulation”)
provides for specifications and regulatory requirements for quality, hygiene
and safety of flour treatment agents used as food additives.
2.
Regulated entities
This
Regulation applies to:
2.1.
Importers, exporters, producers, traders and users of preservatives used as
flour treatment agents used as food additives (hereinafter referred to as
“entities”).
2.2.
Relevant regulatory bodies.
3.
Interpretation of terms and acronyms:
3.1.
“flour treatment agent” refers to a food additive added to flour or dough to
improve its baking quality or color.
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3.3.
“C.A.S number” (Chemical Abstracts Service) refers to registry numbers of
chemical substances identified by the American Chemical Society.
3.4. “TS”
stands for test solution.
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 azodicarbonamide used as a flour treatment agent
are specified in the Annex to this Regulation.
2.
Specifications specified in this Regulation are tested under JECFA monograph 1
- Vol. 4, except for some specific tests described in the Annex. 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
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1.1.
Flour treatment agents 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/QĐ-BKHCN dated September 28, 2007 of
the Minister of Science and Technology and regulations of laws.
2.
Inspection of flour treatment agents
The
quality, hygiene and safety of flour treatment agents must be inspected in
accordance with the regulations of law.
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 flour
treatment agents 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.
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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
SPECIFICATIONS AND TESTS FOR
AZODICARBONAMIDE
1.
Synonyms
Azobisformamide;
INS
927a
2.
Definition
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Azodicarbonamide,
azodicarboxylic acid diamide
C.A.S.
number
123-77-3
Chemical
formula
C2H4N4O2
Structural
formula
Formula
weight
116.08
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Yellow
to orange-red, odourless, crystalline powder
4.
Functional uses
Flour
treatment agent
5.
Specifications
5.1.
Identification
Solubility
Practically
insoluble in water and in ethanol; slightly soluble in dimethyl sulfoxide
Melting
range
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Test
for oxidation
Passes
test (liberates iodine from potassium iodide TS solution in the presence of
10% sulfuric acid)
Test
for carbon dioxide
Passes
test.
5.2.
Purity
Loss on
drying
Not
more than 0.5% (50o, 2h in vacuo).
pH
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Sulfated
ash
Not
more than 0.15% (Test 1.5 g of the sample (Method I))
Lead
Not
more than 2 mg/kg.
5.3.
Content
Not
less than 98.6%; not less than 47.2% and not more than 48.7% of N on the
dried basis
6. Tests
6.1.
Identification
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Test
for carbon dioxide
Heat
about 10 mg of the sample in a crucible. A drop of barium hydroxide solution
held above the sample by means of a glass rod becomes turbid.
6.2.
Purity
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 essay
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Titrimetric
method/azodicarbonamide:
Transfer
about 225 mg of the accurately weighed sample, previously dried in a vacuum
oven at 50o for 2 h, into a 250-ml glass-stoppered iodine flask. Add about 23
ml of dimethyl sulfoxide to the flask, washing any adhered sample down with
the solvent, stopper the flask, and place about 2 ml of the solvent in the
cup or lip of the flask. Swirl occasionally until complete solution of the
sample is effected, and then loosen the stopper to drain the remainder of
solvent into the flask and to rinse down any dissolved sample into the
solution. Add 5 g of potassium iodide followed by 15 ml of water, immediately
pipet 10 ml of 0.5 N hydrochloric acid into the flask, and stopper quickly.
Swirl until the potassium iodide dissolves, and allow to stand for 20-25 min
protected from light. Titrate the liberated iodine with 0.1 N sodium
thiosulfate to the disappearance of the yellow colour. Titrate with
additional thiosulfate if any yellow colour appears within 15 min. Perform a
blank determination on a solution consisting of 25 ml of dimethyl sulfoxide,
5 g of potassium iodide, 15 ml of water, and 5 ml of 0.5 N hydrochloric acid,
and make any necessary correction. Each ml of 0.1 N sodium thiosulfate is equivalent
to 5.804 mg of C2H4N4O2.
Kjeldahl
method (semimicro)/nitrogen:
Transfer
about 50 mg of the accurately weighed sample, previously dried in a vacuum
oven at 50o for 2 h, into a 100-ml Kjeldahl flask, add 3 ml of hydriodic acid
(min. 57%) and digest the mixture for 75 min adding sufficient water, when
necessary, to maintain the original volume. Increase the heat at the end of
the digestion period and continue heating until the volume is reduced by
about one-half. Cool to room temperature, add 1.5 g of potassium sulfate and
3 ml of water. Carefully add 4.5 ml of concentrated sulfuric acid and heat
until iodine fumes are no longer evolved. Allow the mixture to cool, wash
down the sides of the flask with water, heat until charring occurs, and again
cool to room temperature. To the charred material add 40 mg of mercuric
oxide, heat until the colour of the solution is pale yellow, then cool, wash
down the sides of the flask with a few ml of water and digest the mixture for
3 h. Cool the digest, add 20 ml ammonia-free water, 16 ml of a 50% sodium
hydroxide solution and 5 ml of a 44% sodium thiosulfate solution. Connect the
flask to a distillation apparatus and distil, collecting the distillate in 10
ml of a 4% boric acid solution. Add a few drops of methyl red-methylene blue
TS to the distillate and titrate with 0.05 N sulfuric acid. Perform a blank
determination. Each ml of 0.05 N sulfuric acid is equivalent to 0.7004 mg of
N.
ON FOOD ADDITIVE - BULKING AGENT
Foreword
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NATIONAL TECHNICAL REGULATION ON FOOD ADDITIVE – BULKING AGENT
I.
GENERAL
1. Scope
This
National technical regulation (hereinafter referred to as “the Regulation”)
provides for specifications and regulatory requirements for quality, hygiene
and safety of bulking agents used as food additives.
2.
Regulated entities
This
Regulation applies to:
2.1.
Importers, exporters, producers, traders and users of preservatives used as
bulking agents used as food additives (hereinafter referred to as “entities”).
2.2.
Relevant regulatory bodies.
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3.1.
“bulking agent” refers to a food additive added to a food
without contributing significantly to its available energy value.
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.
3.4. “TS”
stands for test solution.
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 bulking agents are specified in the annexes to
this Regulation as follows:
1.1.
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Specifications
and tests for microcrystalline cellulose
1.2.
Annex
2:
Specifications
and tests for carnauba wax
1.3.
Annex
3:
Specifications
and tests for sodium alginate
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.
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1.
Declaration of conformity
1.1.
Bulking agents 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/QĐ-BKHCN dated September 28, 2007 of
the Minister of Science and Technology and regulations of laws.
2.
Inspection of bulking agents
The
quality, hygiene and safety of bulking agents must be inspected in accordance
with the regulations of law.
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 bulking
agents 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
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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
SPECIFICATIONS AND TESTS FOR
MICROCRYSTALLINE CELLULOSE
1.
Synonyms
Mycrocrystalline
cellulose; Cellulose gel;
INS 460
ADI
“Not limited”
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Purified,
partially depolymerized cellulose prepared by treating alphacellulose,
obtained as a pulp from fibrous plant material, with mineral acids. The
degree of polymerization is typically less than 400. Not more than 10% of the
particles have a diameter below 5 µm.
Chemical
names
Cellulose
C.A.S.
number
9004-34-6
Chemical
formula
(C6H10O5)n
3.
Description
Fine,
white or almost white, odourless, free flowing crystalline powder.
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Bulking
agent, emulsifier, stabilizer, anticaking agent, dispersing agent.
5.
Specifications
5.1.
Identification
Solubility
Insoluble
in water, ethanol, ether and dilute mineral acids. Slightly soluble in sodium
hydroxide solution.
Infrared
absorption
The
infrared absorption spectrum of a potassium bromide dispersion of the sample
corresponds to the infrared spectrum below.
Test
for suspensoid
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5.2.
Purity
Loss on
drying
Not more
than 7.0% (105o, 3 h).
pH
5.0 –
7.5
Water
soluble
Not
more than 0.24%.
Sulfated
ash
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Starch
Not
detectable.
Lead
Not
more than 2 mg/kg.
5.3.
Content
Not
less than 97% of carbohydrate calculated as cellulose on the dry basis.
6.
Tests
6.1.
Identification
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Mix 30
g of the sample with 270 ml of water in a high-speed (18,000 rpm) blender for
5 min. Transfer 100 ml of the mixture to a 100-ml graduated cylinder, and
allow to stand for 3 h. A white, opaque, bubble-free dispersion that forms a
supernatant, is obtained.
6.2.
Purity
pH
Shake 5
g of the sample with 40 ml of water for 20 min and centrifuge. Determine the
pH of the supernatant.
Water
soluble
Shake 5
g of the sample with approximately 80 ml of water for 10 min, filter through
Whatman No. 42 or equivalent filter paper into a tared beaker, wash residue
with 20 ml of water and evaporate to dryness on a steam bath. Dry at 105o
for 1 h., cool, weigh and calculate as percentage.
Sulfated
ash
Tested
according to JECFA monograph 1 - Vol. 4 - Method 1, (Test 10 g of the
sample).
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To 20
ml of the dispersion obtained in the identification test for starch, add a
few drops of iodine TS, and mix. No purplish to blue or blue colour should be
obtained.
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 essay
Transfer
about 125 mg of the sample, accurately weighed, to a 300 ml Erlenmeyer flask,
using about 25 ml of water. Add 50.0 ml of 0.5N potassium dichromate and mix.
Carefully add 100 ml of sulfuric acid and heat to boiling. Remove from heat,
allow to stand at room temperature for 15 min and cool in a water bath.
Transfer the contents into a 250 ml volumetric flask, rinse flask with
distilled water, add rinsings to the volumetric flask and dilute with water
almost to volume. Allow the volumetric flask to reach room temperature (25o),
then make up to volume with water and mix. Titrate a 50.0 ml aliquot with
0.1N ferrous ammonium sulfate using 2 or 3 drops of ortho-phenanthroline TS
as the indicator and record the volume required as S in ml. Perform a blank
determination and record the volume of 0.1N ferrous ammonium sulfate required
as B in ml. Calculate the percentage of cellulose in the sample by the
formula:
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W is
the weight of sample taken, in mg, corrected for loss on drying.
Infrared
spectrum
Microcrystalline
cellulose
ANNEX 2
SPECIFICATIONS AND TESTS FOR
CARNAUBA WAX
1.
Synonyms
INS 903
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2.
Definition
The
refined wax obtained from the fronds of the Brazilian tropical palm tree
Copernicia cerifera (Arruda) Mart. [syn. C. purnifera (Muell.)]; a complex
mixture of several chemical compounds, predominantly esters, e.g.,
-
aliphatic esters (straight-chain acids with even-numbered carbon chains from
C24 to C28 and straight-chain alcohols with even-numbered carbon chains from
C30 to C34).
- -
alpha-hydroxy esters (straight-chain hydroxy acids with even-numbered carbon
chains from C22 to C28, straight-chain acids with even-numbered carbon chains
from C24 to C28, straight-chain monohydric alcohols with evennumbered carbon
chains from C24 to C34 and dihydric alcohols with evennumbered carbon chains
from C24 to C34).
-
cinnamic aliphatic diesters (p-methoxycinnamic acid and dihydric alcohols
with even-numbered carbon chains from C24 to C34).
It also
contains free acids (straight-chain acids with even-numbered carbon chains
from C24 to C28), free alcohols (straight-chain alcohols with evennumbered
carbon chains from C30 to C34), hydrocarbons (straight-chain oddnumbered carbon
chains from C27 to C31) and resins.
C.A.S.
number
8015-86-9
3.
Description
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4.
Functional uses
Glazing
agent, bulking agent, acidity regulator, carrier.
5.
Specifications
5.1.
Identification
Solubility
Insoluble
in water; partially soluble in boiling ethanol; soluble in ether.
Melting
range
80oC
- 86oC
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Acid
value
Between
2 and 7.
Saponification
value
Between
78 and 95.
Ester
value
Between
71 and 93.
Subtract
the Acid value from the Saponification value to obtain the Ester value.
Sulfated
ash
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Unsaponifiable
matter
Between
50% and 55%.
Lead
Not
more than 2 mg/kg.
6.
Tests
6.1.
Purity
Sulfated
ash
Heat a
2-g sample in a tared, open porcelain or platinum dish over an open flame. It
volatilizes without emitting an acrid odour. Ignite as described in procedure
for Ash (sulfated ash) Method I - JECFA monograph 1 - Vol.4).
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Weigh
accurately about 5 g of the sample into a 250-ml flask, add a solution of 2 g
of potassium hydroxide in 40 ml ethanol, and boil gently under reflux for 1 h
or until saponification is complete. Transfer the content of the flask to a
glass-stoppered extraction cylinder (approximately 30 cm in length, 3.5 cm in
diameter and graduated at 40, 80 and 130 ml). Wash the flask with sufficient
alcohol to achieve a volume of 40 ml in the cylinder, and complete the
transfer with warm and then cold water until the total volume is 80 ml. Finally
wash the flask with a few ml of petroleum ether, add the washings to the
cylinder, cool the contents of the cylinder to room temperature and add 50 ml
of petroleum ether. Insert the stopper and shake the cylinder vigorously for
at least 1 min, and allow both layers to become clear. Siphon the upper ether
layer as completely as possible without removing any of the lower layer,
collecting the ether fraction in a 500-ml separator. . Repeat extraction and siphoning at least six times with 50-ml
portions of petroleum ether, shaking vigorously each time. Wash the combined
extracts, with vigorous shaking, with 25-ml portions of 10% ethanol until the
wash water is neutral to phenolphthalein, and discard the washings. Transfer
the ether extract to a tared beaker and rinse the separator with 10-ml of
ether, adding the rinsings to the beaker. Evaporate the ether at a steam bath
just to dryness, and dry the residue to constant weight, preferably at 75º to
80º under vacuum of not more than 200 mm of Hg, or at 100º for 30 min. Cool
in a desiccator and weigh to obtain weight of unsaponifiable matter.
Dissolve
the residue in 50 ml of warm neutral ethanol and titrate with 0.02N sodium
hydroxide using phenolphthalein as indicator. Each ml of 0.02N sodium
hydroxide is equivalent to 5.659 mg of fatty acids, calculated as oleic acid.
Subtract
the calculated weight of fatty acids from the weight of the residue to obtain
the corrected weight of unsaponifiable matter in the sample.
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.”
ANNEX 3
SPECIFICATIONS AND TESTS FOR
SODIUM ALGINATE
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INS 401
ADI
“Not limited”
2.
Definition
Sodium
salt of alginic acid
C.A.S.
number
9005-38-3
Chemical
formula
(C6H7NaO6)n
Structural
formula
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The
number and sequence of the Mannuronate and Glucuronate residues shown above
vary in the naturally occurring alginate. The water molecules associated with
the alginate molecule are not shown in the above structural formula.
Formula
weight
Structural
unit: 198.11 (theoretical), 222 (actual average)
Macromolecule:
10,000 - 600,000 (typical average)
3.
Description
White
to yellowish brown filamentous, grainy, granular or powdered forms.
4.
Functional uses
Bulking
agent, stabilizer, thickener, gelling agent, emulsifier
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5.1.
Identification
Solubility
Dissolves
slowly in water, forming a viscous solution. Insoluble in ethanol and ether.
Precipitate
formation with calcium chloride
Passes
test.
Precipitate
formation with ammonium sulphate
Passes
test.
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Test
for alginate
Passes
test.
Test
for sodium
Passes
test.
5.2.
Purity
Loss on
drying
Not
more than 15% (105o, 4 h).
Water-insoluble
matter
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Arsenic
Not
more than 3.0 mg/kg.
Lead
Not
more than 5 mg/kg.
5.3. Microbiological criteria
Total
plate count
Not
more than 5,000 colonies per gram.
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Not
more than 500 colonies per gram
Coliforms
Negative
by test
Salmonella
Negative
by test
5.3.
(C6H7NaO6)n content
Yields,
on the dried basis, not less than 18.0% and not more than 21.0% of carbon
dioxide (CO2), equivalent to not less than 90.8% and not more than 106.0% of
sodium alginate (C6H7NaO6)n.
6.
Tests
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Precipitate
formation with calcium chloride
To a
0.5% solution of the sample in sodium hydroxide TS add one-fifth of its
volume of a 2.5% solution of calcium chloride. A voluminous, gelatinous
precipitate is formed. This test distinguishes sodium alginate from gum
arabic, sodium carboxymethyl cellulose, carrageenan, gelatin, gum ghatti,
karaya gum, carob bean gum, methyl cellulose and tragacanth gum.
Precipitate
formation with ammonium sulphate
To a
0.5% solution of the sample in sodium hydroxide TS add one-half of its volume
of a saturated solution of ammonium sulfate. No precipitate is formed. This
test distinguishes sodium alginate from agar, sodium carboxymethyl cellulose,
carrageenan, de-esterified pectin, gelatin, carob bean gum, methyl cellulose
and starch.
Test
for alginate
Tested
according to JECFA monograph 1 - Vol.4.
Test
for sodium
Tested
according to JECFA monograph 1 - Vol.4.
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Water-insoluble
matter
Disperse
2 g of the sample, weighed to the nearest 0.1 mg, in 800 ml of water in a
2,000-ml flask. Neutralize to pH 7 with sodium hydroxide TS and then add 3 ml
in excess. Add 40 ml of hydrogen peroxide solution containing 30% by weight
H2O2, cover the flask and boil for 1 h with frequent stirring. Filter while
hot through a tared Gooch crucible provided with a glass fibre filter (2.4
cm, No 934 AH, Reeve Angel & Co, Clifton, N.Y.,USA, or equivalent). If
slow filtration is caused by high viscosity of the sample solution, boil
until the viscosity is reduced enough to permit filtration. Wash the crucible
thoroughly with hot water, dry the crucible and its contents at 105o for 1 h,
cool and weigh. Calculate as percentage of the dry weight.
Arsenic
Tested
according to JECFA monograph 1 - Vol.4, Method II.
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.
Microbiological criteria
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Total
plate count
Initially
prepare a 10-1 dilution by adding a 50 g sample to 450 ml of Butterfield’s
phosphate buffered dilution water and homogenizing in a high speed blender.
6.2.
Method of essay
Proceed
as directed under Carbon Dioxide Determination by Decarboxylation in JECFA
monograph 1 - Vol. 4.
Each ml
of 0.25 N sodium hydroxide consumed is equivalent to 5.5 mg of carbon dioxide
(CO2) or 27.75 mg of sodium alginate (equivalent weight 222).
FOOD ADDITIVE - PROPELLANT
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QCVN 4-
: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.
44/2010/TT-BYT dated December 22, 2010 of the Minister of Health.
NATIONAL TECHNICAL REGULATION ON FOOD ADDITIVE - PROPELLANT
I.
GENERAL
1. Scope
This
National technical regulation (hereinafter referred to as “the Regulation”)
provides for specifications and regulatory requirements for quality, hygiene
and safety of propellants used as food additives.
2.
Regulated entities
This
Regulation applies to:
2.1.
Importers, exporters, producers, traders and users of preservatives used as
propellants used as food additives (hereinafter referred to as “entities”).
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3.
Interpretation of terms and acronyms:
3.1.
“propellant” refers to a gaseous food additive that is added to food.
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.
3.4. “TS”
stands for test solution.
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 propellants are specified in the annexes to this Regulation as
follows:
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Annex
1:
Specifications
and tests for nitrogen
1.2.
Annex
2:
Specifications
and tests for nitrogen oxyde
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
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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/QĐ-BKHCN dated September 28, 2007 of
the Minister of Science and Technology and regulations of laws.
2.
Inspection of propellants
The
quality, hygiene and safety of propellants must be inspected in accordance with
the regulations of law.
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 propellants
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.
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ANNEX 1
YÊU CẦU KỸ THUẬT VÀ PHƯƠNG PHÁP
THỬ ĐỐI VỚI KHÍ NITROGEN
1.
Synonyms
Nitrogen
INS 941
ADI
“Not limited”
2.
Definition
This
monograph defines nitrogen with a maximum oxygen content of 1%, which is
suitable only for some food applications. There are food applications that
require a higher purity (i.e., lower oxygen content).
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Nitrogen
C.A.S.
number
7727-37-9
Chemical
formula
N2
Formula
weight
28.0
3.
Description
Colourless,
odourless gas or liquid.
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Freezing
agent, propellant, packaging gas
5.
Specifications
5.1.
Identification
Flame
test
A flame
is extinguished in an atmosphere of the sample.
5.2.
Purity
Oxygen
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Carbon
monoxide
Not
more than 10 µl/l (see description under Tests).
5.3.
Content
Not
less than 99.0% v/v.
6.
Tests
6.1.
Purity
Oxygen
Use an
oxygen analyser with a detector scale ranging from 0 µl/l to 100 µl/l and
equipped with an electrochemical cell. The gas to be examined is passed
through a detection cell containing an aqueous solution, generally potassium
hydroxide. Oxygen in the sample gas produces variation in the electrical
signal recorded at the outlet of the cell that is proportional to the oxygen
content.
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Carbon
monoxide
Pass
1050 ± 50 ml of the gas sample through a carbon monoxide detector tube at the
rate specified for the tube. The indicator change corresponds to not more
than 10 µl/l.
6.2.
Method of essay
Determine
by Gas chromatography using the following conditions:
Column:
material:
stainless steel
length:
2 m
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packing
material: appropriate molecular sieve capable of absorbing molecules with
diameters up to 0.5 nm.
Carrier
gas:
- gas:
helium (not less than 99.995 % (v/v) of He)
- flow:
40 ml/min
Detector:
thermal conductivity detector
Injector:
loop injector
Column
temperature: 50°
Detector
temperature: 130°
Reference
gas (a): ambient air
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Procedure:
Inject
reference gas (a). Adjust the injected volumes and operating conditions so
that the height of the peak due to nitrogen in the chromatogram is at least
35 % of full scale of the recorder. The assay is not valid unless the
chromatograms obtained show a clear separation of oxygen and nitrogen.
Inject
the gas to be examined and the reference gas (b). In the chromatogram
obtained with the gas to be examined, the area of the principal peak is at
least 99.0 % of the area of the principal peak in the chromatogram obtained
with reference gas (b).
ANNEX 2
SPECIFICATIONS AND TESTS FOR
NITROGEN OXYDE
1.
Synonyms
Nitrogen
oxyde, dinitrogen monoxyde,
INS 942
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2.
Definition
Chemical
names
Dinitrogen
monoxyd
C.A.S.
number
10024-97-2
Chemical
formula
N2O
Formula
weight
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3.
Description
Colourless,
odourless gas.
4.
Functional uses
Propellant,
antioxidant, packaging gas, foaming agent
5.
Specifications
5.1.
Identification
Solubility
1
volume dissolves in 1.5 volumes of water (20o, 760 mm Hg)
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A
glowing splinter of wood in contact with nitrous oxide bursts into flame
(distinction from nitrogen).
Pyrogallol
test
Passes
test (distinction from oxygen).
5.2.
Purity
Carbon
monoxide
Not
more than 10 µl/l.
Nitric
oxide and nitrogen dioxide
Not
more than 5 µl/l.
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Not
more than 5 µl/l.
Arsine
and phosphine
Passes
test.
5.3.
Content
Not
less than 97% (v/v).
6.
Tests
6.1.
Identification
Pyrogallol
test
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6.2.
Purity
NOTE:
For the following tests keep the cylinder of gas from which the sample is
taken at room temperature for not less than 6 h before carrying out the
tests. In all the tests the cylinder is kept in the vertical position with
the outlet valve uppermost when delivering the gas. Pass the gas at a steady
rate of 4 l/h unless otherwise stated and carry out the tests or calculate
the results with reference to the gas at 20o and 760 mm Hg.
Carbon
monoxide
Principle:
Carry
out the test on the first portion of gas issuing from the cylinder. Use 5.0 l
of the nitrous oxide in the test and 5.0 l of carbon monoxide-free air as the
control. The difference between the volumes of 0.002 N sodium thiosulfate
used in the two titrations is not greater than 0.5 ml.
Apparatus:
The
apparatus consists of the following parts connected in series:
-
U-tube containing anhydrous silica gel impregnated with chromium trioxide.
-
Scrubber bottle (dreschel type) containing 100 ml of a 40% w/v solution of
potassium hydroxide.
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-
U-tube containing phosphorous pentoxide dispersed on previously granulated,
fused pumice.
- Tube
containing recrystallized iodic anhydride (I2O5) in granules, previously dried at 200o and kept at a temperature of
120o. The iodic anhydride is packed in the tube in 1 cm columns
separated by 1 cm columns of glass wool to give an effective length of 5 cm.
- Flask
containing 2.0 ml of potassium iodide TS and 3 drops of starch solution TS.
Procedure
Flush
the apparatus with 5.0 l of carbon dioxide-free air and, if necessary,
discharge the blue colour in the iodide solution by adding the smallest necessary
quantity of freshly prepared 0.002 N sodium thiosulfate. Continue flushing
until not more than 0.045 ml of 0.002 N sodium thiosulfate is required after
passing 5.0 l of carbon dioxide-free air.
Pass
the gas from the cylinder through the apparatus, using the volume and the
rate of flow prescribed in the monograph. Flush the last traces of liberated
iodine into the reaction flask by passing through the apparatus 1.0 l of
carbon monoxide-free air. Titrate the liberated iodine with 0.002 N sodium thiosulfate.
Carry
out a blank assay under the same conditions, using the carbon monoxide-free
gas prescribed in the monograph. The difference between the volumes of 0.002
N sodium thiosulfate used in the two titrations is not greater than the limit prescribed in the monographs.
Nitric
oxide and nitrogen dioxide
Principle:
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Sulfanilic
acid/naphthylenediamine TS:
Solution
I: Dissolve 2 g of sulfanilic acid TS in a mixture of 10 ml of glacial acetic
acid and 180 ml of water.
Solution
II: Dissolve 0.2 g of naphthylenediamine dihydrochloride in 10 ml of a 50%
v/v glacial acetic acid solution heating gently and dilute to 200 ml with
water.
Mix 9
volumes of Solution I with 1 volume of Solution II
Procedure
Introduce
20.0 ml of sulfanilic acid/naphthylenediamine TS into the sampling tube by
dipping the end into a dish containing the mixture and carefully opening the
tap. Shake the tube and allow to stand for 10 min with occasional shaking.
Prepare the reference solution by adding 0.25 ml of 0.00308% w/v sodium
nitrite solution to 20.0 ml of the sulfanilic acid/naphthylenediamine TS.
Measure the absorbance of a 1 cm layer of the resulting solutions at 550 nm
and correct the result to 1.0 l of the gas at 20o and 760 mm Hg.
The
extinction of 1.0 l of the test substance is not greater than that of the
reference solution.
Halogens
and hydrogen sulfide
NOTE:
For the following test pass the gas into a closed, flat-bottomed glass
cylinder fitted with (a) a delivery tube having an orifice of 1 mm internal
diameter and reaching to 2 mm from the bottom of the cylinder and (b) an
outlet tube. The delivery tube is immersed in the reagent to a depth of 12 to
14 cm.
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Arsine
and phosphine
Silver
DDC/Quinoline TS: Dissolve 50 mg of finely powdered silver nitrate in 100 ml
of quinoline and add 0.2 g of silver diethyldithiocarbamate. The reagent
should be freshly prepared.
Procedure:
Pass 10.0 l at a rate of 1.0 l/min through a glass tube packed with lead
acetate TS on cotton wool and a gas distribution head of the domed, sintered
type, of porosity 100, into a tube of about 2.5 cm internal diameter,
containing 5 ml of Silver DDC/Quinoline TS, the domed head being almost in
contact with the bottom of the tube. The colour of the Silver DDC/Quinoline
TS is not changed.
6.3.
Method of essay
Use a
gas burette (see Figure below) of 100 ml capacity having as its upper end a
two-way tap connected to two capillaries, one of which (tube A) is used to
introduce the gas into the apparatus, the other (tube B) connected to the
condenser (C) and the manometer (M). The lower part of the gas burette has a
one-way tap connected to a mercury reservoir by a rubber tube. The gas
burette is graduated form 0 to 5 ml in tenths of a ml in the upper part and
from 99.5 to 100.5 ml in tenths of a ml in the lower part. The capillary tube
(B) is connected to a vertical capillary arm to form a four-way junction. The
descending arm of the junction is connected to a condenser (C) of about 60 ml
capacity. The right arm of the junction is connected to a mercury manometer
(M). A tap (D) on the upper vertical arm of the junction opens to the air.
Close
the three taps and immerse the condenser in liquid nitrogen, keeping the
level slightly above the upper part of the condenser. By manipulating the
two-way tap and the mobile reservoir create a partial vacuum in the
apparatus, choosing an arbitrary pressure Po between 50 and 60 mm Hg,
accurately measured. This pressure must remain constant for 10 min to
demonstrate that the apparatus is gas-tight.
Open
the two-way tap to tube (A) and completely fill the burette and tube (A) with
mercury. Close the two-way tap. Connect a rubber tube to the exit valve of
the nitrous oxide cylinder through a suitable pressure relieving device and
pass a current of nitrous oxide through the rubber tube for 1 min. Whilst the
gas is still flowing, connect the rubber tube to the end of tube (A) and
immediately open the two-way tap to tube (A). Allow 100 ml of nitrous oxide
to enter the burette by lowering the mercury reservoir. Close the two-way
taps.
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Place
the mercury reservoir in its bottom position, open the tap of the burette to
make connection with the condenser. Move the mercury reservoir until the
manometer reading is the same as the initial pressure Po. Close the tap of
the burette and by means of the mercury reservoir bring the pressure of the
gas in the burette to atmospheric pressure. The number of ml of gas
represents the non-condensible volume in 100 ml of nitrous oxide. The volume
of non-condensible gas must not exceed 3 ml. After each series of 10
determinations allow atmospheric air to enter by opening the tap (D), remove
the liquid nitrogen from the condenser and allow the condenser to warm to
room temperature.