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MINISTRY OF
HEALTH
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SOCIALIST
REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
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No.: 01/2011/TT-BYT
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Hanoi, January
13, 2011
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CIRCULAR
PROMULGATION OF NATIONAL TECHNICAL REGULATIONS ON FOOD
ADDITIVE
MINISTER OF HEALTH
Pursuant to the Law on technical standards
and regulations dated June 29, 2006 and the Government's Decree No. 127/2007/ND-CP
dated August 01, 2007 detailing the implementation of a number of articles of
the Law on Technical regulations and standards;
Pursuant to the Ordinance on food hygiene and
safety dated August 07, 2003 and the Government's Decree No. 163/2004/ND-CP
dated September 07, 2004 detailing the implementation of a number of articles
of the Ordinance on food hygiene and safety;
Pursuant to the Government's Decree No.
188/2007/ND-CP dated December 27, 2007 defining the functions, tasks, powers
and organizational structure of Ministry of Health;
At the request of Directors of Vietnam Food
Administration, the Science and Education Department and the Legal Department,
STIPULATES:
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1. QCVN 4-18:2011/BYT National technical
regulation on Food Additive – Modified starches;
2. QCVN 4-19:2011/BYT National technical
regulation on Food Additive – Enzyme;
3. QCVN 4-20:2011/BYT National technical
regulation on Food Additive – Glazing agent;
4. QCVN 4-21:2011/BYT National technical
regulation on Food Additive – Thickener;
5. QCVN 4-22:2011/BYT National technical
regulation on Food Additive – Emulsifier;
6. QCVN 4-23:2011/BYT National technical regulation
on Food Additive – Foaming agent.
Article 2. This Circular takes effect as of August 01, 2011.
Article 3. Director of Vietnam Food Administration, heads of Ministry
of Health’s departments and affiliates, directors of departments of health of
central-affiliated cities or provinces and relevant organizations and
individuals shall implement this Circular./.
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PP MINISTER
VICE-MINISTER
Trinh Quan Huan
QCVN 4-19:2011/BYT
NATIONAL TECHNICAL REGULATION ON FOOD ADDITIVE – ENZYME
Preface
QCVN 4-19:201/BYT is compiled
by the Drafting Board of national technical regulations on food additive and
processing aids, submitted for approval by Vietnam Food Administration and
promulgated under Circular No. 01/2011/TT-BYT dated January 13, 2011 by Minister
of Health.
NATIONAL
TECHNICAL REGULATION ON FOOD ADDITIVE – ENZYME
I. GENERAL PROVISIONS
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This national technical regulation (hereinafter
referred to as the Regulation) provides for specifications and administrative
requirements on quality, hygiene and safety of enzymes used as food additive.
2. Regulated entities
This Regulation applies to:
2.1. Importers, exporters, producers, traders
and users of enzymes as food additive (hereinafter referred to as entities).
2.2. Relevant regulatory agencies.
3. Interpretation of terms and acronyms:
3.1. JECFA monograph 1 - Vol. 4 refers to 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 ( or referenced) in the food
additive specifications; compiled by JECFA; issued by FAO in 2006.
3.2. C.A.S (Chemical
Abstracts Service) number refers to registry numbers of chemical substances
identified by the American Chemical Society.
3.3. TS (test solution) means reagent liquid.
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3.5. INS stands for the international numbering
system for food additives.
II. SPECIFICATIONS, METHODS
OF ASSAY AND SAMPLING
1. Specifications and methods of assay
for enzymes are defined in annexes to this Regulation:
1.1.
Annex 1 :
Specifications and methods of
assay for amylase
1.2.
Annex 2 :
Specifications and methods of
assay for protease
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Annex 3 :
Specifications and methods of
assay for papain
1.4.
Annex 4 :
Specifications and methods of
assay for bromelain
1.5.
Annex 5 :
Specifications and methods of
assay for glucose oxidase and catalase
2. Specifications
in this Regulation are tested according to JECFA monograph 1 - Vol. 4, except
for certain specific methods of assay prescribed in annexes herein. Methods of
assay as prescribed in this Regulation are not mandatory. Different methods of
assay with equivalent degree of precision may be employed.
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III.
ADMINISTRATVIE REQUIREMENTS
1. Declaration of conformity
1.1. The conformity of enzymes
must be declared according to this Regulation.
1.2. The method and procedure for
declaration of conformity shall be governed by regulations on certification and
declaration of conformity enclosed to Decision No. 24/2007/QD-BKHCN dated
September 28, 2007 by Minister of Science and Technology and by relevant laws.
2. Inspection of enzymes
The quality,
hygiene and safety of enzymes must be inspected in accordance with the law
regulations.
IV.
RESPONSIBILITIES OF ENTITIES
1. Entities
must declare their conformity with this Regulation, register their declaration
of conformity at Vietnam Food Administration and ensure the quality, hygiene
and safety of enzymes as declared.
2. Entities shall only be permitted to import, export, produce, sell and
use enzymes upon their completion of registration of declaration of conformity
and their fulfillment of law regulations on quality, hygiene, safety and
labeling.
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1. Vietnam Food Administration shall lead and cooperate with authorities
concerned to instruct and organize the implementation of this Regulation.
2. Vietnam Food Administration, according to its administrative devoirs, shall
be responsible for proposing to the Ministry of Health the amendments and
supplements to this Regulation.
3. If international guidelines for methods of assay and laws referred to
in this Regulation are amended, supplemented or replaced, revised documents
shall prevail.
ANNEX 1
SPECIFICATIONS AND METHODS OF ASSAY
FOR α-AMYLASE AND GLUCOAMYLASE
INS 1100
Produced by the controlled
fermentation of non-toxicogenic and nonpathogenic strains of Aspergillus
oryzae and isolated from the growth medium
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Glucan
1,4-alpha-glucosidase (synonyms: amyloglucosidase, acid maltase, lysosomal alpha-glucosidase,
exo-1,4-alpha-glucosidase)
1,4-alpha-D-Glucan
glucanohydrolase
EC 3.2.1.1
alpha-Amylase hydrolyzes
1,4-alpha-glucosidic linkages in polysaccharides yielding dextrins, oligosaccharides
and glucose
Glucoamylase
hydrolyzes 1,4-alpha- and 1,6-alpha-glucosidic linkages in polysaccharides
yielding glucose
Lipase (EC
3.1.1.3)
Tannase (EC
3.1.1.20)
Cellulase
(EC 3.2.1.4)
Endo-1,3-beta-glucanase
(EC 3.2.1.6)
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Maltase (EC
3.2.1.20)
Lactase (EC
3.2.1.23)
Endo-1,4-beta-mannanase
(EC 3.2.1.78)
Protease
Tan amorphous powders or
tan to dark-brown liquids that may be dispersed in diluents (purely used in
food) and may contain stabilizers and preservatives; soluble in water and
practically insoluble in ethanol and ether
Enzyme preparation.
Used in the hydrolysis of
cereals and starch; in the preparation of fruit and vegetable products,
beverages, sugar, confectionery and bakery products and in honey.
Must
conform to the general specifications for enzyme preparations used in food
processing
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Reaction shows typical
glucoamilase activity (from Aspergillus oryzae, var ) (use methods of assay in JECFA monograph 1 - Vol.4)
ANNEX 2
SPECIFICATIONS AND METHODS OF ASSAY
FOR PROTEASE (FROM FUNGAL)
INS 1101(i)
Produced by the controlled
fermentation of non-toxicogenic and nonpathogenic strains of Aspergillus
oryzae and isolated from the growth medium
Endo- and
exopeptidases
1. Aminopeptidases
(EC 3.4.11)
2. Serine
endopeptidases (EC 3.4.21)
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1. Hydrolysis of proteins
at the N-terminal, liberating amino acids
2. Hydrolysis of proteins
containing serine peptide bonds
3. Hydrolysis of proteins
containing aspartic acid bonds
alpha-amylase
(EC 3.2.1.1)
Off-white to tan amorphous powders
dispersed in dispersion medium or carriers (purely used in food); may contain
stabilizers and preservatives; soluble in water and practically insoluble in
ethanol and ether
Enzyme preparation.
Used in the preparation of
meat and fish products, beverages, soup and broths, dairy and bakery
products.
Must
conform to the general specifications for enzyme preparations used in food
processing (see instructions)
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Reaction
shows typical proteolytic activity (Use method of assay for proteolytic,
Fungal (HUT))
SPECIFICATIONS AND METHODS OF ASSAY
FOR PAPAIN
INS 1101(ii)
Purified proteolytic
substances derived from the fruit of Carica papaya (L) (Fam. Caricaceae)
1. Papain (papaya
peptidase I, cystein proteinase)
2. Chymopapain
(cystein proteinase)
1. None
(EC 3.4.22.2)
2. None
(EC 3.4.22.6)
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White to light tan
amorphous powder or liquids; soluble in water, the solutions being colourless
to light yellow and somewhat opalescent; practically insoluble in alcohol,
chloroform and ether
Enzyme preparation.
Used in
the processing and preparation of beef, processing of meat, preparation of
cereals, and production of protein hydrolysates
Must
conform to the general specifications for enzyme preparations used in food
processing (see instructions)
Reaction
shows typical plant proteolytic activity
SPECIFICATIONS AND METHODS OF ASSAY
FOR BROMELAIN
INS 1101(iii)
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Bromelain (crystein
proteinase)
None
(EC 3.4.22.4)
The enzyme hydrolyzes polypeptides, amides and esters, especially at
linkages involving basic amino acids, or leucine or glycine, yielding
peptides of lower molecular weight.
White
to light tan amorphous powder; soluble in water, the solutions being
colourless to light yellow and somewhat opalescent; practically insoluble in
alcohol, chloroform and ether
Enzyme preparation.
Used in
the processing of beef, processing of meat, preparation of cereals, and production
of protein hydrolysates
Must
conform to the general specifications for enzyme preparations used in food
processing
Reaction shows
typical plant proteolytic activity (see Proteolytic activity, plant)
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SPECIFICATIONS AND METHODS OF ASSAY
FOR GLUCOSE OXIDASE AND CATALASE FROM ASPERGILLUS NIGER var.
Glucose
oxyhydrase, glucose aerodehydrogenase, notatin, aero-glucose dehydrogenase;
INS 1102
Commercial enzyme
preparations are produced by the controlled fermentation of Aspergillus
niger va r.
1. Glucose oxidase
2. Catalase
1. ß-D-glucose:
oxygen 1-oxidoreductase (EC 1.1.3.4)
2. Hydrogen-peroxide:
hydrogen-peroxide oxidoreductase (EC 1.11.1.6)
1. ß-D-glucose + O2
--> D-glucono-delta-lactone + H2O2
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Invertase
(EC 3.2.1.26)
Off-white
to brown liquids; soluble in water and practically insoluble in ethanol,
chloroform and ether
Enzyme preparation.
Used in
the preparation or use of milk, cheese, eggs, beverages and salads
Must
conform to the general specifications for enzyme preparations used in food
processing
Reaction
shows glucose oxidase activity (see Vol 4.)
Reaction
shows typical catalase activity (see Vol 4.)
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Foreword
QCVN 4-21:2011/BYT is prepared by the Drafting Board of
national technical regulations on food additive and processing aids, presented
by the Vietnam Food Administration and promulgated under the Circular No.
01/2011/TT-BYT dated January 13, 2011 of the Minister of Health.
I.
GENERAL
1. Scope
This
national technical regulation (hereinafter referred to as “document”) provides
for specifications and regulatory requirements for quality, hygiene and safety
of thickeners used as food additive.
2. Regulated
entities
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2.1. Importers,
exporters, producers, traders and users of thickeners as food additive
(hereinafter referred to as “entities”).
2.2. Relevant regulatory
agencies.
3. Interpretation of
terms and acronyms:
3.1. “thickener” refers
to a food additive which is used to increase the viscosity of a foodstuff.
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).
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 for Food Additives.
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1. Specifications and tests for thickeners
are provided in annexes to this document:
1.1.
Annex 1:
Specifications and tests for alginic
acid
1.2.
Annex 2:
Specifications and tests for potassium
alginate
1.3.
Annex 3:
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1.4.
Annex 4:
Specifications and tests for calcium
alginate
1.5.
Annex 5:
Specifications and tests for propylene
glycol alginate
1.6.
Annex 6:
Specifications and tests for agar
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Annex 7:
Specifications and tests for
carrageenan and its Na, K, NH4 salts
1.8.
Annex 8:
Specifications and tests for carob bean
gum
1.9.
Annex 9:
Specifications and tests for guar
gum
1.10.
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Specifications and tests for tragacanth
gum
1.11.
Annex 11:
Specifications and tests for arabic gum
1.12.
Annex 12:
Specifications and tests for xanthan
gum
1.13.
Annex 13:
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1.14.
Annex 14:
Specifications and tests for tara gum
1.15.
Annex 15:
Specifications and tests for gellan gum
1.16.
Annex 16:
Specifications and tests for pectins
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Annex 17:
Specifications and tests for methyl
cellulose
1.18.
Annex 18:
Specifications and tests for methyl
ethyl cellulose
1.19.
Annex 19:
Specifications and tests for sodium
carboxymethyl cellulose
1.20.
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Specifications and tests for edible
gelatin
2. Specifications in this document are
tested according to JECFA monograph 1 - Vol. 4, except for certain specific tests
prescribed in annexes herein. Tests prescribed in this document are not
mandatory. Different tests with equivalent degree of precision may be employed.
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 law regulations.
III. REGULAORY REQUIREMENTS
1. Declaration of
conformity
1.1. Declarations of
conformity of thickeners shall be submitted in accordance with
regulations of this document.
1.2. Methods and procedures
for submission of declarations of conformity shall comply with the Regulation
on certification and declaration of conformity and conformance under the
Decision No. 24/2007/QD-BKHCN dated September 28, 2007 by Minister of Science
and Technology and the laws.
2. Inspection
of thickeners
The
quality, hygiene and safety of thickeners must be inspected in accordance with
the law regulations.
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1. Entities must declare
their conformity with the specifications mentioned this document, register
their declarations of conformity at the Vietnam Food Administration and ensure
the quality, hygiene and safety of thickeners as declared.
2. Entities are
only entitled to import, export, produce, sell and use thickeners after their
completion of registration of declarations of conformity and their fulfillment
of law regulations on quality, hygiene, safety and labeling.
V. IMPLEMENTATION
1. Vietnam Food Administration shall take charge and
cooperate with authorities concerned to provide guidance on and organize the
implementation of this document.
2. The Vietnam Food
Administration shall, according to its managerial duties, recommend amendments
to this document to the Ministry of Health.
3. In the cases where any of the international guidelines for
tests and regulations referred to in this document is amended or replaced, the
newest one shall apply