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

Thông tư 01/2011/TT-BYT về Quy chuẩn kỹ thuật quốc gia về phụ gia thực phẩm do Bộ trưởng Bộ Y tế ban hành