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MINISTRY OF HEALTH
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THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No. 35/2010/TT-BYT
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Hanoi, June 02, 2010
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CIRCULAR
PROMULGATING NATIONAL TECHNICAL REGULATION FOR SOFT DRINKS
THE MINISTER OF HEALTH
Pursuant to the Law on
Technical Standards and Regulations dated June 29, 2006 and Government’s Decree
No. 127/2007/ND-CP dated August 01, 2007 on elaboration of some Articles of the
Law on Technical Standards and Regulations;
Pursuant to the
Ordinance on Food Safety and Hygiene dated August 08, 2003 and Government’s
Decree No. 163/2004/ND-CP dated September 07, 2004 on elaboration of some
Articles of the Ordinance on Food Safety and Hygiene;
Pursuant to the
Government’s Decree No. 188/2007/ND-CP dated December 27, 2007 defining
functions, tasks, entitlements and organizational structure of the Ministry of
Health;
At the request of the
Director of the Vietnam Food Administration, the Director of the Department of
Science and Training and the Director of the Department of Legal Affairs,
HEREBY DECIDES:
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Article
2. This Circular comes into force from January 01, 2011.
Article
3. The Director of the Vietnam Food Administration,
heads of affiliates of the Ministry of Health, affiliates of 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
Foreword
QCVN 6-2:2010/BYT is
prepared by the Drafting Committee for national technical regulation on food
safety and hygiene for drinks, is presented by the Vietnam Food Administration,
and is promulgated together with the Circular No. 33/2010/TT-BYT dated June 02,
2010 by the Minister of Health.
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1.
GENERAL
1.1. Scope
This document provides for
food safety criteria and requirements for management of soft drinks, including
vegetable and fruit juices, vegetable and fruit nectars and soft drinks.
This document does not
apply to functional foods.
1.2. Regulated
entities
This document applies to:
a) Importers, producers
and sellers of soft drinks in Vietnam;
b) Relevant organizations
and individuals.
1.3. Definitions
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1.3.1. Vegetable or
fruit juice
refers to a product in
which vegetable/fruit juice predominates, which may contain a small amount of
vegetable/fruit pulp and may be concentrated to form a concentrated
fruit/vegetable juice or fermented to form a fermented vegetable/fruit juice.
1.3.2. Vegetable or
fruit nectar
refers to a product
obtained by grinding vegetable/fruit cells together with solute, sugars and
other additives. The product shall comply with requirements specified in the
Appendix of TCVN 7946 : 2008 Fruit juices and nectars.
1.3.3. Soft drink
refers to a product that
is obtained from the mixture of water and natural or synthetic substances and
may contain CO2.
2.
SPECIFICATIONS
2.1. Requirements for
quality of water used to produce soft drinks
Water used to produce
soft drinks shall meet the specifications in QCVN 01:2009/BYT on drinking water
quality promulgated together with the Circular No. 04/2009/TT-BYT dated June
17, 2009 of the Minister of Health.
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2.2.1. Maximum levels for contaminants are provided in the
Appendix I of this document.
2.2.2. Microbiological criteria are provided in the Appendix II of
this document.
2.2.3. The list of permitted food additives is pertinent to
applicable regulations.
2.2.4. It is permissible to employ test methods with precision
equivalent to that of methods defined by criteria specified in the Appendix I
and Appendix II of this document.
2.2.5. Codes and full names of sampling methods and test methods
are provided in the Appendix III of this document.
2.2.6. The Ministry of Health shall regulate tests for criteria
whose test methods are not available in this document according to accredited
methods being employed locally or abroad.
2.3. Labeling
The labeling of soft drinks
shall comply with regulations in the Government's Decree No. 89/2006/ND-CP
dated August 30, 2006 and relevant written guidelines.
3.
MANAGEMENT REGULATIONS
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3.1.1. Declarations of conformity of imported and domestic soft
drinks must be submitted in accordance with regulations of this document.
3.1.2. 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.
3.2. Inspection of
soft drinks
The inspection of the
quality, hygiene and safety of soft drinks must abide by the laws.
4.
RESPONSIBILITIES OF ORGANIZATIONS AND INDIVIDUALS
4.1. Importers and producers of soft drinks shall declare
conformity according to the specifications mentioned in this document and
register such declarations of conformity with competent authorities defined by
the Ministry of Health. Quality, hygiene and safety of the products shall be
maintained according to such declarations of conformity.
4.2. Organizations and individuals can only import, produce and
sell soft drinks when they complete the registration of the declaration of conformity
and ensure that the quality, food safety and hygiene, and labeling thereof are
conformable to prevailing laws.
5.
IMPLEMENTATION
5.1. The Vietnam Food Administration shall take charge and
coordinate with relevant authorities to provide guidance and organize the
implementation of this document.
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5.3. In the cases where any of the standards and regulations
referred to in this document is amended or replaced, the newest one shall
apply.
APPENDIX I
MAXIMUM LEVELS FOR
CONTAMINANTS FOR SOFT DRINKS
Entry
Maximum level
Test method
Category of criteria 1)
I. Heavy metal
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1. Lead, mg/l
0,05
TCVN 8126:2009
A
2. Tin (for products
stored in tin coated containers), mg/l
150
TCVN 7769:2007 (ISO 17240:2004); TCVN 7788:2007
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II. Mycotoxin
1. Patulin soluble in
apple juice and nectar (applicable to both apple juice and nectar used as
ingredients in other types of drinks), mg/l
50
TCVN 8161:2009 (EN 14177:2003)
A
III. Residues of
pesticides
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1. Fruit juices and nectars (Citrus)
-
Piperonyl butoxid, mg/l
0,05
US FDA PAM, Vol. I, Section 302,
E1/E4+C4
A
2. Orange juice and nectar
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-
2-Phenylphenol, mg/l
0,5
US FDA PAM, Vol. I, Section 302,
E1, E2
A
- Propargit, mg/l
0,3
US FDA PAM, Vol. I, Section 302,
E1, E2
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3. Apple juice and nectar
- Diphenylamin, mg/l
0,5
US FDA PAM, Vol. I, Section 302,
E1, E2
A
- Propargit, mg/l
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US FDA PAM, Vol. I, Section 302,
E1, E2
A
4. Grape juice and
nectar
- Propargit, mg/l
1
US FDA PAM, Vol. I, Section 302,
E1, E2
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5. Tomato juice and nectar
- Carbaryl, mg/l
3
TCVN 8171-1:2009 (EN 14185-1:2003)
A
- Malathion, mg/l
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AOAC 970.53
A
- Piperonyl butoxid,
mg/l
0,3
US FDA PAM, Vol. I, Section 302,
E1/E4+C4
A
1) Category A: tests are required for assessment of
conformity.
APPENDIX II
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Entry
Maximum level
Test method
Category of criteria 2)
1. Total aerobic count,
CFU/ml product
100
TCVN 4884:2005 (ISO 4833:2003)
A
2. Coliform, CFU/ml
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TCVN 6848:2007 (ISO 4832:2006);
TCVN 4882:2007 (ISO 4831:2006)
A
3. E. coli,
CFU/ml
Not permitted
TCVN 7924-1:2008 (ISO 16649-1:2001); TCVN 7924-2:2008
(ISO 16649-2:2001); TCVN 7924-3:2008 (ISO/TS 16649-3:2005)
A
4. Streptococci faecal, CFU/ml
Not permitted
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A
5.
Pseudomonas aeruginosa, CFU/ml
Not permitted
ISO 16266:2006
A
6. Staphylococcus
aureus, CFU/ml
Not permitted
TCVN 4830-1:2005 (ISO 6888-1:1999, With Amd. 1:2003);
TCVN 4830-2:2005 (ISO 6888-2:1999, With Amd. 1:2003);
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A
7. Clostridium perfringens, CFU/ml
Not permitted
TCVN 4991:2005 (ISO 7937:2004)
A
8. Total yeast and
mould count, CFU/ml
10
TCVN 8275-1:2009 (ISO 21527-1:2008)
A
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APPENDIX III
LIST OF TEST METHODS FOR FOOD
SAFETY CRITERIA FOR SOFT DRINKS
I. Test methods for
heavy metal
1.
TCVN 7769:2007 (ISO 17240:2004) Fruit and vegetable products - Determination of
tin content – Method using flame atomic absorption spectrometry.
2.
TCVN 7788:2007 Canned foods - Determination of tin content by atomic absorption
spectrophotometric method
3. TCVN 8126:2009 Foods -
Determination of lead, cadmium, zinc, copper, and iron-Atomic absorption
spectrophotometry after microwave digestion.
II.
Test methods for mycotoxin
1. TCVN 8161:2009 (EN
14177:2003) Foodstuffs - Determination of patulin in clear and cloudy apple
juice and puree - High performance liquid chromatographic (HPLC) method with
liquid/liquid partition clean-up
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1. TCVN 8171-1:2009 (EN
14185-1:2003) Non-fatty food – Determination of N-methylacarbamate residues –
Part 1: High performance liquid chromatographic (HPLC) method with solid phase
extraction (SPE) clean-up
2. AOAC 970.53
Organophosphorus Pesticide Residues. Polarographic Confirmatory Method
3. Pesticide Analytical
Manual (PAM), Food and Drug Administration, Washington, D.C., USA, Vol. I, 3rd
edition, Section 302
IV. Microbiological
test methods
1. TCVN 4830-1:2005 (ISO
6888-1:1999, With Amd. 1:2003) Microbiology of food and animal feeding stuffs –
Horizontal method for the enumeration of coagulase-positive staphylococci
(Staphylococcus aureus and other species) - Part 1: Technique using
Baird-Parker agar medium.
2. TCVN 4830-2:2005 (ISO 6888-2:1999,
With Amd. 1:2003) Vi Microbiology of food and animal feeding stuffs -
Horizontal method for the enumeration of coagulase-positive staphylococci
(Staphylococcus aureus and other species) - Part 2: Technique using rabbit
plasma fibrinogen agar medium.
3. TCVN 4830-3:2005 (ISO
6888-3:2003), Microbiology of food and animal feeding stuffs - Horizontal
method for the enumeration of coagulase-positive staphylococci (Staphylococcus
aureus and other species) - Part 3: Detection and MPN technique for low
numbers.
4. TCVN 4882:2007 (ISO
4831:2006) Microbiology of food and animal feeding stuffs - Horizontal method
for the detection and enumeration of coliforms - Most probable number
technique.
5. TCVN 4884:2005 (ISO
4833:2003), Microbiology of food and animal feeding stuffs - Horizontal method
for the enumeration of microorganisms - Colony count technique at 300C.
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7. TCVN 6189-2:1996 (ISO
7899-2:1984) Water quality – Detection and enumeration of faecal streptococci -
Part 2: Method by membrane filtration.
8. TCVN 6848:2007 (ISO 4832:2006)
Microbiology of food and animal feeding stuffs – Horizontal method for the
enumeration of coliforms – Colony-count technique.
9. TCVN 7924-1:2008 (ISO
16649-1:2001) Microbiology of food and animal feeding stuffs – Horizontal
method for the enumeration of β-glucuronidase-positive Escherichia coli – Part
1: Colony-count technique at 44 °C using membranes and
5-bromo-4-chloro-3-indolyl β-D-glucuronida.
10. TCVN 7924-2:2008 (ISO
16649-2:2001) Microbiology of food and animal feeding stuffs - Horizontal
method for the enumeration of β-glucuronidase-positive Escherichia coli - Part
2: Colony-count technique at 44 °C using 5-bromo-4-chloro-3-indolyl
β-D-glucuronide.
11. TCVN 7924-3:2008
(ISO/TS 16649-3:2005) Microbiology of food and animal feeding stuffs –
Horizontal method for the enumeration of b-glucuronidase-positive Escherichia
coli – Part 3: Most probable number technique using 5-bromo-4-chloro-3-indolyl
b-D-glucuronide.
12. TCVN 8275-1:2009 (ISO
21527-1:2008) Microbiology of food and animal feeding stuffs - Horizontal
method for the enumeration of yeasts and moulds - Part 1: Colony count
technique in products with water activity greater than 0,95.
13. ISO 16266:2006 Water
quality – Detection and enumeration of Pseudomonas aeruginosa – Method by membrane
filtration.