MINISTRY OF
HEALTH
--------
|
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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|
No.
03/2017/TT-BYT
|
Hanoi, March 22,
2017
|
CIRCULAR
QCVN 5-1:2017/BYT - NATIONAL
TECHNICAL REGULATION FOR FLUID MILK PRODUCT
Pursuant to the Law on
Technical Standards and Regulation dated June 29, 2006 and the Government’s Decree No. 127/2007/ND-CP dated
August 01, 2007
elaborating the implementation of some articles of
the Law on Technical Standards and Regulation;
Pursuant to the Law on Food
Safety dated June 17, 2010 and the Government’s Decree No. 38/2012/ND-CP dated April 25, 2012 elaborating
the implementation of some articles of the Law on Food Safety;
Pursuant to the Government’s
Decree No. 75/2017/ND-CP dated June 20, 2017 defining functions, tasks, powers and organizational structure of the
Ministry of National Defense;
At the request of
the Director General of Vietnam
Food Administration;
The Minister of Health promulgates QCVN 5-1:2017/BYT - National technical
regulation for fluid milk product.
Article 1. QCVN 5-1:2017/BYT - National technical regulation for fluid
milk product is promulgated together with this Circular.
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QCVN 5-1:2010/BYT
- National technical regulation for fluid milk product
promulgated together with the Circular No. 30/2010/TT-BYT
dated June 02, 1010 of the Minister of Health expires from the effective date
of this Circular.
Article 3. The Director General of
Vietnam Food Administration, heads of units affiliated to the Ministry of
Health, units affiliated to the Ministry of Health; Directors of Departments of
Health of provinces and central-affiliated cities and relevant authorities,
organizations and individuals are responsible for implementing this Circular./.
PP. MINISTER
DEPUTY MINISTER
Truong Quoc Cuong
QCVN 5-1:2017/BYT
NATIONAL TECHNICAL REGULATION FOR FLUID MILK PRODUCTS
Foreword
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NATIONAL
TECHNICAL REGULATION FOR FLUID MILK PRODUCTS
I. GENERAL PROVISIONS
1. Scope
This Regulation provides for the safety limits and
management requirements for fluid milk products, including fresh milk (pasteurized/sterilized fresh whole milk,
pasteurized/sterilized fresh skimmed whole milk,
pasteurized/sterilized fresh milk, pasteurized/sterilized fresh skimmed milk), pasteurized/sterilized reconstituted milk, pasteurized/sterilized composite milk, condensed milk and sweetened
condensed milk (condensed milk, sweetened condensed milk, a blend of evaporated
skimmed milk and vegetable fat, a blend of sweetened condensed skimmed milk and
vegetable fat).
This Regulation shall not apply to formula milk
products for young children aged 36 months or below and formula milk for
special medical purposes for infants, and functional food.
2. Regulated entities
This Regulation shall apply to producers, sellers
and importers of fluid milk products in Vietnam and relevant organizations and
individuals.
3. Rules for formulation
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3.1. The safety of consumers' health is ensured.
3.2. Condition of production, trading and import in
Vietnam is conformed to.
3.3. National standards and regulations of Vietnam
law are conformed to.
3.4. International standards and regulations are
conformed to avoid creating barriers to trade exchange between Vietnam and
other countries in the world.
3.5. Risk management recommendations from domestic
and foreign competent authorities, Food and Agriculture Organization (FAO),
World Health Organization (WHO) and Codex Alimentarius Commission (CODEX) are updated.
4. Definitions
For the purposes of this Regulation, the terms
below are construed as follows:
4.1 “raw fresh milk” is fluid milk
that is obtained from cows, buffaloes, goats and sheep without either addition
to it or extraction from it is not processed by any method and used as an
ingredient for processing.
4.2. “milk product” is a product obtained by
any processing of milk, which may contain food additives, and other necessary
ingredients functionally necessary for the processing.
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4.4. “milk fat” is the fat that is derived
from milk or milk products and processed by a method that can remove most of
the water and milk solids-non-fat.
4.5. “milk solids-non-fat” is a product
resulting from removal of water and milk fat from raw fresh milk.
4.6. Fresh milk
4.6.1. “pasteurized/sterilized fresh whole milk” is a product that is completely
prepared from raw fresh milk without the addition or removal of any milk
constituents and without the addition of any other constituent, and that has
undergone pasteurization/sterilization.
4.6.2. “pasteurized/sterilized
fresh skimmed whole milk” is a product that is completely prepared from raw
fresh milk, separated from milk fat without the addition or removal of any
other milk constituent and without the addition of any other constituent, and
that has undergone pasteurization/sterilization.
4.6.3. “pasteurized/sterilized
fresh milk” is a product that is mainly prepared from raw fresh milk (raw
fresh milk accounts for at least 90% calculated according to the volume of the
final product)
This product may be added with other constituents
without substituting the main constituents and has
undergone pasteurization/sterilization.
4.6.4. “pasteurized/sterilized fresh skimmed milk” is a product that is mainly
prepared from raw fresh milk separated from milk fat (raw fresh milk separated
from milk fat accounts for at least 90% calculated according to the volume of
the final product).
This product may be added with other constituents without substituting the main constituents and
has undergone pasteurization/sterilization.
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This product may be added with other constituents
without substituting the main constituents and has
undergone pasteurization/sterilization. The
constituents of reconstituted milk account for at least
90% calculated according to the volume of the final product.
4.8. “pasteurized/sterilized composite milk” is a product that is prepared
from the combination of raw fresh milk, milk products or milk constituents.
This product may be added with other constituents
without substituting the main constituents and has
undergone pasteurization/sterilization. The constituents
of composite milk account for at least 90% calculated according
to the volume of the final product.
4.9. Condensed milk and sweetened condensed milk
4.9.1. “condensed milk” is a product that is
obtained by the partial removal of water
from raw fresh milk by heat, or by any other process. The fat and/or
protein content of the milk may have been adjusted by the addition and/or
removal of milk constituents in such a way as not to alter the whey protein to
casein ratio of the milk being adjusted.
This product may be added with other constituents without substituting
the main constituents.
4.9.2. “sweetened condensed milk” is a product that is obtained by the partial removal of water from raw fresh
milk or addition of water to powdered milk, with the addition of sugar. The
fat and/or protein content of the milk may have been adjusted by the addition
and/or removal of milk constituents in such a way as not to alter the whey
protein to casein ratio of the milk being adjusted.
This product may be added with other constituents without substituting
the main constituents.
4.9.3. “a blend of evaporated skimmed
milk and vegetable fat” is a product
that is prepared by recombining skimmed milk and potable water, or by the
partial removal of water, with the addition of vegetable fat.
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4.9.4. “a blend of condensed skimmed milk and
vegetable fat” is a product that is
prepared by recombining skimmed milk and potable water, or by the partial
removal of water, with the addition of sugar and vegetable fat.
This product may be added with other constituents without substituting
the main constituents.
II.
TECHINCAL REQUIREMENTS
5. Requirements for raw
fresh milk for production of fluid milk products
The raw fresh milk used for production of fluid
milk products must satisfy quality and food safety requirements according to
regulations of the Minister of Agriculture and Rural Development.
6. Physical and chemical
and safety criteria for fluid
milk products
6.1. Physical and chemical criteria are
specified in Appendix I of this Regulation.
6.2. Maximum limits of
pollutants are specified in Appendix II of this Regulation.
6.3. Maximum
limits of microbial contamination are specified in
Appendix II of this Regulation.
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6.5. Test methods are specified in the Appendix IV
of this Regulation.
6.6. In the cases where test methods are yet
to be specified in this Regulation, the Ministry of Health shall decide the
test methods according to applicable domestic and foreign methods.
7. Labeling
7.1. The labeling of fluid milk products
shall comply with regulations set forth in the Government’s Decree No. 43/2017/ND-CP dated April 14, 2017 on goods labels, and other
relevant legislative documents.
7.2. The characteristics of the product must
be specified on the front side of the product package in accordance with this
Regulation.
III. MANAGEMENT
REQUIREMENTS
8. Declaration of
Conformity
8.1. Declarations of conformity of imported
and domestic fluid milk products must be submitted in accordance with
regulations of this document.
8.2. Methods and procedures for submission
of declarations of conformity shall comply with the Government’s Decree No. 38/2012/ND-CP dated April 25, 2012 elaborating the
implementation of some articles of the Law on Food Safety, the Circular No. 19/2012/TT-BYT dated September 11, 2012 of the Minister of
Health providing guidance on submission of declarations of conformity and
conformity with regulation on food safety and other relevant regulations.
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9.1. Certificate of submission of Declaration of
Conformity
The fluid milk product that has
been issued with a Certificate of submission of Declaration of Conformity
according to the national technical regulation QCVN 5-1:2010/BYT
for fluid milk products shall continue to use this Certificate for production,
import and trading until the expiry date of the Certificate.
9.2. Product labels and commercial containers
attached to the product labels
9.2.1. The fluid milk product
that has been labeled in accordance with the national
technical regulation QCVN 5-1:2010/BYT for fluid milk products and
produced, imported, sold and used before the effective date of this Regulation shall continue to be sold and used until the
expiry date specified in such product label.
9.2.2.
The product labels and commercial containers
attached to product labels in accordance with the national
technical regulation QCVN 5-1:2010/BYT for fluid milk products that have
been produced and printed before the
effective date of this Regulation shall continue to be used not
exceeding 06 months from the effective date of this Regulation.
9.2.3. Producers and importers of fluid milk
products are responsible for declaring the number of products labeled in
accordance with regulations of law before March 01, 2018 and informing the
Ministry of Health (Vietnam Food Administration) thereof.
V. IMPLEMENTATION
10.
Vietnam Food Administration shall take charge and cooperate with
relevant authorities in providing guidance and organizing the implementation of
this Regulation.
11. Based
on the management requirements, Vietnam Food Administration
is responsible for requesting the Ministry of Health to make amendments to this
Regulation.
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APPENDIX I
PHYSICAL AND CHEMICAL CRITERIA
Criteria
Specified limit
Test methods
I. Fresh milk
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2.7 %
TCVN
8099-5:2009
(ISO 8968-5:2001)
2. Density at 20°C, not less
than
1.026
TCVN
5860:2007
TCVN 7028:2009
II. Reconstituted milk
and composite milk
1. Milk protein content, not less
than
2.7 %
TCVN
8099-5:2009
(ISO 8968-5:2001)
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1. Milk protein content in
milk solids-non-fat, not less than
34
%
TCVN
8099-5:2009
(ISO 8968-5:2001);
TCVN 8099-1:2015
(ISO 8968-1:2014)
APPENDIX II
MAXIMUM LIMITS OF POLLUTANTS
Critieria
Allowable
maximum limit
Test
methods
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1. Lead, mg/kg for the products specified in Clauses 4.6 to 4.8,
or mg/kg of the finished product for immediate for the
products specified in Clause 4.9.
0.02
TCVN
7933:2009
(ISO/TS 6733:2006); TCVN 7929:2008
(EN 14083:2003);
TCVN 10643:2014;
TCVN 10912:2015
EN 15763:2009)
2. Tin (for products in tin-coated
packaging), mg/kg
250
TCVN
7730:2007
(ISO/TS 9941:2005); TCVN 8110:2009
(ISO 14377:2002);
TCVN 7788:2007;
TCVN 10913:2015
(EN 15764:2009);
TCVN 10914:2015
(EN 15765:2009)
II. Mycotoxins
1. Aflatoxin M1, µg/kg
0.5
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III. Melamine, mg/kg
1. Melamine1), mg/kg
2.5
TCVN
9048:2012
(ISO/TS 15495:2010)
1) Melamine content is not mandatory for
conformity assessment but producers, importers and processors of fluid milk
products must not exceed the aforementioned maximum limits.
APPENDIX III
MAXIMUM LIMITS OF MICROBIAL CONTAMINATION
Critieria
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Test
methods
n 2)
M 3)
1. Enterobacteriaceae (only
applied to pasteurized fluid milk products)
5
10
CFU/ml
TCVN
5518-2:2007
(ISO 21528-2:2004);
TCVN 9980:2013
(AOAC 2003.01)
2. L. monocytogenes
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TCVN
7700-2:2007
(ISO 11290-2:1998, With amd.1:2004)
2) n:
The number of samples taken from
the batch/shipment to be inspected.
3)
M: The maximum limit.
APPENDIX IV
LIST OF TEST METHODS
I. Sampling
1. TCVN 6400 (ISO 707) Milk and milk
products - Guidance on sampling.
II. Methods of testing
physical and chemical criteria
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3. TCVN 7028:2009 Sterilized fresh
milk
4. TCVN 8099-1:2015 (ISO 8968-1:2014)
Milk - Determination of nitrogen content - Part 1: Kjeldahl method
5. TCVN 8099-5:2009 (ISO 8968-5:2001)
Milk - Determination of nitrogen content - Part 5: Kjeldahl method
III.
Methods of testing pollutants
III.1. Heavy metals
6. TCVN 7933:2009 (ISO/TS 6733:2006)
Milk and milk products - Determination of lead content - Graphite furnace
atomic absorption spectrometric method
7. TCVN 7929:2008 (EN 14083:2003)
Foodstuffs - Determination of trace elements - Determination of lead, cadmium,
chromium and molybdenum by graphite furnace atomic absorption spectrometry
(GFAAS) after pressure digestion
8. TCVN 10912:2015 (EN 15763:2009)
Foodstuffs - Determination of trace elements - Determination of arsenic, cadmium, mercury and lead in foodstuffs by
inductively coupled plasma mass spectrometry (ICP-MS)
after pressure digestion
9. TCVN 7730:2007 (ISO/TS 9941:2005)
Milk and canned evaporated milk - Determination of tin content - Spectrometric
method
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11. TCVN 10913:2015 (EN 15764:2009)
Foodstuffs - Determination of trace elements - Determination of tin by flame and graphite furnace atomic absorption
spectrometry (FAAS and GFAAS) after pressure digestion
12. TCVN 10914:2015 (EN 15765:2009)
Foodstuffs - Determination of trace elements - Determination of tin by
inductively coupled plasma mass spectrometry (ICP-MS) after pressure digestion
13. TCVN 10643:2014 Foodstuffs - Determination of lead, cadmium, copper, iron, and zinc -
Atomic absorption spectrophotometric method after dry ashing
14. TCVN 8110:2009 (ISO 14377:2002)
Canned evaporated milk - Determination of tin content -
Method using graphite furnace atomic absorption spectrometry
III.2. Mycotoxins
15. TCVN 6685:2009 (ISO 14501:2007)
Milk and milk powder – Determination fo aflatoxin M1 content – Clean-up by
immunoaffinity chromatography and determination by high-performance liquid
chromatography
III.3. Melamine
16. TCVN 9048:2012 (ISO/TS
15495:2010) Milk, milk products and infant formulae - Guidelines for the
quantitative determination of melamine and cyanuric acid by
liquid chromatography - tandem mass spectrometry (LC-MS/MS)
IV.
Methods of testing microbiological criteria
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18. TCVN 9980:2013 Microbiology of
food and animal feeding stuffs – Enumeration of Enterobacteriaceae using
Petrifilm™ count plate
19. TCVN 7700-2:2007 (ISO
11290-2:1998, With amd.1:2004) Microbiology of food and animal feeding stuffs -
Horizontal method for the detection and enumeration of Listeria monocytogenes -
Part 2: Enumeration method
(Other test methods with
equivalent accuracy may be used.)