MINISTRY OF HEALTH
-------No.: 22/2012/TT-BYT
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
--------------Hanoi, November 15, 2012
CIRCULAR
ISSUING NATIONAL TECHNICAL REGULATION ON FOLLOW-UP FORMULAS FOR
INFANTS FROM 6TH MONTH ON AND YOUNG CHILDREN UP TO 36 MONTHS OF AGE
MINISTER OF HEALTH
Pursuant to the Law on Food Safety dated June 17, 2010 and Decree No. 38/2012/ND-CP dated
April 25, 2012 of the Government detailing the implementation of some articles of the Law on Food
Safety;
Pursuant to the Law on Standards and Technical regulation dated June 29, 2006 and Decree No.
127/2007/ND-CP dated August 1, 2007 of the Government detailing the implementation of some
articles of the Law on Standards and Technical regulation;
Pursuant to Decree No. 63/2012/ND-CP dated August 31, 2012 of the Government defining the
functions, tasks, powers and organizational structure of the Ministry of Health;
At the proposal of Director of Department of Food Safety;
The Minister issues Circular on national technical regulation on follow-up formulas for infants from
6th month on and young children up to 36 months of age;
Article 1. Issuing together with this Circular:
QCVN 11-3:2012/BYT - National technical regulation on follow-up formulas for infants from 6th
month on and young children up to 36 months of age;
Article 2. This Circular takes effect on June 01, 2013.
Article 3. Director of Department of Food Safety, heads of units under the Ministry of Health and
units directly under the Ministry of Health, Director of Service of Health of provinces and centrallyaffiliated cities and organizations and individuals concerned are liable to execute this Decision.
FOR THE MINISTER
DEPUTY MINISTER
Nguyen Thanh Long
QCVN 11-3:2012/BYT
NATIONAL TECHNICAL REGULATION
ON FOLLOW-UP FORMULAS FOR INFANTS FROM 6TH MONTH ON AND YOUNG
CHILDREN UP TO 36 MONTHS OF AGE
FOREWORD
QCVN 11-3:2012/BYT is written by the Drafting Committee of national technical regulations on
food for infantss and young children, submitted for approval by the Department of Food Safety and
issued under Circular No. 22/2012 / TT-BYT dated November 15, 2012 by the Minister of Health.
NATIONAL TECHNICAL REGULATION
ON FOLLOW-UP FORMULAS FOR INFANTS FROM 6TH MONTH ON AND YOUNG
CHILDREN UP TO 36 MONTHS OF AGE
I. GENERAL PROVISION
1. Scope of adjustment
This regulation prescribes the indicators of quality, food safety and management requirements for
management of follow-up formulas for infants from 6th month on and young children up to 36
months of age.
2. Subjects of application
This regulation applies to:
2.1. Organizations and individuals importing, producing and trading the follow-up formulas for
infants from 6th month on and young children up to 36 months of age in Vietnam;
2.2. The state management agencies concerned.
3. Explanation of terms and abbreviated symbols
In this regulation, the terms and abbreviated symbols below are construed as follows:
3.1. The follow-up formulas for infants from 6th month on and young children up to 36 months of
age (hereafter referred to as product): The product is in powder or liquid form and made from:
- Cow's milk or other dairy animals and (or);
- Ingredients are derived from animals and plants.
The product must meet nutritional needs for the normal development of infants from 6th month on
and young children up to 36 months of age. The liquid product can be used directly or diluted with
water before use, the powder product must be mixed with water before use.
- GMP:Good Manufacturing Practice
- CODEX: Codex Alimentarius Commission
- IU: International Unit:
- RE: Retinol Equivalent
II. TECHNICAL REGULATION
1. Basic ingredients
1.1. General requirements
1.1.1. Materials and food additives put into production must ensure the quality and food safety and
hygiene and be appropriate for the digestion of infants from 6th month on and young children up to
36 months of age.
1.1.2. The product is made from:
- Cow’s milk or other animal’s milk and (or);
- Preparations of animal protein and (or) vegetable (proven suitable for infants from 6th month on
and young children up to 36 months of age);
- Other materials necessary to meet the requirements for the products specified in Clause 1.2 and
1.3, Part II of this Regulation.
1.1.3. The product having basic ingredient of milk is made from materials specified at Point 1.1.2,
Part II of this Regulation must ensure that 100 kcal of product (prepared according to the
manufacturer's instructions for direct use) contain at least 3g of protein (or 0,7 g/100 kJ) originating
from skimmed milk and full cream milk and accounts for at least 90% of the total protein amount in
the product, the protein content can be regulated, but the content of vitamins and minerals in milk
must not be reduced.
1.2. Energy
The product (prepared according to the manufacturer's instructions for direct use) must meet:
Unit
kcal/100 ml
kJ/100 ml
1.3. Nutrient ingrdients
Minimum
60
250
Maximum
85
355
The product (prepared according to the manufacturer's instructions for direct use) must meet:
1.3.1. Protein content
Unit
Minimum (1)
Maximum
3,0
5,5
g/100 kcal
Note
(1)
Protein in the product has the nutritional quality
equivalent to casein. In case of using other protein
g/100 kJ
0,7
1,3
with nutritional quality lower than casein, then the
protein content must increase in inverse proportion to
the nutritional quality. The nutritional quality of the
protein is not lower than 85% compared with casein.
The essential amino acid may be supplemented to improve the nutritional value of the product. In
this case, only supplementing essential amino acid of L isomer shape with sufficient content to
improve protein quality.
1.3.2. Lipid content
Unit
Total fat
g/100 kcal
g/100 kJ
Linoleic acid (glycerid )
mg/100 kcal
mg/100 kJ
1.3.3. Carbohydrate content
Minimum
Maximum
3,0
0,7
6,0
1,4
300
71,7
-
The carbohydrate in product must:
- Be suitable for infants from 6th month on and young children up to 36 months of age,
- The content meeting the requirements for energy specified in Clause 1.2, Part II of this Regulation
(taking into account the energy from protein and fat in the product).
1.3.4. Vitamin content
Unit
Vitamin A
IU/100 kcal
mg RE /100 kcal
IU/100 kJ
mg RE/100 kJ
Vitamin D
IU/100 kcal
mg/100 kcal
IU/100 kJ
mg/100 kJ
Vitamin E (a - tocopherol)
Minimum
Maximum
250
75
60
18
750
225
180
54
40
1
10
0,25
120
3
30
0,75
Note
(2)
Contains at least 0.7 IU / g linoleic
acid or 0.7 IU / g poly unsaturated acid
calculated by linoleic acid
IU/100 kcal
IU/100 kJ
Vitamin C (Ascorbic acid)
mg/100 kcal
mg/100 kJ
Vitamin B1 (thiamin)
mg/100 kcal
mg/100 kJ
Vitamin B2 (Riboflavin)
mg/100 kcal
mg/100 kJ
Nicotinamide
mg/100 kcal
mg/100 kJ
Vitamin B6
mg/100 kcal
mg/100 kJ
Folic acid
mg/100 kcal
mg/100 kJ
Pantothenic acid
mg/100 kcal
mg/100 kJ
Vitamin B12
mg/100 kcal
mg/100 kJ
0,7(2)
0,15(2)
-
8,0
1,9
-
40
10
-
60
14
-
250
60
(3)
Containing at least 15mg vitamin
B6/g protein
45(3)
11(3)
-
4
1
-
300
70
-
0,15
0,04
-
Vitamin K1
mg/100 kcal
4
mg/100 kJ
1
Vitamin H (Biotin)
mg/100 kcal
1,5
mg/100 kJ
0,4
The forms of vitamin supplemented into the product as prescribed by the Ministry of Health. In the
absence of regulation from the Ministry of Health, just follow the CODEX guidance at CAC/GL 101979, Rev.1-2008 - Advisory List of Mineral Salts and Vitamin compounds for Use in Foods for
Infants and Children
1.3.5. Mineral content
Unit
Sodium
mg/100 kcal
mg/100 kJ
Kali
mg/100 kcal
mg/100 kJ
Chloride
mg/100 kcal
mg/100 kJ
Calcium
mg/100 kcal
mg/100 kJ
Phospho
mg/100 kcal
mg/100 kJ
Ratio of Calcium/phospho
Minimum
Maximum
20
5
85
21
80
20
-
55
14
-
90
22
-
60
14
-
1,0
2,0
Note
Magnesium
mg/100 kcal
6,0
mg/100 kJ
1,4
Iron
mg/100 kcal
1,0
2,0
mg/100 kJ
0,25
0,50
Iodine
mg/100 kcal
5,0
mg/100 kJ
1,2
Zinc
mg/100 kcal
0,5
mg/100 kJ
0,12
The forms of mineral supplemented into the product as prescribed by the Ministry of Health. In the
absence of regulation from the Ministry of Health, just follow the CODEX guidance at CAC/GL 101979, Rev.1-2008 - Advisory List of Mineral Salts and Vitamin compounds for Use in Foods for
Infants and Children.
2. Optional ingredients
In addition to vitamins and minerals specified at Point 1.3.4 và 1.3.5, Part II of this Regulation, the
product may be supplemented with other nutritional ingredients to suit with the mixed ration of
infants from 6th month on and young children up to 36 months of age. The effect of these nutrients
must be proven scientifically. The nutrients supplemented into the product must have sufficient
content to meet the needs of infants from 6th month on and young children up to 36 months of age.
3. Requirements for product after preparation
After preparation according to the manufacturer's instructions, the product must not have clotting
phenomenon.
4. Treated with ionizing radiation
The product and materials must not be treated with ionizing radiation.
5. Food additives
The food additives used in the follw-up formulas for infants from 6th month on and young children
up to 36 months of age are in accordance with regulations of the Ministry of Health.
6. Contaminant
6.1. Residue of pesticide
Products are processed according to the principles of GMP so that no longer residue of pesticide
(used in the production, storage or processing of raw materials / food ingredients). In case of
technical reasons, there are still residues of pesticide, then their contents must be minimized to meet
the current regulations.
6.2. Melamin
Unit
mg/kg product
6.3. Heavy metal
Maximum level
2,5
Note
As prescribed by QCVN 8-2:2011/BYT - National technical standards for limit of heavy metal
contamination in food.
6.4. Fungal toxin
As prescribed by QCVN 8-1:2011/BYT - National technical standards for limit of fungal toxin in
food.
6.5. Other contaminants
No containing of residue of hormones, antibiotic and other pollutants is allowed, especially
substances with pharmaceutical characteristics.
7. Microorganism
As prescribed by QCVN 8-3:2011/BYT - National technical standards for limit of fungal toxin
contamination in food.
8. Labelling
The labelling of formulas with special medical purposes for infants up to 12 months old must
comply with the provisions in the Government’s Decree No. 89/2006/ND-CP dated August 30, 2006
on goods labels on goods labeling and documents guiding the implementation of regulations of law.
III. METHOD OF SAMPLING AND TESTING
1. Sampling
Taking sample as prescribed in Circular No. 16/2009/TT-BKHCN dated June 02, 2009 of the
Ministry of Science and Technology on guiding the State inspection of quality of goods being
circulated in the market ; Circular No. 14/2011/TT-BYT dated April 01, 2011 of the Ministry of
Health generally guiding the sampling of food for inspection and examination of quality, food
hygiene and safety and other regulations of relevant laws.
If in need of examining the indicators which have not specified the methods of testing in this
Regulation, the Ministry of Health will base on the foreign or domestic current methods which have
been certified with their use value.
2. Method of testing
The technical requirements prescribed in this Regulation are in accordance with the methods in
Annex of this Regulation (These methods are not mandatorily applied and other equivalent methods
may be used instead).
If in need of examining the indicators which have not specified the methods of testing in this
Regulation, the Ministry of Health will base on the foreign or domestic current methods which have
been certified with their use value.
IV. PROVISIONS ON MANAGEMENT
1. Conformity announcement
1.1. The follow-up formulas for infants from 6th month on and young children up to 36 months of age before import,
production and trading locally must be announced with conformity in accordance with the provisions in this Regulation.
1.2. The method, order and procedures for conformity announcement will comply with the Decree
No. 38/2012/ND-CP dated April 25, 2012 of the Government detailing the implementation of a
number of articles of the Law on Food Safety, Cicular No. 19/2012/TT-BYT dated September 11,
2012 of the Ministry of Health guiding the conformity announcement and announcement of
conformance with regulations on food safety and hygiene and other regulations of law.
2. Quality examination
The safety and quality examination for the follow-up formulas for infants from 6th month on and
young children up to 36 months of age must comply with regulations of law.
V. RESPONSIBILITIES OF ORGANIZATIONS AND INDIVIDUALS
1. Organizations and individuals producing, importing and trading the follow-up formulas for infants from 6th month on
and young children up to 36 months of age must announce the conformity and conformance with technical provisions in
this Regulation; register the conformity announcement at the competent management agencies as decentralized by the
Ministry of Health and ensure the quality and safety in accordance with the announced contents.
2. Organizations and individuals are only permitted to produce, import and trade the follow-up
formulas for infants from 6th month on and young children up to 36 months of age after completing
their registration of conformity announcement and ensure the quality and safety and labeling in
accordance with regulations of law.
V. IMPLEMENTATION ORGANIZATION
1. Department of Food Safety will assume the prime responsibility and coordinate with the agencies
concerned to guide the deployment and implementation of this Regulation.
2. Based on the management requirements, the Department of Food Safety will request the Ministry
of Health to amend and supplement this Regulation.
3. In case the standards and regulations of law referred to in this Regulation have changes and
supplementation or are superseded, the regulations of those legal documents will apply.
ANNEX
LIST OF TESTING METHOD OF FOOD SAFETY INDICATORS FOR FOLLOW-UP
FORMULAS FOR INFANTS FROM 6TH MONTH ON AND YOUNG CHILDREN UP TO 36
MONTHS OF AGE
I. Protein
1. TCVN 8099-5:2009 (ISO 8968-5:2001) Milk - Determination of nitrogen - Part 5: Methods
for determination of protein nitrogen.
2. TCVN 8100:2009 (ISO 14891:2002) Milk and dairy products – Determination of nitrogen
content – Common method according to Dumas Combustion Principle
II. Lipid
3. TCVN 6688-1:2007 (ISO 8262-1:2005) Milk and dairy products – Berntrop Determination
of fat content by the Weibull – Berntrop quantity method (Standard method) – Part 1: Food for
infants
4. TCVN 7084:2002 (ISO 1736:2000) Powdered milk and powdered milk products –
Determination of fat content – Quantity method (Standard method)
5. AOAC 996.06 Fat (Total, Saturated, and Unsaturated) in Foods. Hydrolytic Extraction Gas
Chromatographic Method
6. ISO 23065:2009 Milk fat from enriched dairy products – Determination of omega-3 and
omega-6 fatty acid content by gas-liquid chromatography
7. AOAC 992.25 Linoleic Acid in Ready-To-Feed Milk-Based Infants Formula. Gas
Chromatographic Method
III. Carbohydrat
8. AOAC 986.25 Proximate Analysis of Milk-Based Infants Formula
IV. Vitamin
9. EN 12823-1:2000 Foodstuffs – Determination of vitamin A by high performance liquid
chromatography – Part 1: Measurements of all-trans-retinol and 13-cis-retinol
10. EN 12823-2:2000 Foodstuffs – Determination of vitamin A by high performance liquid
chromatography – Part 2: Measurements of Beta-carotene
11. AOAC 974.29 Vitamin A in Mixed Feeds, Premixes, and Human and Pet Foods.
Colorimetric Method
12. AOAC 941.15 Carotene in Fresh Plant Materials and Silages. Spectrophotometric Method
13. AOAC 992.06 Vitamin A (Retinol) in Milk-Based Infants Formula. Liquid
Chromatographic Method
14. AOAC 992.04 Vitamin A (Retinol Isomers) in Milk and Milk-Based Infants Formula.
Liquid Chromatographic Method
15. EN 12821:2009 Foodstuffs – Determination of vitamin D by high performance liquid
chromatography – Measurement of cholecalciferol (D3) or ergocalciferol (D2)
16. AOAC 936.14 Vitamin D in Milk, Vitamin Preparations, and Feed Concentrates
17. AOAC 995.05 Vitamin D in Infants Formulas and Enteral Products. Liquid
Chromatographic Method
18. AOAC 992.26 Vitamin D3 (Cholecalciferol) in Ready-To-Feed Milk-Based Infants
Formula. Liquid Chromatographic Method
19. TCVN 8276:2010 (EN 12822:2000) Food –Determination of vitamin E by high
performance liquid chromatography
20. AOAC 971.30 -Tocopherol and -Tocopheryl Acetate in Foods and Feeds. Colorimetric
Method
21. AOAC 992.03 Vitamin E Activity (All-rac- -Tocopherol) in Milk-Based Infants Formula.
Liquid Chromatographic Method
22. EN 14148:2003 Foodstuffs – Determination of vitamin K1 by HPLC
23. AOAC 992.27 trans-Vitamin K1 (Phylloquynone) in Ready-To-Feed Milk-Based Infants
Formula. Liquid Chromatographic Method
24. TCVN 5164:2008 (EN 14122:2003) Foodstuffs - Determination of vitamin B1 by high
performance liquid chromatography (HPLC).
25. AOAC 942.23 Thiamine (Vitamin B1) in Human and Pet Foods. Fluorometric Method
26. AOAC 986.27 Thiamine (Vitamin B1) in Milk-Based Infants Formula. Fluorometric
Method
27. EN 14152:2003 Foodstuffs – Determination of vitamin B2 by HPLC
28. AOAC 970.65 Riboflavin (Vitamin B2) in Foods and Vitamin Preparations. Fluorometric
Method
29. AOAC 985.34 Niacin and Niacinamide (Nicotinic Acid and Nicotinamide)
in Ready-to-Feed Milk-Based Infants Formula. Microbiological-Turbidimetric Method
30. AOAC 944.13 Niacin and Niacinamide (Nicotinic Acid and Nicotinamide)
in Vitamin Preparations. Microbiological Methods
31. AOAC 961.14 Niacin and Niacinamide in Drugs, Foods, and Feeds. Colorimetric Method
32. EN 14164:2008 Foodstuffs – Determination of vitamin B6 by HPLC
33. EN 14166:2009 Foodstuffs – Determination of vitamin B6 by microbiological assay
34. EN 14663:2005 Foodstuffs – Determination of vitamin B6 (including its glycosylated
forms) by HPLC
35. AOAC 961.15 Vitamin B6 (Pyridoxine, Pyridoxal, Pyridoxamine) in Food Extracts.
Microbiological Method
36. AOAC 985.32 Vitamin B6 (Pyridoxine, Pyridoxal, Pyridoxamine) in Ready-to-Feed
Milk-Based Infants Formula. Microbiological Method
37. AOAC 986.23 Cobalamin (Vitamin B12 Activity) in Milk-Based Infants Formula.
Turbidimetric Method
38. AOAC 952.20 Cobalamin (Vitamin B12 Activity) in Vitamin Preparations.
Microbiological Methods
39. AOAC 992.07 Pantothenic Acid in Milk-Based Infants Formula. Microbiological
Turbidimetric Method
40. AOAC 945.74 Pantothenic Acid in Vitamin Preparations. Microbiological Methods
41. EN 14131:2003 Foodstuffs – Determination of folate by microbiological assay
42. AOAC 992.05 Folic Acid(Pteroylglutamic Acid) in Infants Formula. Microbiological
Methods
43. AOAC 944.12 Folic Acid (Pteroylglutamic Acid) in Vitamin Preparations.
Microbiological Methods
44. EN 14130:2003 Foodstuffs – Determination of vitamin C by HPLC
45. AOAC 985.33 VitaminC(Reduced Ascorbic Acid) in Ready-to-Feed Milk-Based Infants
Formula. 2,6-Dichloroindophenol Titrimetric Method
46. AOAC 967.22 VitaminC(Total) in Vitamin Preparations. Microfluorometric Method
47. AOAC 984.26 VitaminC(Total) in Food. Semiautomated Fluorometric Method
48. EN 15607:2009 Foodstuffs – Determination of d-biotin by HPLC
V. Minerals and trace elements
49. TCVN 6269:2008 (ISO 8070:2007) Milk and dairy products - Determination of calcium,
sodium, potassium and magnesium content- Method of Atomic Absorption Spectrometry
50. TCVN 8126:2009 Foodstuffs - Determination of lead, cadmium, zinc, copper and iron Method atomic absorption spectrometry after microwave decomposition (AOAC 999.10)
51. TCVN 6838:2001 (ISO 12081:1998) Milk - Determination of calcium content – Titration
method
52. TCVN 6271:2007 (ISO 9874:2006) Milk - Determination of total phosphorus content Method of Molecular Absorption Spectrometry
53. TCVN 7080:2002 (ISO 14378:2000) Milk and powdered milk - Determination of iodide
content - Method of using high-performance liquid chromatography
54. AOAC 986.24Phosphorus in Infants Formula and Enteral Products. Spectrophotometric
Method
55. AOAC 976.25 Sodium in Foods for Special Dietary Use. Ion Selective Electrode Method
56. AOAC 985.35 Minerals in Infants Formula, Enteral Products, and Pet Foods. Atomic
Absorption Spectrophotometric Method
57. AOAC 984.27Calcium, Copper, Iron, Magnesium, Manganese, Phosphorus, Potassium,
Sodium, and Zinc in Infants Formula. Inductively Coupled Plasma Emission Spectroscopic
Method
58. AOAC 986.26 Chloride in Milk-Based Infants Formula. Potentiometric Method
59. EN 15111:2007 Foodstuffs – Determination of trace elements – Determination of iodine
by ICP-MS (inductively coupled plasma mass spectrometry)
60. AOAC 992.24 Iodide in Ready-To-Feed Milk-Based Infants Formula. Ion-Selective
Electrode Method
61. AOAC 986.15 Arsenic, Cadmium, Lead, Selenium, and Zinc in Human and Pet Foods.
Multielement Method
62. TCVN 6841:2001 (ISO 11813:1998) Milk and dairy products - Determination of zinc
content – Method of Flame Atomic Absorption Spectrometric
VI. Contaminant
63. TCVN 7602:2007 TCVN 7602:2007 Foodstuffs - Determination of lead content by means
of atomic absorption spectroscopy (AOAC 972.25)
64. TCVN 7933:2009 (ISO/TS 6733:2006) Milk and dairy products - Determination of lead
content - atomic absorption spectrophotometry using graphite furnace
65. TCVN 7788:2007 Canned foods - Determination of tin by means of atomic absorption
spectroscopy
66. TCVN 7730:2007 (ISO/TS 9941:2005) Milk and canned condensed milk - Determination
of tin content - Spectrometric method
67. ISO 15495:2010 Milk, milk products and infant formulae – Guidelines for the quantitative
determination of melamine and cyanuric acid by LC-MS/MS
68. TCVN 6685:2009 (ISO 14501:2007) Milk and powdered milk - Determination of
aflatoxin M1 content - Cleaned by immune affinity chromatography and determined by high
performance liquid chromatography
69. TCVN 7785:2007 (ISO 14674:2005) Milk and powdered milk - Determination of aflatoxin
M1 content - Cleaned by immune affinity chromatography and determined by thin-layer
chromatography
70. TCVN 7700-1:2007 (ISO 11290-1:1996, With Amd 1:2004) Microorganism in food and
animal feed – Method of identification and quantification of Listeria monocytogenes - Part 1:
Identification method
71. TCVN 4829:2005 (ISO 6579:2002, Cor 1:2004) Microorganisms in foodstuffs and animal
feed – Method of Identification of Salmonella on agar plates
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