Circular No. 20/2012/TT-BYT issues National Technical Regulations on infant formula products up to 12 months old, specifying quality standards, food safety requirements, and management requirements. This document applies to organizations and individuals importing, producing, and trading these products in the Vietnamese market.
适用范围
Organizations and individuals importing, producing, and trading infant formula products up to 12 months old; relevant state management agencies.
要点
- Infant formula products up to 12 months old must meet specific standards for energy, protein, fat, carbohydrates, vitamins, minerals, and trace elements as prescribed.
- The DHA content must not be lower than the arachidonic acid content; the eicosapentaenoic acid content must not exceed the DHA content if added to the product.
- Infant formula products up to 12 months old must not contain fluoride, melamine, and heavy metals exceeding the specified threshold.
- Product labeling must comply with legal regulations.
- Prior to importation, production, and trading, infant formula products up to 12 months old must be declared as compliant with this Standard.
🌐 本文件的社会影响
- Positive impact: Ensuring food quality and safety for young children, reducing the risk of nutritional deficiencies.
- Negative impact: Increased production costs due to strict adherence to technical regulations.
❓ 常见问题
What criteria must infant formula products up to 12 months old meet?
These products must meet specific standards for energy, protein, fat, carbohydrates, vitamins, minerals, and trace elements as prescribed in this Standard.
What requirements are there for adding DHA to infant formula products?
If DHA is added, the arachidonic acid content must not be lower than the DHA content; the eicosapentaenoic acid content must not exceed the DHA content.
What additional components can be added to infant formula products up to 12 months old?
In addition to the prescribed components, the product may include substances commonly found in breast milk, but scientific evidence of safety and suitability for nutritional needs must be provided.
What substances must not be present in infant formula products up to 12 months old?
Fluoride, melamine, and heavy metals exceeding the specified threshold must not be present.
What must be done before importing infant formula products for children?
Before importing, the product must be declared as compliant with this Standard and the declaration of compliance registered with the competent state management agency.
全文
CIRCULAR
Issuing National Technical Regulations for infant formula products for children up to 12 months oldfor infants up to 12 months of age
____________________
THE MINISTER OF HEALTH
Pursuant to the Food Safety Law dated June 17, 2010 and Decree No. 38/2012/NĐ-CP dated April 25, 2012 of the Government detailing the implementation of certain provisions of the Food Safety Law;
Pursuant to the Law on Standards and Technical Regulations dated June 29, 2006 and Decree No. 127/2007/NĐ-CP dated August 1, 2007 of the Government detailing the implementation of certain provisions of the Law on Standards and Technical Regulations;
Pursuant to Decree No. 63/2012/NĐ-CP dated August 31, 2012 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;
At the proposal of the Director of the Food Safety Administration;
The Minister of Health issues this Circular on issuing national technical regulations for infant formula products for children up to 12 months old.
Article 1. 1. National Technical Regulation on Railway Traffic Signals, number QCVN 21:2025/BXD.
QCVN 11-1:2012/BYT - National Technical Regulations for infant formula products for children up to 12 months old;
Article 2. This Circular takes effect from June 1, 2013.
Article 3. The Director of the Food Safety Administration, heads of units under the Ministry of Health, units directly under the Ministry of Health; directors of provincial health services and centrally-administered city health services and relevant organizations and individuals are responsible for implementing this Circular./.
|
DEPUTY MINISTER
|
AMENDMENT 1:2025 QCVN 07:2023/BXD
FOR INFANT FORMULA
FOR CHILDREN FOR CHILDREN
National technical regulation
on infant formula (for children up to 12 months of age)
This technical regulation sets out technical requirements, testing methods, sampling procedures; management requirements; responsibilities of organizations and individuals producing, trading, and importing cigarettes.
Thông tư này quy định chi tiết khoản 4 Điều 38 Luật Thủy sản số 18/2017/QH14 đã được sửa đổi, bổ sung tại điểm c khoản 21 Điều 14 Luật số 146/2025/QH15.
These regulations specify quality standards, food safety requirements, and management requirements for infant formula products for children up to 12 months old.
Thông tư này áp dụng đối với tổ chức, cá nhân có liên quan đến hoạt động kinh doanh đối tượng thủy sản nuôi chủ lực trên lãnh thổ Việt Nam.
This Regulation applies to:
2.1. Organizations and individuals importing, producing, and trading infant formula products for children up to 12 months old for circulation in the Vietnamese market.
2.2. Relevant state management agencies.
3. Definitions and abbreviations
In these regulations, the following terms and abbreviations have the meanings set forth below:
3.1. Infant formula product for children up to 12 months old: A liquid or powder product that meets the nutritional needs of children up to 12 months old, processed from:
- Cow's milk or other animal milk or a mixture thereof,
- Other suitable components.
Infant formula products for children up to 12 months old may be used as a substitute for breast milk according to Circular Joint No. 10/2006/TTLT/BYT-BTM-BVHTT-UBDSGĐTE dated August 25, 2006 guiding the implementation of Decree No. 21/2006/NĐ-CP dated February 27, 2006 of the Government on trading and using nutrition products for young children.
3.2. GUL (Guidance Upper Levels): Maximum guidance level. This level applies to nutrients for which there is insufficient information to assess risk based on scientific evidence. These values are established based on meeting nutritional requirements for children up to 12 months old and data on safe usage, which can be adjusted based on relevant scientific and technological progress. The purpose of GUL is to provide guidance to manufacturers and should not be understood as a target value. Nutrient content in infant formula products for children up to 12 months old must not exceed GUL values except when higher nutrient levels result from changes in raw material composition or for technological reasons. Manufacturers must not increase nutrient levels to reach GUL values when the product form has lower than GUL values.
3.3. GMP (Good Manufacturing Practice): Good manufacturing practices.
3.4. DHA: Docosahexaenoic acid.
3.5. IU (International Unit): International unit.
3.6. PUFA (Poly-unsaturated Fatty Acids): Polyunsaturated fatty acids.
1. Requirements for maximum tar and nicotine content in smoke from one cigarette
1. Basic Components
1.1. General Requirements
1.1.1. Raw materials and food additives used in production must ensure food hygiene and safety, must not contain gluten, and must be suitable for digestion by children up to 12 months old.
1.1.2. Nutritional safety and the ability to fully meet nutritional requirements of the product must be scientifically proven to support the development of children up to 12 months old.
1.2. Energy
Infant formula products for children up to 12 months old (prepared according to the manufacturer's instructions for direct use) must meet:
|
Unit |
Minimum |
Maximum |
|---|---|---|
|
kcal/100 ml |
60 |
70 |
|
kJ/100 ml |
250 |
295 |
1.3. Nutrient Composition
Infant formula products for children up to 12 months old (prepared according to the manufacturer's instructions for direct use) must meet:
1.3.1. Protein Content1), 2), 3)
|
Unit |
Minimum 4) |
Maximum |
GUL |
Remarks |
|
g/100 kcal |
1,8 |
3,0 |
– |
For products made from cow's milk protein. |
|
2,25 |
3,0 |
– |
For products made from soy protein. |
|
|
g/100 kJ |
0,45 |
0,7 |
– |
For products made from cow's milk protein. |
|
0,5 |
0,7 |
– |
For products made from soy protein. |
|
|
Note: 1) The protein content of infant formula products for children up to 12 months old (prepared according to the manufacturer's instructions for direct use) is calculated by multiplying N by 6.25 (N is the nitrogen content). Scientific evidence must be provided when applying a different conversion factor. The protein levels specified in these regulations are based on a nitrogen-to-protein conversion factor of 6.25. The value 6.38 is typically set according to a specific conversion factor suitable for converting nitrogen to protein in products from sources other than milk, and the value 5.71 is the nitrogen-to-protein conversion factor in soy-based products. 2) For equivalent energy values, the product must contain at least the amount of each essential amino acid or conditionally essential amino acid present in breast milk (reference values are listed in Appendix 1 of these regulations); in calculations, the tyrosine and phenylalanine contents may be combined. If the methionine and cysteine ratio is less than 2:1, they may be combined; if the ratio is between 2:1 and 3:1, clinical trials must prove the suitability of the product. 3) Individual amino acids may only be added to infant formula products for children up to 12 months old to enhance nutritional value. Essential or conditionally essential amino acids may only be added in necessary quantities to improve protein quality. Only L-form amino acids may be used. 4) If infant formula products for children up to 12 months old made from unhydrolyzed milk protein have a protein content of less than 2 g/100 kcal or made from hydrolyzed protein with a protein content of less than 2.25 g/100 kcal, they must undergo clinical evaluation. |
||||
1.3.2. Fat Content
|
Unit |
Minimum |
Maximum |
GUL |
Remarks |
|---|---|---|---|---|
|
Total fat 5), 6) |
5) Hydrogenated oils and fats must not be used to produce infant formula products for children up to 12 months old. 6)Lauric acid and myristic acid are components of fat but their total amount must not exceed 20% of the total fatty acids. The level of trans fatty acids must not exceed 3% of the total fatty acids. Trans fatty acids are endogenous components of milk fat. Up to 3% trans fatty acids are accepted to allow the use of milk fat in formula products for children up to 12 months old. The level of erucic acid must not exceed 1% of the total fatty acids. The level of phospholipids must not exceed 300 mg/100 kcal (72 mg/100 kJ). |
|||
|
g/100 kcal |
4,4 |
6,0 |
– |
|
|
g/100 kJ |
1,05 |
1,4 |
– |
|
|
Linoleic acid |
||||
|
mg/100 kcal |
300 |
– |
1.400 |
|
|
mg/100 kJ |
70 |
– |
330 |
|
|
Acid a-linolenic |
||||
|
mg/100 kcal |
50 |
– |
– |
|
|
mg/100 kJ |
12 |
– |
– |
|
|
The ratio between linoleic acid /acid a-linolenic |
|
|||
|
|
5:1 |
15:1 |
– |
|
1.3.3. Carbohydrate Content
|
Unit |
Minimum |
Maximum |
GUL |
Remarks |
|---|---|---|---|---|
|
Total carbohydrates 7) |
7) Priority should be given to lactose and high molecular weight glucose as carbohydrate sources in products derived from bovine milk proteins and hydrolyzed proteins. Only pre-gelatinized and/or gluten-free starch may be added to the product with a maximum carbohydrate content of 30% of total carbohydrates and not more than 2 g/100 ml. Due to potential risks for infants with genetic inability to tolerate fructose, sucrose and fructose can only be used in the product when necessary. |
|||
|
g/100 kcal |
9,0 |
14,0 |
– |
|
|
g/100 kJ |
2,2 |
3,3 |
– |
|
1.3.4. Vitamin Content
|
Unit |
Minimum |
Maximum |
GUL |
Remarks |
||
|---|---|---|---|---|---|---|
|
Vitamin A |
8) Measured in mg RE. 1 mg RE = 3,33 IU vitamin A = 1 mg all-trans retinol. The retinol content must be created from precursors, excluding carotenoids from the vitamin A content in the product. |
|||||
|
mg8)/100 kcal |
60 |
180 |
– |
|||
|
mg8)/100 kJ |
14 |
43 |
– |
|||
|
Vitamin D3 |
9) Measured in calciferol. 1 mg calciferol = 40 IU vitamin D |
|||||
|
mg9) /100 kcal |
1 |
2,5 |
– |
|||
|
mg9) /100 kJ |
0,25 |
0,6 |
– |
|||
|
Vitamin E |
10) Measured in alpha-tocopherol equivalents (alpha-TE). 1 mg alpha-TE = 1 mg d-alpha-tocopherol 11) The minimum vitamin E content must reach 0.5 mg alpha-TE/g PUFA, using the following equivalent factors to accept the minimum vitamin E content for the number of double bonds of fatty acids in the product: 0.5 mg alpha-TE/g linoleic acid (18:2 n-6); 0.75 alpha-TE/g alpha-linolenic acid (18:3 n-3); 1.0 mg alpha-TE/g arachidonic acid (20:4 n-6); 1.25 mg alpha-TE/g eicosapentaenoic acid (20:5 n-3); 1.5 mg alpha-TE/g docosahexaenoic acid (22:6 n-3) |
|||||
|
mg10)/100 kcal |
0,511) |
– |
5 |
|||
|
mg10)/100 kJ |
0,1211) |
– |
1,2 |
|||
|
Vitamin K |
|
|||||
|
mg/100 kcal |
4 |
– |
27 |
|||
|
mg/100 kJ |
1 |
– |
6,5 |
|||
|
Vitamin B1 (Thiamin) |
|
|||||
|
mg/100 kcal |
60 |
– |
300 |
|||
|
mg/100 kJ |
14 |
– |
72 |
|||
|
Vitamin B2 (Riboflavin) |
|
|||||
|
mg/100 kcal |
80 |
– |
500 |
|||
|
mg/100 kJ |
19 |
– |
119 |
|||
|
Niacin12) |
12) For niacin precursors
|
|||||
|
mg/100 kcal |
300 |
– |
1.500 |
|||
|
mg/100 kJ |
70 |
– |
360 |
|||
|
Vitamin B6 |
|
|||||
|
mg/100 kcal |
35 |
– |
175 |
|||
|
mg/100 kJ |
8,5 |
– |
45 |
|||
|
Vitamin B12 |
|
|||||
|
mg/100 kcal |
0,1 |
– |
1,5 |
|||
|
mg/100 kJ |
0,025 |
– |
0,36 |
|||
|
Pantothenic acid |
|
|||||
|
mg/100 kcal |
400 |
– |
2.000 |
|||
|
mg/100 kJ |
96 |
– |
478 |
|||
|
Folic acid |
|
|||||
|
mg/100 kcal |
10 |
– |
50 |
|||
|
mg/100 kJ |
2,5 |
– |
12 |
|||
|
Vitamin C |
13) Measured as ascorbic acid 14) This level takes into account significant losses during the shelf life of liquid products; powdered products need to specify lower levels. |
|||||
|
mg13)/100 kcal |
10 |
– |
70 14) |
|||
|
mg13)/100 kJ |
2,5 |
– |
17 14) |
|||
|
Vitamin H (Biotin) |
|
|||||
|
mg/100 kcal |
1,5 |
– |
10 |
|||
|
mg/100 kJ |
0,4 |
– |
2,4 |
|||
Forms of vitamins added to the product according to the regulations of the Ministry of Health. In cases where there are no regulations from the Ministry of Health, follow the guidelines of CODEX at CAC/GL 10-1979, Rev.1-2008 Advisory List of Mineral Salts and Vitamin Compounds for Use in Foods for Infants and Children (Recommended list of mineral salts and vitamin compounds for use in foods for infants and young children).
1.3.5. Mineral and Trace Element Content
|
Unit |
Minimum |
Maximum |
GUL |
Remarks |
|---|---|---|---|---|
|
Iron |
|
|||
|
mg/100 kcal |
0,45 |
– |
– |
|
|
mg/100 kJ |
0,1 |
– |
– |
|
|
Calcium |
|
|||
|
mg/100 kcal |
50 |
– |
140 |
|
|
mg/100 kJ |
12 |
– |
35 |
|
|
Phosphorus |
15) This GUL value needs to consider higher requirements for nutritional products for children up to 12 months old that use soy. |
|||
|
mg/100 kcal |
25 |
– |
100(15) |
|
|
mg/100 kJ |
6 |
– |
24(15) |
|
|
Calcium/phosphorus ratio |
|
|||
|
|
1 :1 |
2 :1 |
– |
|
|
Magnesium |
|
|||
|
mg/100 kcal |
5 |
– |
15 |
|
|
mg/100 kJ |
1,2 |
– |
3,6 |
|
|
Sodium |
|
|||
|
mg/100 kcal |
20 |
60 |
– |
|
|
mg/100 kJ |
5 |
14 |
– |
|
|
Chloride |
|
|||
|
mg/100 kcal |
50 |
160 |
– |
|
|
mg/100 kJ |
12 |
38 |
– |
|
|
Potassium |
|
|||
|
mg/100 kcal |
60 |
180 |
– |
|
|
mg/100 kJ |
14 |
43 |
– |
|
|
Manganese |
|
|||
|
mg/100 kcal |
1 |
– |
100 |
|
|
mg/100 kJ |
0,25 |
– |
24 |
|
|
Iodine |
|
|||
|
mg/100 kcal |
10 |
– |
60 |
|
|
mg/100 kJ |
2,5 |
– |
14 |
|
|
Selenium |
|
|||
|
mg/100 kcal |
1 |
– |
9 |
|
|
mg/100 kJ |
0,24 |
– |
2,2 |
|
|
Copper |
|
|||
|
mg/100 kcal |
35 |
– |
120 |
|
|
mg/100 kJ |
8,5 |
– |
29 |
|
|
Zinc |
|
|||
|
mg/100 kcal |
0,5 |
– |
1,5 |
|
|
mg/100 kJ |
0,12 |
– |
0,36 |
|
Forms of minerals and trace elements added to the product according to the regulations of the Ministry of Health. In cases where there are no regulations from the Ministry of Health, follow the guidelines of CODEX at CAC/GL 10-1979, Rev.1-2008 Advisory List of Mineral Salts and Vitamin Compounds for Use in Foods for Infants and Children (Recommended list of mineral salts and vitamin compounds for use in foods for infants and young children).
1.3.6. Other Component Content
|
Unit |
Minimum |
Maximum |
GUL |
Remarks |
|---|---|---|---|---|
|
Choline |
|
|||
|
mg/100 kcal |
7 |
– |
50 |
|
|
mg/100 kJ |
1,7 |
– |
12 |
|
|
Myo-inositol |
|
|||
|
mg/100 kcal |
4 |
– |
40 |
|
|
mg/100 kJ |
1 |
– |
9,5 |
|
|
L-carnitine |
|
|||
|
mg/100 kcal |
1,2 |
– |
– |
|
|
mg/100 kJ |
0,3 |
– |
– |
|
2. Optional Components In addition to the components specified in Clause 1.3, Part II of this Standard, to provide nutrients commonly found in breast milk, infant formula products up to 12 months old may include additional components.
When adding these components, scientific evidence of safety and suitability for the nutritional needs of children up to 12 months old must be provided. The content of these components in infant formula products up to 12 months old (taking into account the existing content in breast milk) must be sufficient to achieve the claimed effects.
Specific provisions for certain optional components:
Taurine
|
Unit |
Minimum |
Maximum |
GUL |
Remarks |
|---|---|---|---|---|
|
For products ready to use according to the manufacturer's instructions |
Docosahexaenoic acid |
|||
|
mg/100 kcal |
– |
12 |
– |
|
|
mg/100 kJ |
– |
3 |
– |
|
|
If DHA (22:6 n-3) is added to infant formula products up to 12 months old, the content of arachidonic acid (20:4 n-6) must not be less than the content of DHA. The content of eicosapentaenoic acid (20:5 n-3) in LC-PUFA sources must not exceed the content of DHA. 16) |
Docosahexaenoic acid 16)% fatty acids |
|||
|
Only the L(+) lactic acid bacteria strain may be used. |
– |
– |
0,5 |
|
|
|
|
|
|
|
- 3. Fluoride
- Fluoride shall not be added to infant formula products up to 12 months old.
- The fluoride content is regulated as follows:
Requirements for prepared products
|
Unit |
Maximum |
Remarks |
|---|---|---|
|
mg/100 kcal |
100 |
Docosahexaenoic acid
|
|
mg/100 kJ |
24 |
4. When prepared according to the manufacturer's instructions for immediate use, the product must be suitable for children up to 12 months old, without clumping.
Ionizing radiation treatment
5. Products and initial raw materials must not be treated with ionizing radiation.
Food additives
6. Food additives used in infant formula products up to 12 months old must comply with the regulations of the Ministry of Health.
7. Contaminants
7.1. Residues of plant protection products The product must be processed according to Good Manufacturing Practices (GMP) to eliminate residues of plant protection products (used in production, storage, or processing of raw materials/components). In cases where technical reasons still result in residues, their levels must be minimized to meet current regulations.
8.2. Melamine
mg/kg
For powdered infant formula products up to 12 months old
|
Unit |
Maximum |
Remarks |
|---|---|---|
|
8.3. Heavy Metals |
1 |
According to the National Technical Regulation QCVN 8-2:2011/BYT on limits of heavy metal contamination in food |
8.4. Toxins
mycotoxins
According to the National Technical Regulation QCVN 8-1:2011/BYT on limits of mycotoxin contamination in food 8.5. Other Contaminants
Shall not contain contaminants/unwanted substances (such as biologically active substances) at levels that could harm children.
Products subject to this Standard must comply with the maximum allowable limits set by the Ministry of Health. In cases where specific regulations have not been established by the Ministry of Health, the Codex regulations shall apply.
9. Microorganisms
According to the National Technical Regulation QCVN 8-3:2012/BYT on limits of mycotoxin contamination in food.
9. Microorganisms
In accordance with the National Technical Regulation QCVN 8-3:2012/BYT on limits of mycotoxin contamination in food.
10. Labelling
The labelling of infant formula products up to 12 months old must comply with the provisions set out in Decree No. 89/2006/NĐ-CP dated August 30, 2006 of the Government on product labels, Decree No. 21/2006/NĐ-CP dated February 27, 2006 of the Government on the business and use of nutritional products for infants, and other guiding documents and relevant legal regulations.
III. "5. The pre-tax weighted average cost of capital i (%) is determined according to the formula below:HAMENDING AND SUPPLEMENTING CERTAIN PROVISIONS OF CIRCULAR NO. 16/2025/TT-BCT DATED FEBRUARY 1, 2025 OF THE MINISTER OF INDUSTRY AND TRADE ON THE OPERATION OF THE COMPETITIVE WHOLESALE ELECTRICITY MARKETGRACEIV. SAMPLING AND TESTING METHODS
1Sampling
Sampling shall be conducted in accordance with the guidelines provided in Circular No. 16/2009/TT-BKHCN dated June 2, 2009 of the Ministry of Science and Technology on state quality inspection guidance for goods circulating in the market; Circular No. 14/2011/TT-BYT dated April 1, 2011 of the Ministry of Health on general sampling guidance for food inspection, quality control, and food safety, and other relevant legal regulations.
2Testing Methods law; a) Technologies and methods researched for the first time in Vietnam;
Technical requirements stipulated in this Standard shall be tested according to the methods specified in Appendix 2 of this Standard (these methods are not mandatory, alternative equivalent testing methods may be used).
In cases where testing methods for criteria not specified in this Standard are required, the Ministry of Health will specify the basis according to current domestic or international methods that have been confirmed for their utility value.
IV. MANAGEMENT PROVISIONS
1. Declaration of compliance with technical regulations
1.1. Infant formula products up to 12 months old must be declared compliant with this Standard before importation, production, and domestic trade.
1.2. The procedures and formalities for declaring compliance are carried out in accordance with Decree No. 38/2012/NĐ-CP dated April 25, 2012 of the Government detailing certain provisions of the Food Safety Law, Circular No. 19/2012/TT-BYT dated September 11, 2012 of the Ministry of Health guiding the declaration of compliance and conformity with food safety regulations, and other relevant legal regulations.
2. Quality Inspection
Quality and safety inspections for infant formula products up to 12 months old shall be conducted in accordance with legal regulations.
V. RESPONSIBILITIES OF ORGANIZATIONS AND INDIVIDUALS
1. Organizations and individuals producing, importing, and trading infant formula products up to 12 months old must declare compliance in accordance with technical regulations in this Standard, register the declaration of compliance with competent authorities at the level assigned by the Ministry of Health, and ensure quality and safety in accordance with the declared content.
2. Organizations and individuals are only permitted to produce, import, and trade infant formula products up to 12 months old after completing the registration of the declaration of compliance and ensuring quality, safety, and labelling in accordance with legal regulations.
VI. IMPLEMENTATION
1. The National Food Safety Authority shall lead and coordinate with relevant agencies to guide the implementation and organization of this Standard.
2. Based on management requirements, the National Food Safety Authority has the responsibility to propose amendments and supplements to this Standard to the Ministry of Health.
3. Where standards and legal regulations cited in this Standard are amended, supplemented, or replaced, they shall be applied according to the relevant legal documents.
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