Circular No. 22/2012/TT-BYT stipulates quality standards, food safety requirements, and conditions for formula nutritional products for children from 6 to 36 months old. It applies to organizations and individuals producing, importing, and trading such products in Vietnam.
适用范围
Organizations and individuals producing, importing, and trading formula nutritional products for supplementary feeding of children from 6 to 36 months old in Vietnam; Relevant state management agencies.
要点
- Organizations and individuals producing, importing, and trading formula nutritional products must declare conformity in accordance with this national technical regulation.
- Formula nutritional products must meet energy, protein, lipid, carbohydrate, vitamin, and mineral content criteria expressed in kcal and kJ units.
- Formula nutritional products must not be processed using ionizing radiation.
- Food additives used in formula nutritional products must comply with the regulations of the Ministry of Health.
- Labeling of formula nutritional products must conform to the provisions set forth in Decree No. 89/2006/NĐ-CP.
🌐 本文件的社会影响
- Positive impact: Ensuring the quality and food safety of children from 6 to 36 months old.
- Negative impact: May increase production and trading costs for organizations and individuals.
❓ 常见问题
What criteria must formula nutritional products meet?
Formula nutritional products must meet energy content criteria (60-85 kcal/100 ml, 250-355 kJ/100 ml), protein content criteria (3-5.5 g/100 kcal, 0.7-1.3 g/100 kJ), lipid content criteria (3-6 g/100 kcal, 0.7-1.4 g/100 kJ), vitamin A content criteria (250-750 IU/100 kcal, 75-225 mg RE/100 kcal), and other mineral content criteria as specified.
Can formula nutritional products be processed using ionizing radiation?
Formula nutritional products and raw materials for their production must not be processed using ionizing radiation.
Who must food additives used in formula nutritional products comply with?
Food additives used in formula nutritional products for supplementary feeding of children from 6 to 36 months old must comply with the regulations of the Ministry of Health.
What regulations must labeling of formula nutritional products follow?
Labeling of formula nutritional products for supplementary feeding of children from 6 to 36 months old must conform to the provisions set forth in Decree No. 89/2006/NĐ-CP.
How can formula nutritional products be declared for conformity?
Formula nutritional products for supplementary feeding of children from 6 to 36 months old must be declared for conformity in accordance with the provisions of this regulation before importation, production, and domestic trade.
全文
CIRCULAR
Issuing National Technical Regulations onfor nutritional products with a formula intended for supplementary feedingfor children aged 6 to 36 months
__________________
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 certain provisions of the Food Safety Law;
Pursuant to the Law on Technical Standards and Regulations dated June 29, 2006 and Decree No. 127/2007/NĐ-CP dated August 1, 2007 of the Government detailing certain provisions of the Law on Technical Standards and 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 national technical regulations for nutritional products with a formula intended for supplementary feeding for children aged 6 to 36 months.
Article 1. 1. National Technical Regulation on Railway Traffic Signals, number QCVN 21:2025/BXD.
QCVN 11-3:2012/BYT - National technical regulation for nutritional products with a formula intended for supplementary feeding for children aged 6 to 36 months;
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 departments and centrally-administered city health departments, and organizations and individuals related thereto shall be responsible for implementing this Circular./.
|
DEPUTY MINISTER
|
AMENDMENT 1:2025 QCVN 07:2023/BXD
FOR NUTRITIONAL PRODUCTS WITH A FORMULA INTENDED FOR SUPPLEMENTARY FEEDING FOR CHILDREN AGED 6 TO 36 MONTHS
National technical regulation
on follow-up formula (for infants from 6ENVIRONMENT month onwards and young children up to 36 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.
This standard specifies quality criteria, food safety requirements, and management requirements for nutritional products with a formula intended for supplementary feeding for children aged 6 to 36 months.
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 producing, importing, and trading nutritional products with a formula intended for supplementary feeding for children aged 6 to 36 months in Vietnam;
2.2. Relevant state management agencies.
3. Explanation of terms and abbreviations
In this standard, the following terms and abbreviations have the meanings set forth below:
3.1. Nutritional product with a formula intended for supplementary feeding for children aged 6 to 36 months (hereinafter referred to as the product): A product in powder form or liquid form, processed from:
- Cow's milk or other animal milk and/or;
- Animal and plant-based ingredients.
The product must meet the nutritional needs for normal development of children aged 6 to 36 months. Liquid products may be used directly or diluted with water before use; powdered products must be mixed with water before use.
- GMP (Good Manufacturing Practice): Good manufacturing practices.
- CODEX: International Food Standards Committee.
- IU (International Unit): International unit.
- RE (Retinol Equivalent): Retinol equivalent.
1. Requirements for maximum tar and nicotine content in smoke from one cigarette
1. Basic Composition
1.1. General Requirements
1.1.1. Raw materials and food additives used in production must ensure quality and food hygiene safety; they must also be suitable for digestion by children aged 6 to 36 months.
1.1.2. The product is processed from:
- Cow's milk or other animal milk and/or;
- Animal and/or plant-based protein preparations (already proven suitable for children aged 6 to 36 months);
- Other necessary raw materials to meet the requirements specified in Clause 1.2 and 1.3, Part II of this standard.
1.1.3. Products with a basic composition of milk produced from raw materials as specified in Point 1.1.2, Part II of this standard must contain at least 3 g of protein (or 0.7 g/100 kJ) from fat-free milk, whole milk, and must account for at least 90% of the total protein in the product; the protein content can be adjusted but must not reduce the vitamin and mineral content in the milk.
1.2. Energy
The product (prepared according to the manufacturer's instructions for direct use) must meet:
|
Unit |
Minimum |
Maximum |
|---|---|---|
|
kcal/100 ml |
60 |
85 |
|
kJ/100 ml |
250 |
355 |
1.3. Nutrient Composition
The product (prepared according to the manufacturer's instructions for direct use) must meet:
1.3.1. Protein Content
|
Unit |
Minimum (1) |
Maximum |
Remarks |
|
g/100 kcal |
3,0 |
5,5 |
(1) Protein in the product has a nutritional quality equivalent to casein; if other proteins with lower nutritional quality than casein are used, the protein content must increase inversely proportional to the nutritional quality. The nutritional quality of the protein must not be less than 85% compared to casein. |
|
g/100 kJ |
0,7 |
1,3 |
|
|
|
|
|
Essential amino acids may be added to improve the nutritional value of the product. In such cases, only L-form essential amino acids in sufficient quantities to improve protein quality may be added.
1.3.2. Lipid Content
|
Unit |
Minimum |
Maximum |
|---|---|---|
|
Total Fat |
||
|
g/100 kcal |
3,0 |
6,0 |
|
g/100 kJ |
0,7 |
1,4 |
|
Linoleic Acid (as glyceride) mg/100 kcal |
||
|
mg/100 kJ |
300 |
- |
|
1.3.3. Carbohydrate Content |
71,7 |
- |
Carbohydrates in the product must:
- Be suitable for digestion by children aged 6 to 36 months,
- Meet the energy requirements specified in Clause 1.2, Part II of this standard (taking into account the energy from protein and fat in the product).
1.3.4. Vitamin Content
IU/100 kcal
|
Unit |
Minimum |
Maximum |
Remarks |
|---|---|---|---|
|
Vitamin A |
|
||
|
mg RE /100 kcal |
250 |
750 |
|
|
IU/100 kJ |
75 |
225 |
|
|
mg RE/100 kJ |
60 |
180 |
|
|
Vitamin D |
18 |
54 |
|
|
Vitamin E (tocopherol compounds) |
|
||
|
mg RE /100 kcal |
40 |
120 |
|
|
mg/100 kJ |
1 |
3 |
|
|
mg RE/100 kJ |
10 |
30 |
|
|
1.3.3. Carbohydrate Content |
0,25 |
0,75 |
|
|
Contains at least 0.7 IU/g linoleic acid or 0.7 IU/g unsaturated fatty acid based on linoleic acid a Vitamin C (ascorbic acid) |
(2) Vitamin B |
||
|
mg RE /100 kcal |
0,7(2) |
- |
|
|
mg RE/100 kJ |
0,15(2) |
- |
|
|
(thiamin) |
|
||
|
mg/100 kJ |
8,0 |
- |
|
|
1.3.3. Carbohydrate Content |
1,9 |
- |
|
|
(riboflavin)1 Nicotinamide |
|
||
|
mg/100 kJ |
40 |
- |
|
|
1.3.3. Carbohydrate Content |
10 |
- |
|
|
(riboflavin)2 Contains at least 15 mg vitamin B |
|
||
|
mg/100 kJ |
60 |
- |
|
|
1.3.3. Carbohydrate Content |
14 |
- |
|
|
/g protein |
|
||
|
mg/100 kJ |
250 |
- |
|
|
1.3.3. Carbohydrate Content |
60 |
- |
|
|
(riboflavin)6 |
(3) Folic Acid6Pantothenic Acid |
||
|
mg/100 kJ |
45(3) |
- |
|
|
1.3.3. Carbohydrate Content |
11(3) |
- |
|
|
Vitamin K |
|
||
|
mg/100 kJ |
4 |
- |
|
|
1.3.3. Carbohydrate Content |
1 |
- |
|
|
Vitamin H (Biotin) |
|
||
|
mg/100 kJ |
300 |
- |
|
|
1.3.3. Carbohydrate Content |
70 |
- |
|
|
(riboflavin)12 |
|
||
|
mg/100 kJ |
0,15 |
- |
|
|
1.3.3. Carbohydrate Content |
0,04 |
- |
|
|
Forms of vitamins added to the product in accordance with the Ministry of Health's regulations. If there are no regulations from the Ministry of Health, the guidelines of CODEX at CAC/GL 10-1979, Rev.1-2008 shall apply.1 |
|
||
|
mg/100 kJ |
4 |
- |
|
|
1.3.3. Carbohydrate Content |
1 |
- |
|
|
Advisory List of Mineral Salts and Vitamin Compounds for Use in Foods for Infants and Young Children |
|
||
|
mg/100 kJ |
1,5 |
- |
|
|
1.3.3. Carbohydrate Content |
0,4 |
- |
|
Recommended list of vitamin and mineral compounds for use in foods for infants and young children 1.3.5. Mineral Content (Potassium).
Chloride
|
Unit |
Minimum |
Maximum |
Remarks |
|---|---|---|---|
|
Sodium |
|
||
|
mg/100 kJ |
20 |
85 |
|
|
1.3.3. Carbohydrate Content |
5 |
21 |
|
|
Calcium |
|
||
|
mg/100 kJ |
80 |
- |
|
|
1.3.3. Carbohydrate Content |
20 |
- |
|
|
Calcium/phosphorus ratio |
|
||
|
mg/100 kJ |
55 |
- |
|
|
1.3.3. Carbohydrate Content |
14 |
- |
|
|
Magnesium |
|
||
|
mg/100 kJ |
90 |
- |
|
|
1.3.3. Carbohydrate Content |
22 |
- |
|
|
Phosphorus |
|
||
|
mg/100 kJ |
60 |
- |
|
|
1.3.3. Carbohydrate Content |
14 |
- |
|
|
Iodine |
|
||
|
|
1,0 |
2,0 |
|
|
Forms of minerals added to the product in accordance with the Ministry of Health's regulations. If there are no regulations from the Ministry of Health, the guidelines of CODEX at CAC/GL 10-1979, Rev.1-2008 shall apply. |
|
||
|
mg/100 kJ |
6,0 |
- |
|
|
1.3.3. Carbohydrate Content |
1,4 |
- |
|
|
Iron |
|
||
|
mg/100 kJ |
1,0 |
2,0 |
|
|
1.3.3. Carbohydrate Content |
0,25 |
0,50 |
|
|
2. Optional Components |
|
||
|
mg/100 kJ |
5,0 |
- |
|
|
1.3.3. Carbohydrate Content |
1,2 |
- |
|
|
Zinc |
|
||
|
mg/100 kJ |
0,5 |
- |
|
|
1.3.3. Carbohydrate Content |
0,12 |
- |
|
optional components 1.3.5. Mineral Content (Potassium).
2. Components optional
In addition to the vitamins and minerals specified in Points 1.3.4 and 1.3.5, Part II of this Standard, the product may be supplemented with other nutritional components to meet the combined diet requirements for children from 6 to 36 months old. The effects of these nutrients must be scientifically proven. Nutrients added to food must have sufficient quantities to meet the needs of children from 6 to 36 months old.
3. Requirements for the product after preparation
After preparation according to the manufacturer's usage instructions, the product shall not exhibit clumping.
4. Ionizing radiation treatment
The product and raw materials for production shall not be treated with ionizing radiation.
5. Food additives
Food additives used in formula nutrition products intended for complementary feeding of children from 6 to 36 months old shall comply with the regulations of the Ministry of Health.
6. Contaminants
6.1. Residues of plant protection products
The product must be processed according to Good Manufacturing Practices (GMP) principles to eliminate residues of plant protection products (used in production, storage, or processing of raw materials/food components). If technical reasons still result in residues, their levels must be minimized to the extent possible in accordance with current regulations.
6.2. Melamine
|
Unit |
Maximum level |
Remarks |
|---|---|---|
|
mg/kg of product |
2,5 |
|
6.3. Heavy metals
In accordance with the National Technical Regulation QCVN 8-2:2011/BYT on limits of heavy metal contamination in food.
6.4. Toxins mycotoxins
In accordance with the National Technical Regulation QCVN 8-1:2011/BYT on limits of mycotoxin contamination in food.
6.5. Other contaminants
Shall not contain hormone residues, antibiotic residues, and other pollutants, especially those with medicinal properties.
7. Microorganisms
In accordance with the National Technical Regulation QCVN 8-3:2012/BYT on limits of microbial contamination in food.
8. Labelling
Labelling of formula nutrition products intended for complementary feeding of children from 6 to 36 months old must comply with the provisions of Government Decree No. 89/2006/NĐ-CP dated August 30, 2006 on product labelling, implementing guidelines, and relevant laws.
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 MARKETONLEGAL TAKING FORM AND TESTING METHODS
1Sampling
Sampling shall be conducted in accordance with the guidelines set forth in Circular 16/2009/TT-BKHCN dated June 2, 2009 of the Ministry of Science and Technology on state inspection of the quality of goods circulating in the market; Circular 14/2011/TT-BYT dated April 1, 2011 of the Ministry of Health on general guidelines for sampling food for inspection, quality control, and food safety, and other relevant legal provisions.
2Testing methods
The technical requirements stipulated in this Standard shall be tested using the methods provided in the Appendix of this Standard (these methods are not mandatory, alternative equivalent testing methods may be used).
In cases where testing criteria not covered by the testing methods specified in this Standard need to be checked, the Ministry of Health will specify the basis according to currently recognized domestic or international methods.
IV. MANAGEMENT PROVISIONS
1. Declaration of compliance with technical regulations
1.1. Formula nutrition products intended for complementary feeding of children from 6 to 36 months old must be declared compliant before importation, production, and sale within the country, in accordance with the provisions of this Standard.
1.2. The procedures, steps, and formalities for declaring compliance are carried out in accordance with Government Decree No. 38/2012/NĐ-CP dated April 25, 2012 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 laws.
2. Quality Inspection
Quality and safety inspections of formula nutrition products intended for complementary feeding of children from 6 to 36 months old must be conducted in accordance with legal provisions.
V. RESPONSIBILITIES OF ORGANIZATIONS AND INDIVIDUALS
1. Organizations and individuals producing, importing, and selling formula nutrition products intended for complementary feeding of children from 6 to 36 months old must declare compliance in accordance with the technical provisions of this Standard, register the declaration of compliance with the competent national authority according to the classification of the Ministry of Health, and ensure quality and safety in accordance with the contents of the declaration.
2. Organizations and individuals are only allowed to produce, import, and sell formula nutrition products intended for complementary feeding of children from 6 to 36 months old after completing the registration of the declaration of compliance, ensuring quality and safety, and labeling in accordance with legal provisions.
V. IMPLEMENTATION
1. The Department of Food Safety shall take the lead and coordinate with relevant functional agencies to guide the implementation and organization of the enforcement of this Standard.
2. Based on management requirements, the Department of Food Safety shall be responsible for proposing the Ministry of Health to amend and supplement this Standard.
3. In case the standards and legal provisions cited in this Standard are changed, supplemented, or replaced, they shall be implemented according to the relevant document.
DEPUTY MINISTER
原始文件(PDF)
关系图
点击文件即可打开。红色边框=改变效力的关系。
译本
本文件提供以下语言版本: