Circular No. 21/2012/TT-BYT issues national technical regulations on special medical purpose formula products for infants up to 12 months old, applicable to organizations and individuals importing, producing, and trading these products. Detailed provisions regarding composition, nutritional content, minerals, vitamins, microorganisms, labeling, and quality inspection are provided.
Đối tượng áp dụng
Organizations and individuals importing, producing, and trading special medical purpose formula products for infants up to 12 months old; relevant state management agencies.
Các điểm cốt lõi
- Special medical purpose formula products for infants up to 12 months old must meet energy, protein, lipid, carbohydrate, vitamin, mineral, and microorganism standards as prescribed.
- The minimum protein content is 1.8 g/100 kcal (from bovine milk protein) or 2.25 g/100 kcal (from soy protein), with a maximum lipid content of 6.0 g/100 kcal.
- The product must not contain gluten and must comply with food safety quality regulations.
- Compliance with these regulations must be announced before importation, production, or trading of the product.
- Quality inspection, labeling, and irradiation treatment of the product must comply with current regulations.
🌐 Tác động xã hội từ văn bản này
- Positive impact: Ensuring food safety for young children, supporting special nutritional development.
- Negative impact: Increased production and import costs due to compliance with technical regulations.
- Organizations and individuals failing to comply may have their business rights restricted.
❓ Câu hỏi thường gặp
What is the minimum protein content of special medical purpose formula products for infants up to 12 months old?
The minimum protein content is 1.8 g/100 kcal (from bovine milk protein) or 2.25 g/100 kcal (from soy protein).
Can special medical purpose formula products for infants up to 12 months old be supplemented with DHA?
Yes, the product can be supplemented with docosahexaenoic acid (DHA), but the level of arachidonic acid (AA) must not be lower than that of DHA.
Can special medical purpose formula products for infants up to 12 months old be supplemented with fluoride?
No, the product cannot be supplemented with fluoride. The maximum fluoride content is 100 mg/100 kcal for prepared products.
Special medical purpose formula products for infants up to 12 months old must be declared as compliant in accordance with the regulations set forth in this standard, and the declaration must be registered with the competent state management agency according to the classification of the Ministry of Health.
The product must be declared as compliant in accordance with the regulations set forth in this standard, and the declaration must be registered with the competent state management agency according to the分级限制不符合要求，我将直接提供翻译，不进行任何解释或额外说明：
How is the quality inspection of special medical purpose formula products for infants up to 12 months old carried out?
Quality and safety inspections of the product are conducted in accordance with legal regulations.
Toàn văn
CIRCULAR
Issuing National Technical Regulations for nutritional formula products with special medical purposes for infants up to 12 months old.
with special medical purposes for infants up to 12 months old
__________________
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 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 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 nutritional formula products with special medical purposes for infants up to 12 months old.
Article 1. 1. National Technical Regulation on Railway Traffic Signals, number QCVN 21:2025/BXD.
QCVN 11-2:2012/BYT - National Technical Regulations for nutritional formula products with special medical purposes for infants 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, centrally governed cities and relevant organizations and individuals are responsible for implementing this Circular./.
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DEPUTY MINISTER (Signed)
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AMENDMENT 1:2025 QCVN 07:2023/BXD
FOR NUTRITIONAL FORMULA
WITH SPECIAL MEDICAL PURPOSES FOR INFANTS UP TO 12 MONTHS OLD
National technical regulation
on formulas for special medical purposes intended for infants (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 standards specify quality criteria, food safety requirements, and management requirements for nutritional formula products with special medical purposes for infants 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 nutritional formula products with special medical purposes for infants up to 12 months old for circulation in the Vietnamese market.
2.2. Relevant state management agencies.
3. Explanation of terms and abbreviations
In this regulation, the following terms are understood as follows:
3.1. Nutritional formula products with special medical purposes for infants up to 12 months old: Products in liquid or powder form made from synthetic or natural components of animal or plant origin, produced to meet specific nutritional needs of infants up to 12 months old who have diseases, disorders, or require medical care.
Nutritional formula products with special medical purposes for infants up to 12 months old may be used as substitutes for breast milk according to Joint Circular No. 10/2006/TTLT/BYT-BTM-BVHTT-UBDSGĐTE dated August 25, 2006 regarding guidance on implementing Decree No. 21/2006/NĐ-CP dated February 27, 2006 of the Government on trading and using nutritional 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 special medical nutritional needs for infants 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. The nutrient content in nutritional formula products with special medical purposes for infants up to 12 months old must not exceed GUL values except when higher nutrient levels are due to changes in raw material composition or technological reasons. Manufacturers shall not increase nutrient levels to reach GUL when the product form has a lower GUL value.
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 Composition
1.1. General Requirements
1.1.1. Raw materials and food additives used in production must ensure quality and food hygiene safety, must not contain gluten, and must be suitable for the digestion of infants up to 12 months old.
1.1.2. The composition of nutritional formula products with special medical purposes for infants up to 12 months old must be based on nutritional and medical principles.
1.1.3. Nutritional safety and the ability of the product to fully meet nutritional needs must be scientifically proven to support development for infants up to 12 months old with special medical purposes while also supporting development for the targeted infant population.
1.1.4. Energy and nutritional component requirements for nutritional formula products with special medical purposes for infants up to 12 months old must comply with the provisions of Clause 1.2 and 1.3, Part II of these Standards. However, the product composition may be adjusted to meet the specific nutritional needs of infants (due to illness, disorders, and medical care).
1.2. Energy
Nutritional formula products with special medical purposes for infants up to 12 months old (prepared according to manufacturer instructions for direct use) must meet:
|
Unit |
Minimum |
Maximum |
|---|---|---|
|
kcal/100 ml |
60 |
70 |
|
kJ/100 ml |
250 |
295 |
1.3. Nutritional Components
Nutritional formula products with special medical purposes for infants up to 12 months old (prepared according to manufacturer 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 processed from bovine milk protein. |
|
2,25 |
3,0 |
– |
For products processed from soy protein. |
|
|
g/100 kJ |
0,45 |
0,7 |
– |
For products processed from bovine milk protein. |
|
0,5 |
0,7 |
– |
For products processed from soy protein. |
|
|
Note: 1) The protein content of nutritional formula products with special medical purposes for infants up to 12 months old (prepared according to manufacturer instructions for direct use) is calculated by N x 6.25 (N is the nitrogen content). Scientific evidence must be provided when applying a different conversion factor. The protein levels specified in these Standards are based on a nitrogen-to-protein conversion factor of 6.25. A value of 6.38 is typically set for a specific conversion factor appropriate for converting nitrogen to protein in other dairy products, and a value of 5.71 is the nitrogen-to-protein conversion factor for soy-based products. 2) For equivalent energy value, the product must contain at least the amount of each essential or conditionally essential amino acid present in breast milk (reference content values are set out in Appendix 1 of this Standard); for calculation purposes, the content of tyrosine and phenylalanine may be combined. If the ratio of methionine and cysteine content is less than 2:1, they may be combined; if the ratio is between 2:1 and 3:1, the suitability of the product must be demonstrated through clinical trials. 3) Individual amino acids may be added to special medical purpose infant formula up to 12 months of age for specific medical purposes only to enhance nutritional value. Essential or conditionally essential amino acids may be added only in necessary quantities to improve protein quality. Only L-form amino acids shall be used. 4) If special medical purpose infant formula up to 12 months of age made from unhydrolyzed milk protein with a protein content of less than 2 g protein/100 kcal or from hydrolyzed protein with a protein content of less than 2.25 g protein/100 kcal is produced, it must undergo clinical evaluation. |
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1.3.2. Amino Acid Content
|
Unit |
Minimum |
Maximum |
GUL |
Remarks |
|---|---|---|---|---|
|
Total Fat 5), 6) |
5) Hydrogenated fats and oils shall not be used to produce special medical purpose infant formula up to 12 months of age. 6) The total content of lauric and myristic acids in fat shall not exceed 20% of total fatty acids. The content of trans fatty acids shall not exceed 3% of total fatty acids. Trans fatty acids are endogenous components of milk fat. Up to 3% of trans fatty acids are acceptable to allow the use of milk fat in special medical purpose infant formula up to 12 months of age. The content of erucic acid shall not exceed 1% of total fatty acids. The content of phospholipids shall 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) Lactose and high molecular weight glucose should be prioritized as carbohydrate sources in products derived from bovine milk protein and hydrolyzed protein. Starch that has been pre-gelatinized and/or gelatinized without natural gluten may be added to the product with a maximum content of 30% of total carbohydrates and not more than 2 g/100 ml. Due to potential risks for infants with genetic intolerance to fructose, sucrose and fructose should only be used 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) Calculated 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) Calculated 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) Calculated 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) calculated as ascorbic acid 14) This level takes into account significant losses during the shelf life of liquid products; powdered products need to specify a lower level. |
|||
|
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 (Advisory List of Mineral Salts and Vitamin Compounds for Use in Foods for Infants and 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 special medical purpose infant formula up to 12 months of age that uses 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 |
|
|
Chromium |
|
|||
|
mg/100 kcal |
1,5 |
– |
10 |
|
|
mg/100 kJ |
0,4 |
– |
2,4 |
|
|
Molybdenum |
|
|||
|
mg/100 kcal |
1,5 |
– |
10 |
|
|
mg/100 kJ |
0,4 |
– |
2,4 |
|
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 (Advisory List of Mineral Salts and Vitamin Compounds for Use in Foods for Infants and 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 optional
In addition to the components specified in Clause 1.3, Part II of this Standard, special medical purpose infant formula up to 12 months of age for children with diseases, disorders, or requiring special medical care may include additional components to provide substances commonly found in breast milk.
When adding these components, scientific evidence of safety and suitability for special medical purposes must be provided. The content of these components in special medical purpose infant formula up to 12 months of age must be sufficient to achieve the claimed effects.
Specific provisions for certain optional components:
|
Unit |
Minimum |
Maximum |
GUL |
Remarks |
|
|---|---|---|---|---|---|
|
Taurine |
For products prepared for direct use according to the manufacturer's instructions |
||||
|
mg/100 kcal |
– |
12 |
– |
||
|
mg/100 kJ |
– |
3 |
– |
||
|
Docosahexaenoic Acid 16) |
For products prepared for direct use according to the manufacturer's instructions 16) If DHA (22:6 n-3) is added to special medical purpose infant formula up to 12 months of age, the content of arachidonic acid (20:4 n-6) shall not be lower than the content of DHA. The content of eicosapentaenoic acid (20:5 n-3) in long-chain polyunsaturated fatty acid sources shall not exceed the content of DHA. |
||||
|
% fatty acid |
– |
– |
0,5 |
||
|
|
|
|
|
||
- Only L(+) lactic acid bacteria strains may be used.
3. Fluoride
- Fluoride shall not be added to special medical purpose infant formula up to 12 months of age.
- The fluoride content is regulated as follows:
|
Unit |
Maximum |
Remarks |
|---|---|---|
|
mg/100 kcal |
100 |
For products prepared for direct use according to the manufacturer's instructions |
|
mg/100 kJ |
24 |
4. State of the product after preparation
When prepared according to the usage instructions on the label, the product must be suitable for special medical purposes for infants up to 12 months of age, without clumping.
5. Ionizing Radiation Treatment
Products and initial raw materials shall not be processed using ionizing radiation.
6. Food additives
Food additives used in special medical purpose infant formula products for children up to 12 months old must comply with the regulations of the Ministry of Health.
7. Contaminants dirty
7.1. Residues of plant protection products
The product must be processed according to Good Manufacturing Practices (GMP) principles so that residues of plant protection products (used in production, storage, or processing of raw materials/components) are eliminated. In cases where technical reasons prevent complete elimination, their levels must be reduced to the maximum extent possible in accordance with current regulations.
7.2. Melamine
|
Unit |
Maximum |
Remarks |
|---|---|---|
|
mg/kg |
1 |
For powdered special medical purpose infant formula products for children up to 12 months old |
7.3. Heavy metals
In accordance with the National Technical Regulation QCVN 8-2:2011/BYT on limits of heavy metal contamination in food.
7.4. Mycotoxins fungal
In accordance with the National Technical Regulation QCVN 8-1:2011/BYT on limits of mycotoxin contamination in food.
7.5. Other contaminants
Shall not contain unwanted substances/toxicants (such as biologically active substances) at levels that may harm infants.
Products subject to this Standard must comply with the maximum allowable limits set forth by the Ministry of Health; if the Ministry of Health has not issued specific regulations, then the Codex Alimentarius Commission's provisions shall apply.
8. Microorganisms
In accordance with the National Technical Regulation QCVN 8-3:2012/BYT on limits of mycotoxin contamination in food.
9. Labelling
Labelling of special medical purpose infant formula products for children up to 12 months old must comply with the provisions of Government Decree No. 89/2006/NĐ-CP dated August 30, 2006 on product labelling, Government Decree No. 21/2006/NĐ-CP dated February 27, 2006 on the operation and use of nutritional products for infants, and other guiding documents 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 MARKETDAMAGESAMPLING AND TESTING METHODS
1Sampling
Sampling shall be conducted in accordance with the guidelines set out in Circular No. 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 No. 14/2011/TT-BYT dated April 1, 2011 of the Ministry of Health on general guidelines for sampling food for inspection and testing purposes, and other relevant legal provisions.
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 methods may be used).
In cases where testing criteria not covered by this Standard require testing, the Ministry of Health will specify the basis for testing according to currently recognized domestic or international methods.
IV. REGULATIONS ON MANAGEMENTREASON
1. Declaration of compliance with technical regulations
1.1. Special medical purpose infant formula products for children up to 12 months old must be declared compliant with the provisions of this Standard before importation, production, and domestic sale.
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 special medical purpose infant formula products for children up to 12 months old shall be conducted in accordance with relevant laws.
V. RESPONSIBILITIES OF ORGANIZATIONS AND INDIVIDUALS
1. Organizations and individuals producing, importing, and selling special medical purpose infant formula products for children up to 12 months old must declare compliance with the technical requirements of 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 may only produce, import, and sell special medical purpose infant formula products for children up to 12 months old after completing the registration of the declaration of compliance, ensuring quality and safety, and complying with labelling requirements as stipulated by law.
VI. IMPLEMENTATION
1. The Food Safety Administration shall take the lead and coordinate with relevant agencies to guide the implementation and organization of this Standard.
2. Based on management requirements, the Food Safety Administration shall have the responsibility to propose amendments and supplements to this Standard to the Ministry of Health.
3. Where standards and legal provisions cited in this Standard are amended, supplemented, or replaced, they shall be applied in accordance with the relevant legal document.
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