After 13 years of implementation, several provisions in the current National Technical Regulations (QCVN) have become outdated and no longer align with practical realities and updated international standards, particularly those from the Codex Alimentarius. Revising these regulations is essential to enhance consumer protection and facilitate international trade.
The draft revision includes the following National Technical Regulations (QCVN):
- QCVN 11-1:2012/BYT – National technical regulation on infant formula (for children up to 12 months of age)
- QCVN 11-2:2012/BYT – National technical regulation on formulas for special medical purposes intended for infants (up to 12 months of age)
- QCVN 11-3:2012/BYT – National technical regulation on follow-up formula (for infant from 6th month on and young children up to 36 months of age)
Key Revisions
- Scope of Application
QCVN 11-3, previously covering follow-up formula for children aged 6 to 36 months, is now divided into two distinct groups: Products for children aged 6–12 months and Products for children aged 1–3 years. This division reflects a more tailored approach to the nutritional needs of each developmental stage.
- Updated Nutritional and Micronutrient Requirements Based on New Scientific Data
For QCVN 11-1 and QCVN 11-2, key changes include:
|
Nutritional Component |
Per 100 kcal/100kJ |
QCVN 11-1, QCVN 11-2 |
Proposed Revision |
|
Energy (/100ml) |
kJ |
250 – 295 |
251 - 293 |
|
Protein cow’s milk (g) |
kJ |
0.45 – 0.7 |
0.43 – 0.72 |
|
Protein soy protein (g) |
kJ |
0.5 |
0.54 |
|
Fat (g) |
kJ |
1.05 – 1.4 |
1.1 – 1.4 |
|
Linoleic acid (mg) |
kJ |
70 – 330 |
72-335 |
|
Vitamin D (ug) |
kJ |
0.25 - 0.6 |
0.24 - 0.6 |
|
Vitamin K (µg) |
kJ |
1 - 6.5 |
0.96 - 6 |
|
Riboflavin (µg) |
kJ |
19 - 119 |
19 - 120 |
|
Niacin (µg) |
kJ |
70 - 360 |
72 - 359 |
|
Vitamin B6 (µg) |
kJ |
8.5 - 45 |
8 - 42 |
|
Vitamin B12 (µg) |
kJ |
0.025 - 0.36 |
0.02 - 0.36 |
|
Folic acid (µg) |
kJ |
2.5 - 12 |
2.4 - 12 |
|
Vitamin C (µg) |
kJ |
2.5 - 17 |
2.4 - 17 |
|
Biotin (µg) |
kJ |
0.4 - 2.4 |
0.36 - 2.4 |
|
Sodium (mg) |
kJ |
5 - 14 |
4.8 - 14 |
|
Manganese (µg) |
kJ |
0.25 - 24 |
0.24 - 24 |
|
Iodine (µg) |
kJ |
2.5 - 14 |
2.4 - 14 |
|
Copper (µg) |
kJ |
8.5 - 29 |
8 - 29 |
|
Taurine (mg) |
kJ |
N.S - 3 |
N.S - 2.9 |
|
Myo-inositol (µg) |
kJ |
1 - 9.5 |
1 - 10 |
For QCVN 11-3, due to the reclassification into two age groups, several changes are proposed:
|
QCVN 11-3 |
Draft (6–12 months) |
Draft (1–3 years) |
|
|
Number of micronutrients |
22 |
25 |
8 |
|
Vitamin A (µg RE/100 kcal) |
75 – 225 |
75 – 180 |
60 - 180 |
|
Vitamin D (µg /100 kcal) |
1 – 3 |
1 – 3 |
1.5 – 4.5 |
|
Vitamin C (mg /100 kcal) |
≥ 8 |
≥ 10 |
≥ 10 |
|
Vitamin B1 (µg /100 kcal) |
≥ 40 |
≥ 60 |
- |
|
Vitamin D (ug) |
kJ |
0.25 - 0.6 |
0.24 - 0.6 |
|
Sodium (mg/100 kcal) |
20 - 85 |
20 - 60 |
- |
|
Potassium (mg/100 kcal) |
≥ 80 |
60 – 180 |
- |
|
Chloride (mg/100 kcal) |
≥ 55 |
50 - 160 |
|
|
Calcium (mg/100 kcal) |
≥ 90 |
≥ 50 |
≥ 90 |
|
Phosphorus (mg/100 kcal) |
≥ 60 |
≥ 25 |
- |
|
Calcium/Phosphorus ratio |
1 – 2 |
1:1 – 2:1 |
- |
|
Magnesium (mg/100 kcal) |
≥ 6 |
≥ 5 |
- |
|
Iron (mg/100 kcal) |
1 – 2 |
1 – 2 |
|
- Administrative Updates
- Labeling: Updated to comply with Decree 43/2017/NĐ-CP and Decree 111/2021/NĐ-CP.
- Sampling: Replaces outdated circulars with new regulations.
- Testing Methods: Aligned with international standards and current Vietnamese standards (TCVN).
- Product Declaration: Transition from conformity announcement to product registration under Decree 15/2018/NĐ-CP.
Implementation Timeline
- Initial Draft: Late 2025 – Early 2026
- Consultation & Finalization: Throughout 2026–2027
- Official Issuance: Expected in October or November 2027
Reference link: https://emohbackup.moh.gov.vn/publish/home?documentId=10879
