Nội dung toàn văn Circular No. 22/2012/TT-BYT follow-up formulas for infants from 6th month on and young children up to 36 months of age
MINISTRY OF HEALTH | SOCIALIST REPUBLIC OF VIETNAM |
No.: 22/2012/TT-BYT | 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 centrally-affiliated cities and organizations and individuals concerned are liable to execute this Decision.
| FOR THE MINISTER |
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 | Minimum | Maximum |
kcal/100 ml | 60 | 85 |
kJ/100 ml | 250 | 355 |
1.3. Nutrient ingrdients
The product (prepared according to the manufacturer's instructions for direct use) must meet:
1.3.1. Protein content
Unit | Minimum (1) | Maximum | Note |
g/100 kcal | 3,0 | 5,5 | (1) Protein in the product has the nutritional quality equivalent to casein. In case of using other protein 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. |
g/100 kJ | 0,7 | 1,3 | |
|
|
|
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 | Minimum | Maximum |
Total fat | ||
g/100 kcal | 3,0 | 6,0 |
g/100 kJ | 0,7 | 1,4 |
Linoleic acid (glycerid ) | ||
mg/100 kcal | 300 | - |
mg/100 kJ | 71,7 | - |
1.3.3. Carbohydrate content
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 | Minimum | Maximum | Note |
Vitamin A |
| ||
IU/100 kcal | 250 | 750 | |
mg RE /100 kcal | 75 | 225 | |
IU/100 kJ | 60 | 180 | |
mg RE/100 kJ | 18 | 54 | |
Vitamin D |
| ||
IU/100 kcal | 40 | 120 | |
mg/100 kcal | 1 | 3 | |
IU/100 kJ | 10 | 30 | |
mg/100 kJ | 0,25 | 0,75 | |
Vitamin E (a - tocopherol) |
(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 | 0,7(2) | - | |
IU/100 kJ | 0,15(2) | - | |
Vitamin C (Ascorbic acid) |
| ||
mg/100 kcal | 8,0 | - | |
mg/100 kJ | 1,9 | - | |
Vitamin B1 (thiamin) |
| ||
mg/100 kcal | 40 | - | |
mg/100 kJ | 10 | - | |
Vitamin B2 (Riboflavin) |
| ||
mg/100 kcal | 60 | - | |
mg/100 kJ | 14 | - | |
Nicotinamide |
| ||
mg/100 kcal | 250 | - | |
mg/100 kJ | 60 | - | |
Vitamin B6 | (3) Containing at least 15mg vitamin B6/g protein | ||
mg/100 kcal | 45(3) | - | |
mg/100 kJ | 11(3) | - | |
Folic acid |
| ||
mg/100 kcal | 4 | - | |
mg/100 kJ | 1 | - | |
Pantothenic acid |
| ||
mg/100 kcal | 300 | - | |
mg/100 kJ | 70 | - | |
Vitamin B12 |
| ||
mg/100 kcal | 0,15 | - | |
mg/100 kJ | 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 10-1979, 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 | Minimum | Maximum | Note |
Sodium |
| ||
mg/100 kcal | 20 | 85 | |
mg/100 kJ | 5 | 21 | |
Kali |
| ||
mg/100 kcal | 80 | - | |
mg/100 kJ | 20 | - | |
Chloride |
| ||
mg/100 kcal | 55 | - | |
mg/100 kJ | 14 | - | |
Calcium |
| ||
mg/100 kcal | 90 | - | |
mg/100 kJ | 22 | - | |
Phospho |
| ||
mg/100 kcal | 60 | - | |
mg/100 kJ | 14 | - | |
Ratio of Calcium/phospho |
| ||
| 1,0 | 2,0 | |
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 10-1979, 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 | Maximum level | Note |
mg/kg product | 2,5 |
|
6.3. Heavy metal
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) |
30. AOAC 944.13 Niacin and Niacinamide (Nicotinic Acid and Nicotinamide) |
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 Vitamin C (Reduced Ascorbic Acid) in Ready-to-Feed Milk-Based Infants Formula. 2,6-Dichloroindophenol Titrimetric Method |
46. AOAC 967.22 Vitamin C (Total) in Vitamin Preparations. Microfluorometric Method |
47. AOAC 984.26 Vitamin C (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 986.24 Phosphorus 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 984.27 Calcium, 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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