CIRCULAR

ISSUING NATIONAL TECHNICAL REGULATION ON FOLLOW-UP FORMULAS FOR INFANTS FROM 6^TH 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 6^th month on and young children up to 36 months of age;

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QCVN 11-3:2012/BYT - National technical regulation on follow-up formulas for infants from 6^th 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
DEPUTY MINISTER




Nguyen Thanh Long

QCVN 11-3:2012/BYT

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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 6^th month on and young children up to 36 months of age.

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This regulation applies to:

2.1. Organizations and individuals importing, producing and trading the follow-up formulas for infants from 6^th 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 6^th 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 6^th 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.

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- 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 6^th 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);

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- 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

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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

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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

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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

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0,7

1,4

Linoleic acid (glycerid )

mg/100 kcal

300

-

mg/100 kJ

71,7

-

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The carbohydrate in product must:

- Be suitable for infants from 6^th 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

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IU/100 kcal

250

750

mg RE /100 kcal

75

225

IU/100 kJ

60

180

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18

54

Vitamin D

IU/100 kcal

40

120

mg/100 kcal

1

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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

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0,7⁽²⁾

-

IU/100 kJ

0,15⁽²⁾

-

Vitamin C (Ascorbic acid)

mg/100 kcal

8,0

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mg/100 kJ

1,9

-

Vitamin B₁ (thiamin)

mg/100 kcal

40

-

mg/100 kJ

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-

Vitamin B₂ (Riboflavin)

mg/100 kcal

60

-

mg/100 kJ

14

-

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mg/100 kcal

250

-

mg/100 kJ

60

-

Vitamin B₆

⁽³⁾ Containing at least 15mg vitamin B₆/g protein

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45⁽³⁾

-

mg/100 kJ

11⁽³⁾

-

Folic acid

mg/100 kcal

4

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mg/100 kJ

1

-

Pantothenic acid

mg/100 kcal

300

-

mg/100 kJ

...

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-

Vitamin B₁₂

mg/100 kcal

0,15

-

mg/100 kJ

0,04

-

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mg/100 kcal

4

-

mg/100 kJ

1

-

Vitamin H (Biotin)

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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

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Note

Sodium

mg/100 kcal

20

85

mg/100 kJ

5

21

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mg/100 kcal

80

-

mg/100 kJ

20

-

Chloride

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55

-

mg/100 kJ

14

-

Calcium

mg/100 kcal

90

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mg/100 kJ

22

-

Phospho

mg/100 kcal

60

-

mg/100 kJ

...

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-

Ratio of Calcium/phospho

1,0

2,0

Magnesium

mg/100 kcal

...

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mg/100 kJ

1,4

-

Iron

mg/100 kcal

1,0

2,0

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0,25

0,50

Iodine

mg/100 kcal

5,0

-

mg/100 kJ

1,2

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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.

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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

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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.

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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

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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

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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

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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

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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)

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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

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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)
in Ready-to-Feed Milk-Based Infants Formula. Microbiological-Turbidimetric Method

30. AOAC 944.13 Niacin and Niacinamide (Nicotinic Acid and Nicotinamide)
in Vitamin Preparations. Microbiological Methods

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

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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

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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

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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)

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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

Thông tư 22/2012/TT-BYT về Quy chuẩn kỹ thuật quốc gia đối với sản phẩm dinh dưỡng công thức với mục đích ăn bổ sung cho trẻ từ 6 đến 36 tháng tuổi do Bộ trưởng Bộ Y tế ban hành