CIRCULAR

ISSUING NATIONAL TECHNICAL REGULATION ON FORMULAS FOR SPECIAL MEDICAL PURPOSES INTENDED FOR INFANTS (UP TO 12 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 formulas for special medical purposes intended for infants (up to 12 months of age)

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QCVN 11-2:2012/BYT - National technical regulation on formulas for special medical purposes intended for infants (up to 12 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 11-2:2012/BYT

National technical regulations

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Foreword

QCVN 11-1:2012/BYT is written by the Drafting Committee of national technical regulations on food for infants and young children, submitted for approval by the Department of Food Safety and issued under Circular No. 21/2012 / TT-BYT dated November 15, 2012 by the Minister of Health.

National technical regulations

on formulas for special medical purposes intended for infants (up to 12 months of age)

I. GENERAL PROVISIONS

1. Scope of adjustment

This regulation prescribes the indicator of quality, food safety and management requirements for formulas with special medical purposes for infants up to 12 months old.

2. Subjects of application

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2.1. Organizations and individuals importing, producing and trading formulas with special medical purposes for infants up to 12 months old for circulation in Vietnamese market.

2.2. The state management agencies concerned.

3. Explanation of terms and abbreviated symbols

In this regulation, the terms below are construed as follows:

3.1. Formulas with special medical purposes for infants up to 12 months old: Products with liquid or powdered form processed from synthetic or natural ingredients with origin from animals or plants are produced to meet the special nutritional needs for infants up to 12 months suffering from illness, disorders or in need of medical care.

Formulas with special medical purposes for infants up to 12 months old can be used as a food source to replace breast milk as prescribed in Joint Circular No. 10/2006/TTLT/BYT- BTM-BVHTT-CPFC dated August 25, 2006 on guiding the implementation of Decree No. 21/2006/ND-CP dated February 27, 2006 of the Government on the trading and use of nutritional products for young children.

3.2. GUL (Guidance Upper Levels): Guidance Upper Levels. This level is applied to the nutrients which do not have enough information for risk assessment based on science. These values ​​are set on the basis of meeting nutritional requirements with special medical purposes for infants up to 12 months of age and data about safety use can be adjusted based on relevant scientific and technological progress. The purpose of GUL is providing guidance for the manufacturers and must not be understood as the value to be reached. The nutrient content in the formulas with the special medical purposes for infants up to 12 months of age must not exceed the GUL values except for cases of higher nutritional levels due to the change of the ingredients or technological reasons. Manufacturers mut not increase nutritional levels to reach GUL values when the form of product has the level lower than GUL value.

3.3. GMP: Good Manufacturing Practice

3.4. DHA: Acid docosahexaenoic.

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3.6. PUFA: Poly-unsaturated Fatty Acids:

II. TECHNICAL REGULATION

1. Basic ingredient

1.1. General requirements

1.1.1. Materials and food additives put into production must ensure the quality and food safety and hygiene, not contain gluten and be appropriate for the digestion of infants up to 12 months old.

1.1.2. The ingredients of formulas with special medical purposes for infants up to 12 months old must be developed on the principles of nutrition and medicine.

1.1.3. Nutritional safety and capacity to fully meet nutrition of products must be scientifically proven about the capacity to support the development for infants up to 12 months old with special medical purposes and capacity to support the development for young children to whom the product aim.

1.1.4. The energy factors and nutritional ingredients of formulas with special medical purposes for infants up to 12 months must comply with the provisions of Clauses 1.2 and 1.3, Part II of this Regulation. However, the product ingredient can be adjusted to meet the special nutritional needs of children (due to illness, disorder and need for medical care).

1.2. Energy

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Unit

Minimum

Maximum

kcal/100 ml

60

70

kJ/100 ml

250

295

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The formulas with special medical purposes for infants up to 12 months (prepared according to the manufacturer's instructions for direct use) must satisfy:

1.3.1. Protein content^{1), 2), 3)}

Unit

Minimum ⁴⁾

Maximum

GUL

Note

g/100 kcal

1,8

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–

For products made ​​from cow's milk protein

2,25

3,0

–

For products made from soybean protein.

g/100 kJ

0,45

0,7

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For products made from cow's milk protein

0,5

0,7

–

For products made from soybean protein.

Note:

¹⁾ The protein content of the formulas with special medical purposes for infants up to 12 months (prepared according to the manufacturer's instructions for direct use) is calculated by N x 6,25 (N is nitrogen content). There must be scientific evidences upon application of other conversion factors. The protein levels specified in this regulation is based on the nitrogen conversion factor of 6.25. The value 6.38 is usually set by specific factors appropriate for conversion of nitrogen to protein in other dairy products and the value 5.71 is the conversion factor of nitrogen to protein in products from soybeans.

²⁾ For equivalent energy value, the products must contain an amount available of each type of essential or conditionally essential amino acid at least equal to the amount contained in breast milk (refer to content value in Annex 1 of this Regulation); for calculation, the content of tyrozin and phenylalanin can be aggregated together. If the ratio of methionine and cysteine ​​content is less than 2:1, the aggregation may be done, if that ratio is between 2:1 and 3:1, then the suitability of this product should be demonstrated by clinical test.

³⁾ The single amino acid can be added to the formulas with special medical purposes for infants up to 12 months just to increase the nutritional value. The essential or conditionally essential amino acid may be added with necessary amount to increase the quality of protein. Only amino acid L-isomer can be used.

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1.3.2. Lipid content

Unit

Minimum

Maximum

GUL

Note

Total fat ^{5), 6)}

⁵⁾ Do not use hydrogenated fats and oils to produce the formulas with special medical purposes for infants up to 12 months old.

⁶⁾ Acid and lauric acid is mystiric are components of fat, but their sum does not exceed 20% of total fatty acids. The content of trans fatty acid must not exceed 3% of total fatty acids. The trans fatty acids are endogenous components of milk fat. Accepting up to 3% of trans fatty acid for permissible use of milk fat in the formulas with special medical purposes for infants up to 12 months old. The erucic acid content must not exceed 1% of total fatty acid. The phospholipid content must not exceed 300 mg/100 kcal (72 mg/100 kJ).

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g/100 kcal

4,4

6,0

–

g/100 kJ

1,05

1,4

–

Linoleic acid

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300

–

1.400

mg/100 kJ

70

–

330

Alpha-Linolenic Acid

mg/100 kcal

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–

–

mg/100 kJ

12

–

–

Ratio between  linoleic acid / Alpha-Linolenic Acid

5:1

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–

1.3.3. Carbohydrat content

Unit

Minimum

Maximum

GUL

Note

Total Carbohydrat  ⁷⁾

⁷⁾ Prioritizing the use of lactose and glucose polymer which is carbohydrate resource in products with protein originated from cows' milk and protein hydrolyzate. Only adding preliminarily processed starch and / or gelatinized without natural gluten in products with a content not exceeding 30% of total carbohydrate and no more than 2 g/100 ml. Due to the potential risks to the infants who cannot tolerate fructose due to heredity. Only using sucrose and fructose in the product as needed.

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g/100 kcal

9,0

14,0

–

g/100 kJ

2,2

3,3

–

1.3.4. Vitamin content

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Minimum

Maximum

GUL

Note

Vitamin A

⁸⁾ Calculating by mg RE. 1 mg RE = 3,33 IU vitamin A = 1 mg all-trans retinol. The retinol content must be generated by pre- retinol, regardless of the amount of carotenoid into the vitamin A  content in the product

mg⁸⁾/100 kcal

60

180

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mg⁸⁾/100 kJ

14

43

–

Vitamin D₃

⁹⁾ Calculated by calciferol.

1 mg calciferol = 40 IU vitamin D

mg⁹⁾ /100kcal

1

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–

mg⁹⁾ /100 kJ

0,25

0,6

–

Vitamin E

¹⁰⁾ Calculated by equivalent a-tocopherol (a-TE).

1 mg a-TE = 1 mg d-a-tocopherol

¹¹⁾ The minimum Vitamin E content must be at least 0.5 mg a-TE/g PUFA, using the following equivalent factors to accept the minimum Vitamin E content for a number of double bonds of fatty acid in the product: 0,5 mg a-TE /g linoleic acid, (18:2 n-6); 0,75 a-TE/g acid a-linolenic (18:3 n-3); 1,0 mg a-TE/g acid arachidonic (20:4 n-6); 1,25 mg a-TE/g acid eicosapentaenoic (20:5 n-3); 1,5 mg a-TE/g acid docosahexaenoic (22:6 n-3)

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mg¹⁰⁾/100 kcal

0,5¹¹⁾

–

5

mg¹⁰⁾/100 kJ

0,12¹¹⁾

–

1,2

Vitamin K

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mg/100 kcal

4

–

27

mg/100 kJ

1

–

6,5

Vitamin B₁ (Thiamin)

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mg/100 kcal

60

–

300

mg/100 kJ

14

–

72

Vitamin B₂ (Riboflavin)

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mg/100 kcal

80

–

500

mg/100 kJ

19

–

119

Niacin¹²⁾

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mg/100 kcal

300

–

1.500

mg/100 kJ

70

–

360

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...

mg/100 kcal

35

–

175

mg/100 kJ

8,5

–

45

...

...

...

mg/100 kcal

0,1

–

1,5

mg/100 kJ

0,025

–

0,36

...

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...

mg/100 kcal

400

–

2.000

mg/100 kJ

96

–

478

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...

mg/100 kcal

10

–

50

mg/100 kJ

2,5

–

12

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¹³⁾ Calculated by ascorbic acid

¹⁴⁾ This level has taken the possibility of huge loss into account in the shelf life of liquid products. For powdered products, the lower level should be prescribed.

mg¹³⁾/100kcal

10

–

70 ¹⁴⁾

mg¹³⁾/100 kJ

2,5

–

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Vitamin H (Biotin)

mg/100 kcal

1,5

–

10

mg/100 kJ

0,4

–

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The forms of vitamin supplemented in products 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. The content of minerals and trace elements

Unit

Minimum

Maximum

GUL

Note

Iron

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0,45

–

–

mg/100 kJ

0,1

–

–

Calcium

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50

–

140

mg/100 kJ

12

–

35

Phospho

¹⁵⁾ This GUL value should take into account with higher demand for nutritional products with special medical purposes for infants up to 12 months with the use of soybean.

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25

–

100⁽¹⁵⁾

mg/100 kJ

6

–

24⁽¹⁵⁾

Ratio of calcium/phospho

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1 :1

2 :1

–

Magnesium

mg/100 kcal

5

–

15

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1,2

–

3,6

Sodium

mg/100 kcal

20

60

–

...

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5

14

–

Chloride

mg/100 kcal

50

160

–

...

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...

12

38

–

Kali

mg/100 kcal

60

180

–

...

...

...

14

43

–

Mangan

mg/100 kcal

1

–

100

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0,25

–

24

Iod

mg/100 kcal

10

–

60

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2,5

–

14

Selen

mg/100 kcal

1

–

9

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0,24

–

2,2

Đồng

mg/100 kcal

35

–

120

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8,5

–

29

Kẽm

mg/100 kcal

0,5

–

1,5

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0,12

–

0,36

Chrom

mg/100 kcal

1,5

–

10

...

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0,4

–

2,4

Molybden

mg/100 kcal

1,5

–

10

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0,4

–

2,4

The forms of minerals and trace elements supplemented in products 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

1.3.6. Content of other ingredients:

Unit

Minimum

Maximum

GUL

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Choline        

mg/100 kcal

7

–

50

mg/100 kJ

1,7

–

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Myo-inositol

mg/100 kcal

4

–

40

mg/100 kJ

1

–

...

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L-Carnitine

mg/100 kcal

1,2

–

–

mg/100 kJ

0,3

–

...

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2. Optional ingredients

In addition to the ingredients specified in Clause 1.3, Part II of this Regulation, to provide substances commonly found in breast milk, the formulas with special medical purposes for infants up to 12 months old suffering from illness, disorders or in need of medical care may be supplemented with other ingredients.

In case of supplementation, there must be scientific evidence of safety in line with the nutritional needs with special medical purposes. The content of these ingredients in the formulas with special medical purposes for infants up to 12 months old should be sufficient to achieve the effect as announced.

Specific provisions for a number of optional ingredients:

Unit

Minimum

Maximum

GUL

Note

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Taurine

For products that have been prepared for direct use by

the manufacturer's instructions

mg/100 kcal

–

12

–

...

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–

3

–

Docosahexaenoic acid ¹⁶⁾

For products that have been prepared for direct use by the manufacturer's instructions

¹⁶⁾ If supplementing DHA (22:6 n-3) into the formulas with special medical purposes for infants up to 12 months old, the arachidonic acid content  (20:4 n-6) must not be lower than the content of DHA. The eicosapentaenoic acid content (20:5 n-3) existing in LC-PUFA resources must not exceed DHA content.

% fatty acid

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–

0,5

- Only using microorganisms of L-(+)-lactic acid

3. Fluoride

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- The fluoride content is prescribed as follows:

Unit

Maximum

Note

mg/100 kcal

100

For products that have been prepared for direct use by the manufacturer's instructions

mg/100 kJ

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4. State of product after preparation

When prepared as directed on the label, the product must be appropriate with the special medical purposes for infants up to 12 months old without clotting phenomenon.

5. Treated with ionizing radiation

Products and initial materials must not be treated with ionizing radiation.

6. Food additives

The food additives used in the formulas with special medical purposes for infants up to 12 months old are in accordance with regulations of the Ministry of Health.

7. Contaminant

7.1. 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.

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Unit

Maximum

Note

mg/kg

1

For the formulas with special medical purposes for infants up to 12 months old

7.3. Heavy metal

As prescribed by QCVN 8-2:2011/BYT - National technical standards for limit of heavy metal contamination in food.

7.4. Fungal toxin

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7.5. Other contaminants

Do not contain contaminants / unwanted substances (eg: biologically active substances) with the content possibly causing harm to infants.

Products under the scope of this Regulation is subject to maximum limit allowed in the regulations of the Ministry of Health. In case of no specific regulations from the Ministry of Health, the provisions of Codex will apply.

8. Microorganism

As prescribed by QCVN 8-3:2011/BYT - National technical standards for limit of fungal toxin contamination in food.

9. 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, the Government’s Decree No. 21/2006/ND-CP dated February 27, 2006 on the trading and use of nutritional products for infants and documents guiding the implementation of regulations of law.

III. METHOD OF SAMPLING AND TESTING

1.Sampling

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2. Method of testing

The technical requirements prescribed in this Regulation are in accordance with the methods in Annex 2 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 formulas with special medical purposes for infants up to 12 months old 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 formulas with special medical purposes for infants up to 12 months old will comply with regulations of law.

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1. Organizations and individuals producing, importing and trading the formulas with special medical purposes for infants up to 12 months old 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 formulas with special medical purposes for infants up to 12 months old after completing their registration of conformity announcement and ensure the quality and safety and labeling in accordance with regulations of law.

VI. 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 1

REFERENCE CONTENT

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No.

Amino acids

Average content

mg/g nitrogen

mg/g protein

mg/100 kcal

1

Cysteine

131

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38

2

Histidine

141

23

41

3

Iso-leucin

319

...

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92

4

Leucin

586

94

169

5

Lysine

395

...

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114

6

Methionine

85

14

24

7

Phenylalanin

282

...

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81

8

Threonin

268

43

77

9

Trytophan

114

...

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33

10

Tyrosine

259

42

75

11

Valin

315

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90

ANNEX 2

LIST OF METHODS OF TESTING OF INDICATORS FOR THE FORMULAS WITH SPECIAL MEDICAL PURPOSES FOR INFANTS UP TO 12 MONTHS OLD

I. Protein

1.       TCVN 8099-5:2009 (ISO 8968-5:2001) Milk–Determination of nitrogen content – Part 5: Method of determination of protein nitrogen content.

2.       TCVN 8100:2009 (ISO 14891:2002) Milk and dairy products – Determination of nitrogen content – Common method according to Dumas Combustion Principle

3.       AOAC 960.48 Protein Efficiency Ratio

II. Lipid

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5.       TCVN 7084:2002 (ISO 1736:2000) Powdered milk and powdered milk products – Determination of fat content – Quantity method (Standard method)

6.       AOAC 996.06 Fat (Total, Saturated, and Unsaturated) in Foods. Hydrolytic Extraction Gas Chromatographic Method

7.       ISO 23065:2009 Milk fat from enriched dairy products – Determination of omega-3 and omega-6 fatty acid content by gas-liquid chromatography

8.       AOAC 992.25 Linoleic Acid in Ready-To-Feed Milk-Based Infant Formula. Gas Chromatographic Method

III. Carbohydrat

9.       AOAC 986.25 Proximate Analysis of Milk-Based Infant Formula

IV. Vitamin

10.  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

11.  EN 12823-2:2000 Foodstuffs – Determination of vitamin A by high performance liquid chromatography – Part 2: Measurements of Beta-carotene

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13.  AOAC 941.15 Carotene in Fresh Plant Materials and Silages. Spectrophotometric Method

14.  AOAC 992.06 Vitamin A (Retinol) in Milk-Based Infant Formula. Liquid Chromatographic Method

15.  AOAC 992.04 Vitamin A (Retinol Isomers) in Milk and Milk-Based Infant Formula. Liquid Chromatographic Method

16.  EN 12821:2009 Foodstuffs – Determination of vitamin D by high performance liquid chromatography – Measurement of cholecalciferol (D3) or ergocalciferol (D2)

17.  AOAC 936.14 Vitamin D in Milk, Vitamin Preparations, and Feed Concentrates

18.  AOAC 995.05 Vitamin D in Infant Formulas and Enteral Products. Liquid Chromatographic Method

19.  AOAC 992.26 Vitamin D3 (Cholecalciferol) in Ready-To-Feed Milk-Based Infant Formula. Liquid Chromatographic Method

20.  TCVN 8276:2010 (EN 12822:2000) Food –Determination of vitamin E by high performance liquid chromatography

21.  AOAC 971.30 -Tocopherol and -Tocopheryl Acetate in Foods and Feeds. Colorimetric Method

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23.  EN 14148:2003 Foodstuffs – Determination of vitamin K1 by HPLC

24.  AOAC 999.15 Vitamin K in Milk and Infant Formulas. Liquid Chromatographic Method

25.  AOAC 992.27 trans-Vitamin K1 (Phylloquinone) in Ready-To-Feed Milk-Based Infant Formula. Liquid Chromatographic Method

26.  TCVN 5164:2008 (EN 14122:2003) Foodstuffs - Determination of vitamin B1 by high performance liquid chromatography (HPLC).

27.  AOAC 942.23 Thiamine (Vitamin B1) in Human and Pet Foods. Fluorometric Method

28.  AOAC 986.27 Thiamine (Vitamin B1) in Milk-Based Infant Formula. Fluorometric Method

29.  EN 14152:2003 Foodstuffs – Determination of vitamin B2 by HPLC

30.  AOAC 970.65 Riboflavin (Vitamin B2) in Foods and Vitamin Preparations. Fluorometric Method

31.  EN 15652:2009 Foodstuffs – Determination of niacin by HPLC

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

34.  AOAC 961.14 Niacin and Niacinamide in Drugs, Foods, and Feeds. Colorimetric Method

35.  EN 14164:2008 Foodstuffs – Determination of vitamin B6 by HPLC

36.  EN 14166:2009 Foodstuffs – Determination of vitamin B6 by microbiological assay

37.  EN 14663:2005 Foodstuffs – Determination of vitamin B6 (including its glycosylated forms) by HPLC

38.  AOAC 961.15 Vitamin B6 (Pyridoxine, Pyridoxal, Pyridoxamine) in Food Extracts. Microbiological Method

39.  AOAC 985.32 Vitamin B6 (Pyridoxine, Pyridoxal, Pyridoxamine) in Ready-to-Feed Milk-Based Infant Formula. Microbiological Method

40.  AOAC 986.23 Cobalamin (Vitamin B12 Activity) in Milk-Based Infant Formula. Turbidimetric Method

41.  AOAC 952.20 Cobalamin (Vitamin B12 Activity) in Vitamin Preparations. Microbiological Methods

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43.  AOAC 945.74 Pantothenic Acid in Vitamin Preparations. Microbiological Methods

44.  EN 14131:2003 Foodstuffs – Determination of folate by microbiological assay

45.  AOAC 992.05 Folic Acid (Pteroylglutamic Acid) in Infant Formula. Microbiological Methods

46.  AOAC 944.12 Folic Acid (Pteroylglutamic Acid) in Vitamin Preparations. Microbiological Methods

47.  EN 14130:2003 Foodstuffs – Determination of vitamin C by HPLC

48.  AOAC 985.33 Vitamin C (Reduced Ascorbic Acid) in Ready-to-Feed Milk-Based Infant Formula. 2,6-Dichloroindophenol Titrimetric Method

49.  AOAC 967.22 Vitamin C (Total) in Vitamin Preparations. Microfluorometric Method

50.  AOAC 984.26 Vitamin C (Total) in Food. Semiautomated Fluorometric Method

51.  EN 15607:2009 Foodstuffs – Determination of d-biotin by HPLC

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52.  TCVN 8126:2009 Foodstuffs - Determination of lead, cadmium, zinc, copper and iron - Method atomic absorption spectrometry after microwave decomposition (AOAC 999.10)

53.  AOAC 984.27 Calcium, Copper, Iron, Magnesium, Manganese, Phosphorus, Potassium, Sodium, and Zinc in Infant Formula. Inductively Coupled Plasma Emission Spectroscopic Method

54.  AOAC 985.35 Minerals in Infant Formula, Enteral Products, and Pet Foods. Atomic Absorption Spectrophotometric Method

55.  TCVN 6269:2008 (ISO 8070:2007) Milk and dairy products - Determination of calcium, sodium, potassium and magnesium content- Method of Atomic Absorption Spectrometry

56.  TCVN 6838:2001 (ISO 12081:1998) Milk - Determination of calcium content – Titration method

57.  TCVN 6271:2007 (ISO 9874:2006) Milk - Determination of total phosphorus content - Method of Molecular Absorption Spectrometry

58.  AOAC 986.24 Phosphorus in Infant Formula and Enteral Products. Spectrophotometric Method

59.  AOAC 976.25 Sodium in Foods for Special Dietary Use. Ion Selective Electrode Method

60.  AOAC 986.26 Chloride in Milk-Based Infant Formula. Potentiometric Method

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62.  EN 15111:2007 Foodstuffs – Determination of trace elements – Determination of iodine by ICP-MS (inductively coupled plasma mass spectrometry)

63.  AOAC 992.24 Iodide in Ready-To-Feed Milk-Based Infant Formula. Ion-Selective Electrode Method

64.  EN 14627:2005 Foodstuffs – Determination of trace elements – Determination of total arsenic and selenium by hydride generation atomic absorption spectrometry (HGAAS) after pressure digestion

65.  AOAC 986.15 Arsenic, Cadmium, Lead, Selenium, and Zinc in Human and Pet Foods. Multielement Method

66.  AOAC 974.15 Selenium in Human and Pet Food. Fluorometric Method

67.  TCVN 7086:2007 (ISO 5738:2004)

Milk and dairy products - Determination of copper content - Photometric method (Standard method)

68.  TCVN 6841:2001 (ISO 11813:1998) Milk and dairy products - Determination of zinc content – Method of Flame Atomic Absorption Spectrometric

69.  TCVN 7929:2008 (EN 14083:2003) Foodstuffs - Determination of trace elements - Determination of lead, cadmium, chromium, molybdenum by atomic absorption spectrometry using graphite furnace (GFAAS) after decomposition with pressure.

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70.  AOAC 999.14 Choline in Infant Formula and Milk Enzymatic Colorimetric Method

71.  AOAC 991.39 Fatty Acids in Encapsulated Fish Oils and Fish Oil Methyl and Ethyl Esters. Gas Chromatographic Method

VII. Fluoride

72.  AOAC 944.08 Fluorine in Food. Distillation Method

73.  AOAC 961.16 Microchemical Determination of Fluorine. Titrimetric Method

VIII. Chất nhiễm bẩn Contaminant

74.  TCVN 7602:2007 Foodstuffs - Determination of lead content by means of atomic absorption spectroscopy

75.  TCVN 7933:2009 (ISO/TS 6733:2006) Milk and dairy products - Determination of lead content - atomic absorption spectrophotometry using graphite furnace

76.  TCVN 7788:2007 Canned foods - Determination of tin by means of atomic absorption spectroscopy

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78.  ISO 15495:2010 Milk, milk products and infant formulae – Guidelines for the quantitative determination of melamine and cyanuric acid by LC-MS/MS

79.  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

80.  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

81.  TCVN 7700-1:2007 (ISO 11290-1:1996, With Amd 1:2004) Microorganism in food and animal feed – Method of detection and quantification of Listeria monocytogenes - Part 1: Detection method

82.  TCVN 7850:2008 (ISO/TS 22964:2006) Milk and dairy products - Detection of Enterobacter sakazakii

83.  TCVN 5518-1:2007 (ISO 21528-1:2004) Microorganism in food and animal feed - Method of detection and quantification of Enterobactericeae - Part 1: Detection and quantification by MPN technique with pre-enrichment

Thông tư 21/2012/TT-BYT về Quy chuẩn kỹ thuật quốc gia đối với sản phẩm dinh dưỡng công thức với mục đích y tế đặc biệt cho trẻ đến 12 tháng tuổi do Bộ trưởng Bộ Y tế ban hành