CIRCULAR

ISSUING NATIONAL TECHNICAL REGULATIONSS ON PROCESSED CEREAL-BASED FOODS 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 processed cereal-based foods for infants from 6^th month on and young children up to 36 months of age.

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QCVN 11-4:2012/BYT - National technical regulation on processed cereal-based foods 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 11-4:2012/BYT

NATIONAL TECHNICAL REGULATION

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Foreword

QCVN 11-4:2012/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. 23/2012 / TT-BYT dated November 15, 2012 by the Minister of Health.

NATIONAL TECHNICAL REGULATION

ON PROCESSED CEREAL-BASED FOODS 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 processed cereal-based foods for infants from 6^th month on and young children up to 36 months of age.

2. Subject of application

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2.1. Organizations and individuals importing, producing and trading the processed cereal-based foods 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 processed cereal-based foods for infants from 6^th month on and young children up to 36 months of age: The product is primarily processed from one or more milled grains, particularly cereal accounting for 25% of the final mixture by weight of dry matter. The processed cereal-based foods for infants from 6^th month on and young children up to 36 months of age are classified into the following groups:

3.1.1. Product containing cereal served with milk or other appropriate liquid nutritional products;

3.1.2. Cereal fortified with protein-rich foodstuffs is served with water or other appropriate liquid nutritional products contain protein;

3.1.3. Pasta served after being cooked with water or other appropriate liquid products;

3.1.4. Rusk and biscuit are directly served or crushed; may be used with water, milk or other appropriate liquid products.

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3.3. CODEX: Codex Alimentarius Commission

3.4. GMP: Good Manufacturing Practice

II. TECHNICAL REGULATION

1. Basic ingredients

1.1. General requirements

- The products specified in Clause 3.1, Part I of this Regulation, are processed from one or more milled cereals such as wheat, rice, barley, oats, rye, corn, millet, sorghum and buckwheat. In addition, the ingredients can include beans, starchy tubers (arrowroot, sweet potato or cassava) or starchy trunk; oilseeds with smaller proportion. The ingredients must ensure quality, food safety as prescribed.

- The course of processing and drying must be done to minimize the loss of nutritional value, particularly protein quality.

- Moisture of products comply with principles of GMP for each separate group of product. The moisture level must be achieved to minimize the growth of microorganisms while minimizing the loss of nutritional value of the product.

1.2. Energy

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Minimum

Maximum

kcal/g

0,8

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kJ/g

3,3

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1.3. Nutritional ingredient

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The chemical index of protein in materials must be at least 80% compared with standard casein or PER indicator of protein in the mixture must be at least 70% compared with standard casein. Only supplementing the amino acid of L-isomer shape with the appropriate ratio into the product to improve the nutritional value of protein mixture.

The protein content must meet the following requirements:

Group of product

Minimum⁽¹⁾

Maximum⁽²⁾

g/100 kcal

g/100 kJ

g/100 kcal

g/100 kJ

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2,0

0,48

5,5

1,3

Products specified at Point 3.1.4, Part I of this Regulation

1,5

0,36

5,5

1,3

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⁽²⁾ For protein content in the product

1.3.2. Lipid content

The Lipid content must meet the following requirements

Group of product

Minimum

Maximum

g/100 kcal

g/100 kJ

g/100 kcal

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Products specified at Point 3.1.2, Part I of this Regulation⁽³⁾

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4,5

1,1

Products specified at Point 3.1.1 and 3.1.4, Part I of this Regulation

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3,3

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⁽³⁾ If the lipid content is greater than 0.8 g/100kJ (3.3 g/100 kcal), the linoleic acid and lauric acid content in the product must meet the following:

Unit

Minimum

Maximum

Linoleic acid content (in the form of triglyceride-linoleat)

mg/100 kcal

300

1.200

mg/100 kJ

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285

Acid lauric content

%/ total lipid

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15

Myristic acid content

%/ total lipid

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15

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- If the products specified at Point 3.1.1 and Point 3.1.4, Part I of this Regulation are used with sucrose, fructose, glucose, glucose syrup or honey, they must meet the following requirements:

Unit

Minimum

Maximum

Total amount of supplemented carbohydrate (from above sources)

g/100 kcal

-

7,5

g/100 kJ

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1,8

Amount of supplemented fructose

g/100 kcal

-

3,75

g/100 kJ

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0,9

- If the products specified at Point 3.1.2, Part I of this Regulation are used with sucrose, fructose, glucose, glucose syrup or honey, they must meet the following requirements:

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Minimum

Maximum

Total amount of supplemented carbohydrate (from above sources)

g/100 kcal

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5,0

g/100 kJ

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1,2

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g/100 kcal

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2,5

g/100 kJ

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0,6

1.4. Vitamin contain

Unit

Minimum

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Note

Vitamin B₁

For 04 groups of product classified in Clause 3.1, Part I of this Regulation.

mg/100 kcal

50

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mg/100 kJ

12,5

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- Calculated by equivalent retinol

- For the groups of product specified at Point 3.1.2, Part I of this Regulation and other groups of product specified in Clause 3.1, Part I of this Regulation, if vitamin A is supplemented.

mg/100 kcal

60

180

mg/100 kJ

14

43

Vitamin D

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mg/100 kcal

1

3

mg/100 kJ

0,25

0,75

The forms of vitamin supplemented into the processed cereal-based foods for infants from 6^th month on and young children up to 36 months of age 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

1.5. Mineral content

Unit

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Maximum

Note

Natri

For 04 groups of product classified in Clause 3.1, Part I of this Regulation.

mg/100 kcal

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100

mg/100 kJ

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Calci

mg/100 kcal

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80

For the groups of product specified at Point 3.1.2, Part I of this Regulation 

mg/100 kJ

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20

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50

Only applying to groups of product specified in clause 3.1.4, Part I of this regulation, when served with milk.

mg/100 kJ

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12

The forms of mineral supplemented into the processed cereal-based foods for infants from 6^th month on and young children up to 36 months of age 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 ingredients specified in Clause 1.1, Part II of this Regulation, the other appropriate ingredients may be used for infants from 6th month on and young children up to 36 months of age.

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If the product contains honey or maple syrup, during the processing, the Clostridium botulinum spores must be destroyed.

3. Flavoring

Unit

Minimum

Maximum

Note

Natural fruit extract and vanilla extract

mg/100g

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GMP

Ethyl vanillin and vanillin

For product prepared according to the manufacturer's instructions for direct use

mg/100g

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7

4. Requirements for product upon use

- When prepared as directed on the label, the processed foods from cereals must be convenient for eating with spoon suitable for child (aged 6 to 36 months old).

- The rusks and biscuits can be used in dried form to encourage children to chew or can be used in liquid form by mixing with water or other suitable liquid, with similar consistency as for dried cereal.

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- Do not treat products and materials for production with ionizing radiation.

- Do not use partially hydrogenated fats for these products.

6. Food additives

The food additives used in processed cereal-based foods for infants from 6^th month on and young children up to 36 months of age 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.

7.2. 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.

7.4. Melamin

Unit

Maximum

Note

mg/kg

2,5

7.5. Other contaminants

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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 the processed cereal-based foods for infants from 6^th month on and young children up to 36 months of age 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.

2. Testing

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.

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1. Conformity announcement

1.1. The processed cereal-based foods for infants from 6^th 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 processed cereal-based foods for infants from 6^th month on and young children up to 36 months of age must comply with regulations of law.

IV. RESPONSIBILITIES OF ORGANIZATIONS AND INDIVIDUALS

1. Organizations and individuals producing, importing and trading the processed cereal-based foods for infants from 6^th 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 processed cereal-based foods for infants from 6^th 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

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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 THE PROCESSED CEREAL-BASED FOODS FOR INFANTS FROM 6^TH MONTH ON AND YOUNG CHILDREN UP TO 36 MONTHS OF AGE

I. Protein

1. TCVN 8125:2009 (ISO 20483:2006) Cereals and beans - Determination of nitrogen content and calculation of crude protein content - Kjeldahl method.

2. ISO 16634-2:2009 Food products – Determination of the total nitrogen content by combustion according to the Dumas principle and calculation of the crude protein content – Part 2: Cereals, pulses and milled cereal products

3. AOAC 960.48. Protein Efficiency Ratio

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4. TCVN 6555:1999 (ISO 7302:1982) Cereals and cereal products - Determination of fat content

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 Infant Formula. Gas Chromatographic Method

III. Carbohydrat

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

IV. Vitamin

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

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

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

13. AOAC 974.29 Vitamin A in Mixed Feeds, Premixes, and Human and Pet Foods. Colorimetric Method

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

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

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

V. Mineral

17. EN 15505:2008 Foodstuffs – Determination of trace elements – Determination of sodium and magnesium by flame atomic absorption spectrometry (AAS) after microwave digestion

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

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

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20. TCVN 8126:2009 Foodstuffs - Determination of lead, cadmium, zinc, copper and iron - Method atomic absorption spectrometry after microwave decomposition.

21. 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

22. TCVN 7602:2007 Foodstuffs - Determination of lead content by means of atomic absorption spectroscopy (AOAC 972.25)

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

24. TCVN 7596:2007 (ISO 16050:2003) Foodstuffs - Determination of aflatoxin B1 and total content of aflatoxin B1, B2, G1 and G2 in cereals, grains and their products - method of high performance liquid chromatography

25. TCVN 7930:2008 (EN 12955:1999) Foodstuffs - Determination of aflatoxin B1 and total aflatoxin B1, B2, G1 and G2 in cereals, fruits with peel and their products - Methods of high performance liquid chromatography with conductivity after column and cleanup with immune affinity column

26. EN 15851:2010 Foodstuffs - Determination of aflatoxin B1 in cereal based foods for infants and young children - HPLC method with immunoaffinity column cleanup and fluorescence detection

27. TCVN 7595-1:2007 (ISO 15141-1:1998) Foodstuffs - Determination ocratoxin A in cereals and cereal products - Part 1: Method of high-performance liquid chromatography with silica gel cleanup

28. TCVN 7595-2:2007 (ISO 15141-2:1998) Foodstuffs - Determination of ocratoxin A in cereals and cereal products - Part 2: Method of high-performance liquid chromatography with bicarbonate cleanup

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30. EN 15791:2009 Animal feeding stuffs – Determination of Deoxynivalenol in animal feed – HPLC method with UV detection and immunoaffinity column clean-up

31. EN 15850:2010 Foodstuffs - Determination of zearalenone in maize based baby food, barley flour, maize flour, polenta, wheat flour and cereal based foods for infants and young children - HPLC method with immunoaffinity column cleanup and fluorescence detection

32. ISO 6870:2002 Animal feeding stuffs – Qualitative determination of zearalenone

33. ISO 17372:2008 Animal feeding stuffs – Determination of zearalenone by immunoaffinity column chromatography and high performance liquid chromatography

34. EN 15792:2009 Animal feeding stuffs – Determination of zearalenone in animal feed – High performance liquid chromatographic method with fluorescence detection and immunoaffinity column clean-up

35. TCVN 8162:2009 (EN 13585:2001) Foodstuffs - Determination of fumonisin B1 and B2 in corn - Method of high-performance liquid chromatography with solid phase extraction (SPE) clean-up

36. EN 14352:2004 Foodstuffs – Determination of fumonisin B1 and B2 in maize based foods – HPLC method with immunoaffinity column clean up

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

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Thông tư 23/2012/TT-BYT về Quy chuẩn kỹ thuật quốc gia đối với sản phẩm dinh dưỡng chế biến từ ngũ cốc cho trẻ từ 6 đến 36 tháng tuổi do Bộ trưởng Bộ Y tế ban hành