|
MINISTRY
OF HEALTH
--------
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No.:
23/2012/TT-BYT
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Hanoi,
November 15, 2012
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CIRCULAR
ISSUING NATIONAL TECHNICAL REGULATIONSS ON PROCESSED
CEREAL-BASED FOODS 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 processed cereal-based foods for infants from 6th
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 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
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 6th 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 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 processed cereal-based foods for
infants from 6th 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 6th 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
-
kJ/g
3,3
-
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)
-
-
4,5
1,1
Products specified at Point 3.1.1 and 3.1.4,
Part I of this Regulation
-
-
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
-
15
Myristic acid content
%/ total lipid
-
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
-
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
-
5,0
g/100 kJ
-
1,2
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g/100 kcal
-
2,5
g/100 kJ
-
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
-
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 6th 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
-
100
mg/100 kJ
-
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Calci
mg/100 kcal
-
80
For the groups of product specified at Point 3.1.2, Part I of this
Regulation
mg/100 kJ
-
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
-
12
The forms of
mineral supplemented into the processed cereal-based foods for infants
from 6th 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
-
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 6th 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 6th
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 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 processed cereal-based foods for infants from 6th
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 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 processed cereal-based foods 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
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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 6TH 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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