Circular 20/2012/tt-Byt: Enactment Of National Technical Regulation For Nutritional Products Formulated For Babies Up To 12 Months Old

Original Language Title: Thông tư 20/2012/TT-BYT: Ban hành Quy chuẩn kỹ thuật quốc gia đối với sản phẩm dinh dưỡng công thức cho trẻ đến 12 tháng tuổi

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The CIRCULAR issued to national technical regulation for nutritional product formula for babies up to 12 months old _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ MINISTER of health pursuant to the law on food safety, June 17th 2010 and Decree No. 38/2012/ND-CP dated 25 April 2012 of the Government detailing the implementation of a number of articles of the law on food safety;
Pursuant to the law of standards and technical regulation on June 29, 2006 and Decree No. 127/2007/ND-CP on 1st August 2007 detailing the Government's implementation of some articles of the law on technical regulation and standards;
Pursuant to Decree No. 63/2012/ND-CP on August 31, 2012 of the Government functions, tasks, powers and organizational structure of the Ministry of health;
At the suggestion of the Director of food safety;
The Minister of Health issued a circular issued national technical regulation for nutritional product formula for babies up to 12 months of age.
Article 1. Attached to this circular: QCVN 11-1:2012/BYT-national technical regulation for nutritional product formula for babies up to 12 months of age;
Article 2. This circular is effective from June 1, 2013.
Article 3. Director food safety, heads of units of the Ministry of health, Ministry of health; the Director of the Health Department of the province, central cities and other organizations and individuals concerned is responsible for the implementation of this circular.
 

DEPUTY MINISTER signature (signed) Nguyen Thanh Long NATIONAL TECHNICAL REGULATION for NUTRITIONAL PRODUCT FORMULA for BABIES UP to 12 MONTHS of AGE National technical regulation on infant formula (for children up to 12 months of age) i. GENERAL PROVISIONS 1. Scope this regulation regulates the quality criteria, food safety and regulatory requirements for nutritional product formula for babies up to 12 months of age.
2. The object of applying this Regulation applies to: 2.1. The Organization, the individual import, manufacturing, business formula nutritional products for infants to age 12 months to circulate on the Vietnam market.
2.2. the management authority of the State concerned.
3. Explanation of terms and abbreviation notation In this regulation, the terms and abbreviation notation here is understood as follows: 3.1. Nutritional products formulated for babies up to 12 months of age: products in the form of liquid or powder form to meet the nutritional needs of children up to 12 years old, is made from cow's Milk or milk:-other animals or mixtures of them,-The other appropriate components.
Recipe nutrition products for infants to age 12 months may be used as alternative food sources breast milk as defined in circular No. 10/2006/TTLT/BYT-BTM-BVHTT-UBDSGĐTE on 25/8/2006 on the implementation of Decree No. 21/2006/ND-CP dated 27/2/2006 of the business and the Government on the use of nutritional products for young children.
3.2. GUL (Guidance Upper Levels): maximum limit of guide Levels. This rate is applicable for the nutrients do not have enough information to assess the risk is based on science. These values are set on the basis of the nutritional requirements for children up to 12 years and data on safe use, can be adjusted based on the progress of science and technology related. The purpose of GUL is to provide guidance for manufacturers and not be understood as values that need to reach. Nutrient concentrations in the product nutrition formula for babies up to 12 months of age should not exceed the value of GUL unless a higher nutritional level due to the change of the composition of raw materials or for reasons of technology. Non-manufacturers are increasing the nutrient levels to reach the value of GUL when the form has a lower level product value GUL.
3.3. GMP (Good Manufacturing Practice): good manufacturing practices.
3.4. DHA: docosahexaenoic Acid.
3.5. IU (International Unit): the international unit.
3.6. PUFA (Poly-unsaturated Fatty Acids): unsaturated fatty acids.
II. TECHNICAL REGULATIONS 1. 1.1 basic components. General requirements 1.1.1. Raw materials and food additives put into production to ensure quality and food safety, do not contain gluten and suitable for the child's digestion to 12 months of age.
1.1.2. the nutritional safety and ability to meet the adequate nutrition of the product must be proven scientifically about the ability to support the development of children up to 12 months of age.
1.2. The energy formula nutritional products for babies up to 12 months of age (concocted according to the manufacturer's instructions for use) must meet minimum maximum units: kcal/100 ml 60 70 kJ/100 ml 250 295 1.3. Nutrition the nutritional product formula for babies up to 12 months of age (prepared according to the manufacturer's instructions for use) must meet: 1.3.1. Protein1 concentrations), 2), 3) minimum 4 units) maximum GUL notes g/100 kcal 1.8 3.0-for products made from cow's milk protein.



2.25 3.0-for products made from soy protein.



g/100 kJ 0.45 0.7-for products made from cow's milk protein.



0.5 0.7-for products made from soy protein.



Notes: 1) protein content of formula nutritional products for babies up to 12 months of age (concocted according to the manufacturer's instructions for use) are calculated by N x 6.25 (N is low). Is there scientific evidence when applying other conversion factor. Protein level specified in this regulation, based on the nitrogen conversion factor of 6.25. The value 6.38 usually set according to the specific number system suitable for the conversion of nitrogen on the protein in milk and other products worth 5.71 is the nitrogen conversion factor of protein in soy products.

2) for equal energy value, the products must contain the amount of each essential amino acid essential condition or at least equal to the amount contained in breast milk (concentration values of reference in annex 1 of this Regulation); to calculate the amounts of tyrozin and phenylalanin can be included together. If the ratio of methionine and cysteine concentrations less than 2:1 it may be included; If the ratio from 2:1 to 3:1 the relevance of this product should be demonstrated by clinical trials.

3) The single amino acid can be added to formula nutritional products for infants to age 12 months just to increase the nutritional value. Can supplement the essential amino acid essential condition or with just the amount needed in order to increase the quality of the protein. Only used the amino acid L-isomer forms.

4) If formula nutritional products for infants to age 12 months, made from milk proteins hydrolysis with small content of not more than 2 g of protein/100 kcal or prepared from protein hydrolysis with smaller concentrations of 2.25 g protein/100 kcal should be evaluated clinically.


1.3.2. The Lipid content of the maximum minimum unit GUL notes total fat 5) 6) 5) do not use the types of fats and oils have chemical hydrogen to produce nutritional products formulated for babies up to 12 months of age.

lauric Acid and mystiric acid 6) is the component of total fat but not exceeding 20% of the total fatty acids. The trans form fatty acid content of not more than 3% of the total fatty acids. Fatty acids form trans is the endogenous components of milk fat. Accept up to 3% of the fatty acids form trans to allow the use of milk fat in the product nutrition formula for babies up to 12 months of age. Erucic acid content of not more than 1% of the total fatty acids. Phospholipid concentrations are not too 300 mg/100 kcal (72 mg/100 kJ).



g/100 kcal 4.4 6.0-g/100 kJ 1.05 1.4-linoleic Acid mg/100 kcal 300-1,400 mg/100 kJ 70-330 a-linolenic Acid mg/100 kcal 50-mg/100 kJ-12--the ratio between/acid a-linolenic acid linoleic acid 5:1 16:1-1.3.3. Carbohydrates content of minimum maximum unit GUL notes total Carbohydrates 7) 7) priority use lactose and glucose molecules are the source of carbohydrates in products derived from bovine milk proteins and protein hydrolysis. Just added starch was preliminary and/or have gelatin in natural gluten-free goods to products with no more than 30% of the total number of carbohydrates and not more than 2 g/100 ml. Because of the potential risk for small children was due to the fructose intolerance hereditary, just use sucrose and fructose in the product when needed g/100 kcal 9.0 14.0-g/100 kJ 3.3 2.2-1.3.4. Vitamin minimum maximum unit GUL notes) 8 mg Vitamin A RE. 1 mg of RE = 3.33 IU vitamin A = 1 mg all-trans retinol. Retinol content must be created by the money regardless of the amount of retinol carotenoids into vitamin A in the product mg8)/100 kcal 60 180-mg8)/100 kJ 14 43-Vitamin D3 9) calculated according to the calciferol.


1 mg of calciferol = 40 IU vitamin D mg9)/100kcal 1 2.5-mg9)/100 kJ 0.25 0.6-Vitamin E 10) by a-tocopherol equivalent (a-TE).

1 mg a-TE = 1 mg of d-a-tocopherol 15) vitamin E minimum must reach 0.5 mg a-TE/g PUFA, use the following equivalent coefficient to accept vitamin E minimum for the number of double bonds of fatty acids in the product: 0.5 mg a-TE/g linoleic acid (18:2 n-6); 0.75 a-TE/g a-linolenic acid (18:3 n-3); 1.0 mg a-TE/g arachidonic acid (20:4 n-6); 1.25 mg a-TE/g eicosapentaenoic acid (20:5 n-3); 1.5 mg a-TE/g docosahexaenoic acid (22:6 n-3)/100 kcal) 0.511 mg10)-5 mg10)/100 kJ 0.1211)-1.2 mg/100 kcal 4 Vitamin K – 27 mg/100 kJ 1 – 6.5 Vitamins B1 (Thiamine) mg/100 kcal 60-300 mg/100 kJ 14-72 Vitamin B2 (Riboflavin) mg/100 kcal 80-500 mg/100 kJ 19-119) 12 Niacin12) for money niacin mg/100 kcal 300-1,500 mg/100 kJ 70



-360 mg of Vitamin B6 per 100 kcal 35-175 mg/100 kJ 8.5-45 mg/100 kcal Vitamin B12 0.1-1.5 mg/100 kJ 0.025-0.36 mg/100 kcal pantothenic Acid 400-2,000 mg/100 kJ 96-478 folic Acid mg/100 kcal 10-50 mg/100 kJ 2.5-12 Vitamin C ascorbic acid) 13-14) this level was up to large shrinkage in the ability of time using liquid products; powdered products need regulation at lower levels.



mg13)/100kcal 10-70 14) mg13)/100 kJ 2.5-17 14) of Vitamin H (Biotin) mg/100 kcal 1.5-10 mg/100 kJ 0.4-2.4 The form of vitamin supplements on the products according to the regulations of the Ministry of health. In case the provisions of the Ministry of health shall follow the instructions of the CODEX at the CAC/GL 10-1979, Rev. 1-2008 Advisory List of Mineral Salts and Vitamin compounds for Use in Foods for Infants and Children (recommended list of vitamin compounds and mineral substances used in food intended for infants and young children).
1.3.5. the content of mineral substances and trace elements maximum minimum unit GUL noted Iron mg/100 kcal 0.45 mg/100 kJ – 0.1 – – – Calcium mg/100 kcal 50-140 mg/100 kJ 12-35 Phosphorus 15) this consider GUL value the higher demand with the nutritional products for children up to 12 months of age have used soy.



mg/100 kcal



25







100(15)



mg/100 kJ



6







24(15)



Tỉ lệ calci/phospho



 



 



1 :1



2 :1







Magnesi



 



mg/100 kcal



5







15



mg/100 kJ



1,2







3,6



Natri



 



mg/100 kcal



20



60







mg/100 kJ



5



14







Clorid



 



mg/100 kcal



50



160







mg/100 kJ



12



38







Kali



 



mg/100 kcal



60



180







mg/100 kJ



14



43







Manganese mg/100 kcal 1 – 100 mg/100 kJ 0.25-24 Silica mg/100 kcal 9-60 mg/100 kJ 2.5-14 mg/100 kcal Selenium 1-9 mg/100 kJ 0.24-2.2 mg/100 kcal Bronze 35-120 mg/100 kJ 8.5-Zinc 0.5 mg/100 kcal 29-1.5 mg/100 kJ 0.12-0.36 the minerals and trace elements added to the product in accordance with the NH Department of health. In case the provisions of the Ministry of health shall follow the instructions of the CODEX at the CAC/GL 10-1979, Rev. 1-2008 Advisory List of Mineral Salts and Vitamin compounds for Use in Foods for Infants and Children (recommended list of vitamin compounds and mineral substances used in food intended for infants and young children).
1.3.6. other components of the unit the maximum minimum GUL reverse cholinergic notes mg/100 kcal 7-50 mg/100 kJ 1.7-12 Myo-inositol mg/100 kcal 3 – 40 mg/100 kJ 1 – L-carnitin 9.5 mg/100 kcal 1.2-0.3 mg/100 kJ---2. The optional component in addition to the components specified in Clause 1.3, part II of this regulation, to provide the substance usually contained in breast milk, formula nutritional products for children up to 12 years old can add the other ingredients.
In the case of supplements to have scientific evidence of safety, consistent with the nutritional needs for up to 12 months of age. The content of this component in the formula nutritional products for children up to 12 years (taking into account the available concentrations in breast milk) is sufficient to achieve effective as announced.
Specific regulations for certain optional components: minimum maximum unit GUL Taurin notes for the product have been concocted to use directly under the guidance of producer mg/100 kcal-12-mg/100 kJ-3 docosahexaenoic Acid-16) for the product have been concocted to use directly under the guidance of producer 16) If additional DHA (22:6 n-3) on nutritional products formulated for babies up to 12 months of age, the levels of arachidonic acid (20:4 n-6) not been lower levels of DHA. Levels of eicosapentaenoic acid (20:5 n-3) PUFA LC-sources there in the not greater than concentrations of DHA.



% fatty acid--0.5-used only strains of microorganisms in L (+) lactic acid.
3.-Fluorid fluorid supplements on formula nutritional products for infants to age 12 months.
-Fluorid content are defined as follows: maximum units of 100 mg/100 kcal notes for the product have been concocted to use directly under the guidance of producer mg/100 kJ 24 4. Requirements for product after processing When mixing according to the manufacturer's instructions for use directly, the products must be suitable for a child up to 12 months of age, there is the phenomenon of clumping.
5. Processing by ionizing products and raw materials are processed by ionic radiation.
6. food additives food additives used in nutritional products formulated for children up to 12 months of age as prescribed by the Ministry of health.
7. The substance contamination 7.1. Plant protection drugs residue

Products must be processed according to GMP guidelines to the defunct plant protection drugs residue (has been used in the manufacture, storage or processing of raw materials, food ingredients). In case of technical reasons still exist residual plant protection drugs then their content must be reduced to meet the maximum possible under current rules.
8.2. Melamine max units notes mg/kg 1 for formula products for children up to age 12 8.3 powder. Heavy metals in accordance with QCVN 8-2:2011/BYT national technical standards for heavy metal pollution limits in food 8.4. Mycotoxin in accordance QCVN 8-1: BYT/2011 national technical regulation for pollution limits mycotoxin in food 8.5. Other contamination substances not containing the substance contamination/unwanted substances (for example: the biologically active substances) with possible harm to the child.
Products in the scope of this regulation should comply with the maximum limit allowed in the regulations of the Ministry of health, in case the Health Ministry does not yet have specific rules shall apply in accordance with the Codex.
9. Micro-organisms as defined by QCVN 8-3:2012/BYT national technical regulation for pollution limits mycotoxin in foods.
10. Labeling The labeling formula nutritional products for babies up to 12 months of age must be in accordance with the provisions of Decree No. 89/2006/ND-CP on August 30, 2006 by the Government on goods labels, Decree No. 21/2006/ND-CP dated 27 February 2006 from the Government about the business and the use of nutritional products for small children and the writing guide and enforcement of the provisions of the law.
III. METHODS Of SAMPLING And TEST METHODS 1. Sampling sampling according to guidelines in circular 16/2009/TT-BKHCN on June 2, 2009 by the Ministry of science and technology on State inspection guidelines for the quality of goods on the market; Circular 13/TT-BYT/2011 January 4, 2011 the Ministry of health about the General guidelines on sampling inspection service, food quality, food safety and other regulations of the relevant law.
2. Test method technical requirements specified in this regulation be tried according to the method in annex 2 of this Regulation (this method does not apply, can use other equivalent test method) to check the targets not yet specified test method in this regulation The Ministry of health will rule according to the current method in the country or abroad has been confirmed the value of use.
IV. REGULATIONS On MANAGING 1. Announced combination rules 1.1. Recipe nutrition products for infants to age 12 months before the import, production, domestic business must be announced conformity in accordance with the provisions of this regulation.
1.2. Method, the sequence, the procedure announced conformity is made according to Decree No. 38/2012/ND-CP dated 25 April 2012 of the Government detailing the implementation of a number of articles of the law on food safety, circular No. 01/2012/TT-BYT of September 11 September 2012 the Ministry of health published the Guide conformity and consistent regulations publication of food safety and the other provisions of the law.
2. check the quality of the examination quality, safe product for nutrition formula for babies up to 12 months of age is made according to the provisions of the law.
V. The RESPONSIBILITY Of Individual ORGANIZATIONS 1. The Organization, individual manufacturing, importing, trading formula nutritional products for infants to age 12 months to publicize the case rules in accordance with the technical provisions in this regulation, the registration of a conformity announced at the State Agency has the authority under the decentralization of the Ministry of health and quality assurance safety, according to published content.
2. organizations, individuals, production, import, product business formula nutritional products for infants to age 12 months after registration of a published case rules and ensure the quality, safety, labelling in accordance with the provisions of the law.
VI. IMPLEMENTATION 1. The Bureau of food safety, in coordination with the relevant authorities the deployment guide and organize the implementation of this regulation.
2. Pursuant to the request of management, the Department is responsible for food safety recommendations to the Ministry of health revised and supplemented in this regulation.
3. where the criteria and rules of the law was invoked in this regulation have the change, addition or replacement shall apply according to the law.