Circular 22/2012/tt-Byt: Enactment Of National Technical Regulation For Nutritional Products Formulated With The Aim Of Additional Food For Babies From 6 To 36 Months Old

Original Language Title: Thông tư 22/2012/TT-BYT: Ban hành Quy chuẩn kỹ thuật quốc gia đối với sản phẩm dinh dưỡng công thức với mục đích ăn bổ sung cho trẻ từ 6 đến 36 tháng tuổi

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The CIRCULAR issued to national technical regulation for nutritional products formulated with the aim of additional food for babies from 6 to 36 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 products;
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 products formulated with the aim of additional food for babies from 6 to 36 months of age.
Article 1. Attached to this circular: QCVN 11-3:2012/BYT-national technical regulation for nutritional products formulated with the aim of additional food for babies from 6 to 36 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 PRODUCTS FORMULATED with the AIM of ADDITIONAL FOOD for BABIES from 6 to 36 MONTHS OLD National technical regulation on follow-up formula (for infant from 6th month on and young children up to 36 months of age) i. GENERAL PROVISIONS 1. Scope this regulation regulates the quality criteria, food safety and the requirements for the management of nutritional products formulated with the aim of additional food for babies from 6 to 36 months of age.
2. The object of applying this Regulation applies to: 2.1. The organizations and individuals who produce, import, business formula nutritional products with the aim of additional food for babies from 6 to 36 months of age in Vietnam;
2.2. the management authority of the State concerned.
3. Explanation of terms and symbols written off In this regulation, the terms and abbreviation notation here is understood as follows: 3.1. Nutritional products formulated with the aim of additional food for babies from 6 to 36 months of age (hereafter referred to as products): product in powder form or liquid form, made from cow's milk or milk:-other animals and (or);
-The ingredients of animal origin, plant.
Products must meet the nutritional needs for the normal development of children from 6 to 36 months of age. Liquid product can be used directly or diluted with the country before use; powdered products must be mixed with water before use.
-GMP (Good Manufacturing Practice): good manufacturing practices.
-CODEX: Standardization Committee of international food.
-IU (International Unit): the international unit.
-RE (Retinol Equivalent): Retinol equivalent.
II. TECHNICAL REGULATIONS 1. 1.1 basic components. General requirements 1.1.1. Raw materials and additives in food production to ensure quality, food safety and hygiene; at the same time appropriate for the child's digestive from 6 to 36 months of age.
1.1.2. The product is made from cow's milk or milk:-other animals and (or);
-Preparations for animal protein and (or) plant (proven with from 6 to 36 months);
-Other raw materials needed to achieve the requirements for products specified in Clause 1.2 and 1.3, part II of this regulation.
1.1.3. basic components products is milk produced from materials specified in point 1.1.2, part II of this regulation and to ensure 100 kcal in products (dispensing according to the manufacturer's instructions for use directly) contains at least 3 g of protein (or 0.7 g/100 kJ) is derived from milk fat raw milk, cream and constitute a minimum of 90% of the total protein in the product; can adjust the amount of protein but not decrease the amount of vitamins and minerals in milk.
1.2. Energy product (concocted according to the manufacturer's instructions for use) must meet minimum maximum units: kcal/100 ml 60 85 kJ/100 ml 250 355 1.3. Nutrition products (dispensing according to the manufacturer's instructions for use) must meet: 1.3.1. The protein content of the minimum unit (1) with maximum note g/100 kcal 3.0 5.5 (1) proteins in nutrition-quality products comparable with casein; use cases for other protein nutritional quality is lower than casein protein amounts are increases inversely with quality nutrition. Nutritional quality of not lower than 85% protein compared to casein.



g/100 kJ 0.7 1.3 can supplement the essential amino acid to improve the nutritional value of the product. In this case, only an outhouse are supplemented essential amino acid L-isomer form to sufficient content in order to improve the quality of the protein.
1.3.2. the lipid content of the unit the maximum minimum total fat g/100 kcal 3.0 6.0 g/100 kJ 0.7 1.4 linoleic Acid (in the form of glycerid) mg/100 kcal 300-mg/100 kJ 71.7-1.3.3. Carbohydrates Carbohydrates content in the product is:-match the Digest of the child from 6 to 36 months of age,-meet energy requirements specified in Clause 1.2, part II of this Regulation (as energy from proteins and fats in products).
1.3.4. vitamin minimum maximum unit notes Vitamin A IU/100 kcal 250 750 mg 75 225 IU/100 kcal/100 RE kJ 60 180 mg RE/100 kJ 18 54 Vitamin D IU/100 kcal 40 120 mg/100 kcal 1 3 IU/100 kJ 10 30 mg/100 kJ 0.25 0.75 Vitamin E (a-tocopherol compounds) (2) Containing a minimum of 0.7 IU/g linoleic acid or 0.7 IU/g acid yet maximum saturation by linoleic acid IU/100 kcal (2)-0.7 IU/100 kJ 0.15 (2)-Vitamin C (ascorbic acid) mg/100 kcal 8.0-1.9 mg/100 kJ-Vitamin B1 (thiamine) mg/100 kcal 40-mg/100 kJ 10-Vitamin B2 (riboflavin) mg/100 kcal 60-mg/100 kJ 14-Nicotinamide mg/100 kcal 250-mg/100 kJ 60-Vitamin B6 (3) Containing a minimum of 15 mg of vitamin B6, mg/100 kcal protein 45 g (3)-mg/100 kJ



11 (3)-folic Acid mg/100 kcal 3-mg/100 kJ 1 – 300 mg/100 kcal pantothenic Acid-mg/100 kJ 70-Vitamin B12 mg/100 kcal-0.15 mg/100 kJ-Vitamin K1 0.04 mg/100 kcal 3-mg/100 kJ 1 – Vitamin H (Biotin) mg/100 kcal 1.5-mg/100 kJ 0.4-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 salts used in food intended for infants and young children).
1.3.5. mineral substances content units maximum minimum note Sodium mg/100 kcal 20 85 mg/100 kJ 5 21 Potassium mg/100 kcal 80-mg/100 kJ-20 Clorid mg/100 kcal 55-mg/100 kJ 14-Calci mg/100 kcal 90-mg/100 kJ-22 mg/100 kcal in phosphorus 60-mg/100 kJ calcium/phosphorus ratio-14 1.0 2.0




Magnesium mg/100 kcal 6.0-mg/100 kJ-1.4 mg Iron/100 kcal 1.0 2.0 mg/100 kJ 0.25 0.50 Silica mg/100 kcal 5.0-mg/100 kJ zinc-1.2 mg/100 kcal 0.5-mg/100 kJ 0.12-The minerals form added to the product as defined by 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 salts used in food intended for infants and young children).
2. optional components in addition of vitamins and minerals specified in Point 1.3.4 and 1.3.5, part II of this regulation, products can be supplemented with other nutritional ingredients to fit the diet of children from 6 to 36 months of age. The effect of this nutrient must be proven scientifically. The nutrients added to food to have enough content to meet the needs of children from 6 to 36 months of age.
3. Requirements for the product after processing after blending it according to the manual of the manufacturer, the product is non clumping phenomenon.
4. Processed by non-ionizing radiation is handled by ion for products and raw materials for production.
5. food additives food additives used in nutritional products formulated with the aim of additional food for babies from 6 to 36 months of age as prescribed by the Ministry of health.
6. contaminated Substances 6.1. Residues of medicines and plant protection 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.
6.2. maximum Level unit Melamine notes mg/kg 2.5 6.3 products. Heavy metals As QCVN 8-2:2011/BYT national technical standards for heavy metal pollution limits in food.
6.4. Mycotoxin By QCVN 8-1: BYT/2011 national technical regulation for pollution limits mycotoxin in foods.
6.5. The other contamination must not contain substances exist residual hormones, antibiotics and other pollutants, especially not contain medicinal substances.
7. Micro-organisms according to QCVN 8-3:2012/BYT national technical standards for microorganisms pollution limits in food.
8. Labeling The labeling of nutritional products formulated with the aim of additional food for babies from 6 to 36 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, documents guiding the implementation of laws and regulations.
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 methods in the annex of this Regulation (this method does not apply, can use other equivalent test method).
In case of need to check the norms are not yet defined in this regulation test method, 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. Nutritional products formulated with the aim of additional food for babies from 6 to 36 months old prior to import, manufacture, 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 for the quality checking of the quality, safety and hygiene for the nutritional products formulated with the aim of additional food for babies from 6 to 36 months of age must be made according to the provisions of the law.
V. The RESPONSIBILITY Of Individual ORGANIZATIONS 1. The Organization, the individual production, imports, sales of nutritional products formulated with the aim of additional food for babies from 6 to 36 months of age must publish conformity 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 and individuals just be production, imports, sales of nutritional products formulated with the aim of additional food for babies from 6 to 36 months old after completing registration of a published case rules and ensure the quality, safety, labelling in accordance with the provisions of the law.
V. 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 text.