Thông tư 22/2012/TT-BYT về 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 do Bộ trưởng Bộ Y tế ban hành

CIRCULAR

ISSUING NATIONAL TECHNICAL REGULATION ONFOLLOW-UP FORMULAS 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 follow-up formulas for infants from 6th month on and young children up to 36 months of age;

Article 1. Issuing together with this Circular:

QCVN 11-3:2012/BYT - National technical regulation onfollow-up formulas 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.

QCVN 11-3:2012/BYT

NATIONAL TECHNICAL REGULATION

ON FOLLOW-UP FORMULAS FOR INFANTS FROM 6TH MONTH ON AND YOUNG CHILDREN UP TO 36 MONTHS OF AGE

FOREWORD

QCVN 11-3:2012/BYT is written by the Drafting Committee of national technical regulations on food for infantss and young children, submitted for approval by the Department of Food Safety and issued under Circular No. 22/2012 / TT-BYT dated November 15, 2012 by the Minister of Health.

NATIONAL TECHNICAL REGULATION

ON FOLLOW-UP FORMULAS 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 follow-up formulas for infants from 6th month on and young children up to 36 months of age.

2. Subjects of application

This regulation applies to:

2.1. Organizations and individuals importing, producing and trading the follow-up formulas 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 follow-up formulas for infants from 6th month on and young children up to 36 months of age (hereafter referred to as product): The product is in powder or liquid form and made from:

- Cow's milk or other dairy animals and (or);

- Ingredients are derived from animals and plants.

The product must meet nutritional needs for the normal development of infants from 6th month on and young children up to 36 months of age. The liquid product can be used directly or diluted with water before use, the powder product must be mixed with water before use.

- GMP:Good Manufacturing Practice

- CODEX: Codex Alimentarius Commission

- IU: International Unit:

- RE: Retinol Equivalent

II. TECHNICAL REGULATION

1. Basic ingredients

1.1. General requirements

1.1.1. Materials and food additives put into production must ensure the quality and food safety and hygiene and be appropriate for the digestion of infants from 6th month on and young children up to 36 months of age.

1.1.2. The product is made from:

- Cow’s milk or other animal’s milk and (or);

- Preparations of animal protein and (or) vegetable (proven suitable for infants from 6th month on and young children up to 36 months of age);

- Other materials necessary to meet the requirements for the products specified in Clause 1.2 and 1.3, Part II of this Regulation.

1.1.3. The product having basic ingredient of milk is made from materials specified at Point 1.1.2, Part II of this Regulation must ensure that 100 kcal of product (prepared according to the manufacturer's instructions for direct use) contain at least 3g of protein (or 0,7 g/100 kJ) originating from skimmed milk and full cream milk and accounts for at least 90% of the total protein amount in the product, the protein content can be regulated, but the content of vitamins and minerals in milk must not be reduced.

1.2. Energy

The product (prepared according to the manufacturer's instructions for direct use) must meet:

1.3. Nutrient ingrdients

The product (prepared according to the manufacturer's instructions for direct use) must meet:

1.3.1. Protein content

The essential amino acid may be supplemented to improve the nutritional value of the product. In this case, only supplementing essential amino acid of L isomer shape with sufficient content to improve protein quality.

1.3.2. Lipid content

1.3.3. Carbohydrate content

The carbohydrate in product must:

- Be suitable for infants from 6th month on and young children up to 36 months of age,

- The content meeting the requirements for energy specified in Clause 1.2, Part II of this Regulation (taking into account the energy from protein and fat in the product).

1.3.4. Vitamin content

The forms of vitamin supplemented into the product 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. Mineral content

The forms of mineral supplemented into the product 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 vitamins and minerals specified at Point 1.3.4 và 1.3.5, Part II of this Regulation, the product may be supplemented with other nutritional ingredients to suit with the mixed ration of infants from 6th month on and young children up to 36 months of age. The effect of these nutrients must be proven scientifically. The nutrients supplemented into the product must have sufficient content to meet the needs of infants from 6th month on and young children up to 36 months of age.

3. Requirements for product after preparation

After preparation according to the manufacturer's instructions, the product must not have clotting phenomenon.

4. Treated with ionizing radiation

The product and materials must not be treated with ionizing radiation.

5. Food additives

The food additives used in the follw-up formulas 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.

6. Contaminant

6.1. 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.

6.2. Melamin

6.3. Heavy metal

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

6.4. Fungal toxin

As prescribed by QCVN 8-1:2011/BYT - National technical standards for limit of fungal toxin in food.

6.5. Other contaminants

No containing of residue of hormones, antibiotic and other pollutants is allowed, especially substances with pharmaceutical characteristics.

7. Microorganism

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

8. 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 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.

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.

2. Method of testing

The technical requirements prescribed in this Regulation are in accordance with the methods in Annex 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 follow-up formulas 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 follow-up formulas for infants from 6th month on and young children up to 36 months of age must comply with regulations of law.

V. RESPONSIBILITIES OF ORGANIZATIONS AND INDIVIDUALS

1. Organizations and individuals producing, importing and trading the follow-up formulas 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 follow-up formulas 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

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

LIST OF TESTING METHOD OF FOOD SAFETY INDICATORS FOR FOLLOW-UP FORMULAS FOR INFANTS FROM 6TH MONTH ON AND YOUNG CHILDREN UP TO 36 MONTHS OF AGE

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