Decree No. 21/2006/NĐ-CP On the Business and Use of Nutritional Products for Children

DECREE

Regarding the business and use of nutritional products for infants

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THE GOVERNMENT

Pursuant to the Law on Organization of the Government dated December 25, 2001;

Pursuant to the Law on Protection, Care and Education of Children dated June 15, 2004;

Pursuant to the Law on Trade dated June 14, 2005;

Based on the Advertising Ordinance dated November 16, 2001;

Pursuant to the Ordinance on Product Quality dated December 24, 1999;

Pursuant to the Ordinance on Food Safety and Hygiene dated July 26, 2003;

Considering the proposal of the Minister of Health

DECREE

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation and Applicability

1. This Decree stipulates matters concerning information, education, communication, advertising, business and use of nutritional products for infants, artificial nipple bottles and dummy teats.

2. This Decree applies to organizations and individuals within the country; foreign organizations and individuals in Vietnam.

Article 2. Interpretation of Terms

In this Decree, the following terms are understood as follows:

1. Nutritional products for infants are milk and food produced through industrial methods, meeting prescribed standards, suitable for the special physiological conditions and developmental stages of infants, including:

a) Milk and food of animal or plant origin for infants under six months old;

b) Milk for infants from six months to twenty-four months old.

2. Supplementary food is food processed to be added alongside breast milk for infants from six months to twenty-four months old.

3. Infants are children from birth to twenty-four months old.

4. Label of nutritional products for infants is an image, drawing or other description; printed, embossed writing attached to or displayed on the packaging of nutritional products for infants.

5. Sample gift of nutritional products for infants is providing a small quantity of nutritional products for infants free of charge.

6. Advertising of nutritional products for infants is an activity introducing nutritional products for infants in any form with the purpose of profit-making.

7. Medical examination and treatment facilities include general hospitals, obstetric and pediatric hospitals, maternity homes; general outpatient clinics, obstetric and pediatric clinics; regional general outpatient clinics, commune health stations, ward health stations, town health stations.

8 . Medical practitioners, healthcare personnel are those with professional qualifications in healthcare including doctors, medical assistants, nursing aides, midwives working at medical examination and treatment facilities.

Chapter II

INFORMATION, EDUCATION, COMMUNICATION AND ADVERTISING

Article 3. Information, education, and communication on the benefits of breastfeeding

1. Information, education, and communication on the benefits of breastfeeding and methods of infant care must be prioritized in programs on information, education, and communication regarding maternal and child health protection, prevention, and control of malnutrition in children.

2. The Ministry of Health shall coordinate with the Ministry of Culture, Sports and Tourism, the Ministry of Trade, the Ministry of Education and Training, the National Committee for Population, Family and Children, the Central Committee of the Vietnam Fatherland Front, the Central Committee of the Vietnam Women's Union, the Central Committee of the Ho Chi Minh Communist Youth Union, the Central Committee of the Vietnam Farmers' Association, the General Confederation of Labor of Vietnam, and other social agencies to promote and educate about the superiority of breast milk, the importance of exclusive breastfeeding, and maintaining breastfeeding up to twenty-four months or longer.

Article 4. Information, education, and communication materials on infant care

1. The content of information, education, and communication materials on infant care must be clear, easy to read and understand, ensuring objectivity and scientific accuracy.

2. Information, education, and communication materials on infant care must contain the following contents:

a) Benefits and superiority of breastfeeding, affirming that breast milk is the best food for the health and comprehensive development of infants;

b) Guidance on exclusive breastfeeding until six months of age and continuing breastfeeding until twenty-four months or longer, and introducing supplementary foods appropriately from six months of age;

c) Factors preventing infection, especially antibodies unique to breast milk which help prevent diarrhea, respiratory infections, and other infectious diseases;

d) Disadvantages of not breastfeeding;

đ) Negative impacts of bottle feeding, pacifier use, and introduction of supplementary foods before six months of age;

e) Guidance on preparing, storing, and using supplementary foods for infants at home in simple ways that ensure hygiene, safety, and appropriate nutrition using available food items.

3. Prohibition of information, education, and communication materials on infant care containing the following contents:

a) Images or texts encouraging bottle feeding or not promoting breastfeeding;

b) Comparisons stating that nutritional products for infants are equivalent or better than breast milk;

c) Names or symbols of nutritional products for infants, artificial nipple bottles, and dummy teats.

Article 5. Information-Education-Communication Materials on the Use of Nutritional Products for Infants

The information-education-communication materials on the use of nutritional products for infants must meet the following requirements:

1. Guide the correct use of nutritional products for infants.

2. Guide the cleaning and sterilization of utensils used to feed infants.

3. Guide the feeding of infants with clean and hygienic cups and spoons.

4. Potential harmful effects on the health of infants if they are fed using bottles.

5. The costs associated with feeding infants with nutritional products.

Article 6. Advertising of Nutritional Products for Infants

1. Strictly prohibit advertising infant formula for children under 12 months old, food for children under 6 months old, bottles with artificial nipples, and pacifiers in any form.

2. Advertising of milk for children aged from 12 to 24 months must comply with the following requirements:

a) The beginning of the advertisement must include the content: "Breast milk is the best food for the health and comprehensive development of infants."

b) The content of the advertisement must be consistent with the provisions of Articles 4 and 5 of this Decree and other laws on advertising.

3. Before implementing advertisements for milk for children aged from 12 to 24 months, organizations and individuals must submit registration files for advertising to the Ministry of Health in accordance with the law on advertising.

 Chapter III

BUSINESS OF NUTRITIONAL PRODUCTS FOR INFANTS

Article 7. Announcement of Quality Standards and Food Safety

Nutritional products for infants must be announced with quality standards and food safety before being put on the market, in accordance with the provisions of the law on product quality and food safety.

Article 8. Labeling Requirements for Nutritional Products for Infants

1. The label of nutritional products for infants must meet the following requirements:

a) Must have the capitalized letters: "NOTICE", followed by lowercase letters regarding the content that needs attention as follows: "Breast milk is the best food for the health and comprehensive development of infants. Antibodies, especially those found only in breast milk, help protect against diarrhea, respiratory infections, and other infectious diseases." The height of the letters must not be less than 2 mm;

b) Must have lowercase letters: "Use this product according to the doctor's instructions. Mix according to the directions. Feed the child with clean and hygienic cups and spoons." The height of the letters must not be less than 1.5 mm;

c) Must clearly indicate the appropriate age range for the product;

d) The label of the product must print the certification number for the announcement of quality standards and food safety;.

2. Other contents of the label of nutritional products for infants must comply with the regulations of the law on labeling of goods circulating domestically, exported, and imported goods, and must meet the following requirements:

a) Correct mixing instructions and simple, easy-to-understand charts in Vietnamese;

b) Fully and accurately introduce the origin, production date, expiration date, ingredients, certification number for the announcement of quality standards and food safety, and nutritional information of the product;

c) The label of the product must not contain images or drawings of children under 12 months old, bottles with artificial nipples, or pacifiers; it must not use language or images suggesting that the product is equivalent to or better than breast milk.

Article 9. Labels for baby bottles and artificial nipples

1. The label of baby bottles must meet the following requirements:

a) Must have the following text (in regular font): "Follow the correct hygiene and sterilization instructions. Using a baby bottle may cause infants to stop breastfeeding and increase the risk of diarrhea." The height of the regular font text must not be less than 2 mm;

b) Instructions on how to maintain hygiene and sterilize correctly;

c) The accurate name and address of the production facility and distributor.

2. Packaging or labels of artificial nipples must include the following text (in regular font): "Using artificial nipples can negatively affect breastfeeding." The height of the regular font text must not be less than 2 mm.

3. The provisions of paragraphs 1 and 2 of this Article apply to both domestically produced and imported baby bottles with artificial nipples.

Article 10. Responsibilities of Heads of Production and Business Facilities for Infant Nutritional Products or Their Legal Representatives

1. The heads of production and business facilities or their legal representatives are responsible for:

a) Selling infant nutritional products that ensure quality and food safety according to published standards;

b) Providing scientific information and correct usage methods for infant nutritional products to doctors and healthcare staff.

2. The heads of production and business facilities or their legal representatives shall not:

a) Organize the production or sale of infant nutritional products without published quality and food safety standards, or those that do not meet such standards, expired products, or products without labels or packaging;

b) Assign employees to directly or indirectly interact with mothers, pregnant women, or family members at medical facilities to promote or sell milk for children under 12 months old or food for children under 6 months old;

c) Organize the gift of milk for children under 12 months old or food for children under 6 months old to doctors, healthcare staff, or medical facilities; material benefits or other forms of expression bearing the name or logo of milk for children under 12 months old or food for children under 6 months old;

d) Organize the display of milk for children under 12 months old or food for children under 6 months old at medical facilities, except hospital pharmacies; apply promotional measures for milk for children under 12 months old or food for children under 6 months old;;

e) Use scholarship sponsorship, research funding, training funding, conference funding, course funding, telephone consultation services, or other forms to directly or indirectly introduce products to promote sales or use of milk for children under 12 months old or food for children under 6 months old.

Chapter IV

USE OF INFANT NUTRITIONAL PRODUCTS

Article 11. Responsibilities of Heads of Medical Examination and Treatment Facilities

1. The heads of medical examination and treatment facilities are responsible for:

a) Organizing publicity and encouraging breastfeeding;

b) Creating conditions for mothers to breastfeed within one hour after giving birth.

2. The heads of medical examination and treatment facilities shall not:

a) Organize the sale or allow the sale of milk for children under 12 months old or food for children under 6 months old at medical examination and treatment facilities, except hospital pharmacies;

b) Allow production and business facilities of infant nutritional products to display or post the names of infant nutritional products, baby bottles with artificial nipples at medical examination and treatment facilities, except hospital pharmacies.

Article 12. Responsibilities of Medical Doctors and Health Care Personnel in Medical Examination and Treatment Facilities

1. Medical doctors and health care personnel in medical examination and treatment facilities shall be responsible for:

a) Promoting and encouraging breastfeeding;

b) Guiding the correct use of nutritional products for infants, for mothers, or for family members in special cases where such products must be used.

2. Medical doctors and health care personnel in medical examination and treatment facilities shall not:

a) Directly or indirectly accept infant formula for children under 12 months old, food for children under 6 months old; material benefits or other forms of expression bearing the name or logo of infant formula for children under 12 months old given by manufacturers, traders of nutritional products for infants or their representatives;

b) Assist manufacturers, traders in distributing samples or gifts related to nutritional products for infants;

c) Advise or prescribe the use of nutritional products for infants when it is unnecessary to use such products.

Chapter V

IMPLEMENTING PROVISIONS

Article 13. Management Responsibilities

1. The Ministry of Health shall take the lead and coordinate with the Ministry of Trade, the Ministry of Culture, Sports and Tourism, the National Committee on Population, Family and Children, and relevant ministries and sectors to manage the use of nutritional products for infants; ensure quality and hygiene safety of nutritional products for infants; organize inspections and checks on the implementation of legal regulations regarding the business and use of nutritional products for infants.

2. The Ministry of Culture, Sports and Tourism shall take the lead and coordinate with the Ministry of Trade and the Ministry of Health to manage information and advertising of nutritional products for infants within their assigned authority.

Article 14. Effective Date

This Decree shall take effect fifteen days after its publication in the Official Gazette.

Repeal Decree No. 74/2000/NĐ-CP dated December 6, 2000 of the Government on Business and Use of Breast Milk Substitutes to Protect and Encourage Breastfeeding.

Article 15. Responsibility for Implementation

1. The Minister of Health shall take the lead and coordinate with the Minister of Trade, the Minister of Culture, Sports and Tourism, the Chairman of the National Committee on Population, Family and Children to guide the implementation of this Decree.

2. Ministers, Heads of ministerial-level agencies, Heads of government-affiliated agencies, Chairmen of provincial and centrally-administered city People's Committees are responsible for implementing this Decree./.