Decree No. 100/2014/ND-CP on business operations and use of nutritional products for infants, baby bottles, and artificial nipples

DECREE

Regarding the business and use of nutritional products for infants, baby bottles, and artificial nipples

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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 Advertising Law dated June 21, 2012;

Pursuant to the Food Safety Law dated June 17, 2010;

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

At the proposal of the Minister of Health,

The Government issues this Decree to regulate the business and use of nutritional products for infants, baby bottles, and artificial nipples.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Decree stipulates information, education, communication, advertising; business and use of nutritional products for infants, baby bottles, and artificial nipples; responsibilities in the business and use of nutritional products for infants aimed at reducing malnutrition rates based on encouraging and protecting breastfeeding - the best food for the health and comprehensive development of infants.

Article 2. Interpretation of Terms

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

1. Nutritional products for infants are milk substitutes and supplementary nutritional products for children under 24 months of age produced industrially, meeting specified standards, suitable for nutritional needs according to developmental stages or special physiological conditions of infants.

2. Milk substitutes for children under 24 months of age include:

a) Formula milk products in liquid or powder form made from cow's milk or other animal milk with appropriate components that can replace breast milk for children under 12 months of age (infant formula);

b) Formula milk products in liquid or powder form made from cow's milk or other animal milk with appropriate components or of animal or plant origin intended for complementary feeding for children aged 6 to 24 months (follow-up formula);

c) Other formula milk products in liquid or powder form made from cow's milk or other animal milk with appropriate components or of animal or plant origin presented or described as suitable for children under 24 months of age, but not including supplementary foods in the diet for children over 6 months of age.

3. Supplementary nutritional products (abbreviated as supplementary foods) are thick or solid foods containing all four groups of components: carbohydrates, proteins, fats, vitamins, and minerals prepared ready for consumption in addition to breast milk or milk substitutes for children under 24 months of age.

4. Infants are children from birth to 24 months of age.

5. Product labels for nutritional products for infants are written, printed, drawn, photographed characters or images affixed, printed, attached, engraved, carved directly onto goods, packaging of the product or on other materials attached to nutritional products for infants.

6. Free sample distribution of nutritional products for infants is providing a small quantity of nutritional products for infants free of charge.

7. Healthcare facilities include: General hospitals with pediatric and obstetric departments; specialized obstetric and pediatric hospitals; midwifery houses; general outpatient clinics, specialized obstetric and pediatric outpatient clinics; regional general outpatient clinics; health stations in communes, wards, towns; research institutions or nutritional counseling centers for infants.

8. Medical personnel, healthcare staff include: Doctors, medical assistants, nursing aides, midwives, nutritional counseling staff or other professional titles, including voluntary workers who work without pay at healthcare facilities.

9. Staff of production and business establishments of nutritional products for infants include: Contract employees receiving monthly salaries, sales representatives receiving commissions from enterprises, collaborators, product promotion staff for nutritional products for infants.

Chapter II

INFORMATION, EDUCATION, COMMUNICATION AND ADVERTISING

Article 3. Information, Education, and Communication on the Benefits of Breastfeeding

Information, education, and communication on the benefits of breastfeeding and methods for nurturing infants must be prioritized in programs for information, education, and communication on maternal and child health protection and improving children's nutritional status.

Article 4. Information, Education, and Communication Materials on Nurturing Infants

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

2. Information, education, and communication materials on nurturing infants must include the following content:

a) The benefits and superiority of breastfeeding, affirming that breast milk is the best food for the health and comprehensive development of infants; factors preventing infection, particularly antibodies unique to breast milk, which help prevent diarrhea, respiratory infections, and other infectious diseases;

b) Guidance on exclusively breastfeeding infants up to six months of age and continuing to breastfeed until twenty-four months or longer, introducing appropriate complementary foods from seven months of age;

c) Disadvantages of not breastfeeding and instead feeding infants with substitute milk products, such as inability to provide the immune capabilities present in breast milk, economic costs, time consumption, potential infections if formula is prepared incorrectly, and other disadvantages;

d) Negative impacts of using bottles, artificial nipples, or introducing complementary foods before six months of age;

đ) Guidance on preparing, storing, selecting, and using complementary foods at home in simple, safe, and nutritionally appropriate ways with available food items;

e) Proper nutrition for mothers to maintain sufficient breast milk production.

3. Prohibit information, education, and communication materials on nurturing infants from containing the following content:

a) Images, text, or other forms that encourage feeding infants with substitute milk products, bottle feeding, or discourage breastfeeding;

b) Comparisons suggesting that substitute milk products are equivalent to or better than breast milk;

c) Names or symbols of substitute milk products, bottles, or artificial nipples.

Article 5. Information, Education, and Communication Materials on Using Nutritional Products for Infants

The content of information, education, and communication materials on using nutritional products for infants must meet the following requirements:

1. Guidance on selecting and properly using nutritional products for infants;

2. Guidance on cleaning and sterilizing utensils used for infant feeding;

3. Guidance on feeding infants hygienically using cups and spoons;

4. Warnings about potential health risks to infants if they use artificial nipples, bottle feeding, or complementary feeding before six months of age;

5. Information on the risk of infection when infants bottle feed and when substitute milk products are not prepared and fed correctly;

6. Warning about the costliness of feeding infants with substitute milk products.

Article 6. Advertising of Nutritional Products for Infants

1. Strictly prohibit advertising substitute milk products for infants under 24 months old; supplementary food for infants under 6 months old; artificial baby bottles and pacifiers in any form; using images of fetuses or infants in advertisements for milk intended for pregnant women.

2. Advertising of supplementary food for infants under 24 months old must comply with the following requirements:

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

b) The content of the advertisement must clearly state "This product is supplementary food and should be consumed in addition to breast milk for infants over 6 months old"; in accordance with the provisions of Article 4 and Article 5 of this Decree and other laws on advertising and food safety.

3. The content, conditions, and procedures for advertising shall be carried out in accordance with the provisions of the law on advertising.

Chapter III

BUSINESS AND USE OF NUTRITIONAL PRODUCTS FOR INFANTS, ARTIFICIAL BABY BOTTLES, AND PACIFIERS

DỤNG CỤ CHO TRẺ NHỎ, TIỆN ÍCH BÌNH BÚ VÀ VÚ NGẬM NHÂN TẠO

Article 7. Declaration of Compliance and Declaration of Conformity with Food Safety Regulations

1. Nutritional products for infants must be declared as compliant or declared as conforming to food safety regulations before being put into circulation on the market, in accordance with the law on food safety.

2. The Minister of Health shall issue National Technical Regulations for infant formula nutritional products.

Article 8. Labeling Requirements for Substitute Milk Products for Infants

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

a) Must have 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. The color of the letters must be clear and contrast with the background color of the label;

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

c) Must clearly indicate the appropriate age range for children when using substitute milk products;

d) The label of substitute milk products for infants must not contain images or drawings of infants, breastfeeding mothers, baby bottles; must not use language or images suggesting that substitute milk products are equivalent to or better than breast milk or encouraging infants to use bottles; must not resemble labels for milk intended for pregnant women;

đ) On the label of substitute milk products for infants, there must be printed the receipt number for the declaration of compliance or the confirmation number for the declaration of conformity with food safety regulations.

2. Other contents of the label of substitute milk products for infants must comply with the relevant laws on labeling domestic goods, exported goods, imported goods, food safety, and must meet the following requirements:

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

b) Sanitation guidelines for mixing equipment;

c) Storage conditions, expiration date before and after opening the package.

Article 9. Labeling requirements for supplementary food for infants

1. The label of supplementary food for infants must meet the following requirements:

a) Must clearly state: "This product is supplementary food and should be consumed in addition to breast milk for infants over six months old." This statement must be on the front of the product, in capital letters, with a height of at least 2 mm. The color of the text must be clear and have a contrasting color to the background of the label.

b) Must have the word "NOTICE" in capital letters, followed by regular text regarding the content that requires attention as follows: "Breast milk is the best food for the health and comprehensive development of infants." The height of the text must not be less than 2 mm;

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

d) The product label must not contain images or drawings of infants, breastfeeding mothers, or baby bottles; it must not use language or images suggesting that the product has quality equivalent to or better than breast milk or encouraging infants to feed from bottles;

đ) The product label must print the registration number of the conformity declaration or the confirmation number of compliance with food safety regulations.

2. Other contents of the label for supplementary food for infants must comply with the legal provisions on labeling of goods circulating domestically, exported, imported, and food safety.

Article 10. Labeling requirements for artificial nipples and pacifiers

1. The label of the bottle product must meet the following requirements:

a) Must have regular text stating: "Follow proper hygiene and sterilization instructions. Using a bottle may cause infants to stop breastfeeding and increase the risk of diarrhea." The height must not be less than 2 mm. The color of the text must be clear and have a contrasting color to the background of the label;

b) Proper guidance on maintaining hygiene and sterilization;

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

2. Packaging or labels of artificial nipples must have regular text stating: "Using an artificial nipple can negatively affect breastfeeding." The height must not be less than 2 mm. The color of the text must be clear and have a contrasting color to the background of the label.

3. The label of bottle products and artificial nipples must not contain images or drawings of newborns and infants, breastfeeding mothers, or images and language suggesting that the product resembles a mother's nipple.

4. The labeling requirements for bottle products and artificial nipples specified in Clause 1, 2, and 3 of this Article apply to both domestically produced and imported bottle products and artificial nipples.

Chapter IV

RESPONSIBILITIES IN THE SALE AND USE OF

SUPPLEMENTARY FOOD FOR INFANTS

Article 11. Responsibilities of producers and traders of supplementary food for infants

1. Producers and traders have the responsibility to:

a) Sell supplementary food for infants that meet quality and food safety standards as published;

b) Provide accurate, scientific information and proper usage methods for supplementary food for infants in accordance with Articles 4 and 5 of this Decree to healthcare professionals, medical staff, and consumers.

2. Producers and traders shall not:

a) Organize the production and sale of supplementary food for infants that do not comply with published standards or specifications; expired products; products without labels or packaging;

b) Send employees to directly or indirectly contact pregnant women, mothers, or family members at healthcare facilities or outside healthcare facilities for the purpose of advertising, promoting, or encouraging the use of milk substitutes instead of breast milk;

c) Display milk substitutes or supplementary food for infants under six months old at healthcare facilities; display the name and logo of milk substitutes on banners, posters, and other promotional materials in supermarkets, retail stores, and healthcare facilities;

d) Implement promotional activities for milk substitutes such as giving out free samples, discount coupons, prizes, gifts, loyalty points, discounts, or any other form;

đ) Use scholarship funding, research funding, training funding, conference funding, seminar funding, course funding, concert funding, competition funding, drama funding, film funding, video clip funding, telephone consultation services, or any other form to promote the sale or use of milk substitutes;

e) Conduct or support information, education, and communication related to infant feeding aimed at promoting the sale or use of milk substitutes.

Article 12. Responsibilities of Healthcare Facilities

1. Healthcare facilities shall be responsible for:

a) Organizing the implementation of measures to provide breastfeeding counseling for pregnant women, mothers with infants, and family members;

b) Organizing propaganda, hanging posters, displaying banners, or broadcasting images containing the provisions stipulated in Articles 4 and 5 of this Decree in antenatal clinics, waiting rooms, postpartum rooms, nutrition counseling rooms, or other places easily observed by pregnant women, mothers with infants, and their family members;

c) Creating conditions for mothers to breastfeed their infants within the first hour after birth, exclusively breastfeed for the first six months, and continue breastfeeding for up to twenty-four months or longer.

2. Healthcare facilities shall not:

a) Organize the sale or permit the sale of breast milk substitutes at healthcare facilities, except in hospital pharmacies;

b) Permit manufacturers or traders of breast milk substitutes to display or advertise any items or equipment bearing the name or logo of breast milk substitutes, bottles, or artificial nipples at healthcare facilities;

c) Permit employees of manufacturers or traders of breast milk substitutes to contact mothers with infants or pregnant women in any form;

d) Accept breast milk substitutes; material benefits; items bearing the name or logo of breast milk substitutes given by manufacturers or traders.

Article 13. Responsibilities of Physicians and Healthcare Staff in Healthcare Facilities

1. Physicians and healthcare staff in healthcare facilities shall be responsible for:

a) Encouraging, supporting, and protecting breastfeeding; understanding and strictly implementing the provisions of this Decree;

b) Providing information to mothers with infants and pregnant women about the benefits of breastfeeding and how to do it;

c) Assisting mothers to breastfeed within the first hour after giving birth;

d) Guiding mothers on how to breastfeed and maintain their milk supply even when they are away from their infants;

đ) Advising mothers and family members to exclusively breastfeed for the first six months;

e) Guiding and assisting mothers to stay close to their infants immediately after giving birth;

g) Encouraging mothers to breastfeed on demand;

h) Guiding mothers and family members not to give infants bottles or artificial nipples;

i) Encouraging the establishment of breastfeeding support groups and introducing mothers to these groups upon discharge from the hospital;

k) Prescribing cases where infants must use breast milk substitutes.

2. Physicians and healthcare staff in healthcare facilities shall not:

a) Guide infants under six months old to use breast milk substitutes, except in cases prescribed by a physician;

b) Inform pregnant women, mothers with infants, or their family members that feeding infants breast milk substitutes is equivalent or better than breastfeeding;

c) Directly or indirectly accept breast milk substitutes; material benefits; items bearing the name or logo of breast milk substitutes;

d) Permit manufacturers or traders to give samples or gifts related to breast milk substitutes;

đ) Provide lists of names, ages, addresses, and contact phone numbers of mothers with infants or pregnant women to employees of manufacturers or traders of breast milk substitutes or permit employees of manufacturers or traders of breast milk substitutes to contact pregnant women or mothers with infants at healthcare facilities.

Article 14. Management Responsibility

1. The Ministry of Health, relevant ministries, sectors, People's Committees at all levels within their respective duties and powers shall be responsible for managing the use of nutritional products for infants; managing the quality and safety of nutritional products for infants; organizing inspections and checks on the implementation of legal provisions regarding the business and use of nutritional products for infants, baby bottles, and artificial nipples.

2. The Ministry of Culture, Sports and Tourism shall take the lead and coordinate with the Ministry of Health, the Ministry of Industry and Trade, and the Ministry of Information and Communications to manage information and advertising of nutritional products for infants in accordance with the law.

3. The Ministry of Health shall take the lead and coordinate with the Vietnam Women's Union Central Committee, political-social organizations, and social organizations to organize propaganda and guidance on the implementation of legal provisions regarding the business and use of nutritional products for infants, baby bottles, and artificial nipples for pregnant women, mothers, and family members.

Chapter V

IMPLEMENTING PROVISIONS

Article 15. Implementation Provisions

1. This Decree takes effect from March 1, 2015.

2. The Government Decree No. 21/2006/NĐ-CP dated February 27, 2006 on the business and use of nutritional products for infants shall cease to be effective from the date this Decree takes effect.

3. Nutritional products for infants currently circulating in the market may continue to circulate until their expiration date as indicated on the product packaging.

Article 16. Responsibility for Implementation

Clause 1. The Minister of Health shall be responsible for guiding and organizing the implementation of this Decree.

2. Ministers, heads of ministerial-level agencies, heads of government agencies, Chairpersons of People's Committees at all levels; related agencies, organizations, and individuals shall be responsible for implementing this Decree./.