Nghị định 100/2014/NĐ-CP quy định về kinh doanh và sử dụng sản phẩm dinh dưỡng dùng cho trẻ nhỏ, bình bú và vú ngâm nhân tạo

THE GOVERNMENT -------	THE SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom – Happiness ----------------
No. 100/2014/ND-CP	Hanoi, November 6, 2014

 

DECREE

ON THE TRADING IN AND USE OF NUTRITIOUS PRODUCTS FOR INFANTS, FEEDING BOTTLES AND TEATS

THE GOVERNMENT

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

Pursuant to the June 15, 2004 Law on Child Protection, Care and Education;

Pursuant to the June 21, 2012 Law on Advertising; Pursuant to the June 17, 2010 Law on Food Safety; Pursuant to the June 14, 2005 Commercial Law;

At the proposal of the Minister of Health,

The Government promulgates the Decree on the trading in and use of nutritious products for infants, feeding bottles and teats.

Chapter I 

GENERAL PROVISIONS

Article 1. Scope of regulation

This Decree prescribes information, education, communication, advertising for, trading in and use of nutritious products for infants, feeding bottles and teats; responsibilities in trading in, and use of, nutritious products for infants so as to reduce the malnutrition rate based on the promotion and protection of breastfeeding - the best for the health and all-sided growth of infants.

Article 2. Interpretation of terms

In this Decree, the terms below are construed as follows:

1. Nutritious products for infants include breast milk substitutes and nutritious complementary foods for under 24-month infants produced by industrial methods, which are up to the set standards and suitable to nutritional needs of each growth stage or special physiological conditions of infants.

2. Breast milk substitutes for under-24 month infants include:

a/ Liquid or powdered infant formulas made from milk of cows or other animals and containing appropriate ingredients which may be used to substitute breast milk for under-12 month infants;

b/ Liquid or powdered follow-up formulas made from milk of cows or other animals and containing appropriate ingredients or animal- or plant- derived ingredients which may be used for infants aged 6-24 months during the complementary feeding period;

c/ Other liquid or powdered follow-up formulas made from milk of cows or other animals and containing appropriate ingredients or animal- or plant- derived ingredients which are presented or introduced as suitable to under-24 month infants but are not included in complementary foods in the nutritional structure for infants aged over 6 months.

3. Nutritious complementary foods (below referred to as complementary foods) means ready-made semi-solid or solid foods containing 4 groups of ingredients: carbonhydrates, proteins, fats and vitamins and minerals for additional use together with breast milk or breast milk substitutes for under-24 month infants.

4. Infant means a child who is under 24 months old.

5. Label of nutritious product for infants means a writing, print, drawing or photocopy of characters and images stuck, printed, appended, cast or engraved directly on goods and commercial packages of products or on other materials affixed on the nutritious product for infants and commercial packages thereof.

6. Giving of samples of nutritious products for infants means free-of- charge supply of a small quantity of nutritious products for infants.

7. Medical establishments include general hospitals having obstetrics and pediatrics departments; obstetrics and pediatrics specialized hospitals; maternity homes; general clinics and obstetrics and pediatrics clinics; regional general clinics; commune, ward and township health stations; infant nutrition research establishments or infant nutrition counseling establishments.

8. Physicians and medical workers include doctors, intermediate-level physicians, convalescence workers, midwives, nutrition counselors and persons holding other professional titles, including unpaid voluntary workers in medical establishments.

9. Employees of establishments producing and trading in nutritious products for infants include monthly-paid contract workers, salesperson enjoying enterprises’ commissions, collaborators, and sales promoters of nutritious products for infants.

Chapter II

INFORMATION, EDUCATION, COMMUNICATIONS AND ADVERTISING

Article 3. Information, education and communications about benefits of breastfeeding

Information, education and communications about benefits of breastfeeding and on infant nurturing methods must be prioritized in programs on information, education and communications about mother and child health protection and infant nutrition improvement.

Article 4. Information, education and communications documents on nurturing infants

1. Contents of information, education and communications documents on nurturing infants must be clear, easy to read and understand, objective and scientific.

2. Information, education and communications documents on nurturing infants must have the following contents:

a/ Benefits and superiority of breastfeeding, affirming that breast milk is the best food for the health and all-sided growth of infants; antibacterial elements, especially antibodies, only present in breast milk, which help prevent and control diarrhea, respiratory infections and some other infectious diseases;

b/ Instructions on infant breastfeeding until full 6 months of age and continued breastfeeding until at least full 24 months of age, and proper and rational feeding of infants with complementary foods when they reach 7 months;

c/ Disadvantages of feeding infants with breast milk substitutes instead of breast milk, such as providing infants with no immunological elements which can be found only in breast milk, requiring more money and time, possible child infection in case of improper preparation, and other disadvantages;

d/ Adverse impacts of bottle-feeding, use of teats and complementary foods on infants aged under 6 months;

dd/ Instructions on simple preparation, storage, selection and use of complementary foods at home for infants, ensuring safety and rational nutrition with available foods;

e/ Rational nutrition for mothers to maintain their breast milk.

3. Information, education and communications documents on nurturing infants which have the following contents are banned:

a/ Images, words or other communications forms to encourage the use of breast milk substitutes or bottle feeding or discourage breast feeding;

b/ Comparisons leading to the conclusion that breast milk substitutes are as good as or better than breast milk;

c/ Names or logos of breast milk substitutes, feeding bottles and teats.

Article 5. Information, education and communications documents on the use of nutritious products for infants

Contents of information, education and communications documents on the use of nutritious products for infants must:

1. Provide instructions on the selection and use of nutritious products for infants.

2. Provide instructions on the cleaning and sterilization of infant feeding utensils.

3. Provide instructions on the feeding of infants using clean cups and spoons.

4. Give cautions about possible harms to infants’ health caused by teats, bottle feeding or complementary foods when they are under 6 months.

5. Provide information on possible infections caused by bottle feeding and inproper preparation of and feeding with breast milk substitutes.

6. Give cautions about high costs of infant feeding with breast milk substitutes.

Article 6. Advertising of nutritious products for infants

1. To strictly prohibit the advertising of breast milk substitutes for under-24 month infants; complementary foods for under-6 month infants; feeding bottles and teats in any forms; the use of fetus or infant images in advertisements for milk for pregnant women.

2. The advertising of complementary foods for under-24 month infants must satisfy the following requirements:

a/ The first part of the advertisement must have the phrase “Breast milk is the best food for health and all-sided growth of infants”;

b/ Advertising contents must clearly state “This product is a complementary food and may be used as a supplement to breast milk for infants over 6 months”; and comply with Articles 4 and 5 of this Decree and the laws on advertising and food safety.

3. Advertising contents, conditions and procedures must comply with the law on advertising.

Chapter III

TRADING AND USE OF NUTRITIOUS PRODUCTS FOR INFANTS, FEEDING BOTTLES AND TEATS

Article 7. Announcement of regulation conformity and conformity with food safety regulations

1. Nutritious products for infants, before being marketed, must be subject to regulation conformity and conformity with regulations on food safety in accordance with the law on food safety.

2. The Minister of Health promulgates the national technical regulations for infant formulas.

Article 8. Labels of breast milk substitutes for infants

1. The label of a breast milk substitute for infants must satisfy the following requirements:

a/ Having the words “CHU Y” (Attention) in upper case, followed by the following phrases in lower case: “Breast milk is the best food for the health and all-sided growth of infants. Antibacterial elements, especially antibodies, only present in breast milk, help prevent and control diarrhea, respiratory infections and some other infectious diseases”. The height of characters must be at least 2 mm. The color of characters must be bright and contrast with the background color of the label;

b/ Having the following phrases in lower case: “Use this product only under physician’s instructions. Strictly follow the preparation instructions. Feed children with clean cups and spoons”. The height of characters must be at least 1.5mm;

c/ Clearly writing infant age group suitable to the breast milk substitute;

d/ Having no images or drawings of infants, breastfeeding mothers and feeding bottles; no words or images implying that the breast milk substitute is as good as or better than breast milk in quality or encouraging bottle feeding; no images similar to those of labels of milk for pregnant women;

dd/ Being printed with the number of the receipt of the written announcement of regulation conformity or the number of the certificate of announcement of conformity with food safety regulations.

2. Other contents of labels of breast milk substitutes must comply with the law on labeling of domestically circulated, imported or exported goods and food safety, and must:

a/ Provide proper instructions on preparation, illustrated with simple and easy-to-understand tables in Vietnamese;

b/ Provide instructions on the cleaning of preparation utensils;

c/ Specify storage conditions, and state expiry date before and after opening.

Article 9. Labels of complementary foods for infants

1. The label of a complementary food for infants must satisfy the following requirements:

a/ Clearly stating that “This product is complementary food and may be used as a supplement to breast milk for infants over 6 months”. This phrase must be presented in uppercase words of the size of at least 2 mm and displayed in the front of the product. The color of characters must be bright and contrast with the background color of the label;

b/ Having the words “CHU Y” (Attention) in upper case, followed by the following phrases in lower case: “Breast milk is the best food for the health and all-sided growth of infants”. The height of characters must be at least 2 mm;

c/ Clearly writing the infant age group suitable to the product;

d/ Having no images or drawings of infants, breastfeeding mothers and feeding bottles; no words or images implying that the product is as good as or better than breast milk in quality or encouraging bottle feeding;

dd/ Being printed with the number of the receipt of the written announcement of regulation conformity or the number of the certificate of announcement of conformity with food safety regulations.

2. Other contents of labels of complementary foods for infants must comply with the law on labeling of domestically circulated, imported or exported goods and food safety

Article 10. Labels of feeding bottles and teats

1. The label of a feeding bottle product must satisfy the following requirements:

a/ Having the following phrases in lower case “Strictly follow the instructions on hygiene and sterilization. The use of feeding bottles may make children refuse breast feeding, or cause diarrhea.” The height of characters must be at least 2 mm. The color of characters must be bright and contrast with the background color of the label.

b/ Providing proper instructions on hygiene-keeping and sterilization;

c/ Having accurate names and addresses of the producer and distributor.

2. Packages or labels of teats must display the following phrase in lower case: “Use of teats may negatively affect breast feeding.” The height of characters must be at least 2 mm. The color of characters must be bright and contrast with the background color of the label.

3. Labels of feeding bottles and teats must not contain images or drawings of newborns and infants, breastfeeding mothers; images and words implying that these products are similar to the mother’s nipples.

4. Regulations on labels of feeding bottles and teats in Clauses 1, 2 and

3 of this Article apply to both domestically made and imported feeding bottles and teats.

Chapter IV

RESPONSIBILITIES IN TRADING AND USE OF NUTRITIOUS PRODUCTS FOR INFANTS

Article 11. Responsibilities of establishments producing and trading in nutritious products for infants

1. Production and business establishments shall:

a/ Sell nutritious products for infants which meet the published food quality and safety regulations and standards;

b/ Provide accurate and scientific information on and proper usage of nutritious products for infants to physicians, medical workers and consumers under Articles 4 and 5 of this Decree.

2. Production and business establishments may not:

a/ Produce or trade in nutritious products for infants which fail to meet the published regulations or standards; or trade in products with expired use duration or without labels or packages;

b/ Send their employees to directly or indirectly contact mothers, pregnant women or members of their families at or outside medical establishments in order to advertise, disseminate and encourage the use of breast milk substitutes;

c/ Display breast milk substitutes or complementary foods for under-6 month infants at medical establishments; display names or logos of breast milk substitutes on banners, posters and other leaflets in supermarkets, retail stores and medical establishments;

d/ Apply sales promotion measures for breast milk substitutes such as giving free samples, coupons, rewards, gifts, point accumulation for rewards, discount or any other forms;

dd/ Grant scholarships, provide funds for scientific research, training courses, conferences, workshops, music concerts, contests, stage performances, making of films or video clips, telephone counseling services or other forms in order to disseminate and introduce products, promote the sales or use of breast milk substitutes;

e/ Provide or support the provision of information, education and communications about infant nurturing so as to disseminate, introduce and promote the sales and use of breast milk substitutes.

Article 12. Responsibilities of medical establishments

1. Medical establishments shall:

a/ Provide counseling about breastfeeding to pregnant women, nursing mothers and members of their families;

b/ Disseminate, put up panels and posters or broadcast images with contents prescribed in Articles 4 and 5 of this Decree at antenatal clinics, labor and delivery clinics, postpartum rooms, nutrition counseling clinics or easy-to-notice places or places where concentrate pregnant women, nursing mothers and members of their families;

c/ Create conditions for mothers to feed their newborns within the first hour after birth, exclusively breastfeed for the first six months of life, and continue breastfeeding until 24 months and beyond.

2. Medical establishments may not:

a/ Sell, or permit the sale of, breast milk substitutes at medical establishments, except hospital drugstores;

b/ Permit establishments producing or trading in breast milk substitutes to display or post up any utensils or equipment bearing names or logos of breast milk substitutes, feeding bottles and teats at medical establishments;

c/ Permit employees of establishments producing or trading in breast milk substitutes to meet or contact nursing mothers and pregnant mothers in any forms;

d/ Receive breast milk substitutes; material benefits; utensils bearing names or logos of breast milk substitutes which are given by production and business establishments.

Article 13. Responsibilities of physicians and medical workers of medical establishments

1. Physicians and medical workers of medical establishments shall:

a/ Promote, support and protect breastfeeding; understand and strictly comply with this Decree;

b/ Inform nursing mothers and pregnant women of the benefits of breastfeeding and ways of breastfeeding and proper breastfeeding positions;

c/ Help mothers breastfeed their newborns within the first hour after birth;

d/ Give mothers guidance on proper breastfeeding positions and maintain their breast milk when they are far from their infants;

dd/ Counsel mothers and members of their families about exclusive breastfeeding for the first 6 months of life;

e/ Guide and help mothers stay close to their newborns right after birth;

g/ Encourage mothers to breastfeed infants as desired;

h/ Guide mothers and members of their families neither to bottle feed nor use teats;

i/ Encourage the establishment of breastfeeding support groups and introduce mothers to the groups after they are discharged from hospitals;

k/ Identify infants that have to use breast milk substitutes.

2. Physicians and medical workers in medical establishments may not:

a/ Guide the use of breast milk substitutes for under-6 month infants, except the case prescribed by doctors;

b/ Inform pregnant women, nursing mothers or members of their families that breast milk substitutes are as good as or better than breast milk;

c/ Receive directly or indirectly breast milk substitutes, other material benefits or utensils bearing names or logos of breast milk substitutes;

d/ Help production and business establishments give sample products or gifts related to breast milk substitutes;

dd/ Provide lists of names, ages, addresses and telephone numbers of nursing mothers and pregnant women to employees of breast milk substitute production and business establishments or permit them to meet pregnant women and nursing mothers at medical establishments.

Article 14. Management responsibilities

1. The Ministry of Health and other ministries and sectors, the People’s Committees at all levels shall, within the ambit of their tasks and powers, manage the use of nutritious products for infants; manage quality and safety of nutritious products for infants; inspect and examine the implementation of regulations on trading and use of nutritious products for infants, feeding bottles and teats.

2. The Ministry of Culture, Sports and Tourism shall assume the prime responsibility for, and work with the Ministries of Health; Industry and Trade; and Information and Communications in, managing communications on and advertising of nutritious products for infants in accordance with law.

3. The Ministry of Health shall assume the prime responsibility for, and work with the Vietnam Women’s Union Central Committee, socio-political and social organizations in, disseminating and guiding pregnant women, nursing mothers and members of their families the implementation of regulations on trading and use of nutritious products for infants, feeding bottles and teats.

Chapter V 

IMPLEMENTATION PROVISIONS

Article 15. Implementation provisions

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

2. The Government’s Decree No. 21/2006/ND-CP of February 27, 2006, on the trading and use of nutritious products for infants ceases to be effective on the effective date of this Decree.

3. Nutritious products for infants that are on the market may continue to circulate until the expiry date on the packages.

Article 16. Implementation responsibilities

1. The Minister of Health shall guide and organize the implementation of this Decree.

2. Ministers, heads of ministerial-level agencies and government- attached agencies, chairpersons of the People’s Committees at all levels; related agencies, organizations and individuals shall implement this Decree.-

 

ON BEHALF OF THE GOVERNMENT PRIME MINISTER Nguyen Tan Dung