The Government, No 100-2014-ND-CP-On trading in and using of nutritional products for infants, feeding bottles and dummies

Update: 5/7/2015 - View: 4058

THE GOVERNMENT

________

No: 100/2014/ND-CP

SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness

____________________________________

 Hanoi,06th November 2014

 

DECREE

 On trading in and using of nutritional products for infants, feeding bottles and dummies

__________

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

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

Pursuant to the Law on Advertisement dated June 21, 2012;

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

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

At the proposal of the Minister of Health,

The Government promulgates Decree on trading in and using of nutritional products for infants, bottle and nipples.

 

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation

1. This Decree provides information, education, communication on, advertisement for, trading in and use of nutritional products for infants, feeding bottles and dummies; responsibilities to trading and using of nutritional products for infants in order to reduce the incidence of malnutrition based on the promotion and protection of breastfeeding – best food for young children’s health and comprehensive development.

Article 2. Interpretation of terms

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

1. Nutritional products for young children is breastmilk substitutes and complementary foods for children up to 24 months which are produced by industrial method, up to the prescribed standards and suitable to each period of growth and the special physiological conditions of infants.

2. Breastmilk substitutes for infants up to the age of 24 months include:

a) Formulated nutritional products in form of liquid or powder produced from the milk of cow or other animals with the appropriate supplement components which can be used as breastmilk replacement for infants up to the age of 12 months (infant formula)

b) Formulated nutritional products in form of liquid or powder produced from the milk of cow or other animals with the appropriate components or originated from animal and vegetable, which can be used in complementary feeding period for infants from the age of 06 - 24 months (follow up formula);

c) Other formulated nutritional products in form of liquid or powder produced from the milk of cow or other animals with the appropriate components or originated from animal and vegetable, which are presented or introduced as suitable to use for the infants under the age of 24 months, but not including the complementary foods in the nutritional regime for infants over the age of 06 months.

3. Complementary nutritional products (in abbreviation: complementary food) are a kind of solid or semisolid food including 04 food groups: starch, protein, fat, vitamin and minerals; is ready made to supplement breastmilk or breastmilk substitutes for children from 6 to 24 months.

4. Infants mean children who are from newborn to 24 months old.

5. Label of nutritional products for infants is writing, printing, drawing, photocopying versions, images which are pasted, printed, attached, molded, laid, carved directly on products, commercial package of products or other materials attached to the products, commercial packaged of nutritional products for infants.

6. Sample of nutritional products for infants is to provide for free of charge a small amount of these products.

7. Health facilities included general hospitals having pediatric and obstetric clinics, obstetric or pediatric hospitals, maternity house; general clinics, obstetric or pediatric clinics; regional general clinics, and commune, ward and township health stations, facilities for examination, treatment, research or counseling on nutrition for infants.

8. Physicians and medical staffs included medical doctors, intermediated-level physicians, nutritional counselors, midwives or other professional practitioners, including unpaid voluntary employees working at health facilities.

9. Staff of production and business establishments of nutritional products for infants included contracted staff, sale staff who entitled sale commission, collaborator, and promotion staff of nutritional products for infants. 

 

Chapter II

INFORMATION, EDUCATION, COMMUNICATION AND ADVERTISEMENT

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

Information, education and communication on the benefits of breastfeeding and on the methods of nurturing infants must be given priority in programs on information, education and communication program on the protection of mothers' and children's health, and on improvement of children’s nutritional status.

Article 4. Information, educational and communication documents on nurturing infants

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

2. Information, education and communication documents on infants feeding must cover the following contents:

a) Benefits and superiority of breastfeeding, affirming that breastmilk is the best food for the health and all-sided growth of infants; antibacterial elements, especially antibodies, available in breastmilk only, which help children prevent and be against diarrhea, respiratory infections and other infectious diseases;

b) Guide on exclusive breastfeeding until infants are 6 months old and continuation of breastfeeding until they are 24 months or older, correctly and properly feeding them with complementary food when they are 7 months old;

c) Disadvantages of non-breastfeeding and feeding with breastmilk substitutes, such as: no immunization elements provided as from breastmilk, great cost and time-consuming; bacterial contamination in cases of preparing the formula improperly and other disadvantages;

d) Adverse impacts of bottle-feeding, using dummies, and providing complementary foods for children before they are 6 months old;

đ) Instructions on how to prepare, preserve, choose and use of complementary food for infants at home by simple methods, ensuring hygiene, safety and proper nutrition with available kinds of food.

e) Proper nutrition for mothers to maintain breastmilk supply for breastfeeding.

3. Information, education and communication documents on nurturing infants that have the following contents are prohibited:

a) Pictures, words or other ways used to encourage the use of breastmilk substitutes; bottle-feeding or discourage breastfeeding;

b) Comparing formula for infants as being equivalent as or better than breastmilk;

c) Names or logos of nutritional products, bottle and dummies for infants.

Article 5. Information, education and communication documents on the use of nutritional products for infants

Contents of information, education and communication documents on the use of nutritional products for infants must provide information on the following:

1. How to correctly choose and use nutritional products for infants.

2. How to clean and sterilize utensils used for feeding infants.

3. How to feed infants with clean cups and spoons.

4. Giving warns on possible harms to infants' health caused by dummies, bottle-feeding or providing complementary food for infants before they are 6 months old;

5. Giving information on risk of getting infected/contaminated from bottles  and when breastmilk substitutes are not prepared and given to children properly.

6. Warning about cost consuming of feeding infants with breastmilk substitutes.

Article 6. Advertisement of nutritional products for infants

1. All forms of advertisement for breastmilk substitutes for under-24 month infants; complementary food using for under-6 month infants; feeding bottles and dummies; image of fetus or infants in advertisements for milk products for pregnant women are strictly prohibited;

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

a) The first part of the advertisement must have the statement: ''Breastmilk is the best food for the health and comprehensive growth of infants'';

b) Contents of advertisement must state “This product is complementary foods and can supplement with breastmilk, using for over-6 month infants”; in line with the provisions of Articles 4 and 5 of this Decree and other regulations of law on advertisement and food safety.

3. Content, conditions and procedures of advertisement are in line with regulations on advertisement.

Chapter III

BUSINESS and USE of NUTRITIONAL PRODUCTS for INFANTS, BOTTLE and DUMMIES

Article 7. Regulation conformity announcement and announcement on conformity with food safety regulations

1. Nutritional products for infants must be announced about regulation conformity or announced on conformity with regulations on product standard before being introduced on the market.

2. The Minister of Health issues national technical standard for formulated nutritional products for infants.

Article 8. Regulations on labels of breastmilk substitute products for infants

1. Labels of breastmilk substitute products for infants must meet the following requirements:

a) There must be the words ''CHU Y'' (attention) in upper case, followed by the words in lower case that highlight the with the following contents: ''Breastmilk is the best food for the health and comprehensive growth of infants. Antibacterial elements, especially antibodies, available in breastmilk only, help children prevent and be against diarrhea, respiratory infections and several other infectious diseases.'' The height of letters must not be less than 2 mm. The color of letters must be clear and contrast with the background color of the label.

b) There must be the following words in lower case: ''Use this product only under physicians' instructions. Strictly follow preparation instructions. Feed children by hygiene cups and spoons.'' The height of letters must not be less than 1.5 mm;

c) Infants' age that suitable to use the product must be clearly written;

d) Labels of the breastmilk substitutes must not have pictures or drawings of infants, breastfeeding mothers, feeding-bottles or dummies; words and images implying that the product is equivalent or better than breastmilk in quality or encouraging the bottle-feeding must not be used; the labels of these products must not be similar to those for pregnant women;

đ) Labels of breastmilk substitutes must be printed with the number of the acceptance of conformity announcement or Confirmation of conformity with regulations on food safety.

2. Other contents on labels of breastmilk substitutes for infants must in line with the regulations on labeling of domestically circulated, imported or exported goods, food safety and must meet the following required contents:

a) Guide on proper way of preparation, illustrated with simple and easy-to-understand tables in Vietnamese;

b) Instruction on sterilizing the feeding tools;

c) Preservation conditions, expiry date before and after opening the can.

Article 9. Regulations on labels of complementary foods for infants

1. Labels of complementary foods for infants must meet the following requirements:

a) It should clearly state: “This product is complementary food and can supplement breastmilk for over-6 month infants”.  These texts should be placed on the front face of the product, in upper case letters which as high as 2mm or more. The color of the letters must be clear and contrast with the background color of the label.

b) There must be the words in upper case: “ATTENTION”, followed by the words in lower case that highlight the following contents: ''Breastmilk is the best food for the health and comprehensive development of infants'' The height of the letters must not be less than 2 mm;

c) Infants' age that suitable to use the product must be clearly written;

d) Labels of the product must not have pictures or drawings of infants, breastfeeding mothers, feeding-bottles or dummies; words and images implying that the product is equivalent or better than breastmilk in quality or encouraging the bottle-feeding must not be used;

đ) Labels of the products must be printed with the number of the acceptance of conformity announcement or number of confirmation of conformity with regulations on food safety.

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

 

Article 10. Labels of feeding bottles, pacifiers and dummies

       1. Labels of feeding bottles must meet the following requirements:

a) There must be the words in lower case: “Strictly follow instructions on hygiene and sterilization.  Using feeding bottles can make infants refused breastfeeding and face with the risk of getting diarrhea.  The height of lower-case letters must not be less than 2 mm. The color of letters must be clear and contrast with the background color of the label.

b) Guide properly on how to clean and sterilize;

c) Provide names and addresses of producers and distributors.

2. Packages of or labels of dummies must display the words in lower case: ''Using dummies shall negatively affect breastfeeding.'' The height of lower-case letters must not be less than 2 mm. The color of letters must be clear and contrast with the background color of the label.

3. Labels of feeding bottles and dummies must not contain pictures or drawings of newborns and infants, breastfeeding mothers, pictures or words implying that the product is similar to mother's nipples.

4. The regulations on labels of feeding bottles and pacifiers specified in points 1, 2 and 3 of this Article shall apply also to all in-country produced or imported feeding bottles and dummies.

 

Chapter IV

RESPONSIBILITIES IN DOING BUSINESS AND USE OF NUTRITIONAL PRODUCTS FOR INFANTS

Article 11. Responsibilities of production and business establishments of nutritional products for infants

  1. The production and business establishments are responsible to:

a) Sell nutritional products for infants that ensure quality and food safety according to the published standards or regulations;

b) Provide medical doctors, health workers and consumers with accurate scientific information and proper usage of nutrition products for infants as regulated in Article 4 and 5 of this Decree.

       2. The production and business establishments must not:

a) Produce and sell nutritional products for infants which are followed the published standards or regulations; are expired or without packages or labeling. 

b) Appoint their employees to directly or indirectly contact mothers, pregnant women or members of their families at health facilities or other venues with purposes of advertising, communicating and promoting the use of breastmilk substitutes;

c) Display breastmilk substitutes, complementary foods for children from 0 – 6 months, at health facilities, display names and logos of breastmilk substitutes on banners, posters and other advertising materials in supermarkets, retail shops and health facilities; .

d) Apply forms of promotion for breastmilk substitutes, such as giving sample products, discount coupons, awards and gifts, accumulating points for reward bonus, discount or any other forms;

e) Provide scholarship, funds for scientific research, training courses, conferences, workshops, concerts; organizing contests, performance, film and video clip developing, telephone counseling service or other forms to communicate propaganda, introduce, promote the business and use of breastmilk substitutes;

f) Implement or support the education and communication related to infants and young children feeding in order to communicate, introduce, promote the business and use of breastmilk substitutes.

Article 12. Responsibilities of health facilities

  1. Health facilities are responsible to:

a) Implement the counseling sessions on  breastfeeding  for pregnant women, mothers who have young children and their family members;

b) Organize communication sessions, hang posters and banners or broadcast images that have contents as requested in Articles 4 and 5 of this Decree, at pregnancy check up rooms, pre and postpartum rooms, nutrition counseling rooms or places easily observed, gathering pregnant women, mothers having young children and their family members;

c) Create condition for mothers to initiate breastfeeding their newborns within one hour after birth, exclusively breastfeed in first 6 months and continue breastfeeding to 24 months or longer.  

       2.Health facilities must not:

a) Sell or allow  the sale of breastmilk substitutes for infants at health facilities, except for hospital pharmacies;

b) Permit production and business establishments of breastmilk substitutes to display, post any tool and instrument that have names or logos of the breastmilk substitutes, bottle and nipples at health facilities;

c) Allow employees of production and business establishments of breastmilk substitutes  to approach mothers who have young children and pregnant women in every form;

d) Receive breastmilk substitutes; material benefits; tools that have names or logos of breastmilk substitutes, which are given by production and business establishments.

Article 13. Responsibilities of physicians and health workers in health facilities

  1. Physicians and health workers in health facilities have responsibilities to:

        a) Promote, support and protect breastfeeding; understand and strictly implement regulations of this Decree;
        b) Inform pregnant women and mothers who have young children about benefits of breastfeeding and how to practice;
        c) Support mothers breastfeed their newborns within one hour after birth;
        d) Guide mothers on how to breastfeed and maintain lactation even when they have to be away from their babies;
        e) Counsel mothers and family members on exclusively breastfeeding in first 6 months;
        f) Guide, help mothers to be near their babies immediately after birth;
        g) Encourage mothers to breastfeed babies at their demand.
        h) Request mothers and family member to not give babies any bottle feeding or pacifiers/teats.
        i) Encourage the establishment of “breastfeeding mothers’ support groups” and refer mothers to these groups after discharging from hospital.
        j) Prescribe breastmilk substitutes if needed.

          2. Physicians and health workers in health facilities must not:

a) Prescribe the use of breastmilk substitutes for infants 0 – 6 months, except for doctor's instruction.

b) Inform pregnant women, mothers who have young children or members of their families that feeding infants with breastmilk substitutes is equivalent or better than breastfeeding in value;

c) Receive directly or indirectly nutrition products for infants; material benefits; tools that have names or logos of breastmilk substitutes for infants;

d) Allow production and business establishments to give sample products or gifts related to breastmilk substitutes for infants;

e) Provide the employees of production and business establishments with lists of names, ages, addresses and telephone contact number of pregnant women and mothers, or permit them to approach pregnant women and mothers who have young children at health facilities.

Article 14. Management Responsibilities

  1. The Ministry of Health and ministries, branches, people’s committee at all levels within the scope of their authorities and responsibilities, shall controll the use of nutritional products for infants, quality and safety management of nutritional products for young children; conduct monitoring/inspection of compliance with policies on business and usage of nutritional products for infants, feeding bottles and dummies.
  2. The Ministry of Culture, Sports and Tourism chairs and coordinates with Ministry of Health, Ministry of Commerce and Industry, Ministry of Information and Communication to manage the information and advertisement of nutritional products for infants according to their legitimate assigned authorities.
  3. The Ministry of Health chairs and coordinates with the Viet Nam Women’s Union and social-political organizations, social organizations to disseminate to and guide the implementation of regulations on business and usage of nutritional products for infants.

Chapter V

IMPLEMENTATION PROVISIONS

Article 15. Implementation effect

  1. This Decree takes effect on 01 March 2015.
  2. Discard the Government’s Decree No. 21/2006/ND-CP dated February 27, 2006, on the business and usage of nutritional products for infants as this Decree takes effect.
  3. In cases where nutritional products for infants are circulating in the market, the continued circulation is permitted according to the expiry date shown on the packaging.

Article 16. Implementation responsibilities

  1. The Minister of Health shall have the responsibilities to instruct, implement the enforcement of this Decree.
  2. Ministers, heads of ministerial-level agencies, heads of Government agencies, and Chairmen of People's Committees at all levels, and related agencies and individuals shall have to implement this Decree.

                                                  ON BEHALF OF THE GOVERNMENT

                                                                     PRIME MINISTER

                                                                     NGUYEN TAN DUNG