JOINT CIRCULAR No. 04/2001/TTLT/YT-TM-VHTT-UBBVCSTEVN guiding the implementation of Decree No. 74/2000/NĐ-CP dated December 6, 2000 of the Government on trading and using breast milk substitutes to protect and encourage breastfeeding.

JOINT CIRCULAR

Guidelines for Implementing Decree No. 74/2000/NĐ-CP dated December 6, 2000 of the Government on Trading and Using Breast Milk Substitutes to Protect and Encourage Breastfeeding

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Pursuant to Decree No. 74/2000/NĐ-CP dated December 6, 2000 of the Government on Trading and Using Breast Milk Substitutes to Protect and Encourage Breastfeeding, and Directive No. 28/2000/CT-TTg dated December 27, 2000 of the Prime Minister on the Implementation of the Labeling Regulations issued together with Decision No. 178/1999/QĐ-TTg dated August 30, 1999 of the Prime Minister, the Ministry of Health, the Ministry of Trade, the Ministry of Culture and Information, and the Vietnam National Committee for Child Protection and Care hereby provide guidance as follows:

I. GENERAL PROVISIONS:

1. Trading and using breast milk substitutes must comply with regulations concerning information, education, communication, advertising, trading, and using breast milk substitutes, artificial nipples, and pacifiers, measures to encourage breastfeeding as stipulated in Decree No. 74/2000/NĐ-CP dated December 6, 2000 of the Government on Trading and Using Breast Milk Substitutes to Protect and Encourage Breastfeeding, trade-related laws and regulations, advertising laws and regulations, product quality laws and regulations, labeling laws and regulations, and other relevant laws and regulations.

2. This Circular applies to:

a. Enterprises producing and trading breast milk substitutes, including representative offices and individuals acting on behalf of such enterprises;

b. Individual traders and individuals trading breast milk substitutes;

c. Organizations and individuals providing advertising services;

d. Obstetric and pediatric facilities (including specialized obstetric and pediatric hospitals, obstetric and pediatric departments in general hospitals, district and commune health centers, maternity homes, village health stations) under state management, private, public-private partnerships, and foreign-invested entities;

e. State administrative agencies and other state agencies related to the management of breast milk substitutes.

II. INFORMATION, EDUCATION, AND COMMUNICATION:

1. The content of informational, educational, and communicative materials on the benefits of breastfeeding, infant and child care; and informational and educational materials on the use of breast milk substitutes must comply with the provisions of Articles 5, 6, and 7 of Decree No. 74/2000/NĐ-CP dated December 6, 2000 of the Government on Trading and Using Breast Milk Substitutes to Protect and Encourage Breastfeeding.

2. Organizations and individuals producing and trading breast milk substitutes are permitted to provide scientific information and correct usage instructions for breast milk substitutes to obstetric and pediatric facilities, doctors, and healthcare workers employed there.

3. Doctors and healthcare workers working in obstetric and pediatric facilities have the right to guide the use of breast milk substitutes for mothers or their family members according to Clause 1, Article 14 of Decree No. 74/2000/NĐ-CP dated December 6, 2000 of the Government on Trading and Using Breast Milk Substitutes to Protect and Encourage Breastfeeding in the following cases:

a. Infants suffering from severe swallowing difficulties, hypoglycemia, or requiring alternative methods to treat hypoglycemia that cannot be improved through increased breastfeeding.

b. Infants whose mothers suffer from serious illnesses (such as mental illness, epilepsy, shock...).

c. Infants with metabolic diseases.

d. Infants experiencing severe dehydration (for example, due to diarrhea) despite increased breastfeeding.

e. Infants whose mothers must take contraindicated medications (such as anti-cancer drugs, radiation therapy, thyroid hormone antagonists...) or mothers infected with HIV/AIDS (specific advice from healthcare staff is required for each case).

III. ADVERTISING:

1. Strictly prohibit advertising in any form breast milk substitutes for infants from birth to six months old (if the substitute is intended for infants from under six months to 24 months, advertising for use from under six months to six months is prohibited), and artificial nipples and pacifiers as stipulated in Clause 1, Article 8 of Decree No. 74/2000/NĐ-CP dated December 6, 2000 of the Government on Trading and Using Breast Milk Substitutes to Protect and Encourage Breastfeeding.

2. Advertising for milk products for infants from six months to 24 months old must strictly comply with the conditions specified in Clause 2, Article 8 of Decree No. 74/2000/NĐ-CP dated December 6, 2000 of the Government on Trading and Using Breast Milk Substitutes to Protect and Encourage Breastfeeding. The mandatory content at the beginning of the advertisement: "Breast milk is best for the health and development of infants and young children" must meet the following specific requirements:

a. In television advertisements where only images are shown without sound, the content "Breast milk is best for the health and development of infants and young children" must be clearly displayed in writing so viewers can read it. If the advertisement uses both images and voice, the content: "Breast milk is best for the health and development of infants and young children" must be displayed in writing and spoken clearly so viewers can read and hear it.

b. In radio advertisements, the phrase "Breast milk is best for the health and development of infants and young children" must be clearly spoken so listeners can hear it.

c. In newspaper, publication, signboard, billboard, or other forms of advertising, the content "Breast milk is best for the health and development of infants and young children" must be clearly displayed so readers can read it.

3. Advertisers, organizations, and individuals implementing advertisements, in addition to complying with the provisions of Points 1 and 2 of this Section, must also comply with other advertising laws and regulations.

IV. TRADING BREAST MILK SUBSTITUTES:

1. All breast milk substitutes must register their food safety and hygiene quality with the Ministry of Health (Food Safety and Quality Management Department) before being put on the market.

2. Labels for products that replace breast milk, baby bottles, and artificial nipples, in addition to complying with the provisions of Article 10 and Article 11 of Decree No. 74/2000/NĐ-CP dated December 6, 2000 of the Government on trading and using products that replace breast milk to protect and encourage breastfeeding, must also strictly implement Decision No. 178/1999/QĐ-TTg dated August 30, 1999 of the Prime Minister promulgating the Labeling Regulations for goods circulating domestically and exported/imported goods, Decision No. 95/2000/QĐ-TTg dated August 15, 2000 of the Prime Minister amending and supplementing certain contents of the above regulations, Directive No. 28/2000/CT-TTg dated December 27, 2000 of the Prime Minister on implementing the Labeling Regulations issued together with Decision No. 178/1999/QĐ-TTg dated August 30, 1999 of the Prime Minister, Circular No. 34/1999/TT-BTM dated December 15, 1999 of the Ministry of Trade guiding the implementation of the Labeling Regulations for goods circulating domestically and exported/imported goods, and Circular No. 15/2000/TT-BYT dated June 30, 2000 of the Ministry of Health guiding the labeling of food products.

3. Production and business establishments of products that replace breast milk or their representatives are responsible for strictly implementing Clause 1, Clause 2 (Point a, Point c) of Article 12 of Decree No. 74/2000/NĐ-CP dated December 6, 2000 of the Government on trading and using products that replace breast milk to protect and encourage breastfeeding. In addition to complying with the above regulations, production and business establishments of products that replace breast milk shall not be permitted to:

a. Give away products that replace breast milk to mothers and members of their families at obstetric and pediatric facilities, private residences, public places, or any other location.

b. Sponsor scholarships, scientific research, training funding, conferences, seminars, courses, concerts, telephone counseling services, or other forms such as product introductions, brand promotions, names of manufacturing and selling establishments, or use scientific research results to promote and advertise products to encourage the use of products that replace breast milk.

V. RESPONSIBILITIES OF OBSTETRIC AND PEDIATRIC FACILITIES AND DOCTORS AND HEALTH CARE STAFF WORKING IN SUCH FACILITIES:

1. Obstetric and pediatric facilities are responsible for creating conditions for mothers to breastfeed within half an hour after childbirth, strictly implementing the provisions of this Circular, and meeting ten conditions to become "Baby-Friendly Hospitals" (Annex attached to this Circular).

2. The Ministry of Health will organize inspections and issue certificates recognizing the title of "Baby-Friendly Hospital." During inspections and audits, if obstetric and pediatric facilities recognized with the aforementioned title fail to comply with the conditions stipulated in Section V, Clause 1 above, they will be subject to penalties under the law, have their certificates revoked by the Ministry of Health, and simultaneously notified to the People's Committee of the province if the hospital is under local management.

3. Obstetric and pediatric facilities, doctors, and health care staff working in these facilities may accept products that replace breast milk through charitable organizations to nurture abandoned children or in special cases where the use of products that replace breast milk is required according to Point 3, Section II of this Circular. If obstetric and pediatric facilities lack sufficient products that replace breast milk to nurture abandoned children, they may purchase the necessary quantity based on actual needs.

4. Obstetric and pediatric facilities, doctors, and health care staff working in these facilities shall not directly accept gifts of products that replace breast milk; shall not accept financial contributions for conferences, seminars, and scholarships aimed at encouraging the use of products that replace breast milk as stipulated in Point 3, Section IV of this Circular; shall not provide scientific research results for the promotion and advertising of products that replace breast milk; shall not assist manufacturers and traders in giving samples, gifts, promotional materials, introductions, and advertisements of products that replace breast milk.

5. In addition to the provisions set forth in Points 3 and 4 above, obstetric and pediatric facilities will be deemed to have violated Article 14 of Decree No. 74/2000/NĐ-CP dated December 6, 2000 of the Government on trading and using products that replace breast milk to protect and encourage breastfeeding if there are products or gifts bearing the names or images of products that replace breast milk, or the names or images of manufacturing and selling establishments of such products, within the hospital.

VI. STATE MANAGEMENT RESPONSIBILITIES:

1. The Ministry of Health shall take the lead in coordinating with the Ministry of Trade, the Ministry of Culture, Sports and Tourism, the Vietnam National Child Protection Committee, and relevant agencies to manage the trading and use of products that replace breast milk; manage the quality and hygiene safety of products that replace breast milk; organize inspections and audits of compliance with legal regulations on trading and using products that replace breast milk nationwide.

2. Provincial Health Departments shall take the lead and coordinate with Provincial Trade Departments, Provincial Culture, Sports and Tourism Departments, Child Protection Committees of provinces and centrally-administered cities, and relevant agencies to manage the trading and use of products that replace breast milk; manage the quality and hygiene safety of food products that replace breast milk; organize inspections and audits of compliance with legal regulations on trading and using products that replace breast milk within their respective provinces and centrally-administered cities within their authority.

VII. IMPLEMENTATION PROVISIONS:

1. This Circular takes effect fifteen days from the date of issuance. It abolishes Joint Circular No. 18/TTLB dated November 3, 1994 of the Joint Ministries of Health, Trade, Culture and Information, and the Vietnam National Child Protection Committee guiding the implementation of Decision No. 307/TTg dated June 10, 1994 of the Prime Minister on certain issues related to trading and using products that replace breast milk to support breastfeeding, and Circular No. 07/BYT-TT dated April 18, 1995 of the Ministry of Health guiding the importation of products that replace breast milk.

2. For substitute milk products, baby bottles, and artificial nipples, including both domestically produced and imported products, if there are old labels that were printed before this Circular takes effect and do not violate the provisions of Decision No. 307/TTg dated June 10, 1994 of the Prime Minister on certain issues regarding the business and use of substitute milk products to support breastfeeding, Circular No. 18/TTLB dated November 3, 1994 of the Joint Ministries of Health, Trade, Culture-Information, and the Vietnam Committee for Child Protection and Care guiding the implementation of Decision No. 307/TTg, Decision No. 178/1999/QĐ-TTg dated August 30, 1999 of the Prime Minister promulgating the Labeling Regulations for goods circulating in the domestic market and exported/imported goods, Decision No. 95/2000/QĐ-TTg dated August 15, 2000 of the Prime Minister amending and supplementing certain contents of the aforementioned regulations, Directive No. 28/2000/TTg dated December 27, 2000 on the implementation of the labeling regulations issued with Decision No. 178/1999/QĐ-TTg dated August 30, 1999 of the Prime Minister, and other guiding legal documents, the production and business entities shall be responsible for reporting the quantity of remaining labels to the Ministry of Health (National Food Safety Quality Control Department) before May 30, 2001 for inspection and confirmation before continuing circulation, but must affix additional Vietnamese language label supplements containing information missing from the old product labels compared to the provisions of Article 10 and Article 11 of Government Decree No. 74/2000/NĐ-CP dated December 6, 2000 on the business and use of substitute milk products to protect and encourage breastfeeding.

3. For substitute milk products with expiration dates marked prior to the effective date of this Circular and packaged in commercial packaging made of materials such as metal, glass, ceramic, with old product labels directly printed on the product or packaging that cannot be changed to new labeled packaging, if they are still within their expiration period, they may continue to circulate until the expiration date, but the production and business entities must supplement the missing information on the old product labels according to the provisions of Article 10 and Article 11 of Government Decree No. 74/2000/NĐ-CP dated December 6, 2000 on the business and use of substitute milk products to protect and encourage breastfeeding.

4. In cases where the legal regulatory documents cited in this Circular are replaced or amended, the newly issued legal regulatory documents shall be applied automatically.

5. During the implementation process, if difficulties or obstacles arise, units and localities are requested to promptly report them to the Ministry of Health, Ministry of Trade, Ministry of Culture-Information, and the Vietnam Committee for Child Protection and Care for consideration and appropriate amendment./.