JOINT CIRCULAR No. 10/2006/TTLT/BYT-BTM-BVHTT-UBDSGĐTE GUIDING THE IMPLEMENTATION OF THE GOVERNMENT DECREE No. 21/2006/NĐ-CP dated February 27, 2006 ON BUSINESS AND USE OF NUTRITIONAL PRODUCTS FOR INFANTS

JOINT CIRCULAR

Guidelines for Implementing Decree No. 21/2006/NĐ-CP

dated February 27, 2006 of the Government on Trading and Using Nutritional Products for Infants

nutritional products for infants and young children

Pursuant to Decree No. 21/2006/NĐ-CP dated February 27, 2006 of the Government on Trading and Using Nutritional Products for Infants, the Joint Circular issued by the Ministry of Health, the Ministry of Trade, the Ministry of Culture, Sports and Tourism, and the Population Family and Youth Agency provides guidance as follows:

This technical regulation sets out technical requirements, testing methods, sampling procedures; management requirements; responsibilities of organizations and individuals producing, trading, and importing cigarettes.

1. The trading and use of nutritional products for infants must comply with the provisions of Decree No. 21/2006/NĐ-CP dated February 27, 2006 of the Government on Trading and Using Nutritional Products for Infants (hereinafter referred to as Decree No. 21/2006/NĐ-CP), as well as the provisions of laws and regulations concerning trade, advertising, product quality, labeling, and other relevant laws and regulations.

2. This Circular applies to:

a) Enterprises producing and trading in nutritional products for infants, including representative offices and individuals acting on behalf of such enterprises;

b) Individual households and individuals trading in nutritional products for infants;

c) Organizations and individuals providing advertising services;

d) Medical facilities as stipulated in Clause 7, Article 2; doctors and healthcare staff as stipulated in Clause 8, Article 2 of Decree No. 21/2006/NĐ-CP;

đ) State management agencies and state agencies related to the management of nutritional products for infants.

II. INFORMATION, EDUCATION, AND COMMUNICATION

1. Information, education, and communication materials on the benefits of breastfeeding and infant care must comply with the provisions of Articles 3 and 4 of Decree No. 21/2006/NĐ-CP; information, education, and communication materials on the use of nutritional products for infants must comply with the provisions of Article 5 of Decree No. 21/2006/NĐ-CP.

2. Enterprises and individuals producing and trading in nutritional products for infants are permitted to provide medical facilities, doctors, and healthcare staff working in these facilities with scientific, truthful, accurate information and methods for correctly using nutritional products for infants. The materials must clearly state "For doctors and healthcare staff only."

3. Doctors and healthcare staff have the responsibility to guide mothers or family members on the correct use of nutritional products for infants according to Point b, Clause 1, Article 12 of Decree No. 21/2006/NĐ-CP in the following special cases:

a) Infants whose mothers are seriously ill and unable to breastfeed or express milk.

b) Infants whose mothers are undergoing radiation therapy or taking contraindicated medications such as antithyroid drugs or cancer treatments.

c) Infants whose mothers are HIV positive.

d) Infants suffering from metabolic disorders that cannot tolerate breast milk.

III. ADVERTISING

Advertising for milk intended for children aged 12 months to 24 months must comply with the conditions stipulated in Clause 2 and Clause 3, Article 6 of Decree No. 21/2006/NĐ-CP as follows:

1. The mandatory content at the beginning of the advertisement: "Breast milk is the best food for the health and comprehensive development of infants" must meet the following requirements:

a) In television advertisements where there are images but no spoken words, the content "Breast milk is the best food for the health and comprehensive development of infants" must be clearly displayed in writing with sufficient duration for viewers to read it. If the advertisement includes both images and spoken words, the content "Breast milk is the best food for the health and comprehensive development of infants" must be displayed in writing and spoken clearly and coherently so that viewers can both read and hear it.

b) In radio advertisements, the content "Breast milk is the best food for the health and comprehensive development of infants" must be spoken clearly and coherently so that listeners can hear it.

c) In print media, online publications, printed materials, signs, billboards, or other advertising media, the content "Breast milk is the best food for the health and comprehensive development of infants" must be clearly displayed so that readers can read it.

2. Organizations and individuals registering advertisements, and organizations and individuals providing advertising services, in addition to complying with the provisions of Clause 1 of this Section, must also comply with the provisions of Joint Circular No. 01/2004/TTLT-BVHTT-BYT dated January 12, 2004 of the Ministry of Culture, Sports and Tourism and the Ministry of Health regarding advertising activities in the healthcare sector and other relevant advertising laws.

IV. TRADING IN NUTRITIONAL PRODUCTS FOR INFANTS

1. Nutritional products for infants must be registered for product standards with the Ministry of Health (Food Safety and Nutrition Department) before being put on the market.

2. Labels for nutritional products for infants, feeding bottles, and artificial nipples, in addition to complying with the provisions of Articles 8 and 9 of Decree No. 21/2006/NĐ-CP, must also comply with other legal provisions concerning product labeling.

V. RESPONSIBILITIES OF HEADS, DOCTORS, AND HEALTHCARE STAFF OF MEDICAL FACILITIES

1. Heads of medical facilities, doctors, and healthcare staff working in these facilities are responsible for implementing:

a) The provisions of Articles 11 and 12 of Decree No. 21/2006/NĐ-CP;

b) Ten conditions for successful breastfeeding in medical facilities (as attached in this Circular).

2. The Ministry of Health shall organize inspections to verify the implementation of ten conditions for breastfeeding in medical examination and treatment facilities, on this basis, consider issuing a Certificate recognizing the title "Baby-Friendly Hospital." During the inspection process, if a medical examination and treatment facility that has been recognized with the aforementioned title does not comply with the conditions stipulated in Clause 1 of this Section, the Ministry of Health will revoke the Certificate and simultaneously notify the Provincial Department of Health if the medical examination and treatment facility falls under local management.

3. The heads of medical examination and treatment facilities, doctors, and healthcare staff may accept nutritional products for infants through charitable organizations to nurture abandoned children or in special cases where such products must be used according to the provisions of Clause 3, Section II of this Circular. In cases where medical examination and treatment facilities lack sufficient nutritional products for abandoned children, they may purchase the necessary quantity based on actual needs.

VI. RESPONSIBILITIES FOR STATE MANAGEMENT

1. The Ministry of Health shall take the lead and coordinate with the Ministry of Trade, the Ministry of Culture, Sports and Tourism, the Population, Family and Children Committee, and related agencies to manage the business operations and use of nutritional products for infants; manage the quality and hygiene safety of nutritional products for infants; organize inspections and verifications of compliance with legal regulations regarding the business operations and use of nutritional products for infants nationwide.

2. The Provincial Department of Health shall take the lead and coordinate with the Provincial Department of Trade, the Provincial Department of Culture, Sports and Tourism, the Population, Family and Children Committee of provinces and centrally-administered cities, and related agencies to manage the business operations and use of nutritional products for infants; manage the quality and hygiene safety of nutritional products for infants; organize inspections and verifications of compliance with legal regulations regarding the business operations and use of nutritional products for infants within their respective jurisdictions.

VII. IMPLEMENTATION ORGANIZATION

1. This Circular shall take effect fifteen days from the date of publication in the Official Gazette. The Joint Circular No. 04/2001/TTLT/YT-TM-VHTT-UBBVCSTEVN dated March 14, 2001 guiding the implementation of Decree No. 74/2000/NĐ-CP dated December 6, 2000 of the Government on the business operations and use of breast milk substitutes to protect and promote breastfeeding is hereby repealed.

2. For nutritional products for infants, baby bottles, and artificial nipples, including both domestically produced and imported products, if the old labels were printed before the effective date of this Circular and still exist without violating the provisions of Decree No. 74/2000/NĐ-CP dated December 6, 2000 of the Government on the business operations and use of breast milk substitutes to protect and promote breastfeeding and the Joint Circular No. 04/2001/TTLT/YT-TM-VHTT-UBBVCSTEVN dated March 14, 2001 guiding the implementation of Decree No. 74/2000/NĐ-CP dated December 6, 2000 of the Government on the business operations and use of breast milk substitutes to protect and promote breastfeeding, the production and business entities shall report the quantity of remaining labels to the Ministry of Health (Food Safety Bureau) for verification and confirmation before continuing circulation but must supplement a Vietnamese label with information missing from the old product label compared to the provisions of Article 8 and Article 9 of Decree No. 21/2006/NĐ-CP.

3. For nutritional products for infants with expiration dates marked prior to the effective date of this Circular and packaged in durable metal, glass, ceramic containers with old 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 a label with information missing from the old product label compared to the provisions of Article 8 of Decree No. 21/2006/NĐ-CP.

4. Advertisements for infant formula for children aged six to twelve months that have advertising contracts signed with advertising service providers before the effective date of this Circular and are still valid shall continue to be implemented until the end of the contract term. During the implementation, if there are difficulties or issues, units and localities are requested to promptly report to the Ministry of Health, the Ministry of Trade, the Ministry of Culture, Sports and Tourism, and the Population, Family and Children Committee for review and appropriate amendments.

During the implementation, if there are difficulties or issues, units and localities are requested to promptly report to the Ministry of Health, the Ministry of Trade, the Ministry of Culture, Sports and Tourism, and the Population, Family and Children Committee for review and appropriate amendments./.