Decree No. 100/2014/ND-CP on the trading in and use of nutritious products for infants, feeding bottles and teats

4 OFFICIAL GAZETTE l ssut> nos 01-03/Novt>mber 2014 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<*J 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 info1mation, education, communication, adve1i ising 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 te1ms In this Decree, the te1ms below are construed as follows: 1. Nutritious products for infants include breast milk substitutes and nutritious complementaiy 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 fo1mulas 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 fo1mulas 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 complementaiy feeding period; c/ Other liquid or powdered follow-up fo1mulas made from milk of cows or other animals and containing appropriate ingredients or animal- or plant-derived ingredients which ai·e presented or introduced as suitable to under-24 month infants but ai·e not included in f*J Cong Bao Nos 991-992 (19111/2014) ©Vietnam Law and Legal Fornm lssut> nos 01-03/Novt>mbt>r 2014 OFFICIAL GAZETTE 5 complementaiy foods in the nutritional strncture for infants aged over 6 months. 3. Nutritious complementaiy foods (below referred to as complementaiy foods) means ready-made semi-solid or solid foods containing 4 groups of ingredients: cai·bonhydrates, 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 chai·acters 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-chai·ge 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, wai·d and township health stations; infant nutrition research establishments or infant nutrition counseling establishments. 8. Physicians and medical workers include doctors, inte1mediate-level physicians, convalescence workers, midwives, nutrition counselors and persons holding other professional titles, including unpaid voluntaiy 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. Info1mation, education and communications about benefits of breastfeeding Info1mation, education and communications about benefits of breastfeeding and on infant nurturing methods must be prioritized in programs on info1mation, education and communications about mother and child health protection and infant nutrition improvement. Article 4. Info1mation, education and communications documents on nmiuring infants 1. Contents of info1mation, education and communications documents on nmiuring infants must be clear, easy to read and understand, objective and scientific. 2. Info1mation, education and communications documents on nmiuring infants must have the following contents: a/ Benefits and superiority of breastfeeding, affiiming 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 diaiThea, respirato1y infections and some other infectious diseases; b/ Instrnctions 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 complementaiy 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 prepai·ation, and other disadvantages; ©Vietnam Law and Legal Fomm 6 OFFICIAL GAZETTE l ssut> nos 01-03/Novt>mber 2014 di Adverse impacts of bottle-feeding, use of teats and complementa1y foods on infants aged under 6 months; dd/ Instrnctions on simple preparation, storage, selection and use of complementa1y foods at home for infants, ensuring safety and rational nutrition with available foods; e/ Rational nutrition for mothers to maintain their breast milk. 3. Info1mation, education and communications documents on muturing infants which have the following contents are banned: a/ Images, words or other communications fo1ms to encourage the use of breast milk substitutes or bottle feeding or discourage breast feeding; bl 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. Info1mation, education and communications documents on the use of nutritious products for infants Contents of info1mation, education and communications documents on the use of nutritious products for infants must: 1. Provide instiuctions on the selection and use of nutritious products for infants. 2. Provide instiuctions on the cleaning and sterilization of infant feeding utensils. 3. Provide instiuctions on the feeding of infants using clean cups and spoons. 4. Give cautions about possible ha1ms to infants' health caused by teats, bottle feeding or complementa1y foods when they are under 6 months. 5. Provide info1mation 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. Adve1tising of nutritious products for infants 1. To strictly prohibit the adveliising of breast milk substitutes for under-24 month infants; complementa1y foods for under-6 month infants; feeding bottles and teats in any fo1ms; the use of fetus or infant images in adveliisements for milk for pregnant women. 2. The adve1tising of complementary foods for under-24 month infants must satisfy the following requirements: a/ The first part of the adve1tisement must have the phrase "Breast milk is the best food for health and all-sided growth of infants"; b/ Adve1tising contents must clear·ly 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 Aliicles 4 and 5 of this Decree and the laws on adve1tising and food safety. 3. Advertising contents, conditions and procedures must comply with the law on adve1tising. Chapter III TRADING AND USE OF NUTRITIOUS PRODUCTS FOR INFANTS, FEEDING BOTTLES AND TEATS Article 7. Announcement of regulation confo1mity and confo1mity with food safety regulations ©Vietnam Law and Legal Fornm lssut> nos 01-03/Novt>mbt>r 2014 OFFICIAL GAZETTE 7 1. Nutritious products for infants, before being marketed, must be subject to regulation confonnity and confonnity 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 f01mulas. 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 diru.Thea, respirato1y infections and some other infectious diseases". The height of chai·acters must be at least 2 mm. The color of chai·acters 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 instmctions. Strictly follow the prepai·ation instructions. Feed children with clean cups and spoons". The height of chai·acters must be at least 1.5mm; c/ Cleai·ly 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 confo1mity or the number of the ce1iificate of announcement of confo1mity with food safety regulations. 2. Other contents oflabels of breast milk substitutes must comply with the law on labeling of domestically circulated, impo1ied or expo1ied goods and food safety, and must: a/ Provide proper instmctions 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 expiiy date before and after opening. Article 9. Labels of complementa1y foods for infants 1. The label of a complementa1y food for infants must satisfy the following requii·ements: 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/ Cleai·ly 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 confo1mity or the number of the ce1iificate of announcement of confo1mity with food safety regulations. ©Vietnam Law and Legal Fomm 8 OFFICIAL GAZETTE lssut> nos 01-03/Novt>mber 2014 2. Other contents of labels of complementaiy foods for infants must comply with the law on labeling of domestically circulated, impo1ied 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 instrnctions on hygiene and sterilization. The use offeeding bottles may make children refose breast feeding, or cause diaIThea." The height of chai·acters 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 ofteats must display the following phrase in lower case: "Use of teats may negatively affect breast feeding." The height of chai·acters must be at least 2 mm. The color of chai·acters must be bright and conti·ast 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 standai·ds; b/ Provide accurate and scientific info1mation on and proper usage of nuti·itious products for infants to physicians, medical workers and consumers under Aliicles 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 standai·ds; 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 adveitise, disseminate and encourage the use of breast milk substitutes; c/ Display breast milk substitutes or complementaiy foods for under-6 month infants at medical establishments; display names or logos of breast milk substitutes on banners, posters and other leaflets in supe1markets, 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 fo1ms; dd/ Grant scholarships, provide fonds for scientific reseai·ch, training courses, conferences, workshops, music concerts, contests, stage perfo1mances, making of films or video clips, telephone counseling services or other fo1ms in order to disseminate and introduce products, promote the sales or use of breast milk substitutes; ©Vietnam Law and Legal Fornm lssut> nos 01-03/Novt>mbt>r 2014 OFFICIAL GAZETTE 9 el Provide or supp01t the provision of info1mation, education and communications about infant nm1uring 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 cOlmseling about breastfeeding to pregnant women, nmsing mothers and members of their families; bl Disseminate, put up panels and posters or broadcast images with contents prescribed in Alticles 4 and 5 of this Decree at antenatal clinics, labor and delive1y clinics, postpartum rooms, nutrition counseling clinics or easy-to-notice places or places where concentrate pregnant women, nmsing mothers and members of their families; cl Create conditions for mothers to feed their newborns within the first hom after bnth, exclusively breastfeed for the first six months of life, and continue breastfeeding until 24 months and beyond. 2. Medical establishments may not: al Sell, or pe1mit the sale of, breast milk substitutes at medical establishments, except hospital drngstores; bl Pe1mit 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; cl Pe1mit employees of establishments producing or trading in breast milk substitutes to meet or contact nmsing mothers and pregnant mothers in any fo1ms; 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: al Promote, suppo1t and protect breastfeeding; understand and strictly comply with this Decree; bl Info1m nmsing mothers and pregnant women of the benefits of breastfeeding and ways of breastfeeding and proper breastfeeding positions; cl Help mothers breastfeed then· newborns within the first hom after bi1th; d/ Give mothers guidance on proper breastfeeding positions and maintain their breast milk when they are far from then· infants; dd/ Counsel mothers and members of then· families about exclusive breastfeeding for the first 6 months of life; el Guide and help mothers stay close to then· newborns right after bnth; g/ Encomage mothers to breastfeed infants as desn·ed; h/ Guide mothers and members of their families neither to bottle feed nor use teats; ii Encomage the establishment of breastfeeding suppo1t groups and introduce mothers to the groups after they are discharged from hospitals; kl Identify infants that have to use breast milk substitutes. 2. Physicians and medical workers in medical establishments may not: ©Vietnam Law and Legal Fomm 10 OFFICIAL GAZETTE lssut> nos 01-03/Novt>mber 2014 a/ Guide the use of breast milk substitutes for under-6 month infants, except the case prescribed by doctors; b/ Inf01m 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 pe1mit them to meet pregnant women and nursing mothers at medical establishments. Article 14. Management responsibilities 1. The Ministiy of Health and other minisu-ies and sectors, the People 's Committees at all levels shall, within the ambit of their tasks and powers, manage the use of nuu-itious products for infants; manage quality and safety of nuti·itious products for infants; inspect and examine the implementation of regulations on ti·ading and use of nutl'itious products for infants, feeding bottles and teats. 2 . The Ministiy of Culture, Spo1ts 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 adve1tising of nuu-itious products for infants in accordance with law. 3. The Ministiy of Health shall assume the prime responsibility for, and work with the Vietnam Women's Union Centi·al Committee, socio-political and social organizations in, disseminating and guiding pregnant women, nursing mothers and members of their families the implementation of regulations on ti·ading and use of nutl'itious products for infants, feeding bottles and teats. ChapterV 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 ofFebmaiy 27, 2006, on the ti·ading and use of nutritious products for infants ceases to be effective on the effective date of this Decree. 3. Nuu-itious products for infants that ai·e on the market may continue to circulate until the expi1y 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 ©Vietnam Law and Legal Fornm