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Act To Promote Breastfeeding And Marketing Of Their Substitutes

Original Language Title: LEY DE FOMENTO A LA LACTANCIA MATERNA Y COMERCIALIZACION DE SUS SUCEDANEOS

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law no 3460 law of August 15, 2006

EVO MORALES AYMA CONSTITUTIONAL PRESIDENT OF THE REPUBLIC

For the Honorable National Congress has sanctioned the following Law: THE HONORABLE CONGRESS NATIONAL, D E C R E T A: LAW DE FOMENTO A LA BREASTFEEDING

AND MARKETING OF ITS SUBSTITUTES CHAPTER I GENERAL PROVISIONS ARTICLE 1. The provisions of this Law are of public order, of social and economic interest; these activities may be carried out by any natural, legal or collective, national or foreign person, duly registered; are consistent with the legislation in force in this respect. ARTICLE 2. This Law is applicable to the placing on the market, and practices with it, of the following products: Substitutes for breast milk, including infant preparations; other products of dairy origin; food and beverages; including complementary foods administered with bottle or otherwise, when they are placed on the market or otherwise indicated that they may be used, with or without modification, to replace partially or wholly with breast milk; Bottles, suckers and diversionary suckers. It also applies to the quality and availability of the above products and to the information related to their use. The rules laid down in this Law apply both to domestic products and to imported products. ARTICLE 3. In the framework of national health policies, breastfeeding is established as a priority within the comprehensive care of women and children. CHAPTER II OF THE PURPOSES AND OBJECTIVES ARTICLE 4 (For purposes). This Law sets out the following purposes: To promote, protect and support the practice of breastfeeding exclusively up to six months of age; from the age of six months to two years, breastfeeding will continue with the addition of complementary feeding. Help improve nutritional status and reduce the morbidity and mortality rates of children under five years of age and mothers. ARTICLE 5 (Of Objectives). The objectives of this Law are as follows:

To contribute to the physical-mental and social well-being of the mother-child binomial, by promoting, supporting, promoting and protecting natural breastfeeding and regulating marketing Breast milk substitutes and other related products.

Normar and control information, promotion, distribution, advertising, sales and other aspects inherent in the marketing of breast milk substitutes, food Complementary, biberons, suckers, and diversionary suckers.

CHAPTER III DEFINITIONS ARTICLE 6 (Of the definitions). For the purpose of facilitating the proper understanding and management of the terminology used in this Law, the following definitions are adopted: SUPPLEMENTARY FOOD. Any manufactured or prepared food that can be used as a supplement to breast milk or infant preparations, when those or infant formula are insufficient to meet the nutritional needs of the infant. This type of food is also often called, inadequately, a supplement to breast milk. MERCHANDISING. It is understood by marketing, all activities of promotion, distribution, sale, advertising, public relations, information services or data dissemination by any means, intended to promote

the sale of a product. DISTRIBUTION. Any natural or legal person, public or private sector, which is directly or indirectly engaged in the marketing, wholesale or retail, of one or more products. ENVASE. Any type of unit container that is not part of the nature of the product (including packages and wraps), with the specific mission of maintaining its quality and protecting it from any deterioration or contamination, to facilitate its handling, transport and marketing. LABEL. Any legend, letterhead, mark, label or other descriptive, written, printed, marked, embossed or hollow, fixed, included, accompanying or belonging to the package is considered to be a label. MANUFACTURER. Any natural or legal person or entity engaged in the manufacture of a product, either directly or through an agent or a person linked to it under a contract. DATE OF MAKING. Date with which the individual batches are distinguished and which indicates the date on which the manufacturing was finished, usually expressed for the month and year. EXPIRATION, EXPIRATION, OR EXPIRATION DATE. Date printed on the immediate packaging of a product in a visible manner, designating the date to which the product is expected to satisfy the specifications and safety of the product. This date is set for each batch by adding the useful life period to the manufacturing date. It is the date provided by the manufacturer in a non-codified manner, which is based on the stability and safety of a product and after which the product should not be consumed, the product being considered non-marketable. INFANT FORMULA. Any dairy product of animal or plant origin manufactured industrially, in accordance with the requirements of the rules, intended to feed children under six months of age. TRACKING FORMULA. Any milk product of animal or plant origin, manufactured industrially in accordance with the requirements of the standards, marketed or otherwise presented as suitable for feeding infants over six months of age. SPECIAL FORMULAS. All infant formula marketed for infants who are hypersensitive to cow's milk, lactose intolerance or other metabolic disorders LACTANTE. A child under two years of age. SAMPLE. The representative unit of a product batch. SALES PROMOTER OR MEDICAL VISITOR. Everyone who provides information or public relations services for a particular product. HEALTH RECORD. The procedure whereby a particular product undergoes a strict evaluation for its marketing. HEALTH SERVICE. Any governmental, non-governmental, semi-state, private, Church, or health professional institution or organization dedicated to providing, directly or indirectly, health care or health education, including of childcare, childcare facilities and other related services. BREAST MILK SUBSTITUTES. Any product marketed, presented or offered explicitly or implicitly as a partial or total substitute for breast milk, whether or not it is suitable for this purpose. CHAPTER IV THE NATIONAL AUTHORITY ARTICLE 7. The Ministry of Health, through the departmental health departments, will be responsible for the control, supervision and correct application of this Law and its Rules of Procedure. CHAPTER V ADMINISTRATIVE ORGAN ARTICLE 8 (National Breastfeeding Committee). The National Committee for Breastfeeding Is Recognized, under the chairmanship of the Ministry of Health, which is constituted by entities involved in the promotion, promotion and protection of breastfeeding and in marketing of breast milk substitutes. The conformation, purpose and activities of this Committee shall be defined in the Rules of Procedure of this Law. ARTICLE 9 (The functions of the Committee). The National Breastfeeding Committee will perform the following functions:

Advising the Executive Branch and other institutions involved in caring for women and children under the age of five years.

Promote, protect and encourage breastfeeding.

Vellar for compliance and application of this Law. CHAPTER VI HEALTH RECORD ARTICLE 10. The health record of breast milk substitutes, infant formulas, follow-up formulas and special formulas, will be given as a medicine, through the competent authority of the Ministry of Health. ARTICLE 11. The health record of complementary foods and follow-up formulas for over two years will be granted as food by the National Service for Agricultural and Food Safety (SENASAG). CHAPTER VII LABELLING AND PACKAGING ARTICLE 12. The label of any substitute for breast milk, infant formula, special or follow-up, should:

Appear visibly and instead of words? IMPORTANT NOTICE?, to affirm the superiority of breast milk in feeding infants at least up to six months, for example:? BREAST MILK IS THE BEST THING FOR YOUR BABY, IS IT RECOMMENDED TO USE IT ONLY FOR SIX MONTHS? (Near the product name, printed in visible size and color).

Report on the analytical composition, ingredients, including additives, preservatives and others, as well as the correct use of the product.

Be written in Spanish.

Contain the name and address of the manufacturer.

Be designed so that you DO NOT DISCOURAGE breast-feeding.

The packaging must contain the expiration, expiration, or expiration date, indicating the prohibition of use and placing on the market after expiration. It will also contain, the batch number and storage conditions after the product has been opened for use, if any.

You should only carry photography, design, or other graphical presentation necessary to illustrate or display the product. correct product preparation.

Contain instructions for further preparation and hygienic measures to follow, as well as the age of the child (a) for whom use is indicated.

This product is prohibited from use and marketed on the date after the expiry date. ARTICLE 13. Under no circumstances shall the label of breast milk substitutes, formulas, children, special or follow-up, complementary foods, bottles, suckers or diversionary suckers, contain:

Information and images of children infants intended to discourage breast-feeding.

Legends, drawings, or illustrations that directly or indirectly tend to create the conviction that the product is equivalent or superior to breast milk.

Terms like? maternized?,? humanized? or other analogues.

Statements by associations of professionals or other organizations that support the consumption of the products cited.

Another image other than that of its source,? plant or animal origin? the substitute for breast milk. ARTICLE 14. The label of dairy products, in addition to the Bolivian labelling rules, (condensed, evaporated, whole, skim milk, powder, or fluid), must contain a clear and visible warning, products should not be used for the replacement of breast milk. ARTICLE 15. The complementary food label must contain:

Age, in months completed, after which the product can be used.

Product analytical composition, ingredients used including additives, preservatives and other.

Conservation period, after violation of the security seal, in case of being different than the due date, expiration or expiration.

Requirements and storage conditions. e) Name and address of the manufacturer.

ARTICLE 16. The packaging of diversionary bottles, suckers and suckers must include, in a clear and visible form, the following legends:

? No substitute for breast milk?

? Should the product be sterilized before use?

? The pacifier interferes with the suction pattern, unstimulating breastfeeding?. CHAPTER VIII

MARKETING ARTICLE 17. No manufacturer, importer or distributor, institution or commercial establishment, pharmaceutical, public or private, natural or legal person, may distribute, sell, store or expose substitutes for breast milk, formulas children, special or follow-up, complementary foods or bottles, suckers or diversionary suckers, that would not have met the following requirements:

Health record of the product.

Serial number or batch.

Due date, expiration or expiration and optionally the date of elaboration. CHAPTER IX PROMOTION AND ADVERTISING

ARTICLE 18. No manufacturer, importer or distributor, commercial institution or establishment, or public or private pharmaceutical, natural or legal person, directly or indirectly, may promote or publish any substitute product of milk maternal, infant formula, special or follow-up, supplementary food for children under six months, bottles, diversionary suckers, in premises, health centres, commercial or other place of supply. ARTICLE 19. The following are considered to be prohibited promotional practices for maternal leches, infant formula, special and follow-up, complementary foods for less than six months, bottles, suckers and diversionary suckers, the following:

Advertising of flagged products.

Tactic sales, such as special presentations, discount coupons, linked sales, prizes and gifts.

Free distribution, directly or indirectly to staff health, to any person, especially pregnant or pregnant women breastfeeding, or to institutions, except in the cases described in Articles 22 and 23.

The promotion in the form of financial benefit or the distribution of gifts of any kind to the general public or health personnel carrying the name, logo, graphic representation or brand name of one of the products cited.

The distribution or exposure of printed, hearing or visual materials to pregnant or nursing women and the public in general.

The distribution or exposure of printed, hearing or visual materials in any scientific event related to the health and nutrition of the child (a), bearing the logo, graphic representation or brand name of one of the products.

Any other advertising or promotion practice that the National Committee of Breastfeeding to consider the health and nutrition of the child (a).

ARTICLE 20. The information provided by manufacturers and distributors to health professionals, considering the restrictions of the products covered by this Law, should be restricted to scientific and real issues, and such information must not imply or convince that feeding by means of the bottle is equivalent or superior to breastfeeding. ARTICLE 21. It prohibits the dissemination of messages that:

Suggest, motivate or persuade mothers to substitute breast milk for any substitute for the same, infant formula, special formula or follow-up.

Discouraged breastfeeding maternal, through comparisons with other practices.

Associated with maternal breast substitutes, infant formulas, special or follow-up with breastfeeding, with phrases or signs such as:? Maternized? or? Humanized?.

Use statements such as:? Better?,? Sure?,? Effective?,? Cash?,? No Risk?, etc., referring to infant, special or follow-up formulas.

They suggest the use of breast milk substitutes, infant formulas, special or follow-up formulas. CHAPTER X

ARTICLE 22. The donation of substitutes for breast milk, in direct or indirect form, to any institution providing care services to the child under two years of age, shall be possible only if the institution has express authorisation. by the Ministry of Health. ARTICLE 23. Only organizations or institutions that focus on infants who cannot opt for breastfeeding may use breast-milk substitutes, from donations, after authorization from the authorities. corresponding. CHAPTER XI

BREASTFEEDING ALLOWANCE ARTICLE 24. Breastfeeding allowances, intended to contribute to the feeding of pregnant or breastfeeding women, may not contain substitutes for breast milk, infant formulae and special formulae. ARTICLE 25. The institutions, public or private companies, which deliver the breastfeeding allowance, are obliged to inform pregnant women and mothers that the products of the breastfeeding allowance are intended to promote health and nutrition of the beneficiary and its use is not intended for the infant under six months. Marketing to the public of breastfeeding allowance is prohibited. ARTICLE 26. If milk is part of the breast-feeding allowance, the label must bear a legend that informs pregnant mothers that the product is intended to promote the health and nutrition of the recipient and that it is not intended for use in infants. less than six months. CHAPTER XII BANS AND SANCTIONS ON HEALTH PERSONNEL ARTICLE 27. Health personnel who provide services in public or private institutions or are part of scientific organizations and associations, related to the health and nutrition of the child, are prohibited from:

Accept gifts or financial benefits of any other kind from the manufacturer or distributor as a mechanism for the promotion of breast milk substitutes.

Be a mediator in the distribution of maternal milk substitutes and disseminate messages to the population that they have children under two years.

Conduct practices contrary to the provisions of this Law. In the event of non-compliance with the provisions of this Article, the penalties laid down according to law shall apply. CHAPTER XIII INFRINGEMENTS AND SANCTIONS ARTICLE 28. Any infringement committed for non-compliance with the provisions of this Law and its Rules of Procedure shall be sanctioned in accordance with the provisions of the applicable regulations. The Ministry in the area of health will have the capacity to ensure compliance with the existing rules that cover the scope of this Law. CHAPTER XIV FINAL PROVISIONS First. All provisions contrary to this Law are hereby repealed. Second. The Executive Branch will draft the Regulation to this Law within 90 days of its publication. TRANSITIONAL PROVISION For the application of Article 14, a period of 180 days is granted for the traders and manufacturers to adapt to it. Refer to the Executive Branch for Constitutional purposes. It is given in the Session Room of the Honorable National Congress, two days in August of two thousand six years.

Fdo. Santos Ramírez Valverde, Edmundo Novillo Aguilar, Ricardo Alberto Diaz, Félix Rojas Gutiérrez , Oscar Chirinos Alanoca, Jorge Milton Becerra M. Therefore, he enacted it so that it has and will comply with the law of the Republic. Palace of Government of the city of La Paz, at the fifteen days of the month of August of two thousand six years. FDO. EVO MORALES AYMA, Juan Ramón Quintana Taborga, Heredia Miranda.

DECREE SUPREME N ° 28847 EVO MORALES AYMA

CONSTITUTIONAL PRESIDENT OF THE REPUBLIC CONSIDERING:

That the objective of the Project? Highway of Integration Guayaramerin? Riverside? is to energize and strengthen the productive system, to achieve an effective economic and social development of the area of influence of the road, by integrating the route projected with the national routes and an appropriate link with the routes

That the short-term objectives relate to the direct benefits of the project, the most important of which are: (a) Enable vehicle transit throughout the year; b) Reduce vehicle operating and maintenance costs; c) Reduce vehicle travel times; d) Reduce transportation costs, making transportation accessible to users; and e) Reduce the costs of road maintenance.

What for the execution of the said project, the Andean Development Corporation? CAF, has agreed to grant the Republic of Bolivia a credit of up to $us. 42,000,000.-(FORTY-TWO MILLION 00/100 AMERICAN DOLLARS).

What is required to authorize the subscription of the respective Credit Agreement with the Andean Development Corporation? CAF, in order to materialize the financing of the project. IN COUNCIL OF MINISTERS, D E C R E T A:

ARTICLE 1.-(OBJECT). This Supreme Decree is intended to authorize the Ministry of Development Planning, to subscribe with the Andean Development Corporation? CAF, in the name and representation of the Government of the Republic of Bolivia, a Loan for $us. 42,000,000.-(FORTY-TWO MILLION US DOLLARS 00/100 USD, destined to finance the Project? Highway of Integration Guayaramerin? Riverside?. Once the Loan Contract has been signed, it must be referred to the Legislative Branch, in compliance with the provisions of Article 59, Attribution 5ta., of the Constitution of the State.

ARTICLE 2.-(SUBSCRIPTION OF CONVENTIONS). The participation of the Ministry of Finance, in the subscription of the subsidiary agreements with the implementing entities for the transfer of external resources and execution of the loan agreement, in coordination with the Ministry of Development Planning, through the Vice-Ministry of Public Investment and External Financing.

The Minister of State, in the Office of Development Planning and Finance, is responsible for the execution and fulfillment of this Supreme Decree.

It is given in the Government Palace of the City of La Paz, at thirty-one day of the month of August of the year two thousand six. FDO. EVO MORALES AYMA, David Choquehuanca Cespedes, Juan Ramón Quintana Taborga Minister of the Presidency and Acting National Defense Minister, Alicia Munoz Ala, Casimira Rodríguez Romero, Carlos Villegas Quiroga, Abel Mamani Marca, Celinda Sosa Lunda Minister Production and Microenterprise and Interine Finance, Salvador Ríriera, Hugo Salvatierra Gutiérrez, Andres Soliz Rada, Walter Villarroel Morochi, Santiago Alex Galvez Mamani, Felix Patzi Paco, Nila Heredia Miranda.