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International Code of Marketing of Breast Milk Substitutes

The Member States of the World Health Organization:

Affirming the right of every child and every pregnant and lactating woman to be adequately’ nourished as a means of attaining and maintaining health;

Recognizing that infant malnutrition is part of the wider problems of lack of education, poverty, and social justice;

Recognizing that the health of infants and young children cannot be isolated from the health and nutrition of women, their socio-economic status and their roles as rnothcrs;

Conscious that breast-feeding is an unequalled way of providing ideal food for the healthy growth and development of infants; that it forms a unique biological and emotional basis for the health of both mother and child; that the anti-infective properties of breast milk help to protect infants against disease, and that there is an important relationship between breast feeding and child-spacing;

Recognizing that the encouragement and protection of breast-feeding is an important part of the health, nutrition and other social measures required to promote healthy growth and development of infants and young children; and that breast-feeding is an important aspect of primary health care;

Considering that when mothers do not breast-feed, or only do so partially, there is a legitimate market for infant formula and for suitable ingredients from which to prepare it; that all these products should accordingly be made accessible to those who need them through commercial or non-commercial distribution systems; and that they should not be marketed or distributed m ways that may interfere with the protection and promotion of breast-feeding;

Recognizing further that inappropriate feeding practices lead to infant malnutrition, morbidity and mortality in all countries, and that improper practices in the marketing of breast-milk substitutes and related products can contribute to these major public health problems;

Convinced that it is important for infants to receive appropriate complementary foods, usually when the infant reaches four to six months of age, and that every effort should be made to use locally available foods; and convinced, nevertheless, that such complementary foods should not be used as breast-milk substitutes;

Appreciating that there are a number of social and economic factors affecting breast feeding, and that, accordingly, governments should develop social support systems to protect, facilitate and encourage it, and that they should create an environment that fosters breast-feeding, provides appropriate family and com1nunity support, and protects mothers from factors that inhibit breastfeeding; Affirming that health care systems, and the health professionals and other health workers serving in them, have an essential role to play in guiding infant feeding practices, encouraging and facilitating breastfeeding, and providing objective and consistent advice to Inothers and families about the superior value of breast-feeding, or, where needed, on the proper use of infant formula, whether manufactured industrially or home-prepared;

Affirming further that educational systems and other social services should be involved in the protection and promotion of breast-feeing, and in the appropriate use of complementary food:

Aware that familles, communities, women’s organizations and other nongovernmental organizations have a special role to play in the protection and promotion of breast feeding and in ensuring the support needed by pregnant women and mothers of infants and young children, whether breast-feeding or not;

Affirming the need for governments, organizations of the United Nations system, nongovernmental organizations, experts in various related disciplines, consumer groups and industry: to cooperate in activities aimed at the improvement of rnatcrnal, infant and young child health and nutrition;

Recognizing the governments should undertake a variety of health, nutrition and other social measures to promote healthy growth and development of infants and young children, and that this Code concerns only one aspect of these measures;

Considering that manufacturers and distributors of breast-milk substitutes to have an important and constructive role to pla:y in relation to infant feeding, and in the promotion of the ain1 of this Code and its proper implementation;

Affirming that governments are called upon to take action appropriate to their social and legislative framework and their overall development objectives to give effect to the principles and aim of this Code, including the enactment of legislation, regulations or other suitable measures;

Believing that, in the light of the foregoing considerations, and in view of the vulnerability of infants in the early months of life and the risks involved in inappropriate feeding practices, including the unnecessary and improper use of breast milk substitutes, the marketing of breast-milk substitutes requires special treatment, which makes usual rnarketing practices unsuitable for these products;

THEREFORE:

The Member States hereby agree the following articles which are recommended as a basis for action

Article I. Aim of the Code

This aim of this Code is to contribute to the provision of safe and adequate nutrition for infants, by the protection and promotion of breast-feeding, and by ensuring the proper use of breast-milk substitutes, when these are necessary, on the basis of adequate information and through appropriate marketing and distribution.

Article 2. Scope of the Code The Code applies to the marketing and practices related thereto, of the following products: breast-milk substitutes, including infant formula; other milk products, foods and beverages, including bottle-fed complementary foods, when marketed or otherwise presented to be suitable, with or without modification, for use as a partial or total replacement of breast-milk; feeding bottles and teats. It also applies to their quality and availability, and to information concerning their use.

Article 3. Definitions
For the purpose of this Code:

“Breast-milk substitute”
means any food being marketed or otherwise represented as a partial or total replacement for breast-milk, whether or not suitable for that purpose.

“Complementary food”
means any food, whether manufactured or locally prepared, suitable as a complement to breast milk or to infant formula, when either becomes insufficient to satis(y the nutritional requirements of the infant. Such food is also commonly called “weaning food” or “breast-milk supplement.”

“Distributor”
means a person, corporation or any other entity in the public or private sector engaged in the business (whether directly or indirectly) of marketing at the wholesale or retail level a product within the scope of this Code. A “primary distributor” is a manufacturer’s sales agent, representative, national distributor or broker.

“Health care system”
means governmental, nongovernmental or private institutions or organizations engaged, directly or indirectly, in health care for mothers, infants and pregnant women; and nurseries or child care institutions. It also includes health workers in private practice. For the purposes of this Code, the health care system does not include pharmacies or other established sales outlets.

“Health Worker”
means a person working in a component of such a health care system, whether professional or non-professional, including voluntary, unpaid workers.

“Infant forrnula”
means a breast-milk substituted formulated industrially accordance with applicable Codex Alimentarius standards, to satisfy the normal nutritional requirements of infants up to between four or six months of age, and adapted to their physiological characteristics. Infant formula may also be prepared at home, in which case it is described as home prepared.

“Label”
means a breast-milk substituted formulated industrially m accordance with applicable Codex Alimentarius standards, to satisfy the normal nutritional requirements of infants up to between four or six months of age, and adapted to their physiological characteristics. Infant formula may also be prepared at home, in which case it is described as ‘”home prepared

“Manufacturer”
means a corporation or other entity in the public or private sector engaged in the business or function (whether directly or through an agent or through an entity controlled by or under contract with it) of manufacturing a product within the scope of this Code.

“Marketing”
means product promotion, advertising, product information services.

“Marketing personnel”
means any persons whose functions involve the marketing of a product or products coming within the scope of this Code.

“Samples”
means single or small quantities of a product provided without cost.

Article 4. Information and Education

4.1 Governments should have the responsibility to ensure that objective and consistent information is provided on infant and young child feeding for use by families and those involved in the field of infant and young child nutrition. This responsibility should cover either the planning, provision, design and dissemination of information, or their control

4.2 information and educational materials, whether Titten, audio, or visual, dealing with the feeding of infants and intended to reach pregnant women and mothers of infants and young children, should include clear information on all the following points: (a) the benefits and superiority of breast-feeding: (b) maternal nutrition, and the preparation for maintenance of breast-feeding; {c) the negative effect on breast feeding of introducing partial bottle-feeding; (d) the difficulty of reversing the decision not to breast-feed; and (e) where needed, the proper use of infant formula, whether manufactured industrially or home-prepared. When such materials contain information about the use of infant formula, they should include the social and financial iinplications of its use; the health hazards of inappropriate foods for feeding methods; and, in particular, the health hazards of unnecessary or improper use of infant fonnula and other breast-milk substitutes. Such materials should not use any pictures or text which may idealize the use of breast-milk substitutes.

4.3 Donations of informational or educational equipment or materials by manufacturers or distributors should be made only at the request and with written approval of the appropriate government authority or within guidelines give by governments for this purpose. Such equipment or materials may bear the donating compan_y’s name or logo, but should not refer to a proprietary product that is within the scope of this Code, and should be distributed only through the health care system.

Article 5. The general public and mothers

5.1 There should be no advertising or other form of promotion to the general public of products within the scope of this Code.

5.2 Manufacturers and distributors should not provide, directly or indirectly, to pregnant women, mothers or members of their families, sa1nples of products within the scope of this Code.

5.3 ln conformity with paragraphs I and 2 of this Article, there should be no point-of sale advertising, giving of samples, or any other promotion device to induce sales directly to the consumer at the retail level, such as special displays, discounts coupons, premiums, special sales, loss-leaders and the-in sales, for products within the scope of this Code. This provision should not restrict the establishment of pricing policies and practices intended to provide products at lower prices on a long term basis.

5.4 Manufacturers and distributors should not distribute to pregnant women or mothers of infants and young children any gifts of articles or utensils which may promote the use of breast-milk substitutes or bottle-feeding.

5.5 Marketing personnel, in their business capacity, should not seek direct or indirect contact of any kind with pregnant women or with mothers of infants and young children.

Article 6. Health care systems

6.1 The health authorities in Member States should take appropriate measures to encourage and protect breast-feeding and promote the principles of this Code, and should give appropriate information and advice to health workers in regard to their responsibilities, including the information specified in Article 4.2

6.2 No facility of a health care system should be used for this purpose of promoting infant formula or other products \vi thin the scope of this Code. This code does not, however, preclude the dissemination of informat.ion to health professionals as provided in Article 7.2

6.3 Facilities of health care systems should not be used for the display of products within the scope of this Code, for placards or posters concerning such products, or for the distribution of material provided by a manufacturer or distributor other than that specified in Article 4.3

6.4 The use by the health care system of “professional service representatives,” “mothercraft nurses” or similar personnel, provided or paid for by manufacturers or distributors, should not be permitted.

6.5 Feeding with infant formula, whether manufactured or home-prepared, should be demonstrated only by health \vorkers, or other community vvorkers if necessary; and only to the mothers or familr members who need to use it; and the information given should include a clear explanation of the hazards of improper use.

6.6 Donations or low-price sales to institutions or organizations of supplies of infant formula or other products within the scope of this Code, whether for use in the institutions or for distribution outside them, may be made. Such supplies should only be used or distributed for infants who have to be fed on breast-milk substitutes. If these supplies are distributed for usc outside the institutions, this should be done only by the institutions or organizations concerned. Such donations or low-price sales should not be used by manufacturers or distributors as a sales inducement.

6.7 Where donated supplies of infant formula or other products within the scope of this Code are distributed outside an institution, the institution or organization should take steps to ensure that supplies can be continued as long as the infants concerned need them. Donors, as well as institutions or organizations concerned, should bear in mind this responsibility.

6.8 Equipment and materials, in addition to those referred to in Article 4.3, donated to a health care system may bear a company’s name or logo, but should not refer to any proprietary within the scope of this Code.

Article 7. Health workers

7.1 Health workers should encourage and protect breast-feeding; and those who are concerned in particular with maternal and infant nutrition should make themselves familiar with their responsibilities under this Code, including the information specified in Article 4.2

7.2 Information provided by manufacturers and distributors to health professionals regarding products \vi thin the scope of this Code should be restricted to scientific and factual matters, and such information should not imply or create a belief that bottle-feeding is equivalent or superior to breast-feeding. It should also include the information specified in article 4.2

7.3 No financial or material inducements to promote products \Vithin the scope of this Code should be offered by manufacturers or distributors to health workers or members of their families, nor should these be accepted by health workers or members of their families.

7.4 Samples of infant formula or other products within the scope of this Code, or of equipment or utensils for their preparation or use, should not be provided to health workers except when necessary for the purpose of professional evaluation or research at the institutional level. Health workers should not give samp!cs of infant formula to pregnant women, mother of infants and young children, or mem bcrs of their families.

7.5 Manufacturers and distributors of products within the scope of this Code should disclose to the institution to which a recipient health worker is affiliated any contribution made to him or on his behalf for fellowships, study tours, research grants, attendance at professional conferences, or the like. Similar disclosures should be made by the recipient.

Article 8. Persons employed by manufacturers and distributors

8. 1 In systems of sales incentives for marketing personnel, the volume of sales of products within the scope of this Scope should not be included in the calculation of bonuses, nor should quotas be set specifically for sales of these product. This should not be understood to prevent the payment of bonuses based on the overall sales by a company of other products marketed by it.

8.2 Personnel employed in marketing products within the scope of this Scope should not, as part of their job responsibilities, perform educational functions in relation to pregnant women or mothers of infants and young children. This should not be understood as preventing such personnel from being used for other functions by the health systems at the request and with the written approval of the appropriate authorit_v of the government concerned.

Article 9. Labeling

9.1 Labels should be designed to provide the necessary information about the appropriate use of the product, and so as not to discourage breast-feeding.

9.2 Manufacturers and distributors of infant formula should ensure that each container has a clear. conspicuous, and easily readable and understandable message printed on it, or on a label which cannot readily become separated from it, in an appropriate language, which includes all the following points: (a) the words “Important Notice” or their equivalent; (b) a statement of the superiority of breast-feeding; (c) a statement that the product should be used only on the advice of a health worker as to the need for its use and the proper method of use; (d) instructions for appropriate preparation, and a \Varning against the health hazards of inappropriate preparation. Neither the container nor the label should have pictures of infants, nor should thev have other pictures or text vvhich may idealize the use of infant formula. They may , however, have graphics for easy identification of the product as a breast-milk substitute and for illustrating methods of preparation. The terms “humanized,” “maternalized” or similar terms should not be used. Inserts giving additional information about the product and its proper use, subject to the above conditions, may be included in the package or retail unit. When labels give instructions for modifying a product into infant formula, the above should apply.

9.3 Food products within the scope of this Code, marketed for infant feeding, which do not meet all the requirements of an infant formula, but which can be modified to do so, should carry on the label a warning that the unmodified product should not be the sole source of nourishment of an infant. Since sweetened condensed milk is not suitable for infant feeding, nor for use as a main ingredient of infant formula, its label should not contain purported instructions on how to modify it for that purpose.

9.4 The label of food products within the scope of this Code should also state all the following points: (a) the ingredients used; (b) the composition/analysis of the product; (c) the storage conditions required; and (d) the batch number and the date before which the product is to be consumed. taking into account the climatic and storage conditions of the country concerned.

Article 10. Quality

10.1 The quality of products in an essential clement for the protection of the health of infants and therefore should be of a high recognized standard.

10.2 Food products within the scope of this Code should, when sold-or otherwise distributed, meet applicable standards recommended by the Codex Alimentarius Commission and also the Codex Code of Hygienic Practice for Foods for Infants and Children

Article 11. Implementation and monitoring

11.1 Governments should take action to give effect to the principles and airn of this Code, as appropriate to their social and legislative framework, including the adoption of national legislation, regulations or other suitable measures. For this purpose, governments should seek, when necessary, the cooperation of WHO, UNICEF and other agencies of the United Nations system. National policies and measures, inc!uding laws and regulations, which are adopted to give effect to the principles and aim of this Code should be publicly stated, and should apply on the same basis to all those involved in the manufacture and marketing of products within the scope of this Code.

11.2 Monitoring the application of this Code lies with governments acting individually, and collectively through the World Health Organization as provided in paragraphs 6 and 7 of this Article. The manufacturers and distributors of products within the scope of this Code, and appropriate nongovernmental organizations, professional groups and consumer organizations should collaborate with governments to this end.

11.3 Independently of any other measures taken from implementation of this Code, manufacturers and distributors of products within the scope of this Code should regard themselves as responsible for monitoring their marketing practices according to the principles and aim of this Code, and for taking steps to ensure that their conduct at every level conforms to them.

11.4 Nongovernmental organizations, professional groups, institutions, and individuals concerned should have the responsibility of drawing the attention of manufacturers and distributors to activities v;,rhich are incompatible with the principles and aim of this Code, so that appropriate action can be taken. The appropriate governmental authority should also he informed.

11.5 Manufacturers and primary distributors of products within the scope of this Code should apprise each member of their marketing personnel of the Code and of their marketing personnel of the Code and of their responsibilities under it.

11.6 In accordance with Article 62 of the constitution of the World Health Organization, Member States shall communicate annually to the Director-General information on action taken to give effect to the principles and aim of this Code.

11.7 The Director-General shall report in even years to the World Health Assembly on the status of implementation of the Code; and shall, on request provide technical support to Member States preparing national legislation or regulations, or taking other appropriate measures in implementation and furtherance of the principles and aim of this Code.

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