of Ethics Online Collection: None
INTERNATIONAL CODE OF MARKETING OF BREASTMILK SUBSTITUTES
THIRTY-FOURTH WORLD HEALTH ASSEMBLY WHA34.22 21
May 1981
The Thirty-fourth World Health Assembly,
Recognizing the importance of sound infant and young child nutrition
for the future health and development of the child and adult;
Recalling that breast feeding is the only natural method of infant feeding
and that it must be actively protected and promoted in all countries;
Convinced that governments of Member States have important responsibilities
and a prime role to play in the protection and promotion of breast feeding
as a means of improving infant and young child health;
Aware of the direct and indirect effects of marketing practices of breastmilk
substitutes on infant feeding practices;
Convinced that the protection and promotion of infant feeding, including the
regulation of the marketing of breastmilk substitutes, affect infant and young
child health directly and profoundly, and are a problem of direct concern to
WHO;
Having considered the Draft International Code of Marketing of Breastmilk Substitutes
prepared by the Director-General and forwarded to it by the Executive Board;
Expressing its gratitude to the Director-General and to the Executive Director
of the United Nations Children's Fund for the steps they have taken in ensuring
close consultation with Member States and with all other parties concerned
in the process of preparing the Draft International Code;
Having considered the recommendation made thereon by the Executive Board at
its sixtyseventh session;
Confirming resolution WHA33.32, including the endorsement in their entirety
of the statement and recommendations made by the joint WHO/UNICEF Meeting on
Infant and Young Child Feeding held from 9 to 12 October 1979;
Stressing that the adoption of and adherence to the International Code of Marketing
of Breastmilk Substitutes is a minimum requirement and only one of several
important actions required in order to protect healthy practices in respect
of infant and young child feeding;
1. ADOPTS, in the sense of Article 23 of the Constitution, the International
Code of
Marketing of Breastmilk Substitutes annexed to the present resolution;
2. URGES all Member States:
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(1) to give full and unanimous support to the implementation of the recommendations made by the joint WHO/UNICEF Meeting on Infant and Young Child Feeding and of the provisions of the International Code in its entirety as an expression of the collective will of the membership of the World Health Organization;
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(2) to translate the International Code into national legislation, regulations or other suitable measures;
3) to involve all concerned social and economic sectors and all other concerned parties in the implementation of the International Code and in the observance of the provisions thereof;
(4) to monitor the compliance with the Code;
3. DECIDES that the follow-up to and review of the implementation of
this resolution shall be undertaken by regional committees, the Executive
Board and the Health Assembly in the spirit of resolution WHA33.17;
4. REQUESTS the FAO/WHO Codex Alimentarius Commission to give full consideration,
within the framework of its operational mandate, to action it might take to
improve the quality standards of infant foods, and to support and promote the
implementation of the International Code;
5. REQUESTS the Director-General:
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(1) to give all possible support to Member States, as and when requested, for the implementation of the International Code, and in particular in the preparation of nationallegislation and other measures related thereto in accordance with operative subparagraph 6(6) of resolution WHA33.32;
(2) to use his good offices for the continued cooperation with all parties concerned in the implementation and monitoring of the International Code at country, regional and global levels;
(3) to report to the Thirty-sixth World Health Assembly on the status of compliance with and implementation of the Code at country, regional and global levels;
(4) based on the conclusions of the status report, to make proposals, if necessary, for revision of the text of the Code and for the measures needed for its effective application.
INTERNATIONAL CODE OF MARKETING BREASTMILK SUBSTITUTES
The Member States of the World Health Organization:
Afirming 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 injustice;
Recognizing that the health of infants and young children cannot be isolated
from the health and nutrition of women, their socioeconomic status and their
roles as mothers;
Conscious that breastfeeding is an unequalled way of providing ideal food for the
healthy growth and. developmen t 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 breastmilk help to protect infants
against disease; and that there is an important relationship between
breastfeeding and child-spacing;
Recognizing that the encouragement and protection of breastfeeding 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 breastfeeding is an important aspect of primary health
care;
Considering that when mothers do not breastfeed, 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 in ways that may interfere
with the protection and promotion of breastfeeding;
Recognizing further that inappropriate feeding practices lead to infant malnutrition,
morbidity and mortality in all countries, and that improper practices in the
marketing of breastmilk 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 breastmilk 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 breastfeeding, provides appropriate family and
community 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 mothers and families about the superior
value of breastfeeding 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 breastfeeding, and in the appropriate
use of complementary foods;
Aware that families, communities, women's organizations and other nongovernmental
organizations have a special role to play in the protection and promotion of
breastfeeding and in ensuring the support needed by pregnant women and mothers
of infants and young children, whether breastfeeding 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
maternal, infant and young child health and nutrition;
Recognizing that 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 breastmilk substitutes have
an important and constructive role to play in relation to infant feeding, and
in the promotion of the aim of this Code and its proper implementation;
Affirming that governments are called upon to take action appropriate 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 breastmilk substitutes, the marketing of breastmilk substitutes requires
special treatment, which makes usual marketing 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
The aim of this Code is to contribute to the provision of safe and adequate
nutrition for infants, by the protection and promotion of breastfeeding,
and by ensuring the proper use of breastmilk 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: breastmilk substitutes, including infant formula;
other milk products, foods and beverages, including bottle-fed complementary
foods when marketed or otherwise represented to be suitable, with or
without modification, for use as a partial or total replacement of breastmilk;
feeding bottles and teats. It also applies to their quality and availability,
and to information concerning their use.
Article 3
Definitions
For the purposes of this Code:
"Breastmilk substitute" means any food being marketed or otherwise
represented as a partial or total replacement for breastmilk, whether or not
suitable for that purpose.
"Complementary food" means any food, whether manufactured or locally
prepared,suitable as a complement to breastmilk or to infant formula, when either
becomes insufficient to satisfy the nutritional requirements of the infant. Such
food is also commonly called "weaning food" or "breastmilk supplement".
"Container" means any form of packaging of products for sale as a normal
retail unit, including wrappers.
"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 formula" means a breastmilk substitute formulated industrially
in accordance with applicable Codex Alimentarius standards, to satisfy the normal
nutritional requirements of infants up to between four and 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 any tag, brand, mark, pictorial or other descriptive
matter, written, printed, stencilled, marked, embossed or impressed on, or attached
to, a container (see above) of any products within the scope of this Code.
"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, distribution, selling, advertising,product
public relations, and 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.
"Supplies" means quantities of a product provided for use over an extended
period, free or at a low price, for social purposes, including those provided
to families in need.
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 Informational and educational materials whether written, 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 breastfeeding;
(b) maternal nutrition, and the preparation for and maintenance of breastfeeding;
(c) the negative effect on breastfeeding of introducing partial bottlefeeding;
(d) the difficulty of reversing the decision not to breastfeed; 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 implications of
its use; the health hazards of inappropriate foods or feeding methods; and,
in particular, the health hazards of unnecessary or improper use of infant
formula and other breastmilk substitutes. Such materials should not use any
pictures or text which may idealize the use of breastmilk substitutes.
4.3 Donations of informational or educational equipment or materials by manufacturers
or distributors should be made only at the request and with the written approval
of the appropriate government authority or within guidelines given by governments
for this purpose. Such equipment or materials may bear the donating company'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, samples of products
within the scope of this Code.
5.3 In conformity with paragraphs 1 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, discount coupons, premiums, special sales loss-leaders
and tie-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 breastmilk 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 breastfeeding 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 the purpose of promoting
infant formula or other products within the scope of this Code. This Code does
not, however, preclude the dissemination of information 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
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 Code should not be included in the calculation
of bonuses, nor should quotas be set specifically for sales of these products.
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 Code
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 care system at the request and with the written approval
of the appropriate authority of the government concerned.
Article 9
Labelling
9.1 Labels should be designed to provide the necessary information
about the appropriate use of the product, and so as not to discourage
breastfeeding.
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 breastfeeding; (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 warning against the health hazards of inappropriate preparation. Neither
the container nor the label should have pictures of infants, nor-should they
have other pictures or text which may idealize the use of infant formula. They
may, however, have graphics for easy identification of the product as a breastmilk
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 is an essential element for the protection
of the health of infants and therefore should be of a high recognized
standard.
Article 11
Implementation and monitoring
11.1 Governments should take action to give effect to the principles
and aim 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, including 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 for implementation of this Code,
manufac turers and distributors of products within the scope of this Code should
regard themselves 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 or distributors to activities which are incompatible with
the principles and aim of this Code, so that appropriate action can be taken.
The appropriate governmental authority should also be 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 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.

