Understanding the International Code
Article 1: 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 1.
* The International Code and Resolutions aim to protect infant health
* They aim to protect and support breastfeeding
* They do not ban breastmilk substitutes, but they set out how companies are permitted to market them
"The preamble to the International Code notes that, "breastfeeding 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 breastmilk help to protect infants against disease; and that there is an important relationship between breastfeeding and child-spacing."
The preamble also recognises that there is a "legitimate market for infant formula," but that,
"...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."
Article 2 (and 3): Scope of the Code
"The Code applies to the marketing...of the following products: breastmilk substitutes, including infant formula; other milk products, foods and beverages, including bottlefed 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 2
"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." from Article 3.
The International Code applies to any product which is marketed or otherwise represented as a suitable to replace breastmilk and to feeding bottles and teats. Clearly infant formula, which is marketed for use from
* Infant formula
birth, is such a product. Other products may also be breastmilk substitutes.
* Follow-on formula
* Bottles and teats
* Bottled water, juices, teas, glucose solutions, cereals etc. promoted for use under 6 months of age or as replacements for breastmilk from 6 months of age
* In addition, no infant food may be marketed in ways that undermine breastfeeding
The Code defines "complementary foods" as "any food...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 reastmilk supplement."
The Global Strategy on Infant and Young Child Feeding, adopted by the World Health Assembly in 2004, summarises the recommendations of preceeding Resolutions as follows:
"Breastfeeding is an unequalled way of providing ideal food for the healthy growth and development of infants; it is also an integral part of the reproductive process with important implications for the health of mothers. As a global public health recommendation, infants should be exclusively breastfed for the first six months of life to achieve optimal growth, development and health. Thereafter, to meet their evolving nutritional requirements, infants should receive nutritionally adequate and safe complementary foods while breastfeeding continues for up to two years of age or beyond. Exclusive breastfeeding from birth is possible except for a few medical conditions, and unrestricted exclusive breastfeeding results in ample milk production."
Hence, follow-on milks and complementary foods, including bottled water, juices, teas, glucose solutions, cereals and others foods for babies above 6 months also come within the scope of the International Code if they are marketed as replacements for that part of a childs diet which is best fulfilled by breastmilk. Companies dispute this interpretation and attempt to limit the scope of the International Code to infant formula alone.
The World Health Assembly has also recognised that complementary foods are often marketed in ways that undermine breastfeeding, even when they are not marketed as breastmilk substitutes. Resolution WHA 49.15 calls for measures "to ensure that complementary foods are not marketed for or used in ways that undermine exclusive and sustained breastfeeding."
- Foods marketed for feeding infants younger than 6 months: any such food should be considered "marketed as suitable for replacing breastmilk" and thus, falls within the scope of the Code. Even foods that would ordinarily be thought of as complementary foods become breastmilk substitutes when they are marketed for infants under 6 months.
- Foods marketed for feeding infants from 6 months: any food, such as follow-on milk, which is marketed as a replacement for that part of a childs diet which is best fulfilled by breastmilk comes within the scope of the Code.
- Complementary foods should not be marketed in ways that undermine exclusive and sustained breastfeeding.
- Feeding bottles and teats also come within the scope of the Code.
Article 4: Information and education
* Governments are responsible for the provision of information on infant and young child feeding.
* Materials may only be supplied by companies if requested and approved by the appropriate
government authority or in conformity to government guidelines
* Proprietary products may not be referred to
* Specified warnings must be included
* Information must not idealise the use of breastmilk substitutes
According to Article 4.1 of the International Code, 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."
Article 4.3 states: "Donations of informational or educational equipment or material 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 companys 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."
Monitoring has exposed the misleading and promotional nature of much of the material produced by
companies and its use to encourage mothers to join company aby clubs and to phone company carelines.
In 2005 the World Health Assembly adopted Resolution 58.32 calling for action: "to ensure that financial
support and other incentives for programmes and health professionals working in infant and young-child health do not create conflicts of interest." It can be argued that company materials provided under Article 4.3 violate this Resolution and should no longer be accepted.
Article 4.2 sets out the information which must be included in any informational or educational material (including audio or video presentations) intended to reach pregnant women and mothers of infants and
* "the benefits and superiority of breastfeeding;
young children. Information on the following must be included:
* maternal nutrition and the preparation for and maintenance of breastfeeding;
the negative effect on breastfeeding of introducing partial bottle-feeding;
* the difficulty of reversing the decision not to breastfeed."
Article 4.2 calls for the clear information on, "where needed, the proper use of infant formula; 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.
* in particular, the health hazards of unnecessary or improper use of infant formula and other breastmilk substitutes.
* Most importantly, "such materials should not use any pictures or text which may idealize the use of breastmilk substitutes."
It is true that in many cases the information listed in Article 4.2 is included in materials, but it is usually the smallest text on the leaflet and is over-powered by pictures and text which idealize the use of breastmilk substitutes. The government can refuse approval for such materials (which may only be provided in response
to an official request) or set out in its guidelines how the necessary information is presented (by, for example, stipulating the size of text).
Article 5: The general public and mothers
"There should be no advertising or other form of promotion to the general public of products within the scope of
* Companies are banned from seeking contact with pregnant women and mothers and must not promote products covered by the Code to them or the general public in any way
this Code." Article 5.1
Article 5.1 given above sets out the principle regarding promotion to the general public and mothers: it is banned. Promotion is not defined in the International Code, but it is a very broad term which encompasses all means of encouraging the sale of a product. Advertising is a form of promotion as are: direct mail, leaflets and pamphlets, posters, product samples, free gifts, video shows and lectures. Even sponsorship of events can be considered a form of promotion.
Article 5.2 expands on this general principle: "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."
Article 5.3 covers retail outlets. It clarifies the ban on promotion by citing the following examples:
* "point of sale advertising
giving of samples
* discount coupons, premiums, special sales,
* loss-leaders and tie-in sales."
Article 5.4 clarifies that there should be no gifts given to pregnant women or mothers by manufacturers or distributors.
Article 5.5 states: "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." This means common strategies such as distributing gifts packs, targetting mothers in shopping centres, giving ante and post-natal classes, operating telephone carelines and running mother and baby clubs are all prohibited.
Article 6: Health care system
"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...." Article 6.2
* No promotion of products in the health care system
No free supplies in any part of the health care system
Article 6.2 summarises the general principle of the restrictions on the baby food and bottle and teat companies with regard to the health care system.
The other articles clarify that it is for health workers to advise pregnant women and mothers on infant feeding matters. The following points are made:
"health authorities...should...encourage and protect breastfeeding....and should give appropriate advice to health workers" (Article 6.1)
"Facilities of health care systems should not...display products...placards or posters" or be used for "distribution of material provided by a manufacturer or distributor other than that specified in Article 4.3." (Article 6.3)
"The use by the health care system of...personnel, provided or paid for by manufacturers or distributors, should not be permitted." (Article 6.4)
"Feeding with infant formula...should be demonstrated only by health workers, or other community workers if necessary; and only to the mothers or family members who need to use it." (Article 6.5)
"Equipment and materials, in addition to that described in Article 4.3, donated to a health care system...should not refer to any proprietary product within the scope of the Code" (Article 6.8).
Equipment donated by companies may bear a companys name or logo. Companies use this method to associate their name with the health care system. A government or health facility may, of course, ban the appearance of company logos. Some companies have set up a sub-company with the name used on the breastmilk substitutes or associate the company closely with the brand. In such cases the company name is viewed as the brand name and the restrictions apply.
Article 6.6 refers to the provision of free or low-price supplies. These articles have been clarified and amplified by several Resolutions of the World Health Assembly. Resolution WHA 39.28 stipulated in 1986 that:
"the small amounts of breastmilk substitutes needed for the minority of infants who require them in maternity wards and hospitals are [to be] made available through the normal procurement channels and not through free or subsidized supplies." Resolution WHA 39.28
Resolution WHA 47.5, adopted in 1994, calls on Member States to ensure that there are:
* "..no donations of free or subsidised supplies of breastmilk substitutes and other products...in any part of the health care system." Resolution WHA 47.5
This is a very clear and total ban on free or subsidised supplies in any part of the health care system of products covered by the scope of the Code.
If free or subsidised supplies are given outside of the health care system, Article 6.7 requires donors to bear in mind the responsibility to ensure that the "supplies can be continued as long as the infants concerned need them." In emergency relief operations, supplies should be given only if the following conditions apply:
* "infants have to be fed on breastmilk substitutes, as outlined in the guidelines... (Ref. Document WHO A39/8
Add. 1, 10 April 1986)"
* "the supply is continued for as long as the infants concerned need it" (according to UNICEF this means for the first year of life, after which time unmodified cows milk may be used).
* "the supply must not be used as a sales inducement."
Article 7: Health workers
* Companies are restricted to providing scientific and factual information
* No free samples unless for professional evaluation or institutional research
Funding must not create conflicts of interest, but if company funding is accepted it must be declared.
* Inducements to promote products are banned
Article 7 sets out the following principles:
"those who are concerned...with maternal and infant nutrition should make themselves familiar with...the Code" (Article 7.1)
"Information provided by manufacturers and distributors to health professionals...should be restricted to scientific and factual matters and should not imply or create the belief that bottle-feeding is equivalent or superior to breastfeeding and must include the information set out in Article 4.2" (Article 7.2)
"No financial or material inducements to promote products...should be offered...to health workers or members of their families, nor should these be accepted..." (Article 7.3)
"Samples...of products within the scope of this Code...should not be provided...unless for professional evaluation or research at the institutional level..." (Article 7.4).
Companies "should disclose to the institution...any contribution made....for fellowships...grants...or the like....
Similar disclosures should be made by the recipient." (Article 7.5).
The World Health Assembly Resolution 49.15 further calls for measures to ensure that, "the financial support
for professionals working in infant and young child health does not create conflicts of interest." Resolution 58.32 goes further calling for measures to ensure that: "financial support and other incentives for programmes and health professionals working in infant and young-child health do not create conflicts of interest" and "to ensure
that research on infant and young-child feeding, which may forms the basis for public policies, always contains a declaration relating to conflicts of interest and is subject to independent peer review."
Article 8: Persons employed by manufacturers and distributors
Article 8.1 bans company personnel from being paid on a commission basis for sales of products within the scope of the Code.
Article 8.2 bans company personnel from training mothers and pregnant women (see also Article 6.4).
Article 9: Labelling
"Labels should be designed to provide the necessary information about the appropriate use of the product, and
so as not to discourage breastfeeding." Article 9.1
* Warnings and clear instructions must be included
* No idealising text or pictures
* Text must be in the appropriate language
The general principle regarding labelling is given in Article 9.1 above.
Article 9.2 clarifies what information is required on the labels of infant formula and how it is to be presented. Labels should be "clear, conspicuous, easily readable and understandable...in an appropriate language" and must be attached to the container so that they "cannot readily become separated from it."
After the words "Important Notice" there should be:
* "a statement of the superiority of breastfeeding;
* 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;
* instructions for appropriate preparation and a warning against the health hazards of inappropriate preparation."
Article 9.2 also bans:
* pictures of infants.
pictures or text which may idealise the use of infant formula.
the terms "humanized", "maternalized" or similar terms
While most companies give the information required in the "Important Notice" it is often undermined by
pictures or text which idealise artificial infant feeding or suggest that breastfeeding may be difficult or requires supplementing. Articles 9.1 and 9.2 do not allow this.
Article 9.3 requires that "products which do not meet all the requirements of an infant formula, but which can be modified to do so, should carry a warning that the unmodified product should not be the sole source of nourishment of an infant." It states that "sweetened condensed milk is not suitable for infant feeding...its label should not contain purported instructions on how to modify it for that purpose."
Article 9.4 requires that the following information also appears on the labels of products within the scope
of the Code:
* the ingredients used
* the composition/analysis of the product
* the storage conditions required
the batch number and date before which the product is to be consumed
It is interesting to note that manufacturers generally do not reveal the source of ingredients and many
mothers are not aware that artificial milk is usually modified cows milk. Products may also contain ingredients derived from beef fat, eggs and fish.
Careful analysis of ingredients and composition may also reveal that products which are packaged differently and promoted for different age ranges are, in fact, identical.
The commonplace contamination of powdered formula with Enterobacter Sakazakii and other pathogens came to light in 2002. Resolution 58.32 calls for the risks to be addressed by Codex Alimentarius Commission: "urgently to complete work currently under way on addressing the risk of microbiological contamination of powdered infant formula and establish appropriate microbiological criteria or standards related to E. sakazakii and other
relevant microorganisms in powdered infant formula; and to provide guidance on safe handling and on warning messages on product packaging."
Article 10: Quality
This Article states that products should meet the relevant standards adopted by the FAO/WHO Codex Alimentarius Commission. These standards relate to composition and labelling.
Codex is called on by Resolution WHA 34.22, under which the International Code was adopted "to support and promote the implementation of the International Code." In practice, battles against industry lobbying won at the World Health Assembly have to be fought again at Codex. In Resolution WHA 58.32 the Assembly called on Codex: "to continue to give full consideration, when elaborating standards, guidelines and recommendations, to those resolutions of the Health Assembly that are relevant in the framework of its operational mandate."
Article 11: Implementation and monitoring
Various bodies share responsibility for implementing and monitoring the International Code:
* Governments should implement, monitor and report progress to WHO
* Companies must abide by the provisions independently of other measures
NGOs should monitor and report violations
"Governments should take action to give effect to the principles and aim of this Code...including the adoption of national legislation, regulations or other suitable measures." (Article 11.1).
Governments should monitor the Code both "individually, and collectively through the World Health Organisation....The manufacturers and distributors.. .nongovernmental organisations...should collaborate with governments to this end."
(Article 11.2). (Groups are called on to be co-operative, but companies often argue that this Article gives them the right to be part of the governments monitoring body).
"Independently of any other measures taken...manufacturers and distributors...should regard themselves as responsible for monitoring their marketing practices..." (Article 11.3).
"Nongovernmental organizations (NGOs), professional groups, institutions and individuals ...have the responsibility
of drawing the attention of manufacturers and 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." (Article 11.4).
"Manufacturers and primary distributors ...should appraise each member of their marketing personnel of the Code and of their responsibilities under it." (Article 11.5).
Articles 11.6 and 11.7 require the Member States of the World Health Assembly to provide the Director General of WHO with information on the state of implementation of the Code annually. The Director General is to support Member States in implementing the Code and is to report to the World Health Assembly in even years.
Resolution WHA 34.22, under which the International Code was adopted states, that, "based on the conclusions of the status report [the Director General is] to make proposals, if necessary, for revision of the text of the Code and for the measures needed for its effective application."