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Infant feeding and regulation |
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About the Author: This article was written by Heather Paine BSc MSc CSci FIFST Consultant Food Scientist, Richmond, Surrey, UK.
The information in this article is correct at date of publication: January 2009
Opinions expressed by the author are not necessarily those of the publisher or editorial staff.
Nowadays almost everything we eat and drink is controlled by legislation. We expect our foods to be safe, of appropriate quality and price, adequately packaged and accurately and honestly described. In the past 15 years we have seen increasingly prescriptive legislation on infant formulas which are now one of the most heavily regulated foods, rightly so, bearing in mind they are aimed at such a vulnerable population group. Products must meet stringent composition, safety and quality requirements and are also subject to marketing and advertising controls. Most people are unaware of these restrictions. In-store consumers make choices according to their personal circumstances and few will reflect on why they make those choices or realise that the products (and the range of products) available today are different to those that were on sale a generation ago. Certainly most people are unaware that infant formula manufacturers are heavily restricted in how and what they can communicate to parents and Healthcare Professionals, or that Healthcare Professionals play a crucial role in implementing infant feeding policy and in informing and educating parents. This article examines the background to the current legislation and what effect, if any, it has had on scientific developments and infant feeding practice.
Historical developments
UK government policy has always been to endorse breastfeeding as the best means of infant nutrition. In 1943, the Ministry of Health stressed the importance of the ‘flying start’ that breastfeeding can give and commissioned a report on breastfeeding in response to concern that only 80% of babies were leaving hospital wholly breastfed whereas the figure was 95% for babies born at home1.
By the 1970s even fewer babies were being breastfed and there were problems with early weaning. Government policy was to encourage breastfeeding for healthy infants both at term and during the early months of life, whilst solid foods were not recommended before the age of three months with a mixed diet to be offered by the age of six months1.
Early baby milks were based on dried full-cream milk powder with added sucrose which was reconstituted by the mother with water to the required concentration. Infants were also given oral supplements to provide vitamin C and vitamin D2. In the 1970’s infant formulas based on modified cows’ milk were introduced and by 1976 all unmodified milks were withdrawn from the market.
These new baby milks were designed to resemble human milk as far as possible3,4 and their development owes much to the publication of two reports. In 1977, the first study of mature human milk by modern analytical techniques was published56. This led to important modifications in the composition of infant formulas including a reduction in the protein content, an adjustment of the casein:whey ratio, the replacement of cows’ milk fat with oil blends that match more closely the fatty acid profile of human milk, major adjustments to the mineral content and the addition of micronutrients.
Follow-on milks were launched in the UK in the 1980s although they had existed in several other countries for many years. Aimed at older babies (from six months) and young children, they were introduced to address concerns over the use of whole cows’ milk and the risk of iron deficiency.
Advice on weaning changed in 1994 as a result of a Department of Health report recommending that the majority of infants should not be given solid foods before the age of four months and should be offered a mixed diet by six months. This was followed, in 1980, by the first official, although not statutory, compositional guidelines for infant formulas. The report also stated that whole cows’ milk should not be used as the main drink for infants under one year and acknowledged that both infant formulas and follow-on formulas may be beneficial if there are concerns about iron deficiency during weaning7.
In 2003, the Department of Health changed this advice8 in line with a new World Health Organisation (WHO) global public health policy on the optimal duration of exclusive breastfeeding and the age of weaning. Previously WHO had recommended exclusive breastfeeding from birth to four to six months but, in early 2000, following a systematic review9, WHO changed its policy to recommend exclusive breastfeeding for six months with the introduction of complementary foods at six months and continued breastfeeding for up to two years of age or beyond10.
Since the publication of the 1980 compositional guidelines, the focus of infant nutrition research has changed with the acceptance of ‘early programming’ - a concept that recognises the importance of early nutrition on health in later life. This has led to major new areas of research and development into infant formulas that are now designed to improve health outcomes of the bottlefed infant rather than attempting to mimic the composition of breastmilk. The rationale behind modern infant formulas, therefore, is not to emulate breastmilk in biological detail but to produce a pattern of responses that resembles, as closely as possible, the infant’s physiological responses to breastfeeding.
Background to the legislation
After the Second World War, the field of paediatric nutrition expanded rapidly but until 1995 there were no specific UK regulations on infant milks. In common with other foods, infant formulas were subject to general food safety law and regulations dealing with labelling, additives and contaminants. Certain food additives, such as artificial colours, preservatives, artificial sweeteners and specific antioxidants were banned from all baby foods and there were maximum limits for contaminants, such as lead. In the absence of legislation, manufacturers followed paediatric advice and the Department of Health guidelines.
In 1981, in response to concerns about inappropriate marketing of breastmilk substitutes particularly in developing countries, the World Health Organisation (WHO) adopted an International Code of Marketing of Breastmilk Substitutes11 which, although not legally binding, has had a significant impact on infant feeding and legislation.
The WHO Code produced considerable controversy and after a 10 year delay, the European Union (EU) finally adopted, in 1991, a Directive which combined minimum standards for composition and labelling with restrictions on advertising and promotion12. Generally, legislation lags behind research and development and so the Directive has been updated several times to take account of new developments. The latest version13 has been implemented into UK law14 and comes into force in 2010 (there are similar regulations in Scotland, Wales and Northern Ireland). To accompany the 2007 Regulations the Food Standards Agency (FSA) has also issued Guidance Notes15. These notes are not legislation but represent the FSA’s view of how the Regulations should be interpreted.
Weaning foods are also covered by EU legislation16, implemented in the UK by the Processed Cereal-based Foods and Baby Foods for Infants and Young Children (England) Regulations 200317 (similar Regulations in Scotland, Wales and Northern Ireland). These regulations specify compositional standards and labelling requirements and permit weaning foods to be marketed as suitable from the age of four months.
Changes in infant feeding practices
The most recent infant feeding survey18 shows that breastfeeding initiation rates increased in the previous five years after remaining relatively static between 1985 and 2000. Overall, around 67% of women in England & Wales started breastfeeding in 2005 compared with 62% in 2000. Figures in Scotland and Northern Ireland are lower but also show an increase. The prevalence and duration of breastfeeding also increased.
Most of the marketing restrictions on infant formula came into effect during the late 1980s and early 1990s so this increase in breastfeeding has occurred at a time when the regulations regarding communication about infant formulas have largely remained unchanged. Mothers did not report manufacturers as an influencing factor in their decision to breastfeed and the main reasons cited by women for stopping breastfeeding were insufficient milk, painful breasts/nipples and baby would not suck or rejected the breast18. Clearly other influencing factors were involved.
During this period a host of public and private initiatives designed to promote and support breastfeeding were launched. These initiatives raised awareness of the health benefits of breastfeeding, but breastfeeding rates were also affected by peer influences and when mothers returned to work19. Factors such as employment practices, changes to maternity leave and the provision of feeding facilities outside the home also had an impact20.
What of weaning practices? Legislation on weaning foods has remained unchanged for over a decade but the 2005 survey shows a significant shift in the proportion of mothers appropriately delaying the introduction of solid foods. In 1990 around 95% of mothers introduced solids foods by four months but the percentage had decreased to 85% in 2000 and 51% in 2005. The reduction has been attributed to appropriate advice successfully reaching mothers and to be largely effected by professional support and guidance received19.
The 2005 data on the use of cows’ milk as a main milk drink are not directly comparable with previous surveys but they do suggest a reduction with 6% of mothers giving cows’ milk as a main drink at 8-9 months in 2005 compared to 16% in 199518,21. Again much of this success is due to Healthcare Professional advice but may also be due to an increase in the use of follow-on milks. In 2005, about half of all mothers had given their 8-10 month old baby follow-on milk compared to 25% in 1995. Twenty five percent of mothers said they had been advised to do so by a Healthcare Professional.
Information and informed choice
The overall aim of infant milks legislation is to ensure products are nutritionally suitable as the sole source of nutrition for babies who are not breastfed and to promote and protect breastfeeding through controls on labelling, advertising and other forms of promotion. The controls also extend to information about brands and general information about infant feeding. Currently manufacturers can only provide such information to consumers under certain conditions, and only if specifically requested. There are also restrictions on the information that manufacturers can provide to Healthcare Professionals. Whilst the rationale behind the legislation is to help promote and protect breastfeeding, in reality it may be creating problems for bottlefeeding mothers as many women who use infant formula report having difficulty in accessing information and advice about bottlefeeding22.
In addition, many mothers who choose to bottlefeed often feel marginalised with a sense of failure about not breastfeeding and a feeling of guilt about using infant formula. It has been suggested that the policy of ‘informed choice’ whereby mothers can be told about the benefits of breastfeeding but only the health risks of bottlefeeding may contribute to these feelings of negativity. Formula feeding, therefore, is often represented as ‘risky’ and it has been argued that this approach conveys powerful moralising messages that may stigmatise women who decide to bottlefeed22.
It is against this background that the preparation of infant feeds has been identified as an issue of potential concern19. The FSA and Department of Health have issued guidance for Healthcare Professionals about the safe preparation, storage and handling of powdered infant formula23 and Healthcare Professionals receive bottlefeeding information leaflets to use at their own discretion with parents. Despite this guidance, however, many mothers do not receive practical advice about how to make up feeds. The 2005 infant feeding survey shows that a high proportion of mothers do not follow guidelines (or label instructions) for preparing infant formula and it has been suggested that this indicates a lack of practical support for mothers on feeding practice19.
Conclusions The composition of infant formulas has evolved over the years and historically formulation changes were made in the absence of regulation. Nowadays, most food legislation stems from the EU and must not only provide a high level of consumer protection but must also ensure the free movement of goods and services across the EU. This brings an added complexity to the legislative process which, arguably, has resulted in regulations that do not always address the needs of bottlefeeding mothers. Many organisations, both national and international, are involved in the consultation process including enforcement authorities, baby food manufacturers, retailers, Healthcare Professionals, breastfeeding support organisations and special interest groups - some of whom actively campaign against the infant food industry. In contrast, mothers who bottlefeed their babies have no collective voice.
It is tempting to conclude that changes in infant feeding practice are due to the introduction of marketing restrictions but in reality many factors are involved. Social and cultural influences are important and the role of Healthcare Professionals is crucial. For some, the promotion of breastfeeding has become a campaign against formula use but this ignores the reality that it is an important part of many women’s experience of feeding their babies. Mothers need information, education and support, whether they breastfeed or not, but bottlefeeding mothers have limited access to information about the products they use. Issues of censorship aside this may not be in their, or their babies’, best interests and places a heavy responsibility on Healthcare Professionals in promoting breastfeeding and in informing, educating and supporting parents. References
- DHSS 1988. Present day practice in infant feeding: Third Report. Report on Health & Social Subjects 32. HMSO, London.
- Cuthbertson WFJ. Review article: Evolution of infant nutrition. British Journal of Nutrition 1999; 81:359-371.
- DHSS 1974. Present day practice in infant feeding. Report on Health & Social Subjects 9. HMSO, London
- ESPGHAN Committee on Nutrition. Guidelines on infant nutrition I: Recommendations for the composition of adapted formula. Acta Paediatr Scand 262; Suppl 1: 1-19.
- DHSS 1977. The composition of mature human milk. Report on Health & Social Subjects 12. HMSO, London.
- DHSS 1980. Artificial feeds for the young infant. Report on Health & Social Subjects 18. HMSO, London
- Department of Health 1994. Weaning and the weaning diet. Report on Health and Social Subjects 45. HMSO, London.
- Department of Health 2003. Infant feeding recommendation. http://www.dh.gov.uk/en/Healthcare/Maternity/Maternalandinfantnutrition/index.htm
- Kramer MS & Kakuma R 2001. The optimal duration of exclusive breastfeeding: a systematic review. WHO, Geneva.
- WHO 2001. Report of the Expert Consultation on the optimal duration of exclusive breastfeeding. WHO, Geneva.
- WHO 1981. International Code of Marketing of Breastmilk Substitutes. WHO , Geneva.
- Commission Directive 91/321/EEC on infant formulae and follow-on formulae (OJ L175, 4.7.1991, p35-49).
- Commission Directive 2006/141/EC on infant formulae and follow-on formulae and amending Directive 1999/21/EC (OJ L401, 30.12.2006, p1-33, OJ L314M, 1.12.2007, p739-771).
- The Infant Formula and Follow-on Formula (England) Regulations 2007 (SI No 3521).
- Food Standards Agency, May 2008. Guidance notes on the infant formula and follow-on formula regulations 2007. Revision 1.
- Commission Directive 2006/125/EC (codified version) (OJ L339 6.12.2006 16-35) replacing Directives 2003/13/2003 and 96/5/EC.
- The Processed Cereal-based Foods and Baby Foods for Infants and Young Children (England) Regulations 2003 (SI 2003 No 3207).
- Bolling K, Grant C, Hamlyn B, Thornton A, 2008. Infant feeding survey 2005. The Information Centre.
- Scientific Advisory Committee on Nutrition 2008. Infant feeding survey 2005: a commentary on infant feeding practices. TSO London.
- Hawkins S.S. et al. The impact of maternal employment on breastfeeding duration on the UK Millennium Cohort Study. Public Health Nutrition 2007, 10 (9), 891-896.
- Hamlyn B, Brooker S, Oleinikova K, Wands S. 2002. Infant feeding 2000. TSO, London.
- Lee E. Health, morality and infant feeding: British mothers’ experience of formula milk use in the early weeks. Sociology of Health and Illness 2007, 29(7): 1075-1090.
- Department of Health and Food Standard Agency revised guidance on preparation and storage of infant formula milk 2005. http://www.food.gov.uk/news/newsarchive/2005/nov/infantformulastatementnov05
