Last updated on 30 January 2007

FSA powdered infant formula research

The World Health Assembly adopted a resolution in 2005 that Member States should inform healthcare workers, parents and other caregivers about best practices for preparation, use and handling of powdered infant formula.

This was due to international concern about the risk to infants from pathogenic microorganisms, because powdered infant formula milk is a non-sterile product and as such should be prepared and handled appropriately. In addition, caregivers should be informed through an explicit warning on the packaging that powdered infant formula may contain pathogenic microorganisms.

While infections due to powdered infant formula milk are rare – there have been 50-60 known cases in the past 40 years – they can be severe and the risk is considered to be greatest for pre-term, immuno-compromised and low birth weight infants under the age of two months. The European Food Safety Authority (EFSA) further recommended that guidelines for the preparation and storage of powdered infant formula should be prepared for use in the home and healthcare settings.

Following discussions with stakeholders, the Agency undertook research to explore the understanding of the term non-sterile and attitudes towards labelling and advice on powdered infant formula amongst parents' and healthcare professionals.

Project approach

The purpose of this research was to explore parents' and healthcare professionals' understanding of the term 'non-sterile', potential implications of 'non-sterile' in relation to powdered infant formula milk and attitudes towards information, labelling and advice needs regarding powdered infant formula milk.

A qualitative approach was identified as the most effective methodology and this involved ten group discussions with parents with babies aged between 0-6 months old, including one group with mothers of pre-term and/or low birth weight babies. The parental discussion groups were held in a variety of locations across the UK and included: those who only used formula and those who used formula in additional to breastfeeding; a wide range of ages of parents; mothers or fathers, different socioeconomic groups and ethnic groups.

In addition, there was a focus group discussion with Health Care Professionals (HCPs) and five further individual in-depth interviews. The HCPs included ranged from health visitors, community and hospital midwives, to neonatal nurses and community practitioners. The research was conducted in March and April 2006.

Key findings

Differences in the caregivers' attitude towards use of powdered formula milk and the desire for information and advice was evident and was based on general attitudinal differences to food issues, covering four specific types:

  • avoiders who actively avoid issues in order not to have to change habits
  • pragmatists who only change habits if they believe opinion is widespread
  • headline reactives who tend to display concern which is often short-lived, resulting in a fairly superficial impact (NB pragmatists and headline reactives display similar needs and were jointly termed mainstream for the purposes of this research)
  • purists who are more cautious and knowledgeable than the other types so are more able to decide on what action to take as a result

Parents and healthcare professionals both agreed that advice and information given to parents about bottle feeding is limited, even when parents state a preference for this method of feeding. Parents reported gaining advice and information through a variety of different means, such as seeking advice from family and friends and from on-pack information; which was used by all when starting to formula feed.

The different sources of information and inconsistencies between these resulted in a diversity of understanding about best practices in terms of preparation, storage and use of powdered infant formula milk. However, most caregivers believed that they were following advice carefully and not taking any risks, so there was little concern amongst parents about the use of powdered infant formula.

Within the small sample of healthcare professionals, there was limited awareness that powdered infant formula milk was non-sterile. Awareness was latent and not linked to reasons for advising parents to be more cautious, nor for HCPs to be more prescriptive about its preparation, storage and use.

When parents were asked about the meaning of sterile in relation to food, many assumed most canned or bottled foods are sterile, at least until opened. Hence, this may explain the lack of awareness amongst parents that powdered infant formula milk is a non-sterile foodstuff.

The term 'non-sterile' was not perceived positively by the parents and failed to communicate the nature and level of risk as most did not consider that it meant potentially harmful, but that it was actually harmful. As a result, the news that powdered infant formula milk is non-sterile initially generated concern and confusion until parents were supplied with further detail and an explanation.

Overall, as powdered infant formula may pose a potential risk to babies, parents and healthcare professionals agreed that parents should be informed that it is non-sterile, so that they can are able to make an informed decision about its use and preparation.

Reactions to the new guidelines in the revised Department of Health bottle feeding booklet (see link below) indicated that advice to make up bottles as required with freshly boiled water, rather than in advance, was deemed as very difficult to put into practice by the majority of parents who already made them up in advance. Other changes in practice about using freshly boiled water that has been left to cool for 30 minutes before use, and out of home practices, raised less concern but required further clarification about their implementation.

Key recommendations

The research suggested that the most effective ways of communicating to parents that powdered infant formula is non-sterile are those which help to increase parental responsibility, such as by explaining the potential risk while advising how parents may reduce the risk through following the best practice guidelines.

As information and advice on the use of powdered infant formula milk is drawn from a wide range of sources, it is important that this issue is communicated via all formal channels in order to reach all parents, including healthcare professionals, printed materials, and on-pack information as well as websites and telephone care-lines.

The discussion groups recommended a number of possible amendments that may help to improve the clarity of advice and guidance provided to parents by Government departments, healthcare professionals and on-pack information, for example, by clearly explaining the reasons for the change in advice.