Recommendations for the Preparation and Handling of Powdered Infant Formula (PIF)

Health Canada strongly supports breastfeeding and encourages the promotion of its benefits towards infants and young children. Infant formulas should be chosen based on the nutritional requirements and the medical needs of the individual when a substitute for breast milk is needed. Powdered infant formula (PIF)Footnote 1 has been consumed by infants around the world for many years, and is considered to be a safe product. However, there have been a number of outbreaks among infants due to the consumption of PIF contaminated with harmful bacteria such as Enterobacter sakazakii (Cronobacter spp.) and Salmonella enterica. Proper preparation, handling and storage practices for PIF are recommended to reduce the risk of bacteria-related illness.

Health Canada is drawing attention to the fact that PIF are not sterile products. For infants at greatest risk i.e., pre-term, low-birth weight, immunocompromised, commercially produced liquid infant formulas (i.e., both concentrated and ready-to-use) are recommended to be used unless otherwise advised by a physician or dietitian, as these products are sterile. Unlike liquid formulas, which are subjected to sufficient heat to render them sterile, PIF cannot be manufactured to achieve commercial sterility.

Health Canada's recommendations are based on the Guidelines for the Safe Preparation, Storage and Handling of Powdered Infant Formula prepared by FAO/WHO, which cover general aspects of cleaning and sterilization of feeding and preparation equipment, as well as the safe preparation of PIF. The FAO/WHO Guidelines recommend that PIF should be mixed or prepared with water that has been boiled and then cooled to no less than 70 degrees centigrade (°C) to kill any harmful bacteria that may be contaminating a PIF product. Health Canada would like to inform care providers that it is also safe to prepare infant formula with previously boiled water that has been cooled to room temperature, if the formula is fed immediately after preparation. Formula that is prepared for later use can be stored for up to 24 hours when refrigerated at 4°C.

The following recommendations should be followed when using PIF in the home or in a professional setting (i.e., hospitals and day-care centres):

  • Preparation should take place in a clean environment where counters have been cleaned and sanitized. Hands should be thoroughly washed using soap and lukewarm water.
  • Bottles, spoons and nipples should be sterilized in boiling water for 2 minutes and then air-dried before use or storage. Bottles and equipment should be left covered until ready-for-use.
  • For pre-term and low birth-weight infants under two months of age or immunocompromised infants, water used for preparing PIF should be brought to a rolling boil for 2 minutes, dispensed into containers of a maximum size of 1 L and cooled down to no less than 70°C before adding the powder.
  • To avoid the potential for scalding of the infant's mouth, further cool to room or body temperature.
  • For all other infants, previously boiled water that has been cooled to room or body temperature (37°C) can be used to prepare PIF, but it should be served immediately to the infant.
  • It is best to prepare and serve PIF immediately after cooling to body temperature. Reducing the time from preparation to consumption will reduce the risk to infants. Formula in bottles can be cooled quickly by holding the bottle under running tap water or placing in a container of cold water, as long as the cooling water is below the nipple.
  • If it is not possible to serve immediately, all prepared formula in bottles or other types of containers should be refrigerated at 4°C or lower immediately after the powder has been added and dissolved in water. The prepared formula should be used within 24 hours.
  • Due to the possibility of the growth of harmful bacteria at temperatures above 4°C, stored formula should only be removed from the refrigerator and re-warmed to room or body temperature immediately before feeding. Warm prepared PIF in a bottle warmer or by placing the bottle in a container of warm water for no more than 15 minutes. Warming for extended periods means that the PIF will be held at a temperature that is ideal for the growth of harmful bacteria.
  • Microwave ovens should not be used in the preparation or warming of PIF as uneven heating may result in "hot spots" that can scald the infant's mouth.
  • Once feeding has started, the individual bottle should be used within two hours. Any leftover formula should be discarded.

Guidance on using water that is cooled to 70°C for infants at highest risk (i.e., pre-term and low birth-weight infants under two months of age or immunocompromised infants):

  • When using boiled water cooled to 70°C, thermometers with digital read-outs work best for determining the temperature of the water used to prepare the formula. Approximately 30 minutes is needed to cool 1 L of boiled water to 70°C if left at room temperature.
  • In some cases, PIF cannot be prepared with boiled water cooled to 70°C due to the addition of potentially heat-sensitive ingredients, for example, when adding human milk fortifiers or using formulas for special medical purposes. In addition, if boiled water is not available and potable water must be used instead, it is recommended that the formula be fed immediately, once it is prepared, to prevent the growth of harmful bacteria.
  • Formula that has been mixed or prepared with boiled water that has been cooled to 70°C should be further cooled to room or body temperature, before serving, to avoid scalding of the infant's mouth. The temperature should be checked with a thermometer, preferably digital.

Additional recommendations for PIF preparation in professional settings:

  • Where possible, preparation of PIF in professional settings should occur in a laminar flow hood by trained personnel to minimize contamination from the environment.
  • Trained personnel should take appropriate action in case of a product recall, as well as report and document any illnesses or adverse reactions noted with the use of PIF.
  • Please refer to additional recommendations found in the FAO/WHO Guidelines.
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