CODE OF HYGIENIC PRACTICE FOR POWDERED FORMULAE FOR INFANTS AND YOUNG
CHILDREN CAC/RCP 66 - 2008 INTRODUCTION
It is recognized internationally that breast milk is the best source of nutrition for infants. However, there are
instances where it may be insufficient or not available and thus, may need to be supplemented or replaced.
In those instances, one of the dietary options is the use of powdered formulae (PF).
For the purposes of this document, “powdered formulae” include the following
br/>• Infant formulae and formulae for special medical purposes intended for infants, which serve as the
sole source of nutrition1;
• Follow-up formulae which are used in combination with other foods as part of the weaning diet of
older infants and young children2;
• Powdered formulae for special medical purposes for infants and young children, intended to partially
replace or supplement breast milk, infant formulae or follow-up formulae3;
• Human milk fortifiers used to supplement breast milk.
These products are to be distinguished from ready-to-feed liquid formulae that have been commercially
sterilized.
As dehydrated products, it is not possible using current technology to produce powdered formulae that are
devoid of low levels of microorganisms, i.e., the products cannot be sterilized. Thus, their microbiological
safety requires strict adherence to good hygienic practices during both manufacture and use.
Two FAO/WHO meetings of experts on the microbiological safety of powdered infant formula4,5 considered
cases of illnesses in infants associated with PF consumption either epidemiologically or microbiologically.
They identified three categories of microorganisms based on the strength of evidence of a causal association
between their presence in PF and illness in infants: A) (from gwbzw.com)microorganisms with a clear evidence of causality,
namely, Salmonella enterica6 and Enterobacter sakazakii7; B) microorganisms for which the causality is
plausible but not yet demonstrated, i.e., they are well-established causes of illness in infants and have been
found in PF, but contaminated formula has not been convincingly shown, either epidemiologically or
microbiologically, to be the vehicle and source of infection, e.g., other Enterobacteriaceae; and C)
microorganisms for which causality is less plausible or not yet demonstrated, including microorganisms,
which despite causing illness in infants, have not been identified in PF, or microorganisms which have been
identified in PF but have not been implicated as causing such illness in infants, including Bacillus cereus,
Clostridium botulinum, C. difficile, C. perfringens, Listeria monocytogenes and Staphylococcus aureus.
