Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on the essential composition of infant and follow-on formula. This opinion reviews the opinion provided by the Scientific Committee on Food (SCF) in 2003 on the essential requirements of infant and follow-on formulae in the light of more recent evidence and by considering the Panel’s opinion of October 2013 on nutrient requirements and dietary intakes of infants and young children in the European Union.
There is scientific consensus that breast milk is the preferred food for all healthy infants and provides an adequate supply of all nutrients to support growth and development (with the exception of vitamin K during the first weeks of life and of vitamin D). Whereas the composition of infant formula remains stable over time, breast milk composition changes continuously and therefore infant formula cannot imitate breast milk.
All formulae intended for infants must be safe and suitable to meet the nutritional requirements and promote growth and development of infants born at term when used as a sole source of nutrition during the first months of life, and when used as the principal liquid element in a progressively diversified diet after the introduction of appropriate complementary feeding. Nutrients and substances should be added to formulae for infants only in amounts that serve a nutritional or other benefit. The addition in amounts higher than those serving a benefit or the inclusion of unnecessary substances in formulae may put a burden on the infant’s metabolism and/or on other physiological functions, as substances which are not used or stored have to be excreted.
The minimum content of a nutrient in formula proposed in this opinion is derived from the intake levels the Panel had considered adequate for the majority of infants in the first half of the first year of life in its previous opinion and an average amount of daily energy intake from formula during this period (500 kcal/day). These minimum amounts should be understood as target values which cover the nutritional needs of virtually all infants born at term for optimal growth and development, whereas maximum amounts are driven by safety aspects and also taking into account technological considerations and should not be interpreted as target values but rather as upper limits of a range, which should not be exceeded.
Specifications for the currently permitted maximum amounts of micronutrients in formulae were mostly calculated as three to five times the minimum amounts established at the time and took into account the established history of apparent safe use (Codex Stan 72-1981, Codex Stan 156-1987, the Directive 2006/141/EC, and the SCF) and were not based on scientific evidence for adverse effects owing to the lack of such evidence for most nutrients.
There are no reports on any adverse effects associated with the use of formulae complying with the current specifications for micronutrients as laid down in Directive 2006/141/EC, although there are no studies available which were designed to investigate the short- or long-term health consequences of consumption of formulae containing the currently permitted maximum amounts of micronutrients in infant or follow-on formula. Assuming an energy intake from formula of 500 kcal/day (average of the average requirement for energy of boys and girls aged three to four months), regular consumption of a formula by an infant containing the currently permitted maximum amounts of zinc, iodine, vitamin A and folate (if the whole amount is provided in the form of folic acid) would imply that the Tolerable Upper Intake Levels (ULs) are exceeded for these nutrients. When assuming an energy intake from formula of 700 kcal/day (highest observed mean energy intakes in infants below six months of age), also intakes of selenium would exceed the UL. The Panel acknowledges that the ULs used in this estimation were those derived for young children and there is uncertainty with respect to their extrapolation to infants.
Cow’s milk, goat’s milk and isolated soy protein are safe and suitable protein sources for use in infant and follow-on formulae based on intact protein. The use of other protein sources in infant and follow-on formulae and/or the introduction of new technologies need clinical evaluation and their safety and suitability should be established in the target population prior to their general use in infant and follow-on formulae.
Formulae containing protein hydrolysates are insufficiently characterised by the declared protein content even though they fulfil regulatory criteria concerning amino acid patterns; therefore, the safety and suitability of each specific infant and follow-on formula containing protein hydrolysates have to be established by clinical evaluation in the target population.
The use of a default conversion factor of 6.25 is proposed to calculate the protein content from the total nitrogen content, irrespective of the protein source.
Infant and follow-on formulae should provide on an energy basis indispensable and conditionally indispensable amino acids in amounts at least equal to the reference protein (i.e. breast milk), irrespective of the protein source.
There is no necessity to add arachidonic acid, eicosapentaenoic acid, non-digestible oligosaccharides, “probiotics” or “synbiotics”, chromium, fluoride, taurine and nucleotides to infant and follow-on formulae. There is also no necessity to use phospholipids as a source of long-chain polyunsaturated fatty acids instead of triacylglycerols in infant and follow-on formulae or to use triacylglycerols with palmitic acid predominantly esterified in the sn-2 position in infant and follow-on formulae instead of triacylglycerols from other fat sources. For follow-on formulae, in contrast to infant formulae, the addition of l-carnitine, inositol and choline is not necessary.
The Panel did not consider it necessary to propose specific compositional criteria for formulae consumed after one year of age, as formulae consumed during the first year of life can continue to be used by young children.