EFSA Public consultation on the essential composition of infant and follow-on formulae

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Public consultation on a draft Scientific Opinion on the essential composition of infant and follow-on formulae

24 April 2014

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EFSA has launched a public consultation on its draft Scientific Opinion on the essential composition of infant and follow-on formulae. The Opinion reviews the existing advice, which dates back to 2003, taking into account more recent evidence and EFSA’s previous Opinion on nutrient requirements and dietary intakes of infants and young children in the European Union.


The proposed minimum amounts of nutrients in infant or follow-on formulae are derived from the intake levels which EFSA considered in its previous Opinion to be adequate for the majority of infants in the first half of the first year of life, and on the average amount of formula consumed during this period (500 kcal/day). They cover the nutritional needs of virtually all healthy infants born at term. From a nutritional point of view, there is no need to exceed these amounts in formulae, as nutrients which are not used or stored have to be excreted and this may put a burden on the infant’s metabolism.


EFSA proposes specifications for the content of protein, fat, carbohydrates, micronutrients and certain other ingredients. Among its draft conclusions are the following:


Cow’s milk, goat’s milk and isolated soy protein are safe and suitable sources of protein for use in infant and follow-on formula based on intact protein. Other protein sources should be clinically evaluated and their safety and suitability 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 if they fulfil regulatory criteria concerning amino acid patterns and contents. The safety and suitability of each formula containing protein hydrolysates should be established by clinical evaluation.

Infant and follow-on formula should provide indispensable and conditionally indispensable amino acids in amounts at least equal to those found in breast milk, irrespective of the protein source.

It is not necessary to add arachidonic acid, eicosapentaenoic acid, chromium, taurine, nucleotides, non-digestible oligosaccharides, “probiotics” or “synbiotics” to infant and follow-on formula.

For follow-on formula, unlike with infant formula, the addition of l-carnitine, inositol and choline is not necessary.

The Opinion rests on the assumption that all formulae intended for infants must be safe and meet the nutritional requirements of infants born at term when used as a sole source of nutrition during the early months of life and as the principal liquid element after the introduction of complementary feeding. Nutrients and substances should be added to formulae for infants only in amounts that serve a nutritional or other benefit.


Interested parties are invited to submit written comments on the draft Opinion by 29 May 2014.