EFSA has made recommendations on the intake levels of energy, macronutrients and micronutrients in infant and follow-on formulas. The recommendations are included in a Scientific Opinion on the essential composition of infant and follow-on formulas, which reviews advice provided by the Scientific Committee on Food in 2003, taking into account more recent evidence. It follows an EFSA Opinion published in 2013 on nutrient requirements and dietary intakes of infants and young children in the European Union.
EFSA’s opinion starts with an important prelude, namely that "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 formulas remains stable over time, breast milk composition changes continuously and therefore infant formulas cannot imitate breast milk."
The advice from EFSA’s Panel on Dietetic Products, Nutrition and Allergies rests on the principle that formulas must be safe, meet nutritional requirements and promote the growth and development of infants. This opinion reviews the opinion provided by the Scientific Committee on Food in 2003 on the essential requirements of infant and follow-on formulas in light of more recent evidence, and by considering the Panel’s opinion of October 2013 onnutrient requirements and dietary intakes of infants and young children in the European Union.
The Panel recommends minimum and maximum levels of energy for infants (up to one year old) of 60 kcal per 100 ml of formula and 70 kcal per 100 ml respectively. The proposed amounts for fat and carbohydrate do not differ significantly from those in the current regulations. However, the Panel proposes that the maximum for protein be reduced from 3 g/100 kcal in infant formula and 3.5 g/100 kcal in follow-on formula to 2.5 g/100 kcal in formulae (infant and follow-on) based on milk protein, and to 2.8 g/100 kcal in formulae (infant and follow-on) containing isolated soy protein or hydrolysed protein. This was because the experts considered there to be no evidence of a physiological need for such high protein intakes and because current protein intakes are well above requirements.
For micronutrients the Panel proposes minimum levels. It emphasises that these cover the nutritional needs of virtually all healthy infants born at term and from a nutritional point of view there is no need to exceed these amounts in formulas, as nutrients which are not used or stored have to be excreted and this may put a burden on the infant’s metabolism.
The scientific opinion also notes that "There are no reports on any adverse effects associated with the use of formulas 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 formulas containing the currently permitted maximum amounts of micronutrients in infant or follow-on formula".
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