EFSA updates advice on infant and follow-on formulae
24 July 2014
Key findings:
- 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.
- 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 safety and suitability of other protein sources or new manufacturing technologies should be clinically evaluated prior to their use.
- The safety and suitability of each specific infant and follow-on formula containing protein hydrolysates should also be established by clinical evaluation in the target population prior to use.
- There is no need to add arachidonic acid, eicosapentaenoic acid, non-digestible oligosaccharides, “probiotics” or “synbiotics”, chromium, fluoride, taurine and nucleotides to infant and follow-on formulae.
EFSA has recommended intake levels of energy, macronutrients and micronutrients in infant and follow-on formulae. The recommendations are included in a Scientific Opinion on the essential composition of infant and follow-on formulae, 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.
The advice from EFSA’s Panel on Dietetic Products, Nutrition and Allergies rests on the principle that formulae must be safe, and suitable to meet the nutritional requirements and promote the growth and development of infants.
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. For macronutrients it proposes the following:
| Proposed amounts of macronutrients in IF and FOF (g/100 kcal) | ||||||
|---|---|---|---|---|---|---|
| IF and FOF with | ||||||
| Milk protein | ISP | Hydrolysed protein | ||||
| min | max | min | max | min | max | |
| Protein | 1.8 | 2.5 | 2.25 | 2.8 | – | 2.8 |
| Fat | 4.4 | 6.0 | 4.4 | 6.0 | 4.4 | 6.0 |
| Carbohydrates | 9 | 14 | 9 | 14 | 9 | 14 |
Key: IF = infant formula. FOF = follow-on formula. ISP= isolated soy protein.
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 formulae.
Other key findings from the Opinion:
- 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 safety and suitability of other protein sources or new manufacturing technologies should be clinically evaluated prior to their use.
- The safety and suitability of each specific infant and follow-on formula containing protein hydrolysates should also be established by clinical evaluation in the target population prior to use.
- There is no need to add arachidonic acid, eicosapentaenoic acid, non-digestible oligosaccharides, “probiotics” or “synbiotics”, chromium, fluoride, taurine and nucleotides to infant and follow-on formulae.
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