Opinion of the Scientific Panel on Dietetic products, nutrition and allergies [NDA]  related to the safety and suitability for particular nutritional use by infants of formula based on whey protein partial hydrolysates with a protein content of at least 1.9 g protein/100 kcal


Panel on Dietetic Products, Nutrition and Allergies
Panel members at the time of adoption
Wulf Becker, Francesco Branca, Daniel Brasseur, Jean-Louis Bresson, Albert Flynn, Alan A. Jackson, Pagona Lagiou, Martinus Løvik, Geltrude Mingrone, Bevan Moseley, Andreu Palou, Hildegard Przyrembel, Seppo Salminen, Stephan Strobel, Henk van den Berg, and Hendrik van Loveren.
Opinion of the Scientific Committee/Scientific Panel
Question Number
5 October 2005
9 November 2005
Last Updated
9 November 2005. This version replaces the previous one/s.
European Food Safety Authority (EFSA), Parma, Italy
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No abstract available


The Panel has been asked to provide a scientific opinion on the suitability for the particular nutritional requirements of infants and young children of an infant formulae and follow-on formulae based on protein partial hydrolysates with a protein content of 1.9 g/100 kcal.

The conclusions of the Panel are as follows:

The formula is as suitable to satisfy the particular nutritional requirements of young infants and as safe as a formula based on hydrolysed whey protein with a higher protein content when fed ad libitum. This conclusion is primarily based upon the growth data of term-infants who were studied between the ages of 8 to 112 days. The nitrogen balance data and the protein status parameters are considered to be supportive of this conclusion. The conclusion on the suitability of the formula with a crude protein content of 1.9 g/100 kcal is specific for this formulation and the protein source it contains. While no data on follow-on formula based on hydrolysed whey protein with a protein content of 1.9 g/100 kcal have been submitted, the Panel considers that a formula with this protein formulation is suitable for use in older infants in conjunction with complementary foods. 

Any infant formula with a similar crude protein content but differing in protein quality, protein sources or protein processing needs to be tested in a clinical study and its safety should be documented and assessed.

Recommendations on how to assess the protein quality, sufficiency and suitability in infant formulae have been published. They include a clinical trial of three to four months duration in a group of healthy term infants with a number to provide sufficient statistical power in comparison to an existing infant formula and/or a reference group of breast-fed infants, and starting preferably at or near birth. Data on growth, protein status and on formula intake should be collected.

Infant formula, infant nutrition, protein requirement, partially hydrolysed whey protein, lowprotein formula, growth.