EUROPEAN COMMISSION HEALTH and CONSUMER PROTECTION DIRECTORATE-GENERAL Directorate C - Scientific Opinions C2 - Management of scientific committees; scientific co-operation and networks Scientific Committee on Food SCF/CS/NUT/IF/65 Final 18 May 2003 Report of the Scientific Committee on Food on the Revision of Essential Requirements of Infant Formulae and Follow-on Formulae (adopted on 4 April 2003) Contains a corrigendum made on 17/09/2007 on page 60, chapter 4.7.2 Carnitine B-1049 Bruxelles/ Brussels - Belgium Telephone: direct line (+32-2) 29 581.10/659.48/648.70, exchange 299.11.11. Fax: (+32-2) 299.48.91 Telex: COMEU B 21877. Telegraphic address: COMEUR Brussels. http://europa.eu.int/comm/food/fs/sc/scf/index_en.html TABLE OF CONTENTS LIST OF ABBREVIATIONS................................................................................................ 10 TERMS OF REFERENCE AND BACKGROUND ........................................................... 12 Terms of Reference ................................................................................................................ 12 Background............................................................................................................................. 12 Acknowledgements................................................................................................................. 12 I. INTRODUCTION AND GENERAL ASPECTS..................................................... 13 1. General aspects of infant feeding .................................................................. 13 2. Breast-feeding ................................................................................................. 13 3. Infant formulae and follow-on formulae ...................................................... 14 4. General principles adopted in the Committee’s scientific review on requirements of infant formulae and follow-on formulae .......................... 14 II. ENERGY CONTENT ................................................................................................ 17 1. Current requirements concerning minimum and maximum energy content in infant formulae and follow-on formulae marketed in the EU ............... 17 2. Comments on the existing requirements concerning energy in infant formulae and follow-on formulae in the Infant Formulae Directive ......... 17 2.1. Energy density of human milk.............................................................. 17 2.2. Growth of breast-fed and formula-fed infants ...................................... 17 2.3. Energy requirements of infants............................................................. 19 2.4. Energy expenditure: comparison between breast-fed and formula-fed infants.................................................................................................... 20 2.5. Feeding in early childhood and later growth, and nutritional status..... 22 3. Minimum and maximum energy content in infant formulae and follow-on formulae........................................................................................................... 22 4. Conclusion and recommendation.................................................................. 25 2 III. PROTEIN CONTENT ............................................................................................... 26 1. Introduction .................................................................................................... 26 2. General considerations on protein in formulae ........................................... 26 2.1. Protein composition of infant formulae and human milk..................... 26 2.2. Protein composition of follow-on formulae.......................................... 31 2.3. Effects of processing on nutritional value ............................................ 33 2.4. Recommendation .................................................................................. 34 3. Current requirements concerning protein in infant formulae and follow- on formulae in the Infant Formulae Directive............................................. 34 3.1. Calculation of protein ........................................................................... 34 3.2. Sources of protein ................................................................................. 34 3.3. Protein content ...................................................................................... 35 3.4. Protein quality....................................................................................... 35 3.5. Amino acid pattern of the reference proteins human milk and cows’ milk casein ............................................................................................ 36 4. Comments on the existing requirements for protein................................... 37 4.1. Calculation of protein content............................................................... 37 4.1.1. Calculation from nitrogen content ......................................................37 4.1.2. Protein determination..........................................................................38 4.1.3. Protein as sum of amino acids.............................................................39 4.1.4. Conclusion and recommendation........................................................40 4.2. Protein sources...................................................................................... 41 4.2.1. Proteins permitted ...............................................................................41 4.2.2. Other milks..........................................................................................41 4.2.2.1. Protein and amino acids...................................................................41 4.2.2.2. Digestibility .....................................................................................42 4.2.2.3. Allergenicity ....................................................................................42 4.2.2.4. Bioavailability of nutrients ..............................................................42 4.2.3. Plant proteins (vegetables and legumes)............................................ 42 4.2.3.1. Soy protein-based infant formulae...................................................42 4.2.3.2. Protein and amino acids, digestibility, bioavailability of nutrients, allergenicity of other plant proteins .................................................45 4.2.4. Recommendation ................................................................................45 4.3. Protein hydrolysates.............................................................................. 45 4.3.1. Conclusion and recommendation........................................................48 3 4.4. Protein content ...................................................................................... 48 4.4.1. The model of human milk...................................................................48 4.4.2. Protein requirements from studies with infant formulae compared to the human milk model ........................................................................48 4.4.3. The minimum protein content in infant formulae...............................50 4.4.4. The minimum protein content in follow-on formulae.........................51 4.4.5. The maximum protein content in infant formulae ..............................53 4.4.6. The maximum protein content in follow-on formulae........................53 4.5. Protein quality...................................................................................... .53 4.5.1. Amino acid score ................................................................................54 4.5.2. Protein Efficiency Ratio (PER) and Net Protein Utilisation (NPU) .. 54 4.5.3. Other qualifying factors for protein ....................................................54 4.6. Amino acids in reference proteins ........................................................ 55 4.6.1. Comparison to the FAO/WHO/UNU scoring pattern.........................55 4.6.2. Other scoring patterns.........................................................................56 4.6.3. Recommendation ................................................................................59 4.7. Taurine, carnitine, nucleotides, choline and other nitrogen-containing compounds............................................................................................ 59 4.7.1. Taurine ................................................................................................59 4.7.2. Carnitine..............................................................................................60 4.7.3. Nucleotides and nucleosides ...............................................................60 4.7.4. Choline................................................................................................64 4.7.5. Other nitrogen-containing compounds................................................65 5. Summary of all conclusions and recommendations .................................... 65 6. Recommendations for future work............................................................... 68 IV. FAT CONTENT ......................................................................................................... 69 1. Introduction .................................................................................................... 69 2. Total fat ........................................................................................................... 70 2.1. Structured triglycerides........................................................................