European Community Comments for the

Transcription

1 14/10/02 European Community Comments for the CODEX COMMITTEE ON NUTRITION AND FOODS FOR SPECIAL DIETARY USES WORKING GROUP ON THE ESSENTIAL COMPOSITION OF THE PROPOSED DRAFT REVISED STANDARD FOR INFANT FORMULA CL 2001/47 NFSDU Request for comments on section 3.1 Essential composition of the proposed draft revised standard for infant formula (Alinorm 03/26, Appendix III) COMMENTS ON II RECOMMENDATIONS A. GENERAL PRINCIPLES FOR ESTABLISHING MINIMUM AND MAXIMUM VALUES FOR THE ESSENTIAL COMPOSITION OF INFANT FORMULA The European Community still has to consider the merits of including the General Principles for establishing minimum and maximum values for the essential composition of infant formula in an Annex to the Standard. Part A 10 of section II Recommendations notes alternative options for establishing maximum levels. The European Community notes that infant formula is a food for special dietary use and such products have the principle characteristic that they satisfy the particular nutritional requirements of the specific population group for whom they are intended. The setting of minimum and maximum levels for essential nutrients should be in line with this principle. COMMENTS ON II RECOMMENDATIONS D PROPOSED REVISIONS TO SECTION 3.1 The following are preliminary comments on the essential requirements for protein, fat, carbohydrate, vitamins and iron. The comments are presented in the existing order in the Proposed Draft Revised Standard on Infant Formula. SECTION (A) VITAMINS VITAMIN A Vitamin A 60 µg 180 µg 14 µg 43 µg 1

2 VITAMIN D Vitamin D 1 µg 2.5 µg 0.25 µg 0.6 µg VITAMIN E Vitamin E (d-α-tocopherol equivalent) 0.5 mg/g 10 mg 0.5 mg/g 2 mg polyunsaturated polyunsaturated fatty acids fatty acids expressed as expressed as linoleic acid 1, but linoleic acid 1, but in no case less in no case less than 0.5 mg/100 than 0.1 mg/100 kcal kj 1 The following factors of equivalence shall be used to adapt the minimal vitamin E content to the fatty acid composition of the formula: 0.5 mg d-α-tocopherol equivalent /1g linoleic acid 0.75 mg d-α-tocopherol equivalent /1g α-linolenic acid 1.0 mg d-α-tocopherol equivalent /1g arachidonic acid 1.25 mg d-α-tocopherol equivalent /1g eicosapentaenoic acid 1.5 mg d-α-tocopherol equivalent /1g docosahexaenoic acid VITAMIN C Vitamin C 10 mg Not specified 2.5 mg Not specified THIAMIN Thiamin 60 µg Not specified 14 µg Not specified RIBOFLAVIN Riboflavin 80 µg Not specified 19 µg Not specified NIACIN Niacin 300 µg Not specified 70 µg Not specified 2

3 VITAMIN B 6 Vitamin B 6 35 µg/100 kcal Not specified 9 µg/ 100 kj Not specified FOLIC ACID Folic Acid 10 µg Not specified 2.5 µg Not specified PANTOTHENIC ACID Pantothenic Acid 400 µg Not specified 100 µg Not specified VITAMIN B 12 Vitamin B µg Not specified 0.03 µg Not specified VITAMIN K Vitamin K 4 µg Not specified 1 µg Not specified BIOTIN Biotin 1.2 µg Not specified 0.3 µg Not specified SECTION (B) MINERALS IRON Iron 0.3 mg 1.3 mg 0.07 mg 0.31 mg SECTION (D) PROTEIN The following new calculation is proposed for the calculation of protein content of formulae based on intact proteins: Protein content = [(TN 1 NPN 2 ) + 46% NPN] x TN total nitrogen content 2 NPN non protein nitrogen content 3

4 The proposed new calculation for protein content indicates a minimum level within the range of g protein per 100 kcal ( g protein/100 kj) and maxima of around g protein per 100 kcal ( g protein/100 kj). However, these comments are based on preliminary results of a review of the essential requirements for infant formula within the European Union carried out by our Scientific Committee on Food. In addition two reports are expected to be published, the US Food and Nutrition Board of the Institute of Medicine review of the dietary reference intakes which includes protein, and the WHO/FAO/UNU Expert consultation on protein and amino acids in human nutrition. Therefore, it is proposed that discussion on the protein requirements for infant formula should be deferred until all these reports are published. It is proposed that the reference protein should be breast milk with an amino acid content as follows: per 100 kj (1) per 100 kcal Arginine Cystine 6 24 Histidine Isoleucine Leucine Lysine Methionine 7 29 Phenylalanine Threonine Tryptophan 7 30 Tyrosine Valine (1) 1 kj = kcal. It is proposed that the above table should replace the existing table in Annex I. Isolated amino acids may be added to infant formula only to improve the nutritional value of the proteins, and only in the proportions necessary for that purpose. Only L forms of amino acids shall be used. SECTION (E) FAT AND FATTY ACIDS The product shall contain: - total fat at a level not less than 4.4 g/100 kcal (1.05 g/100 kj) and not more than 6 g/100 kcal (1.4 g/100 kj); - the saturated fatty acids lauric acid and myristic acid content combined shall be not more than 20 % of the total fat; - linoleic acid (in the form of glycerides) at a level of not less than 500 mg/100 kcal (120 mg/100 kj) and not more than 1200 mg/100 kcal (290 mg/100 kj); 4

5 - the linoleic/alpha-linolenic acid ratio shall be not less than 5 nor greater than 15 unless docosahexaenoic and arachodonic acid are added in which case the linoleic/alpha-linolenic acid ratio shall be not less than 5 nor greater than 20; - the trans fatty acid content shall not exceed 3% of the total fat content by weight; - the erucic acid content shall not exceed 1 % of the total fat content by weight. SECTION (F) CARBOHYDRATES The product shall contain carbohydrates at a level of not less than 9.9 g/100 kcal (2.4 g/100 kj) and not more than 13.2 g/100 kcal (3.2 g/100 kj). Except in the case of formula in which soya protein represents more than 50% of the total protein content, the lactose content of the product shall be not less than 50% of the total carbohydrate content. If the source of digestible carbohydrates are to be specified in the Standard then it is proposed that the following should be the only digestible carbohydrates that may be used: lactose; maltose; malto-dextrins; glucose syrup or dried glucose syrup; precooked starch naturally free of gluten; and, gelatinised starch naturally free of gluten. SECTION (G) ENERGY CONTENT The metabolisable energy content of the product shall not be less than 60 kcal/100 ml (250 kj/100 ml) and not more than 70 kcal/100 ml (292 kj/100 ml). 5