Infant Formulae and Follow-on Formulae Regulations, 2002 (L.N. No. 208 of 2002)

INFANT FORMULAE AND FOLLOW-ON FORMULAE [S.L.231.36 1 SUBSIDIARY LEGISLATION 231.36 INFANT FORMULAE AND FOLLOW-ON FORMULAE REGULATIONS 1st August, 2002 Legal Notice 208 of 2002. Title.1. The title of these Regulations is Infant Formulae and Follow-on Formulae Regulations. Applicability of these regulations. 2.1 These Regulations concern compositional and labelling requirements for infant formulae and follow-on formulae intended for use by infants in good health. Interpretation.3.1 In these regulations, unless the context otherwise requires: (a) "infants" means children under the age of 12 months; (b) "young children" means children aged between one and three years; (c) "infant formulae" means foodstuffs intended for particular nutritional use by infants during the first four to six months of life and satisfying by themselves the nutritional requirements of this category of persons; (d) "follow-on formulae" means foodstuffs intended for particular nutritional use by infants aged over four months and constituting the principal liquid element in a progressively diversified diet of this category of persons; (e) "pesticide residue" means the residue in infant formulae and follow-on formulae of a plant protection product, as defined in point 1 of Article 2 of Council Directive 91/414/EEC*, including its metabolites and products resulting from its degradation or reaction. Sale of infant formulae and follow-on formulae. 4.1 No person may place on the market any infant formula or follow-on formula which does not comply with the requirements of these regulations. 4.2 No product other than infant formula may be marketed or otherwise represented as suitable for satisfying by itself the nutritional requirements of normal healthy infants during the first four to six months of life. Manufacture of infant formulae and follow-on formulae. 5.1 Infant formulae shall be manufactured from protein sources defined in the Schedules and other food ingredients, as the case may be, whose suitability for particular nutritional use by infants from birth has been established by generally accepted scientific data. 5.2 Follow-on formulae shall be manufactured from protein sources defined in the Schedules and other food ingredients, as the *OJ L230, 19.8.1991, p.1. 2 [S.L.231.36 INFANT FORMULAE AND FOLLOW-ON FORMULAE case may be, whose suitability for particular nutritional use by infants aged over four months has been established by generally accepted scientific data. 5.3 The prohibitions and limitations on the use of food ingredients laid down in the First and Second Schedules shall be observed. Compositional criteria. 6.1 Infant formulae must comply with the compositional criteria specified in the First Schedule. 6.2 Follow-on formulae must comply with the compositional criteria specified in the Second Schedule. 6.3 In order to make infant formulae and follow-on formulae ready for use, nothing more shall be required, as the case may be, than the addition of water. 6.4 Only the substances listed in the Third Schedule may be used in the manufacture of infant formulae and follow-on formulae in order to satisfy the requirements on: mineral substances, vitamins, amino acids and other nitrogen compounds, other substances having a particular nutritional purpose. 6.5 Infant formulae and follow-on formulae shall not contain any substance in such quantity as to endanger the health of infants and young children. 6.6 Infant formulae and follow-on formulae shall not contain residues of individual pesticides at levels exceeding 0.01 mg/kg of the product as proposed ready for consumption or as reconstituted according to the instructions of the manufacturer. 6.7 Analytical methods for determining the levels of pesticide residues shall be generally acceptable standardised methods. Labelling and presentation of infant formulae and follow-on formulae. 7.1 The name under which the products covered by regulation 3.1(c) and (d) are sold shall be, respectively: "infant formula" and "follow-on formula". However, the name of products manufactured entirely from cows’’ milk proteins, shall be respectively: "infant milk" and "follow-on milk". S.L.231.27 7.2 The labelling shall bear, in addition to those provided for in the Labelling and Presentation of Foodstuffs Regulations, the following mandatory particulars in Maltese and/or English: (a) in the case of infant formulae, a statement to the effect that the product is suitable for particular nutritional use by infants from birth when they are not breastfed; (b) in the case of infant formulae that do not contain added iron, a statement to the effect that, when the product is given to infants over the age of four months, their total iron requirements must be met from other additional INFANT FORMULAE AND FOLLOW-ON FORMULAE [S.L.231.36 3 sources; (c) in the case of follow-on formulae, a statement to the effect that the product is suitable only for particular nutritional use by infants over the age of four months, that it should form only part of a diversified diet and that it is not to be used as a substitute for breast milk during the first four months of life; (d) in the case of infant formulae and follow-on formulae, the available energy value, expressed in kJ and kcal, and the content of proteins, carbohydrates and lipids, expressed in numerical form, per 100 ml of the product ready for use; (e) in the case of infant formulae and follow-on formulae, the average quantity of each mineral substance and of each vitamin mentioned in the First and Second Schedules respectively, and where applicable, of choline, inositol, carnitine and taurine, expressed in numerical form, per 100 ml of the product ready for use; (f) in the case of infant formulae and follow-on formulae, instructions for appropriate preparation of the product and a warning against the health hazards of inappropriate preparation. 7.3 The labelling may bear: (a) the average quantity of nutrients mentioned in the Third Schedule when such declaration is not covered by the provisions of regulation 7.2(e), expressed in numerical form, per 100 ml of the product ready for use; (b) for follow-on formulae in addition to numerical information, information on vitamins and minerals included in the Eighth Schedule, expressed as a percentage of the reference values given therein, per 100 ml of the product ready for use, provided that the quantities present are at least equal to 15 per cent of the reference values. 7.4 The labelling of infant formulae and follow-on formulae shall be designed to provide the necessary information about the appropriate use of the products so as not to discourage breast feeding. The use of the terms "humanised", "maternalised", or similar terms is prohibited. The term "adapted" may only be used in conformity with regulation 7.7 and with point 1 of the Fourth Schedule. 7.5 The labelling of infant formulae shall in addition bear the following mandatory particulars, preceded by the words "Important Notice" or their equivalent: (a) a statement concerning the superiority of breast feeding; (b) a statement recommending that the product be used only on the advice of independent persons having 4 [S.L.231.36 INFANT FORMULAE AND FOLLOW-ON FORMULAE qualifications in medicine, nutrition or pharmacy, or other professionals responsible for maternal and child care. 7.6 The labelling of infant formulae shall not include pictures of infants, nor shall it include other pictures or text which may idealise the use of the product. It may, however, have graphic representations for easy identification of the product and for illustrating methods of preparation. 7.7 The labelling may bear claims concerning the special composition of an infant formula only in the cases listed in the Fourth Schedule and in accordance with the conditions laid down therein. 7.8 The requirements, prohibitions and restrictions referred to in regulations 7.4, 7.5, 7.6 and 7.7 shall also apply to: (a) the presentation of the products concerned, in particular their shape, appearance or packaging, the packaging materials used, the way in which they are arranged and the setting in which they are displayed; (b) advertising. Export of infant formulae and follow-on formulae. 8.1 Infant formulae and follow-on formulae may only be exported from Malta if they comply with: (a) regulation 4.2, regulation 5 and regulation 6 or with relevant applicable world standards established by Codex Alimentarius; (b) regulations 7.2 to 7.7, provided that the language requirements of the importing country shall apply instead of the relevant provisions of regulation 7.2 in the case of infant formulae and follow-on formulae intended exclusively for export; S.L.231.27 (c) the provisions of regulation 16 of the Labelling, Presentation and Advertising of Foodstuffs Regulations, unless otherwise requested or stipulated by provisions established by the importing country. 8.2 Infant formulae and follow-on formulae intended for export from Malta must be labelled in an appropriate language and in such a way as to avoid any risk of confusion between infant formulae and follow-on formulae. 8.3 The stipulations, prohibitions and restrictions laid down in regulations 7.2 to 7.7 shall also apply to the presentation of the products concerned and in par t icu lar the i r form, aspec t or packaging and the packaging materials used. INFANT FORMULAE AND FOLLOW-ON FORMULAE [S.L.231.36 5 FIRST SCHEDULE Essential Composition of Infant Formulae when reconstituted as instructed by the manufacturer NB: The values refer to the product ready for use. 1. Energy Minimum Maximum 250 kJ 315 kJ (60 kcal/100 ml) (75 kcal/100 ml) 2. Proteins (Protein content = nitrogen content x 6.38) for cows’ milk proteins. (Protein content = nitrogen content x 6.25) for Soya protein isolates and protein partial hydrolysates. The "chemical index" shall mean the lowest of the ratios between the quantity of each essential amino acid of the test protein and the quantity of each corresponding amino acid of the reference protein. 2.1 Formulae manufactured from cows’ milk proteins Minimum Maximum 0.45 g/100 kJ 0.7 g/100 kJ (1.8g/100 kcal) (3 g/100 kcal) For an equal energy value, the formula must contain an available quantity of each essential and semi-essential amino acid at least equal to that contained in the reference protein (breast milk, as defined in the Fifth Schedule); nevertheless, for calculation purposes, the concentration of methionine and cystine may be added together. 2.2 Formulae manufactured from protein partial hydrolysates Minimum Maximum 0.56 g/100 kJ 0.7 g/100 kJ (2.25 g/100 kcal) (3 g/100 kcal) For an equal energy value, the formula must contain an available quantity of each essential and semi-essential amino acid at least equal to that contained in the reference protein (breast milk, as defined in the Fifth Schedule); nevertheless, for calculation purposes, the concentrations of methionine and cystine may be added together. The protein efficiency ratio (PER) and the net protein utilisation (NPU) must be at least equal to those of casein. The taurine content shall be equal to at least 10 µmoles/100 kJ (42 µmoles/ 100 kcal) and the L-carnitine content shall be equal to at least 1.8 µmoles/ 100 kJ (7.5 µmoles/100 kcal). 2.3 Formulae manufactured from soya protein isolates, alone 6 [S.L.231.36 INFANT FORMULAE AND FOLLOW-ON FORMULAE or in a mixture with cows’ milk proteins Minimum Maximum 0.56 g/100 kJ 0.7 g/100 kJ (2.56 g/100 kcal) (3 g/100 kcal) Only soya protein isolates must be used in manufacturing these formulae. The chemical index shall be equal to at least 80% of that of the re ference pro te in (breas t mi lk , as def ined in the S ix th Schedule). For an equal energy value, the formula must contain an available quantity of methionine at least equal to that contained in the reference protein (breast milk, as defined in the Fifth Schedule). The L-carnitine content shall be at least equal to 1.8 µmoles/100 kJ (7.5 µmoles/100 kcal). 2.4 In all cases, the addition of amino acids is permitted solely for the purpose of improving the nutritional value of the proteins, and only in the proportions necessary for that purpose. 3. Lipids Minimum Maximum 1.05 g/100 kJ 1.5 g/100 kJ (4.4 g/100 kcal) (6.5 g/100 kcal) 3.1 The use of the following substances is prohibited: sesame seed oil, cotton seed oil. 3.2 Lauric acid Minimum Maximum 15% of the total fat content 3.3 Myristic acid Minimum Maximum 15% of the total fat content 3.4 Linoleic acid (in the form glycerides = linoleates) Minimum Maximum 70 mg/100 kJ 285 mg/100 kJ (300 mg/100 kcal) (1200 mg/100 kcal) 3.5 The alpha-linoleic acid content shall not be less than 12 mg/100 kJ (50 ma/100 kcal). The linoleic/alpha-linoleic acid ratio shall not be less than 5 nor greater than 15. 3.6 The trans fatty acid content shall not exceed 4% of the total fat content. 3.7 The erucic acid content shall not exceed 1% of the total fat content. INFANT FORMULAE AND FOLLOW-ON FORMULAE [S.L.231.36 7 3.8 Long-chain (20 and 22 carbon atoms) polyunsaturated fatty acids (LCP) may be added. In that case their content shall not exceed: 1% of the total fat content for n-3 LCP and 2% of the total fat content for n-6 LCP (1% of the total fat content for arachidonic acid) The eicosapentaenoic acid (20:5 n-3) content shall not exceed that of docosahexaenoic (22:6 n-3) acid content. 4. Carbohydrates Minimum Maximum 1.7 g/100 kJ 3.4 g/100 kJ (7 g/100 kcal) (14 g/100 kcal) 4.1 Only the following carbohydrates may be used: lactose, maltose, sucrose, maltodextrins, glucose syrup or dried glucose syrup, pre-cooked starch (naturally free of gluten), gelatinised starch (naturally free of gluten). 4.2 Lactose Minimum Maximum 0.85 g/100 kJ (3.5 g/100 kcal) This provision does not apply to formulae in which soya proteins represent more than 50% of the total protein content. 4.3 Sucrose Minimum Maximum 20% of the total carbohydrate content 4.4 Pre-cooked starch and/or gelatinized starch Minimum Maximum 2 g/100 ml, and 30% of the total carbohydrate content 5. Mineral substances 5.1 Formulae manufactured from cows’ milk proteins per 100 kJ per 100 kcal Minimum Maximum Minimum Maximum Sodium (mg) 5 14 20 60 Potassium (mg) 15 35 60 145I I I 8 [S.L.231.36 INFANT FORMULAE AND FOLLOW-ON FORMULAE The calcium/phosphorus ratio shall not be less than 1.2 nor greater than 2.0. 5.2 Formulae manufactured from soya proteins, alone or in a mixture with cows’ milk proteins All requirements of paragraph 5.1 are applicable except those concerning iron and zinc, which are as follows: 6. Vitamins Chloride (mg) 12 29 50 125 Calcium (mg) 12 - 50 Phosphorus (mg) 6 22 25 90 Magnesium (mg) 1.2 3.6 5 15 Iron (mg)1 0.12 0.36 0.5 1.5 Zinc (mg) 0.12 0.36 0.5 1.5 Copper (µg) 4.8 19 20 80 Iodine (µg) 1.2 - 5 Selenium (µg) 2 - 0.7 - 3 1 Limit applicable to formulae with added iron. 2 Limit applicable to formulae with added selenium. per 100 kJ per 100 kcal Minimum Maximum Minimum Maximum Iron (mg) 0.25 0.5 1 2 Zinc (mg) 0.18 0.6 0.75 2.4 per 100 kJ per 100 kcal Minimum Maximum Minimum Maximum Vitamin A (µg-RE) 3 14 43 60 180 Vitamin D (µg) 4 0.25 0.65 1 2.5 Thiamine (µg) 10 - 40 Riboflavin (µg) 14 - 60 Niacin (mg-NE)5 0.2 - 0.8 Pantothenic acid (µg) 70 - 300 Vitamin B6 (µg) 9 - 3.5 Biotin (µg) 0.4 - 1.5 Folic acid (µg) 1 - 4 Vitamin B 12 (µg) 0.025 - 0.1 Vitamin C (µg) 1.9 - 8 Vitamin K (µg) 1 - 4 V i t a m i n E ( m g ∝ TE)6 0.5/g of poly unsaturated fatty acids expressed as linoleic acid but in no case less than 0.1 mg per 100 available kJ 0.5/g of poly unsaturated fatty acids expressed as linoleic acid but in no case less than 0.1 mg per 100 available kJ INFANT FORMULAE AND FOLLOW-ON FORMULAE [S.L.231.36 9 7. The following nucleotides may be added: 3 RE = all trans retinol equivalent. 4 In the form of cholecalciferol, of which 10 µg = 400 i.u. of vitamin D. 5 NE = niacin equivalent = mg nicotinic acid + mg tryptophan/60. 6 ∝-TE = d-∝-tocopherol equivalent. Maximum7 (mg/100kJ) (mg/100kcal) Cytidine 5'-monophosphate 0.60 2.50 Uridine 5'-monophosphate 0.42 1.75 Adenosine 5'-monophosphate 0.36 1.50 Guanosine 5'-monophosphate 0.12 0.50 Inosine 5'-monophosphate 0.24 1.00 7 The total concentration of nucleotides shall not exceed 1.2 mg/100 kJ (5 mg/ 100 kcal). 10 [S.L.231.36 INFANT FORMULAE AND FOLLOW-ON FORMULAE SECOND SCHEDULE Essential Composition of Follow-on Formulae when reconstituted as instructed by the manufacturer NB: The values refer to the product ready for use. 1. Energy Minimum Maximum 250 kJ/100 ml 335 kJ/100 ml (60 kcal/100 ml) (80 kcal/100 ml) 2. Proteins (Protein content = nitrogen content x 6.38) for cows’ milk proteins. (Protein content = nitrogen content x 6.25) for soya protein isolates. Minimum Maximum 0.5 g/100 kJ 1 g/100 kJ (2.25 g/100 kcal) (4.5 g/100 kcal) The chemical index of the proteins present shall be at least equal to 80% of that of the reference protein (casein or breast milk as defined in the Sixth Schedule). The "chemical index" shall mean the lowest of the ratios between the quantity of each essential amino acid of the test protein and the quantity of each corresponding amino acid of the reference protein. For follow-on formulae manufactured from soya proteins, alone or in a mixture with cows’ milk proteins, only protein isolates from soya may be used. Amino acids may be added to follow-on formulae for the purpose of improving the nutritional value of the proteins, in the proportions necessary for that purpose. For an equal energy value, these formulae must contain an available quantity of methionine at least equal to that contained in breast milk as defined in the Fifth Schedule. 3. Lipids Minimum Maximum 0.8 g/100 kJ 1.5 g/100 kJ (3.3 g/100 kcal) (6.5 g/100 kcal) 3.1 The use of the following substances is prohibited: sesame seed oil, cotton seed oil. 3.2 Lauric acid Minimum Maximum 15% of the total fat content INFANT FORMULAE AND FOLLOW-ON FORMULAE [S.L.231.36 11 3.3 Myristic acid Minimum Maximum 15% of the total fat content 3.4 Linoleic acid (in the form of glycerides = linoleates) Minimum Maximum 70 mg/100 kJ (300 mg/100 kcal) this limit applies only to follow-on formulae containing vegetable oils 3.5 The trans fatty acid content shall not exceed 4% of the total fat content. 3.6 The erucic acid content shall not exceed 1% of the total fat content. 4. Carbohydrates Minimum Maximum 1.7 g/100 kJ 3.4 g/100 kJ (7 g/100 kcal) (14 g/100 kcal) 4.1 The use of ingredients containing gluten is prohibited. 4.2 Lactose Minimum Maximum 0.45 g/100 kJ (1.8 g/100 kcal) This provision does not apply to follow-on formulae in which soya proteins represent more than 50% of the total protein content. 4.3 Sucrose, fructose, honey Minimum Maximum separately or as a whole: 20% of the total carbohydrate content 5. Mineral substances 5.2 Zinc 5.2.1 Follow-on formulae manufactured entirely from cows’ milk Minimum Maximum 0.12 mg/100 kJ per 100 kJ per 100 kcal Minimum Maximum Minimum Maximum Iron (mg) 0.25 0.5 1 2 Iodine (µg) 1.2 - 5 12 [S.L.231.36 INFANT FORMULAE AND FOLLOW-ON FORMULAE (0.5 mg/100 kcal) 5.2.2 Follow-on formulae containing soya protein isolates, or mixed with cows’ milk Minimum Maximum 0.18 mg/100 kJ (0.75 mg/100 kcal) 5.3 Other mineral substances The concentrations are at least equal to those normally found in cows’ milk, reduced, where appropriate, in the same ratio as the protein concentration of the follow-on formulae to that of cows’ milk. The typical composition of cows’ milk is given, for guidance, in the Eighth Schedule. 5.4 The calcium/phosphorus ratio shall not exceed 2.0. 6. Vitamins 7. The following nucleotides may be added: per 100 kJ per 100 kcal Minimum Maximum Minimum Maximum Vitamin A (µg-RE) 1 14 43 60 180 Vitamin D (µg) 2 0.25 0.75 1 3 Vitamin C (µg) 1.9 - 8 V i t a m i n E ( m g ∝ TE)3 0.5/g of poly unsaturated fatty acids expressed as linoleic acid but in no case less than 0.1 mg per 100 available kJ 0.5/g of poly unsaturated fatty acids expressed as linoleic acid but in no case less than 0.1 mg per 100 available kJ 1 RE = all trans retinol equivalent. 2 In the form of cholecalciferol, of which 10 µg = 400 i.u. of vitamin D. 3 ∝-TE = d-∝-tocopherol equivalent. Maximum4 (mg/100kJ) (mg/100kcal) Cytidine 5'-monophosphate 0.60 2.50 Uridine 5'-monophosphate 0.42 1.75 Adenosine 5'-monophosphate 0.36 1.50 Guanosine 5'-monophosphate 0.12 0.50 Inosine 5'-monophosphate 0.24 1.00 4 The total concentration of nucleotides shall not exceed 1.2 mg/100 kJ (5 mg/ 100 kcal). I INFANT FORMULAE AND FOLLOW-ON FORMULAE [S.L.231.36 13 THIRD SCHEDULE Nutritional Substances 1. Vitamins Vitamins Vitamin formulation Vitamin A Retinyl acetate Retinyl palmitate Beta-carotene Retinol Vitamin D Vitamin D2 (ergocalciferol) Vitamin D3 (cholecalciferol) Vitamin B l Thiamine hydrochloride Thiamine mononitrate Vitamin B2 Riboflavin Riboflavin-5'-phosphate, sodium Niacin Nicotinamide Nicotinic acid Vitamin B6 Pyridoxine hydrochloride Pyridoxine-5'-phosphate Folate Folic acid Pantothenic acid D-pantothenate, calcium D-pantothenate, sodium Dexpanthenol Vitamin B12 Cyanocobalamin Hydroxocobalamin Biotin D-biotin Vitamin C L-ascorbic acid Sodium L-ascorbate 14 [S.L.231.36 INFANT FORMULAE AND FOLLOW-ON FORMULAE Calcium L-ascorbate 6-palmityl-L-ascorbic acid (ascorbyl palmitate) Potassium ascorbate Vitamin E D-alpha tocopherol DL-alpha tocopherol D-alpha tocopherol acetate DL-alpha tocopherol acetate Vitamin K Phylloquinone (Phytomenadione) 2. Mineral substances Mineral substances Permitted salts Calcium (Ca) Calcium carbonate Calcium chloride Calcium salts of citric acid Calcium gluconate Calcium glycerophosphate Calcium lactate Calcium salts of orthophosphoric acid Calcium hydroxide Magnesium (Mg) Magnesium carbonate Magnesium chloride Magnesium oxide Magnesium salts of orthophosphoric acid Magnesium sulphate Magnesium gluconate Magnesium hydroxide Magnesium salts of citric acid Iron (Fe) Ferrous citrate Ferrous gluconate Ferrous lactate Ferrous sulphate INFANT FORMULAE AND FOLLOW-ON FORMULAE [S.L.231.36 15 Ferric ammonium citrate Ferrous fumarate Ferric diphosphate (Ferric pyrophosphate) Copper (Cu) Cupric citrate Cupric gluconate Cupric sulphate Cupric-lysine complex Cupric carbonate Iodine (I) Potassium iodide Sodium iodide Potassium iodate Zinc (Zn) Zinc acetate Zinc chloride Zinc lactate Zinc sulphate Zinc citrate Zinc gluconate Zinc oxide Manganese (Mn) Manganese carbonate Manganese chloride Manganese citrate Manganese sulphate Manganese gluconate Sodium (Na) Sodium bicarbonate Sodium chloride Sodium citrate Sodium gluconate Sodium carbonate Sodium lactate Sodium salts of orthophosphoric acid Sodium hydroxide 16 [S.L.231.36 INFANT FORMULAE AND FOLLOW-ON FORMULAE Potassium (K) Potassium bicarbonate Potassium carbonate Potassium chloride Potassium salts of citric acid Potassium gluconate Potassium lactate Potassium salts of orthophosphoric acid Potassium hydroxide Selenium (Se) Sodium selenate Sodium selenite 3. Amino acids and other nitrogen compounds L-arginine and its hydrochloride L-cystine and its hydrochloride L-histidine and its hydrochloride L-isoleucine and its hydrochloric L-leucine and its hydrochloride L-cystine and its hydrochloride L-methionine L-phenylalanine L-threonine L-tryptophan L-tyrosine L-valine L-carnitine and its hydrochloride Taurine Cytidine 5'-monophosphate and its sodium salt Uridine 5'-monophosphate and its sodium salt Adenosine 5'-monophosphate and its sodium salt Guanosine 5'-monophosphate and its sodium salt Inosine 5'-monophosphate and its sodium salt 4. Others Choline Choline chloride INFANT FORMULAE AND FOLLOW-ON FORMULAE [S.L.231.36 17 Choline citrate Choline bitartrate Inositol 18 [S.L.231.36 INFANT FORMULAE AND FOLLOW-ON FORMULAE FOURTH SCHEDULE Compositional Criteria for Infant Formulae, warranting a corresponding claim Claim related to: Conditions warranting the claim 1. Adapted protein The protein content is lower than 0.6 g/ 100 kJ (2 .5 g /100 kca l ) and the whey protein/casein ratio is not less than 1.0. 2. Low sodium The sodium content is lower than 9 mg/ 100 kJ (39 mg/100 kcal). 3. Sucrose free No sucrose is present. 4. Lactose only Lactose is the only carbohydrate present. 5. Lactose free No lactose is present. 6. Iron enriched Iron is added. 7. Reduction of risk to allergy to mi lk p ro te ins . This claim may i n c l u d e t e r m s r e f e r r i n g t o r e d u c e d a l l e r g e n o r reduced antigen properties. (a) The formulae shall satisfy the provisions laid down in paragraph 2.2 of the First Schedule and the amount of immunoreactive protein measured with methods generally acceptable as appropriate shall be less than 1% of nitrogen containing substances in the formulae; (b) The label shall indicate that the protein must not be consumed by infants allergic to the intact proteins f r o m w h i c h i t i s m a d e u n l e s s generally accepted clinical tests provide proof of the formulae’s to l e r ance i n more t han 90% o f infants (confidence interval 95%) hypersens i t ive to prote ins f rom which the hydrolysate is made; (c) The formulae administered orally should not induce sensitisation, in animals, to the intact proteins from which the formulae are derived; (d) Objective and scientifically verified d a t a a s p r o o f t o t h e c l a i m e d properties must be available. INFANT FORMULAE AND FOLLOW-ON FORMULAE [S.L.231.36 19 FIFTH SCHEDULE Essential and Semi-Essential Amino Acids in Breast Milk For the purpose of this report, the essential and semi-essential amino acids in breast milk, expressed in mg per 100 kJ and 100 kcal, are the following: Per 100 kJ1 Per 100 kcal Arginine 16 69 Cystine 6 24 Histidine 11 45 Isoleucine 17 72 Leucine 37 156 Lysine 29 122 Methionine 7 29 Phenylalanine 15 62 Threonine 19 80 Tryptophan 7 30 Tyrosine 14 59 Valine 19 80 1 kJ = 0.239 kcal. 20 [S.L.231.36 INFANT FORMULAE AND FOLLOW-ON FORMULAE SIXTH SCHEDULE Amino Acid Composition of Casein and Breast Milk Protein The amino acid composition of casein and breast milk protein (g/ 100 g of protein): SEVENTH SCHEDULE The Mineral Elements in Cows’ Milk As a reference, the contents of mineral elements in cows’ milk expressed per 100 g of solids-non-fat and per g of proteins are the following: Casein1 Breast milk1 Arginine 3.7 3.8 Cystine 0.3 1.3 Histidine 2.9 2.5 Isoleucine 5.4 4.0 Leucine 9.5 8.5 Lysine 8.1 6.7 Methionine 2.8 1.6 Phenylalanine 5.2 3.4 Threonine 4.7 4.4 Tryptophan 1.6 1.7 Tyrosine 5.8 3.2 Valine 6.7 4.5 1 Amino acid content of foods and biological data on protein. FAO Nutritional Studies, No. 24, Rome 1970, items 375 and 383. Per 100 g SNF1 Per g of proteins Sodium (mg) 550 15 Potassium (mg) 1680 43 Chloride (mg) 1050 28 Calcium (mg) 1350 35 Phosphorus (mg) 1070 28 Magnesium (mg) 135 3.5 Copper (µg) 225 6 Iodine NS2 NS 1 SNF: 'solids-non-fats'. 2 NS: non-specified, varies widely according to season and stock farming conditions. INFANT FORMULAE AND FOLLOW-ON FORMULAE [S.L.231.36 21 EIGHTH SCHEDULE Reference Values for Nutrition Labelling for Foods intended for Infants and Young Children Nutrient Labelling Reference Value Vitamin A 400 µg Vitamin D 10 µg Vitamin C 25 mg Thiamine 0.5 mg Riboflavin 0.8 mg Niacin equivalents 9 mg Vitamin B6 0.7 mg Folate 100 µg Vitamin B 12 0.7 µg Calcium 400 mg Iron 6 mg Zinc 4 mg Iodine 70µg Selenium 10 µg Copper 0.4 mg