Infant Formulae and Follow-on Formulae, 2007 (L.N. 304 of 2007)

B 3880 L.N. 304 of 2007 FOOD SAFETY ACT (CAP. 449) Infant Formulae and Follow-on Formulae, 2007 IN exercise of the powers conferred by article 10 of the Food Safety Act, the Minister of Health, the Elderly and Community Care has made the following regulations> 1. The title of these regulations is the Infant Formulae and Follow on Formulae Regulations, 2007. 2. (1) These regulations implement the provisions of Commission Directive 2006#141#EC of 22nd December, 2006, and they shall enter into force on 31st December, 2007. (2) The provisions shall apply in such a way as to> (a) permit trade in products complying with this regulation by the 1st January, 2008 at the latest, (b) without prejudice to paragraph 13, prohibit, with effect from 31st December, 2009 trade in products which do not comply with this regulation. 3. These regulations concern compositional and labelling requirements for infant formulae and follow-on formulae intended for use by infants in good health. 4. (1) For the purpose of these regulations, the definitions ‘claim’, ‘nutrition claim’, ‘health claim’ and ‘reduction of disease risk claim’ in Article 2(2)(1), (4), (5) and (6) of Regulation (EC) No 1924#2006 shall apply. (2) The following definitions shall also apply> (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 months of life and satisfying by themselves the nutritional requirements of such Title. Commencement and scope. Applicability. Definitions. B 3881 infants until the introduction of appropriate complementary feeding< (d) ‘follow-on formulae’ means foodstuffs intended for particular nutritional use by infants when appropriate complementary feeding is introduced and constituting the principal liquid element in a progressively diversified diet of such infants< (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 Directive 91#414#EEC, including its metabolites and products resulting from its degradation or reaction. 5. (1) Infant formulae and follow-on formulae may be marketed within the Community only if they comply with these regulations. (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 months of life until the introduction of appropriate complementary feeding. 6. (1) Infant formulae shall be manufactured from protein sources defined in point 2 of the First Schedule 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. (2) Follow-on formulae shall be manufactured from protein sources defined in point 2 of the Second Schedule and other food ingredients, as the case may be, whose suitability for particular nutritional use by infants aged over six months has been established by generally accepted scientific data. (3) Such suitability, as mentioned in paragraphs 6(1) and 6(2), shall be demonstrated through a systematic review of the available data relating to the expected benefits and to safety considerations as well as, where necessary, appropriate studies, performed following generally accepted expert guidance on the design and conduct of such studies. (4) The prohibitions and limitations on the use of food ingredients in infant formulae and follow-on formulae set out in the First and Second Schedules shall be observed. Sale of infant formulae and follow-on formulae. Manufacture of infant formulae and follow-on formulae. B 3882 7. (1) Infant formulae shall comply with the compositional criteria set out in the First Schedule taking into account the specifications of the Fifth Schedule. In the case of infant formulae manufactured from cows’ milk proteins defined in point 2.1 of the First Schedule with a protein content between the minimum and 0,5 g#100 kJ (2 g#100 kcal), the suitability of the infant formula for the particular nutritional use by infants shall be demonstrated through appropriate studies, performed following generally accepted expert guidance on the design and conduct of such studies. In the case of infant formulae manufactured from protein hydrolysates defined in point 2.2 of the First Schedule with a protein content between the minimum and 0,56 g#100 kJ (2,25g#100 kcal), the suitability of the infant formula for the particular nutritional use by infants shall be demonstrated through appropriate studies, performed following generally accepted expert guidance on the design and conduct of such studies and shall be in accordance with the appropriate specifications set out in the Sixth Schedule. (2) Follow-on formulae shall comply with the compositional criteria set out in the Second Schedule taking into account the specifications set out in the Fifth Schedule. (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. (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> (a) mineral substances< (b) vitamins< (c) amino acids and other nitrogen compounds< (d) other substances having a particular nutritional purpose. (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. Compositional Criteria. B 3883 (6) Purity criteria for substances, concerning the use of substances listed in the Third Schedule, in the manufacture of foodstuffs for purposes other than those covered by this Regulation, shall apply. (7) For those substances for which no purity criteria have been provided for in Community legislation, generally acceptable purity criteria recommended by international bodies shall apply until the adoption of such criteria at Community level. However, national rules setting stricter purity criteria than those recommended by international bodies may be maintained. (8) 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. Analytical methods for determining the levels of pesticide residues shall be generally acceptable standardised methods. (9) The pesticides listed in the Eight Schedule shall not be used in agricultural products intended for the production of infant formulae and follow-on formulae. However, for the purpose of controls> (a) pesticides listed in Table 1 of the Eighth Schedule are considered not to have been used if their residues do not exceed a level of 0,003 mg#kg. This level, which is considered to be the limit of quantification of the analytical methods, shall be kept under regular review in the light of technical progress< (b) pesticides listed in Table 2 of the Eighth Schedule are considered not to have been used if their residues do not exceed a level of 0,003 mg#kg. This level shall be kept under regular review in the light of data on environmental contamination. (10) By way of derogation from paragraph 7(8), for the pesticides listed in the Ninth Schedule, the maximum residue levels specified therein shall apply. (11) The levels referred to in paragraphs 7(9) and 7(10) shall apply to the products as proposed ready for consumption or as reconstituted according to the instructions of the manufacturers. B 3884 8. (1) To facilitate the efficient official monitoring of infant formulae, when a food business operator places an infant formula on the market he shall notify the Food Safety Commission by forwarding a model of the label used for the product. (2) The competent authorities for the purposes of this paragraph are those referred to in paragraphs 19(13) to 19(18) of the Regulation of 2004 concerning the Labelling, Presentation and Advertising of Foodstuffs, Regulations, 2004. 9. (1) (a) Except as provided for in paragraph 9(2), the name under which infant formulae and follow-on formulae are sold shall be, respectively> (i) in English> ‘infant formula’ and ‘follow-on formula’ (ii) in Maltese> ‘formula tat-trabi’ and ‘formula tal prosegwiment’ (b) The name under which the products covered by regulation 4(2) (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”. (c) Without prejudice to paragraph (b) above, the list provided for in the Tenth Schedule specifies the names under which the products covered by regulation 4(2) (c) and (d) are sold in all the European Community languages. (2) The name under which infant formulae and follow-on formulae manufactured entirely from cows’ milk proteins are sold, shall be respectively> (i) in English> ‘infant milk’ and ‘follow-on milk’ (ii) in Maltese> ‘[alib tat-trabi’ and ‘[alib tal-prosegwiment’ (3) The labelling shall bear, in addition to those provided for in paragraph 5(1) of the Labelling, Presentation and Advertising of Foodstuffs Regulations, 2004, the following mandatory particulars in Maltese and, or English> Monitoring of infant formulae. L.N. 483 of 2004. Labelling and Presentation of infant formulae and follow-on formulae. B 3885 (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 breast fed< (b) 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 six months, that it should form only part of a diversified diet, that it is not to be used as a substitute for breast milk during the first six months of life and that the decision to begin complementary feeding, including any exception to six months of age, should be made only on the advice of independent persons having qualifications in medicine, nutrition or pharmacy, or other professionals responsible for maternal and child care, based on the individual infant’s specific growth and development needs< (c) 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< (d) 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 and carnitine, expressed in numerical form, per 100 ml of the product ready for use< (e) in the case of infant formulae and follow-on formulae, instructions for appropriate preparation, storage and disposal of the product and a warning against the health hazards of inappropriate preparation and storage. (4) The labelling may bear the following particulars> (a) for infant formulae and follow-on formulae the average quantity of nutrients mentioned in the Third Schedule when such declaration is not covered by paragraph (3)(d) of this regulation, 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 Seventh Schedule, expressed as a percentage of the reference values given therein, per 100 ml of the product ready for use. (5) The labelling of infant formulae and follow-on formulae shall be designed to provide the necessary information about the B 3886 appropriate use of the products so as not to discourage breast feeding. The use of the terms ‘humanised’, ‘maternalised’, ‘adapted’, or similar terms shall be prohibited. (6) The labelling of infant formulae shall, in addition, bear the following mandatory particulars, preceded by the words ‘Important Notice’ or their equivalent> (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 qualifications in medicine, nutrition or pharmacy, or other professionals responsible for maternal and child care. (7) 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. (8) The labelling of infant formulae may bear nutrition and health claims only in the cases listed in the Fourth Schedule and in accordance with the conditions set out therein. (9) Infant formulae and follow-on formulae shall be labelled in such a way that it enables consumers to make a clear distinction between such products so as to avoid any risk of confusion between infant formulae and follow-on formulae. (10) The requirements, prohibitions and restrictions referred to in paragraphs 10(5) to 10(9) 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. 10. (1) Advertising of infant formulae shall be restricted to publications specialising in baby care and scientific publications. Such advertisements for infant formulae shall be subject to the conditions laid down in paragraphs 9(5) to 9(9) and paragraph 9(10)(b) and contain only information of a scientific and factual nature. Such information Advertising of infant formulae. B 3887 shall not imply or create a belief that bottle-feeding is equivalent or superior to breast feeding. (2) There shall be no point-of-sale advertising, giving of samples or any other promotional device to induce sales of infant formula directly to the consumer at the retail level, such as special displays, discount coupons, premiums, special sales, loss-leaders and tie-in sales. (3) Manufacturers and distributors of infant formulae shall not provide, to the general public or to pregnant women, mothers or members of their families, free or low-priced products, samples or any other promotional gifts, either directly or indirectly via the health care system or health workers. 11. (1) Objective and consistent information shall be provided on infant and young child feeding for use by families and those involved in the field of infant and young child nutrition covering the planning, provision, design and dissemination of information and their control. (2) Informational and educational materials, whether written or audiovisual, dealing with the feeding of infants and intended to reach pregnant women and mothers of infants and young children, shall include clear information on all the following points> (a) the benefits and superiority of breast feeding< (b) maternal nutrition and the preparation for and maintenance of breast feeding< (c) the possible negative effect on breast feeding of introducing partial bottle feeding< (d) the difficulty of reversing the decision not to breast feed< (e) where needed, the proper use of infant formulae. When such materials contain information about the use of infant formulae, they shall include the social and financial implications of its use, the health hazards of inappropriate foods or feeding methods, and, in particular, the health hazards of improper use of infant formulae. Such material shall not use any pictures which may idealise the use of infant formulae. Providing consistent information on infant formulae and follow-on formulae. B 3888 (3) Donations of informational or educational equipment or materials by manufacturers or distributors shall be made only on request and with the written approval of the appropriate national authority or within guidelines given by that authority for this purpose. Such equipment or materials may bear the donating company’s name or logo, but shall not refer to a proprietary brand of infant formulae and shall be distributed only through the health care system. (4) Donations or low-price sales of supplies of infant formulae to institutions or organisations, whether for use in the institutions or for distribution outside them, shall only be used by or distributed for infants who have to be fed on infant formulae and only for as long as required by such infants. 12. The new requirements set out in paragraphs 7(1) and 7(2) of these regulations shall not apply mandatorily to dietary foods for special medical purposes intended specifically for infants, as referred to in point 4 of the Schedule to the Dietary Foods for Special Medical Purposes until 1st January 2012. 13. The Infant Formulae and Follow-on Formulae Regulations, 2002 are hereby repealed and any reference to those regulations shall be construed as a reference to these regulations. Dietary foods for special medical purposes intended specifically for infants. L.N. 309 of 2001. Repeals L.N. 208 of 2002. 10 FIRST SCHEDULE ESSENTIAL COMPOSITION OF INFANT FORMULAE WHEN RECONSTITUTED AS INSTRUCTED BY THE MANUFACTURER The values set out in this Schedule refer to the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer. 1. ENERGY Minimum Maximum 250 kJ/100 ml 295 kJ/100 ml (60 kcal/100 ml) (70 kcal/100 ml) 2. PROTEINS (Protein content = nitrogen content × 6,25) 2.1 Infant formulae manufactured from cows’ milk proteins Minimum (1) Maximum 0,45 g/100 kJ 0,7 g/100 kJ (1,8 g/100 kcal) (3 g/100 kcal) (1) Infant formulae manufactured from cows’ milk protein with a protein content between the minimum and 0,5 g/100 kJ (2 g/100 kcal) shall be in accordance with the second subparagraph of paragraph 7(1). For an equal energy value, the infant formula must contain an available quantity of each indispensable and conditionally indispensable 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 if the methionine:cystine ratio is not greater than 2, and the concentration of phenylalanine and tyrosine may be added together if the tyrosine:phenylalanine ratio is not greater than 2. The ratio of methionine: cystine may be greater than 2 but shall not be greater than 3 provided that the suitability of the product for the particular nutritional use by infants is demonstrated through appropriate studies, performed following generally accepted expert guidance on the design and conduct of such studies. 2.2 Infant formulae manufactured from protein hydrolysates Minimum (1) Maximum 0,45 g/100 kJ 0,7 g/100 kJ (1,8 g/100 kcal) (3 g/100 kcal) (1) Infant formulae manufactured from protein hydrolysates with a protein content between the minimum and 0,56 g/100 kJ (2,25 g/100 kcal) shall be in accordance with the third subparagraph of Article 7(1). B 3889 11 For an equal energy value, the infant formula must contain an available quantity of each indispensable and conditionally indispensable 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 if the methionine:cystine ratio is not greater than 2, and the concentration of phenylalanine and tyrosine may be added together if the tyrosine:phenylalanine ratio is not greater than 2. The ratio of methionine:cystine may be greater than 2 but shall not be greater than 3 provided that the suitability of the product for the particular nutritional use by infants is demonstrated through appropriate studies, performed following generally accepted expert guidance on the design and conduct of such studies. The L-carnitine content shall be at least equal to 0,3 mg/100 kJ (1,2 mg/100 kcal). 2.3 Infant formulae manufactured from soya protein isolates, alone or in a mixture with cows’ milk proteins Minimum Maximum 0,56 g/100 kJ 0,7 g/100 kJ (2,25 g/100 kcal) (3 g/100 kcal) Only protein isolates from soya shall be used in manufacturing these infant formulae. For an equal energy value the infant formula must contain an available quantity of each indispensable and conditionally indispensable 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 if the methionine:cystine ratio is not greater than 2, and the concentration of phenylalanine and tyrosine may be added together if the tyrosine:phenylalanine ratio is not greater than 2. The ratio of methionine:cystine may be greater than 2 but shall not be greater than 3 provided that the suitability of the product for the particular nutritional use by infants is demonstrated through appropriate studies, performed following generally accepted expert guidance on the design and conduct of such studies. The L-carnitine content shall be at least equal to 0,3 mg/100 kJ (1,2 mg/100 kcal). 2.4 In all cases, amino acids may be added to infant formulae solely for the purpose of improving the nutritional value of the proteins, and only in the proportions necessary for that purpose. 3. TAURINE If added to infant formulae, the amount of taurine shall not be greater than 2,9 mg/100 kJ (12 mg/100 kcal). 4. CHOLINE Minimum Maximum 1,7 mg/100 kJ 12 mg/100 kJ (7 mg/100 kcal) (50 mg/100 kcal) B 3890 12 5. LIPIDS Minimum Maximum 1,05 g/100 kJ 1,4 g/100 kJ (4,4 g/100 kcal) (6,0 g/100 kcal) 5.1 The use of the following substances shall be prohibited: — sesame seed oil, — cotton seed oil. 5.2 Lauric acid and myristic acid Minimum Maximum separately or as a whole: 20 % of the total fat content 5.3 The trans fatty acid content shall not exceed 3 % of the total fat content. 5.4 The erucic acid content shall not exceed 1 % of the total fat content. 5.5 Linoleic acid (in the form of glycerides = linoleates) Minimum Maximum 70 mg/100 kJ 285 mg/100 kJ (300 mg/100 kcal) (1 200 mg/100 kcal) 5.6 The alpha-linolenic acid content shall not be less than 12 mg/100 kJ (50 mg/100 kcal). The linoleic:alpha-linolenic acid ratio shall not be less than 5 nor greater than 15. 5.7 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 (20:4 n-6)) The eicosapentaenoic acid (20:5 n-3) content shall not exceed that of docosahexaenoic (22:6 n-3) acid content. The docosahexaenoic acid (22:6 n-3) content shall not exceed that of n-6 LCP. B 3891 13 6. PHOSPHOLIPIDS The amount of phospholipids in infant formulae shall not be greater than 2 g/l. 7. INOSITOL Minimum Maximum 1 mg/100 kJ 10 mg/100 kJ (4 mg/100 kcal) (40 mg/100 kcal) 8. CARBOHYDRATES Minimum Maximum 2,2 g/100 kJ 3,4 g/100 kJ (9 g/100 kcal) (14 g/100 kcal) 8.1 Only the following carbohydrates may be used: — lactose, — maltose, — sucrose, — glucose, — malto-dextrins, — glucose syrup or dried glucose syrup, — pre-cooked starch naturally free of gluten. — gelatinised starch 8.2 Lactose Minimum Maximum 1,1 g/100 kJ (4,5 g/100 kcal) This provision shall not apply to infant formulae in which soya protein isolates represent more than 50 % of the total protein content. B 3892 } 14 8.3 Sucrose Sucrose may only be added to infant formulae manufactured from protein hydrolysates. If added, the sucrose content shall not exceed 20 % of the total carbohydrate content. 8.4 Glucose Glucose may only be added to infant formulae manufactured from protein hydrolysates. If added, the glucose content shall not exceed 0,5 g/100 kJ (2 g/100 kcal). 8.5 Pre-cooked starch and/or gelatinised starch Minimum Maximum — 2 g/100 ml, and 30 % of the total carbohydrate content 9. FRUCTO-OLIGOSACCHARIDES AND GALACTO-OLIGOSACCHARIDES Fructo-oligosaccharides and galacto-oligosaccharides may be added to infant formulae. In that case their content shall not exceed: 0,8 g/100 ml in a combination of 90 % oligogalactosyl-lactose and 10 % high molecular weight oligofructosyl-saccharose. Other combinations and maximum levels of fructo-oligosaccharides and galacto-oligosaccharides may be used in accordance with paragraph 6. 10. MINERAL SUBSTANCES 10.1 Infant formulae manufactured from cows’ milk proteins or protein hydrolysates Per 100 kJ Per 100 kcal Minimum Maximum Minimum Maximum Sodium (mg) 5 14 20 60 Potassium (mg) 15 38 60 160 Chloride (mg) 12 38 50 160 Calcium (mg) 12 33 50 140 Phosphorus (mg) 6 22 25 90 Magnesium (mg) 1,2 3,6 5 15 Iron (mg) 0,07 0,3 0,3 1,3 Zinc (mg) 0,12 0,36 0,5 1,5 Copper ( g) 8,4 25 35 100 Iodine ( g) 2,5 12 10 50 Selenium ( g) 0,25 2,2 1 9 Manganese ( g) 0,25 25 1 100 Fluoride ( g) - 25 - 100 The calcium:phosphorus ratio shall not be less than 1 nor greater than 2. B 3893 15 10.2 Infant formulae manufactured from soya protein isolates, alone or in a mixture with cows’ milk proteins All requirements of point 10.1 shall apply, except for those concerning iron and phosphorus, which shall be as follows: Per 100 kJ Per 100 kcal Minimum Maximum Minimum Maximum Iron (mg) 0,12 0,5 0,45 2 Phosphorus (mg) 7,5 25 30 100 11. VITAMINS Per 100 kJ Per 100 kcal Minimum Maximum Minimum Maximum Vitamin A ( g-RE) (1) 14 43 60 180 Vitamin D ( g) (2) 0,25 0,65 1 2,5 Thiamin ( g) 14 72 60 300 Riboflavin ( g) 19 95 80 400 Niacin ( g) (3) 72 375 300 1 500 Pantothenic acid ( g) 95 475 400 2 000 Vitamin B6 ( g) 9 42 35 175 Biotin ( g) 0,4 1,8 1,5 7,5 Folic Acid ( g) 2,5 12 10 50 Vitamin B12 ( g) 0,025 0,12 0,1 0,5 Vitamin C (mg) 2,5 7,5 10 30 Vitamin K ( g) 1 6 4 25 Vitamin E (mg -TE) (4) 0,5/g of polyunsaturated fatty acids expressed as linoleic acid as corrected for the double bonds (5) but in no case less than 0,1 mg per 100 available kJ 1,2 0,5/g of polyunsaturated fatty acids expressed as linoleic acid as corrected for the double bonds (5) but in no case less than 0,5 mg per 100 available kcal 5 (1) RE = all trans retinol equivalent. (2) In the form of cholecalciferol, of which 10 g = 400 i.u. of vitamin D. (3) Preformed niacin. (4) -TE = d- -tocopherol equivalent. (5) 0,5 mg -TE/1 g linoleic acid (18:2 n-6); 0,75 mg -TE/1 g -linolenic acid (18:3 n-3); 1,0 mg -TE/1 g arachidonic acid (20:4 n-6); 1,25 mg -TE/1 g eicosapentaenoic acid (20:5 n-3); 1,5 mg -TE/1 g docosahexaenoic acid (22:6 n-3). B 3894 16 12. NUCLEOTIDES The following nucleotides may be added: Maximum (1) (mg/100 kJ) (mg/100 kcal) 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 (1) The total concentration of nucleotides shall not exceed 1,2 mg/100 kJ (5 mg/100 kcal). B 3895 17 SECOND SCHEDULE ESSENTIAL COMPOSITION OF FOLLOW-ON FORMULAE WHEN RECONSTITUTED AS INSTRUCTED BY THE MANUFACTURER The values set out in this Schedule refer to the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer. 1. ENERGY Minimum Maximum 250 kJ/100 ml 295 kJ/100 ml (60 kcal/100 ml) (70 kcal/100 ml) 2. PROTEINS (Protein content = nitrogen content × 6,25) 2.1 Follow-on formulae manufactured from cows' milk proteins Minimum Maximum 0,45 g/100 kJ 0,8 g/100 kJ (1,8 g/100 kcal) (3,5 g/100 kcal) For an equal energy value, the follow-on formula must contain an available quantity of each indispensable and conditionally indispensable 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 if the methionine:cystine ratio is not greater than 3, and the concentration of phenylalanine and tyrosine may be added together if the tyrosine:phenylalanine ratio is not greater than 2. 2.2 Follow-on formulae manufactured from protein hydrolysates Minimum Maximum 0,56 g/100 kJ 0,8 g/100 kJ (2,25 g/100 kcal) (3,5 g/100 kcal) For an equal energy value, the follow-on formula must contain an available quantity of each indispensable and conditionally indispensable 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 if the methionine:cystine ratio is not greater than 3, and the concentration of phenylalanine and tyrosine may be added together if the tyrosine:phenylalanine ratio is not greater than 2. B 3896 18 2.3 Follow-on formulae manufactured from soya protein isolates, alone or in a mixture with cows’ milk Proteins Minimum Maximum 0,56 g/100 kJ 0,8 g/100 kJ (2,25 g/100 kcal) (3,5 g/100 kcal) Only protein isolates from soya shall be used in manufacturing these formulae. For an equal energy value the follow-on formula must contain an available quantity of each indispensable and conditionally indispensable 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 if the methionine:cystine ratio is not greater than 3, and the concentration of phenylalanine and tyrosine may be added together if the tyrosine:phenylalanine ratio is not greater than 2. 2.4 In all cases, amino acids may be added to follow-on formulae solely for the purpose of improving the nutritional value of the proteins, and only in the proportions necessary for that purpose. 3. TAURINE If added to follow-on formulae, the amount of taurine shall not be greater than 2,9 mg/100 kJ (12 mg/100 kcal). 4. LIPIDS Minimum Maximum 0,96 g/100 kJ 1,4 g/100 kJ (4,0 g/100 kcal) (6,0 g/100 kcal) 4.1 The use of the following substances shall be prohibited: — sesame seed oil, — cotton seed oil. 4.2 Lauric acid and myristic acid Minimum Maximum — separately or as a whole: 20 % of the total fat content 4.3. The trans fatty acid content shall not exceed 3 % of the total fat content. 4.4 The erucic acid content shall not exceed 1% of the total fat content. B 3897 19 4.5 Linoleic acid (in the form of glycerides = linoleates) Minimum Maximum 70 mg/100 kJ 285 mg/100 kJ (300 mg/100 kcal) (1 200 mg/100 kcal) 4.6 The alpha-linolenic acid content shall not be less than 12 mg/100 kJ (50 mg/100 kcal). The linoleic:alpha-linolenic acid ratio shall not be less than 5 nor greater than 15. 4.7 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 (20:4 n-6)) The eicosapentaenoic acid (20:5 n-3) content shall not exceed that of docosahexaenoic (22:6 n-3) acid content. The docosahexaenoic (22:6 n-3) acid content shall not exceed that of n-6 LCP. 5. PHOSPHOLIPIDS The amount of phospholipids in follow-on formulae shall not be greater than 2 g/l. 6. CARBOHYDRATES Minimum Maximum 2,2 g/100 kJ 3,4 g/100 kJ (9 g/100 kcal) (14 g/100 kcal) 6.1 The use of ingredients containing gluten shall be prohibited. 6.2 Lactose Minimum Maximum 1,1 g/100 kJ (4,5 g/100 kcal) — This provision shall not apply to follow-on formulae in which soya protein isolates represent more than 50 % of the total protein content. B 3898 20 6.3 Sucrose, fructose, honey Minimum Maximum — separately or as a whole: 20 % of the total carbohydrate content Honey shall be treated to destroy spores of Clostridium botulinum. 6.4 Glucose Glucose may only be added to follow-on formulae manufactured from protein hydrolysates. If added, the glucose content shall not exceed 0,5 g/100 kJ (2 g/100 kcal). 7. FRUCTO-OLIGOSACCHARIDES AND GALACTO-OLIGOSACCHARIDES Fructo-oligosaccharides and galacto-oligosaccharides may be added to follow-on formulae. In that case their content shall not exceed: 0,8 g/100 ml in a combination of 90 % oligogalactosyl-lactose and 10 % high molecular weight oligofructosyl-saccharose. Other combinations and maximum levels of fructo-oligosaccharides and galacto-oligosaccharides may be used in accordance with paragraph 7(2). 8. MINERAL SUBSTANCES 8.1 Follow-on formulae manufactured from cows’ milk proteins or protein hydrolysates Per 100 kJ Per 100 kcal Minimum Maximum Minimum Maximum Sodium (mg) 5 14 20 60 Potassium (mg) 15 38 60 160 Chloride (mg) 12 38 50 160 Calcium (mg) 12 33 50 140 Phosphorus (mg) 6 22 25 90 Magnesium (mg) 1,2 3,6 5 15 Iron (mg) 0,14 0,5 0,6 2 Zinc (mg) 0,12 0,36 0,5 1,5 Copper ( g) 8,4 25 35 100 Iodine ( g) 2,5 12 10 50 Selenium ( g) 0,25 2,2 1 9 Manganese ( g) 0,25 25 1 100 Fluoride ( g) - 25 - 100 The calcium:phosphorus ratio in follow-on formulae shall not be less than 1,0 nor greater than 2,0. B 3899 21 8.2 Follow-on formulae manufactured from soya protein isolates, alone or in a mixture with cows’ milk Proteins All requirements of point 8.1 shall apply, except for those concerning iron, and phosphorus, which shall be as follows: Per 100 kJ Per 100 kcal Maximum Minimum Maximum Minimum Iron (mg) 0,22 0,65 0,9 2,5 Phosphorus (mg) 7,5 25 30 100 9. VITAMINS Per 100 kJ Per 100 kcal Maximum Minimum Maximum Minimum Vitamin A ( g-RE) (1) 14 43 60 180 Vitamin D ( g) (2) 0,25 0,75 1 3 Thiamin ( g) 14 72 60 300 Riboflavin ( g) 19 95 80 400 Niacin ( g) (3) 72 375 300 1 500 Pantothenic acid ( g) 95 475 400 2 000 Vitamin B6 ( g) 9 42 35 175 Biotin ( g) 0,4 1,8 1,5 7,5 Folic Acid ( g) 2,5 12 10 50 Vitamin B12 ( g) 0,025 0,12 0,1 0,5 Vitamin C (mg) 2,5 7,5 10 30 Vitamin K ( g) 1 6 4 25 Vitamin E (mg -TE) (4) 0,5/g polyunsaturated fatty acids expressed as linoleic acid as corrected for the double bonds (5) but in no case less than 0,1 mg per 100 available kJ 1,2 0,5/g polyunsaturated fatty acids expressed as linoleic acid as corrected for the double bonds (5) but in no case less than 0,5 mg per 100 available kcal 5 (1) RE = all trans retinol equivalent. (2) In the form of cholecalciferol, of which10 g = 400 i.u. of vitamin D. (3) Preformed niacin. (4) -TE = d- -tocopherol equivalent. (5) 0,5 mg -TE/1 g linoleic acid (18:2 n-6); 0,75 mg -TE/1 g -linolenic acid (18:3 n-3); 1,0 mg -TE/1 g arachidonic acid (20:4 n-6); 1,25 mg -TE/1 g eicosapentaenoic acid (20:5 n-3); 1,5 mg -TE/1 g docosahexaenoic acid (22:6 n-3). B 3900 22 10. NUCLEOTIDES The following nucleotides may be added: Maximum (1) (mg/100 kJ) (mg/100 kcal) 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 (1) The total concentration of nucleotides shall not exceed 1,2 mg/100 kJ (5 mg/100 kcal). B 3901 23 THIRD SCHEDULE NUTRITIONAL SUBSTANCES 1. Vitamins Vitamin Vitamin formulation Vitamin A Retinyl acetate Retinyl palmitate Retinol Vitamin D Vitamin D2 (ergocalciferol) Vitamin D3 (cholecalciferol) Vitamin B1 Thiamin hydrochloride Thiamin 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 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) B 3902 24 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 Ferric ammonium citrate Ferrous fumarate Ferric diphosphate (Ferric pyrophosphate) Ferrous bisglycinate Copper (Cu) Cupric citrate Cupric gluconate Cupric sulphate Copper-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 B 3903 25 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 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 B 3904 26 3. Amino acids and other nitrogen compounds L-cystine and its hydrochloride L-histidine and its hydrochloride L-isoleucine and its hydrochloride L-leucine and its hydrochloride L-lysine and its hydrochloride L-cysteine and its hydrochloride L-methionine L-phenylalanine L-threonine L-tryptophan L-tyrosine L-valine L-carnitine and its hydrochloride L-carnitine-L-tartrate Taurine Cytidine 5 Uridine 5 Adenosine 5 Guanosine 5 Inosine 5 4. Other nutritional substances Choline Choline chloride Choline citrate Choline bitartrate Inositol B 3905 27 FOURTH SCHEDULE NUTRITION AND HEALTH CLAIMS FOR INFANT FORMULAE AND CONDITIONS WARRANTING A CORRESPONDING CLAIM 1. NUTRITION CLAIMS Nutrition claim related to Conditions warranting the nutrition claim 1.1 Lactose only Lactose is the only carbohydrate present. 1.2 Lactose free Lactose content is not greater than 2,5 mg/100 kJ (10 mg/100 kcal). 1.3 Added LCP or an equivalent nutrition claim related to the addition of docosahexaenoic acid The docosahexaenoic acid content is not less than 0,2 % of the total fatty acid content. 1.4 Nutrition claims on the addition of the following optional ingredients: 1.4.1 taurine 1.4.2 fructo-oligosaccharides and galacto-oligosaccharides 1.4.3 nucleotides Voluntarily added at a level that would be appropriate for the intended particular use by infants and in accordance with the conditions set out in the First Schedule . 2. HEALTH CLAIMS (INCLUDING REDUCTION OF DISEASE RISK CLAIMS) Nutrition claim related to Conditions warranting the health claim 2.1 Reduction of risk to allergy to milk proteins. This health claim may include terms referring to reduced allergen or reduced antigen properties. (a) Objective and scientifically verified data as proof to the claimed properties must be available; (b) The infant formulae shall satisfy the provisions set out in point 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; (c) The label shall indicate that the product must not be consumed by infants allergic to the intact proteins from which it is manufactured unless generally accepted clinical tests provide proof of the infant formulae’s tolerance in more than 90 % of infants (confidence interval 95 %) hypersensitive to proteins from which the hydrolysate is manufactured; (d) The infant formulae administered orally must not induce sensitisation, in animals, to the intact proteins from which the infant formulae are manufactured. B 3906 } 28 FIFTH SCHEDULE INDISPENSABLE AND CONDITIONALLY INDISPENSABLE AMINO ACIDS IN BREAST MILK For the purpose of this Directive, the indispensable and conditionally indispensable amino acids in breast milk, expressed in mg per 100 kJ and 100 kcal, are the following: Per 100 kJ (1) Per 100 kcal Cystine 9 38 Histidine 10 40 Isoleucine 22 90 Leucine 40 166 Lysine 27 113 Methionine 5 23 Phenylalanine 20 83 Threonine 18 77 Tryptophan 8 32 Tyrosine 18 76 Valine 21 88 (1) 1 kJ = 0,239 kcal. B 3907 29 SIXTH SCHEDULE Specification for the protein content and source and the processing of protein used in the manufacture of infant formulae with a protein content less than 0,56 g/100 kJ (2,25 g/100 kcal) manufactured from hydrolysates of whey proteins derived from cows’ milk protein 1. Protein content Protein content = nitrogen content × 6,25 Minimum Maximum 0,44 g/100 kJ 0,7 g/100 kJ (1,86 g/100 kcal) (3 g/100 kcal) 2. Protein source Demineralised sweet whey protein derived from cows’ milk after enzymatic precipitation of caseins using chymosin, consisting of: (a) 63 % caseino-glycomacropeptide free whey protein isolate with a minimum protein content of 95 % of dry matter and protein denaturation of less than 70 % and a maximum ash content of 3 %; and (b) 37 % sweet whey protein concentrate with a minimum protein content of 87 % of dry matter and protein denaturation of less than 70 % and a maximum ash content of 3,5 %. 3. Protein processing Two-stage hydrolysis process using a trypsin preparation with a heat-treatment step (from 3 to 10 minutes at 80 to 100 °C) between the two hydrolysis steps. B 3908 30 SEVENTH SCHEDULE REFERENCE VALUES FOR NUTRITION LABELLING FOR FOODS INTENDED FOR INFANTS AND YOUNG CHILDREN Nutrient Labelling reference value Vitamin A ( g) 400 Vitamin D ( g) 7 Vitamin E (mg TE) 5 Vitamin K ( g) 12 Vitamin C (mg) 45 Thiamin (mg) 0,5 Riboflavin (mg) 0,7 Niacin (mg) 7 Vitamin B6 (mg) 0,7 Folate ( g) 125 Vitamin B12 ( g) 0,8 Pantothenic acid (mg) 3 Biotin ( g) 10 Calcium (mg) 550 Phosphorus (mg) 550 Potassium (mg) 1 000 Sodium (mg) 400 Chloride (mg) 500 Iron (mg) 8 Zinc (mg) 5 Iodine ( g) 80 Selenium ( g) 20 Copper (mg) 0,5 Magnesium (mg) 80 Manganese (mg) 1,2 B 3909 31 EIGHTH SCHEDULE PESTICIDES WHICH SHALL NOT BE USED IN AGRICULTURAL PRODUCTION INTENDED FOR THE PRODUCTION OF INFANT FORMULAE AND FOLLOW ON FORMULAE Table 1 Chemical name of the substance (residue definition) Disulfoton (sum of disulfoton, disulfoton sulfoxide and disulfoton sulfone expressed as disulfoton) Fensulfothion (sum of fensulfothion, its oxygen analogue and their sulfones, expressed as fensulfothion) Fentin, expressed as triphenyltin cation Haloxyfop (sum of haloxyfop, its salts and esters including conjugates, expressed as haloxyfop) Heptachlor and trans-heptachlor epoxide, expressed as heptachlor Hexachlorobenzene Nitrofen Omethoate Terbufos (sum of terbufos, its sulfoxide and sulfone, expressed as terbufos) Table 2 Chemical name of the substance Aldrin and dieldrin, expressed as dieldrin Endrin B 3910 32 NINTH SCHEDULE SPECIFIC MAXIMUM RESIDUE LEVELS OF PESTICIDES OR METABOLITES OF PESTICIDES IN INFANT FORMULAE AND FOLLOW-ON FORMULAE Chemical name of the substance Maximum residue level (mg/kg) Cadusafos 0,006 Demeton-S-methyl/demeton-S-methyl sulfone/oxydemeton-methyl (individually or combined, expressed as demeton-S-methyl) 0,006 Ethoprophos 0,008 Fipronil (sum of fipronil and fipronil-desulfinyl, expressed as fipronil) 0,004 Propineb/propylenethiourea (sum of propineb and propylenethiourea) 0,006 B 3911 33 TENTH SCHEDULE Names under which products covered by Regulation 4(2) (c) and (d) are sold in all the European Community Languages: — in English: ‘infant formula’ and ‘follow-on formula’, — in Danish: ‘Modermælkserstatning’ and ‘Tilskudsblanding’, — in German: ‘Säuglingsanfangsnahrung’ and ‘Folgenahrung’, — in Greek: ‘ ’ and ‘ ’, — in Spanish: ‘Preparado para lactantes’ and ‘Preparado de continuación’, — in French: ‘Préparation pour nourrissons’ and ‘Préparation de suite’, — in Italian: ‘Alimento per lattanti’ and ‘Alimento di proseguimento’, —in Dutch: ‘Volledige zuigelingenvoeding’ and ‘Opvolgzuigelingenvoeding’, — in Portuguese: ‘Fórmula para lactentes’ and ‘Fórmula de transição’, — in Finnish: ‘Äidinmaidonkorvike’ and ‘Vieroitusvalmiste’, — in Swedish: ‘Modersmjölksersättning’ and ‘Tillskottsnäring’, — in Czech: ‘po áte ní kojenecká výživa’ and ‘pokra ovací kojenecká výživa’, — in Estonian: ‘imiku piimasegu’ and ‘jätkupiimasegu’, — in Latvian: ‘M ksl gais mais jums z dai iem’ un ‘M ksl gais papildu din šanas mais jums z dai iem’, — in Lithuanian: ‘mišinys k dikiams iki papildomo maitinimo vedimo’ and ‘mišinys k dikiams, vedus papildom maitinim ’, — in Hungarian: ‘anyatej-helyettesít tápszer’ and ‘anyatejkiegészít tápszer’, —in Maltese: ‘formula tat-trabi’ and ‘formula tal-prosegwiment’, — in Polish: ‘preparat do pocz tkowego ywienia niemowl t’ and ‘preparat do dalszego ywienia niemowl t’, — in Slovenian: ‘za etna formula za dojen ke’ and ‘nadaljevalna formula za dojen ke’, — in Slovak: ‘po iato ná doj enská výživa’ and ‘následná doj enská výživa’. — in Bulgarian: ‘ ’ and ‘ ’, — in Romanian: ‘preparate pentru sugari’ and ‘preparate pentru copii de vârst mic ’. B 3912 34 Names under which products manufactured entirely from cows’ milk proteins are sold in all the European Community languages: — in English: ‘infant milk’ and ‘follow-on milk’, — in Danish: ‘Modermælkserstatning udelukkende baseret påmælk’ and ‘Tilskudsblanding udelukkende baseret på mælk’, — in German: ‘Säuglingsmilchnahrung’ and ‘Folgemilch’, — in Greek: ‘ ’ and ‘ ’, — in Spanish: ‘Leche para lactantes’ and ‘Leche de continuación’, — in French: ‘Lait pour nourrissons’ and ‘Lait de suite’, — in Italian: ‘Latte per lattanti’ and ‘Latte di proseguimento’, — in Dutch: ‘Volledige zuigelingenvoeding op basis van melk’ or ‘Zuigelingenmelk’ and ‘Opvolgmelk’, — in Portuguese: ‘Leite para lactentes’ and ‘Leite de transição’, — in Finnish: ‘Maitopohjainen äidinmaidonkorvike’ and ‘Maitopohjainen vieroitusvalmiste’, — in Swedish: ‘Modersmjölksersättning uteslutande baserad på mjölk’ and ‘Tillskottsnäring uteslutande baserad på mjölk’, — in Czech: ‘po áte ní mlé ná kojenecká výživa’ and ‘pokra ovací mlé ná kojenecká výživa’, — in Estonian: ‘Piimal põhinev imiku piimasegu’ and ‘Piimal põhinev jätkupiimasegu’, — in Latvian: ‘M ksl gais piena mais jums z dai iem’ un ‘M ksl gais papildu din šanas piena mais jums z dai iem’, — in Lithuanian: ‘pieno mišinys k dikiams iki papildomo maitinimo vedimo’ and ‘pieno mišinys k dikiams vedus papildom maitinim ’, — in Hungarian: ‘tejalapú anyatej-helyettesít tápszer’ and ‘tejalapú anyatej-kiegészít tápszer’, — in Maltese: ‘ alib tat-trabi’ and ‘ alib tal-prosegwiment’, — in Polish: ‘mleko pocz tkowe’ and ‘mleko nast pne’, — in Slovenian: ‘za etno mleko za dojen ke’ and ‘nadaljevalno mleko za dojen ke’, — in Slovak: ‘po iato ná doj enská mlie na výživa’ and ‘následná doj enská mlie na výživa’, — in Bulgarian: ‘ ’ and ‘ ’, — in Romanian: ‘lapte pentru sugari’ and ‘lapte pentru copii de vârst mic ’. B 3913 Ippubblikat mid-Dipartiment ta’ l-Informazzjoni (doi.gov.mt) — Valletta — Published by the Department of Information (doi.gov.mt) — Valletta Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press Prezz#Price Lm1.40 (€3.26)