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 breastfeeding. 
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 breastfeeding; 
(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 particular their form, aspect 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 reference protein (breast milk, as defined in the Sixth 
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 60 145

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 - 
Vitamin E (mg µ 
-TE)6 
0.5/g of 
polyunsaturated 
fatty acids 
expressed 
as linoleic 
acid but in 
no case less 
than 0.1 mg 
per 100 
available kJ 
0.5/g of 
polyunsaturated 
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 µ-TE = d-µ-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 - 
Vitamin E (mg µ 
-TE)3 
0.5/g of 
polyunsaturated 
fatty acids 
expressed 
as linoleic 
acid but in 
no case less 
than 0.1 mg 
per 100 
available kJ 
0.5/g of 
polyunsaturated 
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 µ-TE = d-µ-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).

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 kcal) 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 
milk proteins. 
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 
allergen or 
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 
tolerance in more than 90% of 
infants (confidence interval 95%) 
hypersensitive to proteins from 
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

