MT
Infant Formulae and Follow-on Formulae, 2007
Table of Provisions (24)
Statutory Text (24 Articles)
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>-
The title of these regulations is the Infant Formulae and Follow-
on Formulae Regulations, 2007.
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)
( ) 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)
( ) 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).
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)
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.
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.
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)
Potassium (mg)
Chloride (mg)
Calcium (mg)
Phosphorus (mg)
Magnesium (mg)
1,2
3,6
Iron (mg)
0,07
0,3
0,3
1,3
Zinc (mg)
0,12
0,36
0,5
1,5
Copper (μg)
8,4
Iodine (μg)
2,5
Selenium (μg)
0,25
2,2
Manganese (μg)
0,25
Fluoride (μg)
-
-
The calcium:phosphorus ratio shall not be less than 1 nor greater than 2.
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
Phosphorus (mg)
7,5
11. VITAMINS
Per 100 kJ
Per 100 kcal
Minimum
Maximum
Minimum
Maximum
Vitamin A (μg-RE) ( 1 )
Vitamin D (μg) ( 2 )
0,25
0,65
2,5
Thiamin (μg)
Riboflavin (μg)
Niacin (μg) ( )
1 500
Pantothenic acid (μg)
2 000
Vitamin B6 (μg)
Biotin (μg)
0,4
1,8
1,5
7,5
Folic Acid (μg)
2,5
Vitamin B12 (μg)
0,025
0,12
0,1
0,5
Vitamin C (mg)
2,5
7,5
Vitamin K (μg)
0,5/g of
0,5/g of
Vitamin E (mg α-TE) ( )
polyunsaturated
polyunsaturated
fatty acids
fatty acids
expressed as linoleic
expressed as linoleic
1,2
acid as corrected for
acid as corrected for
the double bonds ( 5 )
the double bonds ( 5 )
but in no case less
but in no case less
than 0,1 mg per 100
than 0,5 mg per 100
available kJ
available kcal
( 1 ) RE = all trans retinol equivalent.
( 2 ) In the form of cholecalciferol, of which 10 μg = 400 i.u. of vitamin D.
( 3 ) Preformed niacin.
( 4 ) α-TE = d-α-tocopherol equivalent.
( 5 ) 0,5 mg α-TE/1 g linoleic acid (18:2 n-6); 0,75 mg α-TE/1 g α-linolenic acid (18:3 n-3); 1,0 mg α-TE/1 g arachidonic acid (20:4 n-6); 1,25
mg α-TE/1 g eicosapentaenoic acid (20:5 n-3); 1,5 mg α-TE/1 g docosahexaenoic acid (22:6 n-3).
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
( ) The total concentration of nucleotides shall not exceed 1,2 mg/100 kJ (5 mg/100 kcal).
(1) These regulations implement the provisions of
Commission Directive 2006#141#EC of 22 nd December, 2006, and they
shall enter into force on 31 st December, 2007.
(2) The provisions shall apply in such a way as to>
(a) permit trade in products complying with this regulation
by the 1 st January, 2008 at the latest,
(b) without prejudice to paragraph 13, prohibit, with effect
from 31 st December, 2009 trade in products which do not comply
with this regulation.
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.
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.
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.
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)
Potassium (mg)
Chloride (mg)
Calcium (mg)
Phosphorus (mg)
Magnesium (mg)
1,2
3,6
Iron (mg)
0,14
0,5
0,6
Zinc (mg)
0,12
0,36
0,5
1,5
Copper (μg)
8,4
Iodine (μg)
2,5
Selenium (μg)
0,25
2,2
Manganese (μg)
0,25
Fluoride (μg)
-
-
The calcium:phosphorus ratio in follow-on formulae shall not be less than 1,0 nor greater than 2,0.
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
9. VITAMINS
Per 100 kJ
Per 100 kcal
Maximum
Minimum
Maximum
Minimum
Vitamin A (μg-RE) ( 1 )
Vitamin D (μg) ( 2 )
0,25
0,75
Thiamin (μg)
Riboflavin (μg)
Niacin (μg) ( 3 )
1 500
Pantothenic acid (μg)
2 000
Vitamin B6 (μg)
Biotin (μg)
0,4
1,8
1,5
7,5
Folic Acid (μg)
2,5
Vitamin B12 (μg)
0,025
0,12
0,1
0,5
Vitamin C (mg)
2,5
7,5
Vitamin K (μg)
1,2
0,5/g
0,5/g
polyunsaturated
polyunsaturated
fatty
fatty
acids expressed as
acids expressed as
linoleic acid as
linoleic acid as
Vitamin E (mg α-TE) ( 4 )
corrected for the
corrected for the
double bonds ( 5 )
double bonds ( 5 )
but
but
in no case less than
in no case less than
0,1 mg per 100
0,5 mg per 100
available kJ
available kcal
( 1 ) RE = all trans retinol equivalent.
( 2 ) In the form of cholecalciferol, of which10 μg = 400 i.u. of vitamin D.
( 3 ) Preformed niacin.
( 4 ) α-TE = d-α-tocopherol equivalent.
( 5 ) 0,5 mg α-TE/1 g linoleic acid (18:2 n-6); 0,75 mg α-TE/1 g α-linolenic acid (18:3 n-3); 1,0 mg α-TE/1 g arachidonic acid (20:4 n-6); 1,25
mg α-TE/1 g eicosapentaenoic acid (20:5 n-3); 1,5 mg α-TE/1 g docosahexaenoic acid (22:6 n-3).
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
( ) The total concentration of nucleotides shall not exceed 1,2 mg/100 kJ (5 mg/100 kcal).
These regulations concern compositional and labelling
requirements for infant formulae and follow-on formulae intended for
use by infants in good health.
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)
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
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
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
(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
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.
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
The docosahexaenoic acid content is not less than
addition of docosahexaenoic acid
0,2 % of the total fatty acid content.
1.4 Nutrition claims on the addition of the following optional
ingredients
1.4.1 taurine
Voluntarily added at a level that would be appropriate
1.4.2 fructo-oligosaccharides and galacto-oligosaccharides
for the intended particular use by infants and in
1.4.3 nucleotides
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
(a) Objective and scientifically verified data as proof to the
proteins. This health claim may include
claimed properties must be available;
terms referring to reduced allergen or
reduced antigen properties.
(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.
(1) Infant formulae and follow-on formulae may be marketed Sale of infant
formulae and
within the Community only if they comply with these regulations.
follow-on formulae.
(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.
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
Histidine
Isoleucine
Leucine
Lysine
Methionine
Phenylalanine
Threonine
Tryptophan
Tyrosine
Valine
( 1 ) 1 kJ = 0,239 kcal.
(1) Infant formulae shall be manufactured from protein Manufacture of
infant formulae and
sources defined in point 2 of the First Schedule and other food follow-on formulae.
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.
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.
(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.
(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.
Monitoring of infant
REFERENCE VALUES FOR NUTRITION LABELLING FOR FOODS INTENDED FOR INFANTS
AND YOUNG CHILDREN
Nutrient
Labelling reference value
Vitamin A
(μg) 400
Vitamin D
(μg) 7
Vitamin E
(mg TE) 5
Vitamin K
(μg) 12
Vitamin C
(mg) 45
Thiamin
(mg) 0,5
Riboflavin
(mg) 0,7
Niacin
(mg) 7
Vitamin B6
(mg) 0,7
Folate
(μg) 125
Vitamin B12
(μg) 0,8
Pantothenic acid
(mg) 3
Biotin
(μg) 10
Calcium
(mg) 550
Phosphorus
(mg) 550
Potassium
(mg) 1 000
Sodium
(mg) 400
Chloride
(mg) 500
Iron
(mg) 8
Zinc
(mg) 5
Iodine
(μg) 80
Selenium
(μg) 20
Copper
(mg) 0,5
Magnesium
(mg) 80
Manganese
(mg) 1,2
(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.
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
(1) (a) Except as provided for in paragraph 9(2), the name
under which infant formulae and follow-on formulae are sold shall be,
follow-on formulae.
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>
(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
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.
SPECIFIC MAXIMUM RESIDUE LEVELS OF PESTICIDES OR METABOLITES OF PESTICIDES
IN INFANT FORMULAE AND FOLLOW-ON FORMULAE
Maximum residue level
Chemical name of the substance
(mg/kg)
Cadusafos
0,006
Demeton-S-methyl/demeton-S-methyl
0,006
sulfone/oxydemeton-methyl (individually or combined, expressed as demeton-S-methyl)
Ethoprophos
0,008
Fipronil (sum of fipronil and fipronil-desulfinyl, expressed as fipronil)
0,004
Propineb/propylenethiourea (sum of propineb and propylenethiourea)
0,006
(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
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.
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: ‘Παρασκεύασμα για βρέφη’ and ‘Παρασκεύασμα δεύτερης βρεφικής ηλικίας’,
— 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: ‘počáteční kojenecká výživa’ and ‘pokračovací kojenecká výživa’,
— in Estonian: ‘imiku piimasegu’ and ‘jätkupiimasegu’,
— in Latvian: ‘Mākslīgais maisījums zīdaiņiem’ un ‘Mākslīgais papildu ēdināšanas maisījums zīdaiņiem’,
— in Lithuanian: ‘mišinys kūdikiams iki papildomo maitinimo įvedimo’ and ‘mišinys kūdikiams, įvedus
papildomą maitinimą’,
— in Hungarian: ‘anyatej-helyettesítő tápszer’ and ‘anyatejkiegészítő tápszer’,
— in Maltese: ‘formula tat-trabi’ and ‘formula tal-prosegwiment’,
— in Polish: ‘preparat do początkowego żywienia niemowląt’ and ‘preparat do dalszego żywienia niemowląt’,
— in Slovenian: ‘začetna formula za dojenčke’ and ‘nadaljevalna formula za dojenčke’,
— in Slovak: ‘počiatočná dojčenská výživa’ and ‘následná dojčenská výživa’.
— in Bulgarian: ‘храни за кърмачета’ and ‘преходни храни’,
— in Romanian: ‘preparate pentru sugari’ and ‘preparate pentru copii de vârstă mică’.
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: ‘Γάλα για βρέφη’ and ‘Γάλα δεύτερης βρεφικής ηλικίας’,
— 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: ‘počáteční mléčná kojenecká výživa’ and ‘pokračovací mléčná kojenecká výživa’,
— in Estonian: ‘Piimal põhinev imiku piimasegu’ and ‘Piimal põhinev jätkupiimasegu’,
— in Latvian: ‘Mākslīgais piena maisījums zīdaiņiem’ un ‘Mākslīgais papildu ēdināšanas piena maisījums
zīdaiņiem’,
— in Lithuanian: ‘pieno mišinys kūdikiams iki papildomo maitinimo įvedimo’ and ‘pieno mišinys kūdikiams
įvedus papildomą maitinimą’,
— in Hungarian: ‘tejalapú anyatej-helyettesítő tápszer’ and ‘tejalapú anyatej-kiegészítő tápszer’,
— in Maltese: ‘ħalib tat-trabi’ and ‘ħalib tal-prosegwiment’,
— in Polish: ‘mleko początkowe’ and ‘mleko następne’,
— in Slovenian: ‘začetno mleko za dojenčke’ and ‘nadaljevalno mleko za dojenčke’,
— in Slovak: ‘počiatočná dojčenská mliečna výživa’ and ‘následná dojčenská mliečna výživa’,
— in Bulgarian: ‘млека за кърмачета’ and ‘преходни млека’,
— in Romanian: ‘lapte pentru sugari’ and ‘lapte pentru copii de vârstă mică’.
Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press
Lm1.40 (€3.26)
(1) Objective and consistent information shall be Providing consistent
information on
provided on infant and young child feeding for use by families and infant formulae and
those involved in the field of infant and young child nutrition follow-on formulae.
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.
(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.
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 1 st January 2012.
The Infant Formulae and Follow-on Formulae Regulations,
Repeals L.N. 208 of
2002. 2002 are hereby repealed and any reference to those regulations shall
be construed as a reference to these regulations.