INFANT FORMULAE AND FOLLOW-ON FORMULAE REGULATIONS

INFANT FORMULAE AND FOLLOW-ON FORMULAE

SUBSIDIARY LEGISLATION 449.52

INFANT FORMULAE AND FOLLOW-ON

FORMULAE REGULATIONS

31st December, 2007

LEGAL NOTICE 304 of 2007, as amended by Legal Notices 285 of 2013

and 75 of 2014.

The title of these regulations is the Infant Formulae and

Follow-on Formulae Regulations.

Amended by

L.N. 75 of 2014.

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 or goats’ 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 or goats’ 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

regulation 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 ty rosine m ay be add ed toget her 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 paragraph of

regulation 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 ty rosine m ay be add ed toget her 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

INFANT FORMULAE AND FOLLOW-ON FORMULAE

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 or goats’ 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

co ncentrati on of pheny lalanine an d tyrosine m ay 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,

} naturally free of gluten.

-

pre-cooked starch

-

gelatinised starch

8.2

Lactose

Minimum

Maximum

1,1 g/100 kJ

-

(4,5 g/100 kcal)

-

INFANT FORMULAE AND FOLLOW-ON FORMULAE

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 or goats’ 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 or goats’ 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) 3

Vitamin D (µg) 4

0.25

0.65

2.5

Thiamine (µg)

Riboflavin (µg)

Niacin (mg-NE) 5

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 B 12 (µg)

0.025

0.12

0.1

0.5

Vitamin C (mg)

2.5

7.5

Vitamin K (µg)

Vitamin E (mg  -TE) 6

1.2

0.5/g of poly-

0.5/g of poly-

unsaturated fatty

unsaturated fatty

acids expressed

acids expressed as

as linoleic acid as

linoleic acid as

corrected for the

corrected for the

double bonds but

double bonds but

in no case less

in no case less than

than 0.1 mg per

0.5 mg per 100

100 available kJ

available kJ

RE = all trans retinol equivalent.

In the form of cholecalciferol, of which 10 µg = 400 i.u. of vitamin D.

NE = niacin equivalent = mg nicotinic acid + mg tryptophan/60.

-TE = d--tocopherol equivalent.

7 0,5 mg a-TE/1 g linoleic acid (18:2 n-6); 0,75 mg a-TE/1 g a-linolenic acid (18:3 n-3); 1,0 mg a-TE/

1 g arachidonic acid (20:4 n-6); 1,25 mg a-TE/1 g eicosapentaenoic acid (20:5 n-3); 1,5 mg a-TE/1 g

docosahexaenoic acid (22:6 n-3).

12. NUCLEOTIDES

The following nucleotides may be added

Maximum 8

(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

The total concentration of nucleotides shall not exceed 1.2 mg/100 kJ (5 mg/100 kcal).

INFANT FORMULAE AND FOLLOW-ON FORMULAE

(1) These regulations implement the provisions of

Commission Directive 2006/141/EC of 22nd December, 2006 and

Commission Directive 2013/26/EU of 8 February 2013 adapting

certain directives in the field of food safety, veterinary and

phytosanitary policy, by reason of the accession of Croatia; these

regulations also implement the provisions of Commission Directive

2013/46/EU of 28 August 2013 amending Directive 2006/141 with

regard to protein requirements for infant formulae and follow-on

formulae.

(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) prohibit, with effect from 31st December, 2009 trade

in products which do not comply with this regulation.

Amended by

L.N. 75 of 2014.

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 or goats’ 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 (1)

Maximum

0,45 g/100 kJ

0,8 g/100 kJ

(1,8 g/100 kcal)

(3,5 g/100 kcal)

(1) Follow-on 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 second subparagraph of

regulation 7(2).

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 or goats’ milk proteins

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.

INFANT FORMULAE AND FOLLOW-ON FORMULAE

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 regulation 7(2).

8. MINERAL SUBSTANCES

8.1 Follow-on formulae manufactured from cows’ milk or goats’ 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 calciumphosphorus 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 or goats’ milk proteins

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

Minimum

Maximum

Minimum

Maximum

Iron (mg)

0,22

0,65

0,9

2,5

Phosphorus (mg)

7,5

9. VITAMINS

per 100 kJ

per 100 kcal

Minimum

Maximum

Minimum

Maximum

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)

Vitamin E (mg α-TE)

1,2

0,5/g

0,5/g

(4)

polyunsaturated

polyunsaturated

fatty acids

fatty acids

expressed as

expressed as

linoleic acid as

linoleic acid as

corrected for the

corrected for the

double bonds (5)

double bonds (5)

but in no case less

but in no case less

than 0,1 mg per

than 0,5 mg per

100 available kJ

100 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 a-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

INFANT FORMULAE AND FOLLOW-ON FORMULAE

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

(1)

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.

Amended by

L.N. 75 of 2014.

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

INFANT FORMULAE AND FOLLOW-ON FORMULAE

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-arginine and its hydrochloride (1)

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'

(1) L-arginine and its hydrochloride shall only be used in the manufacture of infant formulae referred

to in the third subparagraph of regulation 7(1) and follow-on formulae referred to in the second

subparagraph of regulation 7(2).

4. Other nutritional substances

Choline

Choline chloride

Choline citrate

Choline bitartrate

Inositol

INFANT FORMULAE AND FOLLOW-ON FORMULAE

(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 twelve

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;

INFANT FORMULAE AND FOLLOW-ON FORMULAE

(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 The docosahexaenoic acid content is not less than 0,2%

n u t r i t i o n c l a i m r e l a t e d t o t h e of the total fatty acid content.

addition of docosahexaenoic acid

1.4 Nutrition claims on the

addition of the following optional

ingredients

}

1.4.1 taurine

Vo l u n t a r i l y a d d e d a t a l e v e l t h a t w o u l d b e

1.4.2 fructo-oligosaccharides and

appropriate for the intended particular use by

galacto-oligosaccharides

infants and in accordance with the conditions set

out in the First Schedule.

1.4.3 nucleotides

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 (a) Objective and scientifically verified data as proof

milk proteins. This health claim to the claimed properties must be available;

m a y i n c l u d e t e r m s r e f e r r i n g t o (b) The infant formulae shall satisfy the provisions

reduced allergen or reduced antigen set out in point 2.2 of the First Schedule and the amount

properties.

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 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.

INDISPENSABLE AND CONDITIONALLY INDISPENSABLE AMINO ACIDS

IN BREAST MILK

For the purpose of these regulations, 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

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 sub-regulations (1) and

(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.

Amended by

L.N. 75 of 2014.

Specification for the protein content and source and the processing of protein used in the

manufacture of infant formulae and follow-on 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%.

INFANT FORMULAE AND FOLLOW-ON FORMULAE

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 or goats’ 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

INFANT FORMULAE AND FOLLOW-ON FORMULAE

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.

In the case of follow-on formulae manufactured from

protein hydrolysates defined in point 2.2 of the Second Schedule

with a protein content between the minimum and 0,56 g/100 kJ

(2,25 g/100 kcal), the suitability of the follow-on 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.

(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

INFANT FORMULAE AND FOLLOW-ON FORMULAE

(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 sub-regulation (8), for the

pesticides listed in the Ninth Schedule, the maximum residue levels

specified therein shall apply.

(11) The levels referred to in sub-regulations (9) and (10) shall

apply to the products as proposed ready for consumption or as

reconstituted according to the instructions of the manufacturers.

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

regulation are those referred to in paragraphs 19(13) to (18) of the

Labelling, Presentation and Advertising of Foodstuffs Regulations.

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 sub-regulation (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 the products manufactured

entirely from cows’ milk or goats’ milk proteins, shall

be respectively

"infant milk" and "follow-on milk"..

(c) Without prejudice to paragraph (b), 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 or goats’ milk

proteins are sold shall be respectively

(i)

in English: "infant milk" and "follow-on milk"

INFANT FORMULAE AND FOLLOW-ON FORMULAE

(ii)

in Maltese: "]alib

tat-trabi"

and

"]alib

tal-

prosegwiment".

(3) The labelling shall bear, in addition to those provided for in

regulation 5(1) of the Labelling, Presentation and Advertising 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 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 sub-

regulation (3)(d), 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

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 sub-regulations (5) to (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

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,

0,006

expressed as demeton-S-methyl)

Ethoprophos

0,008

Fipronil (sum of fipronil and fipronil-desulfinyl,

0,004

expressed as fipronil)

Propineb/propylenethiourea (sum of propineb and

0,006

propylenethiourea)

INFANT FORMULAE AND FOLLOW-ON FORMULAE

(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 regulation 9(5) to (9) and regulation

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.

INFANT FORMULAE AND FOLLOW-ON FORMULAE

Substituted by

L.N. 285 of 2013.

Names under which products covered by regulation 4(2)(c) and (d) are sold

in all the European Community

- in Bulgarian: "храни за кърмачета" and "преходни храни",

- in Spanish: "Preparado para lactantes" and "Preparado de continuación",

- in Czech: "počáteční kojenecká výživa" and "pokračovací kojenecká výživa",

- in Danish: "Modermælkserstatning" and "Tilskudsblanding",

- in German: "Säuglingsanfangsnahrung" and "Folgenahrung",

- in Estonian: "imiku piimasegu" and "jätkupiimasegu",

- in Greek: "Παρασκεύασμα για βρέφη" and "Παρασκεύασμα δεύτερης βρεφικής

ηλικίας",

- in English: "infant formula" and "follow-on formula",

- in French: "Préparation pour nourrissons" and "Préparation desuite",

- in Croatian: "početna hrana za dojenčad" and "prijelazna hrana za dojenčad",

- in Italian: "Alimento per lattanti" and "Alimento di proseguimento",

- 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 Dutch: "Volledige zuigelingenvoeding" and "Opvolgzuigelingenvoeding",

- in Polish: "preparat do początkowego żywienia niemowląt" and "preparat do

dalszego żywienia niemowląt",

- in Portuguese: "Fórmula para lactentes" and "Fórmula de transição",

- in Romanian: "preparate pentru sugari" and "preparate pentru copii de vârstă

mică",

- in Slovak: "počiatočná dojčenská výživa" and "následná dojčenská výživa",

- in Slovenian: "začetna formula za dojenčke" and "nadaljevalna formula za

dojenčke",

- in Finnish: "Äidinmaidonkorvike" and "Vieroitusvalmiste",

- in Swedish: "Modersmjölksersättning" and "Tillskottsnäring".

Names under which products manufactured entirely from cows’ milk proteins are

sold in all the European Community languages

- in Bulgarian: "млека за кърмачета" and "преходни млека",

- in Spanish: "Leche para lactantes" and "Leche de continuación",

- in Czech: "počáteční mléčná kojenecká výživa" and "pokra-čovací mléčná

kojenecká výživa",

- in Danish: "Modermælkserstatning ud elukkende baseret på m ælk" and

"Tilskudsblanding udelukkende baseret på mælk",

- in German: "Säuglingsmilchnahrung" and "Folgemilch",

- in Estonian: "Piimal põhinev imiku piimasegu" and "Piimal põhinev

jätkupiimasegu",

- in Greek: "Γάλα για βρέφη" and "Γάλα δεύτερης βρεφικής ηλικίας",

- in English: "infant milk" and "follow-on milk",

- in French: "Lait pour nourrissons" and "Lait de suite",

- in Croatian: "početna mliječna hrana za dojenčad" and "prijelazna mliječna hrana

za dojenčad",

- in Italian: "Latte per lattanti" and "Latte di proseguimento",

- in Latvian: "Mākslīgais piena maisījums zīdaiņiem" and "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",

- i n D u t c h : " Vo l l e d i g e z u i g e l i n g e n v o e d i n g o p b a s i s v a n m e l k " o r

"Zuigelingenmelk" and "Opvolgmelk",

- in Polish: "mleko początkowe" and "mleko następne",

- in Portuguese: "Leite para lactentes" and "Leite de transição",

- in Romanian: "lapte pentru sugari" and "lapte pentru copii de vârstă mică",

- in Slovak: "počiatočná dojčenská mliečna výživa" and "následná dojčenská

mliečna výživa",

- in Slovenian: "začetno mleko za dojenčke" and "nadaljevalno mleko za

dojenčke",

- in Finnish: "Maitopohjainen äidinmaidonkorvike’ and ‘Maitopohjainen

vieroitusvalmiste",

- in Swedish: "Modersmjölksersättning uteslutande baserad på mjölk" and

‘Tillskottsnäring uteslutande baserad på mjölk".

(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.

(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 regulation 7(1) and (2)

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

Regulations until 1st January 2012.