Commission Directive 2006/141/EC (repealed)Show full title

ANNEX I U.K. ESSENTIAL COMPOSITION OF INFANT FORMULAE WHEN RECONSTITUTED AS INSTRUCTED BY THE MANUFACTURER

The values set out in this Annex refer to the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer.

1. ENERGY U.K.

Minimum	Maximum
250 kJ/100 ml	295 kJ/100 ml
(60 kcal/100 ml)	(70 kcal/100 ml)

2. PROTEINS U.K.

(Protein content = nitrogen content × 6,25)

[F1 2.1. Infant formulae manufactured from cows’ milk or goats’ milk proteins] U.K.

a [F1 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 Article 7(1).]
Minimuma	Maximum
0,45 g/100 kJ	0,7 g/100 kJ
(1,8 g/100 kcal)	(3 g/100 kcal)

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 Annex V). 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.

Textual Amendments

F1 Substituted by Commission Directive 2013/46/EU of 28 August 2013 amending Directive 2006/141/EC with regard to protein requirements for infant formulae and follow-on formulae (Text with EEA relevance).

2.2 Infant formulae manufactured from protein hydrolysates U.K.

a 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).
Minimuma	Maximum
0,45 g/100 kJ	0,7 g/100 kJ
(1,8 g/100 kcal)	(3 g/100 kcal)

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 Annex V). 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).

[F1 2.3. Infant formulae manufactured from soya protein isolates, alone or in a mixture with cows’ milk or goats’ milk proteins] U.K.

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 Annex V). 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. U.K.

3. TAURINE U.K.

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 U.K.

Minimum	Maximum
1,7 mg/100 kJ	12 mg/100 kJ
(7 mg/100 kcal)	(50 mg/100 kcal)

5. LIPIDS U.K.

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: U.K.

• sesame seed oil,

• cotton seed oil.

5.2 Lauric acid and myristic acid U.K.

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. U.K.

5.4 The erucic acid content shall not exceed 1 % of the total fat content. U.K.

5.5 Linoleic acid (in the form of glycerides = linoleates) U.K.

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). U.K.

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: U.K.

• 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 U.K.

The amount of phospholipids in infant formulae shall not be greater than 2 g/l.

7. INOSITOL U.K.

Minimum	Maximum
1 mg/100 kJ	10 mg/100 kJ
(4 mg/100 kcal)	(40 mg/100 kcal)

8. CARBOHYDRATES U.K.

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: U.K.

— lactose,
— maltose,
— sucrose,
— glucose,
— malto-dextrins,
— glucose syrup or dried glucose syrup,
— pre-cooked starch	naturally free of gluten.
— gelatinised starch

8.2 Lactose U.K.

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 U.K.

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 U.K.

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 U.K.

Minimum	Maximum
—	2 g/100 ml, and 30 % of the total carbohydrate content

9. FRUCTO-OLIGOSACCHARIDES AND GALACTO-OLIGOSACCHARIDES U.K.

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 Article 5.

10. MINERAL SUBSTANCES U.K.

[F1 10.1. Infant formulae manufactured from cows’ milk or goats’ milk proteins or protein hydrolysates] U.K.

	Per 100 kJ		Per 100 kcal
	Minimum	Maximum	Minimum	Maximum
Sodium (mg)	5	14	20	60
Potassium (mg)	15	38	60	160
Chloride (mg)	12	38	50	160
Calcium (mg)	12	33	50	140
Phosphorus (mg)	6	22	25	90
Magnesium (mg)	1,2	3,6	5	15
Iron (mg)	0,07	0,3	0,3	1,3
Zinc (mg)	0,12	0,36	0,5	1,5
Copper (μg)	8,4	25	35	100
Iodine (μg)	2,5	12	10	50
Selenium (μg)	0,25	2,2	1	9
Manganese (μg)	0,25	25	1	100
Fluoride (μg)	—	25	—	100

The calcium:phosphorus ratio shall not be less than 1 nor greater than 2.

[F1 10.2. Infant formulae manufactured from soya protein isolates, alone or in a mixture with cows’ milk or goats’ milk proteins] U.K.

All requirements of point 10.1 shall apply, except for those concerning iron and phosphorus, which shall be as follows:

	Per 100 kJ		Per 100 kcal
	Minimum	Maximum	Minimum	Maximum
Iron (mg)	0,12	0,5	0,45	2
Phosphorus (mg)	7,5	25	30	100

11. VITAMINS U.K.

a RE = all trans retinol equivalent.
b In the form of cholecalciferol, of which 10 μg = 400 i.u. of vitamin D.
c Preformed niacin.
d α-TE = d-α-tocopherol equivalent.
e 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).
	Per 100 kJ		Per 100 kcal
	Minimum	Maximum	Minimum	Maximum
Vitamin A (μg-RE)a	14	43	60	180
Vitamin D (μg)b	0,25	0,65	1	2,5
Thiamin (μg)	14	72	60	300
Riboflavin (μg)	19	95	80	400
Niacin (μg)c	72	375	300	1 500
Pantothenic acid (μg)	95	475	400	2 000
Vitamin B6 (μg)	9	42	35	175
Biotin (μg)	0,4	1,8	1,5	7,5
Folic Acid (μg)	2,5	12	10	50
Vitamin B12 (μg)	0,025	0,12	0,1	0,5
Vitamin C (mg)	2,5	7,5	10	30
Vitamin K (μg)	1	6	4	25
Vitamin E (mg α-TE)d	0,5/g of polyunsaturated fatty acids expressed as linoleic acid as corrected for the double bondse but in no case less than 0,1 mg per 100 available kJ	1,2	0,5/g of polyunsaturated fatty acids expressed as linoleic acid as corrected for the double bondse but in no case less than 0,5 mg per 100 available kcal	5

12. NUCLEOTIDES U.K.

The following nucleotides may be added:

a The total concentration of nucleotides shall not exceed 1,2 mg/100 kJ (5 mg/100 kcal).
	Maximuma
	(mg/100 kJ)	(mg/100 kcal)
cytidine 5′-monophosphate	0,6	2,5
uridine 5′-monophosphate	0,42	1,75
adenosine 5′-monophosphate	0,36	1,5
guanosine 5′-monophosphate	0,12	0,5
inosine 5′-monophosphate	0,24	1,0

ANNEX II U.K. ESSENTIAL COMPOSITION OF FOLLOW-ON FORMULAE WHEN RECONSTITUTED AS INSTRUCTED BY THE MANUFACTURER

The values set out in this Annex refer to the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer.

1. ENERGY U.K.

Minimum	Maximum
250 kJ/100 ml	295 kJ/100 ml
(60 kcal/100 ml)	(70 kcal/100 ml)

2. PROTEINS U.K.

(Protein content = nitrogen content × 6,25)

[F1 2.1. Follow-on formulae manufactured from cows’ milk or goats’ milk proteins] U.K.

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 Annex V). 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 U.K.

a 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 Article 7(2).]
[F1 Minimum a	Maximum
0,45 g/100 kJ (1,8 g/100 kcal)	0,8 g/100 kJ (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 Annex V). 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.

[F1 2.3. Follow-on formulae manufactured from soya protein isolates, alone or in a mixture with cows’ milk or goats’ milk proteins] U.K.

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 Annex V). 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. U.K.

3. TAURINE U.K.

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 U.K.

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: U.K.

• sesame seed oil,

• cotton seed oil.

4.2 Lauric acid and myristic acid U.K.

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. U.K.

4.4 The erucic acid content shall not exceed 1 % of the total fat content. U.K.

4.5 Linoleic acid (in the form of glycerides = linoleates) U.K.

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). U.K.

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: U.K.

• 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 U.K.

The amount of phospholipids in follow-on formulae shall not be greater than 2 g/l.

6. CARBOHYDRATES U.K.

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. U.K.

6.2 Lactose U.K.

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 U.K.

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 U.K.

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 U.K.

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 Article 6.

8. MINERAL SUBSTANCES U.K.

[F1 8.1. Follow-on formulae manufactured from cows’ milk or goats’ milk proteins or protein hydrolysates] U.K.

	Per 100 kJ		Per 100 kcal
	Minimum	Maximum	Minimum	Maximum
Sodium (mg)	5	14	20	60
Potassium (mg)	15	38	60	160
Chloride (mg)	12	38	50	160
Calcium (mg)	12	33	50	140
Phosphorus (mg)	6	22	25	90
Magnesium (mg)	1,2	3,6	5	15
Iron (mg)	0,14	0,5	0,6	2
Zinc (mg)	0,12	0,36	0,5	1,5
Copper (μg)	8,4	25	35	100
Iodine (μg)	2,5	12	10	50
Selenium (μg)	0,25	2,2	1	9
Manganese (μg)	0,25	25	1	100
Fluoride (μg)	—	25	—	100

The calcium:phosphorus ratio in follow-on formulae shall not be less than 1,0 nor greater than 2,0.

[F1 8.2. Follow-on formulae manufactured from soya protein isolates, alone or in a mixture with cows’ milk or goats’ milk proteins] U.K.

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	25	30	100

9. VITAMINS U.K.

a RE = all trans retinol equivalent.
b In the form of cholecalciferol, of which10 μg = 400 i.u. of vitamin D.
c Preformed niacin.
d α-TE = d-α-tocopherol equivalent.
e 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).
	Per 100 kJ		Per 100 kcal
	Minimum	Maximum	Minimum	Maximum
Vitamin A (μg-RE)a	14	43	60	180
Vitamin D (μg)b	0,25	0,75	1	3
Thiamin (μg)	14	72	60	300
Riboflavin (μg)	19	95	80	400
Niacin (μg)c	72	375	300	1 500
Pantothenic acid (μg)	95	475	400	2 000
Vitamin B6 (μg)	9	42	35	175
Biotin (μg)	0,4	1,8	1,5	7,5
Folic Acid (μg)	2,5	12	10	50
Vitamin B12 (μg)	0,025	0,12	0,1	0,5
Vitamin C (mg)	2,5	7,5	10	30
Vitamin K (μg)	1	6	4	25
Vitamin E (mg α-TE)d	0,5/g poly-unsaturated fatty acids expressed as linoleic acid as corrected for the double bondse but in no case less than 0,1 mg per 100 available kJ	1,2	0,5/g poly-unsaturated fatty acids expressed as linoleic acid as corrected for the double bondse but in no case less than 0,5 mg per 100 available kcal	5

10. NUCLEOTIDES U.K.

The following nucleotides may be added:

a The total concentration of nucleotides shall not exceed 1,2 mg/100 kJ (5 mg/100 kcal).
	Maximuma
	(mg/100 kJ)	(mg/100 kcal)
cytidine 5′-monophosphate	0,6	2,5
uridine 5′-monophosphate	0,42	1,75
adenosine 5′-monophosphate	0,36	1,5
guanosine 5′-monophosphate	0,12	0,5
inosine 5′-monophosphate	0,24	1,0

ANNEX III U.K. NUTRITIONAL SUBSTANCES

1. Vitamins U.K.

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 U.K.

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 U.K.

[F2 L-arginine and its hydrochloride] (1)

Textual Amendments

F2 Inserted by Commission Regulation (EC) No 1243/2008 of 12 December 2008 amending Annexes III and VI to Directive 2006/141/EC as regards compositional requirements for certain infant formulae (Text with EEA relevance).

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′-monophosphate and its sodium salt

Uridine 5′-monophosphate and its sodium salt

Adenosine 5′-monophosphate and its sodium salt

Guanosine 5′-monophosphate and its sodium salt

Inosine 5′-monophosphate and its sodium salt

4. Other nutritional substances U.K.

Choline

Choline chloride

Choline citrate

Choline bitartrate

Inositol

ANNEX IV U.K.

NUTRITION AND HEALTH CLAIMS FOR INFANT FORMULAE AND CONDITIONS WARRANTING A CORRESPONDING CLAIM

1. NUTRITION CLAIMS
Nutrition claim related to	Conditions warranting the nutrition claim
1.1 Lactose only	Lactose is the only carbohydrate present.
1.2 Lactose free	Lactose content is not greater than 2,5 mg/100 kJ (10 mg/100 kcal).
1.3 Added LCP or an equivalent nutrition claim related to the addition of docosahexaenoic acid	The docosahexaenoic acid content is not less than 0,2 % of the total fatty acid content.
1.4 Nutrition claims on the addition of the following optional ingredients:
1.4.1 taurine	Voluntarily added at a level that would be appropriate for the intended particular use by infants and in accordance with the conditions set out in Annex I.
1.4.2 fructo-oligosaccharides and galacto-oligosaccharides
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 milk proteins. This health claim may include terms referring to reduced allergen or reduced antigen properties.	(a) Objective and scientifically verified data as proof to the claimed properties must be available; (b) The infant formulae shall satisfy the provisions set out in point 2.2 of Annex I 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.

ANNEX V U.K. 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:

a 1 kJ = 0,239 kcal.
	Per 100 kJa	Per 100 kcal
Cystine	9	38
Histidine	10	40
Isoleucine	22	90
Leucine	40	166
Lysine	27	113
Methionine	5	23
Phenylalanine	20	83
Threonine	18	77
Tryptophan	8	32
Tyrosine	18	76
Valine	21	88

ANNEX VI U.K. [F1 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 U.K.

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 U.K.

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 U.K.

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.

[F2 4. Protein quality U.K.

The indispensable and conditionally indispensable amino acids in breast milk, expressed in mg per 100 kJ and 100 kcal, are the following:

a 1 kJ = 0,239 kcal.]
	Per 100 kJ a	Per 100 kcal
Arginine	16	69
Cystine	6	24
Histidine	11	45
Isoleucine	17	72
Leucine	37	156
Lysine	29	122
Methionine	7	29
Phenylalanine	15	62
Threonine	19	80
Tryptophan	7	30
Tyrosine	14	59
Valine	19	80

ANNEX VII U.K.

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

ANNEX VIII U.K. 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) U.K.

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 U.K.

Aldrin and dieldrin, expressed as dieldrin

Endrin

ANNEX IX U.K.

SPECIFIC MAXIMUM RESIDUE LEVELS OF PESTICIDES OR METABOLITES OF PESTICIDES IN INFANT FORMULAE AND FOLLOW-ON FORMULAE

Chemical name of the substance	Maximum residue level(mg/kg)
Cadusafos	0,006
Demeton-S-methyl/demeton-S-methyl sulfone/oxydemeton-methyl (individually or combined, expressed as demeton-S-methyl)	0,006
Ethoprophos	0,008
Fipronil (sum of fipronil and fipronil-desulfinyl, expressed as fipronil)	0,004
Propineb/propylenethiourea (sum of propineb and propylenethiourea)	0,006

ANNEX X U.K.

PART A U.K. Repealed Directive, with list of its successive amendments(referred to in Article 19)

Commission Directive 91/321/EEC (OJ L 175, 4.7.1991, p. 35).

• Point XI.C.IX.5 of Annex I to the 1994 Act of Accession, p. 212.

• Commission Directive 96/4/EC (OJ L 49, 28.2.1996, p. 12).

• Commission Directive 1999/50/EC (OJ L 139, 2.6.1999, p. 29).

• Commission Directive 2003/14/EC (OJ L 41, 14.2.2003, p. 37).

• Point 1.J.3 of Annex II to the 2003 Act of Accession, p. 93.

PART B U.K. List of time limits for transposition into national law(referred to in Article 19)

Directive	Time limit for transposition	Permission of trade in products complying with this Directive	Prohibition of trade in products not complying with this Directive
91/321/EEC		1 December 1992	1 June 1994
96/4/EC	31 March 1997	1 April 1997	31 March 1999
1999/50/EC	30 June 2000	30 June 2000	1 July 2002
2003/14/EC	6 March 2004	6 March 2004	6 March 2005

ANNEX XI U.K.

CORRELATION TABLE

Directive 91/321/EEC	This Directive
Article 1(1)	Article 1
Article 1(2)	Article 2
Article 2	Article 3
Article 3(1)	Article 5
Article 3(2)	Article 6
Article 3(3)	Article 7(4)
Article 4	Article 7(1) to (3)
Article 5(1), first subparagraph	Article 8(1)
Article 5(1), second subparagraph	Article 8(2) and (3)
Article 5(2)	—
—	Article 9
Article 6(1), first sentence	Article 4
Article 6(1), second sentence	—
Article 6(2)	Article 10(1)
Article 6(3)(a), introductory phrase	Article 10(2), introductory phrase
Article 6(3)(a)(i)	Article 10(2)(a)
Article 6(3)(a)(ii)	Article 10(2)(b)
Article 6(3)(b), first subparagraph	Article 10(3)
Article 6(3)(b), second subparagraph	—
Article 6(3)(c)	Article 10(4)
Article 6(4)	—
Article 7(1), first subparagraph	Article 11
Article 7(1), second subparagraph	Article 12
Article 7(2)(a)	Article 13(1)(a)
Article 7(2)(b)	—
Article 7(2)(c)	Article 13(1)(b)
Article 7(2)(d)	Article 13(1)(c)
Article 7(2)(e)	Article 13(1)(d)
Article 7(2)(f)	Article 13(1)(e)
Article 7(2a)	Article 13(2)
Article 7(3)	Article 13(3)
Article 7(4)	Article 13(4)
Article 7(5)	Article 13(5)
Article 7(6)	Article 13(6)
—	Article 13(7)
Article 7(7)	Article 13(8)
Article 8	Article 14
Article 9	Article 15
Article 10	—
—	Article 16
—	Article 17
—	Article 18
—	Article 19
—	Article 20
Article 11	Article 21
Annexes I to V	Annexes I to V
Annex VI	—
Annex VII	—
—	Annex VI
Annexes VIII to X	Annexes VII to IX
—	Annex X
—	Annex XI

(1)

[F2 [F1 L-arginine and its hydrochloride shall only be used in the manufacture of infant formulae referred to in the third subparagraph of Article 7(1) and follow-on formulae referred to in the second subparagraph of Article 7(2).] ]

Textual Amendments

F1 Substituted by Commission Directive 2013/46/EU of 28 August 2013 amending Directive 2006/141/EC with regard to protein requirements for infant formulae and follow-on formulae (Text with EEA relevance).

F2 Inserted by Commission Regulation (EC) No 1243/2008 of 12 December 2008 amending Annexes III and VI to Directive 2006/141/EC as regards compositional requirements for certain infant formulae (Text with EEA relevance).