Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC (Text with EEA relevance) (repealed) (c. 141)

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)

2.1 Infant formulae manufactured from cows’ milk proteins U.K.

a 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 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.

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).

2.3 Infant formulae manufactured from soya protein isolates, alone or in a mixture with cows’ 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.

10.1 Infant formulae manufactured from cows’ 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.

10.2 Infant formulae manufactured from soya protein isolates, alone or in a mixture with cows’ 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