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December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC (Text with EEA relevance) (repealed) (c. 141)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

2.1 Follow-on formulae manufactured from cows' 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.

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 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.

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

Minimum	Maximum
0,56 g/100 kJ	0,8 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.

8.1 Follow-on 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)	0,14	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.

8.2 Follow-on formulae manufactured from soya protein isolates, alone or in a mixture with cows’ 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