Commission Directive of 14 May 1991 on infant formulae and follow-on formulae (91/321/EEC) (repealed)

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

NB: U.K.

The values refer to the product ready for use U.K.

1. Energy U.K.

Minimum	Maximum
250 kJ	315 kJ
(60 kcal/100 ml)	(75 kcal/100 ml)

[F1 2. Protein U.K.

(Protein content = nitrogen content × 6,38) for cows' milk proteins.

(Protein content = nitrogen content × 6,25) for soya protein isolates and protein partial hydrolysates.

The ‘ chemical index ’ shall mean the lowest of the ratios between the quantity of each essential amino acid of the test protein and the quantity of each corresponding amino acid of the reference protein.

2.1. Formulae manufactured from cows' milk proteins U.K.

Minimum	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 formula must contain an available quantity of each essential and semi-essential 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.

2.2. Formulae manufactured from protein partial hydrolysates U.K.

Minimum	Maximum
0,56 g/100 kJ	0,7 g/100 kJ
(2,25 g/100 kcal)	(3 g/100 kcal)

For an equal energy value, the formula must contain an available quantity of each essential and semi-essential 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.

The protein efficiency ratio (PER) and the net protein utilization (NPU) must be at least equal to those of casein.

The taurine content shall be equal to at least 10 μmoles/100 kJ (42 μmoles/100 kcal) and the L-carnitine content shall be equal to at least 1,8 μmoles/100 kJ (7,5 μmoles/100 kcal).]

2.3. 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
(2,56 g/100 kcal)	(3 g/100 kcal)

Only soya protein isolates must be used in manufacturing these formulae.

The chemical index shall be equal to at least 80 % of that of the reference protein (breast milk, as defined in Annex VI).

For an equal energy value the formula must contain an available quantity of methionine at least equal to that contained in the reference protein (breast milk, as defined in Annex V).

The L-carnitine content shall be at least equal to 1,8 μmoles/100 kJ (7,5 μmoles/100 kcal).

2.4. In all cases, the addition of amino acids is permitted solely for the purpose of improving the nutritional value of the proteins, and only in the proportions necessary for that purpose. U.K.

Textual Amendments

F1 Substituted by Commission Directive 96/4/EC of 16 February 1996 amending Directive 91/321/EEC on infant formulae and follow-on formulae (Text with EEA relevance).

3. Lipids U.K.

[F1 Minimum	Maximum
1,05 g/100 kJ	1,5 g/100 kJ
(4,4 g/100 kcal)]	(6,5 g/100 kcal)

3.1. The use of the following substances is prohibited: U.K.

• sesame seed oil,

• cotton seed oil,

• [F2 . . . . .]

Textual Amendments

F2 Deleted by Commission Directive 96/4/EC of 16 February 1996 amending Directive 91/321/EEC on infant formulae and follow-on formulae (Text with EEA relevance).

3.2. Lauric acid U.K.

Minimum	Maximum
—	15 % of the total fat content

3.3. Myristic acid U.K.

Minimum	Maximum
—	15 % of the total fat content

3.4. 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)

[F3 3.5. 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.

Textual Amendments

F3 Inserted by Commission Directive 96/4/EC of 16 February 1996 amending Directive 91/321/EEC on infant formulae and follow-on formulae (Text with EEA relevance).

3.6. The trans fatty acid content shall not exceed 4 % of the total fat content. U.K.

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

3.8. 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)

• The eicosapentaenoic acid (20:5 n-3) content shall not exceed that of docosahexaenoic (22:6 n-3) acid content.]

4. Carbohydrates U.K.

Minimum	Maximum
1,7 g/100 kJ	3,4 g/100 kJ
(7 g/100 kcal)	(14 g/100 kcal)

4.1. Only the following carbohydrates may be used: U.K.

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

4.2. Lactose U.K.

Minimum	Maximum
0,85 g/100 kJ	—
(3,5 g/100 kcal)	—

This provision does not apply to formulae in which soya proteins represent more than 50 % of the total protein content.

4.3. Sucrose U.K.

Minimum	Maximum
—	20 % of the total carbohydrate content

4.4. Pre-cooked starch and/or gelatinized starch U.K.

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

5. Mineral substances U.K.

5.1. Formulae manufactured from cows' milk proteins U.K.

a Limit applicable to formulae with added iron.
b Limit applicable to formulae with added selenium.]
	Per 100 kJ		Per 100 kcal
	Minimum	Maximum	Minimun	Maximum
Sodium (mg)	5	14	20	60
Potassium (mg)	15	35	60	145
Chloride (mg)	12	29	50	125
Calcium (mg)	12	—	50	—
Phosphorus (mg)	6	22	25	90
Magnesium (mg)	1,2	3,6	5	15
Iron (mg)a	0,12	0,36	0,5	1,5
Zinc (mg)	0,12	0,36	0,5	1,5
Copper (μg)	4,8	19	20	80
Iodine (μg)	1,2	—	5	—
[F3 Selenium b μg	—	0,7	—	3

The calcium/phosphorus ratio shall not be less than 1,2 nor greater than 2,0.

5.2. Formulae manufactured from soya proteins, alone or in a mixture with cows' milk proteins U.K.

All requirements of paragraph 5.1. are applicable except those concerning iron and zinc, which are as follows:

	Per 100 kJ		Per 100 kcal
	Minimum	Maximum	Minimum	Maximum
Iron (mg)	0,25	0,5	1	2
Zinc (mg)	0,18	0,6	0,75	2,4

6. 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 α-TE = d-α- tocopherol equivalent.
	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)	10	—	40	—
Riboflavin (μg)	14	—	60	—
[F1 Niacin (mg-NE)	0,2	—	0,8	—]
Pantothenic acid (μg)	70	—	300	—
Vitamin B6 (μg)	9	—	35	—
Biotin (μg)	0,4	—	1,5	—
Folic Acid (μg)	1	—	4	—
Vitamin B12 (μg)	0,025	—	0,1	—
Vitamin C (μg)	1,9	—	8	—
Vitamin K (μg)	1	—	4	—
Vitamin E (mg α-TE)c	0,5/g of polyunsaturated fatty acids expressed as linoleic acid but in no case less than 0,1 mg per 100 available kJ	—	0,5/g of polyunsaturated fatty acids expressed as linoleic acid but in no case less than 0,5 mg per 100 available kcal	—

[F3 7. The following nucleotides may be added: U.K.

a The total concentration of nucleotides shall not exeed 1,2 mg/100 kJ (5 mg/100 kcal).]
	Maximum a
	(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