Commission Directive of 14 May 1991 on infant formulae and follow-on formulae (91/321/EEC) (repealed)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

ANNEX II U.K. ESSENTIAL COMPOSITION OF FOLLOW-ON 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/100 ml	335 kJ/100 ml
(60 kcal/100 ml)	(80 kcal/100 ml)

2. Proteins U.K.

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

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

Minimum	Maximum
0,5 g/100 kJ	1 g/100 kJ
(2,25 g/100 kcal)	(4,5 g/100 kcal)

The chemical index of the proteins present shall be at least equal to 80 % of that of the reference protein (casein [F3 or breast milk]as defined in Annex VI).

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.

For follow-on formulae manufactured from soya proteins, alone or in a mixture with cows' milk proteins, only protein isolates from soya may be used.

Amino acids may be added to follow-on formulae for the purpose of improving the nutritional value of the proteins, in the proportions necessary for that purpose.

[F3 For an equal energy value, these formulae must contain an available quantity of methionine at least equal to that contained in breast milk as defined in Annex V.]

3. Lipids U.K.

Minimum	Maximum
0,8 g/100 kJ	1,5 g/100 kJ
(3,3 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 . . . . .]

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	—
(300 mg/100 kcal): this limit applies only to follow-on formulae containing vegetable oils

[F3 3.5. The trans fatty acid content shall not exceed 4 % of the total fat content. U.K.

3.6. The eruic acid content shal not exceed 1 % of the total fat content.] U.K.

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. The use of ingredients containing gluten is prohibited. U.K.

4.2. Lactose U.K.

Minimum	Maximum
0,45 g/100 kJ	—
(1,8 g/100 kcal)

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

4.3. Sucrose, fructose, honey U.K.

Minimum	Maximum
—	separately or as a whole: 20 % of the total carbohydrate content

5. Mineral substances U.K.

5.1.

	Per 100 kJ		Per 100 kcal
	Minimum	Maximum	Minimum	Maximum
Iron (mg)	0,25	0,5	1	2
Iodine (μg)	1,2	—	5	—

5.2. Zinc U.K.

5.2.1. Follow-on formulae manufactured entirely from cows' milk U.K.

Minimum	Maximum
0,12 mg/100 kJ	—
(0,5 mg/100 kcal)

5.2.2. Follow-on formulae containing soya protein isolates, or mixed with cows' milk U.K.

Minimum	Maximum
0,18 mg/100 kJ	—
(0,75 mg/100 kcal)

5.3. Other mineral substances U.K.

The concentrations are at least equal to those normally found in cows' milk, reduced, where appropriate, in the same ratio as the protein concentration of the follow-on formulae to that of cows' milk. The typical composition of cows' milk is given, for guidance, in Annex VIII.

5.4. The calcium/phosphorus ratio shall not exceed 2,0. U.K.

6. Vitamins U.K.

a RE = all trans retinol equivalent.
b In the form of cholecalciferol, of which10 μg = 400 u.i. of vitamin D.
c α-TE = d-α-tocopherol equivalent.
	Per 100 kJ		Per 100 kcal
	Minimum	Maximum	Minimum	Maximum
Vitamin A (μg-ER)a	14	43	60	180
Vitamin D (μg)b	0,25	0,75	1	3
Vitamin C (μg)	1,9	—	8	—
Vitamin E (mg α-TE)c	0,5/g polyunsaturated fatty acids expressed as linoleic acid but in no case less than 0,1 mg per 100 available kJ	—	0,5/g 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 exceed 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

ANNEX III U.K. NUTRITIONAL SUBSTANCES

1. Vitamins U.K.

Vitamin	Vitamin formulation
Vitamin A	Retinyl acetate Retinyl palmitate Beta-carotene Retinol
Vitamin D	Vitamin D2 (ergocalciferol) Vitamin D3 (cholecalciferol)
Vitamin B1	Thalmin hydrochloride Thalmin 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)
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
[F3 Selenium	Sodium selenate Sodium selenite]

3. Amino acids and other nitrogen compounds U.K.

• L-arginine and its hydrochloride

• L-cystine and its hydrochloride

• L-histidine and its hydrochloride

• L-isoleucine and its hydrochloride

• L-leucine and its hydrochloride

• L-cysteine 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

• Taurine

• [F3 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. Others U.K.

• Choline

• Choline chloride

• Choline citrate

• Choline bitartrate

• Inositol

ANNEX IV U.K. COMPOSITIONAL CRITERIA FOR INFANT FORMULAE, WARRANTING A CORRESPONDING CLAIM

a When determined by a method the detection limits of which will be established at a later stage.
Claim related to	Conditions warranting the claim
1. Adapted protein	The protein content is lower than 0,6 g/100 kJ (2,5 g/100 kcal) and the whey protein/casein ratio is not less than 1,0.
2. Low sodium	The sodium content is lower than 9 mg/100 kJ (39 mg/100 kcal).
3. Sucrose free	No sucrose is present.
4. Lactose only	Lactose is the only carbohydrate present.
5. Lactose free	No lactose is presenta.
6. Iron enriched	Iron is added.
[F3 7. Reduction of risk to allergy to milk proteins. This claim may include terms referring to reduced allergen of reduced antigen properties.	(a) The formulae shall satisfy the provisions laid down in Section 2.2 of Annex I and the amount of immunoreactive protein measured with methods gererally acceptable as appropriate shall be less than 1 % of nitrogen containing substances in the formulae; (b) The label shall indicate that the product must not be consumed by infants allergic to the intact proteins from which it is made unless generally accepted clinical tests provide proof of the formulae's tolerance in more than 90 % of infants (confidence interval 95 %) hypersensitive to proteins from which the hydrolysate is made; (c) The formulae administered orally should not induce sensitization, in animals, to the intact proteins from which the formulae are derived; (d) Objective and scientifically verified data as proof to the claimed properties must be available.]

ANNEX V U.K. ESSENTIAL AND SEMI-ESSENTIAL AMINO ACIDS IN BREAST MILK

For the purpose of this report, the essential and semi-essential 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
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 VI U.K. Amino acid composition of casein and breast milk protein

The amino acid composition of casein and breast milk protein:

a Amino acid content of foods and biological data on protein. FAO Nutritional Studies, No 24, Rome 1970, items 375 and 383.
(g/100 g of protein)
	Caseina	Breast milka
Arginine	3,7	3,8
Cystine	0,3	1,3
Histidine	2,9	2,5
Isoleucine	5,4	4,0
Leucine	9,5	8,5
Lysine	8,1	6,7
Methionine	2,8	1,6
Phenylalanine	5,2	3,4
Threonine	4,7	4,4
Tryptophan	1,6	1,7
Tyrosine	5,8	3,2
Valine	6,7	4,5

ANNEX VII U.K. The mineral elements in cows' milk

As a reference, the contents of mineral elements in cows' milk expressed per 100 g of solids-non-fat and per g of proteins are the following:

a SNF : ‘solids no fats’.
b NS : non-specified, varies widely according to season and stock farming conditions.
	Per 100 g SNFa	Per g of proteins
Sodium (mg)	550	15
Potassium (mg)	1 680	43
Chloride (mg)	1 050	28
Calcium (mg)	1 350	35
Phosphorus (mg)	1 070	28
Magnesium (mg)	135	3,5
Copper (μg)	225	6
Iodine	NSb	NS

[F3 ANNEX VIII 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) 10
Vitamin C	(mg) 25
Thiamin	(mg) 0,5
Riboflavin	(mg) 0,8
Niacin equivalents	(mg) 9
Vitamin B6	(mg) 0,7
Folate	(μg) 100
Vitamin B12	(μg) 0,7
Calcium	(mg) 400
Iron	(mg) 6
Zinc	(mg) 4
Iodine	(μg) 70
Selenium	(μg) 10
Copper	(mg) 0,4]

[F4 ANNEX IX U.K. Pesticides which shall not be used in agricultural production intended for the production of infant formulae and follow-on formulae

Textual Amendments

F4 Substituted by Commission Directive 2003/14/EC of 10 February 2003 amending Directive 91/321/EEC on infant formulae and follow-on formulae (Text with EEA relevance).

Table 1 U.K.

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 U.K.

Chemical name of the substance

• Aldrin and dieldrin, expressed as dieldrin

• Endrin]

[F5 ANNEX X U.K. Specific maximum residue levels of pesticides or metabolites of pesticides in infant formulae and follow-on formulae

Textual Amendments

F5 Inserted by Commission Directive 2003/14/EC of 10 February 2003 amending Directive 91/321/EEC on infant formulae and follow-on formulae (Text with EEA relevance).

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]