- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Pwynt Penodol mewn Amser (01/01/2007)
- Gwreiddiol (Fel y’i mabwysiadwyd gan yr UE)
When the UK left the EU, legislation.gov.uk published EU legislation that had been published by the EU up to IP completion day (31 December 2020 11.00 p.m.). On legislation.gov.uk, these items of legislation are kept up-to-date with any amendments made by the UK since then.
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Version Superseded: 01/01/2008
EU Directives are published on this site to aid cross referencing from UK legislation. Since IP completion day (31 December 2020 11.00 p.m.) no amendments have been applied to this version.
The values refer to the product ready for useU.K.
Minimum | Maximum |
---|---|
250 kJ | 315 kJ |
(60 kcal/100 ml) | (75 kcal/100 ml) |
(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.
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.
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).]
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).
Textual Amendments
[F1Minimum | Maximum |
---|---|
1,05 g/100 kJ | 1,5 g/100 kJ |
(4,4 g/100 kcal)] | (6,5 g/100 kcal) |
sesame seed oil,
cotton seed oil,
[F2. . . . .]
Textual Amendments
Minimum | Maximum |
---|---|
— | 15 % of the total fat content |
Minimum | Maximum |
---|---|
— | 15 % of the total fat content |
Minimum | Maximum |
---|---|
70 mg/100 kJ | 285 mg/100 kJ |
(300 mg/100 kcal) | (1 200 mg/100 kcal) |
The linoleic/alpha-linolenic acid ratio shall not be less than 5 nor greater than 15.
Textual Amendments
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.]
Minimum | Maximum |
---|---|
1,7 g/100 kJ | 3,4 g/100 kJ |
(7 g/100 kcal) | (14 g/100 kcal) |
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.
Minimum | Maximum |
---|---|
— | 20 % of the total carbohydrate content |
Minimum | Maximum |
---|---|
— | 2 g/100 ml, and 30 % of the total carbohydrate content |
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 | — |
[F3Selenium b μg | — | 0,7 | — | 3 |
The calcium/phosphorus ratio shall not be less than 1,2 nor greater than 2,0.
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 |
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 | — |
[F1Niacin (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 | — |
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 |
The values refer to the product ready for useU.K.
Minimum | Maximum |
---|---|
250 kJ/100 ml | 335 kJ/100 ml |
(60 kcal/100 ml) | (80 kcal/100 ml) |
(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 [F3or 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.
[F3For 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.]
Minimum | Maximum |
---|---|
0,8 g/100 kJ | 1,5 g/100 kJ |
(3,3 g/100 kcal) | (6,5 g/100 kcal) |
sesame seed oil,
cotton seed oil,
[F2. . . . .]
Minimum | Maximum |
---|---|
— | 15 % of the total fat content |
Minimum | Maximum |
---|---|
— | 15 % of the total fat content |
Minimum | Maximum |
---|---|
70 mg/100 kJ | — |
(300 mg/100 kcal): this limit applies only to follow-on formulae containing vegetable oils |
Minimum | Maximum |
---|---|
1,7 g/100 kJ | 3,4 g/100 kJ |
(7 g/100 kcal) | (14 g/100 kcal) |
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.
Minimum | Maximum |
---|---|
— | separately or as a whole: 20 % of the total carbohydrate content |
Per 100 kJ | Per 100 kcal | |||
---|---|---|---|---|
Minimum | Maximum | Minimum | Maximum | |
Iron (mg) | 0,25 | 0,5 | 1 | 2 |
Iodine (μg) | 1,2 | — | 5 | — |
Minimum | Maximum |
---|---|
0,12 mg/100 kJ | — |
(0,5 mg/100 kcal) |
Minimum | Maximum |
---|---|
0,18 mg/100 kJ | — |
(0,75 mg/100 kcal) |
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.
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 | — |
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 |
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) |
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 |
[F3Selenium | Sodium selenate Sodium selenite] |
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
[F3cytidine 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.]
Choline
Choline chloride
Choline citrate
Choline bitartrate
Inositol
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. |
[F37. 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.] |
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 |
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 |
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:
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] |
Textual Amendments
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)
Chemical name of the substance
Aldrin and dieldrin, expressed as dieldrin
Endrin]
Textual Amendments
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] |
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