- Latest available (Revised)
- Point in Time (25/09/2015)
- Original (As adopted by EU)
Commission Delegated Regulation (EU) 2016/127 of 25 September 2015 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for infant formula and follow-on formula and as regards requirements on information relating to infant and young child feeding (Text with EEA relevance)
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Version Superseded: 02/05/2018
Point in time view as at 25/09/2015.
There are currently no known outstanding effects for the Commission Delegated Regulation (EU) 2016/127, ANNEX II.
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Minimum | Maximum |
---|---|
250 kJ/100 ml | 293 kJ/100 ml |
(60 kcal/100 ml) | (70 kcal/100 ml) |
(Protein content = nitrogen content × 6,25)
Minimum | Maximum |
---|---|
0,43 g/100 kJ | 0,6 g/100 kJ |
(1,8 g/100 kcal) | (2,5 g/100 kcal) |
For an equal energy value, follow-on formula manufactured from cows' milk or goats' milk proteins must contain an available quantity of each indispensable and conditionally indispensable amino acid at least equal to that contained in the reference protein as set out in Section A of Annex III. Nevertheless, for calculation purposes, the concentration of methionine and cysteine and the concentration of phenylalanine and tyrosine may be added together.
Minimum | Maximum |
---|---|
0,54 g/100 kJ | 0,67 g/100 kJ |
(2,25 g/100 kcal) | (2,8 g/100 kcal) |
Only protein isolates from soya shall be used in manufacturing this follow-on formula.
For an equal energy value, follow-on formula manufactured from soya protein isolates, alone or in a mixture with cows' milk or goats' milk proteins, must contain an available quantity of each indispensable and conditionally indispensable amino acid at least equal to that contained in the reference protein as set out in Section A of Annex III. Nevertheless, for calculation purposes, the concentration of methionine and cysteine and the concentration of phenylalanine and tyrosine may be added together.
Minimum | Maximum |
---|---|
0,44 g/100 kJ | 0,67 g/100 kJ |
(1,86 g/100 kcal) | (2,8 g/100 kcal) |
Demineralised sweet whey protein derived from cows' milk after enzymatic precipitation of caseins using chymosin, consisting of:
63 % caseino-glycomacropeptide free whey protein isolate with a minimum protein content of 95 % of dry matter and protein denaturation of less than 70 % and a maximum ash content of 3 %; and
37 % sweet whey protein concentrate with a minimum protein content of 87 % of dry matter and protein denaturation of less than 70 % and a maximum ash content of 3,5 %.
Two-stage hydrolysis process using a trypsin preparation with a heat-treatment step (from 3 to 10 minutes at 80 to 100 °C) between the two hydrolysis steps.
For an equal energy value, follow-on formula manufactured from protein hydrolysates must contain an available quantity of each indispensable and conditionally indispensable amino acid at least equal to that contained in the reference protein as set out in Section B of Annex III. Nevertheless, for calculation purposes, the concentration of methionine and cysteine and the concentration of phenylalanine and tyrosine may be added together.
If added to follow-on formula, the amount of taurine shall not be greater than 2,9 mg/100 kJ (12 mg/100 kcal).
Minimum | Maximum |
---|---|
1,1 g/100 kJ | 1,4 g/100 kJ |
(4,4 g/100 kcal) | (6,0 g/100 kcal) |
sesame seed oil,
cotton seed oil.
Minimum | Maximum |
---|---|
120 mg/100 kJ | 300 mg/100 kJ |
(500 mg/100 kcal) | (1 200 mg/100 kcal) |
Minimum | Maximum |
---|---|
12 mg/100 kJ | 24 mg/100 kJ |
(50 mg/100 kcal) | (100 mg/100 kcal) |
Minimum | Maximum |
---|---|
4,8 mg/100 kJ | 12 mg/100 kJ |
(20 mg/100 kcal) | (50 mg/100 kcal) |
The eicosapentaenoic acid (20:5 n-3) content shall not exceed that of docosahexaenoic (22:6 n-3) acid content.
The amount of phospholipids in follow-on formula shall not be greater than 2 g/l.
Minimum | Maximum |
---|---|
2,2 g/100 kJ | 3,3 g/100 kJ |
(9 g/100 kcal) | (14 g/100 kcal) |
Minimum | Maximum |
---|---|
1,1 g/100 kJ | — |
(4,5 g/100 kcal) | — |
Those minimum levels shall not apply to follow-on formula:
in which soya protein isolates represent more than 50 % of the total protein content, or
bearing the statement ‘lactose free’ in accordance with Article 9(2).
Minimum | Maximum |
---|---|
— | separately or as a whole: 20 % of the total carbohydrate content |
Honey shall be treated to destroy spores of Clostridium botulinum.
Glucose may only be added to follow-on formula manufactured from protein hydrolysates. If added, the glucose content shall not exceed 0,5 g/100 kJ (2 g/100 kcal).
Glucose syrup or dried glucose syrup may be added to follow-on formula manufactured from cows' milk or goats' milk proteins or follow-on formula manufactured from soya protein isolates (alone or in a mixture with cows' milk or goats' milk proteins) only if its dextrose equivalent does not exceed 32. If glucose syrup or dried glucose syrup is added to these products, the glucose content resulting from glucose syrup or dried glucose syrup shall not exceed 0,2 g/100 kJ (0,84 g/100 kcal).
The maximum glucose amounts laid down in point 6.4 shall apply if glucose syrup or dried glucose syrup is added to follow-on formula manufactured from protein hydrolysates.
Fructo-oligosaccharides and galacto-oligosaccharides may be added to follow-on formula. 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, provided that their suitability for infants is demonstrated in accordance with Article 3(3).
a Total phosphorus. | ||||
Per 100 kJ | Per 100 kcal | |||
---|---|---|---|---|
Minimum | Maximum | Minimum | Maximum | |
Sodium (mg) | 6 | 14,3 | 25 | 60 |
Potassium (mg) | 19,1 | 38,2 | 80 | 160 |
Chloride (mg) | 14,3 | 38,2 | 60 | 160 |
Calcium (mg) | 12 | 33,5 | 50 | 140 |
Phosphorus (mg)a | 6 | 21,5 | 25 | 90 |
Magnesium (mg) | 1,2 | 3,6 | 5 | 15 |
Iron (mg) | 0,14 | 0,48 | 0,6 | 2 |
Zinc (mg) | 0,12 | 0,24 | 0,5 | 1 |
Copper (μg) | 14,3 | 24 | 60 | 100 |
Iodine (μg) | 3,6 | 6,9 | 15 | 29 |
Selenium (μg) | 0,72 | 2 | 3 | 8,6 |
Manganese (μg) | 0,24 | 24 | 1 | 100 |
Molybdenum (μg) | — | 3,3 | — | 14 |
Fluoride (μg) | — | 24 | — | 100 |
The calcium:available phosphorus molar ratio shall not be less than 1 nor greater than 2. The amount of available phosphorus shall be calculated as 80 % of total phosphorus for follow-on formula manufactured from cow's milk protein, goats' milk protein or protein hydrolysates.
All requirements of point 8.1 shall apply, except for those concerning iron, phosphorus and zinc, which shall be as follows:
a Total phosphorus. | ||||
Per 100 kJ | Per 100 kcal | |||
---|---|---|---|---|
Minimum | Maximum | Minimum | Maximum | |
Iron (mg) | 0,22 | 0,6 | 0,9 | 2,5 |
Phosphorus (mg)a | 7,2 | 24 | 30 | 100 |
Zinc (mg) | 0,18 | 0,3 | 0,75 | 1,25 |
The calcium:available phosphorus molar ratio shall not be less than 1 nor greater than 2. The amount of available phosphorus shall be calculated as 70 % of total phosphorus for follow-on formula manufactured from soya protein isolates.
a Preformed vitamin A; RE = all trans retinol equivalent. | ||||
b Preformed niacin. | ||||
c Dietary folate equivalent: 1 μg DFE = 1 μg food folate = 0,6 μg folic acid from formula. | ||||
d Based on vitamin E activity of RRR-α-tocopherol. | ||||
Per 100 kJ | Per 100 kcal | |||
---|---|---|---|---|
Minimum | Maximum | Minimum | Maximum | |
Vitamin A (μg-RE)a | 16,7 | 27,2 | 70 | 114 |
Vitamin D (μg) | 0,48 | 0,72 | 2 | 3 |
Thiamine (μg) | 9,6 | 72 | 40 | 300 |
Riboflavin (μg) | 14,3 | 95,6 | 60 | 400 |
Niacin (mg)b | 0,1 | 0,36 | 0,4 | 1,5 |
Pantothenic acid (mg) | 0,1 | 0,48 | 0,4 | 2 |
Vitamin B6 (μg) | 4,8 | 41,8 | 20 | 175 |
Biotin (μg) | 0,24 | 1,8 | 1 | 7,5 |
Folate (μg-DFE)c | 3,6 | 11,4 | 15 | 47,6 |
Vitamin B12 (μg) | 0,02 | 0,12 | 0,1 | 0,5 |
Vitamin C (mg) | 0,96 | 7,2 | 4 | 30 |
Vitamin K (μg) | 0,24 | 6 | 1 | 25 |
Vitamin E (mg α-tocopherol)d | 0,14 | 1,2 | 0,6 | 5 |
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 | 0,60 | 2,50 |
uridine 5′-monophosphate | 0,42 | 1,75 |
adenosine 5′-monophosphate | 0,36 | 1,50 |
guanosine 5′-monophosphate | 0,12 | 0,50 |
inosine 5′-monophosphate | 0,24 | 1,00 |
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