EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10354/2015 ANNEX 
(POOL/E4/2015/10354/10354-EN 
ANNEX.doc) […](2015) XXX  draft 
ANNEXES 1 to 7 
  
ANNEXES 
to the 
COMMISSION DELEGATED REGULATION (EU) …/... 
supplementing Regulation (EU) No 609/2013 of the European Parliament and of the 
Council as regards the specific compositiona l and information requirements for infant 
formula and follow-on formul a and as regards requirement s on information relating to 
infant and young child feeding 
  
EN 2   EN ANNEX I  
COMPOSITIONAL REQUIREMENTS REFERRED TO IN ARTICLE 2(1)   
1. ENERGY 
Minimum Maximum 
250 kJ/100 ml 293 kJ/100 ml 
(60 kcal/100 ml) (70 kcal/100 ml) 
2. PROTEINS  
(Protein content = nitrogen content × 6,25) 
2.1. Infant formula manufactured from co ws’ milk or goats’ milk proteins  
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, infant formul a manufactured from cows’ milk or goats’ 
milk proteins must contain an availabl e 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 may be added together if the 
methionine:cysteine ratio is not great er than 2, and the concentration of 
phenylalanine and tyrosine may be added toge ther if the tyrosine:phenylalanine ratio 
is not greater than 2. The ratio of methio nine:cysteine and of tyrosine:phenylalanine 
may be greater than 2, provided that th e suitability of the product concerned for 
infants is demonstrated in accordance with Article 3(3).  
The L-carnitine content shall be at least e qual to 0,3 mg/100 kJ (1,2 mg/100 kcal).  
2.2. Infant formula manufactured from soya pr otein isolates, alone or in a mixture 
with cows’ milk or goats’ milk proteins 
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 s oya shall be used in manufact uring this infant formula. 
For an equal energy value, infant 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 re ference protein as set out in Section A of 
Annex III. Nevertheless, for calculation pur poses, the concentration of methionine 
and cysteine may be added together if th e methionine:cysteine ratio is not greater 
than 2, and the concentration of phenylalanine  and tyrosine may be added together if 
the tyrosine:phenylalanine ratio is not greater than 2. The ratio of methionine:cysteine and of tyrosine:phenyl alanine may be greate r than 2, provided  
EN 3   EN that the suitability of the product concerned for infants is  demonstrated in accordance 
with Article 3(3). 
The L-carnitine content shall be at least equal to 0,3 mg/100 kJ (1,2 mg/100 kcal). 
2.3. Infant formula manufactured from protein hydrolysates  
Minimum Maximum 
0,44 g/100 kJ 0,67 g/100 kJ 
(1,86 g/100 kcal) (2,8 g/100 kcal) 
2.3.1. Protein source  
Demineralised sweet whey protein derived from cows’ milk after enzymatic 
precipitation of caseins usi ng chymosin, consisting of: 
(a) 63 % caseino-glycomacropeptide free wh ey protein isolate with a minimum 
protein content of 95 % of  dry matter and protein de naturation of less than 
70 % and a maximum ash content of 3 %; and 
(b) 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 %. 
2.3.2. Protein processing  
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. 
2.3.3. Indispensable and conditionally indi spensable amino acids and L-carnitine 
For an equal energy value, infant formul a manufactured from protein hydrolysates 
must contain an available quantity of each indispensable and conditionally indispensable amino acid at least equal to th at contained in the reference protein as 
set out in Section B of Annex III. Nevertheless, for calculation purposes, the concentration of methionine and cyst eine may be added together if the 
methionine:cysteine ratio is not great er than 2, and the concentration of 
phenylalanine and tyrosine may be added toge ther if the tyrosine:phenylalanine ratio 
is not greater than 2. The ratio of methio nine:cysteine and of tyrosine:phenylalanine 
may be greater than 2, provided that th e suitability of the product concerned for 
infants is demonstrated in accordance with Article 3(3).  
The L-carnitine content shall be at least equal to 0,3 mg/100 kJ (1,2 mg/100 kcal).  
2.4. In all cases, amino acids may be added to  infant formula solely for the purpose of 
improving the nutritional value of the protei ns, and only in the proportions necessary 
for that purpose.  
3. TAURINE  
If added to infant formula, the amount of taurine shall not  be greater than 
2,9 mg/100 kJ (12 mg/100 kcal).   
EN 4   EN 4. CHOLINE  
Minimum Maximum 
6,0 mg/100 kJ 12 mg/100 kJ 
(25 mg/100 kcal) (50 mg/100 kcal)
5. LIPIDS  
Minimum Maximum 
1,1 g/100 kJ 1,4 g/100 kJ 
(4,4 g/100 kcal) (6,0 g/100 kcal) 
5.1. The use of the following substances shall be prohibited:  
– sesame seed oil, 
– cotton seed oil. 
5.2. The trans fatty acid content shall not exceed 3 % of the total fat content.  
5.3. The erucic acid content shall not exceed 1 % of the total fat content.   
5.4. Linoleic acid 
Minimum Maximum 
120 mg/100 kJ 300 mg/100 kJ 
(500 mg/100 kcal) (1200 mg/100 kcal) 
5.5. Alpha-linolenic acid 
Minimum Maximum 
12 mg/100 kJ 24 mg/100 kJ 
(50 mg/100 kcal) (100 mg/100 kcal) 
5.6. Docosahexaenoic acid 
Minimum Maximum 
4,8 mg/100 kJ 12 mg/100 kJ 
(20 mg/100 kcal) (50 mg/100 kcal) 
5.7. Other long-chain (20 and 22 carbon atom s) polyunsaturated fatty acids may be 
added. In that case the cont ent of long-chain polyunsaturated fatty acids shall not 
exceed 2 % of the total fat content for n-6 long-chain polyunsaturated fatty acids (1 % of the total fat content fo r 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. 
6. PHOSPHOLIPIDS  
The amount of phospholipids in infant form ula shall not be greater than 2 g/l.  
EN 5   EN 7. INOSITOL  
Minimum Maximum 
0,96 mg/100 kJ 9,6 mg/100 kJ  
(4 mg/100 kcal) (40 mg/100 kcal) 
8. CARBOHYDRATES  
Minimum Maximum 
2,2 g/100 kJ 3,3 g/100 kJ 
(9 g/100 kcal) (14 g/100 kcal) 
8.1. Only the following carbohydrates may be used:   
– lactose, 
– maltose, 
– sucrose, 
– glucose, 
– glucose syrup or dried glucose syrup, 
– malto-dextrins, 
– pre-cooked starch (naturally free of gluten), 
– gelatinised starch (natur ally free of gluten). 
8.2. Lactose 
Minimum Maximum 
1,1 g/100 kJ - 
(4.5 g/100 kcal) - 
Those minimum levels shall not apply to infant formula: 
– in which soya protein isolates represen t more than 50 % of the total protein 
content, or 
– bearing the statement "lactose free" in accordance with Article 9(2).  
8.3. Sucrose 
Sucrose may only be added to infant  formula manufactured from protein 
hydrolysates. If added, the sucrose cont ent shall not exceed 20 % of the total 
carbohydrate content. 
8.4. Glucose 
Glucose may only be added to infant  formula manufactured from protein 
hydrolysates. If added, the glucose conten t shall not exceed 0,5 g/100 kJ (2 g/100 
kcal).   
EN 6   EN 8.5. Glucose syrup or dried glucose syrup  
Glucose syrup or dried glucose syrup may be added to infant formula manufactured 
from cows’ milk or goats’ milk proteins or  infant 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 cont ent 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 poi nt 8.4 shall apply if glucose syrup or 
dried glucose syrup is added to infa nt formula manufact ured from protein 
hydrolysates.  
8.6. Pre-cooked starch and/or gelatinised starch 
Minimum Maximum 
- 2 g/100 ml, and 30 % of 
the total carbohydrate 
content 
9. FRUCTO-OLIGOSACCHARIDES AND GALACTO-OLIGOSACCHARIDES  
Fructo-oligosaccharides and galacto-oligosaccharides may be added to infant 
formula. In that case their content shall not exceed: 0,8 g/100 ml in a combination of 
90 % oligogalactosyl-lactose and 10 % hi gh 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).  
10. MINERAL SUBSTANCES  
10.1. Infant formula manufactured from cows ’ milk or goats’ milk proteins or 
protein hydrolysates  
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)(1) 6 21,5 25 90 
Magnesium 
(mg) 1,2 3,6 5 15 
Iron (mg) 0,07 0,31 0,3 1,3  
EN 7   EN 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 
(1) Total phosphorus.  
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 infant formula manufactured  from cow's milk protein, goats’ milk 
protein or protein hydrolysates.  
10.2. Infant formula manufactured from soya pr otein isolates, alone or in a mixture 
with cows’ milk or goats’ milk proteins  
All requirements of point 10.1 shall appl y, except for those concerning iron, 
phosphorus and zinc, which shall be as follows: 
Per 100 kJ Per 100 kcal  
Minimum Maximum Minimum Maximum 
Iron (mg) 0,11 0,48 0,45 2 
Phosphorus 
(mg)(1) 7,2 24 30 100 
Zinc (mg) 0,18 0,3 0,75 1,25 
(1) Total phosphorus.  
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 infant formula manufactur ed from soya protein isolates.  
11. VITAMINS  
Per 100 kJ Per 100 kcal  
Minimum Maximum Minimum Maximum 
Vitamin A ( μg-RE)(1)  16,7 27,2 70 114 
Vitamin D ( μg)  0,48 0,72 2 3 
Thiamin ( μg) 9,6 72 40 300 
Riboflavin ( μg) 14,3 95,6 60 400  
EN 8   EN Niacin (mg)(2) 0,1 0,36 0,4 1,5 
Pantothenic acid (mg) 0,1 0,48 0,4 2 
Vitamin B 6 (μg) 4,8 41,8 20 175 
Biotin (μg) 0,24 1,8 1 7,5 
Folate (μg-DFE)(3) 3,6 11,4 15 47,6 
Vitamin B 12 (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)(4)  0,14 1,2 0,6 5 
(1) Preformed vitamin A; RE = all trans retinol equivalent. 
(2) Preformed niacin. 
(3) Dietary folate equivalent: 1 μg DFE = 1 μg food folate = 0.6 μg folic acid from 
formula.   
(4) Based on vitamin E activity of RRR- α-tocopherol.  
12. NUCLEOTIDES  
The following nucleotides may be added: 
Maximum(1)  
(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 
(1) The total concentration of nucleotides shall not exceed 1,2 mg/100 kJ 
(5 mg/100 kcal).   
EN 9   EN ANNEX II  
COMPOSITIONAL REQUIREMENTS REFERRED TO IN ARTICLE 2(2)   
1. ENERGY  
Minimum Maximum 
250 kJ/100 ml 293 kJ/100 ml 
(60 kcal/100 ml) (70 kcal/100 ml) 
2. PROTEINS  
(Protein content = nitrogen content × 6,25) 
2.1. Follow-on formula manufactured from co ws’ milk or goats’ milk proteins  
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 form ula manufactured from cows’ milk or 
goats’ milk proteins must contain an av ailable 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.  
2.2. Follow-on formula manufactured from soya protein isolates, alone or in a 
mixture with cows’ milk or goats’ milk proteins 
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 fo rmula 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 pur poses, the concentration of methionine 
and cysteine and the concentration of phenylalanine and tyrosine may be added 
together.  
2.3. Follow-on formula manufactured from protein hydrolysates  
Minimum Maximum 
0,44 g/100 kJ 0,67 g/100 kJ 
(1,86 g/100 kcal) (2,8 g/100 kcal)  
EN 10   EN 2.3.1. Protein source  
Demineralised sweet whey protein derived from cows’ milk after enzymatic 
precipitation of caseins usi ng chymosin, consisting of: 
(a) 63 % caseino-glycomacropeptide free wh ey protein isolate with a minimum 
protein content of 95 % of  dry matter and protein de naturation of less than 
70 % and a maximum ash content of 3 %; and 
(b) 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 %. 
2.3.2. Protein processing  
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. 
2.3.3. Indispensable and conditionally indispensable amino acids 
For an equal energy value, follow- on formula manufactured from protein 
hydrolysates must contain an availabl e 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.  
2.4. In all cases, amino acids may be added to  follow-on formula solely for the purpose of 
improving the nutritional value of the protei ns, and only in the proportions necessary 
for that purpose.  
3. TAURINE 
If added to follow-on formula, the amount of taurine shall not  be greater than 
2,9 mg/100 kJ (12 mg/100 kcal). 
4. LIPIDS  
Minimum Maximum 
1,1 g/100 kJ 1,4 g/100 kJ 
(4,4 g/100 kcal) (6,0 g/100 kcal) 
4.1. The use of the following substances shall be prohibited:  
– sesame seed oil, 
– cotton seed oil. 
4.2. The trans fatty acid content shall not exceed 3 % of the total fat content.  
4.3. The erucic acid content shall not exceed 1 % of the total fat content.   
4.4. Linoleic acid  
Minimum Maximum 
120 mg/100 kJ 300 mg/100 kJ 
(500 mg/100 
kcal) (1200 mg/100 
kcal)  
EN 11   EN 4.5. Alpha-linolenic acid 
Minimum Maximum 
12 mg/100 kJ 24 mg/100 kJ 
(50 mg/100 kcal) (100 mg/100 kcal)
4.6. Docosahexaenoic acid 
Minimum Maximum 
4,8 mg/100 kJ 12 mg/100 kJ 
(20 mg/100 kcal) (50 mg/100 kcal)
4.7. Other long-chain (20 and 22 carbon atom s) polyunsaturated fatty acids may be 
added. In that case the cont ent of long-chain polyunsaturated fatty acids shall not 
exceed 2 % of the total fat content for n-6 long-chain polyunsaturated fatty acids (1 % of the total fat content fo r 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. 
5. PHOSPHOLIPIDS  
The amount of phospholipids in follow-on form ula shall not be greater than 2 g/l. 
6. CARBOHYDRATES  
Minimum Maximum 
2,2 g/100 kJ 3,3 g/100 kJ 
(9 g/100 kcal) (14 g/100 kcal) 
6.1. The use of ingredients containi ng gluten shall be prohibited.  
6.2. Lactose 
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 represen t more than 50 % of the total protein 
content, or 
– bearing the statement "lactose free" in accordance with Article 9(2).  
6.3. Sucrose, fructose, honey 
Minimum Maximum 
- separately or as a whole: 
20 % of the total 
carbohydrate content  
EN 12   EN Honey shall be treated to destroy spores of Clostridium botulinum .  
6.4. Glucose 
Glucose may only be added to follow- on formula manufactured from protein 
hydrolysates. If added, the glucose conten t shall not exceed 0,5 g/100 kJ (2 g/100 
kcal). 
6.5. Glucose syrup or dried glucose syrup  
Glucose syrup or dried glucose syr up may be added to follow-on formula 
manufactured from cows’ milk or goats ’ milk proteins or follow-on formula 
manufactured from soya protei n 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 gluc ose content resulting 
from glucose syrup or dried glucose sy rup shall not exceed 0,2 g/100 kJ (0,84 g/100 
kcal). 
The maximum glucose amounts laid down in poi nt 6.4 shall apply if glucose syrup or 
dried glucose syrup is added to follo w-on formula manufactured from protein 
hydrolysates. 
7. FRUCTO-OLIGOSACCHARIDES AND GALACTO-OLIGOSACCHARIDES  
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 % hi gh 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). 
8. MINERAL SUBSTANCES  
8.1. Follow-on formula manufactured from cows ’ milk or goats’ milk proteins or 
protein hydrolysates  
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)(1) 6 21,5 25 90 
Magnesium 
(mg) 1,2 3,6 5 15  
EN 13   EN 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 
(1) Total phosphorus.  
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. 
8.2. Follow-on formula manufactured from soya protein isolates, alone or in a 
mixture with cows’ milk or  goats’ milk proteins  
All requirements of poin t 8.1 shall apply, except for those concerning iron, 
phosphorus and zinc, which shall be as follows: 
Per 100 kJ Per 100 kcal  
Minimum Maximum Minimum Maximum 
Iron (mg) 0,22 0,6 0,9 2,5 
Phosphorus 
(mg)(1) 7,2 24 30 100 
Zinc (mg) 0,18 0,3 0,75 1,25 
(1) Total phosphorus. 
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 manufactur ed from soya protein isolates.  
9. VITAMINS  
Per 100 kJ Per 100 kcal  
Minimum Maximum Minimum Maximum 
Vitamin A ( μg-RE)(1) 16,7 27,2 70 114 
Vitamin D ( μg) 0,48 0,72 2 3 
Thiamin ( μg) 9,6 72 40 300  
EN 14   EN Riboflavin ( μg) 14,3 95,6 60 400 
Niacin (mg)(2) 0,1 0,36 0,4 1, 5 
Pantothenic acid (mg) 0,1 0,48 0,4 2 
Vitamin B 6 (μg) 4,8 41,8 20 175 
Biotin (μg) 0,24 1,8 1 7,5 
Folate (μg-DFE)(3) 3,6 11,4 15 47,6 
Vitamin B 12 (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)(4) 0,14 1,2 0,6 5 
(1) Preformed vitamin A; RE = all trans retinol equivalent. 
(2) Preformed niacin. 
(3) Dietary folate equivalent: 1 μg DFE = 1 μg food folate = 0.6 μg folic acid from 
formula. 
(4) Based on vitamin E activity of RRR- α-tocopherol.  
10. NUCLEOTIDES  
The following nucleotides may be added: 
Maximum(1)  
(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 
(1) The total concentration of nucleotides shall not exceed 1,2 mg/100 kJ 
(5 mg/100 kcal).   
EN 15   EN ANNEX III  
INDISPENSABLE AND CONDITIONALLY INDISPENSABLE AMINO ACIDS IN 
BREAST MILK 
For the purposes of point 2 of Annexes I and II, breast milk shall be used as reference protein 
as set out in Sections A and B of this Annex, respectively. 
A. Infant formula and follow-on formula manufactured from cows’ milk or goats’ 
milk proteins and infant formula and follow-on formula manufactured from soya protein isolates, alone or in a mi xture with cows’ m ilk or goats’ milk 
proteins  
For the purposes of points 2.1. and 2.2. of Annexes I and II, the indispensable and 
conditionally indispensable amino acids in breast milk, expressed in mg per 100 kJ 
and 100 kcal, are the following: 
 Per 100 
kJ
(1) Per 100 
kcal 
Cysteine 9 38 
Histidine 10 40 
Isoleucine 22 90 
Leucine 40 166 
Lysine 27 113 
Methionine 5 23 
Phenylalanine 20 83 
Threonine 18 77 
Tryptophan 8 32 
Tyrosine 18 76 
Valine 21 88 
(1) 1 kJ = 0,239 kcal.  
B. Infant formula and follow-on formula manufactured from protein hydrolysates  
For the purposes of point  2.3. of Annexes I and II , the indispensable and 
conditionally indispensable amino acids in breast milk, expressed in mg per 100 kJ 
and 100 kcal, are the following: 
 Per 100 
kJ(1) Per 100 
kcal 
Arginine  16 69 
Cysteine  6 24 
Histidine  11 45 
Isoleucine  17 72 
Leucine  37 156  
EN 16   EN Lysine  29 122 
Methionine  7 29 
Phenylalanine 15 62 
Threonine  19 80 
Tryptophan  7 30 
Tyrosine  14 59 
Valine  19 80 
(1) 1 kJ = 0,239 kcal.   
EN 17   EN ANNEX IV  
ACTIVE SUBSTANCES REFERRED  TO IN ARTICLE 4(3) 
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 
  
EN 18   EN ANNEX V  
ACTIVE SUBSTANCES REFERRED  TO IN ARTICLE 4(4) 
Chemical name of the substance (residue definition) 
Aldrin and dieldrin, ex pressed as dieldrin  
Disulfoton (sum of disulfoton, disulfoton sulf oxide and disulfoton sulfone expressed as 
disulfoton) 
Endrin 
Fensulfothion (sum of fensulfothion, its oxyge n analogue and their sulfones, expressed as 
fensulfothion) 
Fentin, expressed as triphenyltin cation 
Haloxyfop (sum of haloxyfop, its  salts and esters includi ng conjugates, expressed as 
haloxyfop) 
Heptachlor and trans -heptachlor epoxide, expressed as heptachlor 
Hexachlorobenzene 
Nitrofen 
Omethoate 
Terbufos (sum of terbufos, its sulfoxi de and sulfone, expressed as terbufos)  
EN 19   EN ANNEX VI  
NAMES REFERRED TO IN ARTICLE 5 
Part A 
Name referred to in Article 5(1)  
The name of infant formula and follow-on form ula other than infant formula and follow-on 
formula manufactured entirely from cows' milk or  goats' milk proteins shall be respectively: 
– in Bulgarian: ‘ Храни  за кърмачета ’ and ‘Преходни  храни ’, 
– in Spanish: ‘Preparado para lactante s’ and ‘Preparado de continuación’, 
– in Czech: ‘Po čáteční kojeneckou výživou’ and ‘Pokra čovací kojeneckou výživou’, 
– in Danish: ‘Modermælkserstatni ng’ and ‘Tilskudsblanding’, 
– in German: ‘Säuglingsanfangsnahrung’ and ‘Folgenahrung’, 
– in Estonian: ‘Imiku piimasegu’ and ‘Jätkupiimasegu’, 
– in Greek: ‘ Παρασκεύασμα  για βρέφη ’ and ‘Παρασκεύασμα  δεύτερης  βρεφικής  
ηλικίας ’, 
– in English: ‘Infant formula’ and ‘Follow-on formula’, 
– in French: ‘Préparation pour nourriss ons’ and ‘Préparation de suite’, 
– in Croatian: ‘Po četna hrana za dojen čad’ and ‘Prijelazna hrana za dojen čad’, 
– in Italian: ‘Formula per lattanti’  and ‘Formula di proseguimento’, 
– in Latvian: ‘Mais ījums zīdaiņiem’ and ‘Papildu ēdināšanas mais ījums zīdaiņiem’, 
– in Lithuanian: ‘Pradinio maitinimo k ūdikių mišiniai’ and ‘Tolesnio maitinimo 
kūdikių mišiniai’, 
– in Hungarian: ‘Anyatej-helyettesít ő tápszer’ and ‘Anyatej-kiegészít ő tápszer’, 
– in Maltese: ‘Formula tat-trabi’ and ‘Formula tal-prosegwiment’, 
– in Dutch: ‘Volledige zuigelingenvo eding’ and ‘Opvolgzuigelingenvoeding’, 
– in Polish: ‘Preparat do pocz ątkowego żywienia niemowl ąt’ and ‘Preparat do 
dalszego żywienia niemowl ąt’, 
– in Portuguese: ‘Fórmula para lacten tes’ and ‘Fórmula de transição’, 
– in Romanian: ‘Formul ă de început’ and ‘Formul ă de continuare’, 
– in Slovak: ‘Po čiatočná dojčenská výživa’ and ‘Následná doj čenská výživa’. 
– in Slovenian: ‘Za četna formula za dojen čke’ and ‘Nadaljevalna formula’, 
– in Finnish: ‘Äidinmaidonkorvikkeella ’ and ‘Vieroitusvalmisteella’, 
– in Swedish: ‘Modersmjölksersätt ning’ and ‘Tillskottsnäring’.  
EN 20   EN Part B 
Name referred to in Article 5(2) 
The name of infant formula and follow-on formul a manufactured entirely from cows’ milk or 
goats’ milk proteins shall be respectively: 
– in Bulgarian: ‘ Млека  за кърмачета ’ and ‘Преходни  млека ’, 
– in Spanish: ‘Leche para lactante s’ and ‘Leche de continuación’, 
– in Czech: ‘Po čáteční mléčná kojenecká výživa’ and ‘Pokra čovací mlé čná kojenecká 
výživa’, 
– in Danish: ‘Modermælkserstatning ude lukkende baseret på mælk’ and 
‘Tilskudsblanding udelukkende baseret på mælk’, 
– in German: ‘Säuglingsmilchnahrung’ and ‘Folgemilch’, 
– in Estonian: ‘Piimal põhinev imiku piimas egu’ and ‘Piimal põhinev jätkupiimasegu’, 
– in Greek: ‘ Γάλα  για βρέφη ’ and ‘Γάλα  δεύτερης  βρεφικής  ηλικίας ’, 
– in English: ‘Infant milk’ and ‘Follow-on milk’, 
– in French: ‘Lait pour nourri ssons’ and ‘Lait de suite’, 
– in Croatian: ‘Po četna mlije čna hrana za dojen čad’ and ‘Prijelazna mlije čna hrana za 
dojenčad’, 
– in Italian: ‘Latte per lattanti’  and ‘Latte di proseguimento’, 
– in Latvian: ‘Piena mais ījums zīdaiņiem’ and ‘Papildu ēdināšanas piena mais ījums 
zīdaiņiem’, 
– in Lithuanian: ‘Pradinio maitinimo k ūdikių pieno mišiniai’ and ‘Tolesnio maitinimo 
kūdikių pieno mišiniai’, 
– in Hungarian: ‘Tejala pú anyatej-helyettesít ő tápszer’ and ‘T ejalapú anyatej-
kiegészítő tápszer’, 
– in Maltese: ‘ Ħalib tat-trabi’ and ‘ Ħalib tal-prosegwiment’, 
– in Dutch: ‘Volledige zuigelingenvoeding op basis van melk’ or ‘Zuigelingenmelk’ 
and ‘Opvolgmelk’, 
– in Polish: ‘Mleko pocz ątkowe’ and ‘Mleko nast ępne’, 
– in Portuguese: ‘Leite para lacten tes’ and ‘Leite de transição’, 
– in Romanian: ‘Lapte pentru sugari’ and ‘Lapte pentru copii de vârst ă mică’, 
– in Slovak: ‘Po čiatočná dojčenská mlie čna výživa’ and ‘Následná doj čenská mlie čna 
výživa’, 
– in Slovenian: ‘Za četno mleko za dojen čke’ and ‘Nadaljevalno mleko’, 
– Finnish: ‘Maitopohjainen äidinm aidonkorvike’ and ‘Maitopohjainen 
vieroitusvalmiste’, 
– in Swedish: ‘Modersmjölksersättning uteslutande baserad på mjölk’ and 
‘Tillskottsnäring utesluta nde baserad på mjölk’.  
EN 21   EN ANNEX VII  
REFERENCE INTAKES REFERRED TO IN ARTICLE 7(7) 
Nutrient  Reference intake  
Vitamin A  (μg) 400  
Vitamin D  (μg) 7 
Vitamin E  (mg TE) 5  
Vitamin K  (μg) 12  
Vitamin C  (mg) 45  
Thiamin  (mg) 0,5  
Riboflavin  (mg) 0,7  
Niacin  (mg) 7  
Vitamin B 6  (mg) 0,7  
Folate  (μg) 125  
Vitamin B 12  (μg) 0,8  
Pantothenic acid  (mg) 3  
Biotin  (μg) 10  
Calcium  (mg) 550  
Phosphorus  (mg) 550  
Potassium  (mg) 1 000  
Sodium  (mg) 400  
Chloride  (mg) 500  
Iron (mg) 8  
Zinc (mg) 5  
Iodine  (μg) 80  
Selenium  (μg) 20  
Copper  (mg) 0,5  
Magnesium  (mg) 80  
Manganese  (mg) 1,2