EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10356/2015 ANNEX (POOL/E4/2015/10356/10356-EN ANNEX.doc) […](2015) XXX  draft 
ANNEXES 1 to 4 
  
ANNEXES 
to the 
COMMISSION DELEGATED REGULATION (EU) …/… 
supplementing Regulation (EU) No 609/2013 of the Europe an Parliament and of the 
Council as regards the specifi c compositional and informatio n requirements for food for 
special medical purposes 
  
EN 2   EN ANNEX I  
COMPOSITIONAL REQUIREMENTS REFERRED TO IN ARTICLE 2(3) 
Part A 
Food for special medical purposes developed 
to satisfy the nutritional requirements of infants 
1. Products referred to in Article 2(1)(a ) developed to satisfy the nutritional 
requirements of infants shall contain the vita mins and mineral substances as specified 
in Table 1.  
2. Products referred to in Article 2(1)(b ) developed to satisfy the nutritional 
requirements of infants shall contain the vita mins and mineral substances as specified 
in Table 1, without prejudice to modificati ons for one or more of these nutrients 
rendered necessary by the inte nded use of the product. 
3. Maximum levels of vitamins and mineral s ubstances present in products referred to 
in Article 2(1)(c) developed to satisfy the nutritional requirements of infants shall not 
exceed those specified in Table 1, without pr ejudice to modifications for one or more 
of these nutrients rendered necessary by the intended use of the product.  
4. Where this is not contrary to the requir ements dictated by the intended use, food for 
special medical purposes developed to satis fy the nutritional requirements of infants 
shall comply with the provisions relating to  other nutrients applicable to infant 
formula and follow-on formula, as the ca se may be, laid dow n in Commission 
Delegated Regulation (EU) […/…]1. 
TABLE 1 
Values for vitamins and minerals in food  for special medical purposes developed to 
satisfy the nutritional requirements of infants 
Per 100 kJ Per 100 kcal 
 Minimum Maximum Minimum Maximum 
Vitamins     
Vitamin A (µg-
RE)(1) 16,7 43 70 180 
Vitamin D (µg) 0,48 0,72 2 3 
Vitamin K (µg) 0,24 6 1 25 
Vitamin C (mg) 0,96 7,2 4 30 
Thiamin (µg) 9,6 72 40 300 
Riboflavin (µg) 14,3 107 60 450 
Vitamin B 6 (µg) 4,8 72 20 300 
Niacin (mg)(2) 0,1 0,72 0,4 3  
Folate (µg-
DFE)(3) 3,6 11,4 15 47,6 
                                                 
1 COMMISSION DELEGATED REGULA TION (EU) …/... of XXX supp lementing 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, OJ …, XXX.  
EN 3   EN Vitamin B 12 (µg) 0,02 0,12 0,1 0,5 
Panthotenic Acid 
(mg) 0,1 0,48 0,4 2 
Biotin (µg) 0,24 4,8 1 20 
Vitamin E (mg α-
tocopherol)(4) 0,14 1,2 0,6 5 
Minerals  
 Sodium (mg) 6 14,3 25 60 
 Chloride (mg) 14,3 38,2 60 160 
 Potassium (mg) 19,1 38,2 80 160 
 Calcium (mg)(5) 12 60 50 250 
 Phosphorus 
(mg)(6) 6 24 25 100 
 Magnesium (mg) 1,2 3,6 5 15 
 Iron (mg) 0,07 0,6 0,3 2,5 
 Zinc (mg) 0,12 0,6 0,5 2,4 
 Copper (µg) 14,3 29 60 120 
 Iodine (µg) 3,6 8,4 15 35 
 Selenium (µg) 0,72 2 3 8,6 
 Manganese (µg) 0,24 24 1 100 
 Chromium (µg) - 2,4 - 10 
 Molybdenum 
(µg) - 3,3 - 14 
 Fluoride (µg) - 47,8 - 200 
(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. 
(5) The calcium:available phosphorus molar ratio shall not be less than 1 nor greater than 2.  
(6) Total phosphorus.  
  
EN 4   EN Part B 
Food for special medical purposes other than that 
developed to satisfy the nutriti onal requirements of infants  
1. Products referred to in Article 2(1)(a) ot her than those developed to satisfy the 
nutritional requirements of infants shall cont ain the vitamins and mineral substances 
as specified in Table 2. 
2. Products referred to in Article 2(1)(b) ot her than those developed to satisfy the 
nutritional requirements of infants shall cont ain the vitamins and mineral substances 
as specified in Table 2, without prejudice to  modifications for one or more of these 
nutrients rendered necessary by the intended use of the product. 
3. Maximum levels of vitamins and mineral s ubstances present in products referred to 
in Article 2(1)(c) other than those developed to satisfy the nutritional requirements of 
infants shall not exceed those specified in Table 2, without prejudice to modifications 
for one or more of these nutrients rende red necessary by the intended use of the 
product. 
TABLE 2 
Values for vitamins and minerals in food for special medical purposes other than that 
developed to satisfy the nutriti onal requirements of infants 
Per 100 kJ Per 100 kcal 
 Minimum Maximum Minimum Maximum 
Vitamins     
Vitamin A (µg-
RE) 8,4 43 35 180 
Vitamin D (µg) 0,12 0,65/0,75(1) 0,5 2,5/3(1) 
Vitamin K (µg) 0,85 5 3,5 20 
Vitamin C (mg) 0,54 5,25 2,25 22 
Thiamin (mg) 0,015 0,12 0,06 0,5 
Riboflavin (mg) 0,02 0,12 0,08 0,5 
Vitamin B 6 (mg) 0,02 0,12 0,08 0,5 
Niacin (mg NE) 0,22 0,75 0,9 3 
Folic Acid (µg) 2,5 12,5 10 50 
Vitamin B 12 (µg) 0,017 0,17 0,07 0,7 
Panthotenic Acid 
(mg) 0,035 0,35 0,15 1,5 
Biotin (µg) 0,18 1,8 0,75 7,5  
Vitamin E (µg α-
TE) 0,5 / g of 
polyunsatu
rated fatty 
acids 
expressed 
as linoleic 
acid but in 0,75 0,5 / g of 
polyunsatu
rated fatty 
acids 
expressed 
as linoleic 
acid but in 3  
EN 5   EN no case 
less than 
0,1 mg per 
100 
available 
kJ no case 
less than 
0,5 mg per 
100 
available 
kcal 
Minerals  
 Sodium (mg) 7,2 42 30 175 
 Chloride (mg) 7,2 42 30 175 
 Potassium (mg) 19 70 80 295 
 Calcium (mg) 8,4/12(1) 42/60 (1) 35/50 (1) 175/250(1) 
 Phosphorus (mg) 7,2 19 30 80 
 Magnesium (mg) 1,8 6 7,5 25 
 Iron (mg) 0,12 0,5 0,5 2 
 Zinc (mg) 0,12 0,36 0,5 1,5 
 Copper (µg) 15 125 60 500 
 Iodine (µg) 1,55 8,4 6,5 35 
 Selenium (µg) 0,6 2,5 2,5 10 
 Manganese (mg) 0,012 0,12 0,05 0,5 
 Chromium (µg) 0,3 3,6 1,25 15 
 Molybdenum 
(µg) 0,72 4,3 3,5 18 
 Fluoride (mg) - 0,05 - 0,2 
(1) For products intended for children of 1 to 10 years of age.   
EN 6   EN ANNEX II  
ACTIVE SUBSTANCES REFERRED  TO IN ARTICLE 3(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 7   EN ANNEX III  
ACTIVE SUBSTANCES REFERRED  TO IN ARTICLE 3(4) 
Chemical name of the substance (residue definition) 
Aldrin and dieldrin, expressed 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 8   EN ANNEX IV  
NAME REFERRED TO IN ARTICLE 4 
The name of food for special medical  purposes shall be respectively: 
– in Bulgarian: ‘ Храни  за специални  медицински  цели ’, 
– in Spanish: ‘Alimento para usos médicos especiales’, 
– in Czech: ‘Potravinami pro zvláštní léka řské účely’, 
– in Danish: ‘Fødevare til sæ rlige medicinske formål’, 
– in German: ‘Lebensmittel für besondere medizinische Zwecke (bilanzierte Diät)’, 
– in Estonian: ‘Meditsiinilisel näidus tusel kasutamiseks ettenähtud toit’, 
– in Greek: ‘ Τρόφιμα  για ειδικούς  ιατρικούς  σκοπούς ’, 
– in English: ‘Food for special medical purposes’, 
– in French: ‘Denrée alimentaire destin ée à des fins médicales spéciales’, 
– in Croatian: ‘Hrana za posebne medicinske potrebe’, 
– in Italian: ‘Alimento a fini medici speciali’, 
– in Latvian: ‘ Īpašiem medic īniskiem nol ūkiem paredz ēta pārtika’, 
– in Lithuanian: ‘Specialios medicinin ės paskirties maisto produktai’, 
– in Hungarian: ‘Speciális gyógyás zati célra szánt élelmiszer’, 
– in Maltese: ‘Ikel g ħal skopijiet medi ċi speċjali', 
– in Dutch: ‘Voeding voor  medisch gebruik’, 
– in Polish: ‘ Żywność specjalnego przeznaczenia medycznego’, 
– in Portuguese: ‘Alimento para fi ns medicinais específicos’, 
– in Romanian: ‘Alimente destinate unor scopuri medica le speciale’, 
– in Slovak: ‘Potraviny na  osobitné lekárske ú čely’, 
– in Slovenian: ‘Živila za pos ebne zdravstvene namene’, 
– in Finnish: ‘Erityisiin lääkinnällisiin tarkoi tuksiin tarkoitettu elintarvike (kliininen 
ravintovalmiste)’, 
– in Swedish: ‘Livsmedel för sp eciella medicinska ändamål’.