Regulation (EU) No 609/2013 of the European Parliament and of the CouncilShow full title

Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (Text with EEA relevance)

ANNEXU.K.

Union list as referred to in Article 15(1)

a

Menaquinone occurring principally as menaquinone-7 and, to a minor extent, menaquinone-6.

b

Selenium-enriched yeasts produced by culture in the presence of sodium selenite as selenium source and containing, in the dried form as marketed, not more than 2,5 mg Se/g. The predominant organic selenium species present in the yeast is selenomethionine (between 60 and 85 % of total extracted selenium in the product). The content of other organic selenium compounds including selenocysteine must not exceed 10 % of total extracted selenium. Levels of inorganic selenium normally must not exceed 1 % of total extracted selenium.

c

For amino acids used in infant formula, follow-on formula, processed cereal-based food and baby food only the hydrochloride specifically mentioned may be used. For amino acids used in food for special medical purposes and in total diet replacement for weight control, as far as applicable, also the sodium, potassium, calcium and magnesium salts as well as their hydrochlorides may be used.

d

In the case of use in infant formula, follow-on formula, processed cereal-based food and baby food, only the form L-cystine may be used.

SubstanceCategory of food
Infant formula and follow on formulaProcessed cereal-based food and baby foodFood for special medical purposesTotal diet replacement for weight control
Vitamins
Vitamin A
retinolXXXX
retinyl acetateXXXX
retinyl palmitateXXXX
beta-caroteneXXX
Vitamin D
ergocalciferolXXXX
cholecalciferolXXXX
Vitamin E
D-alpha tocopherolXXXX
DL-alpha tocopherolXXXX
D-alpha tocopheryl acetateXXXX
DL-alpha tocopheryl acetateXXXX
D-alpha-tocopheryl acid succinateXX
D-alpha-tocopheryl polyethylene glycol-1000 succinate (TPGS)X
Vitamin K
phylloquinone (phytomenadione)XXXX
MenaquinoneaXX
Vitamin C
L-ascorbic acidXXXX
sodium-L-ascorbateXXXX
calcium-L-ascorbateXXXX
potassium-L-ascorbateXXXX
L-ascorbyl 6-palmitateXXXX
Thiamin
thiamin hydrochlorideXXXX
thiamin mononitrateXXXX
Riboflavin
riboflavinXXXX
riboflavin 5’-phosphate, sodiumXXXX
Niacin
nicotinic acidXXXX
nicotinamideXXXX
Vitamin B6
pyridoxine hydrochlorideXXXX
pyridoxine 5’-phosphateXXXX
pyridoxine dipalmitateXXX
Folate
folic acid (pteroylmonoglutamic acid)XXXX
calcium-L-methylfolateXX
Vitamin B12
cyanocobalaminXXXX
hydroxocobalaminXXXX
Biotin
D-biotinXXXX
Pantothenic Acid
D-pantothenate, calciumXXXX
D-pantothenate, sodiumXXXX
dexpanthenolXXXX
Minerals
Potassium
potassium bicarbonateXXX
potassium carbonateXXX
potassium chlorideXXXX
potassium citrateXXXX
potassium gluconateXXXX
potassium glycerophosphateXXX
potassium lactateXXXX
potassium hydroxideXXX
potassium salts of orthophosphoric acidXXX
magnesium potassium citrateXX
Calcium
calcium carbonateXXXX
calcium chlorideXXXX
calcium salts of citric acidXXXX
calcium gluconateXXXX
calcium glycerophosphateXXXX
calcium lactateXXXX
calcium salts of orthophosphoric acidXXXX
calcium hydroxideXXXX
calcium oxideXXX
calcium sulphateXX
calcium bisglycinateXX
calcium citrate malateXX
calcium malateXX
calcium L-pidolateXX
[F1calcium phosphoryl oligosaccharides X ]
Magnesium
magnesium acetateXX
magnesium carbonateXXXX
magnesium chlorideXXXX
magnesium salts of citric acidXXXX
magnesium gluconateXXXX
magnesium glycerophosphateXXX
magnesium salts of orthophosphoric acidXXXX
magnesium lactateXXX
magnesium hydroxideXXXX
magnesium oxideXXXX
magnesium sulphateXXXX
magnesium L-aspartateX
magnesium bisglycinateXX
magnesium L-pidolateXX
magnesium potassium citrateXX
Iron
ferrous carbonateXXX
ferrous citrateXXXX
ferric ammonium citrateXXXX
ferrous gluconateXXXX
ferrous fumarateXXXX
ferric sodium diphosphateXXX
ferrous lactateXXXX
ferrous sulphateXXXX
ferrous ammonium phosphateXX
ferric sodium EDTAXX
ferric diphosphate (ferric pyrophosphate)XXXX
ferric saccharateXXX
elemental iron (carbonyl + electrolytic + hydrogen reduced)XXX
[F2ferrous bisglycinate X X X X]
ferrous L-pidolateXX
Zinc
zinc acetateXXXX
zinc chlorideXXXX
zinc citrateXXXX
zinc gluconateXXXX
zinc lactateXXXX
zinc oxideXXXX
zinc carbonateXX
zinc sulphateXXXX
zinc bisglycinateXX
Copper
cupric carbonateXXXX
cupric citrateXXXX
cupric gluconateXXXX
cupric sulphateXXXX
copper lysine complexXXXX
Manganese
manganese carbonateXXXX
manganese chlorideXXXX
manganese citrateXXXX
manganese gluconateXXXX
manganese glycerophosphateXXX
manganese sulphateXXXX
Fluoride
potassium fluorideXX
sodium fluorideXX
Selenium
sodium selenateXXX
sodium hydrogen seleniteXX
sodium seleniteXXX
selenium enriched yeastbXX
Chromium
chromium (III) chloride and its hexahydrateXX
chromium (III) sulphate and its hexahydrateXX
chromium picolinateXX
Molybdenum
ammonium molybdateXX
sodium molybdateXX
Iodine
potassium iodideXXXX
potassium iodateXXXX
sodium iodideXXXX
sodium iodateXXX
Sodium
sodium bicarbonateXXX
sodium carbonateXXX
sodium chlorideXXX
sodium citrateXXX
sodium gluconateXXX
sodium lactateXXX
sodium hydroxideXXX
sodium salts of orthophosphoric acidXXX
Boron
sodium borateXX
boric acidXX
Amino acidsc
L-alanineXX
L-arginine

X

and its hydrochloride

X

and its hydrochloride

XX
L-aspartic acidX
L-citrullineX
L-cysteine

X

and its hydrochloride

X

and its hydrochloride

XX
Cystined

X

and its hydrochloride

X

and its hydrochloride

XX
L-histidine

X

and its hydrochloride

X

and its hydrochloride

XX
L-glutamic acidXX
L-glutamineXX
glycineX
L-isoleucine

X

and its hydrochloride

X

and its hydrochloride

XX
L-leucine

X

and its hydrochloride

X

and its hydrochloride

XX
L-lysine

X

and its hydrochloride

X

and its hydrochloride

XX
L-lysine acetateXX
L-methionineXXXX
L-ornithineXX
L-phenylalanineXXXX
L-prolineX
L-threonineXXXX
L-tryptophanXXXX
L-tyrosineXXXX
L-valineXXXX
L-serineX
L-arginine-L-aspartateX
L-lysine-L-aspartateX
L-lysine-L-glutamateX
N-acetyl-L-cysteineX
N-acetyl-L-methionineX (in products intended for persons over 1 year of age)
Carnitine and taurine
L-carnitineXXXX
L-carnitine hydrochlorideXXXX
taurineXXX
L-carnitine-L-tartrateXXX
Nucleotides
adenosine 5’-phosphoric acid (AMP)XXX
sodium salts of AMPXXX
cytidine 5’-monophosphoric acid (CMP)XXX
sodium salts of CMPXXX
guanosine 5’-phosphoric acid (GMP)XXX
sodium salts of GMPXXX
inosine 5’-phosphoric acid (IMP)XXX
sodium salts of IMPXXX
uridine 5’-phosphoric acid (UMP)XXX
sodium salts of UMPXXX
Choline and inositol
cholineXXXX
choline chlorideXXXX
choline bitartrateXXXX
choline citrateXXXX
inositolXXXX