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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)
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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. | ||||||
Substance | Category of food | |||||
---|---|---|---|---|---|---|
Infant formula and follow on formula | Processed cereal-based food and baby food | Food for special medical purposes | Total diet replacement for weight control | |||
Vitamins | ||||||
Vitamin A | ||||||
retinol | X | X | X | X | ||
retinyl acetate | X | X | X | X | ||
retinyl palmitate | X | X | X | X | ||
beta-carotene | X | X | X | |||
Vitamin D | ||||||
ergocalciferol | X | X | X | X | ||
cholecalciferol | X | X | X | X | ||
Vitamin E | ||||||
D-alpha tocopherol | X | X | X | X | ||
DL-alpha tocopherol | X | X | X | X | ||
D-alpha tocopheryl acetate | X | X | X | X | ||
DL-alpha tocopheryl acetate | X | X | X | X | ||
D-alpha-tocopheryl acid succinate | X | X | ||||
D-alpha-tocopheryl polyethylene glycol-1000 succinate (TPGS) | X | |||||
Vitamin K | ||||||
phylloquinone (phytomenadione) | X | X | X | X | ||
Menaquinonea | X | X | ||||
Vitamin C | ||||||
L-ascorbic acid | X | X | X | X | ||
sodium-L-ascorbate | X | X | X | X | ||
calcium-L-ascorbate | X | X | X | X | ||
potassium-L-ascorbate | X | X | X | X | ||
L-ascorbyl 6-palmitate | X | X | X | X | ||
Thiamin | ||||||
thiamin hydrochloride | X | X | X | X | ||
thiamin mononitrate | X | X | X | X | ||
Riboflavin | ||||||
riboflavin | X | X | X | X | ||
riboflavin 5’-phosphate, sodium | X | X | X | X | ||
Niacin | ||||||
nicotinic acid | X | X | X | X | ||
nicotinamide | X | X | X | X | ||
Vitamin B6 | ||||||
pyridoxine hydrochloride | X | X | X | X | ||
pyridoxine 5’-phosphate | X | X | X | X | ||
pyridoxine dipalmitate | X | X | X | |||
Folate | ||||||
folic acid (pteroylmonoglutamic acid) | X | X | X | X | ||
[F2calcium-L-methylfolate | X | X | X] | |||
Vitamin B12 | ||||||
cyanocobalamin | X | X | X | X | ||
hydroxocobalamin | X | X | X | X | ||
Biotin | ||||||
D-biotin | X | X | X | X | ||
Pantothenic Acid | ||||||
D-pantothenate, calcium | X | X | X | X | ||
D-pantothenate, sodium | X | X | X | X | ||
dexpanthenol | X | X | X | X | ||
Minerals | ||||||
Potassium | ||||||
potassium bicarbonate | X | X | X | |||
potassium carbonate | X | X | X | |||
potassium chloride | X | X | X | X | ||
potassium citrate | X | X | X | X | ||
potassium gluconate | X | X | X | X | ||
potassium glycerophosphate | X | X | X | |||
potassium lactate | X | X | X | X | ||
potassium hydroxide | X | X | X | |||
potassium salts of orthophosphoric acid | X | X | X | |||
magnesium potassium citrate | X | X | ||||
Calcium | ||||||
calcium carbonate | X | X | X | X | ||
calcium chloride | X | X | X | X | ||
calcium salts of citric acid | X | X | X | X | ||
calcium gluconate | X | X | X | X | ||
calcium glycerophosphate | X | X | X | X | ||
calcium lactate | X | X | X | X | ||
calcium salts of orthophosphoric acid | X | X | X | X | ||
calcium hydroxide | X | X | X | X | ||
calcium oxide | X | X | X | |||
calcium sulphate | X | X | ||||
calcium bisglycinate | X | X | ||||
calcium citrate malate | X | X | ||||
calcium malate | X | X | ||||
calcium L-pidolate | X | X | ||||
[F3calcium phosphoryl oligosaccharides | X ] | |||||
Magnesium | ||||||
magnesium acetate | X | X | ||||
magnesium carbonate | X | X | X | X | ||
magnesium chloride | X | X | X | X | ||
magnesium salts of citric acid | X | X | X | X | ||
magnesium gluconate | X | X | X | X | ||
magnesium glycerophosphate | X | X | X | |||
magnesium salts of orthophosphoric acid | X | X | X | X | ||
magnesium lactate | X | X | X | |||
magnesium hydroxide | X | X | X | X | ||
magnesium oxide | X | X | X | X | ||
magnesium sulphate | X | X | X | X | ||
magnesium L-aspartate | X | |||||
magnesium bisglycinate | X | X | ||||
magnesium L-pidolate | X | X | ||||
magnesium potassium citrate | X | X | ||||
Iron | ||||||
ferrous carbonate | X | X | X | |||
ferrous citrate | X | X | X | X | ||
ferric ammonium citrate | X | X | X | X | ||
ferrous gluconate | X | X | X | X | ||
ferrous fumarate | X | X | X | X | ||
ferric sodium diphosphate | X | X | X | |||
ferrous lactate | X | X | X | X | ||
ferrous sulphate | X | X | X | X | ||
ferrous ammonium phosphate | X | X | ||||
ferric sodium EDTA | X | X | ||||
ferric diphosphate (ferric pyrophosphate) | X | X | X | X | ||
ferric saccharate | X | X | X | |||
elemental iron (carbonyl + electrolytic + hydrogen reduced) | X | X | X | |||
[F4ferrous bisglycinate | X | X | X | X] | ||
ferrous L-pidolate | X | X | ||||
Zinc | ||||||
zinc acetate | X | X | X | X | ||
zinc chloride | X | X | X | X | ||
zinc citrate | X | X | X | X | ||
zinc gluconate | X | X | X | X | ||
zinc lactate | X | X | X | X | ||
zinc oxide | X | X | X | X | ||
zinc carbonate | X | X | ||||
zinc sulphate | X | X | X | X | ||
zinc bisglycinate | X | X | ||||
Copper | ||||||
cupric carbonate | X | X | X | X | ||
cupric citrate | X | X | X | X | ||
cupric gluconate | X | X | X | X | ||
cupric sulphate | X | X | X | X | ||
copper lysine complex | X | X | X | X | ||
Manganese | ||||||
manganese carbonate | X | X | X | X | ||
manganese chloride | X | X | X | X | ||
manganese citrate | X | X | X | X | ||
manganese gluconate | X | X | X | X | ||
manganese glycerophosphate | X | X | X | |||
manganese sulphate | X | X | X | X | ||
Fluoride | ||||||
potassium fluoride | X | X | ||||
sodium fluoride | X | X | ||||
Selenium | ||||||
sodium selenate | X | X | X | |||
sodium hydrogen selenite | X | X | ||||
sodium selenite | X | X | X | |||
selenium enriched yeastb | X | X | ||||
Chromium | ||||||
chromium (III) chloride and its hexahydrate | X | X | ||||
chromium (III) sulphate and its hexahydrate | X | X | ||||
chromium picolinate | X | X | ||||
Molybdenum | ||||||
ammonium molybdate | X | X | ||||
sodium molybdate | X | X | ||||
Iodine | ||||||
potassium iodide | X | X | X | X | ||
potassium iodate | X | X | X | X | ||
sodium iodide | X | X | X | X | ||
sodium iodate | X | X | X | |||
Sodium | ||||||
sodium bicarbonate | X | X | X | |||
sodium carbonate | X | X | X | |||
sodium chloride | X | X | X | |||
sodium citrate | X | X | X | |||
sodium gluconate | X | X | X | |||
sodium lactate | X | X | X | |||
sodium hydroxide | X | X | X | |||
sodium salts of orthophosphoric acid | X | X | X | |||
Boron | ||||||
sodium borate | X | X | ||||
boric acid | X | X | ||||
Amino acidsc | ||||||
L-alanine | — | X | X | |||
L-arginine | X and its hydrochloride | X and its hydrochloride | X | X | ||
L-aspartic acid | X | |||||
L-citrulline | X | |||||
L-cysteine | X and its hydrochloride | X and its hydrochloride | X | X | ||
Cystined | X and its hydrochloride | X and its hydrochloride | X | X | ||
L-histidine | X and its hydrochloride | X and its hydrochloride | X | X | ||
L-glutamic acid | X | X | ||||
L-glutamine | X | X | ||||
glycine | X | |||||
L-isoleucine | X and its hydrochloride | X and its hydrochloride | X | X | ||
L-leucine | X and its hydrochloride | X and its hydrochloride | X | X | ||
L-lysine | X and its hydrochloride | X and its hydrochloride | X | X | ||
L-lysine acetate | X | X | ||||
L-methionine | X | X | X | X | ||
L-ornithine | X | X | ||||
L-phenylalanine | X | X | X | X | ||
L-proline | X | |||||
L-threonine | X | X | X | X | ||
L-tryptophan | X | X | X | X | ||
L-tyrosine | X | X | X | X | ||
L-valine | X | X | X | X | ||
L-serine | X | |||||
L-arginine-L-aspartate | X | |||||
L-lysine-L-aspartate | X | |||||
L-lysine-L-glutamate | X | |||||
N-acetyl-L-cysteine | X | |||||
N-acetyl-L-methionine | X (in products intended for persons over 1 year of age) | |||||
Carnitine and taurine | ||||||
L-carnitine | X | X | X | X | ||
L-carnitine hydrochloride | X | X | X | X | ||
taurine | X | X | X | |||
L-carnitine-L-tartrate | X | X | X | |||
Nucleotides | ||||||
adenosine 5’-phosphoric acid (AMP) | X | X | X | |||
sodium salts of AMP | X | X | X | |||
cytidine 5’-monophosphoric acid (CMP) | X | X | X | |||
sodium salts of CMP | X | X | X | |||
guanosine 5’-phosphoric acid (GMP) | X | X | X | |||
sodium salts of GMP | X | X | X | |||
inosine 5’-phosphoric acid (IMP) | X | X | X | |||
sodium salts of IMP | X | X | X | |||
uridine 5’-phosphoric acid (UMP) | X | X | X | |||
sodium salts of UMP | X | X | X | |||
Choline and inositol | ||||||
choline | X | X | X | X | ||
choline chloride | X | X | X | X | ||
choline bitartrate | X | X | X | X | ||
choline citrate | X | X | X | X | ||
inositol | X | X | X | X |
Textual Amendments
F1Words in Annex heading substituted (E.W.S.) (31.12.2020) by The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 19(19) (as amended by S.I. 2020/1476, regs. 1(2), 5(4)(a)); 2020 c. 1, Sch. 5 para. 1(1)
F2Words in Annex table substituted (10.2.2023) by The Food Supplements and Food for Specific Groups (Miscellaneous Amendments) Regulations 2023 (S.I. 2023/28), regs. 1(2), 3(2) (as amended by S.I. 2023/131, regs. 1(3), 2)
F3Inserted by Commission Delegated Regulation (EU) 2017/1091 of 10 April 2017 amending the Annex to Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the list of substances that may be added to processed cereal-based food and baby food and to food for special medical purposes (Text with EEA relevance).
F4Substituted by Commission Delegated Regulation (EU) 2017/1091 of 10 April 2017 amending the Annex to Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the list of substances that may be added to processed cereal-based food and baby food and to food for special medical purposes (Text with EEA relevance).
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