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)
CHAPTER I
GENERAL PROVISIONS
Article 1
Subject matter
Article 2
Definitions
Article 3
Interpretation decisions
Article 4
Placing on the market
Article 5
Precautionary principle
CHAPTER II
COMPOSITIONAL AND INFORMATION REQUIREMENTS
SECTION 1
General requirements
Article 6
General provisions
Article 7
Opinions of the Authority
Article 8
Access to documents
Article 9
General compositional and information requirements
Article 10
Additional requirements for infant formula and follow-on formula
SECTION 2
Specific requirements
Article 11
Specific compositional and information requirements
Article 12
Milk-based drinks and similar products intended for young children
Article 13
Food intended for sportspeople
Article 14
Technical guidelines
CHAPTER III
UNION LIST
Article 15
Union list
Article 16
Updating the Union list
CHAPTER IV
PROCEDURAL PROVISIONS
Article 17
Committee procedure
Article 18
Exercise of the delegation
Article 19
Urgency procedure
CHAPTER V
FINAL PROVISIONS
Article 20
Repeal
Article 21
Transitional measures
Article 22
Entry into force
ANNEX
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 |
||
Menaquinone(1) |
|
|
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 |
||
calcium-L-methylfolate |
|
|
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 |
||
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 |
||
ferrous bisglycinate |
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 yeast(2) |
|
|
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 acids(3) |
|
|
|
|
|
|
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 |
||
Cystine(4) |
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 |