
Article 1 
This Regulation shall apply to foods for particular nutritional uses, excluding those covered by Directive 2006/125/EC and Directive 2006/141/EC.
Article 2 

1. Among the substances belonging to the categories appearing in Annex to this Regulation, only those listed in that Annex, complying with the relevant specifications as necessary may be added for specific nutritional purposes in the manufacture of foodstuffs for particular nutritional uses covered by Directive 2009/39/EC.
2. Without prejudice to Regulation (EC) No 258/97 of the European Parliament and of the Council, also substances not belonging to the categories appearing in the Annex to this Regulation may be added for specific nutritional purposes in the manufacture of foods for particular nutritional uses.
Article 3 

1. The use of substances added for specific nutritional purposes shall result in the manufacture of safe products that fulfil the particular nutritional requirements of the persons for whom they are intended, as established by generally accepted scientific data.
2. Upon request by the competent authorities referred to in Article 11 of Directive 2009/39/EC, the manufacturer or, where appropriate, the importer shall produce the scientific work and the data establishing that the use of the substances complies with paragraph 1. If such work and data are contained in a readily available publication, a mere reference to that publication shall suffice.
Article 4 

1. The use of the substances listed in the Annex to this Regulation shall comply with any specific provisions concerning those substances that may be laid down in specific directives provided for in Article 4(1) of Directive 2009/39/EC.
2. Purity criteria established by Community legislation which apply to the substances listed in the Annex when they are used in the manufacture of foodstuffs for purposes other than those covered by this Regulation shall also apply to those substances when they are used for purposes covered by this Regulation.
3. For substances listed in the Annex for which purity criteria are not established by Community legislation, and until the adoption of such specifications, generally acceptable purity criteria recommended by international bodies shall apply. National rules setting stricter purity criteria may be maintained.
Article 5 
Directive 2001/15/EC and Directive 2004/6/EC are repealed with effect from 31 December 2009.
Article 6 
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
It shall apply as from 1 January 2010.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 13 October 2009.
For the Commission
Androulla VASSILIOU
Member of the Commission
ANNEX

For the purpose of this table:

— ‘Dietetic foods’ means foods for particular nutritional uses including foods for special medical purposes but excluding infant formulae, follow-on formulae, processed cereal-based foods and baby foods intended for infants and young children,
— ‘Foods for special medical purposes’ means dietary foods for special medical purposes as defined in Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes.

Substance Condition of use
Dietetic foods Foods for special medical purposes
Category 1.Vitamins
VITAMIN A
retinol x 
retinyl acetate x 
retinyl palmitate x 
beta-carotene x 
VITAMIN D
cholecalciferol x 
ergocalciferol x 
VITAMIN E
D-alpha-tocopherol x 
DL-alpha-tocopherol x 
D-alpha-tocopheryl acetate x 
DL-alpha-tocopheryl acetate x 
D-alpha-tocopheryl acid succinate x 
D-alpha-tocopheryl polyethylene glycol-1000 succinate (TPGS)  x
VITAMIN K
phylloquinone (phytomenadione) x 
menaquinone x 
VITAMIN B1
thiamin hydrochloride x 
thiamin mononitrate x 
VITAMIN B2
riboflavin x 
riboflavin 5'-phosphate, sodium x 
NIACIN
nicotinic acid x 
nicotinamide x 
PANTOTHENIC ACID
D-pantothenate, calcium x 
D-pantothenate, sodium x 
dexpanthenol x 
VITAMIN B6
pyridoxine hydrochloride x 
pyridoxine 5'-phosphate x 
pyridoxine dipalmitate x 
FOLATE
pteroylmonoglutamic acid x 
calcium-L-methylfolate x 
VITAMIN B12
cyanocobalamin x 
hydroxocobalamin x 
BIOTIN
D-biotin x 
VITAMIN C
L-ascorbic acid x 
sodium-L-ascorbate x 
calcium-L-ascorbate x 
potassium-L-ascorbate x 
L-ascorbyl 6-palmitate x 
Category 2.Minerals
CALCIUM
calcium carbonate x 
calcium chloride x 
calcium salts of citric acid x 
calcium gluconate x 
calcium glycerophosphate x 
calcium lactate x 
calcium salts of orthophosphoric acid x 
calcium hydroxide x 
calcium oxide x 
calcium sulphate x 
calcium bisglycinate x 
calcium citrate malate x 
calcium malate x 
calcium L-pidolate x 
MAGNESIUM
magnesium acetate x 
magnesium carbonate x 
magnesium chloride x 
magnesium salts of citric acid x 
magnesium gluconate x 
magnesium glycerophosphate x 
magnesium salts of orthophosphoric acid x 
magnesium lactate x 
magnesium hydroxide x 
magnesium oxide x 
magnesium sulphate x 
magnesium L-aspartate  x
magnesium bisglycinate x 
magnesium L-pidolate x 
magnesium potassium citrate x 
IRON
ferrous carbonate x 
ferrous citrate x 
ferric ammonium citrate x 
ferrous gluconate x 
ferrous fumarate x 
ferric sodium diphosphate x 
ferrous lactate x 
ferrous sulphate x 
ferric diphosphate (ferric pyrophosphate) x 
ferric saccharate x 
elemental iron (carbonyl + electrolytic + hydrogen reduced) x 
ferrous bisglycinate x 
ferrous L-pidolate x 
COPPER
cupric carbonate x 
cupric citrate x 
cupric gluconate x 
cupric sulphate x 
copper lysine complex x 
IODINE
potassium iodide x 
potassium iodate x 
sodium iodide x 
sodium iodate x 
ZINC
zinc acetate x 
zinc chloride x 
zinc citrate x 
zinc gluconate x 
zinc lactate x 
zinc oxide x 
zinc carbonate x 
zinc sulphate x 
zinc bisglycinate x 
MANGANESE
manganese carbonate x 
manganese chloride x 
manganese citrate x 
manganese gluconate x 
manganese glycerophosphate x 
manganese sulphate x 
SODIUM
sodium bicarbonate x 
sodium carbonate x 
sodium chloride x 
sodium citrate x 
sodium gluconate x 
sodium lactate x 
sodium hydroxide x 
sodium salts of orthophosphoric acid x 
POTASSIUM
potassium bicarbonate x 
potassium carbonate x 
potassium chloride x 
potassium citrate x 
potassium gluconate x 
potassium glycerophosphate x 
potassium lactate x 
potassium hydroxide x 
potassium salts of orthophosphoric acid x 
magnesium potassium citrate x 
SELENIUM
sodium selenate x 
sodium hydrogen selenite x 
sodium selenite x 
selenium enriched yeast x 
CHROMIUM (III)
chromium (III) chloride and its hexahydrate x 
chromium (III) sulphate and its hexahydrate x 
MOLYBDENUM (VI)
ammonium molybdate x 
sodium molybdate x 
FLUORINE
potassium fluoride x 
sodium fluoride x 
BORON
sodium borate x 
boric acid x 
Category 3.Amino acids
L-alanine x 
L-arginine x 
L-aspartic acid  x
L-citrulline  x
L-cysteine x 
Cystine x 
L-histidine x 
L-glutamic acid x 
L-glutamine x 
glycine  x
L-isoleucine x 
L-leucine x 
L-lysine x 
L-lysine acetate x 
L-methionine x 
L-ornithine x 
L-phenylalanine x 
L-proline  x
L-threonine x 
L-tryptophan x 
L-tyrosine x 
L-valine 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
For amino acids, as far as applicable, also the sodium, potassium calcium and magnesium salts as well as their hydrochlorides may be used  
Category 4.Carnitine and taurine
L-carnitine x 
L-carnitine hydrochloride x 
taurine x 
L-carnitine-L-tartrate x 
Category 5.Nucleotides
adenosine 5'-phosphoric acid (AMP) x 
sodium salts of AMP x 
cytidine 5'-monophosphoric acid (CMP) x 
sodium salts of CMP x 
guanosine 5'-phosphoric acid (GMP) x 
sodium salts of GMP x 
inosine 5'-phosphoric acid (IMP) x 
sodium salts of IMP x 
uridine 5'-phosphoric acid (UMP) x 
sodium salts of UMP x 
Category 6.Choline and inositol
choline x 
choline chloride x 
choline bitartrate x 
choline citrate x 
inositol x 

