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Commission Regulation (EC) No 953/2009 of 13 October 2009 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses (Text with EEA relevance)

Modified by

Commission Regulation (EU) No 1161/2011of 14 November 2011amending Directive 2002/46/EC of the European Parliament and of the Council, Regulation (EC) No 1925/2006 of the European Parliament and of the Council and Commission Regulation (EC) No 953/2009 as regards the lists of mineral substances that can be added to foods(Text with EEA relevance), 32011R1161, November 15, 2011
Regulation (EU) No 609/2013 of the European Parliament and of the Councilof 12 June 2013on 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), 32013R0609, June 29, 2013

Commission Regulation (EC) No 953/2009of 13 October 2009on substances that may be added for specific nutritional purposes in foods for particular nutritional uses(Text with EEA relevance)

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

Article 2Eligible substances1.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 CouncilOJ L 43, 14.2.1997, p. 1., 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 3General requirements1.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 4Specific requirements for substances listed in the Annex1.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 5RepealsDirective 2001/15/EC and Directive 2004/6/EC are repealed with effect from 31 December 2009.

Article 6Entry into force and applicationThis 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.ANNEXSubstances that may be added for specific nutritional purposes in foods for particular nutritional usesFor 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 purposesOJ L 91, 7.4.1999, p. 29..

Menaquinone occurring principally as menaquinone-7 and, to a minor extent, menaquinone-6.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 shall not exceed 10 % of total extracted selenium. Levels of inorganic selenium normally shall not exceed 1 % of total extracted selenium.Category 1.VitaminsVITAMIN AVITAMIN DVITAMIN EVITAMIN KVITAMIN B1VITAMIN B2NIACINPANTOTHENIC ACIDVITAMIN B6FOLATEVITAMIN B12BIOTINVITAMIN CCategory 2.MineralsCALCIUMMAGNESIUMIRONCOPPERIODINEZINCMANGANESESODIUMPOTASSIUMSELENIUMCHROMIUM (III)MOLYBDENUM (VI)FLUORINEBORONCategory 3.Amino acidsCategory 4.Carnitine and taurineCategory 5.NucleotidesCategory 6.Choline and inositol

Substance	Condition of use
Substance	Dietetic foods	Foods for special medical purposes
retinol	x
retinyl acetate	x
retinyl palmitate	x
beta-carotene	x
cholecalciferol	x
ergocalciferol	x
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
phylloquinone (phytomenadione)	x
menaquinone	x
thiamin hydrochloride	x
thiamin mononitrate	x
riboflavin	x
riboflavin 5'-phosphate, sodium	x
nicotinic acid	x
nicotinamide	x
D-pantothenate, calcium	x
D-pantothenate, sodium	x
dexpanthenol	x
pyridoxine hydrochloride	x
pyridoxine 5'-phosphate	x
pyridoxine dipalmitate	x
pteroylmonoglutamic acid	x
calcium-L-methylfolate	x
cyanocobalamin	x
hydroxocobalamin	x
D-biotin	x
L-ascorbic acid	x
sodium-L-ascorbate	x
calcium-L-ascorbate	x
potassium-L-ascorbate	x
L-ascorbyl 6-palmitate	x
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 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
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
ferrous ammonium phosphate	x
ferric sodium EDTA	x
ferric diphosphate (ferric pyrophosphate)	x
ferric saccharate	x
elemental iron (carbonyl + electrolytic + hydrogen reduced)	x
ferrous bisglycinate	x
ferrous L-pidolate	x
cupric carbonate	x
cupric citrate	x
cupric gluconate	x
cupric sulphate	x
copper lysine complex	x
potassium iodide	x
potassium iodate	x
sodium iodide	x
sodium iodate	x
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 carbonate	x
manganese chloride	x
manganese citrate	x
manganese gluconate	x
manganese glycerophosphate	x
manganese sulphate	x
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 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
sodium selenate	x
sodium hydrogen selenite	x
sodium selenite	x
selenium enriched yeast	x
chromium (III) chloride and its hexahydrate	x
chromium (III) sulphate and its hexahydrate	x
chromium picolinate	x
ammonium molybdate	x
sodium molybdate	x
potassium fluoride	x
sodium fluoride	x
sodium borate	x
boric acid	x
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
L-carnitine	x
L-carnitine hydrochloride	x
taurine	x
L-carnitine-L-tartrate	x
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
choline	x
choline chloride	x
choline bitartrate	x
choline citrate	x
inositol	x

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

Article 5RepealsDirective 2001/15/EC and Directive 2004/6/EC are repealed with effect from 31 December 2009.

Substance	Condition of use
Substance	Dietetic foods	Foods for special medical purposes
retinol	x
retinyl acetate	x
retinyl palmitate	x
beta-carotene	x
cholecalciferol	x
ergocalciferol	x
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
phylloquinone (phytomenadione)	x
menaquinone	x
thiamin hydrochloride	x
thiamin mononitrate	x
riboflavin	x
riboflavin 5'-phosphate, sodium	x
nicotinic acid	x
nicotinamide	x
D-pantothenate, calcium	x
D-pantothenate, sodium	x
dexpanthenol	x
pyridoxine hydrochloride	x
pyridoxine 5'-phosphate	x
pyridoxine dipalmitate	x
pteroylmonoglutamic acid	x
calcium-L-methylfolate	x
cyanocobalamin	x
hydroxocobalamin	x
D-biotin	x
L-ascorbic acid	x
sodium-L-ascorbate	x
calcium-L-ascorbate	x
potassium-L-ascorbate	x
L-ascorbyl 6-palmitate	x
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 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
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
ferrous ammonium phosphate	x
ferric sodium EDTA	x
ferric diphosphate (ferric pyrophosphate)	x
ferric saccharate	x
elemental iron (carbonyl + electrolytic + hydrogen reduced)	x
ferrous bisglycinate	x
ferrous L-pidolate	x
cupric carbonate	x
cupric citrate	x
cupric gluconate	x
cupric sulphate	x
copper lysine complex	x
potassium iodide	x
potassium iodate	x
sodium iodide	x
sodium iodate	x
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 carbonate	x
manganese chloride	x
manganese citrate	x
manganese gluconate	x
manganese glycerophosphate	x
manganese sulphate	x
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 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
sodium selenate	x
sodium hydrogen selenite	x
sodium selenite	x
selenium enriched yeast	x
chromium (III) chloride and its hexahydrate	x
chromium (III) sulphate and its hexahydrate	x
chromium picolinate	x
ammonium molybdate	x
sodium molybdate	x
potassium fluoride	x
sodium fluoride	x
sodium borate	x
boric acid	x
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
L-carnitine	x
L-carnitine hydrochloride	x
taurine	x
L-carnitine-L-tartrate	x
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
choline	x
choline chloride	x
choline bitartrate	x
choline citrate	x
inositol	x