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)  
THE COMMISSION OF THE EUROPEAN COMMUNITIES,  
Having regard to the Treaty establishing the European 
Community,  
Having regard to Directive 2009/39/EC of the European 
Parliament and the Council of 6 May 2009 on foodstuffs 
intended for particular nutritional uses (  1 ), and in particular 
Article 4(3) thereof,  
After consulting the European Food Safety Authority,  
Whereas:  
(1) A number of nutritional substances such as vitamins, 
minerals, amino acids and others may be added to 
foods for particular nutritional uses in order to ensure 
that the particular nutritional requirements of the persons 
for whom those foods are intended are fulfilled and/or in 
order to satisfy legal requirements laid down in specific 
directives adopted pursuant to Article 4(1) of Directive 
2009/39/EC. The list of those substances had been estab ­
lished by Commission Directive 2001/15/EC of 
15 February 2001 on substances that may be added 
for specific nutritional purposes in foods for particular 
nutritional uses (  2 ) and, following requests submitted by 
interested parties, new substances have been evaluated by 
the European Food Safety Authority, and consequently, 
that list should be completed and updated. Furthermore, 
it is appropriate to introduce specifications for some 
vitamin and mineral substances for their identification.  
(2) It is neither possible to define nutritional substances as a 
distinct group for the purpose of this Regulation nor to 
draw up at this stage an exhaustive list of all categories of 
nutritional substances that may be added in foodstuffs 
for particular nutritional uses.  
(3) The range of foods for particular nutritional uses is very 
wide and diversified and the technological processes used 
for their manufacture are varied. For this reason, the 
widest possible choice of substances that can be safely 
used in the manufacture of foods for particular nutri ­
tional uses should be available for the categories of nutri ­
tional substances to be listed in this Regulation.  (4) The choice of substances should be based primarily on 
their safety and subsequently on their availability for use 
by humans and on their organoleptic and technological 
properties. Unless otherwise specified in provisions 
applicable to specific categories of foodstuffs, the 
inclusion of substances in the list of those that may be 
used in the manufacture of foodstuffs for particular nutri ­
tional uses does not mean that their addition to those 
foodstuffs is necessary or desirable.  
(5) Where the addition of a nutritional substance has been 
judged necessary, this has been stipulated by specific 
rules in the relevant specific directives together with the 
appropriate quantitative conditions, as the case may be.  
(6) In the absence of any specific rules or in the case of 
foodstuffs for particular nutritional uses not covered by 
specific directives, nutritional substances should be used 
in order to manufacture products that are in conformity 
with the definition of such products and fulfil the 
particular nutritional requirements of the persons for 
whom they are intended. The products in question 
must also be safe when used as instructed by the manu ­
facturer.  
(7) The provisions concerning the list of the nutritional 
substances that may be used in the manufacture of 
infant formulae and follow-on formulae and of 
processed cereal-based foods and baby foods for infants 
and young children are laid down in Commission 
Directive 2006/141/EC of 22 December 2006 on 
infant formulae and follow-on formulae and amending 
Directive 1999/21/EC (  3 ), and Commission Directive 
2006/125/EC of 5 December 2006 on processed 
cereal-based foods and baby foods for infants and 
young children (  4 ). Therefore those provisions need not 
be repeated in this Regulation.  
(8) A number of the nutritional substances may be added for 
technological purposes as additives, colourings, 
flavourings or other such uses including authorised oeno ­
logical practices and processes provided for by relevant 
Community legislation. In this context specifications are 
adopted for them at Community level. It is appropriate 
that those specifications should be applicable for the 
substances whatever the purpose of their use in 
foodstuffs.EN 14.10.2009 Official Journal of the European Union L 269/9  
( 1 ) OJ L 124, 20.5.2009, p. 21.  
( 2 ) OJ L 52, 22.2.2001, p. 19.  ( 3 ) OJ L 401, 30.12.2006, p. 1.  
( 4 ) OJ L 339, 6.12.2006, p. 16.(9) Pending the adoption of purity criteria for the rest of the 
substances at Community level, and in order to ensure a 
high level of protection for public health, generally 
acceptable purity criteria recommended by international 
organisations or agencies including but not limited to the 
Joint FAO/WHO Expert Committee on Food Additives 
(JECFA) and EUP (European Pharmacopoeia) should 
apply. Member States should be permitted to maintain 
national rules setting stricter purity criteria, without 
prejudice to the rules set out in the Treaty.  
(10) Some specific nutrients or their derivatives have been 
identified as specifically necessary for the manufacture 
of some foodstuffs belonging to the group of foodstuffs 
for special medical purposes and their potential use 
should be reserved to the manufacture of these products.  
(11) For the sake of clarity, Directive 2001/15/EC and 
Commission Directive 2004/6/EC of 20 January 2004 
derogating from Directive 2001/15/EC to postpone the 
application of the prohibition of trade to certain 
products (  1 ) should be repealed and replaced by this 
Regulation.  
(12) The measures provided in this Regulation are in 
accordance with the opinion of the Standing 
Committee on the Food Chain and Animal Health,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Scope  
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  
Eligible substances  
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 (  2 ), 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  
General requirements  
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 publi ­
cation shall suffice.  
Article 4  
Specific requirements for substances listed in the Annex  
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  
Repeals  
Directive 2001/15/EC and Directive 2004/6/EC are repealed 
with effect from 31 December 2009.EN L 269/10 Official Journal of the European Union 14.10.2009  
( 1 ) OJ L 15, 22.1.2004, p. 31.  
( 2 ) OJ L 43, 14.2.1997, p. 1.Article 6  
Entry into force and application  
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 CommissionEN 14.10.2009 Official Journal of the European Union L 269/11ANNEX  
Substances that may be added for specific nutritional purposes in foods for particular nutritional uses  
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 (  1 ). 
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 (  1 ) x  
VITAMIN B1  
thiamin hydrochloride  x  
thiamin mononitrate  x  
VITAMIN B2  
riboflavin  xEN L 269/12 Official Journal of the European Union 14.10.2009  
( 1 ) OJ L 91, 7.4.1999, p. 29.Substance  Condition of use  
Dietetic foods  Foods for special medical 
purposes  
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  xEN 14.10.2009 Official Journal of the European Union L 269/13Substance  Condition of use  
Dietetic foods  Foods for special medical 
purposes  
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  xEN L 269/14 Official Journal of the European Union 14.10.2009Substance  Condition of use  
Dietetic foods  Foods for special medical 
purposes  
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  xEN 14.10.2009 Official Journal of the European Union L 269/15Substance  Condition of use  
Dietetic foods  Foods for special medical 
purposes  
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  xEN L 269/16 Official Journal of the European Union 14.10.2009Substance  Condition of use  
Dietetic foods  Foods for special medical 
purposes  
selenium enriched yeast (  2 ) 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  xEN 14.10.2009 Official Journal of the European Union L 269/17Substance  Condition of use  
Dietetic foods  Foods for special medical 
purposes  
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  xEN L 269/18 Official Journal of the European Union 14.10.2009Substance  Condition of use  
Dietetic foods  Foods for special medical 
purposes  
choline chloride  x  
choline bitartrate  x  
choline citrate  x  
inositol  x  
( 1 ) Menaquinone occurring principally as menaquinone-7 and, to a minor extent, menaquinone-6. 
( 2 ) Selenium-enriched yeasts produced by culture in the presence of sodium selenite as selenium source and containing, in the dri ed form 
as marketed, not more than 2,5 mg Se/g. The predominant organic selenium species present in the yeast is selenomethionine (betw een 
60 and 85 % of total extracted selenium in the product). The content of other organic selenium compounds including selenocystei ne 
shall not exceed 10 % of total extracted selenium. Levels of inorganic selenium normally shall not exceed 1 % of total extracte d 
selenium.EN 14.10.2009 Official Journal of the European Union L 269/19