EN    EN EN 
 EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 
C(2009) final 
Draft 
COMMISSION REGULATION 
of 
on substances that may be added for specific nutritional purposes in foods for particular 
nutritional uses 
(Text with EEA relevance) EN 2   EN Draft 
COMMISSION REGULATION 
of 
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 esta blishing the European Community, 
Having regard to Council Dir ective 89/398/EEC of 3 May 1989 on the approximation of the 
laws of the Member States relating to foods tuffs intended for par ticular nutritional uses1, and 
in particular Article 4(2) thereof, 
After consulting the European Food Safety Authority, Whereas: (1) A number of nutritional substa nces such as vitamins, minerals, amino acids and others 
may be added to foods for particular nutrit ional 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 89/398/ EEC. The list of those 
substances had been established by Commi ssion Directive 2001/15/ EC of 15 February 
2001 on substances that may be added for spec ific nutritio nal purposes in foods for 
particular nutritional uses
2 and, following requests submitted by interested parties, new 
substances have been evaluated by th e 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 defi ne nutritional substances as a distinct group for the purpose 
of this Regulation nor to draw up at this st age 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 particul ar nutritional uses is very wide and diversified and the 
technological processes used for their ma nufacture are varied. For this reason, the 
widest possible choice of substances that can be safely used in the manufacture of 
foods for particular nutritional uses should be  available for the categories of nutritional 
substances to be listed in this Regulation. 
(4) The choice of substances should be based pr imarily on their safety and subsequently 
on their availability  for use by humans and on their organoleptic and technological 
                                                 
1 OJ L 186, 30.6.1989, p. 27. 
2 OJ L 52, 22.2.2001, p. 19. EN 3   EN properties. Unless otherwise spec ified in provisions applicable to specific categories of 
foodstuffs, the inclusion of substances in th e list of those that may be used in the 
manufacture of foodstuffs for particular nutritional 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 condi tions, 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 di rectives, nutritional substances should be 
used in order to manufacture products that are in conformity with  the definition of 
such products and fulfil the particular nut ritional requirements of the persons for 
whom they are intended. The products in question must also be safe when used as instructed by the manufacturer. 
(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 dow n in Commission 
Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on 
formulae
3, and Commission Directive 2006/125/EC  of 5 December 2006 on processed 
cereal-based foods and baby foods  for infants and young children4. Therefore those 
provisions need not be rep eated in this Regulation. 
(8) A number of the nutritional substances ma y be added for technological purposes as 
additives, colourings, flavourings or other such uses including authorised oenological 
practices and processes provided for by re levant 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. 
(9) Pending the adoption of purity criteria for th e rest of the substa nces at Community 
level, and in order to ensure a high leve l of protection for publ ic health, generally 
acceptable purity criteria recommended by inte rnational 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 st ricter 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 f oodstuffs belonging to the group of foodstuffs 
for special medical purposes and their pot ential use should be reserved to the 
manufacture of these products. 
(11) For the sake of clarity, Directive 2001/ 15/EC and Directive 2004/6/EC derogating 
from Directive 2001/15/EC to postpone the appl ication of the prohibition of trade to 
certain products
5 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, 
                                                 
3 OJ L 401, 30.12.2006, p. 1. 
4 OJ L 339, 6.12.2006, p. 16. 
5 OJ L 15, 22.1.2004, p. 31. EN 4   EN HAS ADOPTED THIS REGULATION: 
Article 1 
Scope 
This Regulation shall apply to foods for partic ular 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 adde d for specific nutritional purposes in the 
manufacture of foodstuffs fo r particular nutritional us es covered by Directive 
89/398/EEC. 
2. Without prejudice to Regulation (EC) No 258/97 of the European Parliament and of 
the Council6, also substances not be longing to the categories appearing in the Annex 
to this Regulation may be added for specifi c nutritional purposes in the manufacture 
of foods for particul ar 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 th e particular nutritiona l requirements of the 
persons for whom they are intended, as es tablished by generally accepted scientific 
data. 
2. Upon request by the competent authorities referred to in Artic le 9 of Directive 
89/398/EEC, the manufacturer or, where appr opriate, the importer shall produce the 
scientific work and the data establishing th at the use of the substances complies with 
paragraph 1. If such work and data are cont ained in a readily available publication, a 
mere reference to that publication shall suffice. 
Article 4 
Specific requirements for substances listed in the Annex 
1. The use of the substances listed in the A nnex to this Regulation shall comply with 
any specific provisions concerning those substances that may be laid down in 
specific directives provided for in Ar ticle 4(1) of Directive 89/398/EEC. 
2. Purity criteria established by Community legislation which appl y 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 sh all 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 cr iteria are not established by 
Community legislation, and until the adop tion of such specifications, generally 
                                                 
6 OJ L 43, 14.2.1997, p. 1. EN 5   EN acceptable purity criteria recommended by in ternational bodies shall apply. National 
rules setting stricter purity criteria may be maintained. 
Article 5 
Repeals 
Directive 2001/15/EC and Directive 2004/6/EC ar e repealed with effect from 31 December 
2009. 
Article 6 
Entry into force and application 
This Regulation shall enter into  force on the 20th day following th at of 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, 
 For the Commission 
 Androulla VASSILIOU  Member of the Commission EN 6   EN ANNEX  
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 incl uding foods for special 
medical purposes but excluding infant fo rmulae, follow-on formulae, processed 
cereal-based foods and baby foods in tended for infants and young children, 
– ‘Foods for special medical purposes' m eans dietary foods for special medical 
purposes as defined in Directive 1999/21/ EC of 25 March 1999 on dietary foods for 
special medical purposes7.  
Condition of use 
Substance 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  
menaquinone8 x  
VITAMIN B1   
thiamin hydrochloride x  
                                                 
7 OJ L 91, 7.4.1999, p. 29–36. 
8 Menaquinone occurring principally as menaquinone-7 and, to a minor extent, menaquinone-6. EN 7   EN 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  EN 8   EN 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  EN 9   EN 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  EN 10   EN 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 yeast9 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  
                                                 
9 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 selenomet hionine (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. EN 11   EN 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  EN 12   EN 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