2001L0015 — EN — 14.03.2001 — 000.001 — 1
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►B COMMISSION DIRECTIVE 2001/15/EC
of 15 February 2001
on substancesthat may be added for specific nutritional purposes in foods for particular nutritional
uses
(Text with EEA relevance)
(OJ L 52, 22.2.2001, p. 19)
Corrected by:
►C1Corrigendum, OJ L 253, 21.9.2001, p. 34 (2001/15/EC)
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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
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 89/398/EEC of 3 May 1989 on the
approximation of the laws of the Member States relating to foodstuffsintended for particular nutritional uses(
1), as last amended by European
Parliament and Council Directive 1999/41/EC(2), and in particular
Article 4(2) thereof,
After consulting the Scientific Committee for Food,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 intendedare fulfilled and/or in order to satisfy legal requirements laiddown in specific directives adopted pursuant to Article 4(1) ofDirective 89/398/EEC.
(2)It is not possible to define nutritional substances as a distinctgroup for the purpose of this Directive nor to draw up at this stagean exhaustive list of all categories of nutritional substances thatmay be added in foods for particular nutritional uses.
(3)The range of foods for particular nutritional uses is very wide anddiversified and the technological processes used for theirmanufacture are varied. For this reason, the widest possiblechoice of substances that can be safely used in the manufacture offoods for particular nutritional uses should be available for the
categories of nutritional substances to be listed in this Directive.
(4)The choice of substances should be based primarily on their
safety and subsequently on their availability for use by humansand their organoleptic and technological properties. The inclusion
of substances in the list of those that may be used in the
manufacture of foods for particular nutritional uses does not meanthat their addition to those foods 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 quantitativeconditions, as the case may be.
(6)In the absence of any specific rules or in the case of foods forparticular 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 suchproducts and fulfil the particular nutritional requirements of thepersons for whom they are intended. The products in questionmust also be safe when used as instructed by the manufacturer.
(7)The provisions concerning the list of the nutritional substancesthat may be used in the manufacture of infant formulae andfollow-on formulae and of processed cereal-based foods and babyfoodsfor infants and young children are laid downin Commission
Directive 91/321/EEC of 14 May 1991 on infant formulae and
follow-on formulae(
3), as last amended by Directive 1999/50/
EC(4), and Commission Directive 96/5/EC of 16 February 19962001L0015 — EN — 14.03.2001 — 000.001 — 2
(1) OJ L 186, 30.6.1989, p. 27.
(2) OJ L 172, 8.7.1999, p. 38.
(3) OJ L 175, 4.7.1991, p. 35.
(4) OJ L 139, 2.6.1999, p. 29.
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on processed cereal-based foods and baby foods for infants and
young children(1), as last amended by Directive 1999/39/EC(2).
Therefore those provisions need not be repeated in this Directive.
(8)A number of the nutritional substances may also be used in
foodstuffs as food additives. In this context purity criteria have
been or are to be adopted for them at Community level inaccordance with Council Directive 89/107/EEC of 21 December1988 on the approximation of the laws of the Member Statesconcerning food additives authorised for use in foodstuffs
intended for human consumption(
3), as amended by European
Parliament and Council Directive 94/34/EC(4). Those purity
criteria should be applicable for those substances whatever thepurpose of their use in foodstuffs.
(9)Pending the adoption of purity criteria for the rest of the
substances at Community Ievel, and in order to ensure a high
level of protection for public health, generally acceptable puritycriteria recommended by international organisations or agenciesincluding but not limited to the Joint FAO/WHO ExpertCommittee on Food Additives (JECFA), 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 identifiedas specifically necessary for the manufacture of some foods
belonging to the group of foods for special medical purposes and
their potential use should be reserved to the manufacture of theseproducts.
(11)The measures provided in this Directive are in accordance withthe opinion of the Standing Committee on Foodstuffs,
HAS ADOPTED THIS DIRECTIVE:
Article 1
1. For the categories of substances added for specific nutritional
purposes in foods for particular nutritional uses listed in the Annex tothis Directive only the chemical substances mentioned under each
category may be used in the manufacture of foodstuffs for particular
nutritional uses covered by Directive 89/398/EEC.
The use of those substances shall be in conformity with any specific
provisions concerning those substances that may be laid down inspecific directives provided for in Article 4(1) of Directive 89/398/EEC.
2. Without prejudice to European Parliament and Council Regulation
(EC) No 258/97(
5), other substances added for specific nutritional
purposes, not belonging to one of the categories listed in the Annex to
this Directive, may be used in the manufacture of foods for particular
nutritional uses.
3. The use of nutritional substances in foods for particular nutritional
uses shall result in the manufacture of safe products that fulfil theparticular nutritional requirements of the persons for whom they areintended as established by generally accepted scientific data.
4. The competent authorities of Member States, referred to in Article
9 of Directive 89/398/EEC, shall be empowered to require the
manufacturer or, where appropriate, the importer to produce the
scientific work and the data establishing the use of substances addedfor specific nutritional purposes in compliance with paragraph 3. If suchwork is contained in a readily available publication, a mere reference tothis publication shall suffice.2001L0015 — EN — 14.03.2001 — 000.001 — 3
(1) OJ L 49, 28.2.1996, p. 17.
(2) OJ L 124, 18.5.1999, p. 8.
(3) OJ L 40, 11.2.1989, p. 27.
(4) OJ L 237, 10.9.1994, p. 1.
(5) OJ L 43, 14.2.1997, p. 1.
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Article 2
1. Purity criteria for substances listed in the Annex, specified by
Community legislation for their use in the manufacture of foodstuffs for
purposes other than those covered by this Directive, shall apply.
2. For those substances listed in the Annex for which purity criteria
are not specified by Community legislation, and until the adoption ofsuch specifications, generally acceptable purity criteria recommended by
international bodies shall apply. National rules setting stricter purity
criteria may be maintained.
Article 3
Member States shall adopt and publish the provisions necessary to
comply with this Directive by 31 March 2002 at the latest. They shallforthwith inform the Commission thereof.
They shall apply those provisions in such a way as to:
(a) permit trade in products complying with this Directive with effect
from 1 April 2002;
(b) prohibit trade in products which do not comply with this Directive
with effect from 1 April 2004.
When Member States adopt those provisions, they shall contain a
reference to this Directive or be accompanied by such a reference on theoccasion of their official publication. Member States shall determinehow such reference is to be made.
Article 4
This Directive shall enter into force on the 20th day following its
publication in the Official Journal of the European Communities .
Article 5
This Directive is addressed to the Member States.2001L0015 — EN — 14.03.2001 — 000.001 — 4
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ANNEX
SUBSTANCES THAT MAY BE ADDED FOR SPECIFIC NUTRITIONAL PURPOSES IN
FOODS FOR PARTICULAR NUTRITIONAL USES
For the purpose of this table:
— ‘FSMP’ means foods for particular nutritional uses intended for special medical purposes,
— ‘All FPNU’ means dietary foods for particular nutritional uses including FSMPs but excluding
infant formulae, follow-on formulae, processed cereal-based foods and baby foods intended for
infants and young children.
SubstanceCondition of use
All FPNU FSMP
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
VITAMIN K— phylloquinone (phytomenadione) 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
FOLIC ACID
— pteroylmonoglutamic acid x
VITAMIN B12
— cyanocobalamin x
— hydroxocobalamin x2001L0015 — EN — 14.03.2001 — 000.001 — 5
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SubstanceCondition of use
All FPNU FSMP
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
— carbonate x
— chloride x
— salts of citric acid x
— gluconate x
— glycerophosphate x
— lactate x
— salts of orthophosphoric acid x
— hydroxide x
— oxide x
MAGNESIUM
— acetate x
— carbonate x
— chloride x
— salts of citric acid x
— gluconate x
— glycerophosphate x
— salts of orthophosphoric acid x
— lactate x
— hydroxide x
— oxide x
— sulphate 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
COPPER
— cupric carbonate x
— cupric citrate x
— cupric gluconate x2001L0015 — EN — 14.03.2001 — 000.001 — 6
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SubstanceCondition of use
All FPNU FSMP
— cupric sulphate x
— copper lysine complex x
IODINE
— potassium iodide x
— potassium iodate x
— sodium iodide x
— sodium iodate x
ZINC
— acetate x
— chloride x
— citrate x
— gluconate x
— lactate x
— oxide x
— carbonate x
— sulphate x
MANGANESE
— carbonate x
— chloride x
— citrate x
— gluconate x
— glycerophosphate x
— sulphate x
SODIUM
— bicarbonate x
— carbonate x
— chloride x
— citrate x
— gluconate x
— lactate x
— hydroxide x
— salts of orthophosphoric acid x
POTASSIUM
— bicarbonate x— carbonate x
— chloride x
— citrate x
— gluconate x
— glycerophosphate x
— lactate x
— hydroxide x
— salts of orthophosphoric acid x
SELENIUM
— sodium selenate x
— sodium hydrogen selentine x
— sodium selenite x2001L0015 — EN — 14.03.2001 — 000.001 — 7
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SubstanceCondition of use
All FPNU FSMP
CHROMIUM (III) and their hexahydrates
— chloride x— sulphate xMOLYBDENUM (VI)— ammonium molybdate x— sodium molybdate xFLUORINE— potassium fluoride x— sodium fluoride xCategory 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
For animo 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 xCategory 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— insosine 5'-phosphoric acid (IMP) x2001L0015 — EN — 14.03.2001 — 000.001 — 8
▼C1
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SubstanceCondition of use
All FPNU FSMP
— sodim 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 x2001L0015 — EN — 14.03.2001 — 000.001 — 9