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)
Date: 2001-02-15
Institutions: European Commission
Subjects: food additive, foodstuff, foodstuffs legislation, human nutrition, nutrition

22.2.2001

EN

Official Journal of the European Communities

L 52/19

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,

(6)

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 foodstuffs intended 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)

(2)

(3)

(4)

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
89/398/EEC.

It is not possible to define nutritional substances as a
distinct group for the purpose of this Directive nor to
draw up at this stage an exhaustive list of all categories
of nutritional substances that may be added in foods for
particular nutritional uses.

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
nutritional uses should be available for the categories of
nutritional substances to be listed in this Directive.

The choice of substances should be based primarily on
their safety and subsequently on their availability for use
by humans and 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 mean that their addi-
tion 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 quantitative conditions, as the case may be.

(1) OJ L 186, 30.6.1989, p. 27.
(2) OJ L 172, 8.7.1999, p. 38.

In the absence of any specific rules or in the case of
foods 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 partic-
ular nutritional requirements of the persons for whom
they are intended. The products in question must also be
safe when used as instructed by the manufacturer.

formulae

and follow-on formulae

The provisions concerning the list of the nutritional
substances that may be used in the manufacture of
infant
and of
processed cereal-based foods and baby foods for infants
and young children are laid down in 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 1996 on processed cereal-based
foods and baby foods for infants and young children (5),
as last amended by Directive 1999/39/EC (6). Therefore
those provisions need not be repeated in this Directive.

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
in accordance with Council
Directive 89/107/EEC of 21 December 1988 on the
approximation of
the Member States
the laws of
concerning food additives authorised for use in food-
stuffs intended for human consumption (7), as amended
by European Parliament and Council Directive 94/34/
EC (8). Those purity criteria should be applicable for
those substances whatever the purpose of their use in
foodstuffs.

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 purity criteria recommended by international
organisations or agencies including but not limited to
the Joint FAO/WHO Expert Committee on Food Addi-
tives (JECFA), EUP (European Pharmacopoeia) should
apply. Member States should be permitted to maintain
national rules setting stricter purity criteria, without prej-
udice to the rules set out in the Treaty.

(7)

(8)

(9)

(3) OJ L 175, 4.7.1991, p. 35.
(4) OJ L 139, 2.6.1999, p. 29.
(5) OJ L 49, 28.2.1996, p. 17.
(6) OJ L 124, 18.5.1999, p. 8.
(7) OJ L 40, 11.2.1989, p. 27.
(8) OJ L 237, 10.9.1994, p. 1.

L 52/20

EN

Official Journal of the European Communities

22.2.2001

(10)

Some specific nutrients or their derivatives have been
identified as 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 these products.

(11)

The measures provided in this Directive are in accord-
ance with the opinion of the Standing Committee on
Foodstuffs,

HAS ADOPTED THIS DIRECTIVE:

Article 1

For the categories of substances added for specific nutri-
1.
tional purposes in foods for particular nutritional uses listed in
the Annex to this Directive only the chemical substances
mentioned under each category may be used in the manufac-
ture 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 in specific 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 (1), other substances added for
specific nutritional purposes, not belonging to one of the cate-
gories 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 the particular nutritional requirements of the persons
for whom they are intended as established by generally
accepted scientific data.

The competent authorities of Member States, referred to
4.
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 added for specific nutritional purposes in compli-
ance with paragraph 3. If such work is contained in a readily
available publication, a mere reference to this publication shall
suffice.

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 of such 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 shall forthwith 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.

those provisions,

they shall
When Member States adopt
contain a reference to this Directive or be accompanied by
such a reference on the occasion of their official publication.
Member States shall determine how 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.

This Directive is addressed to the Member States.

Article 5

Done at Brussels, 15 February 2001.

For the Commission

David BYRNE

Member of the Commission

(1) OJ L 43, 14.2.1997, p. 1.

22.2.2001

EN

Official Journal of the European Communities

L 52/21

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.

Substance

Condition of use

All FPNU

FSMP

Category 1. Vitamins

VITAMIN A

— retinol

— retinyl acetate

— retinyl palmitate

— beta-carotene

VITAMIN D

— cholecalciferol

— ergocalciferol

VITAMIN E

— D-alpha-tocopherol

— DL-alpha-tocopherol

— D-alpha-tocopheryl acetate

— DL-alpha-tocopheryl acetate

— D-alpha-tocopheryl acid succinate

VITAMIN K

— phylloquinone (phytomenadione)

VITAMIN B1

— thiamin hydrochloride

— thiamin mononitrate

VITAMIN B2

— riboflavin

— riboflavin 5'-phosphate, sodium

NIACIN

— nicotinic acid

— nicotinamide

PANTOTHENIC ACID

— D-pantothenate, calcium

— D-pantothenate, sodium

— dexpanthenol

VITAMIN B6

— pyridoxine hydrochloride

— pyridoxine 5'-phosphate

— pyridoxine dipalmitate

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

L 52/22

EN

Official Journal of the European Communities

22.2.2001

Substance

Condition of use

All FPNU

FSMP

FOLIC ACID

— pteroylmonoglutamic acid

VITAMIN B12

— cyanocobalamin

— hydroxocobalamin

BIOTIN

— D-biotin

VITAMIN C

— L-ascorbic acid

— sodium-L-ascorbate

— calcium-L-ascorbate

— potassium-L-ascorbate

— L-ascorbyl 6-palmitate

Category 2. Minerals

CALCIUM

— carbonate

— chloride

— salts of citric acid

— gluconate

— glycerophosphate

— lactate

— salts of orthophosphoric acid

— hydroxide

— oxide

MAGNESIUM

— acetate

— carbonate

— chloride

— salts of citric acid

— gluconate

— glycerophosphate

— salts of orthophosphoric acid

— lactate

— hydroxide

— oxide

— sulphate

IRON

— ferrous carbonate

— ferrous citrate

— ferric ammonium citrate

— ferrous gluconate

— ferrous fumarate

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

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Official Journal of the European Communities

L 52/23

Substance

Condition of use

All FPNU

FSMP

— ferric sodium diphosphate

— ferrous lactate

— ferrous sulphate

— ferric diphosphate (ferric pyrophosphate)

— ferric saccharate

— elemental

iron (carbonyl + electrolytic + hydrogen reduced)

COPPER

— cupric carbonate

— cupric citrate

— cupric gluconate

— cupric sulphate

— copper lysine complex

IODINE

— potassium iodide

— potassium iodate

— sodium iodide

— sodium iodate

ZINC

— acetate

— chloride

— citrate

— gluconate

— lactate

— oxide

— carbonate

— sulphate

MANGANESE

— carbonate

— chloride

— citrate

— gluconate

— glycerophosphate

— sulphate

SODIUM

— bicarbonate

— carbonate

— chloride

— citrate

— gluconate

— lactate

— hydroxide

— salts of orthophosphoric acid

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

L 52/24

EN

Official Journal of the European Communities

22.2.2001

Substance

Condition of use

All FPNU

FSMP

POTASSIUM

— bicarbonate

— carbonate

— chloride

— citrate

— gluconate

— glycerophosphate

— lactate

— hydroxide

— salts of orthophosphoric acid

SELENIUM

— sodium selenate

— sodium hydrogen selentine

— sodium selenite

CHROMIUM (III) and their hexahydrates

— chloride

— sulphate

MOLYBDENUM (VI)

— ammonium molybdate

— sodium molybdate

FLUORINE

— potassium fluoride

— sodium fluoride

Category 3. Amino acids

— L-alanine

— L-arginine

— L-aspartic acid

— L-citrulline

— L-cysteine

— Cystine

— L-histidine

— L-glutamic acid

— L-glutamine

— glycine

— L-isoleucine

— L-leucine

— L-lysine

— L-lysine acetate

— L-methionine

— L-ornithine

— L-phenylalanine

— L-proline

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

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Official Journal of the European Communities

L 52/25

Substance

Condition of use

All FPNU

FSMP

— L-threonine

— L-tryptophan

— L-tyrosine

— L-valine

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

— L-carnitine hydrochloride

— taurine

Category 5. Nucleotides

— adenosine 5'-phosphoric acid (AMP)

— sodium salts of AMP

— cytidine 5'-monophosphoric acid (CMP)

— sodium salts of CMP

— guanosine 5'-phosphoric acid (GMP)

— sodium salts of GMP

— insosine 5'-phosphoric acid (IMP)

— sodim salts of IMP

— uridine 5'-phosphoric acid (UMP)

— sodium salts of UMP

Category 6. Choline and inositol

— choline

— choline chloride

— choline bitartrate

— choline citrate

— inositol

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x