Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes (Text with EEA relevance)
Date: 1999-03-25
Institutions: European Commission
Subjects: consumer information, dietary product, foodstuff, human nutrition, labelling, nutritional needs, product designation, therapeutics

7. 4. 1999

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Official Journal of the European Communities

L 91/29

COMMISSION DIRECTIVE 1999/21/EC

of 25 March 1999

on dietary foods for special medical purposes

(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 foodstuffs intended for particular nutri-
tional uses (1), as amended by Directive 96/84/EC of the
European Parliament and of the Council (2), and in par-
ticular Article 4(1) thereof,

After consulting the Scientific Committee for food,

(1) Whereas dietary foods for special medical purposes
are intended to meet
the particular nutritional
requirements of persons affected by or malnourished
because of a specific disease, disorder or medical
condition; whereas for this reason they must be used
under medical supervision which may be applied
with the assistance of other competent health profes-
sionals;

(2) Whereas such foods are numerous and their compo-
sition may differ substantially depending on the
specific disease, disorder or medical condition of the
patients for whom they are intended, the age of the
patients and the place in which they receive health
care support, on whether the foods are intended to
be used as the sole source of nourishment or not, and
possibly on other factors;

(3) Whereas, because of the wide diversity of such foods
and the rapidly evolving scientific knowledge on
which they are based, it is not appropriate to lay
down detailed compositional rules;

(4) Whereas, however,

some basic rules concerning
vitamin and mineral substances content can be laid
down for products considered to be nutritionally
complete for covering the particular nutritional
requirements of
the intended user; whereas such
rules for nutritionally incomplete foods can be laid
down only for
these
substances as appropriate;

the maximum levels of

nical progress will be decided in accordance with the
procedure laid down in Article 13 of Directive 89/
398/EEC;

(6) Whereas pursuant to Article 4(2) of Directive 89/
398/EEC, the provisions relating to the substances
with specific nutritional purposes to be used in the
manufacture of foods for special medical purposes
should be laid down in a separate Commission
directive;

(7) Whereas pursuant

to Article 7 of Directive 89/
398/EEC, the products covered by that Directive are
subject to the general rules laid down by Council
Directive 79/112/EEC of 18 December 1978 on the
approximation of
the Member States
the laws of
relating to the labelling, presentation and advertising
foodstuffs (3), as last amended by Commission
of
present
Directive
Directive adopts and expands upon the additions and
exceptions to those general rules, where appropriate;

1999/10/EC (4); whereas

the

(8) Whereas, in particular, in view of the nature and
special medical
for
destination of dietary foods
purposes,
is necessary to provide information
concerning the energy value and principal nutrients
contained in such foods;

it

(9) Whereas, given the particular nature of dietary foods
for special medical purposes, additional means to
those usually available to monitoring bodies should
be available in order to facilitate efficient monitoring
of those products;

it

(10) Whereas, in accordance with the principle of propor-
tionality,
is necessary and appropriate for the
achievement of the basic objective of approximating
the laws of the Member States relating to foodstuffs
intended for particular nutritional uses to lay down
rules on foods for special medical purposes; whereas
this Directive confines itself to what is necessary in
order to achieve the objectives pursued in accordance
with the third paragraph of Article 3b of the Treaty;

(5) Whereas this Directive reflects current knowledge
about those products; whereas any modification to
allow for innovation based on scientific and tech-

(11) Whereas the measures provided for in this Directive
are in accordance with the opinion of the Standing
Committee on foodstuffs,

(1) OJ L 186, 30.6.1989, p. 27.
(2) OJ L 48, 19.2.1997, p. 20.

(3) OJ L 33, 8.2.1979, p. 1.
(4) OJ L 69, 16.3.1999, p. 22.

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Official Journal of the European Communities

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HAS ADOPTED THIS DIRECTIVE:

Article 3

Article 1

1.
This Directive is a specific Directive within the
meaning of Article 4(1) of Directive 89/398/EEC and lays
down compositional
for
dietary foods for special medical purposes as defined in
paragraph 2 and presented as such.

and labelling requirements

2.

For the purposes of this Directive:

(a)

‘infants' means children under the age of 12 months;

(b)

foods

‘dietary foods for special medical purposes' means a
category of
for particular nutritional uses
specially processed or formulated and intended for the
dietary management of patients and to be used under
medical supervision. They are intended for the exclu-
sive or partial
feeding of patients with a limited,
impaired or disturbed capacity to take, digest, absorb,
metabolise or excrete ordinary foodstuffs or certain
nutrients contained therein or metabolites, or with
other medically-determined nutrient
requirements,
whose dietary management cannot be achieved only
by modification of the normal diet, by other foods for
particular nutritional uses, or by a combination of the
two.

3. Dietary foods for special medical purposes are classi-
fied in the following three categories:

(a) nutritionally complete foods with a standard nutrient
formulation which, used in accordance with the
manufacturer’s instructions, may constitute the sole
source of nourishment for the persons for whom they
are intended;

(b) nutritionally complete foods with a nutrient-adapted
formulation specific for a disease, disorder or medical
condition which, used in accordance with the manu-
facturer’s instructions, may constitute the sole source
of nourishment for the persons for whom they are
intended;

(c) nutritionally incomplete foods with a standard formu-
lation or a nutrient-adapted formulation specific for a
disease, disorder or medical condition which are not
suitable to be used as the sole source of nourishment.

The foods referred to in points (b) and (c) may also be
used as a partial replacement or as a supplement to the
patient’s diet.

Article 2

Member States shall ensure that dietary foods for special
medical
be marketed within the
Community only if they comply with the rules laid down
in this Directive.

purposes may

The formulation of dietary foods for special medical
purposes shall be based on sound medical and nutritional
principles. Their use, in accordance with the manufac-
turer’s instructions, shall be safe and beneficial and effec-
tive in meeting the particular nutritional requirements of
the persons for whom they are intended, as demonstrated
by generally accepted scientific data.

They must comply with the compositional criteria speci-
fied in the Annex.

Article 4

The name under which dietary foods for special

1.
medical purposes are sold shall be respectively:

(cid:190) in Spanish:

‘Alimento diet(cid:130)tico para usos m(cid:130)dicos especiales'

(cid:190) in Danish:

‘Levnedsmiddel/Levnedsmidler til særlige medicinske
form(cid:134)l'
(cid:190) in German:

‘Di(cid:132)tetisches/Di(cid:132)tetische Lebensmittel f(cid:129)r besondere
medizinische Zwecke (Bilanzierte Di(cid:132)ten)'

(cid:190) in Greek:

‘Diaitgtij(cid:145) tq(cid:149)vila cia eidijo(cid:151)r iatqijo(cid:151)r sjopo(cid:151)r'

(cid:190) in English:

‘Food(s) for special medical purposes'

(cid:190) in French:

‘Aliment(s) di(cid:130)t(cid:130)tique(s) destin(cid:130)(s) a des fins m(cid:130)dicales
sp(cid:130)ciales'
(cid:190) in Italian:

‘Alimento dietetico destinato a fini medici speciali'

(cid:190) in Dutch:

‘Dieetvoeding voor medisch gebruik'

(cid:190) in Portuguese:

‘Produto diet(cid:130)tico de use cl(cid:146)nico'

(cid:190) in Finnish:

‘Kliininen ravintovalmiste/kliinisi(cid:132) ravintovalmisteita'

(cid:190) in Swedish:

‘Livsmedel f(cid:148)r speciella medicinska (cid:132)ndam(cid:134)l'.

2.
The labelling shall bear, in addition to the particu-
lars provided for in Article 3 of Directive 79/112/EEC,
the following mandatory particulars:

(a) the available energy value expressed in kJ and kcal,
and the content of protein, carbohydrate and fat,
expressed in numerical form, per 100 g or per 100 ml
of the product as sold and where appropriate per
100 g or per 100 ml of the product ready for use in
accordance with the manufacturer’s instructions. This
information may in addition be provided per serving
as quantified on the label or per portion, provided that
the number of portions contained in the package is
stated;

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Official Journal of the European Communities

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(b) the average quantity of each mineral substance and
each vitamin mentioned in the Annex present in the
product, expressed in numerical form per 100 g or per
100 ml of the product as sold and where appropriate
per 100 g or per 100 ml of the product ready for use
in accordance with the manufacturer’s instructions.
This information may in addition be provided per
serving as quantified on the label or per portion,
provided that the number of portions contained in the
package is stated;

(c) selectively the content of components of protein,
carbohydrate and fat and/or of other nutrients and
their components the declaration of which would be
necessary for the appropriate intended use of
the
product, expressed in numerical form, per 100 g or
per 100 ml of the product as sold and where appro-
priate per 100 g or per 100 ml of the product ready
for use in accordance with the manufacturer’s instruc-
tions. This information may in addition be provided
per serving as quantified on the label or per portion,
provided that the number of portions contained in the
package is stated;

(d) information on the osmolality or the osmolarity of the

product where appropriate;

(e) information on the origin and the nature of

the
protein and/or protein hydrolysates contained in the
product.

(c) a description of the properties and/or characteristics
that make the product useful in particular, as the case
may be, relating to the nutrients which have been
increased, reduced, eliminated or otherwise modified
and the rationale of the use of the product;

(d) where appropriate a warning that the product is not

for parenteral use.

The labelling shall bear instructions for the appro-
5.
priate preparation, the use and the storage of the product
after the opening of the container, as appropriate.

Article 5

1.
To facilitate efficient official monitoring of dietary
foods for special medical purposes, when a product is
placed on the market,
the manufacturer, or where a
product is manufactured in a third country, the importer,
shall notify the competent authority of the Member States
where the product is being marketed by forwarding to it a
model of the label used for the product. Member States
may,
they can demonstrate that notification is not
necessary in order to monitor those products efficiently in
their territory, not impose that obligation.

if

2.
The competent authorities within the meaning of
this Article are those referred to in Article 9(4) of
Directive 89/398/EEC.

3.
The labelling shall in addition bear the following
mandatory particulars, preceded by the words ‘important
notice' or their equivalent:

Article 6

(a) a statement that the product must be used under

medical supervision;

(b) a statement whether the product is suitable for use as

the sole source of nourishment;

(c) a statement that the product is intended for a specific

age group, as appropriate;

(d) where appropriate a statement that the product poses
a health hazard when consumed by persons who do
not have the diseases, disorders or medical conditions
for which the product is intended.

4.

The labelling shall also include:

(a) the

‘For

statement

dietary management
the
of..................' where the blank shall be filled in with the
diseases, disorders or medical conditions for which the
product is intended;

Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with
this Directive by 30 April 2000 at the latest. They shall
forthwith inform the Commission thereof.

Those laws,
shall be applied in such a way as to:

regulations and administrative provisions

(cid:190) permit

trade

in products

complying with this

Directive with effect from 1 May 2000,

(cid:190) prohibit trade in products which do not comply with
this Directive with effect from 1 November 2001.

When Member States adopt these provisions, these shall
contain a
shall be
reference to this Directive or
accompanied by such reference at the time of their offi-
cial publication. The procedure for such reference shall be
adopted by Member States.

Article 7

(b) where appropriate a statement concerning adequate

precautions and contra-indications;

This Directive shall enter into force on the twentieth day
following that of its publication in the Official Journal of
the European Communities.

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This Directive is addressed to the Member States.

Article 8

Done at Brussels, 25 March 1999.

For the Commission

Martin BANGEMANN

Member of the Commission

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ANNEX

ESSENTIAL COMPOSITION OF FOODS FOR SPECIAL MEDICAL PURPOSES

The specifications refer to the products ready for use, marketed as such or reconstituted as instructed by the
manufacturer.

1. Products referred to in Article 1(3)(a) intended specifically for infants will contain the vitamins and mineral

substances as specified in Table 1.

2. Products referred to in Article 1(3)(b) intended specifically for infants will contain the vitamins and mineral
substances as specified in Table 1, without prejudice to modifications for one or more of these nutrients
rendered necessary by the intended use of the product.

3. Maximum levels of vitamins and mineral substances present in products referred to in Article 1(3)(c)
intended specifically for infants shall not exceed those specified in Table 1, without prejudice to modifica-
tions for one or more of these nutrients rendered necessary by the intended use of the product.

4. Where this is not contrary to the requirements dictated by the intended use, foods for special medical
purposes intended specifically for infants shall comply with the provisions relating to other nutrients
laid down in Directive
applicable to infant formulae and follow-on formulae, as the case may be,
91/321/EEC and its subsequent modifications.

5. Products referred to in Article 1(3)(a), other than those specifically intended for infants will contain the

vitamins and mineral substances as specified in Table 2.

6. Products referred to in Article 1(3)(b) other than those specifically intended for infants will contain the
vitamins and mineral substances as specified in Table 2 without prejudice to modifications for one or more
of these nutrients rendered necessary by the intended use of the product.

7. Maximum levels of vitamins and mineral substances present in products referred to in Article 1(3)(c) other
than those intended specifically for infants shall not exceed those specified in Table 2, without prejudice to
modifications for one or more of these nutrients rendered necessary by the intended use of the product.

TABLE 1

Values for vitamins, mineral and trace elements in nutritionally complete foods intended for use
by infants

Vitamins:

Per 100 kJ

Per 100 kcal

Minimum

Maximum

Minimum

Maximum

Vitamin A (lg ER)

14

Vitamin D (lg)

Vitamin K (lg)

Vitamin C (mg)

Thiamin (mg)

Riboflavin (mg)

Vitamin B6 (mg)

0,25

1

1,9

0,01

0,014

0,009

43

0,75

5

6

0,075

0,1

0,075

60

1

4

8

0,04

0,06

0,035

180

3

20

25

0,3

0,45

0,3

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Per 100 kJ

Per 100 kcal

Minimum

Maximum

Minimum

Maximum

0,75

6

0,12

0,5

5

0,75

0,2

1

0,025

0,07

0,4

0,5/g polyun-
saturated fatty
acids expressed
as linoleic acid
but in no case
less than 0,1
mg per 100
available kJ

3

25

0,5

2

20

3

0,8

4

0,1

0,3

1,5

0,5/g polyun-
saturated fatty
acids expressed
as linoleic acid
but in no case
less than 0,5
mg per 100
available kcal

Per 100 kJ

Per 100 kcal

Minimum

Maximum

Minimum

Maximum

5

12

15

12

6

1,2

0,12

0,12

4,8

1,2

0,25

0,012

(cid:190)

(cid:190)

(cid:190)

14

29

35

60

22

3,6

0,5

0,6

29

8,4

0,7

0,05

2,5

2,5

0,05

20

50

60

50

25

5

0,5

0,5

20

5

1

0,05

(cid:190)

(cid:190)

(cid:190)

60

125

145

250

90

15

2

2,4

120

35

3

0,2

10

10

0,2

Niacin (mg NE)

Folic acid (lg)

Vitamin B

12

(lg)

Pantothenic acid (mg)

Biotin (lg)

Vitamin E (mg a-TE)

Minerals:

Sodium (mg)

Chloride (mg)

Potassium (mg)

Calcium (mg)

Phosphorus (mg) (1)

Magnesium (mg)

Iron (mg)

Zinc (mg)

Copper Cuivre (lg)

Iodine (lg)

Selenium (lg)

Manganese (mg)

Chromium (lg)

Molybdenum (lg)

Fluoride (mg)

(1) The calcium/phosphorus ratio shall not be less than 1,2 nor greater than 2,0.

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TABLE 2

Values for vitamins, minerals and trace elements in nutritionally complete foods other than those
intended for use by infants

Vitamins:

Vitamin A (lg RE)

Vitamin D (lg)

Vitamin K (lg)

Vitamin C (mg)

Thiamin (mg)

Riboflavin (mg)

Vitamin B6 (mg)

Niacin (mg EN)

Folic acid (lg)

Vitamin B12 (lg)

Pantothenic acid (mg)

Biotin (lg)

Vitamin E (mg a-TE)

Per 100 kJ

Per 100 kcal

Minimum

Maximum

Minimum

Maximum

180

2,5/3 (1)

20

22

0,5

0,5

0,5

3

50

0,7

1,5

7,5

3

8,4

0,12

0,85

0,54

0,015

0,02

0,02

0,22

2,5

0,017

0,035

0,18

0,5/g of poly-
unsaturated
fatty acids
expressed as
linoleic acid
but in no case
less than 0,1
mg per 100
available kJ

43

35

0,65/0,75 (1)

5

5,25

0,12

0,12

0,12

0,75

12,5

0,17

0,35

1,8

0,75

0,5

3,5

2,25

0,06

0,08

0,08

0,9

10

0,07

0,15

0,75

0,5/g of poly-
unsaturated
fatty acids
expressed as
linoleic acid
but in no case
less than 0,5
mg per 100
available kcal

(1) For products intended for children of 1 to 10 years of age.

Minerals:

Sodium (mg)

Chloride (mg)

Potassium (mg)

Calcium (mg)

Phosphorus (mg)

Magnesium (mg)

Iron (mg)

Zinc (mg)

Copper (lg)

Iodine (lg)

Per 100 kJ

Per 100 kcal

Minimum

Maximum

Minimum

Maximum

7,2

7,2

19

42

42

70

30

30

80

175

175

295

8,4/12 (1)

42/60 (1)

35/50 (1)

175/250 (1)

7,2

1,8

0,12

0,12

15

1,55

19

6

0,5

0,36

125

8,4

30

7,5

0,5

0,5

60

6,5

80

25

2,0

1,5

500

35

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Per 100 kJ

Per 100 kcal

Minimum

Maximum

Minimum

Maximum

Selenium (lg)

Manganese (mg)

Chromium (lg)

Molybdenum (lg)

Fluoride (mg)

0,6

0,012

0,3

0,72

(cid:190)

2,5

0,12

3,6

4,3

0,05

2,5

0,05

1,25

3,5

(cid:190)

10

0,5

15

18

0,2

(1) For products intended for children of 1 to 10 years of age.