1999L0021 — EN — 01.05.2004 — 001.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COMMISSIONDIRECTIVE1999/21/EC
of25March1999
ondietaryfoodsforspecialmedical purposes
(TextwithEEArelevance)
(OJ L 91, 7.4.1999, p. 29)
Amended by:
Official Journal
No page date
►A1Act concerning the conditions of accession of the Czech Republic, the
Republic of Estonia, the Republic of Cyprus, the Republic of Latvia,
the Republic of Lithuania, the Republic of Hungary, the Republic ofMalta, the Republic of Poland, the Republic of Slovenia and the SlovakRepublic and the adjustments to the Treaties on which the EuropeanUnion is foundedL 236 33 23.9.2003
Corrected by:
►C1Corrigendum, OJ L 2, 5.1.2000, p. 79 (1999/21/EC)
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COMMISSIONDIRECTIVE1999/21/EC
of25March1999
ondietaryfoodsforspecialmedicalpurposes
(TextwithEEArelevance)
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 nutritional uses(1), as amended by Directive 96/
84/EC of the European Parliament and of the Council (2), and in parti-
cular 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 theymust be used under medical supervision which may be appliedwith the assistance of other competent health professionals;
(2)Whereas such foods are numerous and their composition maydiffer substantially depending on the specific disease, disorderor 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 thesole source of nourishment or not, and possibly on other factors;
(3)Whereas, because of the wide diversity of such foods and therapidly 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 andmineral substances content can be laid down for products consid-
ered to be nutritionally complete for covering the particular
nutritional requirements of the intended user; whereas such rulesfor nutritionally incomplete foods can be laid down only for themaximum levels of these substances as appropriate;
(5)Whereas this Directive reflects current knowledge about thoseproducts; whereas any modification to allow for innovationbased on scientific and technical progress will be decided in
accordance with the procedure laid down in Article 13 of Direc-
tive 89/398/EEC;
(6)Whereas pursuant to Article 4(2) of Directive 89/398/EEC, theprovisions relating to the substances with specific nutritionalpurposes to be used in the manufacture of foods for specialmedical purposes should be laid down in a separate Commissiondirective;
(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 18December 1978 on the approximation of the laws of the MemberStates relating to the labelling, presentation and advertising offoodstuffs(
3), as last amended by Commission Directive 1999/
10/EC (4); whereas the present Directive adopts and expands
upon the additions and exceptions to those general rules, where
appropriate;
(8)Whereas, in particular, in view of the nature and destination ofdietary foods for special medical purposes, it is necessary to1999L0021 — EN — 01.05.2004 — 001.001 — 2
(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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provide information concerning the energy value and principal
nutrients contained in such foods;
(9)Whereas, given the particular nature of dietary foods for specialmedical purposes, additional means to those usually available tomonitoring bodies should be available in order to facilitate effi-
cient monitoring of those products;
(10)Whereas, in accordance with the principle of proportionality, it
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 tolay down rules on foods for special medical purposes; whereasthis Directive confines itself to what is necessary in order toachieve the objectives pursued in accordance with the third para-graph of Article 3b of the Treaty;
(11)Whereas the measures provided for in this Directive are inaccordance with the opinion of the Standing Committee on food-
stuffs,
HAS ADOPTED THIS DIRECTIVE:
Article 1
1. This Directive is a specific Directive within the meaning of
Article 4(1) of Directive 89/398/EEC and lays down compositionaland labelling requirements for dietary foods for special medicalpurposes as defined in paragraph 2 and presented as such.
2. For the purposes of this Directive:
(a) ‘infants’ means children under the age of 12 months;
(b) ‘dietary foods for special medical purposes’ means a category of
foods for particular nutritional uses specially processed or formu-
lated and intended for the dietary management of patients and tobe used under medical supervision. They are intended for theexclusive or partial feeding of patients with a limited, impaired ordisturbed capacity to take, digest, absorb, metabolise or excreteordinary foodstuffs or certain nutrients contained therein or meta-
bolites, or with other medically-determined nutrient requirements,
whose dietary management cannot be achieved only by modifica-tion of the normal diet, by other foods for particular nutritionaluses, or by a combination of the two.
3. Dietary foods for special medical purposes are classified 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 forwhom they are intended;
(b) nutritionally complete foods with a nutrient-adapted formulation
specific for a disease, disorder or medical condition which, usedin accordance with the manufacturer's instructions, may constitutethe sole source of nourishment for the persons for whom they are
intended;
(c) nutritionally incomplete foods with a standard formulation 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 (a) and (b) may also be used as a partial
replacement or as a supplement to the patient's diet.1999L0021 — EN — 01.05.2004 — 001.001 — 3
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Article 2
Member States shall ensure that dietary foods for special medical
purposes may be marketed within the Community only if they comply
with the rules laid down in this Directive.
Article 3
The formulation of dietary foods for special medical purposes shall be
based on sound medical and nutritional principles. Their use, in accor-dance with the manufacturer's instructions, shall be safe and beneficial
and effective in meeting the particular nutritional requirements of the
persons for whom they are intended, as demonstrated by generallyaccepted scientific data.
They must comply with the compositional criteria specified in the
Annex.
Article 4
1. The name under which dietary foods for special medical purposes
are sold shall be respectively:
— in Spanish:
‘Alimento dietético para usos médicos especiales’
— in Czech:
‘Dietní potravina ur čená pro zvláštní léka řské ú čely’
— in Danish:
‘Levnedsmiddel/Levnedsmidler til særlige medicinske formål’
— in German:
‘Diätetisches/Diätetische Lebensmittel für besondere medizinische
Zwecke (Bilanzierte Diäten)’
— in Estonian:
‘Toit meditsiinilisel näidustusel kasutamiseks’
— in Greek:
‘∆ιαιτητικά τρόφιµα για ειδικούς ιατρικούς σκοπούς ’
— in English:
‘Food(s) for special medical purposes’
— in French:
‘Aliment(s) diététique(s) destiné(s) a des fins médicales spéciales’
— in Italian:
‘Alimento dietetico destinato a fini medici speciali’
— in Latvian:
‘Diētiskāpārtika cilv ēkiem ar vesel ības trauc ējumiem’
— in Lithuanian:
‘Specialios medicinin ės paskirties maisto produktai’
— in Hungarian:
‘Speciális-gyógyászati célra szánt-tápszer’
— in Maltese:
‘Ikel dijetetiku g ħal skopijiet medi ċis peċifiċi’
— in Dutch:
‘Dieetvoeding voor medisch gebruik’
— in Polish:
‘Dietetyczne środki spo żywcze specjalnego przeznaczenia medycz-
nego’
— in Portuguese:1999L0021 — EN — 01.05.2004 — 001.001 — 4
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‘Produto dietético de uso clínico’
— in Slovak:
‘dietetická potravina na osobitné lekárske ú čely’
— in Slovenian:
‘Dietno (dieteti čno) živilo za posebne zdravstvene namene’
— in Finnish:
‘Kliininen ravintovalmiste/kliinisiä ravintovalmisteita’
— in Swedish:
‘Livsmedel för speciella medicinska ändamål’.
2. The labelling shall bear, in addition to the particulars provided for
in Article 3 of Directive 79/112/EEC, the following mandatory particu-lars:
(a) the available energy value expressed in kJ and kcal, and the content
of protein, carbohydrate and fat, expressed in numerical form, per100 g or per 100 ml of the product as sold and where appropriateper 100 g or per 100 ml of the product ready for use in accordancewith the manufacturer's instructions. This information may in addi-
tion be provided per serving as quantified on the label or per
portion, provided that the number of portions contained in thepackage is stated;
(b) the average quantity of each mineral substance and each vitamin
mentioned in the Annex present in the product, expressed innumerical form per 100 g or per 100 ml of the product as soldand where appropriate per 100 g or per 100 ml of the product readyfor 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 portionscontained 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 ofwhich would be necessary for the appropriate intended use of theproduct, expressed in numerical form, per 100 g or per 100 ml ofthe 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 perserving as quantified on the label or per portion, provided that thenumber 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.
3. The labelling shall in addition bear the following mandatory parti-
culars, preceded by the words ‘important notice’ or their equivalent:
(a) a statement that the product must be used under medical supervi-
sion;
(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 statement ‘For the dietary management of…’ where the blank
shall be filled in with the diseases, disorders or medical conditionsfor which the product is intended;
(b) where appropriate a statement concerning adequate precautions and
contra-indications;1999L0021 — EN — 01.05.2004 — 001.001 — 5
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(c) a description of the properties and/or characteristics that make the
product useful in particular, as the case may be, relating to thenutrients which have been increased, reduced, eliminated or other-
wise modified and the rationale of the use of the product;
(d) where appropriate a warning that the product is not for parenteral
use.
5. The labelling shall bear instructions for the appropriate prepara-
tion, 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, themanufacturer, or where a product is manufactured in a third country,the importer, shall notify the competent authority of the Member Stateswhere the product is being marketed by forwarding to it a model of thelabel used for the product. Member States may, if they can demonstrate
that notification is not necessary in order to monitor those products
efficiently in their territory, not impose that obligation.
2. The competent authorities within the meaning of this Article are
those referred to in Article 9(4) of Directive 89/398/EEC.
Article 6
Member States shall bring into force the laws, regulations and admin-
istrative provisions necessary to comply with this Directive by 30 April2000 at the latest. They shall forthwith inform the Commission thereof.
Those laws, regulations and administrative provisions shall be applied
in such a way as to:
— permit trade in products complying with this Directive with effect
from 1 May 2000,
— 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
reference to this Directive or shall be accompanied by such referenceat the time of their official publication. The procedure for such refer-ence shall be adopted by Member States.
Article 7
This Directive shall enter into force on the twentieth day following that
of its publication in the Official Journal ofthe European Communities.
Article 8
This Directive is addressed to the Member States.1999L0021 — EN — 01.05.2004 — 001.001 — 6
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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 neces-
sary 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 modifications 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 applicable to infant
formulae and follow-on formulae, as the case may be, laid down in Directive
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 modifica-
tions 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
►C1Vitamin A
(µg RE) ◄14 43 60 180
Vitamin D ( µg) 0,25 0,75 1 3
Vitamin K ( µg) 1 5 4 20
Vitamin C (mg) 1,9 6 8 25
Thiamin (mg) 0,01 0,075 0,04 0,3
Riboflavin (mg) 0,014 0,1 0,06 0,45
Vitamin B6 (mg) 0,009 0,075 0,035 0,3
Niacin (mg NE) 0,2 0,75 0,8 3
Folic acid ( µg) 1 6 4 25
Vitamin B12(µg) 0,025 0,12 0,1 0,5
Pantothenic acid
(mg)0,07 0,5 0,3 2
Biotin ( µg) 0,4 5 1,5 201999L0021 — EN — 01.05.2004 — 001.001 — 7
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Per 100 kJ Per 100 kcal
Minimum Maximum Minimum Maximum
Vitamin E (mg α-
TE)0,5/g
polyunsa-
turated
fatty acids
expressed
as linoleic
acid but in
no caseless than
0,1 mg per
100 avail-
able kJ0,75 0,5/g
polyunsa-
turated
fatty acids
expressed
as linoleic
acid but in
no caseless than
0,5 mg per
100 avail-
able kcal3
Minerals:
Per 100 kJ Per 100 kcal
Minimum Maximum Minimum Maximum
Sodium (mg) 5 14 20 60
Chloride (mg) 12 29 50 125
Potassium (mg) 15 35 60 145
Calcium (mg) 12 60 50 250
Phosphorus (mg) (1) 6 22 25 90
Magnesium (mg) 1,2 3,6 5 15
Iron (mg) 0,12 0,5 0,5 2
Zinc (mg) 0,12 0,6 0,5 2,4
►C1Copper
(µg)◄4,8 29 20 120
Iodine ( µg) 1,2 8,4 5 35
Selenium ( µg) 0,25 0,7 1 3
Manganese (mg) 0,012 0,05 0,05 0,2
Chromium ( µg) — 2,5 — 10
Molybdenum ( µg) — 2,5 — 10
Fluoride (mg) — 0,05 — 0,2
(1) The calcium/phosphorus ratio shall not be less than 1,2 nor greater than 2,0.
TABLE 2
Values for vitamins, minerals and trace elements in nutritionally complete foods
other than those intended for use by infants
Vitamins:
Per 100 kJ Per 100 kcal
Minimum Maximum Minimum Maximum
Vitamin A ( µg RE) 8,4 43 35 180
Vitamin D ( µg) 0,12 0,65/0,75 (1) 0,5 2,5/3 (1)
Vitamin K ( µg) 0,85 5 3,5 20
Vitamin C (mg) 0,54 5,25 2,25 22
Thiamin (mg) 0,015 0,12 0,06 0,5
Riboflavin (mg) 0,02 0,12 0,08 0,5
Vitamin B6 (mg) 0,02 0,12 0,08 0,51999L0021 — EN — 01.05.2004 — 001.001 — 8
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Per 100 kJ Per 100 kcal
Minimum Maximum Minimum Maximum
►C1Niacin (mg
NE) ◄0,22 0,75 0,9 3
Folic acid ( µg) 2,5 12,5 10 50
Vitamin B12(µg) 0,017 0,17 0,07 0,7
Pantothenic acid
(mg)0,035 0,35 0,15 1,5
Biotin ( µg) 0,18 1,8 0,75 7,5
Vitamin E (mg α-
TE)0,5/g of
polyunsa-
turated
fatty acids
expressed
as linoleic
acid but in
no case
less than
0,1 mg per
100 avail-
able kJ0,75 0,5/g of
polyunsa-
turated
fatty acids
expressed
as linoleic
acid but in
no case
less than
0,5 mg per
100 avail-
able kcal3
(1) For products intended for children of 1 to 10 years of age.
Minerals:
Per 100 kJ Per 100 kcal
Minimum Maximum Minimum Maximum
Sodium (mg) 7,2 42 30 175
Chloride (mg) 7,2 42 30 175
Potassium (mg) 19 70 80 295
Calcium (mg) 8,4/12 (1) 42/60 (1) 35/50(1) 175/250 (1)
Phosphorus (mg) 7,2 19 30 80
Magnesium (mg) 1,8 6 7,5 25
Iron (mg) 0,12 0,5 0,5 2,0
Zinc (mg) 0,12 0,36 0,5 1,5
Copper ( µg) 15 125 60 500
Iodine ( µg) 1,55 8,4 6,5 35
Selenium ( µg) 0,6 2,5 2,5 10
Manganese (mg) 0,012 0,12 0,05 0,5
Chromium ( µg) 0,3 3,6 1,25 15
Molybdenum ( µg) 0,72 4,3 3,5 18
Fluoride (mg) — 0,05 — 0,2
(1) For products intended for children of 1 to 10 years of age.1999L0021 — EN — 01.05.2004 — 001.001 — 9