1999L0021 — EN — 27.04.1999 — 000.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COMMISSION DIRECTIVE 1999/21/EC
of 25 March 1999
on dietary foods for special medical purposes
(Text with EEA relevance)
(OJ L 91, 7.4.1999, p. 29)
Corrected by:
►C1Corrigendum, OJ L 2, 5.1.2000, p. 79 (1999/21)
1999L0021 — EN — 27.04.1999 — 000.001 — 2
▼B
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 foodstuffsintended for particular nutritional uses(
1), as amended by Directive
96/84/EC of the European Parliament and of the Council(2), and in
particular Article 4(1) thereof,
After consulting the Scientific Committee for food,
(1)Whereas dietary foods for special medical purposes are intended
tomeettheparticularnutritionalrequirementsofpersonsaffectedby or malnourished because of a specific disease, disorder ormedical condition; whereas for this reason they must be usedunder medical supervision which may be applied with the assis-tance of other competent health professionals;
(2)Whereas such foods are numerous and their composition maydiffer substantially depending on the specific disease, disorder ormedicalconditionofthepatientsforwhomtheyareintended,theageofthepatientsandtheplaceinwhichtheyreceivehealthcaresupport, on whether the foods are intended to be used as the solesource 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, itis 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-eredtobenutritionallycompleteforcoveringtheparticularnutri-tional requirements of the intended user; whereas such rules fornutritionally incomplete foods can be laid down only for themaximum levels of these substances as appropriate;
(5)Whereas this Directive reflects current knowledge about thoseproducts;whereasanymodificationtoallowforinnovationbasedonscientificandtechnicalprogresswillbedecidedinaccordancewith the procedure laid down in Article 13 of Directive 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, theproductscoveredbythatDirectivearesubjecttothegeneralruleslaid down by Council Directive 79/112/EEC of 18 December1978 on the approximation of the laws of the Member Statesrelating to the labelling, presentation and advertising of food-stuffs(
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 appro-priate;
(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.
1999L0021 — EN — 27.04.1999 — 000.001 — 3
▼B
(8)Whereas, in particular, in view of the nature and destination of
dietary foods for special medical purposes, it is necessary toprovide information concerning the energy value and principalnutrients 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 isnecessaryandappropriatefortheachievementofthebasicobjec-tive of approximating the laws of the Member States relating tofoodstuffs intended for particular nutritional uses to lay downrules on foods for special medical purposes; whereas thisDirective confines itself to what is necessary in order to achievethe objectives pursued in accordance with the third paragraph ofArticle 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. ThisDirectiveisaspecificDirectivewithinthemeaningofArticle
4(1) of Directive 89/398/EEC and lays down compositional and label-ling requirements for dietary foods for special medical purposes asdefined 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 to beusedundermedicalsupervision.Theyareintendedfortheexclusiveor partial feeding of patients with a limited, impaired or disturbedcapacity to take, digest, absorb, metabolise or excrete ordinaryfoodstuffs or certain nutrients contained therein or metabolites, orwith other medically-determined nutrient requirements, whosedietarymanagementcannotbeachievedonlybymodificationofthenormal diet, by other foods for particular nutritional uses, or by acombination 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, used inaccordance with the manufacturer’s instructions, may constitute thesole source of nourishment for the persons for whom they areintended;
(c) nutritionally incomplete foods with a standard formulation or a
nutrient-adapted formulation specific for a disease, disorder ormedical condition which are not suitable to be used as the solesource of nourishment.
▼
C1
The foods referred to in points (a) and (b) may also be used as a partialreplacement or as a supplement to the patient’s diet.
1999L0021 — EN — 27.04.1999 — 000.001 — 4
▼B
Article 2
Member States shall ensure that dietary foods for special medical
purposes may be marketed within the Community only if they complywith 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 accord-ance with the manufacturer’s instructions, shall be safe and beneficialand effective in meeting the particular nutritional requirements of thepersons 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 Danish:
‘Levnedsmiddel/Levnedsmidler til særlige medicinske formål'
— in German:
‘Diätetisches/Diätetische Lebensmittel für besondere medizinische
Zwecke (Bilanzierte Diäten)'
— 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 Dutch:
‘Dieetvoeding voor medisch gebruik'
— in Portuguese:
‘Produto dietético de use clínico'
— 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, per100g or per 100ml of the product as sold and where appropriateper 100g or per 100ml 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 perportion, provided that the number of portions contained in thepackage is stated;
(b) the average quantity of each mineral substance and each vitamin
mentionedintheAnnexpresentintheproduct,expressedinnumer-ical form per 100g or per 100ml of the product as sold and whereappropriate per 100g or per 100ml of the product ready for use inaccordance with the manufacturer’s instructions. This informationmay in addition be provided per serving as quantified on the label
1999L0021 — EN — 27.04.1999 — 000.001 — 5
▼B
orperportion,providedthatthenumberofportionscontainedinthepackage 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 100g or per 100ml ofthe product as sold and where appropriate per 100g or per 100mlof the product ready for use in accordance with the manufacturer’sinstructions. 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
particulars,precededbythewords‘importantnotice'ortheirequivalent:
(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) whereappropriateastatementthattheproductposesahealthhazard
when consumed by persons who do not have the diseases, disordersor 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;
(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 thecontainer, 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,orwhereaproductismanufacturedinathirdcountry,theimporter, 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 demonstratethat notification is not necessary in order to monitor those productsefficiently 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 adminis-
trative 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:
1999L0021 — EN — 27.04.1999 — 000.001 — 6
▼B
— 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 reference atthe time of their official publication. The procedure for such referenceshall 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 of the European Communities.
Article 8
This Directive is addressed to the Member States.
1999L0021 — EN — 27.04.1999 — 000.001 — 7
▼B
Per100kJ Per100kcal
Minimum Maximum Minimum MaximumANNEX
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, withoutprejudice 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 exceedthose specified in Table 1, without prejudice to modifications for one or moreof 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 shallcomply with the provisions relating to other nutrients applicable to infantformulae and follow-on formulae, as the case may be, laid down in Directive91/321/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 inTable 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 inTable 2 without prejudice to modifications for one or more of these nutrientsrendered 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 infantsshallnotexceedthosespecifiedinTable2,withoutprejudicetomodificationsfor one or more of these nutrients rendered necessary by the intended use ofthe product.
TABLE 1
Values for vitamins, mineral and trace elements in nutritionally complete foods intended for use
by infants
Vitamins:
►
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 20
1999L0021 — EN — 27.04.1999 — 000.001 — 8
▼B
Per100kJ Per100kcal
Minimum Maximum Minimum Maximum
Per100kJ Per100kcal
Minimum Maximum Minimum MaximumVitaminE(mg α-TE) 0,5/gpolyun-
saturatedfattyacidsexpressedaslinoleicacidbutinnocaselessthan0,1mgper100availablekJ0,75 0,5/gpolyun-saturatedfattyacidsexpressedaslinoleicacidbutinnocaselessthan0,5mgper100availablekcal3
Minerals:
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.
1999L0021 — EN — 27.04.1999 — 000.001 — 9
▼B
Per100kJ Per100kcal
Minimum Maximum Minimum Maximum
Per100kJ Per100kcal
Minimum Maximum Minimum MaximumTABLE 2
Values for vitamins, minerals and trace elements in nutritionally complete foods other than those
intended for use by infants
Vitamins:
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 0,5
►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
VitaminE(mg α-TE) 0,5/gofpoly-
unsaturatedfattyacidsexpressedaslinoleicacidbutinnocaselessthan0,1mgper100availablekJ0,75 0,5/gofpoly-unsaturatedfattyacidsexpressedaslinoleicacidbutinnocaselessthan0,5mgper100availablekcal3
(1) For products intended for children of 1 to 10 years of age.
Minerals:
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
1999L0021 — EN — 27.04.1999 — 000.001 — 10
▼B
Per100kJ Per100kcal
Minimum Maximum Minimum Maximum
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.