(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 formulated and intended for the dietary management of patients and to be used under medical supervision. They are intended for the exclusive 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.

(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 manufacturer's instructions, may constitute the 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.

— in Bulgarian:

— 

‘Диетични храни за специални медицински цели’

— in Spanish:

— 

‘Alimento dietético para usos médicos especiales’

— in Czech:

— 

‘Dietní potravina určená pro zvláštní lékařské účely’

— 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:

— 

‘Διαιτητικά 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:

— 

‘Diētiskā pārtika cilvēkiem ar veselības traucējumiem’

— in Lithuanian:

— 

‘Specialios medicininės paskirties maisto produktai’

— in Hungarian:

— 

‘Speciális-gyógyászati célra szánt-tápszer’

— in Maltese:

— 

‘Ikel dijetetiku għal skopijiet mediċi speċifiċi’

— in Dutch:

— 

‘Dieetvoeding voor medisch gebruik’

— in Polish:

— 

‘Dietetyczne środki spożywcze specjalnego przeznaczenia medycznego’

— in Portuguese:

— 

‘Produto dietético de uso clínico’

— in Romanian:

— 

‘Alimente dietetice pentru scopuri medicale speciale’

— in Slovak:

— 

‘dietetická potravina na osobitné lekárske účely’

— in Slovenian:

— 

‘Dietno (dietetično) živilo za posebne zdravstvene namene’

— in Finnish:

— 

‘Kliininen ravintovalmiste/kliinisiä ravintovalmisteita’

— in Swedish:

— 

‘Livsmedel för speciella medicinska ändamål’.

(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;

(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 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;

(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.

(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.

(a) the statement ‘For the dietary management of…’ where the blank shall be filled in with the diseases, disorders or medical conditions for 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 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.

— 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.

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 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 modifications for one or more of these nutrients rendered necessary by the intended use of the product.