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COMMISSION DIRECTIVE 1999/21/EC
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Direktiva Komisije 1999/21/ES
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of 25 March 1999
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z dne 25. marca 1999
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on dietary foods for special medical purposes
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o živilih za posebne zdravstvene namene
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(Text with EEA relevance)
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(Besedilo velja za EGP)
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KOMISIJA EVROPSKIH SKUPNOSTI JE
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THE COMMISSION OF THE EUROPEAN COMMUNITIES,
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ob upoštevanju Pogodbe o ustanovitvi Evropske skupnosti,
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Having regard to the Treaty establishing the European Community,
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ob upoštevanju Direktive Sveta 89/398/EGS z dne 3. maja 1989 o približevanju zakonodaje držav članic, ki se nanaša na živila za posebne prehranske namene [1], spremenjene z Direktivo 96/84/ES Evropskega parlamenta in Sveta [2], in zlasti člena 4(1) direktive,
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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 particular Article 4(1) thereof,
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po posvetovanju z Znanstvenim odborom za živila,
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After consulting the Scientific Committee for food,
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(1) ker so živila za posebne zdravstvene namene namenjena pokrivanju posebnih prehranskih potreb oseb, ki so prizadete ali slabo prehranjene zaradi določene bolezni, motnje ali zdravstvenega stanja; ker jih je zato treba uživati pod zdravniškim nadzorom, ki se lahko izvaja s pomočjo drugih pristojnih zdravstvenih strokovnjakov;
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(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 professionals;
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(2) ker je teh živil veliko, njihova sestava pa se lahko znatno razlikuje glede na specifičnost bolezni, motnje ali zdravstvenega stanja bolnikov, ki so jim namenjena, glede na starost bolnikov in mesto, kjer prejemajo zdravstveno nego, glede na to, ali se bodo ta živila uporabljala kot edini vir prehrane bolnika ali ne, ter glede na nekatere druge dejavnike;
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(2) Whereas such foods are numerous and their composition 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;
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(3) ker zaradi velike raznolikosti teh živil in hitro razvijajočih se znanstvenih dognanj, na katerih ta temeljijo, ni primerno določiti podrobnih pravil glede njihove sestave;
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(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;
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(4) ker se kljub temu lahko določi nekaj osnovnih predpisov glede vsebnosti vitaminov in mineralov za živila, za katera se šteje, da v celoti pokrivajo posebne prehranske potrebe oseb, ki so jim namenjena; ker se taka pravila za živila, ki posebnih prehranskih potreb ne pokrivajo v celoti, lahko po potrebi predpišejo samo za najvišje dovoljene ravni teh snovi;
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(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 the maximum levels of these substances as appropriate;
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(5) ker ta direktiva upošteva sedanja dognanja o teh živilih; ker se bo o kakršnih koli spremembah, ki bi upoštevale novosti na osnovi znanstvenega in tehničnega napredka, odločalo v skladu s postopkom, predpisanim v členu 13 Direktive 89/398/EGS;
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(5) Whereas this Directive reflects current knowledge about those products; whereas any modification to allow for innovation based on scientific and technical progress will be decided in accordance with the procedure laid down in Article 13 of Directive 89/398/EEC;
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(6) ker je v skladu s členom 4(2) Direktive 89/398/EGS določbe v zvezi s snovmi za posebne prehranske namene, ki se uporabljajo v proizvodnji živil za posebne zdravstvene namene, treba predpisati z ločeno direktivo Komisije;
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(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;
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(7) ker se po členu 7 Direktive 89/398/EGS za živila, ki jih zajema ta direktiva, uporabljajo splošna pravila, predpisana z Direktivo Sveta 79/112/EGS z dne 18. decembra 1978 o približevanju zakonodaje držav članic, ter se nanašajo na označevanje, predstavitev in oglaševanje živil [3], nazadnje spremenjene z Direktivo Komisije 1999/10/ES [4]; ker sedanja direktiva upošteva in razširja dodatke in izjeme k tistim splošnim predpisom, pri katerih je to primerno;
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(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 laws of the Member States relating to the labelling, presentation and advertising of foodstuffs(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;
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(8) ker je zlasti glede vrste in namembnosti živil za posebne zdravstvene namene treba zagotoviti podatke o hranilni vrednosti in glavnih hranilnih snoveh, ki jih tovrstna živila vsebujejo;
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(8) Whereas, in particular, in view of the nature and destination of dietary foods for special medical purposes, it is necessary to provide information concerning the energy value and principal nutrients contained in such foods;
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(9) ker naj bi bila glede na posebno vrsto živil za posebne zdravstvene namene organom za spremljanje in nadzor ob običajnih sredstvih na voljo še dodatna sredstva, s katerimi bi tako omogočili učinkovito spremljanje teh živil;
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(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;
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(10) ker je v skladu z načelom sorazmernosti za doseganje temeljnega cilja približevanja zakonov držav članic v zvezi z živili za posebne prehranske namene, potrebno in primerno predpisati pravila glede živil za posebne zdravstvene namene; ker se ta direktiva omejuje na tisto, kar je potrebno za doseganje ciljev v skladu s tretjim odstavkom člena 3b Pogodbe;
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(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 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;
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(11) ker so ukrepi, predvideni s to direktivo, v skladu z mnenjem Stalnega odbora za živila,
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(11) Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on foodstuffs,
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SPREJELA NASLEDNJO DIREKTIVO:
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HAS ADOPTED THIS DIRECTIVE:
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Člen 1
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1. Ta direktiva je posebna direktiva v smislu člena 4(1) Direktive 89/398/EGS ter predpisuje zahteve o sestavi in označevanju živil za posebne zdravstvene namene, kakor so opredeljene v odstavku 2 in ponujene kot take.
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Article 1
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2. Izrazi v tej direktivi imajo naslednji pomen:
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1. This Directive is a specific Directive within the meaning of Article 4(1) of Directive 89/398/EEC and lays down compositional and labelling requirements for dietary foods for special medical purposes as defined in paragraph 2 and presented as such.
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(a) "dojenčki" so otroci, mlajši od 12 mesecev;
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2. For the purposes of this Directive:
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(b) "živila za posebne zdravstvene namene" so skupine živil za posebne prehranske namene, pripravljena na poseben način ali imajo posebno sestavo, in so namenjena bolnikom, katerih stanje zahteva nadzorovano prehrano, ter se uživajo pod zdravniškim nadzorom. Namenjena so za popolno ali delno prehrano bolnikov z omejeno, okvarjeno ali moteno zmožnostjo uživanja, prebave, absorpcije, presnove ali izločanja običajnih živil ali nekaterih hranilnih snovi, ki jih ta vsebujejo, ali presnovkov, ali z drugimi zdravstveno določenimi prehranskimi potrebami, pri katerih ne moremo doseči nadzora s prehrano samo s prilagajanjem običajnih živil, z drugimi živili za posebne prehranske namene ali s kombinacijo teh dveh skupin živil.
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(a) "infants" means children under the age of 12 months;
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3. Živila za posebne zdravstvene namene se delijo v tri skupine:
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(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.
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(a) živila, ki v celoti pokrivajo prehranske potrebe, s standardno sestavo hranil, ki so lahko ob uporabi navodil proizvajalca edini vir prehrane za osebe, ki so jim namenjena;
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3. Dietary foods for special medical purposes are classified in the following three categories:
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(b) živila, ki v celoti pokrivajo prehranske potrebe, s posebej prilagojeno sestavo hranil, specifično za bolezen, motnjo ali zdravstveno stanje, ki so lahko ob uporabi navodil proizvajalca edini vir prehrane za osebe, ki so jim namenjena;
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(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;
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(c) živila, ki prehranskih potreb ne pokrivajo v celoti, s standardno ali prilagojeno sestavo hranil, specifično za bolezen, motnjo ali zdravstveno stanje, in ki niso primerna za uporabo kot edini vir prehrane.
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(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;
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Živila iz točk (b) in (c) se lahko uporabljajo tudi kot delno nadomestilo ali kot dodatek bolnikovi prehrani.
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(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.
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Člen 2
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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.
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Države članice zagotovijo, da se živila za posebne zdravstvene namene v okviru Skupnosti prodajajo samo, če so v skladu s predpisi, določenimi v tej direktivi.
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Člen 3
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Article 2
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Sestava živil za posebne zdravstvene namene temelji na veljavnih dognanjih medicinske stroke in prehranskih načelih. Njihova uporaba, v skladu z navodili proizvajalca, mora biti varna, koristna in učinkovita ter mora ustrezati posebnim prehranskim zahtevam ljudi, ki so jim namenjena, v skladu splošno sprejetimi znanstvenimi dognanji.
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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.
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Živila za posebne zdravstvene namene morajo ustrezati sestavi iz Priloge.
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Člen 4
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Article 3
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1. Ime, pod katerim se živila za posebne zdravstvene namene prodajajo, je:
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The formulation of dietary foods for special medical purposes shall be based on sound medical and nutritional principles. Their use, in accordance 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 generally accepted scientific data.
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- v španščini:
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They must comply with the compositional criteria specified in the Annex.
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"Alimento dietético para usos médicos especiales"
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- v danščini:
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Article 4
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"Levnedsmiddel/Levnedsmidler til særlige medicinske formål"
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1. The name under which dietary foods for special medical purposes are sold shall be respectively:
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- v nemščini:
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- in Spanish:
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"Diätetisches/Diätetische Lebensmittel für besondere medizinische Zwecke (Bilanzierte Diäten)"
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"Alimento dietético para usos médicos especiales"
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- v grščini:
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- in Danish:
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"Διαιτητικά τρόφιμα για ειδικούς ιατρικούς σκοπούς"
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"Levnedsmiddel/Levnedsmidler til særlige medicinske formål"
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- v angleščini:
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- in German:
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"Food(s) for special medical purposes"
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"Diätetisches/Diätetische Lebensmittel für besondere medizinische Zwecke (Bilanzierte Diäten)"
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- v francoščini:
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- in Greek:
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"Aliment(s) diététique(s) destiné(s) à des fins médicales spéciales"
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"Διαιτητικά τρόφιμα για ειδικούς ιατρικούς σκοπούς"
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- v italijanščini:
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- in English:
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"Alimento dietetico destinato a fini medici speciali"
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"Food(s) for special medical purposes"
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- v nizozemščini:
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- in French:
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"Dieetvoeding voor medisch gebruik"
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"Aliment(s) diététique(s) destiné(s) a des fins médicales spéciales"
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- v portugalščini:
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- in Italian:
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"Produto dietético de use clínico"
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"Alimento dietetico destinato a fini medici speciali"
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- v finščini:
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- in Dutch:
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"Kliininen ravintovalmiste/kliinisiä ravintovalmisteita"
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"Dieetvoeding voor medisch gebruik"
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- v švedščini:
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- in Portuguese:
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"Livsmedel för speciella medicinska ändamål"
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"Produto dietético de use clínico"
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2. Na oznaki se poleg podatkov, opredeljenih v členu 3 Direktive 79/112/EGS, obvezno navedejo še naslednji:
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- in Finnish:
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(a) izkoristljiva energijska vrednost, izražena v kilojoulih in kilokalorijah, ter vsebnost beljakovin, ogljikovih hidratov in maščob, izražena v številčni obliki na 100 gramov ali 100 mililitrov živila v prometu in, kadar je to primerno, na 100 gramov ali 100 mililitrov gotovega živila, pripravljenega po navodilih proizvajalca. Ta podatek se lahko navede tudi na določen obrok ali na porcijo, pod pogojem, da je določeno, koliko obrokov ali porcij vsebuje zavitek;
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"Kliininen ravintovalmiste/kliinisiä ravintovalmisteita"
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(b) povprečna količina vsakega minerala in vitamina v živilu, navedenega v Prilogi, izražena v številčni obliki na 100 gramov ali 100 mililitrov živila v prometu in, kadar je to primerno, na 100 g ali 100 mililitrov gotovega živila, pripravljenega po navodilih proizvajalca. Ta podatek se lahko navede tudi na določen obrok ali na porcijo, pod pogojem, da je določeno, koliko obrokov ali porcij vsebuje zavitek;
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- in Swedish:
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(c) izbrane vsebnosti sestavnih delov beljakovin, ogljikovih hidratov in maščob in/ali drugih hranil in njihovih sestavin, katerih označba je nujna za pravilno namensko uporabo živila, izražena v številčni obliki na 100 gramov ali 100 mililitrov živila v prometu in, kadar je to primerno, na 100 gramov ali 100 mililitrov gotovega živila ali pripravljenega po navodilih proizvajalca. Ta podatek se lahko navede tudi na določen obrok ali na porcijo, pod pogojem, da je določeno, koliko obrokov ali porcij vsebuje zavitek;
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"Livsmedel för speciella medicinska ändamål".
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(d) podatek o osmolalnosti in osmolarnosti živila, kadar je to primerno;
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2. The labelling shall bear, in addition to the particulars provided for in Article 3 of Directive 79/112/EEC, the following mandatory particulars:
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(e) podatek o izvoru in naravi beljakovin in/ali beljakovinskih hidrolizatov, ki jih živilo vsebuje.
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(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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3. Na oznaki se navedejo še naslednji obvezni podatki, ki sledijo uvodnim besedam "pomembno opozorilo" ali drugim enakovrednim izrazom:
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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;
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(a) opozorilo, da se mora živilo uživati pod zdravniškim nadzorom;
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(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;
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(b) opozorilo o primernosti ali neprimernosti živila za uporabo kot edinega vira prehrane;
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(d) information on the osmolality or the osmolarity of the product where appropriate;
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(c) po potrebi opozorilo, da je živilo namenjeno določeni starostni skupini;
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(e) information on the origin and the nature of the protein and/or protein hydrolysates contained in the product.
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(d) po potrebi opozorilo, da živilo lahko povzroči zdravstvene težave, če ga uživajo osebe, ki nimajo bolezni, motenj ali zdravstvenih stanj, za katera je živilo namenjeno.
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3. The labelling shall in addition bear the following mandatory particulars, preceded by the words "important notice" or their equivalent:
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4. Oznaka mora vsebovati še:
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(a) a statement that the product must be used under medical supervision;
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(a) opozorilo "Za dietetsko uravnavanje…", pri čemer se v prazni prostor vpišejo bolezni, motnje ali zdravstvena stanja, za katera je živilo namenjeno;
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(b) a statement whether the product is suitable for use as the sole source of nourishment;
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(b) po potrebi opozorilo, ki se nanaša na potrebno previdnost pri uporabi in neželene učinke;
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(c) a statement that the product is intended for a specific age group, as appropriate;
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(c) opis lastnosti in/ali značilnosti s posebnim poudarkom na uporabnosti živila v zvezi s hranili, ki so povečana, zmanjšana, izločena ali kakorkoli drugače spremenjena, in utemeljitev uporabe teh živil;
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(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.
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(d) po potrebi opozorilo, da živilo ni za parenteralno uporabo.
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4. The labelling shall also include:
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5. Če je to potrebno, mora oznaka vsebovati navodila za primerno pripravo, uporabo in shranjevanje živila po odprtju notranje embalaže.
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(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;
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Člen 5
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(b) where appropriate a statement concerning adequate precautions and contra-indications;
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1. Za učinkovito uradno spremljanje in nadzor živil za posebne zdravstvene namene, ko se dajejo na trg, proizvajalec ali, kadar je živilo proizvedeno v tretji državi, uvoznik, uradno obvesti pristojni organ držav članic, v katerih se živilo prodaja, tako da mu pošlje vzorec oznake za živilo. Države članice lahko teh obveznosti ne naložijo, če lahko dokažejo, da uradno obvestilo za učinkovito spremljanje navedenih živil na njihovem ozemlju ni potrebno.
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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 the nutrients which have been increased, reduced, eliminated or otherwise modified and the rationale of the use of the product;
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2. Pristojni organi skladno s tem členom so organi, navedeni v členu 9(4) Direktive 89/398/EGS.
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(d) where appropriate a warning that the product is not for parenteral use.
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Člen 6
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5. The labelling shall bear instructions for the appropriate preparation, the use and the storage of the product after the opening of the container, as appropriate.
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Države članice sprejmejo zakone in druge predpise, potrebne za uskladitev s to direktivo, najpozneje do 30. aprila 2000. O tem takoj obvestijo Komisijo.
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Njihovi zakoni in drugi predpisi se uporabljajo tako, da:
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Article 5
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- dovolijo promet z živili, ki so v skladu s to direktivo z veljavnostjo od 1. maja 2000,
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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, if they can demonstrate that notification is not necessary in order to monitor those products efficiently in their territory, not impose that obligation.
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- prepovejo promet z živili, ki niso v skladu s to direktivo z veljavnostjo od 1. novembra 2001.
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2. The competent authorities within the meaning of this Article are those referred to in Article 9(4) of Directive 89/398/EEC.
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Države članice se v sprejetih predpisih sklicujejo na to direktivo ali pa sklic nanjo navedejo ob njihovi uradni objavi. Način sklicevanja določijo države članice.
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Člen 7
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Article 6
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Ta direktiva začne veljati dvajseti dan po objavi v Uradnem listu Evropskih skupnosti.
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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.
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Člen 8
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Those laws, regulations and administrative provisions shall be applied in such a way as to:
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Ta direktiva je naslovljena na države članice.
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- permit trade in products complying with this Directive with effect from 1 May 2000,
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- prohibit trade in products which do not comply with this Directive with effect from 1 November 2001.
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V Bruslju, 25. marca 1999
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When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.
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Za Komisijo
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Martin Bangemann
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Article 7
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Član Komisije
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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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[1] UL L 186, 30.6.1989, str. 27.
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[2] UL L 48, 19.2.1997, str. 20.
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Article 8
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[3] UL L 33, 8.2.1979, str. 1.
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This Directive is addressed to the Member States.
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[4] UL L 69, 16.3.1999, str. 22.
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Done at Brussels, 25 March 1999.
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PRILOGA
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BISTVENA SESTAVA IVIL ZA POSEBNE ZDRAVSTVENE NAMENE
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For the Commission
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Specifikacije se nanašajo na živila, ki se dajejo v promet kot gotova živila ali so pripravljena po navodilih proizvajalca.
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Martin BANGEMANN
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1. Živila, navedena v členu 1(3)(a), izrecno namenjena dojenčkom, naj vsebujejo vitamine in minerale, kakor je opredeljeno v Tabeli 1.
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Member of the Commission
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2. Živila, navedena v členu 1(3)(b), izrecno namenjena dojenčkom, naj vsebujejo vitamine in minerale, kakor je opredeljeno v Tabeli 1, brez poseganja v spremembe ene ali več hranilnih snovi, potrebnih zaradi namena uporabe živila.
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3. Najvišje ravni vitaminov in mineralov v živilih iz člena 1(3)(c), posebej namenjenih za dojenčke, ne smejo presegati najvišjih ravni, navedenih v Tabeli 1, ne glede na spremembe enega ali več tistih hranil, ki so potrebna zaradi namena uporabe živila.
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(1) OJ L 186, 30.6.1989, p. 27.
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4. Kadar to ni v nasprotju z zahtevami, ki jih narekuje nameravana uporaba, morajo živila za posebne zdravstvene namene za dojenčke ustrezati predpisom o vsebnosti drugih hranil, ki se uporabljajo za pripravke za dojenčke in nadaljevalni prehrani, kot so opredeljena v Direktivi 91/321/EGS in naknadnih spremembah te direktive.
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(2) OJ L 48, 19.2.1997, p. 20.
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5. Živila iz člena 1(3)(a), razen posebej namenjenih za dojenčke, naj vsebujejo vitamine in minerale, kakor je opredeljeno v Tabeli 2.
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(3) OJ L 33, 8.2.1979, p. 1.
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6. Živila iz člena 1(3)(b), razen posebej namenjenih za dojenčke, naj vsebujejo vitamine in minerale, kakor je opredeljeno v Tabeli 2, ne glede na modifikacije enega ali več tistih hranil, ki so potrebna zaradi nameravane uporabe živila.
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(4) OJ L 69, 16.3.1999, p. 22.
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7. Najvišja količina vitaminov in mineralov v živilih iz člena 1(3)(c), ki niso namenjena dojenčkom, ne smejo presegati vrednosti, opredeljenih v Tabeli 2, ne glede na modifikacije enega ali več tistih hranil, ki so potrebna zaradi nameravane uporabe živila.
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TABELA 1
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Vrednosti za vitamine, minerale in elemente v sledovih prehransko popolnih živil, namenjenih za prehrano dojenčkov
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ANNEX
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Vitamini:
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| Na 100 kJ | Na 100 kcal |
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ESSENTIAL COMPOSITION OF FOODS FOR SPECIAL MEDICAL PURPOSES
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| Najmanj | Največ | Najmanj | Največ |
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The specifications refer to the products ready for use, marketed as such or reconstituted as instructed by the manufacturer.
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Vitamin A (μg ER) | 14 | 43 | 60 | 180 |
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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.
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Vitamin D (μg) | 0,25 | 0,75 | 1 | 3 |
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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.
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Vitamin K (μg) | 1 | 5 | 4 | 20 |
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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.
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Vitamin C (mg) | 1,9 | 6 | 8 | 25 |
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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.
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Tiamin (mg) | 0,01 | 0,075 | 0,04 | 0,3 |
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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.
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Riboflavin (mg) | 0,014 | 0,1 | 0,06 | 0,45 |
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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.
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Vitamin B6 (mg) | 0,009 | 0,075 | 9,035 | 0,3 |
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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.
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Minerali:
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TABLE 1
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| Na 100 kJ | Na 100 kcal |
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Values for vitamins, mineral and trace elements in nutritionally complete foods intended for use by infants
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| Najmanj | Največ | Najmanj | Največ |
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Vitamins:
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Natrij (mg) | 5 | 14 | 20 | 60 |
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>TABLE>
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Klor (mg) | 12 | 29 | 50 | 125 |
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Minerals:
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Kalij(mg) | 15 | 35 | 60 | 145 |
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>TABLE>
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Kalcij (mg) | 12 | 60 | 50 | 250 |
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TABLE 2
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Fosfor (mg) | 6 | 22 | 25 | 90 |
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Values for vitamins, minerals and trace elements in nutritionally complete foods other than those intended for use by infants
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Magnezij (mg) | 1,2 | 3,6 | 5 | 15 |
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Vitamins:
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Železo (mg) | 0,12 | 0,5 | 0,5 | 2 |
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>TABLE>
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Cink(mg) | 0,12 | 0,6 | 0,5 | 2,4 |
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Minerals:
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Baker (μg) | 4,8 | 29 | 20 | 120 |
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>TABLE>
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Jod (μg) | 1,2 | 8,4 | 5 | 35 |
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Selen (μg) | 0,25 | 0,7 | 1 | 3 |
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Mangan (mg) | 0,012 | 0,05 | 0,05 | 0,2 |
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Krom (μg) | — | 2,5 | — | 10 |
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Molibden (μg) | — | 2,5 | — | 10 |
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Fluor (mg) | — | 0,05 | — | 0,2 |
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| Na 100 kJ | Na 100 kcal |
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| Najmanj | Največ | Najmanj | Največ |
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Vitamin A (μg ER) | 8,4 | 43 | 35 | 180 |
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Vitamin D (μg) | 0,12 | 0,65/0,75 | 0,5 | 2,5/3 |
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Vitamin K (μg) | 0,85 | 5 | 3,5 | 20 |
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Vitamin C (mg) | 0,54 | 5,25 | 2,25 | 22 |
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Tiamin (mg) | 0,015 | 0,12 | 0,06 | 0,5 |
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Riboflavin (mg) | 0,02 | 0,12 | 0,08 | 0,5 |
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Vitamin B6 (mg) | 0,02 | 0,12 | 0,08 | 0,5 |
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Niacin (mg NE) | 0,22 | 0,75 | 0,9 | 3 |
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Folna kislina (μg) | 2,5 | 12,5 | 10 | 50 |
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Vitamin B12(μg) | 0,017 | 0,17 | 0,07 | 0,7 |
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Pantotenska kislina (mg) | 0,035 | 0,35 | 0,15 | 1,5 |
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Biotin (μg) | 0,18 | 1,8 | 0,75 | 7,5 |
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Vitamin E (mg α-TE) | 0,5/g večkrat-nenasičenih maščobnih kislin, izraženih kot linolenska kislina, vendar nikoli manj kakor 0,1 mg na 100 izkoristljivih kJ | 0,75 | 0,5/g večkrat-nenasičenih maščobnih kislin, izraženih kot linolenska kislina, vendar nikoli manj kakor 0,5 mg na 100 izkoristljivih uporabnih kcal | 3 |
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| Na 100 kJ | Na 100 kcal |
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| Najmanj | Največ | Najmanj | Največ |
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Natrij (mg) | 7,2 | 42 | 30 | 175 |
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Klor (mg) | 7,2 | 42 | 30 | 175 |
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Kalij(mg) | 19 | 70 | 80 | 295 |
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Kalcij (mg) | 8,4/12 | 42/60 | 35/50 | 175/250 |
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Fosfor (mg) | 7,2 | 19 | 30 | 80 |
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Magnezij (mg) | 1,8 | 6 | 7,5 | 25 |
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Železo (mg) | 0,12 | 0,5 | 0,5 | 2 |
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Cink (mg) | 0,12 | 0,36 | 0,5 | 1,5 |
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Baker (μg) | 15 | 125 | 60 | 500 |
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Jod (μg) | 1,55 | 8,4 | 6,5 | 35 |
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