natgillin/translations-raw huggingface dataset:
In order to take account of the specific nature of food for special medical purposes, this Regulation should lay down additions and exceptions to those general rules, where appropriate.
Da bi upoštevali posebno naravo živil za posebne zdravstvene namene, bi bilo s to uredbo po potrebi treba določiti dodatke in izjeme k navedenim splošnim pravilom.
Providing all information that is necessary to ensure the appropriate use of food for special medical purposes should be mandatory for this type of food.
Za živila za posebne zdravstvene namene bi moralo biti obvezno, da se zagotovijo vse informacije, ki so potrebne za pravilno uporabo te vrste živil.
That information should include information on the properties and characteristics in relation to, among others, the special processing and formulation, nutritional composition and rationale of use of the product that make it useful for its specific intended purpose.
Navedene informacije bi morale vsebovati informacije o lastnostih in značilnostih, ki se med drugim nanašajo na poseben postopek predelave in oblikovanja, hranilno sestavo in razlago uporabe proizvoda, zaradi katerih je proizvod koristen za posebno predvideno uporabo.
Such information should not be considered as nutrition and health claims within the meaning of Regulation (EC) No 1924/2006 of the European Parliament and of the Council [10].
Takih informacij ne bi smeli šteti za prehranske in zdravstvene trditve iz Uredbe (ES) št. 1924/2006 Evropskega parlamenta in Sveta [10].
The nutrition declaration for food for special medical purposes is essential in order to guarantee its appropriate use, both for patients consuming that food and for health care professionals who recommend its consumption.
Označba hranilne vrednosti za živilo za posebne zdravstvene namene je ključnega pomena za zagotovitev, da ga pravilno uporabijo pacienti, ki uživajo navedeno živilo, in zdravstveni delavci, ki priporočajo njegovo uživanje.
For that reason and in order to provide more complete information to patients and healthcare professionals, the nutrition declaration should include more particulars than those required by Regulation (EU) No 1169/2011.
Zaradi tega in zaradi popolnejših informacij za paciente in zdravstvene delavce bi označba hranilne vrednosti morala vsebovati več podatkov od tistih, ki jih zahteva Uredba (EU) št. 1169/2011.
In addition, the exemption provided for in point 18 of Annex V to Regulation (EU) No 1169/2011 should not apply and the nutrition declaration should be mandatory for all food for special medical purposes, irrespective of the package or container size.
Poleg tega se izvzetje iz točke 18 Priloge V k Uredbi (EU) št. 1169/2011 ne bi smelo uporabljati in označba hranilne vrednosti bi morala biti obvezna za vsa živila za posebne zdravstvene namene, ne glede na velikost embalaže ali posode.
Consumers of food for special medical purposes have different nutritional needs than the normal population.
Potrošniki živil za posebne zdravstvene namene imajo drugačne prehranske potrebe kot zdravo prebivalstvo.
The expression of nutrition information on the energy value and the amount of nutrients of food for special medical purposes as a percentage of daily reference intake values set out in Regulation (EU) No 1169/2011 would mislead consumers and should therefore not be allowed.
Navajanje informacij o hranilni vrednosti z energijo in količino hranil v živilih za posebne zdravstvene namene kot odstotek vrednosti dnevnega priporočenega vnosa iz Uredbe (EU) št. 1169/2011 bi zavajalo potrošnike in zato ne bi smelo biti dovoljeno.
The use of nutrition and health claims authorised under Regulation (EC) No 1924/2006 to promote food for special medical purposes would not be appropriate, since consumers of such products are patients suffering from a disease, disorder or condition and are, therefore, not part of the general healthy population.
Uporaba prehranskih in zdravstvenih trditev, odobrenih na podlagi Uredbe (ES) št. 1924/2006 za promoviranje živil za posebne zdravstvene namene, ne bi bila primerna, saj so potrošniki takih proizvodov pacienti, ki trpijo za boleznijo, motnjo ali zdravstvenem stanjem in zato niso del splošnega zdravega prebivalstva.
In addition, food for special medical purposes is to be used under medical supervision and its consumption should not be promoted through the use of nutrition and health claims directly targeting consumers.
Poleg tega se živila za posebne zdravstvene namene uživajo pod zdravniškim nadzorom in njihova poraba se ne bi smela spodbujati z uporabo prehranskih in zdravstvenih trditev, ki so namenjene neposredno potrošnikom.
For those reasons, the use of nutrition and health claims should not be allowed for food for special medical purposes.
Iz teh razlogov se uporaba prehranskih in zdravstvenih trditev ne bi smela dovoliti za živila za posebne zdravstvene namene.
In the past years, an increasing number of products have been placed on the market as food for special medical purposes developed to satisfy the nutritional requirements of infants.
V zadnjih letih je vse več proizvodov, ki so bili dani v promet kot živila za posebne zdravstvene namene, pripravljena za zadovoljitev prehranskih potreb dojenčkov.
These products are sometimes promoted with means directly targeting consumers that are not subject to the restrictions under Union legislation applicable to infant formula and follow-on formula.
Navedeni proizvodi se včasih oglašujejo s sredstvi, ki so namenjena neposredno potrošnikom in za katera ne veljajo omejitve iz zakonodaje Unije, ki se uporablja za začetne formule za dojenčke in nadaljevalne formule.
In order to avoid possible abuses linked to the misclassification of products, reduce confusion for consumers on the nature of the different products being offered to them and guarantee conditions of fair competition, it seems appropriate to introduce additional restrictions on the labelling, presentation, advertising, and promotional and commercial practices of food for special medical purposes developed to satisfy the nutritional requirements of infants.
Da bi preprečili morebitne zlorabe, povezane z napačno razvrstitvijo proizvodov, zmanjšali zmedo za potrošnike glede narave različnih proizvodov, ki so jim na voljo, in zagotovili pravične konkurenčne pogoje, se zdi primerno, da se uvedejo dodatne omejitve za označevanje, predstavitev, oglaševanje ter promocijske in trgovinske prakse pri živilih za posebne zdravstvene namene, pripravljenih za zadovoljitev prehranskih potreb dojenčkov.
Those restrictions should be similar to those applicable to infant formula and follow-on formula for healthy infants, with adjustments taking into account the intended use of the product and without prejudice to the need to provide food information to patients and health care professionals to ensure the product's appropriate use.
Te omejitve bi morale biti podobne omejitvam pri začetnih formulah in nadaljevalnih formulah za zdrave dojenčke, vendar s prilagoditvami, ki bi upoštevale predvideno uporabo proizvoda in ne bi posegale v potrebo, da pacienti in zdravstveni delavci dobijo informacije o živilih, s katerimi se zagotovi pravilna uporaba proizvoda.
Given that food for special medical purposes is to be used under medical supervision, those restrictions should not make it more difficult for food business operators to communicate with health care professionals and should allow health care professionals to assess the suitability of different products for their intended use.
Ker se živila za posebne zdravstvene namene uživajo pod zdravniškim nadzorom, navedene omejitve nosilcem živilske dejavnosti ne bi smele oteževati komunikacije z zdravstvenimi delavci in bi zdravstvenim delavcem morale omogočiti, da ocenijo primernost različnih proizvodov za predvideno uporabo.
In this context, in order to facilitate the efficient official monitoring of food for special medical purposes, food business operators placing food for special medical purposes on the market should provide the national competent authorities with a model of the label used and all relevant information considered necessary to demonstrate compliance with this Regulation, unless Member States have a different efficient monitoring system.
V zvezi s tem morajo nosilci živilske dejavnosti, ki dajo v promet živila za posebne zdravstvene namene, predložiti pristojnim nacionalnim organom vzorec uporabljenega označevanja z vsemi ustreznimi informacijami, ki se zdijo potrebne za dokazovanje skladnosti s to uredbo, da bi se olajšalo učinkovito uradno spremljanje živil za posebne zdravstvene namene, razen če imajo države članice različen učinkovit sistem spremljanja.
In order to enable food business operators to adapt to the new requirements, this Regulation should apply from a date that is 3 years after its entry into force.
Da bi nosilcem živilske dejavnosti omogočili, da se prilagodijo novim zahtevam, bi se ta uredba morala začeti uporabljati tri leta po datumu začetka veljavnosti.
Taking into account the number and importance of the new requirements applicable to food for special medical purposes developed to satisfy the nutritional requirements of infants, in respect of such products this Regulation should apply from a date that is 4 years after its entry into force,
Zaradi števila in pomembnosti novih zahtev, ki se uporabljajo za živila za posebne zdravstvene namene, pripravljena za zadovoljitev prehranskih potreb dojenčkov, bi se ta uredba za take proizvode morala začeti uporabljati štiri leta po datumu začetka veljavnosti –
Food for special medical purposes may only be placed on the market if it complies with this Regulation.
Živila za posebne zdravstvene namene se smejo dati v promet, samo če so v skladu s to uredbo.
Food for special medical purposes is classified in the following three categories:
Živila za posebne zdravstvene namene se delijo v tri kategorije:
nutritionally complete food 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 it is intended;
živila, ki v celoti pokrivajo prehranske potrebe, s standardno sestavo hranil, ki so lahko ob uporabi v skladu s proizvajalčevimi navodili edini vir prehrane za osebe, ki so jim namenjena;
nutritionally complete food 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 it is intended;
živila, ki v celoti pokrivajo prehranske potrebe, s posebej prilagojeno sestavo hranil, specifično za bolezen, motnjo ali zdravstveno stanje, ki so lahko ob uporabi v skladu s proizvajalčevimi navodili edini vir prehrane za osebe, ki so jim namenjena;
nutritionally incomplete food with a standard formulation or a nutrient-adapted formulation specific for a disease, disorder or medical condition which is not suitable to be used as the sole source of nourishment.
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.
The food referred to in points (a) and (b) of the first subparagraph may also be used as a partial replacement or as a supplement to the patient's diet.
Živila iz točk (a) in (b) prvega pododstavka se lahko uporabljajo tudi kot delno nadomestilo ali kot dodatek k prehrani pacienta.
The formulation of food for special medical purposes shall be based on sound medical and nutritional principles.
Sestava živil za posebne zdravstvene namene temelji na veljavnih dognanjih medicinske stroke in prehranskih načelih.
Its use, in accordance with the manufacturer's instructions, shall be safe, beneficial and effective in meeting the specific nutritional requirements of the persons for whom it is intended, as demonstrated by generally accepted scientific data.
Njihova uporaba v skladu s proizvajalčevimi navodili mora biti varna, koristna in učinkovita, da ustreza posebnim prehranskim zahtevam ljudi, ki so jim namenjena, v skladu s splošno sprejetimi znanstvenimi dognanji.
Food for special medical purposes developed to satisfy the nutritional requirements of infants shall comply with the compositional requirements set out in Part A of Annex I.
Živila za posebne zdravstvene namene, pripravljena za zadovoljitev prehranskih potreb dojenčkov, izpolnjujejo zahteve glede sestave iz dela A Priloge I.
Food for special medical purposes other than that developed to satisfy the nutritional requirements of infants shall comply with the compositional requirements set out in Part B of Annex I.
Živila za posebne zdravstvene namene, ki niso pripravljena za zadovoljitev prehranskih potreb dojenčkov, izpolnjujejo zahteve glede sestave iz dela B Priloge I.
The compositional requirements set out in Annex I shall apply to the food for special medical purposes ready for use, marketed as such or after preparation in accordance with the manufacturer's instructions.
Zahteve glede sestave iz Priloge I se uporabljajo za živila za posebne zdravstvene namene, ki so pripravljena za uporabo in se tržijo kot taka ali po pripravi v skladu s proizvajalčevimi navodili.
Requirements on pesticides in food for special medical purposes developed to satisfy the nutritional requirements of infants and young children
Zahteve glede pesticidov v živilih za posebne zdravstvene namene, pripravljenih za zadovoljitev prehranskih potreb dojenčkov in majhnih otrok
Food for special medical purposes developed to satisfy the nutritional requirements of infants and young children shall not contain residues at levels exceeding 0,01 mg/kg per active substance.
Živila za posebne zdravstvene namene, pripravljena za zadovoljitev prehranskih potreb dojenčkov in majhnih otrok, ne smejo vsebovati ostankov v vrednostih, višjih od 0,01 mg/kg za aktivno snov.
By way of derogation from paragraph 2, for the active substances listed in Annex II, the maximum residue levels specified in that Annex shall apply.
Z odstopanjem od odstavka 2 za aktivne snovi s seznama v Prilogi II veljajo mejne vrednosti ostankov iz navedene priloge.
Food for special medical purposes developed to satisfy the nutritional requirements of infants and young children shall only be produced from agricultural products for the production of which plant protection products containing the active substances listed in Annex III have not been used.
Živila za posebne zdravstvene namene, pripravljena za zadovoljitev prehranskih potreb dojenčkov in majhnih otrok, se proizvajajo le iz kmetijskih proizvodov, pri proizvodnji katerih niso bila uporabljena fitofarmacevtska sredstva, ki vsebujejo aktivne snovi iz Priloge III.
However, for the purpose of checks, plant protection products containing the active substances listed in Annex III are considered not to have been used if their residues do not exceed a level of 0,003 mg/kg.
Vendar se za namen preverjanja šteje, da se niso uporabljala fitofarmacevtska sredstva, ki vsebujejo aktivne snovi iz Priloge III, če njihovi ostanki ne presegajo vrednosti 0,003 mg/kg.
The levels referred to in paragraphs 2, 3 and 4 shall apply to the food for special medical purposes ready for use, marketed as such or after preparation in accordance with the manufacturer's instructions.
Vrednosti iz odstavkov 2, 3 in 4 se uporabljajo za živila za posebne zdravstvene namene, ki so pripravljena za uporabo in se tržijo kot taka ali po pripravi v skladu s proizvajalčevimi navodili.
The name of food for special medical purposes shall be as set out in Annex IV.
Ime živila za posebne zdravstvene namene mora biti tako, kakor je določeno v Prilogi IV.
Unless otherwise provided in this Regulation, food for special medical purposes shall comply with Regulation (EU) No 1169/2011.
Razen če ni drugače določeno s to uredbo, so živila za posebne zdravstvene namene v skladu z Uredbo (EU) št. 1169/2011.
In addition to the mandatory particulars listed in Article 9(1) of Regulation (EU) No 1169/2011, the following shall be additional mandatory particulars for food for special medical purposes:
Poleg obveznih podatkov iz člena 9(1) Uredbe (EU) št. 1169/2011 so za živila za posebne zdravstvene namene obvezni še naslednji dodatni podatki:
a statement that the product must be used under medical supervision;
opozorilo, da se mora živilo uživati pod zdravniškim nadzorom;
a statement whether the product is suitable for use as the sole source of nourishment;
opozorilo o primernosti ali neprimernosti živila za uporabo kot edinega vira prehrane;
a statement that the product is intended for a specific age group, as appropriate;
po potrebi opozorilo, da je živilo namenjeno določeni starostni skupini;
where appropriate, a statement that the product poses a health hazard when consumed by persons who do not have the disease, disorder or medical condition for which the product is intended;
po potrebi opozorilo, da živilo lahko povzroči zdravstvene težave, če ga uživajo osebe, ki nimajo bolezni, motnje ali zdravstvenega stanja, za katere je živilo namenjeno.
the statement ‘For the dietary management of …’ where the blank shall be filled in with the disease, disorder or medical condition for which the product is intended;
opozorilo „Za prehransko uravnavanje …“, pri čemer se v prazni prostor vpišejo bolezen, motnja ali zdravstveno stanje, za katere je živilo namenjeno;
where appropriate, a statement concerning adequate precautions and contra-indications;
po potrebi opozorilo na potrebno previdnost pri uporabi in kontraindikacije;
a description of the properties and/or characteristics that make the product useful in relation to the disease, disorder or medical condition for the dietary management of which the product is intended, in particular, as the case may be, relating to the special processing and formulation, the nutrients which have been increased, reduced, eliminated or otherwise modified and the rationale of the use of the product;
opis lastnosti in/ali značilnosti, zaradi katerih je proizvod koristen za bolezen, motnjo ali zdravstveno stanje, za katerih prehransko uravnavanje je namenjen, po potrebi s poudarkom na posebnem postopku predelave in oblikovanja proizvoda, hranilih, katerih vsebnost je bila povišana, znižana, ki so bila izločena ali kako drugače spremenjena, in razlagi uporabe proizvoda;
where appropriate, a warning that the product is not for parenteral use;
po potrebi opozorilo, da živilo ni za parenteralno uporabo;
instructions for appropriate preparation, use and storage of the product after the opening of the container, as appropriate.
po potrebi navodila za primerno pripravo, uporabo in shranjevanje živila po odprtju notranje embalaže.
The particulars referred to in points (a) to (d) shall be preceded by the words ‘important notice’ or their equivalent.
Podatki iz točk (a) do (d) sledijo besedam „Pomembno obvestilo“ ali čemu enakovrednemu.
Article 13(2) and (3) of Regulation (EU) No 1169/2011 shall also apply to the additional mandatory particulars referred to in paragraph 2 of this Article.
Člen 13(2) in (3) Uredbe (EU) št. 1169/2011 se uporablja tudi za dodatne obvezne podatke iz odstavka 2 tega člena.
In addition to the information referred to in Article 30(1) of Regulation (EU) No 1169/2011, the mandatory nutrition declaration for food for special medical purposes shall include the following:
Poleg podatkov iz člena 30(1) Uredbe (EU) št. 1169/2011 mora obvezna označba hranilne vrednosti za živila za posebne zdravstvene namene navajati naslednje:
the amount of each mineral substance and of each vitamin listed in Annex I to this Regulation and present in the product;
vsebnost v proizvodu vsakega minerala in vsakega vitamina iz Priloge I k tej uredbi;
the amount of components of protein, carbohydrate, fat and/or of other nutrients and their components, the declaration of which would be necessary for the appropriate intended use of the product;
vsebnost sestavnih delov beljakovin, ogljikovih hidratov in maščob in/ali drugih hranil in njihovih sestavin, katerih označba je nujna za pravilno predvideno uporabo proizvoda;
information on the osmolality or the osmolarity of the product where appropriate;
po potrebi podatek o osmolalnosti in osmolarnosti živila;
information on the source and the nature of the protein and/or protein hydrolysates contained in the product.
podatek o viru in naravi beljakovin in/ali beljakovinskih hidrolizatov, ki jih živilo vsebuje.
By way of derogation from Article 30(3) of Regulation (EU) No 1169/2011, the information included in the mandatory nutrition declaration for food for special medical purposes shall not be repeated on the labelling.
Z odstopanjem od člena 30(3) Uredbe (EU) št. 1169/2011 se podatki, ki so vključeni v obvezno označbo hranilne vrednosti za živila za posebne zdravstvene namene, ne navedejo ponovno pri označevanju.
The nutrition declaration shall be mandatory for all food for special medical purposes, irrespective of the size of the largest surface of the packaging or container.
Označba hranilne vrednosti je obvezna za vsa živila za posebne zdravstvene namene, ne glede na velikost največje površine embalaže ali posode.
Articles 31 to 35 of Regulation (EU) No 1169/2011 shall apply to all the nutrients included in the nutrition declaration for food for special medical purposes.
Členi 31 do 35 Uredbe (EU) št. 1169/2011 se uporabljajo za vse hranilne snovi, vključene v označbo hranilne vrednosti za živila za posebne zdravstvene namene.
By way of derogation from Article 31(3) of Regulation (EU) No 1169/2011, the energy value and the amounts of nutrients of food for special medical purposes shall be those of the food as sold and, where appropriate, those of the food ready for use after preparation in accordance with the manufacturer's instructions.
Z odstopanjem od člena 31(3) Uredbe (EU) št. 1169/2011 se energijska vrednost in vsebnost hranil v živilih za posebne zdravstvene namene navajata za živilo, kot je v prodaji, kadar je primerno pa za živilo, pripravljeno za uporabo po pripravi v skladu s proizvajalčevimi navodili.
By way of derogation from Article 32(3) and (4) of Regulation (EU) No 1169/2011, the energy value and the amount of nutrients of food for special medical purposes shall not be expressed as a percentage of the reference intakes set out in Annex XIII to that Regulation.
Z odstopanjem od člena 32(3) in (4) Uredbe (EU) št. 1169/2011 se energijska vrednost in vsebnost hranil v živilih za posebne zdravstvene namene ne navajata kot odstotek priporočenih vnosov iz Priloge XIII k navedeni uredbi.
The particulars included in the nutrition declaration for food for special medical purposes that are not listed in Annex XV to Regulation (EU) No 1169/2011 shall be presented after the most relevant entry of that Annex they belong to or are components of.
Podatki, ki so vključeni v označbo hranilne vrednosti za živila za posebne zdravstvene namene ter niso navedeni v Prilogi XV k Uredbi (EU) št. 1169/2011, se predstavijo po najustreznejšem vnosu iz navedene priloge, h kateremu pripadajo ali so njegov sestavni del.
The indication of the amount of sodium shall appear together with the other minerals and may be repeated next to the indication of the salt content as follows:
Vsebnost natrija se navede skupaj z drugimi minerali in se lahko ponovi ob navedbi vsebnosti soli, kot sledi:
‘Salt: X g (of which sodium: Y mg)’.
„Sol: X g (od česar natrij: Y mg)“.
Nutrition and health claims
Prehranske in zdravstvene trditve
Nutrition and health claims shall not be made on food for special medical purposes.
Prehranske in zdravstvene trditve se ne smejo navesti na živilih za posebne zdravstvene namene.
Specific requirements for food for special medical purposes developed to satisfy the nutritional requirements of infants
Posebne zahteve za živila za posebne zdravstvene namene, pripravljena za zadovoljitev prehranskih potreb dojenčkov
All mandatory particulars for food for special medical purposes developed to satisfy the nutritional requirements of infants shall appear in a language easily understood by the consumers.
Vsi obvezni podatki za živila za posebne zdravstvene namene, pripravljena za zadovoljitev prehranskih potreb dojenčkov, se navedejo v jeziku, ki ga zlahka razumejo potrošniki.