natgillin/translations-raw huggingface dataset:
"zdravstvena navedba" pomeni vsako navedbo, ki navaja, domneva ali namiguje, da obstaja povezava med kategorijo živil, živilom ali eno od njegovih sestavin na eni strani in zdravjem na drugi strani;
"health claim" means any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health;
"navedbe v zvezi z zmanjšanjem tveganja bolezni" so kakršne koli navedbe o zdravju, ki navajajo, domnevajo ali namigujejo, da uživanje kategorije živil, živila ali njegovega sestavnega dela znatno zmanjšuje dejavnik tveganja za razvoj bolezni;
"reduction of disease risk claim" means any health claim that states, suggests or implies that the consumption of a food category, a food or one of its constituents significantly reduces a risk factor in the development of a human disease;
"povprečni potrošnik" je potrošnik, ki je razmeroma dobro obveščen, pozoren in pazljiv;
"average consumer" means the consumer who is reasonably well informed and reasonably observant and circumspect;
"zdravje'pomeni splošno stanje fizičnega, psihološkega in socialnega dobrega počutja;
"health" means a general state of physical, psychological and social well-being;
"skupina živil'pomeni skupino prehrambenih proizvodov, ki imajo enake lastnosti in vsebnost hranilnih snovi ter uporabo.
"a category of foods" means a group of food products having equivalent properties and nutrient content and uses.
Navedbe hranilne vrednosti in zdravstvene navedbe se lahko uporabljajo pri označevanju, predstavitvi in oglaševanju živil, danih na trg Skupnosti le, če so skladne z določbami te uredbe.
Nutrition and health claims may only be used in the labelling, presentation and advertising of foods placed on the market in the Community if they comply with the provisions of this Regulation.
Brez poseganja v Direktivi 2000/13/ES in 84/450/EGS uporaba navedb hranilne vrednosti in zdravstvenih navedb ne sme:
Without prejudice to Directives 2000/13/EC and 84/450/EEC, the use of nutrition and health claims shall not:
ali zavajajoča;
or misleading;
povzročati dvomov glede varnosti in/ali hranilne primernosti drugih živil;
give rise to doubt about the safety and/or the nutritional adequacy of other foods;
se nanašati na spremembe telesnih funkcij v neprimernih ali zaskrbljujočih pogojih, niti z besedilom niti s slikovnimi, grafičnimi ali simbolnimi prestavitvami;
refer to changes in bodily functions in improper or alarming terms either textually or through pictorial, graphic or symbolic representations;
spodbujati ali opravičevati presežno uživanje hrane ali zmanjšuje pomen zdrave prehrane.
encourage or condone excess consumption of a food or understate the importance of a healthy diet.
Uporaba navedb hranilne vrednosti in zdravstvenih navedb je dovoljena le, če so izpolnjeni naslednji pogoji:
The use of nutrition and health claims shall only be permitted if the following conditions are fulfilled:
prisotnost, odsotnost ali zmanjšana vsebnost
the presence, absence or reduced content of the
hranilne ali druge
nutrient or other
snovi, glede katere so podane navedbe, ima dokazano
substance in respect of which the claim is made has been shown to have
dobrodejni hranilni ali fiziološki učinek, kakor so
beneficial nutritional or physiological effect, as established
pokazala priznana
by accepted
snov, za katero obstajajo navedbe:
substance for which the claim is made:
je v končnem izdelku vsebovana v znatnih količinah, kot je določeno v zakonodaji Skupnosti, ali, če takšni predpisi ne obstajajo, v količini, ki bo ustvarila zahtevani hranilni ali fiziološki učinek, kot so pokazala
is contained in the final product in a significant quantity as defined in Community legislation or, where such rules do not exist, in a quantity that will produce the nutritional or physiological effect claimed as established
ni prisotna ali je prisotna v zmanjšani količini, ki bo ustvarila zahtevani hranilni ali fiziološki učinek, kot so pokazala
is not present or is present in a reduced quantity that will produce the nutritional or physiological effect claimed as established
kjer je to primerno, je
where applicable, the
hranilna ali druga
nutrient or other
snov, za katero so podane navedbe, v obliki, ki je na razpolago za telesno uporabo;
substance for which the claim is made is in a form that is available to be used by the body;
količina izdelka, katere zaužitje se lahko pričakuje, predvideva znatno količino
the quantity of the product that can reasonably be expected to be consumed provides a significant quantity of the
snovi, za katero navedbe veljajo, kot je določeno v zakonodaji Skupnosti, ali, če takšni predpisi ne obstajajo, v znatni količini, ki bo ustvarila zahtevani hranilni ali fiziološki učinek, kot so pokazala
substance to which the claim relates, as defined in Community legislation or, where such rules do not exist, in a significant quantity that will produce the nutritional or physiological effect claimed as established
skladnost s posebnimi pogoji, določenimi v poglavju III ali poglavju IV, če je to
compliance with the specific conditions set out in Chapter III or Chapter IV as
hranilne vrednosti in zdravstvene navedbe veljajo za hrano, pripravljeno za uporabo, v skladu z navodili proizvajalca.
and health claims shall refer to the food ready for consumption in accordance with the manufacturer's instructions.
Znanstvene utemeljitve navedb in trditev
Scientific substantiation for claims
Navedbe hranilne vrednosti in zdravstvene navedbe temeljijo na in so utemeljene
Nutrition and health claims shall be based on and substantiated
s priznanimi
by accepted
Nosilec živilske dejavnosti, ki oblikuje navedbe hranilne vrednosti ali zdravstvene navedbe, mora utemeljiti uporabo te navedbe.
A food business operator making a nutrition or health claim shall justify the use of the claim.
Pristojni organi držav članic lahko zadolžijo nosilca živilske dejavnosti ali osebo, ki da izdelek na trg, da predloži znanstvena dokazila in podatke, ki so v skladu s to uredbo.
The competent authorities of the Member States may request a food business operator or a person placing a product on the market to produce the scientific work and the data establishing compliance with this Regulation.
Podatki o hranilni vrednosti
Nutrition information
Uporaba navedb hranilne vrednosti ali zdravstvenih navedb ne prispeva k prikrivanju celotne hranilne vrednosti živila.
The use of nutrition or health claims shall not contribute to masking the overall nutritional value of a food.
V ta namen se zagotovijo podatki, ki potrošniku omogočajo razumevanje pomembnosti živil z navedbami hranilne vrednosti ali zdravstvenimi navedbami v njegovi dnevni prehrani.
To this end, information shall be provided enabling the consumer to understand the relevance of the food bearing the nutrition or health claim in his/her daily diet.
o hranilni vrednosti
information provided
za zdravstvene
for health
v skupini 2, kot je določeno v členu 4(1) Direktive 90/496/EGS.
in Group 2 as defined in Article 4 (1) of Directive 90/496/EEC.
Sklicevati se je treba tudi na energijsko vrednost in vsebnost hranilnih in drugih snovi na proizvod ali obrok, da bi potrošnikom omogočili lažjo uporabo.
Reference shall also be made to the energy value and the content of nutrients and other substances per package or portion to facilitate matters for consumers.
Poleg tega
In addition,
so blizu navedbe hranilne vrednosti navedeni naslednji podatki, razen če že obstoječa zakonodaja Skupnosti ne zahteva, da se navedejo drugod na oznaki:
the following information shall be stated in proximity to the nutrition information unless already required to be stated elsewhere on the label by existing Community legislation:
hranilnih ali drugih
nutrient(s) or other
snovi, na katero se navezuje navedba hranilne vrednosti ali zdravstvena navedba in ki je ni na oznaki hranilne vrednosti
substance(s) to which a nutrition or health claim relates that does not appear in the nutrition labelling
podatki v zvezi z vlogo živil, ki vsebujejo navedbe hranilne vrednosti ali zdravstvene navedbe v okviru uravnotežene prehrane.
information about the role of the food bearing nutrition or health claims within a balanced diet.
Ti podatki so posredovani z navedbo količine hranilnih ali drugih snovi, prisotnih v živilih, ki nosi navedbo, glede na dnevno referenčno vrednost za zaužito količino za takšne hranilne ali druge snovi.
This information shall be provided by indicating the amount of a nutrient or other substance present in the foodstuff bearing the claim, in relation to the daily reference intake values for such nutrients or other substances.
NAVEDBE HRANILNE VREDNOSTI
NUTRITION CLAIMS Article
Posebni pogoji
Specific conditions
Navedbe hranilne vrednosti so dovoljene samo, če so v skladu s to uredbo in izpolnjujejo pogoje, določene v Prilogi.
Nutrition claims shall only be permitted if they are in conformity with this Regulation and comply with the conditions set out in the Annex.
Spremembe Priloge se sprejmejo v skladu s postopkom iz
Amendments to the Annex shall be adopted in accordance with the procedure referred to in Article
in, če je primerno, po posvetu z Agencijo
(2) and, where appropriate, after consulting
Navedbe o primerljivosti
Comparative claims
Brez poseganja v Direktivo 84/450/EGS je navedba hranilne vrednosti, ki primerja količino hranljive vrednosti in/ali kalorično vrednost živila
Without prejudice to Directive 84/450/EEC, a nutrition claim which compares the quantity of a nutrient and/or the energy value of a food with
z drugačnim živilom ali drugo kategorijo živil
a different food or another category of food
, dopustna le, če so med seboj primerjana živila s strani povprečnega potrošnika lahko prepoznavna ali jasno navedena.
shall only be made if the foods being compared are easily identified by the average consumer or clearly indicated.
Primerjalne navedbe hranilne vrednosti primerjajo sestavo vprašljivega živila s sestavo živila iz vrste živil iste kategorije, katerih sestava ne dovoljuje uporabe navedbe, vključno z živili drugih znamk.
Comparative nutrition claims shall compare the composition of the food in question with a range of foods of the same category, which do not have a composition which allows them to bear a claim, including foods of other brands.
ZDRAVSTVENE NAVEDBE
HEALTH CLAIMS Article
Zdravstvene navedbe so dovoljene, če so v skladu s splošnimi zahtevami iz poglavja II in s posebnimi zahtevami iz tega poglavja
Health claims shall be permitted if they comply with the general requirements in Chapter II and the specific requirements in this Chapter and
ter so bile sporočene v skladu s postopkom iz člena 13, in če
have been notified in accordance with the procedure referred to in Article 13, and if
Komisija ni ugovarjala v roku, določenem v členu 15(1), ali
the Commission has raised no objection within the period laid down in Article 15(1), or
je Komisija ugovarjala, ni pa bila sprejeta nasprotna odločitev v skladu s člena 16(3), v devetih mesecih od prejema obvestila.
where the Commission has raised an objection, no adverse decision has been taken in accordance with Article 16(3) within nine months of receipt of the notification.
Zdravstvene navedbe so dovoljene le, če so na oznaki naslednji podatki:
Health claims shall only be permitted if the following information is included on the label:
kjer je primerno,
where appropriate,
izjava, ki navaja pomembnost uravnotežene prehrane in zdravega načina življenja
a statement indicating the importance of a balanced diet and a healthy lifestyle
(na vidnem mestu na oznaki)
(in a prominent place on the label)
količina hrane in vzorec porabe, ki je potreben za domnevni ugoden učinek;
the quantity of the food and pattern of consumption required to obtain the claimed beneficial effect;
kjer je primerno, izjava, naslovljena na osebe, ki se morajo izogibati uporabi živila;
where appropriate, a statement addressed to persons who should avoid using the food;
kjer je primerno, opozorilo, naj se ne presega količin, ki lahko predstavljajo nevarnost za zdravje.
where appropriate, a warning not to exceed quantities of the product that may represent a risk to health.
Omejitve uporabe nekaterih
Restrictions on the use of certain
zdravstvenih navedb
health claims
navedbe niso dopustne,
claims shall not be allowed
razen če so znanstveno utemeljene
unless scientifically substantiated
navedbe, ki se nanašajo na nasvet zdravnikov ali drugih strokovnjakov na področju zdravstva ali ustreznih poklicnih združenj ali dobrodelnih ustanov
claims which make reference to the advice of doctors or other health professionals, or their professional associations, or charities
, razen če so znanstveno utemeljene in sporočene v skladu s to uredbo;
, unless scientifically substantiated and notified in accordance with this Regulation;
navedbe, ki so namenjene izključno otrokom.
claims which are exclusively directed at children.
Če je primerno, Komisija po posvetovanju z Agencijo
Where appropriate, the Commission, having first consulted the Authority
in organizacijami, ki zastopajo prehrambeno industrijo ter potrošnike,
and organisations representing the food industry and consumers,
objavi podrobne smernice za izvajanje predloženega člena,
shall publish detailed guidelines for the implementation of this article
sestavljene v skladu s postopkom, iz člena 25(2)
, drawn up in accordance with the procedure referred to in Article 25(2)
Zdravstvene navedbe, ki opisujejo splošno sprejet pomen hranilne ali druge snovi
Health claims describing a generally accepted role of a nutrient or other substance
Z odstopanjem od
By way of derogation from Article
in delovanje
substance in growth, development and
telesa na
the functions
podlagi priznanih
of the body, which are based
in nespornih
on accepted and properly substantiated
temeljijo na
based on
seznamu, predvidenem v odstavku 2.
the list provided for in paragraph 2.
in organizacije, ki predstavljajo živilsko industrijo in potrošnike,
and organisations representing the food industry and consumers
na pobudo Komisije ali na zahtevo države članice.
, on the Commission's own initiative or following a request by a Member State.
Navedbe v zvezi z zmanjšanjem tveganja bolezni
Reduction of disease risk claims
Z odstopanjem od člena 2(1) Direktive 2000/13/ES so mogoče navedbe v zvezi z zmanjšanjem tveganja za obolenja, če
By way of derogation from Article 2 (1) of Directive 2000/13/EC, reduction of disease risk claims may be made where they have been
v skladu s to uredbo.
in accordance with this Regulation.
Razen splošnih zahtev, določenih v tej uredbi, in posebnih zahtev iz odstavka 1 morajo oznake za navedbe v zvezi z zmanjšanjem tveganj bolezni vključevati tudi izjavo, da imajo bolezni več dejavnikov tveganja in da ima lahko sprememba enega od teh dejavnikov tveganja ugoden učinek, ni pa njuno.
In addition to the general requirements laid down in this Regulation and the specific requirements of paragraph 1, for reduction of disease risk claims the label shall also bear a statement indicating that diseases have multiple risk factors and that altering one of these risk factors may or may not have a beneficial effect.
pri Agenciji
to the Authority
na običajen način prek pošte, oziroma raje s sodobnimi tehnikami obveščanja (vključno z elektronsko pošto), ko da proizvajalec proizvod prvič v promet ali, v primeru proizvoda, proizvedenega v tretji državi, ko to stori uvoznik
by normal post or, preferably, using modern communication techniques (including e-mail), by the manufacturer when the product is first placed on the market or, in the case of a product manufactured in a third country, by the importer
pisno potrdi prejem
shall acknowledge receipt of
v roku 14 dni po prejemu.
in writing within 14 days of its receipt.
V potrdilu je zabeležen datum prejema
The acknowledgement shall state the date of receipt of the
nemudoma obvesti države članice in Komisijo o
shall inform without delay the Member States and the Commission of the
ter jim
and shall make the
da na razpolago z vsemi ostalimi informacijami, ki jih je predložil
and any supplementary information supplied by the
proizvajalec ali uvoznik
manufacturer or importer
je treba priložiti naslednje podrobnosti in dokumente:
shall be accompanied by the following particulars and documents:
ime in naslov
the name and address of the
proizvajalca ali uvoznika
manufacturer or importer
hranilna ali druga snov ali
the nutrient or other substance or
živilo ali kategorija živila, za katero naj se pripravi zdravstvena navedba, ter njene posebne značilnosti;
the food or the category of food in respect of which the health claim is to be made and its particular characteristics;
kopije drugih znanstvenih študij, ki so pomembne za zdravstveno navedbo;
a copy of other scientific studies which are relevant to that health claim;
ubeseditve zdravstvene
wording of
(v skladu s členom 25(2)se lahko sprejmejo ukrepi, ki posebej malim in srednje velikim podjetjem nudijo ad hoc modele)
; (special illustrative measures for SMEs may be adopted under the procedure referred to in Article 25(2))
kadar je to primerno, vzorec predlaganega pakiranja živila, na katerem je navedba, jasno kaže predlog ubeseditve zdravstvene navedbe in uporabljeno oznako;
where appropriate, a sample of the proposed food packaging on which the claim is to be made, clearly showing the proposal for the wording of the health claim and the label used;
povzetek dokumentacije.
a summary of the dossier.
Izvedbena pravila za uporabo tega člena, vključno s pravili za pripravo in predstavitev
Implementing rules for the application of this Article, including rules concerning the preparation and presentation of the
, se določijo v skladu s postopkom iz
shall be established in accordance with the procedure referred to in Article
, po posvetovanju z Agencijo.
(2), after consultation of the Authority.
Malim in srednje velikim podjetjem naj se nudi znatno pomoč pri pripravi zadev.
SMEs should be given substantial aid in preparing the dossiers.
Agencija pred datumom, s katerim začne veljati ta uredba,
Before the date of application of this Regulation, the Authority shall
določi in
identify and
objavi podrobna navodila, da bi
publish detailed guidance to assist
proizvajalcem in uvoznikom
manufacturers and importers
olajšala pripravo in oddajo
in the preparation and the presentation of
Pravila v zvezi s pripravo in oddajo obvestil vključujejo določbo, ki proizvajalcu ali uvozniku zagotavlja pravico, da svoje obvestilo utemelji pred Agencijo.
The rules concerning the preparation and presentation of notifications shall include a provision granting the right to the manufacturer or importer to defend its notification in front of the Authority.
Ta določba izrecno vključuje pravico zagotavljanja dodatnih podatkov med oceno zadeve s strani Agencije.
This provision will explicitly include the right to provide additional data in the course of the evaluation of the dossier by the Authority.
Komisija lahko v štirih mesecih po predložitvi obvestila v skladu s členom 9(1) Agenciji izda utemeljeno mnenje, če je dosegla stališče, da zdravstvena navedba ni v skladu s splošnimi zahtevami, določenimi v poglavju II, ali posebnimi zahtevami, določenimi v tem poglavju.
The Commission may, within four months of submission of a notification in accordance with Article 9(1), deliver to the Authority a reasoned opinion if it has reached the conclusion that a health claim does not comply with the general requirements set out in Chapter II or the specific requirements set out in this Chapter.
Predložitev utemeljenega mnenja pomeni, da je Agencijo pozvana k predložitvi mnenja o skladnosti zdravstvene navedbe s splošnimi zahtevami, določenimi v poglavju II, in posebnimi zahtevami, določenimi v tem poglavju.
Delivery of the reasoned opinion shall imply that the Authority is called upon to draw up an opinion on the consistency of the health claim with the general requirements set out in Chapter II and the specific requirements set out in this Chapter.
Agencija nemudoma obvesti proizvajalca ali uvoznika, da se mora prenehati uporaba zdravstvene navedbe, dokler
The Authority shall notify the manufacturer or importer without delay that use of the health claim must cease until such time as either:
ni dosežena pozitivna odločitev v skladu s postopkom iz člena 16, ali
a favourable decision has been reached in accordance with the procedure set out in Article 16, or
ni minilo šest mesecev od prejema obvestila v skladu s členom 9(1) brez kakršne koli dosežene odločitve.
a period of six months has elapsed since receipt of the notification in accordance with Article 9(1) without any decision being reached.
Kadar obstajajo dvomi v zvezi z znanstveno utemeljitvijo zdravstvene navedbe, lahko Agencija na zahtevo Komisije pripravi mnenje.
Where there are doubts regarding the scientific substantiation of a health claim the Authority may, at the request of the Commission, draw up an opinion.
Pri sestavljanju mnenja si Agencija prizadeva, da spoštuje rok
In giving its opinion, the Authority shall endeavour to respect a time limit of
mesecev od datuma prejema
months from the date of receipt of
Proizvajalec ali uvoznik imata neposredni dostop do pristojnega sosveta Agencije vključno s pravico biti zaslišan in pravico zagotoviti dodatno dokumentacijo k zadevi.
The manufacturer or importer shall have direct access to the competent panel of the Authority including the right to be heard and the right to provide additional particulars to the dossier.
Za pripravo svojega mnenja Agencija preveri:
In order to prepare its opinion, the Authority shall verify:
je zdravstvena
the health
navedba utemeljena z znanstvenimi podatki;
claim is substantiated by scientific data;
navedba v skladu s kriteriji, določenimi v tej uredbi;
claim complies with the criteria laid down in this Regulation;
navedba razumljiva in pomembna za potrošnika.
claim is understandable and meaningful to the consumer.
Če mnenje podpira uporabo zdravstvene navedbe, mora mnenje vsebovati še naslednje podatke:
In the event of an opinion in favour of approving the health claim, the opinion shall include the following particulars:
oznako živila ali kategorije živil, za katero naj se pripravi navedba, ter njene posebne lastnosti;
the designation of the food or category of food in respect of which a claim is to be used and its particular characteristics;
predlog ubeseditve zdravstvene
a proposal for the wording of the health
kadar je potrebno, pogoje za uporabo živila in/ali dodatno pojasnilo ali opozorilo, ki mora spremljati zdravstveno navedbo na oznaki ali pri oglaševanju.
where necessary, conditions of use of the food and/or an additional statement or warning that should accompany the health claim on the label and advertising.
V primeru pogojnega mnenja o zdravstveni navedbi se to mnenje pošlje proizvajalcu ali uvozniku.
In the event of a conditional opinion on the health claim, the opinion shall be sent to the manufacturer or importer.
Proizvajalec ali uvoznik imata od datuma prejema mnenja en mesec časa, da Agenciji zagotovita nadaljnje podatke, preden je mnenje dokončno sprejeto in objavljeno.
The manufacturer or importer shall have one month from the date of receipt of the opinion to provide further information to the Authority, before an opinion is finally adopted and published.
Agencija posreduje svoje mnenje, vključno s poročilom o oceni zdravstvene navedbe in utemeljitvijo svojega mnenja, Komisiji, državam članicam in
The Authority shall forward its opinion to the Commission, the Member States and the
proizvajalcu ali uvozniku
manufacturer or importer
Javnost lahko v roku 30 dni po objavi Komisiji posreduje svoje pripombe.
The public may submit comments to the Commission within 30 days from such publication.
enem mesecu
one month
po prejemu mnenja Agencije odboru iz
of receipt of the opinion of the Authority, the Commission shall submit to the Committee referred to in Article
predloži osnutek
(1) a draft of the decision to be
čemer se upoštevajo mnenje Agencije
into account the opinion of the Authority
vse zadevne določbe zakonodaje
any relevant provisions of Community
se osnutek odločitve ne ujema z mnenjem Agencije, Komisija pojasni razloge za odstopanje.
the draft Decision is not in accordance with the opinion of the Authority, the Commission shall provide an explanation for the differences.