natgillin/translations-raw huggingface dataset:
Vsak osnutek odločitve, ki predvideva izdajo dovoljenja, vsebuje podatke, ki so navedeni v členu 15(4), in ime
Any draft decision which envisages the granting of authorisation shall include the particulars referred to in Article 15(4) and the name of the
Dokončna odločitev se sprejme v skladu s postopkom iz
be adopted in accordance with the procedure referred to in Article
Komisija nemudoma obvesti
The Commission shall without delay inform the
o svoji odločitvi, podrobnosti te odločitve pa objavi v Uradnem listu Evropske unije.
of the decision taken and publish details of the decision in the Official Journal of the European Union.
lahko v skladu s postopkom iz
may, in accordance with the procedure laid down in Article
zaprosi za spremembo obstoječe
, apply for a modification of an existing
Agencija na lastno pobudo ali na predlog države članice ali Komisije poda mnenje o tem, ali je odločitev v zvezi z uporabo zdravstvene navedbe še vedno v skladu s pogoji iz te uredbe.
On its own initiative or following a request from a Member State or from the Commission, the Authority shall issue an opinion on whether a decision for the use of a health claim continues to meet the conditions laid down in this Regulation.
Agencija svoje mnenje nemudoma posreduje Komisiji,
It shall forthwith transmit its opinion to the Commission, the
in državam članicam.
and the Member States.
Agencija v skladu s členom 38(1) Uredbe (ES) št 178/2002 svoje mnenje objavi.
The Authority, in accordance with Article 38(1) of Regulation (EC) No 178/2002, shall make its opinion public.
Javnost lahko v roku 30 dni po objavi Komisiji posreduje svoje pripombe.
The public may submit comments to the Commission within 30 days of such publication.
v treh mesecih
within three months
Če je primerno se
If appropriate, the
spremeni, začasno prekine ali prekliče, v skladu s postopkom iz člena 16.
shall be modified, suspended or revoked in accordance with the procedure laid down in Article 16.
Komisija po posvetovanju z Agencijo predloži predlog uredbe Evropskega parlamenta in Sveta o uvedbi pristojbin za oceno obvestil.
After consulting the Authority, the Commission shall submit a proposal for a regulation of the European Parliament and of the Council establishing fees for the evaluation of notifications.
SPLOŠNE IN KONČNE DOLOČBE
GENERAL AND FINAL PROVISIONS Article
Komisija izdela in vodi register Skupnosti navedb hranilne vrednosti in zdravstvenih navedb, v nadaljevanju "register".
The Commission shall establish and maintain a Community Register of nutrition and health claims made on food, hereinafter referred to as "the Register".
Register vsebuje naslednje:
The Register shall include the following:
navedbe hranilne vrednosti in zdravstvene navedbe ter pogoje, ki se uporabljajo zanje, kot je navedeno v Prilogi;
the nutrition claims and the conditions applying to them as set out in the Annex;
, ter vsemi pogoji, ki veljajo zanje.
, and any conditions applying to them.
o katerih je bila sprejeta ugodna odločitev
on which a favourable decision has been taken
in ime prvotnega
the health claim and the name of the original
opozorilo o tem, da je
that the
bila sprejeta odločitev
decision was reached
na podlagi zaupnih podatkov;
on the basis of proprietary data;
opozorilo o tem, da je uporaba zdravstvene navedbe omejena, razen če kasnejši
that the health claim is restricted for use unless a subsequent
ugodno odločitev
a favourable decision
brez sklica na zaupne podatke prvotnega
without reference to the proprietary data of the original
Register se objavi.
The Register shall be made available to the public.
Znanstveni podatki in druge informacije, ki jih vsebuje dokumentacija
The scientific data and other information in the
, zahtevana v skladu s
dossier required under Article
, se v roku
for a period of
treh let
three years
dogovoril s prejšnjim
has agreed with the prior
proizvajalcem ali uvoznikom
manufacturer or importer
, da se lahko takšni podatki in informacije uporabijo ob predpostavki, da:
that such data and information may be used, where:
so bili znanstveni podatki in druge informacije označeni kot zaupni s strani prvotnega
the scientific data and other information has been designated as proprietary by the prior
je imel prvotni
the prior
zdravstvena navedba ne bi mogla biti odobrena brez predložitve zaupnih podatkov s strani prvotnega
the health claim could not have been approved without the submission of the proprietary data by the prior
Do preteka obdobja
Until the end of the
, določenega v odstavku 1, se naslednji
period specified in paragraph 1, no subsequent
nima pravice sklicevati na podatke, ki jih je predhodni
shall have the right to refer to data designated as proprietary by a prior
označil kot zaupne, če Komisija ne sprejme odločitve, po kateri se bi lahko izdalo dovoljenje brez podatkov, ki jih je predhodni
unless and until the Commission takes a decision on whether an authorisation could be or could have been granted without the submission of data designated as proprietary by the prior
Obvestilo, registriranje in objava navedbe ne posegajo v pravice intelektualne lastnine, ki bi lahko bile v korist obvestitelja, tako v zvezi s samo navedbo, kot tudi v zvezi s kakršnimi koli znanstvenimi podatki ali informacijami iz dokumentacije.
Notification, registering and publication of claims shall be without prejudice to any intellectual property rights which the person notifying may enjoy in relation to the claim itself or any scientific data or information contained in the dossier.
Take pravice se varuje v skladu z zakonodajo Skupnosti ali nacionalnimi pravnimi določbami, skladnimi z zakonodajo Skupnosti.
Such rights are to be protected in accordance with Community law or national legal provisions consistent with Community law.
Nacionalne določbe
National provisions
Brez poseganja v Pogodbo, zlasti člena 28 in 30, države članice ne smejo omejiti ali prepovedati trgovine z živili ali oglaševanja živil, ki so v skladu s to uredbo, z izvajanjem neusklajenih nacionalnih določb, ki urejajo navedbe na živilih ali živil na splošno.
Without prejudice to the Treaty, in particular Articles 28 and 30 thereof, Member States may not restrict or forbid trade in or advertising of foods which comply with this Regulation by the application of non-harmonised national provisions governing claims made on certain foods or on foods in general.
Postopek obveščanja
Notification procedure
Pri sklicevanju na ta člen se uporablja postopek, določen v odstavkih 2, 3 in 4.
Where reference is made to this Article, the procedure laid down in paragraphs 2, 3 and 4 shall apply.
Če država članica meni, da je treba sprejeti novo zakonodajo, Komisijo in ostale države članice obvesti o predvidenih ukrepih in poda razloge, ki jih opravičujejo.
If a Member State considers it necessary to adopt new legislation, it shall notify the Commission and the other Member States of the envisaged measures and give the reasons justifying them.
Zadevna država članica lahko predvidene ukrepe sprejme šest mesecev po obvestilu iz odstavka 2 pod pogojem, da mnenje Komisije ni negativno.
The Member State concerned may take the envisaged measures six months after the notification referred to in paragraph 2, provided that the Commission's opinion is not negative.
Če je mnenje Komisije negativno, v skladu s postopkom iz
If the Commission's opinion is negative, it shall determine, in accordance with the procedure referred to in Article
in pred iztekom roka iz prvega pododstavka tega odstavka določi, ali je predvidene ukrepe mogoče izvajati.
(2) and before the expiry of the period referred to in the first subparagraph of this paragraph, whether the envisaged measures may be implemented.
Komisija lahko za predvidene ukrepe zahteva nekatere spremembe.
The Commission may require certain amendments to be made to the envisaged measure.
Če ima država članica resne pomisleke, da se navedba ne ujema s to uredbo ali da je znanstvena utemeljitev iz
Where a Member State has serious grounds for considering that a claim does not comply with this Regulation, or that the scientific substantiation provided for in
pomanjkljiva, lahko država članica začasno prekine uporabo te navedbe na svojem ozemlju.
is insufficient, that Member State may temporarily suspend the use of that claim within its territory.
O tem obvesti druge države članice in Komisijo ter navede vzroke za začasno prekinitev.
It shall inform the other Member States and the Commission and give reasons for the suspension.
V skladu s postopkom iz
In accordance with the procedure referred to in Article
se, kadar je to primerno, po pridobitvi mnenja Agencije sprejme odločba.
(2), a decision shall be taken, where appropriate after obtaining an opinion from the Authority.
Komisija lahko postopek začne na lastno pobudo.
The Commission may initiate this procedure on its own initiative.
Država članica iz odstavka 1 lahko začasno prekinitev ohrani dokler ni obveščena o odločbi iz člena 2.
The Member State referred to in paragraph 1 may maintain the suspension until the decision referred to in paragraph 2 has been notified to it.
Komisiji pomaga odbor
The Commission shall be assisted by the Committee
iz člena 23(3)
referred to in Article 23(3)
Obdobje iz člena 5(6) Sklepa 1999/468/ES je tri mesece.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be three months.
Da bi olajšali učinkovito spremljanje živil z navedbami hranilne vrednosti ali zdravstvenimi navedbami, lahko države članice od proizvajalca ali osebe, ki daje takšna živila na trg na njihovem ozemlju, zahtevajo, da s posredovanjem vzorca oznake tega izdelka o tem obvesti pristojne organe.
To facilitate efficient monitoring of foods bearing nutrition or health claims, Member States may require the manufacturer or the person placing such foods on the market in their territory to notify the competent authority of that placing on the market by forwarding it a model of the label used for the product.
Komisija najpozneje do ...
No later than
Tri leta po
Three years after the
zadnjem dnevu
last day of
v mesecu
the month
po datumu sprejema te uredbe.
following the date of adoption of this Regulation.
, skupaj s predlogi sprememb, če je to potrebno.
together with a proposal for amendments if necessary.
To poročilo naj vključuje tudi oceno vpliva te uredbe na javno zdravje.
The report should also include an evaluation of the impact of this Regulation on public health.
Prvi dan
First day of the
Živila, ki so dana na trg ali označena pred
Foods placed on the market or labelled prior to
datumom veljavnosti te uredbe in
the date of entry into force of this Regulation and
Zadnji dan enajstega meseca po
Last day of the eleventh month following the date of
ali po poteku roka uporabe, odvisno katero obdobje je daljše.
or the end of their shelf life, whichever is longer.
Razen navedb iz člena 11(1), ki se uporabljajo v skladu z obstoječimi določbami, se lahko zdravstvene navedbe za živila, kategorije živil ali sestavine živil v času, ko ta uredba stopi v veljavo, še naprej uporabljajo pod pogojem, da se napravi obvestilo v skladu s členom 13 v roku dvanajstih mesecev od začetka veljavnosti te uredbe in do šestih mesecev po sprejetju končne odločitve v skladu s členom 16.
Health claims other than those referred to in Article 11(1) that are used in compliance with existing provisions, for foods, categories of foods or food constituents at the time this Regulation enters into force, may continue to be used provided a notification is made pursuant to Article 13 within twelve months of the date of entry into force of this Regulation and until six months after a final decision is taken pursuant to Article 16.
Navedbe hranilne vrednosti in pogoji, ki se uporabljajo zanje
Nutrition claims and conditions applying to them
NIZKA ENERGIJSKA VREDNOST
LOW ENERGY
Navedba, da ima živilo nizko energijsko vrednost, in katera koli navedba s podobnim pomenom za potrošnika je dopustna samo, kadar izdelek vsebuje manj kot 40 kcal (170 kJ)/100 g in manj kot 20kcal (80 kJ)/100 ml.
A claim that a food is low in energy, and any claim likely to have the same meaning for the consumer, may only be made where the product contains less than 40 kcal (170 kJ)/100g and less than 20kcal (80kJ)/100ml.
Pri živilih z naravno nizko energijsko vrednostjo, se lahko pred to navedbo uporabi izraz "naravno".
In the case of foods naturally low in energy, the term "naturally" may be used as a prefix to this claim.
Navedba, da ima živilo zmanjšano energijsko vrednost, in katera koli navedba s podobnim pomenom za potrošnika je dopustna samo, kadar je energijska vrednost zmanjšana vsaj za 30 % in označuje značilnost(i), ki živilu znižuje(jo) skupno energijsko vrednost.
A claim that a food is energy-reduced, and any claim likely to have the same meaning for the consumer, may only be made where the energy value is reduced by at least 30%, with an indication of the
NIZKA VSEBNOST MAŠČOB
LOW FAT
Navedba, da ima živilo nizko vsebnost maščob, in katera koli navedba s podobnim pomenom za potrošnika je dopustna samo, kadar izdelek ne vsebuje več kot 3 g maščobe na 100 g ali 1,5 g maščobe na 100 ml (1,8 g maščobe na 100 ml za delno posneto mleko).
A claim that a food is low in fat, and any claim likely to have the same meaning for the consumer, may only be made where the product contains no more than 3g of fat per 100g or 1.5g of fat per 100ml (1.8g of fat per 100 ml for semi-skimmed milk).
Pri živilih z naravno nizko vsebnostjo maščob, se lahko pred to navedbo uporabi izraz "naravno".
In the case of foods naturally low in fat, the term "naturally" may be used as a prefix to this claim.
Navedba, da je živilo brez maščob, in katera koli navedba s podobnim pomenom za potrošnika je dopustna samo, kadar izdelek ne vsebuje več kot 0,5 g maščobe na 100 g ali na 100 ml.
A claim that a food is fat-free, and any claim likely to have the same meaning for the consumer, may only be made where the product contains no more than 0.5g of fat per 100g or 100ml.
Vendar pa se navedbe, izražene v "X % brez maščob", prepovejo.
However, claims expressed as "X% fat-free" shall be prohibited.
Pri živilih, ki so po naravi brez maščob, se lahko pred to navedbo uporabi izraz "naravno".
In the case of foods naturally fat-free, the term "naturally" may be used as a prefix to this claim.
NIZKA VSEBNOST NASIČENIH MAŠČOB
LOW SATURATED FAT
Navedba, da ima živilo nizko vsebnost nasičenih maščob, in katera koli navedba s podobnim pomenom za potrošnika je dopustna samo, kadar izdelek ne vsebuje več kot 1,5 g nasičene maščobe na 100 g ali 0,75 g nasičene maščobe na 100 ml (za tekočine); nasičena maščoba ne sme zagotavljati več kot 10 % energije.
A claim that a food is low in saturated fat, and any claim likely to have the same meaning for the consumer, may only be made where the product contains no more than 1.5g of saturates per 100g for solids or, 0.75g of saturates per 100ml for liquids and in either case saturated fat must not provide more than 10% of energy.
Pri živilih z naravno nizko vsebnostjo nasičenih maščob, se lahko pred to navedbo uporabi izraz "naravno".
In the case of foods naturally low in saturated fat, the term "naturally" may be used as a prefix to this claim.
BREZ NASIČENIH MAŠČOB
SATURATED FAT -FREE
Navedba, da je živilo brez nasičenih maščob, in katera koli navedba s podobnim pomenom za potrošnika je dopustna samo, kadar izdelek ne vsebuje več kot 0,1 g nasičene maščobe na 100 g ali na 100 ml.
A claim that a food does not contain saturated fat, and any claim likely to have the same meaning for the consumer, may only be made where the product contains no more than 0.1g of saturated fat per 100g or 100ml.
Pri živilih, ki so po naravi brez nasičenih maščob, se lahko pred to navedbo uporabi izraz "naravno".
In the case of foods naturally saturated fat-free, the term "naturally" may be used as a prefix to this claim.
NIZKA VSEBNOST SLADKORJEV
LOW SUGARS
Navedba, da ima živilo nizko vsebnost sladkorjev, in katera koli navedba s podobnim pomenom za potrošnika je dopustna samo, kadar izdelek ne vsebuje več kot 5 g sladkorjev na 100 g ali na 100 ml.
A claim that a food is low in sugars, and any claim likely to have the same meaning for the consumer, may only be made where the product contains no more than 5g of sugars per 100g or 100ml.
Pri živilih z naravno nizko vsebnostjo sladkorjev, se lahko pred to navedbo uporabi izraz "naravno".
In the case of foods naturally low in sugars, the term "naturally" may be used as a prefix to this claim.
Navedba, da je živilo brez sladkorjev, in katera koli navedba s podobnim pomenom za potrošnika je dopustna samo, kadar izdelek ne vsebuje več kot 0,5 g sladkorjev na 100 g ali na 100 ml.
A claim that a food is sugars-free, and any claim likely to have the same meaning for the consumer, may only be made where the product contains no more than 0.5g of sugars per 100g or 100ml.
Pri živilih, ki so po naravi brez sladkorjev, se lahko pred to navedbo uporabi izraz "naravno".
In the case of foods naturally sugars-free, the term "naturally" may be used as a prefix to this claim.
BREZ DODANIH SLADKORJEV
WITH NO ADDED SUGARS
Navedba, da sladkor živilu ni bil dodan, in katera koli navedba s podobnim pomenom za potrošnika je dopustna samo, kadar izdelek ne vsebuje dodanih mono- ali disaharidov ali drugih živil, uporabljenih zaradi njihovih sladilnih lastnosti.
A claim stating that sugar has not been added to a food, and any claim likely to have the same meaning for the consumer, may only be made where the product does not contain any added mono- or disaccharides or any other food used for its sweetening properties.
NIZKA VSEBNOST NATRIJA / SOLI
LOW SODIUM / SALT
Navedba, da ima živilo nizko vsebnost natrija, in katera koli navedba s podobnim pomenom za potrošnika je dopustna samo, kadar izdelek ne vsebuje več kot 0,12 g natrija ali enake vrednosti soli na 100 g ali na 100 ml.
A claim that a food is low in sodium, and any claim likely to have the same meaning for the consumer, may only be made where the product contains no more than 0.12g of sodium, or the equivalent value for salt, per 100g or per 100ml.
Pri živilih z naravno nizko vsebnostjo natrija, se lahko pred to navedbo uporabi izraz "naravno".
In the case of foods naturally low in sodium, the term "naturally" may be used as a prefix to this claim.
ZELO NIZKA VSEBNOST NATRIJA / SOLI
VERY LOW SODIUM / SALT
Navedba, da ima živilo zelo nizko vsebnost natrija, in katera koli navedba s podobnim pomenom za potrošnika je dopustna samo, kadar izdelek ne vsebuje več kot 0,04 g natrija ali enake vrednosti soli na 100 g ali na 100 ml.
A claim that a food is very low in sodium, and any claim likely to have the same meaning for the consumer, may only be made where the product contains no more than 0.04g of sodium, or the equivalent value for salt, per 100g or per 100 ml.
Pri živilih z zelo nizko naravno vsebnostjo natrija, se lahko pred to navedbo uporabi izraz "naravno".
In the case of foods naturally very low in sodium, the term "naturally" may be used as a prefix to this claim.
Navedba, da je živilo brez natrija, in katera koli navedba s podobnim pomenom za potrošnika je dopustna samo, kadar izdelek ne vsebuje več kot 0,005 g natrija ali enake vrednosti soli na 100 g.
A claim that a food is sodium-free, and any claim likely to have the same meaning for the consumer, may only be made where the product contains no more than 0.005g of sodium, or the equivalent value for salt, per 100g.
Pri živilih, ki so po naravi brez natrija, se lahko pred to navedbo uporabi izraz "naravno".
In the case of foods naturally sodium-free, the term "naturally" may be used as a prefix to this claim.
VIR VLAKNIN
SOURCE OF FIBRE
Navedba, da je živilo vir vlaknin, in katera koli navedba s podobnim pomenom za potrošnika je dopustna samo, kadar izdelek vsebuje vsaj 3 g vlaknin na 100 g ali vsaj 1,5 g vlaknin na 100 kcal.
A claim that a food is a source of fibre, and any claim likely to have the same meaning for the consumer, may only be made where the product contains at least 3g of fibre per 100g or at least 1.5g of fibre per 100kcal.
Pri živilih, ki so po naravi vir vlaknin, se lahko pred to navedbo uporabi izraz "naravno".
In the case of foods that are naturally sources of fibre, the term "naturally" may be used as a prefix to this claim.
VISOKA VSEBNOST VLAKNIN
HIGH FIBRE
Navedba, da ima živilo visoko vsebnost vlaknin, in katera koli navedba s podobnim pomenom za potrošnika je dopustna samo, kadar izdelek vsebuje vsaj 6 g vlaknin na 100 g ali vsaj 3 g vlaknin na 100 kcal.
A claim that a food is high in fibre, and any claim likely to have the same meaning for the consumer, may only be made where the product contains at least 6g of fibre per 100g or at least 3g of fibre per 100kcal.
Pri živilih z naravno visoko vsebnostjo vlaknin, se lahko pred to navedbo uporabi izraz "naravno".
In the case of foods naturally high in fibre, the term "naturally" may be used as a prefix to this claim.
VIR BELJAKOVIN
SOURCE OF PROTEIN
Navedba, da je živilo vir beljakovin, in katera koli navedba s podobnim pomenom za potrošnika je dopustna samo, kadar vsaj 12 % energijske vrednosti živila zagotavljajo beljakovine.
A claim that a food is a source of protein, and any claim likely to have the same meaning for the consumer, may only be made where at least 12% of the energy value of the food is provided by protein.
Pri živilih, ki so po naravi vir beljakovin, se lahko pred to navedbo uporabi izraz "naravno".
In the case of foods that are naturally sources of protein, the term "naturally" may be used as a prefix to this claim.
VISOKA VSEBNOST BELJAKOVIN
HIGH PROTEIN
Navedba, da ima živilo visoko vsebnost beljakovin, in katera koli navedba s podobnim pomenom za potrošnika je dopustna samo, kadar vsaj 20 % energijske vrednosti živila zagotavljajo beljakovine.
A claim that a food is high in protein, and any claim likely to have the same meaning for the consumer, may only be made where at least 20% of the energy value of the food is provided by protein.
Pri živilih z naravno visoko vsebnostjo beljakovin, se lahko pred to navedbo uporabi izraz "naravno".
In the case of foods naturally high in protein, the term "naturally" may be used as a prefix to this claim.
Navedba, da je živilo naravni vir vitaminov in/ali mineralov, in katera koli navedba s podobnim pomenom za potrošnika je dopustna samo, kadar izdelek vsebuje vsaj 15 % priporočene dnevne količine iz Priloge k
A claim that a food is a natural source of vitamins and/or minerals, and any claim likely to have the same meaning for the consumer, may only be made where the product contains at least 15% of the recommended daily allowance specified in the Annex
Direktivi 90/496/EGS
of Directive
na 100 g ali 100 ml.
90/496/EEC per 100 g or 100 ml.
Pri živilih z naravno visoko vsebnostjo vitaminov in/ali mineralov, se lahko pred to navedbo uporabi izraz "naravno".
In case of foods naturally high in vitamins and/or minerals, the term "naturally" may be used as a prefix to this claim.
VSEBNOST (IME HRANILNE ALI DRUGE SNOVI)
CONTAINS (NAME OF THE NUTRIENT OR OTHER SUBSTANCE)
Navedba, da živilo vsebuje hranilno ali drugo snov, in katera koli navedba s podobnim pomenom za potrošnika je dopustna samo, kadar je izdelek v skladu z vsemi veljavnimi določbami te uredbe.
A claim that a food contains a nutrient or another substance, or any claim likely to have the same meaning for the consumer, may only be made where the product complies with all the applicable provisions of this Regulation.
Pri živilih, ki po naravi vsebujejo imenovano hranilno ali drugo snov, se lahko pred to navedbo uporabi izraz "naravno".
In the case of foods that naturally contain the named nutrient or other substance, the term "naturally" may be used as a prefix to this claim.
Navedba, da je vsebnost ene ali več hranilnih snovi povečana, in katera koli navedba s podobnim pomenom za potrošnika je dopustna samo, kadar izdelek izpolnjuje pogoje za navedbo "vir" in kadar je vsebnost v primerjavi s podobnim izdelkom povečana vsaj za 30 %.
A claim stating that the content in one or more nutrients has been increased, and any claim likely to have the same meaning for the consumer, may only be made where the product meets the conditions for the claim "source of" and the increase in content is at least 30% compared to a similar product.