natgillin/translations-raw huggingface dataset:
Ne glede na člen 2(1)(b) Direktive 2000/13/ES so trditve v zvezi z zmanjšanjem tveganja za bolezni
Notwithstanding Article 2(1)(b) of Directive 2000/13/EC, reduction of disease risk claims
dopustne, če so bile v skladu s postopkom iz členov 15
may be made where they have been authorised in accordance with the procedure laid down in Articles 15
te uredbe odobrene za vključitev med takšne dovoljene trditve v seznam Skupnosti, skupaj z vsemi pogoji, potrebnimi za uporabo teh trditev.
of this Regulation for inclusion in a Community list of such permitted claims together with all the necessary conditions for the use of these claims.
Poleg splošnih zahtev, določenih v tej uredbi, in posebnih zahtev iz odstavka 1, je treba pri označevanju ali, če tako označevanje ne obstaja, pri predstavljanju ali oglaševanju trditev v zvezi z zmanjšanjem tveganja za bolezen, navesti, da za bolezen, na katero se trditev nanaša, obstaja več dejavnikov tveganja in da ima sprememba enega teh dejavnikov tveganja lahko ugoden učinek, kar pa ni 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 labelling or, if no such labelling exists, the presentation or advertising shall also bear a statement indicating that the disease to which the claim is referring has multiple risk factors and that altering one of these risk factors may or may not have a beneficial effect.
Ob sklicevanju na ta člen se predloži vloga za odobritev v skladu z naslednjimi odstavki.
When reference is made to this Article, an application for authorisation shall be submitted in accordance with the following paragraphs.
Vloga se pošlje pristojnemu nacionalnemu organu države članice.
The application shall be sent to the national competent authority of a Member State.
Pristojni nacionalni organ:
The national competent authority shall:
pisno potrdi prejem vloge v roku 14 dni po prejemu.
acknowledge receipt of an application in writing within 14 days of its receipt.
o vlogi nemudoma obvesti Agencijo; in
inform without delay the Authority; and
Agenciji da na razpolago vlogo in vse dodatne informacije, ki jih je predložil vlagatelj.
make the application and any supplementary information supplied by the applicant available to the Authority;
nemudoma obvesti druge države članice in Komisijo o vlogi ter jim jo da na razpolago skupaj z vsemi dodatnimi informacijami, ki jih je predložil vlagatelj;
inform without delay the other Member States and the Commission of the application and shall make the application and any supplementary information supplied by the applicant available to them;
da javnosti na voljo povzetek vloge iz odstavka 3(g).
make the summary of the application referred to in paragraph 3(g) available to the public.
Vloga vsebuje :
The application shall include the following:
hranilo ali drugo snov ali živilo ali kategorijo živila, za katero naj velja zdravstvena trditev, ter njene posebne značilnosti;
the nutrient or other substance, or the food or the category of food, in respect of which the health claim is to be made and its particular characteristics;
kopije študij, vključno z - kadar so na voljo - neodvisnimi, strokovno pregledanimi študijami, ki so bile opravljene, da potrdijo zdravstveno trditev, in katerim koli drugim razpoložljivim gradivom, s katerim se lahko dokaže, da je zdravstvena trditev v skladu z merili, določenimi v tej uredbi;
a copy of the studies, including, where available, independent, peer-reviewed studies, which have been carried out with regard to the health claim and any other material which is available to demonstrate that the health claim complies with the criteria provided for in this Regulation;
kjer je to ustrezno, navedbo, kateri podatek velja za zakonsko zaščitenega, vključno s preverljivo utemeljitvijo;
where appropriate, an indication of the information which should be regarded as proprietary accompanied by verifiable justification;
kopije drugih znanstvenih študij, ki so pomembne za to zdravstveno trditev;
a copy of other scientific studies which are relevant to that health claim;
predlog besedila zdravstvene trditve, za katero se išče odobritev, vključno, odvisno od primera, s posebnimi pogoji uporabe;
a proposal for the wording of the health claim for which authorisation is sought including, as the case may be, specific conditions for use;
povzetek vloge.
a summary of the application.
Komisija po posvetovanju z Agencijo in v skladu s postopkom iz člena
The Commission, having first consulted the Authority, shall establish in accordance with the procedure referred to in
(2) določi pravila za izvajanje tega člena, vključno s pravili za pripravo in vložitev vloge.
(2) implementing rules for the application of this Article, including rules concerning the preparation and presentation of the application.
Komisija, v tesnem sodelovanju z Agencijo, da na voljo ustrezna tehnična navodila in orodja za pomoč nosilcem živilske dejavnosti in zlasti MSP pri pripravi in oddaji vloge za znanstveno presojo.
The Commission, in close cooperation with the Authority, shall make available appropriate technical guidance and tools to assist food business operators, in particular SMEs, in the preparation and the presentation of the application for scientific assessment.
Agencija za
In giving its opinion, the Authority
pripravo mnenja
shall respect
petih mesecev
five months
od datuma prejema veljavne vloge.
from the date of receipt of a valid application.
Agencija na podlagi odstavka 2 tega člena od vlagatelja zahteva dodatne informacije
the Authority seeks supplementary information from the applicant as provided for in paragraph 2
Za pripravo svojega mnenja Agencija
In order to prepare its opinion, the Authority shall
je besedilo zdravstvene trditve v skladu z merili, določenimi v tej
the wording of the health claim complies with the criteria laid down in this
V primeru, da mnenje podpira odobritev zdravstvene trditve, mora le- to vsebovati še naslednje podatke:
In the event of an opinion in favour of authorising the health claim, the opinion shall include the following particulars:
hranilo ali drugo snov ali živilo ali kategorijo živila, za katero naj velja trditev, ter njene posebne lastnosti;
the nutrient or other substance, or the food or the category of food, in respect of which a claim is to be made and its particular characteristics;
predlog besedila
a proposal for the wording of the
zdravstvene trditve in, odvisno od primera, posebne pogoje uporabe;
health claim, including, as the case may be, the specific conditions of use;
Agencija posreduje svoje mnenje Komisiji, državam članicam in vlagatelju, vključno s poročilom o oceni zdravstvene trditve in obrazložitvijo svojega mnenja ter podatki, na katerih je bilo mnenje utemeljeno.
The Authority shall forward its opinion to the Commission, the Member States and the applicant, including a report describing its assessment of the health claim and stating the reasons for its opinion and the information on which its opinion was based.
Agencija objavi svoje mnenje v skladu s členom 38(1) Uredbe (ES) št 178/2002.
The Authority, in accordance with Article 38(1) of Regulation (EC) No 178/2002, shall make its opinion public.
Vlagatelj ali javnost lahko v roku 30 dni po taki objavi predložita svoje pripombe Komisiji.
The applicant or members of the public may make comments to the Commission within 30 days from such publication.
mesecev po prejemu mnenja Agencije Komisija odboru iz člena
after receiving the opinion of the Authority, the Commission shall submit to the Committee referred to in
Če se osnutek odločbe ne ujema z mnenjem Agencije, Komisija pojasni razloge za odstopanje.
is not in accordance with the opinion of the Authority, the Commission shall provide an explanation for the differences.
Vsak osnutek odločbe za dopolnitev seznamov dovoljenih zdravstvenih trditev vsebuje podatke, ki so opredeljeni v členu 16(4).
Any draft decision to amend the lists of permitted health claims shall include the particulars referred to in Article 16(4).
Dokončna odločba o vlogi se sprejme v skladu s postopkom iz člena
A final decision on the application shall be adopted in accordance with the procedure referred to in
Zdravstvene trditve, vključene v sezname iz členov 13 in 14, lahko v skladu s pogoji, ki zanje veljajo, uporabljajo vsi nosilci živilske dejavnosti, če uporaba teh trditev ni omejena v skladu z določbami iz člena
Health claims included in the lists provided for in Articles 13 and 14 may be used, in conformity with the conditions applying to them, by any food business operator, if they are not restricted for use in accordance with the provisions of
Pridobitev dovoljenja ne zmanjšuje splošne civilne in kazenske odgovornosti nosilca živilske dejavnosti v zvezi z zadevnim živilom.
The granting of authorisation shall not lessen the general civil and criminal liability of any food business operator in respect of the food concerned.
Trditve iz člena 13(5):
Claims referred to in Article 13(5)
Nosilec živilske dejavnosti, ki namerava uporabiti zdravstveno trditev, ki ni vključena v seznam iz člena 13(3), lahko zaprosi za vključitev trditve v navedeni seznam.
A food business operator intending to use a health claim not included in the list provided for in Article 13(3) may apply for the inclusion of the claim in that list.
Prošnja za to vključitev se predloži pristojnemu nacionalnemu organu države članice, ki prejem pisno potrdi v roku 14 dni po prejemu.
The application for this inclusion shall be submitted to the national competent authority of a Member State which shall acknowledge receipt of the application in writing within 14 days of its receipt.
V potrdilu je zabeležen dan prejema vloge.
The acknowledgement shall state the date of receipt of the application.
Prošnja vključuje podatke, določene v členu 15(3), in razloge za zahtevo.
The application shall include the data provided for in Article 15(3) and the reasons for the request.
Veljavna prošnja, ki je v skladu s smernicami iz člena 15(5), in vse informacije, ki jih je predložil vlagatelj, se takoj pošljejo Agenciji za znanstveno oceno ter Komisiji in državam članicam v vednost.
The valid application, in line with the guidance referred to in Article 15(5), and any information supplied by the applicant shall be sent without delay to the Authority for a scientific assessment as well as to the Commission and the Member States for information.
Agencija poda svoje mnenje v roku petih mesecev od dneva prejema zahteve.
The Authority shall issue its opinion within a time limit of five months from the date of receipt of the request.
Ta rok se lahko podaljša največ za en mesec, če Agencija meni, da je od vlagatelja potrebno zahtevati dodatne informacije.
Such time limit may be extended by up to one month if the Authority considers it necessary to seek supplementary information from the applicant.
V takem primeru vlagatelj predloži zahtevane informacije v 15 dneh od dneva prejema zahteve Agencije.
In such a case the applicant shall submit the requested information within 15 days from the date of receipt of the Authority's request.
Postopek iz člena 16 (3)(a) in (b), (5) in(6) se uporablja smiselno.
The procedure laid down in Article 16(3)(a) and (b), (5) and (6) shall apply mutatis mutandis.
Ko Agencija, na podlagi znanstvene ocene, poda mnenje v podporo vključitvi trditve v seznam iz člena 13(3), Komisija sprejme odločbo o vlogi, pri čemer se upošteva mnenje Agencije, vse zadevne določbe prava Skupnosti in druge zakonite dejavnike, pomembne za obravnavano zadevo, po posvetovanju z državami članicami in v roku dveh mesecev po prejemu mnenja Agencije.
Where the Authority, following scientific assessment, issues an opinion in favour of the inclusion of the claim in the list provided for in Article 13(3), the Commission shall take a decision on the application, taking into account the opinion of the Authority, any relevant provisions of Community law and other legitimate factors relevant to the matter under consideration, after having consulted the Member States and within two months of receiving the opinion of the Authority.
Ko Agencija poda mnenje, ki ne podpira vključitve trditve v navedeni seznam, se odločba o vlogi sprejme v skladu s postopkom iz člena 25(2).
Where the Authority issues an opinion that would not support the inclusion of the claim in that list, a decision on the application shall be taken in accordance with the procedure referred to in Article 25(2).
Sprememba, začasna prekinitev uporabe in preklic dovoljenj
Modification, suspension and revocation of authorisations
Vlagatelj/uporabnik trditve, vključene v enega od seznamov iz členov 13 in 14, lahko zaprosi za spremembo zadevnega seznama.
The applicant/user of a claim included in one of the lists provided for in Articles 13 and 14 may apply for a modification of the relevant list.
Agencija na lastno pobudo ali na predlog države članice ali Komisije poda mnenje o tem, ali zdravstvena trditev, vključena v seznam iz členov 13 in 14, še izpolnjuje pogoje 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 health claim included in the lists provided for in Articles 13 and 14 still meets the conditions laid down in this Regulation.
Agencija svoje mnenje nemudoma posreduje Komisiji, državam članicam in po potrebi prvotnemu vlagatelju vloge za odobritev zadevne zdravstvene trditve.
It shall forthwith transmit its opinion to the Commission, the Member States and, where relevant, to the original applicant of the claim in question.
Agencija v skladu s členom 38(1) Uredbe (ES) št 178/2002 objavi svoje mnenje.
The Authority, in accordance with Article 38(1) of Regulation (EC) No 178/2002, shall make its opinion public.
Vlagatelj/uporabnik ali javnost lahko v roku 30 dni po taki objavi predložijo svoje pripombe Komisiji.
The applicant/user or a member of the public may make comments to the Commission within 30 days of such publication.
Komisija čim prej preuči mnenje Agencije in vse morebitne prejete pripombe.
The Commission shall examine the opinion of the Authority and any comments received as soon as possible.
Po potrebi se dovoljenje spremeni, začasno prekine uporaba ali prekliče po
If appropriate, the authorisation shall be modified, suspended or revoked in accordance with the
Komisija vzpostavi in vodi register Skupnosti v zvezi s prehranskimi in zdravstvenimi trditvami, 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".
prehranske trditve in pogoje, ki veljajo zanje, kakor je navedeno v prilogi;
the nutrition claims and the conditions applying to them as set out in the Annex;
omejitve, sprejete v skladu s členom 4(5);
restrictions adopted in accordance with Article 4(5);
odobrene zdravstvene trditve in pogoje, ki veljajo zanje, kakor je označeno v členih 13(3)
the authorised health claims and the conditions applying to them provided for in Articles 13(3)
(6) in nacionalne ukrepe iz člena
(6) and the national measures referred to in
seznam zavrnjenih zdravstvenih trditev in utemeljitve njihove zavrnitve.
a list of rejected health claims and the reasons for their rejection.
Za zdravstvene trditve, ki so bile odobrene na podlagi pravno zaščitenih podatkov , se v posebno prilogo registra vpišejo skupaj z naslednjimi informacijami:
Health claims authorised on the basis of proprietary data shall be recorded in a separate Annex to the Register together with the following information:
datum odobritve zdravstvene trditve s strani Komisije in ime prvega vlagatelja, ki mu je bilo izdano dovoljenje;
the date the Commission authorised the health claim and the name of the original applicant that was granted authorisation;
dejstvo, da je Komisija odobrila zdravstveno trditev na podlagi pravno zaščitenih podatkov;
the fact that the Commission authorised the health claim on the basis of proprietary data;
dejstvo, da je uporaba zdravstvene trditve omejena, razen če poznejši vlagatelj pridobi dovoljenje za trditev brez sklica na pravno zaščitene podatke prvotnega vlagatelja.
the fact that the health claim is restricted for use unless a subsequent applicant obtains authorisation for the claim without reference to the proprietary data of the original applicant.
Register je dostopen javnosti.
The Register shall be made available to the public.
Znanstveni podatki in druge informacije, ki jih vsebuje vloga vlagatelja, zahtevana v skladu s členom 15(
The scientific data and other information in the application required under
let od datuma izdaje dovoljenja ne smejo uporabiti v prid poznejšega vlagatelja, razen če se je poznejši vlagatelj dogovoril s predhodnim vlagateljem, da se lahko takšni podatki in informacije uporabijo, ob predpostavki, da:
years from the date of authorisation, unless the subsequent applicant has agreed with the prior applicant that such data and information may be used, where:
so bili znanstveni podatki in druge informacije s strani prvotnega vlagatelja v času vlaganja prvotne vloge označeni kot pravno zaščiteni; in
the scientific data and other information has been designated as proprietary by the prior applicant at the time the prior application was made; and
je imel prvotni vlagatelj v času prvotne vloge izključno pravico sklicevanja na pravno zaščitene podatke; in
the prior applicant had exclusive right of reference to the proprietary data at the time the prior application was made; and
zdravstvena trditev ne bi mogla biti odobrena brez predložitve pravno zaščitenih podatkov s strani prvotnega vlagatelja.
the health claim could not have been authorised without the submission of the proprietary data by the prior applicant.
, določenega v odstavku 1, se noben poznejši vlagatelj nima pravice sklicevati na podatke, ki so bili s strani predhodnega vlagatelja označeni kot pravno zaščiteni, vse dokler Komisija ne sprejme odločbe, po kateri bi se trditev lahko ali bi se lahko bila vključila v seznam iz člena 14 ali, kjer je ustrezno, člena 13 brez predložitve podatkov, ki so bili s strani predhodnega vlagatelja označeni kot pravno zaščiteni.
period specified in paragraph 1, no subsequent applicant shall have the right to refer to data designated as proprietary by a prior applicant unless and until the Commission takes a decision on whether a claim could be or could have been included in the list provided for in Article 14 or, where appropriate, Article 13 without the submission of data designated as proprietary by the prior applicant.
Brez poseganja v Pogodbo, zlasti člena 28 in 30 Pogodbe, države članice ne smejo omejiti ali prepovedati trgovine z živili ali oglaševanja živil, ki so v skladu s to uredbo, z izvajanjem neusklajenih nacionalnih predpisov, ki urejajo trditve na nekaterih živilih ali na živilih 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.
Komisija se posvetuje s Stalnim odborom za prehranjevalno verigo in zdravje živali, ustanovljenim s členom 58(1) Uredbe (ES) št. 178/2002 (v nadaljnjem besedilu "odbor"), če meni, da bi bil tak posvet koristen, ali če tako zahteva država članica, ter poda mnenje o predvidenih ukrepih.
The Commission shall consult the Standing Committee on the Food Chain and Animal Health instituted by Article 58(1) of Regulation (EC) No 178/2002 (hereinafter referred to as "the Committee") if it considers such consultation to be useful or if a Member State so requests, and shall give an opinion on the envisaged measures.
Zadevna država članica lahko predvidene ukrepe sprejme šest mesecev po obvestilu iz odstavka 1 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 1, provided that the Commission's opinion is not negative.
Če je mnenje Komisije negativno, je treba v skladu s postopkom iz člena
If the Commission's opinion is negative, it shall determine, in accordance with the procedure referred to in
(2) in pred iztekom roka iz prvega pododstavka tega odstavka ugotoviti, če 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.
V skladu s postopkom iz člena
In accordance with the procedure referred to in
(2) 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.
Država članica iz odstavka 1 lahko začasno prekinitev ohrani dokler ni obveščena o odločbi iz odstavka 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.
Da bi olajšali učinkovito spremljanje živil s prehranskimi ali zdravstvenimi trditvami, lahko države članice od proizvajalca ali osebe, ki daje takšna živila v promet na njihovem ozemlju, zahtevajo, da se o tem obvesti pristojne organe s posredovanjem vzorca označbe tega izdelka le-tem.
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 to it a model of the label used for the product.
Komisija Evropskemu parlamentu in Svetu predloži poročilo o izvajanju te uredbe, še zlasti o razvoju trga živil, za katera so določene prehranske in zdravstvene trditve, ter o tem, kako potrošniki razumejo te trditve, skupaj s predlogi sprememb, če je to potrebno.
at the latest, the Commission shall submit to the European Parliament and to the Council a report on the application of this Regulation, in particular on the evolution of the market in foods in respect of which nutrition or health claims are made and on the consumers' understanding of claims, together with a proposal for amendments if necessary.
Poročilo vključuje tudi oceno vpliva te uredbe na izbiro prehrane in morebiten vpliv na debelost ter nenalezljive bolezni.
The report shall also include an evaluation of the impact of this Regulation on dietary choices and the potential impact on obesity and non-communicable diseases.
Živila, ki so dana na trg ali označena pred datumom uporabe te uredbe, in niso v skladu s to uredbo, se smejo tržiti do izteka njihovega roka uporabe, toda najkasneje do … **
Foods placed on the market or labelled prior to the date of application of this Regulation which do not comply with this Regulation may be marketed until their expiry date, but not later than ... **
meseca po začetku veljavnosti te uredbe.
month following the date of entry into force of this Regulation.
Glede na določbe iz člena 4(1) se živila lahko tržijo najdlje
With regard to the provisions in Article 4(1), foods may be marketed until
mesecev po sprejetju ustreznih profilov hranil in njihovih pogojev uporabe.
months following adoption of the relevant nutrient profiles and their conditions of use.
Izdelki z blagovno znamko ali trgovskim imenom, ki so obstajali pred 1. januarjem 2005 in niso v skladu s to uredbo, se smejo še naprej tržiti do … *
Products bearing trade marks or brand names existing before 1 January 2005 which do not comply with this Regulation may continue to be marketed until … *
začetka veljavnosti te uredbe, +
of entry into force of this Regulation, plus
, potem pa se zanje uporabljajo določbe te Uredbe.
after which time the provisions of this Regulation shall apply.
Prehranske trditve, ki jih je država članica uporabljala pred 1. januarjem
Nutrition claims which have been used in a Member State before 1 January
v skladu z nacionalnimi določbami, veljavnimi zanje, in niso vključene v Prilogo, se lahko uporabljajo do … **
in compliance with national provisions applicable to them and which are not included in the Annex, may continue to be used until … **