natgillin/translations-raw huggingface dataset:
Države članice in organizacije, ki predstavljajo živilsko industrijo in potrošnike pošljejo Komisiji sezname trditev najpozneje do ... [leto dni po zadnjem dnevu v mesecu, v katerem je bila sprejeta ta uredba] v skladu z odstavkom 1.
Member States and organisations representing the food industry and consumers shall provide the Commission with lists of claims as referred to in paragraph 1 by ... at the latest [last day of the month of adoption of this Regulation + 1 year] .
Z odstopanjem od člena 2(1) Direktive 2000/13/ES so mogoče trditve v zvezi z zmanjšanjem tveganja za obolenja, če je to odobreno v skladu s to uredbo.
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 authorised in accordance with this Regulation.
Z odstopanjem od člena 2(1) Direktive 2000/13/ES so mogoče trditve v zvezi z zmanjšanjem tveganja za obolenja, če se o tem obvesti v skladu s to uredbo.
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 notified in accordance with this Regulation.
Ta predlog spremembe izhaja iz predloga spremembe člena 10(1) in spremembe postopka obveščanja iz tega člena.
This amendment follows necessarily from the amendment to Article 10 (1) and the change to a notification procedure provided for in it.
Člen 14, naslov in odstavek 1
Article 14, title and paragraph 1
Vloga za odobritev
Application for authorisation
Za pridobitev dovoljenja iz odstavka 1 člena 10 je treba vložiti vlogo pri upravnem organu.
To obtain the authorisation referred to in Article 10 (1) , an application shall be submitted to the Authority.
Prijava iz odstavka 1 člena 10 , ko da proizvajalec proizvod prvič v promet ali, v primeru proizvoda, proizvedenega v tretji državi, ko to stori uvoznik, se opravi pri upravnem organu na običajen način prek pošte, oziroma raje s sodobnimi tehnikami obveščanja (vključno z elektronsko pošto .
Notification in accordance with Article 10(1) shall be made to the Authority 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 .
Upravni organ:
The Authority:
a) pisno potrdi prejem vloge v roku 14 dni po prejemu.
(a) shall acknowledge receipt of an application in writing within 14 days of its receipt.
V potrdilu je zabeležen datum prejema vloge ;
The acknowledgement shall state the date of receipt of the application ;
a) pisno potrdi prejem prijave v roku 14 dni po prejemu.
(a) shall acknowledge receipt of the notification in writing within 14 days of its receipt.
V potrdilu je zabeležen datum prejema prijave ;
The acknowledgement shall state the date of receipt of the notification ;
b) nemudoma obvesti države članice in Komisijo o vlogi ter jim da na razpolago vlogo z vsemi ostalimi informacijami, ki jih je predložil vlagatelj kot dopolnila;
(b) shall inform without delay the Member States and the Commission of the application and shall make the application and any supplementary information supplied by the applicant available to them;
b) nemudoma obvesti države članice in Komisijo o prijavi ter jim da na razpolago prijavo z vsemi ostalimi informacijami, ki jih je predložil proizvajalec ali uvoznik kot dopolnila;
(b) shall inform without delay the Member States and the Commission of the notification and shall make the notification and any supplementary information supplied by the manufacturer or importer available to them;
(c) povzetek dokumentacije iz odstavka 3(f) da na voljo javnosti.
(c) shall make the summary of the dossier referred to in paragraph 3(f) available to the public.
Postopek odobritve, ki ga je predlagala Komisija, nadomesti manj obremenilen postopek obveščanja ali prijavni postopek.
The authorisation procedure proposed by the Commission is replaced by a less onerous notification procedure.
Z ohranitvijo obveznosti predložitve ustreznih dokumentov se zagotovi, da dobijo pristojni organi vse potrebne podatke.
Retaining the requirement to produce relevant supporting documents ensures that the competent authorities have all the necessary information.
V nasprotju s sistemom, ki ga je predlagala Komisija, je najpomembnejša razlika, da ni treba v vsakem primeru opraviti dolgotrajnega postopka odobritve.
The most important difference between this and the system proposed by the Commission is that the lengthy authorisation procedure does not have to be gone through in every case.
Če nastanejo dvomi v zvezi z znanstveno utemeljitvijo, je zaradi podatkov v prijavnem postopku kljub temu mogoče nujno preverjanje.
If doubts should arise with regard to scientific substantiation, the information submitted under the notification procedure still means that the necessary investigations can be carried out.
Kot je običajno za sodobno upravo, je obveščanje v smislu poenostavitve uprave elektronsko.
In accordance with normal modern administrative practice, electronic means of communication should be used in order to simplify administrative procedures.
To velja tudi v zvezi z enostavnejšim dostopom do postopkov prav za MSP.
This is also important in ensuring easier access for SMEs to administrative procedures.
Člen 14, odstavek 2, uvodni del
Article 14, paragraph 2, introductory part
Vlogi je treba priložiti naslednje informacije in dokazila:
The application shall be accompanied by the following particulars and documents:
Obvestilu je treba priložiti naslednje informacije in dokazila:
The notification shall be accompanied by the following particulars and documents:
Člen 14, odstavek 2, točka (a)
Article 14, paragraph 2, point (a)
(a) ime in naslov vlagatelja ;
(a) the name and address of the applicant ;
(a) ime in naslov proizvajalca ali uvoznika ;
(a) the name and address of the manufacturer or importer ;
Člen 14, odstavek 2, točka (b)
Article 14, paragraph 2, point (b)
(b) živilo ali kategorija živila, za katero naj se pripravi zdravstvena trditev, ter njene posebne značilnosti;
(b) the food or the category of food in respect of which the health claim is to be made and its particular characteristics;
(b) hranilo ali druga snov ali živilo ali kategorija živila, za katero naj se pripravi zdravstvena trditev, ter njene posebne značilnosti;
(b) 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;
Člen 14, odstavek 2, točka (e)
Article 14, paragraph 2, point (e)
(e) predlog ubeseditve v vseh jezikih Skupnosti, za zdravstvene trditve , za katere se predloži vloga, vključno, odvisno od primera, s posebnimi pogoji uporabe ;
(e) a proposal for the wording , in all Community languages, of the health claim for which authorisation is sought including, as the case may be, specific conditions for use ;
(c) predlog ubeseditve za zdravstvene trditve; (v skladu s členom 23(2) so lahko za mala in srednje velika podjetja sprejeti posebni ponazorilni ukrepi);
(e) a proposal for the wording of the health claim ; (special illustrative measures for SMEs may be adopted under the procedure referred to in Article 23(2)) ;
Člen 14, odstavek 2, točka (e a) (novo)
Article 14, paragraph 2, point (e a) (new)
(ea) kjer je to primerno, vzorec predlaganega pakiranja živila, na katerem je trditev, jasno kaže predlog ubeseditve zdravstvene trditve in uporabljeno oznako;
(ea) 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;
Države članice imajo na podlagi člena 24 pravico, da prosijo za vzorec etikete, uporabljene za živilo, za katero proizvajalec predloži trditev..
By virtue of Article 24, Member States have the right to ask for a sample of the labelling used for a food for which the manufacturer is making a claim.
Kot del postopka za odobritev zdravstvenih trditev, na katerega se sklicuje člen 14, je treba prek predlagane ubeseditve trditve, za katero se išče odobritev, zagotoviti tudi vzorec predlaganega pakiranja, ki jasno kaže ubeseditev trditve in uporabljeno etiketo.
As part of the health claims approval procedure to which this Article 14 refers, over and above the proposed wording of the claim for which authorisation is being sought, a sample of the proposed packaging should also be supplied, clearly showing the wording of the claim and the label used.
V zvezi s trditvami sta enako pomembni vsebina in oblika, ki imata lahko večji ali manjši vpliv na obnašanje možnih kupcev.
With regard to information, both the content and the form are equally important, and can have a greater or lesser impact on the attitudes of potential buyers.
Pravila za izvajanje tega člena, vključno s pravili za pripravo in predstavitev vloge , se določijo v skladu s postopkom iz člena 23(2), po posvetovanju z Agencijo.
Implementing rules for the application of this Article, including rules concerning the preparation and presentation of the application shall be established in accordance with the procedure referred to in Article 23 (2), after consultation of the Authority.
Pravila za izvajanje tega člena, vključno s pravili za pripravo in predstavitev obvestila , se določijo v skladu s postopkom iz člena 23(2), po posvetovanju z Agencijo.
Implementing rules for the application of this Article, including rules concerning the preparation and presentation of the notification shall be established in accordance with the procedure referred to in Article 23 (2), after consultation of the Authority.
Malim in srednje velikim podjetjem je treba dati da znatno pomoč pri pripravi dosjejev.
SMEs should be given substantial aid in preparing the dossiers.
Izvajanje novega sistema ne sme oškodovati malih in srednje velikih podjetij.
SMEs must not be penalised by the implementation of the new system.
Agencija objavi pred datumom, s katerim začne veljati ta uredba, smernice, da bi vlagateljem olajšala pripravo in oddajo vlog .
Before the date of application of this Regulation, the Authority shall publish detailed guidance to assist applicants in the preparation and the presentation of applications .
Agencija določi in objavi pred datumom, s katerim začne veljati ta uredba, smernice, da bi proizvajalcem in uvoznikom olajšala pripravo in oddajo obvestil .
Before the date of application of this Regulation, the Authority shall identify and publish detailed guidance to assist manufacturers and importers in the preparation and the presentation of notifications .
Pravila v zvezi s pripravo in oddajo vlog vključujejo določbo, ki zagotavlja vlagatelju pravico, da zastopa svojo vlogo 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 bo izrecno vključevala pravico zagotavljanja dodatnih podatkov med oceno dosjeja 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.
Utemeljeno mnenje Komisije in mnenje Agencije
Reasoned opinion of the Commission and opinion of the Authority
Komisija lahko v štirih mesecih po predložitvi obvestila v skladu s členom 10(1) predloži Agenciji utemeljeno mnenje, če je dosegla sklep, da zdravstvena trditev 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 10(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 se Agencijo pozove k predložitvi mnenja o skladnosti zdravstvene trditve 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 trditve, 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 10(1) brez kakršne koli dosežene odločitve.
- a period of six months has elapsed since receipt of the notification in accordance with Article 10(1) without any decision being reached.
Pri sestavljanju svojega mnenja si Agencija prizadeva, da se drži roka treh mesecev od datuma prejema veljavne vloge .
In giving its opinion, the Authority shall endeavour to respect a time limit of three months from the date of receipt of a valid application .
Ta rok se vedno podaljša takrat, ko Agencija v skladu z odstavkom 2 od vlagatelja zahteva dodatne informacije.
That time limit shall be extended where the Authority seeks supplementary information from the applicant pursuant to paragraph 2.
Kjer so dvomi v zvezi z znanstveno utemeljitvijo zdravstvene trditve 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 svojega mnenja si Agencija prizadeva, da se drži roka šestih mesecev od datuma prejema obvestila .
In giving its opinion, the Authority shall endeavour to respect a time limit of six months from the date of receipt of the notification .
Ta rok se vedno podaljša takrat, ko Agencija v skladu z odstavkom 2 od proizvajalca ali uvoznika zahteva dodatne informacije.
That time limit shall be extended where the Authority seeks supplementary information from the manufacturer or importer pursuant to paragraph 2.
Če so tako resne skrbi v zvezi z znanstveno utemeljitvijo zdravstvenih trditev, da pozitivnega mnenja s strani Agencije ni mogoče pričakovati, lahko Komisija prepove nadaljnjo uporabo zdravstvene trditve..
Where there are such serious concerns with regard to the scientific substantiation of a health claim that a favourable opinion by the Authority cannot be expected, the Commission may prohibit the continued use of the health claim.
Ta predlog spremembe izhaja iz predloga spremembe člena 10 (1) in spremembe postopka obveščanja iz tega člena.
This amendment follows necessarily from the amendment to Article 10 (1) and the change to a notification procedure provided for in it.
2 Agencija lahko po potrebi pozove vlagatelja, naj dopolni dokumentacijo k vlogi v določenem roku.
2 The Authority may, where appropriate, request the applicant to supplement the particulars accompanying the application within a specified time limit.
Proizvajalec ali uvoznik imata neposredni dostop do pristojnega sosveta Agencije vključno s pravico biti zaslišan in pravico zagotoviti dodatno dokumentacijo k dosjeju.
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.
Črtanje možnosti odprtega kataloga dokumentov, zahtevanih med postopkom odobritve trditev, bo zavarovalo postopek obveščanja proti presoji uradnikov.
Deleting an option of open catalogue of documents required during claim authorisation process will secure the notification process against discretion of the officials.
Na drugi strani je bistveno, da se dá vlagatelju možnost predložitve dodatnih razlag in po potrebi dopolnitve dosjeja.
On the other hand it is vital to provide the manufacturer or importer with an option of submitting additional explanations and, if needed, to supplement the dossier.
Ob pripravi svojega mnenja Agencija preveri:
In order to prepare its opinion, the Authority shall verify:
(a) ali je predlagana ubeseditev zdravstvenih trditev, utemeljena z znanstvenimi podatki;
(a) that the proposed wording of the health claim is substantiated by scientific data;
(a) ali so zdravstvene trditve utemeljene z znanstvenimi podatki;
(a) that the health claim is substantiated by scientific data;
(b) ali je ubeseditev zdravstvene trditve v skladu s kriteriji, določenimi v tej uredbi;
(b) that the wording of the heath claim complies with the criteria laid down in this Regulation;
(b) ali so zdravstvene trditve v skladu s kriteriji, določenimi v tej uredbi;
(b) that the health claim complies with the criteria laid down in this Regulation;
(c) ali je predlagana ubeseditev zdravstvenih trditev razumljiva in bistvena za potrošnika.
(c) that the proposed wording of the health claim is understandable and meaningful to the consumer.
(c) ali so zdravstvene trditve razumljive in pomembne za potrošnika.
(c) that the health claim is understandable and meaningful to the consumer.
Člen 15, odstavek 4, točka (a)
Article 15, paragraph 4, point (a)
Člen 15, odstavek 4, točka (c)
Article 15, paragraph 4, point (c)
(c) priporočena ubeseditev v vseh jezikih Skupnosti za predlagano zdravstveno trditev;
(c) the recommended wording , in all Community languages, of the proposed health claim;
(c) predlog ubeseditve za zdravstveno trditev;
(c) a proposal for the wording of the health claim;
Člen 15, odstavek 4 a (novo)
Article 15, paragraph 4 a (new)
V primeru pogojnega mnenja v zvezi z zdravstveno trditvijo 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 zagotovita Agenciji 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 and opinion is finally adopted and published.
Člen 15, odstavek 5
Article 15, paragraph 5
Agencija posreduje svoje mnenje, vključno s poročilom o oceni zdravstvene trditve in z utemeljitvijo za svoje mnenje, Komisiji, državam članicam in vlagatelju .
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.
Agencija posreduje svoje mnenje, vključno s poročilom o oceni zdravstvene trditve in z utemeljitvijo za svoje mnenje, Komisiji, državam članicam in proizvajalcu ali uvozniku .
The Authority shall forward its opinion to the Commission, the Member States and the manufacturer or importer , including a report describing its assessment of the health claim and stating the reasons for its opinion.
Člen 16, naslov in odstavek 1
Article 16, title and paragraph 1
Dovoljenje Skupnosti
Community Authorisation
Odločitev o utemeljenem mnenju
Decision on the reasoned opinion
Komisija predloži v roku treh mesecev po prejemu mnenja Agencije odboru iz člena 23(1) osnutek odlocbe o vlogi , pri čemer se upošteva mnenje Agencije, vse zadevne določbe prava Skupnosti in druge legitimni dejavnike, ki so pomembni za to vprašanje.
Within three months of receipt of the opinion of the Authority, the Commission shall submit to the Committee referred to in Article 23(1) a draft of the decision to be taken in respect of 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 .
Če se osnutek odločbe ne ujema z mnenjem Agencije, Komisija pojasni razloge za odstopanje.
Where the draft Decision is not in accordance with the opinion of the Authority, the Commission shall provide an explanation for the differences.
Komisija predloži v roku enega meseca po prejemu mnenja Agencije odboru iz člena 23(1) osnutek odločbe , pri čemer se upoštevajo mnenje Agencije in vse zadevne določbe prava Skupnosti.
Within one month of receipt of the opinion of the Authority, the Commission shall submit to the Committee referred to in Article 23(1) a draft of the decision to be taken, taking into account the opinion of the Authority and any relevant provisions of Community law.
Ni jasno, kateri drugi legitimni dejavniki bi se lahko še nanašali na sprejemanje odločitve v zvezi z znanstveno utemeljitvijo trditve.
It is not clear what other legitimate factors could be relevant in taking a decision as to the scientific substantiation of a claim.
Vprašanje, o katerem se odloča, je le, ali je zdravstvena trditev resničena in znanstveno utemeljen ali ne.
The question to be decided is simply whether a health claim is truthful and scientifically substantiated or not.
Ni prostora za druge splošne vidike ali vidike zdravstvene politike.
There is no place for other general or health-policy considerations.
Člen 16, odstavek 4
Article 16, paragraph 4
Komisija nemudoma obvesti vlagatelja o svoji odločitvi, podrobnosti te odločbe pa objavi v Uradnem listu Evropske unije .
The Commission shall without delay inform the applicant of the decision taken and publish details of the decision in the Official Journal of the European Union .
Komisija nemudoma obvesti proizvajalca ali uvoznika o svoji odločitvi, podrobnosti te odločitve pa objavi v Uradnem listu Evropske unije .
The Commission shall without delay inform the manufacturer or importer of the decision taken and publish details of the decision in the Official Journal of the European Union .
Člen 17, naslov in odstavek 1
Article 17, title and paragraph 1
Sprememba, prekinitev in preklic dovoljenj
Modification, suspension and revocation of authorisations
Sprememba, prekinitev in preklic odločitev
Modification, suspension and revocation of decisions
Imetnik dovoljenja lahko v skladu s postopkom iz clena 14 zaprosi za spremembo obstojecega dovoljenja .
The authorisation-holder may, in accordance with the procedure laid down in Article 14, apply for a modification of an existing authorisation .
Proizvajalec ali uvoznik lahko v skladu s postopkom iz člena 14 zaprosi za spremembo obstoječe odločitve .
The manufacturer or importer may, in accordance with the procedure laid down in Article 14, apply for a modification of an existing decision .
Komisija nemudoma preveri mnenje Agencije.
The Commission shall examine the opinion of the Authority as soon as possible .
Po potrebi se dovoljenje po postopku iz člena 16 spremeni, prekine ali prekliče.
If appropriate, the authorisation shall be modified, suspended or revoked in accordance with the procedure laid down in Article 16.
Komisija v roku treh mesecev preveri mnenje Agencije.
The Commission shall examine the opinion of the Authority within three months .
Po potrebi se odločitev po postopku iz člena 16 spremeni, prekine ali prekliče.
If appropriate, the decision shall be modified, suspended or revoked in accordance with the procedure laid down in Article 16.
Člen 17 a (novo)
Article 17 a (new)
Člen 17a
Article 17a
Komisija po posvetovanju z Agencijo predloži predlog za uredbo Evropskega parlamenta in Sveta o uvedbi honorarjev 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.
Industrija mora prispevati k upravnim stroškom v zvezi z obvestilom za zdravstevene trditve.
The industry should contribute to the administrative costs linked to a notification for health claims.
Register vsebuje naslednje elemente:
The Register shall include the following:
(a) prehranske navedbe in pogoje, ki veljajo zanje, kot je določeno v prilogi;
(a) the nutrition claims and the conditions applying to them as set out in the Annex;