natgillin/translations-raw huggingface dataset:
Pri vnosu tradicionalnega živila iz tretje države na seznam tradicionalnih živil iz tretjih držav se navede specifikacija živila in po potrebi pogoji uporabe in/ali dodatne posebne zahteve za označevanje zaradi obveščanja končnega potrošnika.
The entry for a traditional food from a third country in the list of traditional foods from third countries shall include a specification of the food, and, where appropriate, specify the conditions of use and/or additional specific labelling requirements to inform the final consumer.
Postopek za vključitev tradicionalnega živila iz tretje države
Procedure for including a traditional food from a third country in the list
Tradicionalna živila iz tretje države
Traditional food from a third country
Z odstopanjem od postopka, določenega v členu 9(1) te uredbe, zainteresirana stran iz člena 3(1) Uredbe (ES) št. 1331/2008, ki namerava dati na trg v Uniji tradicionalno živilo iz tretje države, predloži zahtevek Komisiji .
By way of derogation from the procedure laid down in Article 9(1) of this Regulation, an interested party referred to in Article 3(1) of Regulation (EC) No 1331/2008, who intends to place on the market within the Union a traditional food from a third country , shall submit an application to the Commission .
Nosilec živilske dejavnosti , ki namerava dati na trg v Uniji tradicionalno živilo iz tretje države, o tem obvesti Komisijo in navede ime živila, njegovo sestavo in državo porekla.
A food business operator intending to place a traditional food from a third country on the market in the Union shall notify this to the Commission , indicating the name of the food, its composition and country of origin .
Zahtevek vsebuje:
The application shall include:
(a) ime in opis živila,
(a) the name and description of the food,
(b) sestavo živila,
(b) its composition,
(c) državo porekla živila,
(c) its country of origin,
(d) dokumentacijo, ki dokazujejo pretekle izkušnje o varni uporabi živila v kateri koli tretji državi,
(d) documented data demonstrating the history of safe food use in any third country,
(e) če je to potrebno pogoje uporabe in posebne zahteve za označevanje,
(e) where applicable, the conditions of use and specific labelling requirements,
(f) povzetek vsebine zahtevka.
(f) a summary of the content of the application.
Zahtevek se predloži v skladu z izvedbenimi pravili iz odstavka 7 tega člena.
The application shall be made in accordance with the implementing rules referred to in paragraph 7 of this Article.
Uradnemu obvestilu so priloženi dokumentirani podatki, ki dokazujejo pretekle izkušnje o varni uporabi živila v tretji državi.
The notification shall be accompanied by documented data demonstrating the history of safe food use in any third country.
Komisija državam članicam in Agenciji nemudoma posreduje veljavni zahtevek iz odstavka 1.
The Commission shall forward the valid application referred to in paragraph 1 without delay to the Member States and the Authority .
Komisija državam članicam in Agenciji nemudoma posreduje uradno obvestilo z dokazili o varni uporabi živila iz odstavka 1 in ga da na voljo javnosti na svojih spletnih straneh .
The Commission shall forward the notification including the demonstration of history of safe food use referred to in paragraph 1 without delay to the Member States and the Authority and make it publicly available on its website.
Agencija sprejme mnenje v šestih mesecih od prejema zahtevka.
Within six months of receipt of an application, the Authority shall give its opinion.
Kadar Agencija od zainteresirane strani zahteva dodatne informacije, po posvetovanju s to stranjo določi obdobje, v katerem bo slednja te informacije predložila.
Whenever the Authority seeks supplementary information from the interested party, it shall, after consulting the interested party, lay down a period within which that information shall be provided.
Časovna omejitev šestih mesecev se samodejno podaljša za to dodatno obdobje.
The six-month time limit shall be automatically extended by this additional period.
Agencija da dodatne informacije na voljo državam članicam in Komisiji.
The supplementary information shall be made available to the Member States and the Commission by the Authority.
V štirih mesecih po tem, ko Komisija v skladu z odstavkom 2 posreduje uradno obvestilo iz odstavka 1, lahko država članica in agencija obvestita Komisijo, da imata upravičene varnostne zadržke o dajanju zadevnega tradicionalnega živila na trg, ki temeljijo na znanstvenih dokazih.
Within four months from the date on which the notification provided for in paragraph 1 is forwarded by the Commission according to paragraph 2, a Member State and the Authority may inform the Commission that they have justified safety objections, based on scientific evidence, to the placing on the market of the traditional food concerned.
V tem primeru se živila ne dajo na trg Unije in se uporabijo členi 5a do 9.
In that case, the food shall not be placed on the market in the Community and Articles 5 a - 9 shall apply.
Uradno obvestilo iz odstavka 1 tega člena se šteje za zahtevo iz člena 3(1) Uredbe (ES) št. 1331/2008.
The notification as referred to in paragraph 1 of this Article shall be considered as an application referred to in Article 3(1) of Regulation (EC) No 1331/2008.
Predlagatelj se lahko odloči tudi za umik uradnega obvestila.
Alternatively, the applicant may choose to withdraw the notification.
Komisija ustrezno nemudoma in na dokazljiv način obvesti zadevnega nosilca živilske dejavnosti najkasneje v petih mesecih od datuma uradnega obvestila iz odstavka 1.
The Commission shall inform the food business operator concerned accordingly without undue delay and in a demonstrable manner within no more than five months from the date of the notification provided for in paragraph 1.
Za pripravo svojega mnenja Agencija preveri, da:
In order to prepare its opinion the Authority shall verify that:
(a) so pretekle izkušnje o varni uporabi živila v kateri koli tretji državi utemeljene s kakovostnimi podatki, ki jih predloži zainteresirana stran; ter
(a) the history of safe food use in any third country is substantiated by the quality of data submitted by the interested party; and
(b) sestava živila in po potrebi pogoji za njegovo uporabo ne ogrožajo zdravja potrošnikov v Uniji.
(b) the composition of the food and, where applicable, the conditions of its use, do not pose a health risk to consumers in the Union .
Agencija svoje mnenje posreduje Komisiji, državam članicam in zainteresirani strani.
The Authority shall forward its opinion to the Commission, the Member States and the interested party.
Če niso bil predloženi zadržki glede varnosti na podlagi znanstvenih dokazov in zadevnemu nosilcu živilske dejavnosti v skladu z odstavkom 3 o tem ni bila sporočena nobena informacija, se lahko tradicionalno živilo daje na trg v Uniji po petih mesecih od datuma uradnega obvestila iz odstavka 1.
If no justified safety objections, based on scientific evidence, have been raised and no information thereof has been communicated to the food business operator concerned in accordance with paragraph 3, the traditional food may be placed on the market in the Union after five months from the date of the notification in accordance with paragraph 1.
V treh mesecih po predložitvi mnenja Agencije Komisija v skladu z regulativnim postopkom iz člena 19(2) posodobi seznam tradicionalnih živil iz tretjih držav, pri čemer upošteva mnenje Agencije, vse ustrezne določbe zakonodaje Unije in vse druge dejavnike, ki so pomembni za obravnavano zadevo.
Within three months of the Authority giving its opinion, the Commission shall, in accordance with the regulatory procedure referred to in Article 19(2), update the list of traditional foods from third countries, taking account of the opinion of the Authority, any relevant provisions of Union law and any other legitimate factors relevant to the matter under consideration.
Komisija o tem ustrezno obvesti zainteresirano stran.
The Commission shall inform the interested party accordingly.
Če se Komisija odloči, da ne bo posodobila seznama tradicionalnih živil iz tretjih držav, o tem ustrezno obvesti zainteresirano stran in države članice ter navede razloge, zakaj meni, da posodobitev ni upravičena.
If the Commission decides not to proceed with an update of the list of traditional foods from third countries, it shall inform the interested party and the Member States accordingly, indicating the reasons for not considering the update justified.
Komisija objavi seznam tradicionalnih živil iz tretjih držav, ki se lahko dajejo na trg v Uniji v skladu s členom 4, na temu namenjeni spletni strani Komisije.
The Commission shall publish a list of traditional foods from third countries that may be placed on the market in the Union in accordance with paragraph 4 on a dedicated page of the Commission's website.
Ta stran je dostopna prek spletne strani s seznamom Unije o novih živilih iz člena 5a ter je z njo povezana.
This page shall be accessible from and linked to the page on the Union list of novel foods referred to in Article 5 a .
Zainteresirana stran lahko umakne zahtevek v kateri koli fazi postopka.
At any stage of the procedure the interested party may withdraw its application.
Komisija za zagotovitev neoviranega delovanja postopka obveščanja iz tega člena najpozneje ...* z delegiranimi akti v skladu s členom 21 in pod pogoji iz členov 22 in 23 sprejme podrobna navodila o uporabi tega člena.
In order to ensure smooth functioning of the notification procedure provided for in this Article, the Commission shall, before ... * , adopt detailed rules on the application of this Article by means of delegated acts in accordance with Article 21 and subject to the conditions of Articles 22 and 23.
Komisija sprejme do… podrobna pravila za izvajanje tega člena, v skladu z regulativnim postopkom iz člena 19(2).
By ..… , the Commission shall adopt detailed rules for the implementation of this Article in accordance with the regulatory procedure referred to in Article 19(2).
* UL: Prosimo vstavite datum: 2 let po dnevu začetka veljavnosti te uredbe.
* OJ: please insert date: 2 years after the entry into force of this Regulation.
*Šest mesecev od začetka veljavnosti te uredbe.
* Six month after the date of entry into force of this Regulation
Brez poseganja v izvedbene ukrepe, sprejete na podlagi točke (a) člena 9(1) Uredbe (ES) št. 1331/2008 in do … Komisija po potrebi in v tesnem sodelovanju z Agencijo in po posvetovanju z zainteresiranimi stranmi poskrbi za tehnične smernice in orodja za pomoč zainteresiranim stranem , predvsem nosilcem živilske dejavnosti ter zlasti malim in srednje velikim podjetjem ali drugim zainteresiranim stranem, pri pripravi in predložitvi zahtevkov v skladu s to uredbo.
Without prejudice to the provisions under point (a) of Article 9(1) of Regulation (EC) No 1331/2008 and by .…, the Commission shall, where appropriate, in close cooperation with the Authority and after consultation with interested parties, make available technical guidance and tools to assist interested parties in preparing and submitting applications under this Regulation; in particular, food business operators, especially small and medium-sized enterprises.
Brez poseganja v izvedbene ukrepe, sprejete na podlagi člena 9 a (1)(a) Uredbe (ES) št. 1331/2008 in pred … * Komisija po potrebi in v tesnem sodelovanju z Agencijo , nosilci živilske dejavnosti ter malimi in srednje velikimi podjetji poskrbijo za tehnične smernice in orodja za pomoč nosilcem živilske dejavnosti ter zlasti malim in srednje velikim podjetjem pri pripravi in predložitvi zahtevkov v skladu s to uredbo.
Without prejudice to the provisions of Article 9 a (1) (a) of Regulation (EC) No 1331/2008 and before ... * , the Commission shall, where appropriate, in close cooperation with the Authority, the food business operators and small and medium-sized enterprises make available technical guidance and tools to assist food business operators and especially small and medium-sized enterprises in preparing and submitting applications under this Regulation.
Predlagateljem zahtevkov je na voljo Priporočilo Komisije 97/618/ES z dne 29. julija 1997 o znanstvenih vidikih in predstavitvi informacij, potrebnih za podporo vlog za dajanje na trg novih živil in novih živilskih sestavin, ter o pripravi poročil o začetni presoji v skladu z Uredbo (ES) št. 258/97 Evropskega parlamenta in sveta26, dokler se ne nadomesti z revidiranimi tehničnimi smernicami v skladu s tem členom.
Commission Recommendation 97/618/EC of 29 July 1997 concerning the scientific aspects and the presentation of information necessary to support applications for the placing on the market of novel foods and novel food ingredients and the preparation of initial assessment reports under Regulation (EC) No 258/97 of the European Parliament and of the Council 26 shall be available for use by applicants until replaced by revised technical guidance issued in accordance with this Article.
Tehnične smernice in orodja se objavijo najpozneje ...* na temu namenjeni javno dostopni strani na spletnih straneh Komisije.
The technical guidance and tools shall be published, not later than ... ** , on a publicly accessible page intended for that purpose on the website of the Commission.
* Šest mesecev po dnevu začetka veljavnosti uredbe.
* Six months after the date of entry into force of this Regulation.
** Šest mesecev po dnevu začetka veljavnosti uredbe.
** Six months after the date of entry into force of this Regulation.
Predlog spremembe 69 iz prve obravnave EP.
EP first reading amendment 69.
Člen 13 – uvodni del
Article 13 – introductory part
Agencija pri ocenjevanju varnosti novih živil, kjer je to potrebno , zlasti :
In assessing the safety of novel foods, where appropriate, the Authority shall, in particular :
Agencija pri ocenjevanju varnosti novih živil na podlagi zahtev iz člena 6 :
In assessing the safety of novel foods, the Authority shall, on the basis of the requirements specified in Article 6 :
Predlog spremembe 70 iz prve obravnave EP.
EP first reading amendment 70.
Člen 13 – točka a
Article 13 - point a
(a) primerja, če je živilo enako varno kot živilo iz primerljive živilske kategorije , ki že obstaja na trgu v Uniji, ali enako varno kot živilo, ki ga bo novo živilo nadomestilo ;
(a) consider whether the food is as safe as food from a comparable food category already existing on the market within the Union or as safe as the food that the novel food is intended to replace;
(a) primerja, če je novo živilo, ne glede na to, ali je njegov namen nadomestiti živilo, ki že obstaja na trgu , škodljive ali strupene posledice za človekovo zdravje, pri čemer se upoštevajo tudi posledice novih lastnosti;
(a) consider whether the new food , irrespective of whether or not it is intended to replace a food already existing on the market , poses any risk of harmful or toxic effects to human health , while also taking into account the implications of any new characteristics;
Predlog spremembe 71 iz prve obravnave EP.
EP first reading amendment 71.
Člen 13 – točka b
Article 13 - point b
(b) upošteva pretekle izkušnje o varni uporabi živila.
(b) take into account the history of safe food use.
(b) pri tradicionalnem živilu iz tretje države upošteva pretekle izkušnje o varni uporabi živila.
(b) take into account for traditional food from a third country, the history of safe food use.
Člen 10b iz dokumenta Komisije.
Article 10b from the Commission document.
Člen 13 – odstavek 1a (novo)
Article 13 - paragraph 1a (new)
V primeru etičnih zadržkov se poleg ocene varnosti pridobi mnenje Evropske skupine za etiko v znanosti in novih tehnologijah.
In the event of ethical objections, an opinion shall be sought, over and above the safety assessment, from the E u ropean Group on Ethics in Science and New Techn o logies (EGE).
Predlog spremembe 74 iz prve obravnave EP.
EP first reading amendment 74.
Člen 14 – naslov in odstavek 1
Article 14 - title and paragraph 1
Posebne obveznosti nosilcev živilske dejavnosti
Special obligations on food business operators
Obveznosti nosilcev živilske dejavnosti
Obligations on the food business operators
Komisija lahko zaradi varnosti živil in v skladu z mnenjem Agencije zahteva, da se živilo, po tem ko je dano na trg spremlja.
The Commission may, for food safety reasons and following the opinion of the Authority, impose a requirement for post-market monitoring.
Nosilci živilske dejavnosti, ki živilo dajo na trg v Uniji, so odgovorni za izpolnjevanje zahtev glede spremljanja , kakor so opredeljene pri vnosu zadevnega živila na seznam Unije.
The food business operator placing the food on the market within the Union shall be responsible for fulfilling the post marketing requirements specified in the entry of the food concerned in the Community list of novel foods.
Komisija zaradi varnosti živil in v skladu z mnenjem Agencije zahteva, da se živilo, po tem ko je dano na trg, spremlja.
The Commission shall impose for food safety reasons and following the opinion of the Authority, a requirement for post-market monitoring.
To spremljanje se izvaja pet let po uvrstitvi novega živila na seznam Unije.
This monitoring shall take place five years after the date of inclusion of a novel food in the Union list .
Predlog spremembe 75 iz prve obravnave EP.
EP first reading amendment 75.
Zahteve za spremljanje se uporabljajo tudi za nova živila, ki so že na trgu, vključno z novimi živili, odobrenimi po poenostavljenem postopku (uradno obvestilo) iz člena 5 Uredbe (ES) št. 258/97.
The monitoring requirements shall also apply to novel foods already on the market, including those approved under the simplified procedure ('notification') laid down in Article 5 of Regulation (EC) No 258/97.
Člen 14 – odstavek 1 b (novo)
Article 14 - paragraph 1 b (new)
Proizvajalec in nosilec živilske dejavnosti ali organ takoj obvestita Komisijo o:
The producer and food business operator or the authority shall forthwith inform the Commission of:
Člen 14 – odstavek 2 – pododstavek 1 b (novo)
Article 14 - paragraph 2 - subparagraph 1 b (new)
Pristojni organ države članice poroča Komisiji v treh mesecih po opravljenem inšpekcijskem pregledu.
The Member State 's competent authority shall report to the Commission within three months of the completion of an inspection.
Komisija predloži poročilo Evropskemu parlamentu in Svetu najkasneje eno leto po izteku petletnega obdobja iz odstavka 1.
The Commission shall submit a report to the European Parliament and the Council no later than a year after the expiry of the five-year period referred to in paragraph 1.
Evropska skupina za etiko v znanosti in novih tehnologijah
European Group on Ethics in Science and New Technologies
Evropska skupina za etiko in nove tehnologije
European Group on Ethics and New Technologies
Komisija se lahko po potrebi na lastno pobudo ali zahtevo države članice posvetuje z Evropsko skupino za etiko v znanosti in novih tehnologijah , da bi pridobila njeno mnenje o zelo pomembnih etičnih vprašanjih, povezanih z znanostjo in novimi tehnologijami.
The Commission, on its own initiative or at the request of a Member State, may consult the European Group on Ethics in Science and New Technologies , with a view to obtaining its opinion on ethical questions relating to science and new technologies of major ethical importance.
Po potrebi se lahko Komisija na lastno pobudo ali zahtevo države članice posvetuje z Evropsko skupino za etiko in novih tehnologijah , da bi pridobila njeno mnenje o zelo pomembnih etičnih vprašanjih, povezanih z znanostjo in novimi tehnologijami .
Where appropriate, the Commission may, on its own initiative or at the request of a Member State, consult the European Group on Ethics and new Technologies, with a view to obtaining its opinion on ethical questions relating to science and new technologies of major ethical importance.
Komisija omogoči javnosti dostop do tega mnenja.
The Commission shall make this opinion available to the public.
Komisija omogoči javnosti dostop do tega mnenja Evropske skupine za etiko in nove tehnologije.
The Commission shall make that opinion of the Eur o pean Group on Ethics and new Technol o gies available to the public.
Predlog spremembe 76 iz prve obravnave EP.
EP first reading amendment 76.
Postopek odobritve v primeru varstva podatkov
Authorisation procedure in cases of data protection
Na zahtevo predlagatelja, podprto z ustreznimi in preverljivimi informacijami, vključenimi v dokumentacijo zahtevka, se novi znanstveni dokazi in/ ali znanstveni podatki za podporo zahtevkom v obdobju petih let od datuma vključitve novega živila na seznam Unije ne smejo uporabiti v korist drugega zahtevka brez soglasja prvotnega predlagatelja .
On request by the applicant, supported by appropriate and verifiable information included in the application dossier, newly developed scientific evidence and /or scientific data supporting the application may not be used for the benefit of another application during a period of five years from the date of the inclusion of the novel food in the Union list without the agreement of the prior applicant.
Takšno varstvo pravic je zagotovljeno kadar:
This protection shall be granted where:
Na zahtevo predlagatelja, podprto z ustreznimi in preverljivimi informacijami, vključenimi v dokumentacijo zahtevka, se novi znanstveni dokazi in pravno zaščiteni znanstveni podatki za podporo zahtevkom za obdobje petih let od datuma vključitve novega živila na seznam Unije ne smejo uporabiti v korist drugega zahtevka , razen če se je poznejši predlagatelj dogovoril s prvotnim predlagateljem, da se lahko taki podatki in informacije uporabijo, ob predpostavki, da :
At the request of the applicant, supported by appropriate and verifiable information included in the application dossier, newly developed scientific evidence and proprietary scientific data provided to support the applications may not be used for the benefit of another application for a period of five years from the date of the inclusion of the novel food in the Union list unless the subsequent applicant has agreed with the prior applicant that such data and information may be used, and where:
Predlog spremembe 77 iz prve obravnave EP.
EP first reading amendment 77.
Člen 16 – odstavek 1 – točka a
Article 16 - paragraph 1 - point a
(a) so bili novi znanstveni dokazi in/ali znanstveni podatki s strani predlagatelja v času vlaganja prvega zahtevka označeni kot pravno zaščiteni (pravno zaščiteni znanstveni podatki) ;
(a) newly developed scientific evidence and/or scientific data was designated as proprietary by the applicant at the time the first application was made (proprietary scientific data) ;
(a) so bili znanstveni podatki in druge informacije s strani prvotnega predlagatelja v času vlaganja predhod n ega zahtevka označeni kot pravno zaščiteni;
(a) the scientific data and other information has been designated as proprietary by the prior applicant at the time the prior application was made;
Člen 16 – odstavek 1 – točka b
Article 16 - paragraph 1 - point b
(b) prvotni predlagatelj je imel v času prvega zahtevka izključno pravico sklicevanja na pravno zaščitene znanstvene podatke; ter
(b) the prior applicant had exclusive right of reference to the proprietary scientific data at the time the first application was made; and
(b) prvotni predlagatelj je imel v času prvotnega zahtevka izključno pravico sklicevanja na pravno zaščitene podatke ; ter
(b) the prior applicant had exclusive right of reference to the proprietary data at the time the prior application was made; and
Člen 16 – odstavek 1 – točka c
Article 16 - paragraph 1 - point c
(c) novo živilo ne bi moglo biti odobreno brez predložitve pravno zaščitenih znanstvenih podatkov s strani prvotnega predlagatelja.
(c) the novel food could not have been authorised without the submission of the proprietary scientific data by the prior applicant.
(c) novo živilo ne bi moglo biti odobreno brez predložitve pravno zaščitenih podatkov s strani prvotnega predlagatelja.
(c) the novel food could not have been authorised without the submission of the proprietary data by the prior applicant.
Člen 16 – odstavek 1 a (novo)
Article 16 - paragraph 1 a (new)