natgillin/translations-raw huggingface dataset:
Within three months of the date of publication of the Authority's opinion, the Commission shall submit to the committee referred to in Article 30(1) a draft implementing act authorising the placing on the market within the Union of the traditional food from a third country and updating the Union list, taking into account the following:
Komisija v takšnih primerih, če do njih pride, upošteva stališča držav članic in mnenje Agencije ter vse druge upravičene dejavnike, ki so pomembni za obravnavano posodobitev.
the conditions provided for in points (a) and (b) of Article 7 and, where applicable, point (c) of that Article;
Vložnik lahko kadar koli umakne vlogo iz člena 16, s čimer se postopek odobritve zaključi.
By way of derogation from paragraph 1, the Commission may terminate the procedure at any stage and decide not to proceed with an update where it considers that such an update is not justified.
Člen 19
In such case, where applicable, the Commission shall take account of the views of Member States, the Authority's opinion and any other legitimate factors relevant to the update under consideration.
Posodobitve seznama Unije, kar zadeva odobrena tradicionalna živila iz tretjih držav
The applicant may withdraw its application referred to in Article 16 at any time, thereby terminating the procedure.
Členi 10 do 13 se uporabljajo za črtanje tradicionalnega živila iz tretje države s seznama Unije ali za dodajanje, črtanje ali spreminjanje specifikacij, pogojev uporabe, dodatnih posebnih zahtev za označevanje ali za spremljanje po dajanju na trg, povezanih z vključitvijo tradicionalnega živila iz tretje države na seznam Unije.
Updates to the Union list as regards authorised traditional foods from third countries
Izvedbeni akti, ki določajo upravne in znanstvene zahteve za tradicionalna živila iz tretjih držav
Articles 10 to 13 apply to removing a traditional food from a third country from the Union list or to adding, removing or changing specifications, conditions of use, additional specific labelling requirements or post-market monitoring requirements associated with the inclusion of a traditional food from a third country on the Union list.
Komisija do 1. januarja 2018 sprejme izvedbene akte v zvezi z:
Article 20
vsebino, pripravo in predložitvijo priglasitev iz člena 14 in vlog iz člena 16;
Implementing acts laying down administrative and scientific requirements concerning traditional foods from third countries
ureditvijo takojšnjega preverjanja veljavnosti navedenih priglasitev in vlog;
By 1 January 2018 the Commission shall adopt implementing acts concerning:
ureditvijo za izmenjavo informacij z državami članicami in Agencijo za predložitev ustrezno utemeljenih pripomb glede varnosti iz člena 15(2);
the content, drafting and presentation of the notifications referred to in Article 14 and of applications referred to in Article 16;
vrsto informacij, ki morajo biti vključene v mnenje Agencije iz člena 17.
the arrangements for verifying the validity, without delay, of those notifications and applications;
POGLAVJE IV
the arrangements for the exchange of information with the Member States and with the Authority for submitting duly reasoned safety objections as referred to in Article 15(2);
DODATNA POSTOPKOVNA PRAVILA IN DRUGE ZAHTEVE
the type of information to be included in the opinion of the Authority referred to in Article 17.
Člen 21
CHAPTER IV
Dodatne informacije o obvladovanju tveganja
ADDITIONAL PROCEDURAL RULES AND OTHER REQUIREMENTS
Kadar Komisija od vložnika zahteva dodatne informacije o obvladovanju tveganja, skupaj z vložnikom določi rok, v katerem je treba te informacije predložiti.
Article 21
V takih primerih se lahko rok iz člena 12(1) ali (2) ali iz člena 18(1) ustrezno podaljša.
Additional information concerning risk management
Komisija države članice obvesti o navedenem podaljšanju roka in jim da na voljo dodatne informacije, ko jih prejme.
Where the Commission requests from an applicant additional information on matters concerning risk management, it shall determine, together with the applicant, the period within which that information is to be provided.
Če Komisija ne prejme dodatnih informacij iz odstavka 1 v dodatnem roku iz navedenega odstavka, ukrepa na podlagi razpoložljivih informacij.
In such cases, the period provided for in Article 12(1) or (2) or in Article 18(1) may be extended accordingly.
Člen 22
The Commission shall inform the Member States of that extension and shall make the additional information available to Member States once it has been received.
Ad hoc podaljšanje rokov
Where the additional information referred to in paragraph 1 is not received within the additional period referred to in that paragraph, the Commission shall act on the basis of the available information.
V izjemnih okoliščinah lahko Komisija na lastno pobudo ali po potrebi na zahtevo Agencije podaljša roke iz členov 11(1), 12(1) ali (2), 17(1) in 18(1), če narava obravnavane zadeve upravičuje ustrezno podaljšanje.
Article 22
Komisija o podaljšanju in razlogih zanj obvesti vložnika in države članice.
Ad hoc extension of time periods
Člen 23
In exceptional circumstances, the Commission may extend the time periods provided for in Articles 11(1), 12(1) or (2), 17(1) and 18(1) on its own initiative or, where applicable, at the Authority's request, where the nature of the matter in question justifies an appropriate extension.
Zaupnost vlog za posodobitve seznama Unije
The Commission shall inform the applicant and the Member States of the extension and the reasons therefor.
Vložniki lahko zahtevajo zaupno obravnavo nekaterih informacij, predloženih v skladu s to uredbo, če bi lahko razkritje takih informacij škodovalo njihovemu konkurenčnemu položaju.
Article 23
Za namene odstavka 1 vložniki navedejo, za katere dele predloženih informacij želijo zaupno obravnavo, in zagotovijo vse potrebne podrobnosti za utemeljitev svoje zahteve za zaupno obravnavo.
Confidentiality of applications for updates of the Union list
V takih primerih se poda preverljiva utemeljitev.
Applicants may request confidential treatment of certain information submitted under this Regulation where disclosure of such information may harm their competitive position.
Vložniki lahko v treh tednih po tem, ko so obveščeni o stališču Komisije, umaknejo svojo vlogo, v tem času pa se spoštuje zaupnost predloženih informacij.
For the purposes of paragraph 1, applicants shall indicate which parts of the information provided they wish to be treated as confidential and provide all the necessary details to substantiate their request for confidentiality.
Če vložnik ne umakne vloge in če obstaja nesoglasje, Komisija po poteku roka iz odstavka 3 odloči, katere informacije ostanejo zaupne, ter v primeru sprejete odločitve o tem uradno obvesti države članice in vložnika.
Verifiable justification shall be given in such cases.
Vendar pa zaupna obravnava ne velja za naslednje podatke:
After being informed of the Commission's position on the request, applicants may withdraw their application within three weeks, during which the confidentiality of the information provided shall be observed.
predlagani pogoji uporabe novega živila;
After expiry of the period referred to in paragraph 3, if an applicant has not withdrawn the application and in case of disagreement the Commission shall decide which parts of the information are to remain confidential and, in case a decision has been taken, notify the Member States and the applicant accordingly.
povzetek študij, ki jih je predložil vložnik;
However, confidentiality shall not apply to the following information:
rezultati študij, opravljenih za prikaz varnosti živila;
the proposed conditions of use of the novel food;
vsaka prepoved ali omejitev, ki jo je v zvezi z živilom sprejela tretja država.
a summary of the studies submitted by the applicant;
Komisija, države članice in Agencija sprejmejo ustrezne ukrepe, s katerimi zagotovijo ustrezno zaupnost informacij iz odstavka 4, ki so jih prejele na podlagi te uredbe, razen če gre za informacije, ki morajo biti javno dostopne zaradi varovanja zdravja ljudi.
the results of the studies carried out to demonstrate the safety of the food;
Če vložnik umakne ali je umaknil svojo vlogo, Komisija, države članice in Agencija ne razkrijejo zaupnih informacij, tudi tistih, o zaupnosti katerih Komisija in vložnik ne soglašata.
any prohibition or restriction imposed in respect of the food by a third country.
Uporaba odstavkov 1 do 6 ne vpliva na izmenjavo informacij o vlogi med Komisijo, državami članicami in Agencijo.
The Commission, the Member States and the Authority shall take necessary measures to ensure appropriate confidentiality of the information as referred to in paragraph 4 and received by them under this Regulation, except for information which is required to be made public in order to protect human health.
Komisija lahko z izvedbenimi akti sprejme podrobna pravila o izvajanju odstavkov 1 do 6.
Where an applicant withdraws, or has withdrawn, its application, the Commission, the Member States and the Authority shall not disclose confidential information, including the information whose confidentiality is the subject of disagreement between the Commission and the applicant.
Člen 24
The application of paragraphs 1 to 6 shall not affect the exchange of information concerning the application between the Commission, the Member States and the Authority.
Zahteve za spremljanje po dajanju na trg
The Commission may, by means of implementing acts, adopt detailed rules on the implementation of paragraphs 1 to 6.
Komisija lahko zaradi varnosti živil in ob upoštevanju mnenja Agencije določi zahteve za spremljanje po dajanju na trg.
Article 24
Te zahteve lahko za posamezni primer vključujejo opredelitev ustreznih nosilcev živilske dejavnosti.
Post-market monitoring requirements
Člen 25
The Commission may, for food safety reasons and taking into account the opinion of the Authority, impose post-market monitoring requirements.
Zahteve po dodatnih informacijah
Such requirements may include, on a case-by-case basis, the identification of the relevant food business operators.
Vsak nosilec živilske dejavnosti, ki da na trg novo živilo, Komisijo takoj obvesti o vseh informacijah, ki so mu postale znane glede:
Article 25
kakršnih koli novih znanstvenih ali tehničnih informacij, ki bi lahko vplivale na oceno varnosti uporabe novega živila;
Additional information requirements
kakršne koli prepovedi ali omejitve v tretji državi, v kateri je novo živilo dano na trg.
Any food business operator which has placed a novel food on the market shall immediately inform the Commission of any information of which it has become aware concerning:
Komisija da te informacije na voljo državam članicam.
any new scientific or technical information which might influence the evaluation of the safety of use of the novel food;
POGLAVJE V
any prohibition or restriction imposed by a third country in which the novel food is placed on the market.
VARSTVO PODATKOV
The Commission shall make that information available to the Member States.
Člen 26
CHAPTER V
Postopek odobritve v primeru varstva podatkov
DATA PROTECTION
Na zahtevo vložnika ter kadar so podprti z ustreznimi in preverljivimi informacijami, vključenimi v vlogo v skladu s členom 10(1), se novi znanstveni dokazi ali znanstveni podatki v podporo vlogi v obdobju petih let od datuma odobritve novega živila ne smejo uporabiti v korist poznejše vloge brez privolitve prvotnega vložnika.
Article 26
Komisija zagotovi varstvo podatkov iz člena 27(1), kadar so izpolnjeni naslednji pogoji:
Authorisation procedure in case of data protection
prvotni vložnik je nove znanstvene dokaze ali znanstvene podatke v času vložitve prve vloge označil kot pravno zaščitene;
On request by the applicant, and where supported by appropriate and verifiable information included in the application provided for in Article 10(1), newly developed scientific evidence or scientific data supporting the application shall not be used for the benefit of a subsequent application during a period of five years from the date of the authorisation of the novel food without the agreement of the initial applicant.
prvotni vložnik je imel v času vložitve prve vloge izključno pravico sklicevanja na pravno zaščitene znanstvene dokaze ali znanstvene podatke in
The data protection shall be granted by the Commission under Article 27(1) where the following conditions are met:
Agencija ne bi mogla oceniti in odobriti novega živila, ne da bi prvotni vložnik predložil pravno zaščitenih znanstvenih dokazov ali znanstvenih podatkov.
the newly developed scientific evidence or scientific data was designated as proprietary by the initial applicant at the time the first application was made;
Vendar pa se lahko prvotni in poznejši vložnik dogovorita, da se taki znanstveni dokazi in znanstveni podatki smejo uporabiti.
the initial applicant had exclusive right of reference to the proprietary scientific evidence or scientific data at the time the first application was made; and
Odstavka 1 in 2 se ne uporabljata za priglasitve in vloge za dajanje tradicionalnih živil iz tretjih držav na trg v Uniji.
the novel food could not have been assessed by the Authority and authorised without the submission of the proprietary scientific evidence or scientific data by the initial applicant.
Člen 27
However, the initial applicant may agree with a subsequent applicant that such scientific evidence and scientific data may be used.
Odobritev novega živila in njegova vključitev na seznam Unije na podlagi varovanih pravno zaščitenih znanstvenih dokazov ali znanstvenih podatkov
Paragraphs 1 and 2 shall not apply to notifications and applications concerning the placing on the market within the Union of traditional foods from third countries.
Kadar je novo živilo odobreno in vključeno na seznam Unije v skladu s členi 10 do 12 in na podlagi pravno zaščitenih znanstvenih dokazov ali znanstvenih podatkov, za katere je odobreno varstvo podatkov v skladu s členom 26(1), se pri vnosu tega novega živila na seznam Unije poleg informacij iz člena 9(3) navede naslednje:
Article 27
datum vključitve novega živila na seznam Unije;
Authorisation of a novel food and inclusion in the Union list based on protected proprietary scientific evidence or scientific data
dejstvo, da ta vključitev temelji na pravno zaščitenih znanstvenih dokazih in znanstvenih podatkih, varovanih v skladu s členom 26;
Where a novel food is authorised and included in the Union list pursuant to Articles 10 to 12 based on proprietary scientific evidence or scientific data that are granted data protection as provided for in Article 26(1), the entry of that novel food in the Union list shall indicate, in addition to the information referred to in Article 9(3):
dejstvo, da je v obdobju varstva podatkov dajanje novega živila na trg v Uniji odobreno le vložniku iz točke (c) tega odstavka, razen če poznejši vložnik pridobi odobritev za novo živilo brez sklicevanja na pravno zaščitene znanstvene dokaze ali znanstvene podatke, varovane v skladu s členom 26, ali s privolitvijo prvotnega vložnika;
the date of inclusion of the novel food in the Union list;
končni datum obdobja varstva podatkov iz člena 26.
the fact that that inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26;
Za znanstvene dokaze ali znanstvene podatke, ki so varovani v skladu s členom 26 ali za katere je obdobje varstva podatkov iz navedenega člena poteklo, se ne odobri ponovnega varstva.
the fact that during the period of data protection the novel food is authorised for placing on the market within the Union only by the applicant specified in point (c) of this paragraph, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 or with the agreement of the initial applicant;
Člen 28
the end date of the data protection provided for in Article 26.
Postopek odobritve pri vzporedni vlogi za odobritev zdravstvene trditve
Scientific evidence or scientific data protected in accordance with Article 26 or for which the protection period under that Article has expired shall not be granted renewed protection.
Komisija na zahtevo vložnika prekine postopek odobritve za novo živilo, ki je bil uveden po prejemu vloge, kadar vložnik predloži:
Article 28
zahtevo za varstvo podatkov v skladu s členom 26 ter
Authorisation procedure in case of a parallel application for the authorisation of a health claim
vlogo za odobritev zdravstvene trditve za isto novo živilo v skladu s členom 15 ali 18 Uredbe (ES) št. 1924/2006 v povezavi z zahtevo za varstvo podatkov v skladu s členom 21 navedene uredbe.
The Commission shall, on request by the applicant, stay an authorisation procedure for a novel food started following an application, where the applicant has submitted:
Postopek odobritve se prekine brez poseganja v oceno živila s strani Agencije v skladu s členom 11.
a request for data protection in accordance with Article 26; and
Komisija obvesti vložnika o datumu začetka učinkovanja prekinitve.
an application for the authorisation of a health claim on the same novel food in accordance with Article 15 or 18 of Regulation (EC) No 1924/2006, in conjunction with a request for data protection in accordance with Article 21 of that Regulation.
V času prekinitve postopka odobritve ne teče rok, določen v členu 12(1).
The stay of the authorisation procedure shall be without prejudice to the assessment of the food by the Authority in accordance with Article 11.
Postopek odobritve se nadaljuje, ko Komisija prejme mnenje Agencije o zdravstveni trditvi v skladu z Uredbo (ES) št. 1924/2006.
The Commission shall inform the applicant about the date of effect of the stay.
Komisija obvesti vložnika o datumu nadaljevanja postopka odobritve.
While the authorisation procedure is stayed, time shall cease to run for the purposes of the time-limit laid down in Article 12(1).
Od datuma nadaljevanja začne od začetka teči rok, določen v členu 12(1) te uredbe.
The authorisation procedure shall resume when the Commission has received the opinion of the Authority on the health claim pursuant to Regulation (EC) No 1924/2006.
V primerih iz odstavka 1 tega člena, kadar se varstvo podatkov odobri v skladu s členom 21 Uredbe (ES) št. 1924/2006, obdobje varstva podatkov, odobreno v skladu s členom 26 te uredbe, ni sme biti daljše od obdobja varstva podatkov, odobrenega v skladu s členom 21 Uredbe (ES) št. 1924/2006.
The Commission shall inform the applicant about the date of resumption of the authorisation procedure.
Vložnik lahko kadar koli umakne svojo zahtevo za prekinitev postopka odobritve, predloženo v skladu z odstavkom 1.
From the date of resumption, time shall begin to run afresh from the beginning for the purposes of the time-limit laid down in Article 12(1) of this Regulation.
V tem primeru se postopek odobritve nadaljuje, odstavek 5 pa se ne uporabi.
In the cases referred to in paragraph 1 of this Article, where data protection has been granted in accordance with Article 21 of Regulation (EC) No 1924/2006, the period of data protection granted in accordance with Article 26 of this Regulation shall not exceed the period of data protection granted in accordance with Article 21 of Regulation (EC) No 1924/2006.
POGLAVJE VI
The applicant may withdraw at any time the request for staying the authorisation procedure submitted in accordance with paragraph 1.
KAZNI IN SPLOŠNE DOLOČBE
In that case, the authorisation procedure shall resume and paragraph 5 shall not apply.
Člen 29
CHAPTER VI
Kazni
PENALTIES AND GENERAL PROVISIONS
Države članice določijo pravila o kaznih, ki se uporabljajo v primeru kršitve določb te uredbe, in sprejmejo vse potrebne ukrepe za zagotovitev, da se te kazni izvajajo.
Article 29
Predvidene kazni morajo biti učinkovite, sorazmerne in odvračilne.
Penalties
Države članice uradno obvestijo Komisijo o navedenih določbah do 1. januarja 2018, brez odlašanja pa tudi o vsaki njihovi nadaljnji spremembi.
Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented.
Člen 30
The penalties provided for shall be effective, proportionate and dissuasive.
Postopek v odboru
Member States shall notify those provisions to the Commission by 1 January 2018 and shall notify it without delay of any subsequent amendment affecting them.
Komisiji pomaga Stalni odbor za rastline, živali, hrano in krmo, ustanovljen s členom 58(1) Uredbe (ES) št. 178/2002.
Article 30
Ta odbor je odbor v smislu Uredbe (EU) št. 182/2011 Evropskega parlamenta in Sveta [19].
Committee procedure
Pri sklicevanju na ta odstavek se uporablja člen 4 Uredbe (EU) št. 182/2011.
The Commission shall be assisted by the Standing Committee on Plants, Animals, Food and Feed established by Article 58(1) of Regulation (EC) No 178/2002.
Kadar je treba pridobiti mnenje odbora s pisnim postopkom, se ta postopek zaključi brez izida, če v roku za predložitev mnenja tako odloči predsednik odbora ali če to zahteva navadna večina članov odbora.
That committee shall be a committee within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council [19].
Pri sklicevanju na ta odstavek se uporablja člen 5 Uredbe (EU) št. 182/2011.
Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.
Kadar odbor ne poda mnenja, Komisija osnutka izvedbenega akta ne sprejme in se uporabi tretji pododstavek člena 5(4) Uredbe (EU) št. 182/2011.
Where the opinion of the committee is to be obtained by written procedure, that procedure shall be terminated without result when, within the time-limit for delivery of the opinion, the chair of the committee so decides or a simple majority of committee members so request.
Člen 31
Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
Delegirani akti
Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.
Za namene doseganja ciljev te uredbe Komisija z delegiranimi akti, sprejetimi v skladu s členom 32, prilagodi opredelitev namensko proizvedenih nanomaterialov iz točke (f) člena 3(2) tehničnemu in znanstvenemu napredku ali opredelitvam, ki so bile dogovorjene na mednarodni ravni.
Article 31
Člen 32
For the purposes of achieving the objectives of this Regulation, the Commission shall, by means of delegated acts adopted in accordance with Article 32, adjust and adapt the definition of engineered nanomaterials referred to in point (f) of Article 3(2) to technical and scientific progress or to definitions agreed at international level.
Pooblastilo za sprejemanje delegiranih aktov je preneseno na Komisijo pod pogoji, določenimi v tem členu.
Article 32
Zlasti je pomembno, da Komisija sledi svoji običajni praksi in pred sprejetjem teh delegiranih aktov opravi posvetovanja s strokovnjaki, vključno s strokovnjaki iz držav članic.
It is of particular importance that the Commission follow its usual practice and carry out consultations with experts, including Member States' experts, before adopting those delegated acts.
S sklepom o preklicu preneha veljati prenos pooblastila iz navedenega sklepa.
The power to adopt delegated acts referred to in Article 31 shall be conferred on the Commission for a period of five years from 31 December 2015.
Sklep začne učinkovati dan po njegovi objavi v Uradnem listu Evropske unije ali na poznejši dan, ki je določen v navedenem sklepu.
The delegation of power referred to in Article 31 may be revoked at any time by the European Parliament or by the Council.
Delegirani akt, sprejet na podlagi člena 31, začne veljati le, če mu niti Evropski parlament niti Svet ne nasprotuje v roku dveh mesecev od uradnega obvestila Evropskemu parlamentu in Svetu o tem aktu ali če pred iztekom tega roka tako Evropski parlament kot Svet obvestita Komisijo, da mu ne bosta nasprotovala.
It shall take effect the day following the publication of the decision in the Official Journal of the European Union or on a later date specified therein.
POGLAVJE VII