natgillin/translations-raw huggingface dataset:
At the request of the Authority or a Member State, the applicant shall make available the dossiers submitted for the approval and subsequent renewals of the approval, where it has access to them.
Vlagatelj na zahtevo Agencije ali države članice zagotovi dokumentacijo, predloženo za odobritev in naknadna podaljšanja odobritve, če ima dostop do nje.
Where the supplementary dossiers have not been submitted by the date referred to in Article 6(3), or where at the end of the period set for the submission of the missing elements in accordance with paragraph 2 of this Article the supplementary dossiers still do not contain all the elements provided for in Article 7, the rapporteur Member State shall, without delay, inform the applicant, the co-rapporteur Member State, the Commission, the other Member States and the Authority that the application is inadmissible and of the reasons why it is inadmissible.
Če dopolnilna dokumentacija ni bila predložena do datuma iz člena 6(3) ali če ob izteku roka, določenega za predložitev manjkajočih elementov v skladu z odstavkom 2 tega člena, še vedno ne vsebuje vseh elementov iz člena 7, država članica poročevalka nemudoma obvesti vlagatelja, državo članico soporočevalko, Komisijo, druge države članice in Agencijo, da je vloga nedopustna, in navede razloge, zakaj je nedopustna.
Replacement of the applicant
Nadomestitev vlagatelja
An applicant may be replaced by another producer in respect of all of its rights and obligations under this Regulation by informing the rapporteur Member State, through a joint declaration by the applicant and the other producer.
Vlagatelja lahko glede vseh njegovih pravic in obveznosti, ki izhajajo iz te uredbe, nadomesti drug proizvajalec, tako da vlagatelj in drugi proizvajalec o tem obvestita državo članico poročevalko s skupno izjavo.
In that case, the applicant and the other producer shall, at the same time, inform the co-rapporteur Member State, the Commission, the other Member States, the Authority and any other applicants that have submitted an application for the same active substance of the replacement.
V tem primeru vlagatelj in drugi proizvajalec o nadomestitvi hkrati obvestita državo članico soporočevalko, Komisijo, druge države članice, Agencijo in vse druge vlagatelje, ki so predložili vlogo za isto aktivno snov.
Adoption of non-renewal Regulation
Sprejetje uredbe o zavrnitvi podaljšanja odobritve
The Commission shall adopt a Regulation on the non-renewal of the approval of an active substance in accordance with Article 20(1)(b) of Regulation (EC) No 1107/2009 where all of the applications submitted for that active substance are inadmissible in accordance with Article 3(3) of this Regulation or Article 8(6) thereof.
Komisija sprejme uredbo o zavrnitvi podaljšanja odobritve aktivne snovi v skladu s členom 20(1)(b) Uredbe (ES) št. 1107/2009, če so vse predložene vloge za aktivno snov nedopustne v skladu s členom 3(3) ali členom 8(6).
Assessment by the rapporteur Member State and the co-rapporteur Member State
Ocena države članice poročevalke in države članice soporočevalke
Where the application is admissible in accordance with Article 8(1), the rapporteur Member State shall, after consulting the co-rapporteur Member State, at the latest 12 months after the date referred to in Article 6(3), prepare and submit to the Commission, with a copy to the Authority, a report assessing whether the active substance can be expected to meet the approval criteria, as provided for in Article 4 of Regulation (EC) No 1107/2009 (‘the draft renewal assessment report’).
Če je vloga dopustna v skladu s členom 8(1), država članica poročevalka po posvetovanju z državo članico soporočevalko najpozneje v 12 mesecih po datumu iz člena 6(3) pripravi poročilo o oceni, ali se za aktivno snov lahko pričakuje, da bo izpolnjevala merila za odobritev iz člena 4 Uredbe (ES) št. 1107/2009 (v nadaljnjem besedilu: osnutek poročila o oceni podaljšanja odobritve), in ga predloži Komisiji, Agenciji pa predloži njegovo kopijo.
The draft renewal assessment report shall also include the following:
Osnutek poročila o oceni podaljšanja odobritve vključuje tudi naslednje:
a recommendation with regard to the renewal of the approval;
priporočilo glede podaljšanja odobritve;
a recommendation on whether the substance should be considered a ‘low-risk’ substance;
priporočilo, ali se snov šteje za snov z „majhnim tveganjem“;
a recommendation on whether the substance should be considered a candidate for substitution;
priporočilo, ali se snov šteje za „kandidatko za zamenjavo“;
where relevant, a proposal to set maximum residue levels;
predlog za določitev mejnih vrednosti ostankov, kadar je to ustrezno;
where relevant, a suggestion for the classification or reclassification of the active substance in accordance with Regulation (EC) No 1272/2008;
predlog za razvrstitev ali ponovno razvrstitev aktivne snovi v skladu z Uredbo (ES) št. 1272/2008, kadar je to ustrezno;
a recommendation as to the parts of the report on which a consultation of experts is to be organised in accordance with Article 13(1);
priporočilo glede delov poročila, o katerih je treba v skladu s členom 13(1) organizirati posvetovanje s strokovnjaki;
the points on which the co-rapporteur Member State did not agree with the assessment by the rapporteur Member State, where relevant.
točke, glede katerih se država članica soporočevalka ni strinjala z oceno države članice poročevalke, kadar je to ustrezno.
It shall take into account the supplementary dossiers, and, where appropriate, the dossiers submitted for the approval and subsequent renewals of approval.
Pri tem upošteva dopolnilno dokumentacijo in po potrebi dokumentacijo, predloženo za odobritev in naknadna podaljšanja odobritve.
The rapporteur Member State shall first establish whether the approval criteria set out in points 3.6.2, 3.6.3, 3.6.4 and 3.7 of Annex II to Regulation (EC) No 1107/2009 are satisfied.
Država članica poročevalka najprej ugotovi, ali so izpolnjena merila za odobritev iz točk 3.6.2, 3.6.3, 3.6.4 in 3.7 Priloge II k Uredbi (ES) št. 1107/2009.
Where those criteria are not satisfied, the draft renewal assessment report shall be limited to those parts of the assessment, unless Article 4(7) of Regulation (EC) No 1107/2009 applies.
Kadar ta merila niso izpolnjena, je osnutek poročila o oceni podaljšanja odobritve omejen na te dele ocene, razen če se ne uporablja člen 4(7) Uredbe (ES) št. 1107/2009.
Where the rapporteur Member State requires additional information, it shall set a period for the applicant to supply that information.
Če država članica poročevalka potrebuje dodatne informacije, vlagatelju določi rok za predložitev takih informacij.
That period shall not lead to an extension of the period of 12 months provided for in paragraph 1.
Navedeni rok ne sme pomeniti podaljšanja roka 12 mesecev iz odstavka 1.
The applicant may, pursuant to Article 63 of Regulation (EC) No 1107/2009, request such information to be kept confidential.
Vlagatelj lahko v skladu s členom 63 Uredbe (ES) št. 1107/2009 zahteva, da se ohrani zaupnost takih informacij.
Such consultations and requests shall not lead to an extension of the period of 12 months provided for in paragraph 1.
Taka posvetovanja in zahteve ne smejo pomeniti podaljšanja roka 12 mesecev iz odstavka 1.
Information submitted by the applicant without having been requested, or provided after the expiry of the period set for its submission in accordance with the first sentence of paragraph 5, shall not be taken into account, unless it is submitted in accordance with Article 56 of Regulation (EC) No 1107/2009.
Informacije, ki jih je vlagatelj predložil, čeprav niso bile zahtevane, ali zagotovil po izteku roka, določenega za predložitev v skladu s prvim stavkom odstavka 5, se ne upoštevajo, razen če so bile predložene v skladu s členom 56 Uredbe (ES) št. 1107/2009.
When submitting the draft renewal assessment report to the Commission, the rapporteur Member State shall request the applicant to submit the supplementary summary dossiers, updated to include the additional information requested by the rapporteur Member State in accordance with paragraph 5 or submitted in accordance with Article 56 of Regulation (EC) No 1107/2009, to the co-rapporteur Member State, the Commission, the other Member States and to the Authority.
Država članica poročevalka ob predložitvi osnutka poročila o oceni podaljšanja odobritve Komisiji od vlagatelja zahteva, da predloži posodobljen povzetek dopolnilne dokumentacije z dodatnimi informacijami, ki jih je država članica poročevalka zahtevala v skladu z odstavkom 5 ali pa so bile v skladu s členom 56 Uredbe (ES) št. 1107/2009 predložene državi članici soporočevalki, Komisiji, drugim državam članicam in Agenciji.
The applicant may pursuant to Article 63 of Regulation (EC) No 1107/2009 request such information to be kept confidential.
Vlagatelj lahko v skladu s členom 63 Uredbe (ES) št. 1107/2009 zahteva, da se ohrani zaupnost takih informacij.
Any such requests shall be addressed to the Authority.
Vsi takšni zahtevki se naslovijo na Agencijo.
Comments on the draft renewal assessment report
Pripombe k osnutku poročila o oceni podaljšanja odobritve
The Authority shall circulate the draft renewal assessment report received from the rapporteur Member State to the applicant and to the other Member States at the latest 30 days after its receipt.
Agencija razpošlje osnutek poročila o oceni podaljšanja odobritve, ki ga je prejela od države članice poročevalke, vlagatelju in ostalim državam članicam najpozneje 30 dni po prejemu.
The Authority shall make the draft renewal assessment report available to the public, after giving the applicant two weeks to request, pursuant to Article 63 of Regulation (EC) No 1107/2009, that certain parts of the draft renewal assessment report are kept confidential.
Agencija zagotovi javnosti dostop do osnutka poročila o oceni podaljšanja odobritve, vendar pred tem vlagatelju omogoči, da lahko v dveh tednih v skladu s členom 63 Uredbe (ES) št. 1107/2009 zahteva, da nekateri deli osnutka poročila o oceni podaljšanja odobritve ostanejo zaupni.
The Authority shall allow a period of 60 days from the date the report is made available to the public for the submission of written comments.
Za predložitev pisnih pripomb določi Agencija 60-dnevni rok od dneva, ko je javnosti zagotovljen dostop do poročila.
Such comments shall be communicated to the Authority, which shall collate and forward those comments, including its own comments, to the Commission.
Take pripombe se sporočijo Agenciji, ki jih zbere in vključno s svojimi pripombami posreduje Komisiji.
The Authority shall make the updated supplementary summary dossiers available to the public, excluding any information in respect of which confidentiality has been requested and justified by the applicant pursuant to Article 63 of Regulation (EC) No 1107/2009, unless there is an overriding public interest in its disclosure.
Agencija javnosti zagotovi dostop do posodobljenega povzetka dopolnilne dokumentacije, izključi pa vse informacije, za katere je vlagatelj zahteval in utemeljil zaupno obravnavanje v skladu s členom 63 Uredbe (ES) št. 1107/2009, razen če prevlada javni interes za razkritje.
Within five months from the expiry of the period referred to in Article 12(3), the Authority shall adopt a conclusion in the light of current scientific and technical knowledge using guidance documents applicable at the date of the submission of the supplementary dossiers on whether the active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.
V petih mesecih od izteka roka iz člena 12(3) Agencija na podlagi trenutnih znanstvenih in tehničnih spoznanj s pomočjo smernic, ki se uporabljajo v času predložitve dopolnilne dokumentacije, sprejme sklep, ali se za aktivno snov lahko pričakuje, da bo izpolnjevala merila za odobritev iz člena 4 Uredbe (ES) št. 1107/2009.
The Authority shall, where appropriate, organise a consultation of experts, including experts from the rapporteur Member State and co-rapporteur Member State.
Agencija po potrebi organizira posvetovanje s strokovnjaki, vključno s strokovnjaki iz države članice poročevalke in države članice soporočevalke.
The Authority shall communicate its conclusion to the applicant, the Member States and the Commission.
Agencija pošlje svoj sklep vlagatelju, državam članicam in Komisiji.
By way of derogation from the first subparagraph, the Commission may inform the Authority without delay after the period referred to in Article 12(3) has expired that a conclusion is not necessary.
Z odstopanjem od prvega pododstavka lahko Komisija nemudoma obvesti Agencijo po obdobju iz člena 12(3), da sklep ni potreben.
After giving the applicant two weeks to request, pursuant to Article 63 of Regulation (EC) No 1107/2009, that certain parts of the conclusion be kept confidential, the Authority shall make its conclusion available to the public, excluding any information in respect of which confidentiality has been granted by the Authority, unless there is an overriding public interest in its disclosure.
Agencija omogoči vlagatelju, da lahko v dveh tednih v skladu s členom 63 Uredbe (ES) št. 1107/2009 zahteva, da ostanejo nekateri deli sklepa zaupni, nato pa ga da na voljo javnosti, in izključi vse informacije, v zvezi s katerimi je odobrila zaupno obravnavanje, razen če prevlada javni interes za razkritje.
Where the Authority considers that additional information from the applicant is necessary, it shall, in consultation with the rapporteur Member State, set a period not exceeding one month for the applicant to supply such information to the Member States, the Commission and the Authority.
Če Agencija meni, da mora vlagatelj predložiti dodatne informacije, po posvetovanju z državo članico poročevalko določi rok, ki ni daljši od enega meseca, v katerem mora vlagatelj predložiti takšne informacije državam članicam, Komisiji in Agenciji.
The rapporteur Member State shall, within 60 days from the date of receipt of the additional information evaluate the information received and send its evaluation to the Authority.
Država članica poročevalka v 60 dneh po prejemu dodatnih informacij oceni prejete informacije in to oceno pošlje Agenciji.
Where the first subparagraph applies, the period referred to in paragraph 1 shall be extended by the periods referred to in the first subparagraph of this paragraph.
Če se uporablja prvi pododstavek, se rok iz odstavka 1 podaljša za obdobji iz prvega pododstavka tega odstavka.
The Authority may ask the Commission to consult a European Union reference laboratory designated, pursuant to Regulation (EC) No 882/2004 of the European Parliament and of the Council [6], for the purposes of verifying whether the analytical method for the determination of the residues proposed by the applicant is satisfactory and complies with the requirements in Article 29(1)(g) of Regulation (EC) No 1107/2009.
Agencija lahko Komisijo zaprosi, da se posvetuje z referenčnim laboratorijem Evropske unije, ustanovljenim v skladu z Uredbo (ES) št. 882/2004 Evropskega parlamenta in Sveta [6], zaradi preverjanja, ali je analitska metoda za določitev ostankov, ki jo predlaga vlagatelj, ustrezna in skladna z zahtevami iz člena 29(1)(g) Uredbe (ES) št. 1107/2009.
The applicant shall, if requested by the European Union reference laboratory, provide samples and analytical standards.
Vlagatelj na zahtevo referenčnega laboratorija Evropske unije predloži vzorce in analitske standarde.
Information submitted by the applicant without having been requested, or provided after the expiry of the period set for its submission in accordance with the first subparagraph of paragraph 3, shall not be taken into account, unless it is submitted in accordance with Article 56 of Regulation (EC) No 1107/2009.
Informacije, ki jih je vlagatelj predložil, čeprav niso bile zahtevane, ali zagotovil po izteku roka, določenega za predložitev v skladu s prvim pododstavkom odstavka 3, se ne upoštevajo, razen če so bile predložene v skladu s členom 56 Uredbe (ES) št. 1107/2009.
Renewal report and renewal Regulation
Poročilo o podaljšanju odobritve in uredba o podaljšanju odobritve
The Commission shall present to the Committee referred to in Article 79(1) of Regulation (EC) No 1107/2009 a renewal report and a draft Regulation within six months from the date of receipt of the conclusion of the Authority or in cases where there is no such conclusion of the Authority, the expiry of the period referred to in Article 12(3) of this Regulation.
Komisija predloži odboru iz člena 79(1) Uredbe (ES) št. 1107/2009 poročilo o podaljšanju odobritve in osnutek uredbe v šestih mesecih od datuma prejema sklepa Agencije ali po izteku roka iz člena 12(3) te uredbe, kadar Agencija ne sprejme takega sklepa.
The renewal report and the draft Regulation shall take into account the draft renewal assessment report of the rapporteur Member State, the comments referred to in Article 12(3) of this Regulation and the conclusion of the Authority, where such a conclusion has been submitted.
V poročilu o podaljšanju odobritve in osnutku uredbe se upoštevajo osnutek poročila o oceni podaljšanja odobritve države članice poročevalke, pripombe iz člena 12(3) te uredbe in sklep Agencije, kadar je bil tak sklep predložen.
The applicant shall be given the possibility to submit comments on the renewal report within a period of 14 days.
Vlagatelju se zagotovi možnost, da predloži pripombe k poročilu o podaljšanju odobritve v roku 14 dni.
On the basis of the renewal report and taking into account comments submitted by the applicant within the period referred to in the third subparagraph of paragraph 1, the Commission shall adopt a Regulation in accordance with Article 20(1) of Regulation (EC) No 1107/2009.
Na podlagi poročila o podaljšanju odobritve in ob upoštevanju pripomb, ki jih je vlagatelj predložil v roku iz tretjega pododstavka odstavka 1, Komisija v skladu s členom 20(1) Uredbe (ES) št. 1107/2009 sprejme uredbo.
Regulation (EU) No 1141/2010 shall continue to apply with respect to the renewal of the approval of active substances listed in Annex I thereto.
Uredba (EU) št. 1141/2010 se še naprej uporablja za podaljšanje odobritve aktivnih snovi, navedenih v Prilogi I k navedeni uredbi.
OJ L 200, 27.7.2012, p. 5.
UL L 200, 27.7.2012, str. 5.
Format for applications, as provided for in Article 2(1)
Oblika vloge, kakor je določena v členu 2(1)
The application shall be in writing, signed by the applicant, and sent to the rapporteur Member State and to the co-rapporteur Member State.
Pisno vlogo s podpisom vlagatelja je treba poslati državi članici poročevalki in državi članici soporočevalki.
A copy of the application shall be sent to the European Commission, DG Health and Consumers, 1049 Brussels, Belgium
Kopija vloge se pošlje Evropski komisiji na naslov: European Commission, DG Health and Consumers, 1049 Bruxelles/Brussel, Belgique/België
, to the European Food Safety Authority, Via Carlo Magno 1/A, 43126 Parma, Italy
, Evropski agenciji za varnost hrane na naslov: European Food Safety Authority, Via Carlo Magno 1/A, 43126 Parma, Italija
and to the other Member States.
, in drugim državam članicam.
Information concerning the applicant
Podatki o vlagatelju
Name and address of the applicant including the name of the natural person responsible for the application and other obligations resulting from this Regulation:
Ime in naslov vlagatelja, vključno z imenom fizične osebe, odgovorne za vlogo ter druge obveznosti, ki izhajajo iz te uredbe:
Alternative contact:
Namestnik kontaktne osebe:
Information to facilitate identification
Podatki za lažjo identifikacijo
Common name (proposed or ISO-accepted) specifying, where relevant, any variants thereof such as salts, esters or amines manufactured by the producer.
Splošno ime snovi (predlagano ali sprejeto po ISO) z navedbo, kadar je to ustrezno, vseh njenih variant, kot so soli, estri ali amini, ki jih proizvaja proizvajalec.
CAS, CIPAC and EC numbers (if available).
Številke CAS, CIPAC in ES (če so na razpolago).
Specification of purity of the active substance in g/kg which must be, whenever possible, identical or already accepted as equivalent to the one listed in the Annex to Commission Implementing Regulation (EU) No 540/2011 [1].
Opis čistosti aktivne snovi v g/kg, ki mora biti po možnosti enaka ali že sprejeta kot enaka tisti iz Priloge k Izvedbeni uredbi Komisije (EU) št. 540/2011 [1].
Classification and labelling of the active substance in accordance with the provisions of Regulation (EC) No 1272/2008 of the European Parliament and of the Council [2] (health and environment effects).
Razvrstitev in označitev aktivne snovi v skladu z določbami Uredbe (ES) št. 1272/2008 Evropskega parlamenta in Sveta [2] (učinki na zdravje in okolje).
New information
Nove informacije
List of new information intended to be submitted together with a justification showing that they are considered necessary, in accordance with Article 15(2) of Regulation (EC) No 1107/2009.
Seznam novih informacij, ki naj bi se predložile skupaj z utemeljitvijo, iz katere je razvidno, da veljajo za nujne v skladu s členom 15(2) Uredbe (ES) št. 1107/2009.
List of new studies intended to be submitted on vertebrate animals.
Seznam novih študij na vretenčarjih, ki naj bi se predložile.
Timetable of any new and ongoing studies.
Časovni razpored novih in tekočih študij.
The applicant confirms that the above information submitted included in the application is correct.
Vlagatelj potrjuje točnost zgoraj navedenih podatkov, predloženih z vlogo.
Date and signature (of the person competent to act for the applicant referred to under point 1.1).
Datum in podpis (pristojnega zastopnika vlagatelja iz točke 1.1)
Commission Regulation (EU) No 845/2012
Uredba Komisije (EU) št. 845/2012
imposing a provisional anti-dumping duty on imports of certain organic coated steel products originating in the People's Republic of China
o uvedbi začasne protidampinške dajatve na uvoz nekaterih jeklenih izdelkov, prevlečenih z organskimi premazi, s poreklom iz Ljudske republike Kitajske
On 21 December 2011, the Commission announced, by a notice published in the Official Journal of the European Union [2] ('the notice of initiation'), the initiation of an anti-dumping proceeding with regard to imports into the Union of certain organic coated steel products originating in the People's Republic of China ('the country concerned' or 'the PRC').
Komisija je 21. decembra 2011 z obvestilom („obvestilo o začetku“), objavljenim v Uradnem listu Evropske unije [2], objavila začetek protidampinškega postopka v zvezi z uvozom nekaterih jeklenih izdelkov, prevlečenih z organskimi premazi, s poreklom iz Ljudske republike Kitajske („zadevna država“ ali „LRK“) v Unijo.
The proceeding was initiated following a complaint lodged on 7 November 2011 by Eurofer (‘the complainant’), representing a major proportion, in this case more than 70 %, of the total Union production of certain organic coated steel products.
Postopek je bil uveden na podlagi pritožbe, ki jo je 7. novembra 2011 vložil Eurofer („pritožnik“), ki predstavlja glavni delež, v tem primeru več kot 70 % celotne proizvodnje nekaterih jeklenih izdelkov, prevlečenih z organskimi premazi, v Uniji.
The complaint contained prima facie evidence of dumping of the said product and of material injury resulting therefrom, which was considered sufficient to justify the opening of a proceeding.
Pritožba je vsebovala dokaze prima facie o dampingu navedenega izdelka in znatni škodi, ki je zaradi tega nastala, kar je zadostovalo za upravičenost začetka postopka.
The Commission officially advised the complainants, other known Union producers, the known exporting producers in the PRC, importers, traders, users, suppliers and associations known to be concerned, and the representatives of the PRC of the initiation of the proceeding.
Komisija je pritožnike, druge znane proizvajalce Unije, znane proizvajalce izvoznike v LRK, uvoznike, trgovce, uporabnike, dobavitelje in združenja, za katera je znano, da jih to zadeva, ter predstavnike LRK obvestila o začetku postopka.