natgillin/translations-raw huggingface dataset:
for each point of the data requirements for the plant protection product referred to in Annex III to Directive 91/414/EEC, the summaries and results of tests and studies, the name of their owner and of the person or institute that has carried out the tests and studies relevant to the assessment of the requirements referred to in Article 5 of that Directive taking into account that data gaps in the Annex II or Annex III dossier, resulting from the proposed limited range of representative uses, may lead to restrictions in the Annex I inclusion;
za vsako točko zahtev po podatkih o fitofarmacevtskem sredstvu iz Priloge II k Direktivi 91/414/EGS povzetke in rezultate preskusov in študij, ime njihovega lastnika ter osebe ali zavoda, ki je izvajal preskuse in študije, potrebne za oceno zahtev iz člena 5 navedene direktive, ob upoštevanju, da lahko podatkovne vrzeli v dokumentaciji glede snovi iz prilog II in III, ki so posledica predlaganega omejenega števila reprezentativnih uporab, povzročijo omejitve pri vključitvi v Prilogo I;
a checklist demonstrating that the dossier provided for in paragraph 2 is complete;
kontrolni seznam, ki dokazuje, da je dokumentacija iz odstavka 2 popolna;
the reasons why the test and study reports submitted are necessary for first inclusion of the active substance;
razloge, zakaj so predložena poročila o testih in študijah potrebna za prvo vključitev aktivne snovi;
an assessment of all information submitted.
oceno vseh predloženih informacij.
The complete dossier shall contain the full text of the individual test and study reports concerning all the information referred to in points (b) and (c) of paragraph 1.
Popolna dokumentacija vključuje celotno besedilo poročil o posameznih preskusih in študijah v zvezi z vsemi informacijami iz odstavkov 1(b) in (c).
Completeness check of the dossier
Pregled popolnosti dokumentacije
Within 30 days of receiving the application, the rapporteur Member State shall check whether the dossiers submitted with the application contain all the elements provided for in Article 4, using the checklist referred to in Article 4(1)(d).
V 30 dneh po prejemu zahtevka država članica poročevalka z uporabo kontrolnega seznama iz člena 4(1)(d) preveri, ali dokumentacija, predložena z zahtevkom, vključuje vse elemente iz člena 4.
Where one or more of the elements provided for in Article 4 are missing, the Member State shall inform the applicant, setting a time period for their submission; such time period shall be no more than six months.
Kadar manjka en ali več elementov iz člena 4, države članice o tem obvestijo vlagatelja in določijo rok za njihovo predložitev. Takšen rok ne sme biti daljši od šestih mesecev.
Where at the end of the period, referred to in paragraph 2, the applicant has not submitted the missing elements, the rapporteur Member State shall inform the applicant, the Commission and the other Member States.
Če ob koncu obdobja iz odstavka 2 vlagatelj ne predloži manjkajočih elementov, država članica poročevalka obvesti vlagatelja, Komisijo in druge države članice, da zahtevek ni sprejemljiv.
If, after giving the applicant an opportunity to comment, the Commission determines that the applicant has failed to submit the missing elements, it shall adopt a decision providing that the active substance concerned is not to be included in Annex I to Directive 91/414/EEC.
Če Komisija potem, ko vlagatelju omogoči predložitev pripomb, ugotovi, da ta ni predložil manjkajočih elementov, sprejme sklep, ki določa, da zadevna aktivna snov ne bo uvrščena v Prilogo I k Direktivi 91/414/EGS.
Such a decision shall end the assessment of that active substance under this Regulation.
Tak sklep konča oceno navedene aktivne snovi na podlagi te uredbe.
A new application for the same substance may be submitted at any time.
Nov zahtevek za isto snov se lahko predloži kadar koli.
Where the dossiers submitted with the application contain all the elements provided for in Article 3, the rapporteur Member State shall notify the applicant, the Commission, the other Member States and the Authority of the completeness of the application.
Če dokumentacija, predložena skupaj z zahtevkom, vključuje vse elemente iz člena 3, država članica poročevalka vlagatelja, Komisijo, druge države članice in Agencijo obvesti o popolnosti zahtevka.
Publication of information
Objava informacij
For applications for which completeness has been established the Commission shall make public the following information:
Za zahtevke, za katere je bilo ugotovljeno, da so popolni, Komisija objavi naslednje informacije:
the name of the active substance;
ime aktivne snovi;
the date of application;
datum zahtevka;
the name and address of applicants;
ime in naslov vlagateljev;
the rapporteur Member State.
država članica poročevalka.
Any person or Member State wishing to submit to the rapporteur Member State information which might contribute to the assessment, in particular with regard to the potentially dangerous effects of the active substance or its residues on human and animal health and on the environment shall do so, without prejudice to Article 7 of Directive 91/414/EEC, no later than 90 days after the information referred to in Article 6 is made public.
Katera koli oseba ali država članica, ki želi državi članici poročevalki predložiti informacije, ki so lahko pomembne za oceno, zlasti v zvezi s potencialnimi nevarnimi učinki aktivne snovi ali njenih ostankov na zdravje ljudi in živali ter na okolje, mora to storiti, brez poseganja v člen 7 Direktive 91/414/EGS, najpozneje devetdeset dni po objavi informacij iz člena 6.
The rapporteur Member State shall submit without delay any information received to the Authority and the applicant.
Država članica poročevalka takoj predloži kakršne koli prejete informacije Agenciji in vlagatelju.
The applicant may send its comments on the submitted information to the rapporteur Member State and to the Authority at the latest 60 days after receiving it.
Vlagatelj lahko pošlje svoje pripombe na predložene informacije državi članici poročevalki in Agenciji najpozneje šestdeset dni po prejemu informacij.
Within twelve months of the date of the application provided for in Article 3(1), the rapporteur Member State shall prepare and submit to the Commission with a copy to the Authority a report (hereinafter draft assessment report) assessing whether the active substance can be expected to meet the requirements of Article 5 of Directive 91/414/EEC.
V dvanajstih mesecih po datumu vložitve zahtevka iz člena 3(1) država članica poročevalka pripravi in Komisiji ter s kopijo Agenciji predloži poročilo (v nadaljnjem besedilu „osnutek poročila o oceni“), v katerem oceni, ali je verjetno, da bo aktivna snov izpolnila zahteve iz člena 5 Direktive 91/414/EGS.
It shall at the same time inform the applicant that the draft assessment report has been submitted and request him to forward the updated dossier to the Authority, the Member States and the Commission immediately.
Istočasno obvesti vlagatelja, da je bil predložen osnutek poročila o oceni, in od njega zahteva, da Agenciji, državam članicam in Komisiji nemudoma posreduje posodobljeno dokumentacijo.
The rapporteur Member State may consult the Authority.
Država članica poročevalka se lahko posvetuje z Agencijo.
Where the rapporteur Member State needs additional information, it shall set a time period for the applicant to supply it.
Če država članica poročevalka potrebuje dodatne informacije, določi rok, v katerem jih mora vlagatelj predložiti.
In that case, the twelve-month period shall be extended by the additional time period granted by the rapporteur Member State.
V tem primeru se obdobje dvanajstih mesecev podaljša za dodatno časovno obdobje, ki ga odobri država članica poročevalka.
The additional time period shall be no more than six months and shall cease at the moment when the additional information is received by the rapporteur Member State.
Dodatno časovno obdobje traja največ šest mesecev in preneha v trenutku, ko država članica poročevalka prejme dodatne informacije.
It shall inform the Commission and the Authority.
O tem obvesti Komisijo in Agencijo.
In its assessment the rapporteur Member State shall only take into account information submitted within the time period granted.
V svoji oceni država članica poročevalka upošteva le informacije, predložene v odobrenem časovnem obdobju.
Where at the end of the period referred to in paragraph 3, the applicant has not submitted the missing elements, the rapporteur Member State shall inform the applicant, the Commission and the other Member States.
Če ob koncu obdobja iz odstavka 3 vlagatelj ne predloži manjkajočih elementov, država članica poročevalka obvesti vlagatelja, Komisijo in druge države članice, da zahtevek ni sprejemljiv.
If, after giving the applicant an opportunity to comment, the Commission determines that the applicant has failed to submit missing elements which are necessary to decide on whether the substance meets the requirements of Article 5 of Directive 91/414/EEC, it shall adopt a decision providing that the active substance in question is not to be included in Annex I to that Directive and ending the assessment of that active substance under this Regulation.
Če Komisija potem, ko vlagatelju omogoči predložitev pripomb, ugotovi, da ta ni predložil manjkajočih elementov, ki so potrebni za odločitev, ali snov izpolnjuje zahteve iz člena 5 Direktive 91/414/EGS, sprejme sklep, ki določa, da zadevna aktivna snov ne bo uvrščena v Prilogo I k navedeni direktivi, ter konča oceno navedene aktivne snovi na podlagi te uredbe.
Receipt of and access to the draft assessment report
Prejem in dostop do osnutka poročila o oceni
The Authority shall circulate the draft assessment report received from the rapporteur Member State to the applicant, the other Member States and the Commission after receiving the dossier provided for in Article 8(1).
Po prejemu dokumentacije iz člena 8(1) Agencija osnutek poročila o oceni, ki ga je prejela od države članice poročevalke, posreduje vlagatelju, drugim državam članicam in Komisiji.
It shall make it available to the public, after giving the applicant two weeks to request that certain parts of the draft assessment report be kept confidential.
Agencija da poročilo na voljo javnosti, potem ko vlagatelju omogoči rok dveh tednov, v katerem vlagatelj lahko zahteva, da nekateri deli osnutka poročila o oceni ostanejo zaupni.
The Authority shall allow a period of 90 days for the submission of written comments from Member States and the applicant.
Agencija dovoli za predložitev pisnih pripomb držav članic in vlagatelja obdobje devetdesetih dni.
Where appropriate, the Authority shall organise a peer review, including experts from the Member States.
Agencija po potrebi organizira strokovni pregled, ki vključuje strokovnjake iz držav članic.
Conclusion by the Authority
Sklep Agencije
The Authority shall adopt a conclusion on whether the active substance can be expected to meet the requirements of Article 5 of Directive 91/414/EEC within 90 days of the end of the period provided for in the third paragraph of Article 9 of this Regulation and communicate it to the applicant, the Member States and the Commission.
Agencija sprejme sklep o tem, ali se pričakuje, da bo aktivna snov izpolnila pogoje iz člena 5 Direktive 91/414/EGS v devetdesetih dneh od konca obdobja iz tretjega odstavka člena 9 te uredbe, ter o tem obvesti vlagatelja, države članice in Komisijo.
Where appropriate, the Authority shall address in its conclusion the risk mitigation options in relation to the intended uses identified in the draft assessment report.
Agencija po potrebi v sklepih obravnava možnosti za zmanjševanje tveganja v zvezi z nameravano uporabo, določene v osnutku poročila o oceni.
Where the Authority needs additional information, it shall, in consultation with the rapporteur Member State, set a time period of maximum 90 days for the applicant to supply it to the Authority and the rapporteur Member State.
Če Agencija potrebuje dodatno informacijo, določi v posvetovanju z državo članico poročevalko časovno obdobje največ devetdeset dni, v katerem jo vlagatelj predloži Agenciji in državi članici poročevalki.
In that case, the 90-day period provided for in paragraph 1 shall be extended by the additional period granted by the Authority.
V tem primeru se obdobje devetdesetih dni iz odstavka 1 podaljša za dodatno obdobje, ki ga odobri Agencija.
It shall inform the Commission and the Member States.
O tem obvesti Komisijo in države članice.
In its conclusion the Authority shall only take into account information submitted within the time period granted.
V svojem sklepu Agencija upošteva le informacije, predložene v odobrenem časovnem obdobju.
The rapporteur Member State shall assess the additional information and submit it to the Authority without delay and at the latest within 60 days after the receipt of the additional information.
Država članica poročevalka oceni dodatno informacijo in jo nemudoma predloži Agenciji, najpozneje pa v šestdesetih dneh po prejemu dodatne informacije.
The Commission and the Authority shall agree on the format in which the conclusions of the Authority are submitted.
Komisija in Agencija se dogovorita o obliki za predložitev sklepov Agencije.
Without prejudice to any proposal it may submit with a view to amending the Annex to Council Directive 79/117/EEC [7], the Commission shall, at the latest six months after receipt of the conclusion of the Authority or information that the applicant has failed to submit the missing elements to the dossier, submit to the Committee a draft review report to be finalised at its meeting.The applicant shall be given the possibility to submit comments on the review report within a deadline set by the Commission.
Brez poseganja v kateri koli predlog Komisije za spremembo Priloge k Direktivi Sveta 79/117/EGS [7] Komisija najpozneje šest mesecev po prejemu poročila o oceni ali sklepa Agencije ali informacije, da vlagatelj ni predložil manjkajočih elementov, predloži Odboru osnutek poročila o pregledu, da se na njegovem sestanku pripravi končna različica.Vlagatelj ima možnost predložiti pripombe na poročilo o pregledu v roku, ki ga določi Komisija.
On the basis of the review report provided for in paragraph 1, and taking into account any comments submitted by the applicant within the deadline set by the Commission under paragraph 1, a Directive or a Decision shall be adopted in accordance with the procedure referred to in Article 19(2) of the Directive 91/414/EEC, providing that:
Na podlagi poročila o pregledu, določenega v odstavku 1, in ob upoštevanju kakršnih koli pripomb, ki jih je vlagatelj predložil v roku, ki ga je Komisija določila v odstavku 1, se sprejme direktiva ali odločba v skladu s postopkom iz člena 19(2) Direktive 91/414/EGS, če:
an active substance is included in Annex I to Directive 91/414/EEC subject to conditions and restrictions, where appropriate;
se aktivna snov vključi v Prilogo I k Direktivi 91/414/EGS pod pogoji in omejitvami, kadar je to primerno;
an active substance is not included in Annex I to that Directive.
se aktivna snov ne vključi v Prilogo I k navedeni direktivi.
The adoption of a decision under paragraph 2(b) shall end the assessment of that active substance under this Regulation.
Sprejetje sklepa na podlagi odstavka 2(b) konča oceno navedene aktivne snovi na podlagi te uredbe.
Access to the review report
Dostop do poročila o pregledu
The finalised review report, excluding any parts which refer to confidential information contained in the dossiers and determined as such in accordance with Article 14 of the Directive 91/414/EEC, shall be made available for public consultation.
Končno poročilo o pregledu brez delov, ki se nanašajo na zaupne informacije, vsebovane v dokumentaciji in določene kot take v skladu s členom 14 Direktive 91/414/EGS, se da na vpogled javnosti.
ACCELERATED PROCEDURE
POSPEŠENI POSTOPEK
Conditions for the application of accelerated procedure
Pogoji za uporabo pospešenega postopka
Where a second, third or fourth stage substance has been the subject of a non-inclusion Decision in accordance with Article 6(1) of Directive 91/414/EEC, and a draft assessment report has been prepared, any person who had participated as notifier in the procedure leading up to that decision or any person who in agreement with the original notifier replaced him for the purposes of this Regulation, may submit an application in accordance with the accelerated procedure provided for in Articles 14 to 19 of this Regulation.
Če so bile predmet Odločbe o nevključitvi v skladu s členom 6(1) Direktive 91/414/EGS snovi iz druge, tretje ali četrte faze, osnutek poročila o oceni pa je bil pripravljen, lahko katera koli oseba, ki je sodelovala kot prijavitelj v postopku nastanka navedene odločbe, ali katera koli druga oseba, ki v soglasju z izvirnim prijaviteljem tega nadomešča za namene te uredbe, predloži zahtevek v skladu s pospešenim postopkom, določenim v členih 14 do 19 te uredbe.
Such an application must be submitted within six months from the date of publication of the non-inclusion decision as regards third and fourth stage substances, or, within six months from the date of entry into force of this Regulation as regards second stage substances.
Tak zahtevek je treba predložiti v šestih mesecih od datuma objave odločbe o nevključitvi za snovi iz tretje in četrte faze ali v šestih mesecih od začetka veljavnosti te uredbe za snovi iz druge faze.
The application referred to in Article 13 shall be submitted to the Member State which acted as rapporteur during the assessment procedure which ended with the adoption of the non-inclusion Decision unless another Member State informs the Commission that it is willing to carry out the evaluation in agreement with the original rapporteur Member State.
Zahtevek iz člena 13 se predloži državi članici, ki je med postopkom ocene, ki se je končala s sprejetjem odločbe o nevključitvi, delovala kot poročevalka, razen če druga država članica Komisije ne obvesti, da je pripravljena izvesti oceno v dogovoru s prvotno državo članico poročevalko.
When submitting his application, the applicant may, pursuant to Article 14 of Directive 91/414/EEC, request certain parts of the additional data referred to in paragraph 2 of Article 15 to be kept confidential.
Ob predložitvi svojega zahtevka lahko vlagatelj v skladu s členom 14 Direktive 91/414/EGS zahteva, da nekateri deli dokumentacije iz odstavka 1 navedenega člena ostanejo zaupni.
He shall explain for each document or each part of a document why it is to be considered as confidential.
Za vsak dokument ali del dokumenta pojasni, zakaj ga je treba obravnavati kot zaupnega.
He shall at the same time submit any claims for data protection pursuant to Article 13 of Directive 91/414/EEC.
Hkrati predloži kakršne koli zahteve v zvezi z varstvom podatkov v skladu s členom 13 Direktive 91/414/EGS.
Substantive and procedural requirements
Vsebinske in proceduralne zahteve
The following substantive requirements shall apply:
Uporabijo se naslednje vsebinske zahteve:
the specification of the active substance is the same as was the subject of the non-inclusion Decision.
specifikacija aktivne snovi je ista, kot je bila obravnavana pred izdajo odločbe o nevključitvi.
It may only be changed insofar as this is necessary, in the light of the reasons which gave rise to the non-inclusion Decision, to permit inclusion of that substance in Annex I to Directive 91/414/EEC;
Spremeni se lahko samo, če je potrebno zaradi razlogov, zaradi katerih je bila izdana odločba o nevključitvi, da bi se dovolila vključitev navedene snovi v Prilogo I k Direktivi 91/414/EGS;
the supported uses are the same as those that were the subject of the non-inclusion Decision.
podprte uporabe so iste, kot so bile obravnavane pred izdajo odločbe o nevključitvi.
They may only be changed insofar as this is necessary, in the light of the reasons which gave rise to the non-inclusion Decision, to permit inclusion of that substance in Annex I to Directive 91/414/EEC;
Spremenijo se lahko samo, če je potrebno zaradi razlogov, zaradi katerih je bila izdana odločba o nevključitvi, da bi se dovolila vključitev navedene snovi v Prilogo I k Direktivi 91/414/EGS;
it shall be for the applicant to demonstrate that the requirements in Article 5 of Directive 91/414/EEC are fulfilled.
vlagatelj mora dokazati, da so izpolnjene zahteve iz člena 5 Direktive 91/414/EGS.
With the application the applicant shall submit the following:
Vlagatelj z zahtevkom predloži naslednje:
the additional data necessary to address the specific issues that led to the adoption of the non-inclusion Decision concerned;
dodatne podatke, potrebne za obravnavo posebnih vprašanj, ki so povzročila sprejetje zadevne odločbe o nevključitvi;
any additional data reflecting the current scientific and technical knowledge and in particular changes to scientific and technical knowledge since the submission of the data which led to the non-inclusion decision;
kakršne koli dodatne podatke, ki odražajo trenutno znanstveno in tehnično znanje, zlasti pa spremembe znanstvenega ali tehničnega znanja od predložitve podatkov, ki so povzročili odločbo o nevključitvi;
a supplement to the original dossier, where appropriate;
dopolnilno dokumentacijo k prvotni, kadar je to primerno;
a checklist demonstrating that the dossier is complete and indicating which data are new.
spremni seznam, ki potrjuje popolnost dokumentacije in navaja, kateri podatki so novi.
the Rapporteur Member State.
država članica poročevalka.
Any person or Member State wishing to submit to the rapporteur Member State information which might contribute to the assessment, in particular with regard to the potentially dangerous effects of the active substance or its residues on human and animal health and on the environment shall do so, without prejudice to Article 7 of Directive 91/414/EEC, no later than 90 days after the information referred to in Article 16 is made public.
Katera koli oseba ali država članica, ki želi državi članici poročevalki predložiti informacije, ki so lahko pomembne za oceno, zlasti v zvezi s potencialnimi nevarnimi učinki aktivne snovi ali njenih ostankov na zdravje ljudi in živali ter na okolje, mora to storiti, brez poseganja v člen 7 Direktive 91/414/EGS, najpozneje devetdeset dni po objavi informacij iz člena 16.
The data referred to in Article 15(2) shall be evaluated by the rapporteur Member State referred to in Article 14(1), unless that Member State agrees with another Member State that the latter will act as rapporteur.
Podatke iz člena 15(2) oceni država članica poročevalka iz člena 14(1), razen če se navedena država članica dogovori z drugo državo članico, da bo slednja delovala kot poročevalka.
The applicant, the Commission, the Authority and the other Member States shall be informed of this agreement.
O tem dogovoru se obvestijo vlagatelj, Komisija, Agencija in druge države članice.
Within six months after the submission of the application the rapporteur Member State shall forward to the Authority and the Commission an evaluation of the additional data in a report, (hereinafter additional report), which should reflect current scientific and technical knowledge, and if necessary, information from the original dossier taking into consideration the information available on potentially dangerous effects submitted by any third party and any comments received from the applicant in accordance with Article 17(3).
Država članica poročevalka v šestih mesecih po predložitvi zahtevka posreduje Agenciji in Komisiji oceno dodatnih podatkov v poročilu, v nadaljnjem besedilu „dodatno poročilo“, ki mora odražati trenutno znanstveno in tehnično znanje, in po potrebi informacije iz prvotne dokumentacije, pri čemer upošteva razpoložljive informacije o potencialno nevarnih učinkih, ki jih predloži katera koli tretja stranka, ter kakršne koli pripombe vlagatelja v skladu s členom 17(3).
The additional report shall assess whether the active substance can be expected to meet the requirements of Article 5 of the Directive 91/414/EEC.
Dodatno poročilo oceni, ali se za aktivno snov lahko pričakuje, da bo izpolnjevala zahteve iz člena 5 Direktive 91/414/EGS.