natgillin/translations-raw huggingface dataset:
To speed up the examination process the workflow of the peer review and relationship between notifiers, Member States, the European Food Safety Authority (EFSA) and the Commission and the obligations of each of the parties for the implementation of the programme should be adapted without harming the level of safety for health and the environment.
Za pospešitev pregleda je treba prilagoditi potek strokovnega pregleda in odnos med prijavitelji, državami članicami, Evropsko agencijo za varnost hrane (EFSA) in Komisijo ter obveznosti vsake udeležene strani pri izvedbi programa, ne da bi to vplivalo na raven varovanja zdravja in okolja.
The resources of the EFSA should be used efficiently.
Sredstva EFSA je treba učinkovito uporabiti.
Where there are clear indications that the active substance concerned meets the criteria referred to in Article 5(1) of Directive 91/414/EEC, and in particular does not have any harmful effects on humans or animal health or on groundwater or any unacceptable influence on the environment, that substance should be included in Annex I to that Directive.
Kadar obstajajo jasni znaki, da zadevna aktivna snov izpolnjuje merila iz člena 5(1) Direktive 91/414/EGS ter zlasti nima nobenih škodljivih učinkov na zdravje ljudi ali živali ali na podtalnico oz. nobenega nesprejemljivega vpliva na okolje, je treba navedeno snov vključiti v Prilogo I k navedeni direktivi.
Such clear cases would not require detailed scientific advice from the EFSA before the substance is included in Annex I. The EFSA should, however, deliver its view on those substances later, in particular to ensure a harmonised approach when Member States apply the uniform principles at the evaluation of authorisations.
Za takšne jasne primere EFSA ni treba dati znanstvenega mnenja pred vključitvijo snovi v Prilogo I. Vendar pa mora EFSA svoje stališče o navedenih snoveh predložiti pozneje, zlasti za zagotovitev usklajenega pristopa držav članic pri uporabi enotnih načel za ocenjevanje registracij.
Where, on the contrary, there are clear indications that an active substance has harmful affects; the Commission is not required to have this clear situation confirmed, so it should have the possibility to decide on non-inclusion without consulting the EFSA.
Kadar pa v nasprotnem primeru obstajajo jasni znaki, da aktivna snov ima škodljive učinke, Komisiji ni treba zahtevati potrditve te jasne situacije, zato mora imeti možnost, da se odloči o nevključitvi brez posvetovanja z EFSA.
The EFSA should focus on cases where the remaining doubts need to be resolved before a decision on the inclusion of the active substance concerned can be taken.
EFSA se mora osredotočiti na primere, v katerih je treba razrešiti še obstoječe dvome, preden se lahko sprejme odločitev o vključitvi zadevne aktivne snovi.
To further speed up procedures, it should be possible to grant a longer withdrawal period in cases where there are such remaining doubts and notifiers agree to withdraw their support of the inclusion of the active substance.
Za nadaljnjo pospešitev postopkov je treba v primerih, v katerih še obstajajo takšni dvomi in se prijavitelji strinjajo z umikom svojega predloga za vključitev aktivne snovi, omogočiti daljše obdobje za umik.
This procedure should only apply to cases where there are no clear indications that the substance has harmful effects on humans or animal health or on groundwater or any unacceptable influence on the environment.
Ta postopek se lahko uporablja samo v primerih, v katerih ni jasnih znakov, da aktivna snov ima škodljive učinke na zdravje ljudi ali živali ali na podtalnico oz. kakršen koli nesprejemljiv vpliv na okolje.
To identify cases where there are clear indications of either a substance having no harmful effects or, on the contrary, a substance having such effects, criteria should be set out.
Določiti je treba merila za ugotavljanje primerov, v katerih obstajajo jasni znaki, da snov nima nobenih škodljivih učinkov ali, ravno nasprotno, da snov takšne učinke ima.
In order to ensure that the deadlines for evaluation are met, and to ensure equal treatment of all notifiers, the current legislation provides that notifiers may not submit new studies after a certain stage of the assessment, subject to limited exceptions.
Da se zagotovi upoštevanje rokov za oceno in enaka obravnava vseh prijaviteljev, prijavitelji v skladu s sedanjo zakonodajo, razen nekaterih izjem, po določeni fazi ocenjevanja ne smejo predložiti novih študij.
This general principle should be retained, but it is appropriate to clarify when notifiers may submit new information other than studies.
To splošno načelo je treba ohraniti, vendar je primerno razjasniti, v katerih primerih prijavitelji lahko predložijo nove informacije, ki niso študije.
Regulations (EC) No 1490/2002 and (EC) No 2229/2004 should therefore be amended accordingly.
Uredbo (ES) št. 1490/2002 in Uredbo (ES) št. 2229/2004 je zato treba ustrezno spremeniti.
Amendments to Regulation (EC) No 1490/2002
Spremembe Uredbe (ES) št. 1490/2002
Regulation (EC) No 1490/2002 is amended as follows:
Uredba (ES) št. 1490/2002 se spremeni:
Articles 11 and 12 are replaced by the following:
člena 11 in 12 se nadomestita z naslednjim:
Receipt of and access to the draft assessment report
Prejem in dostop do osnutka poročila o presoji
After receiving the updated summary dossier and the draft assessment report referred to in Article 10(1) the EFSA shall, within 30 days, acknowledge to the rapporteur Member State receipt of that report.
Po prejemu posodobljenega povzetka dokumentacije in osnutka poročila o presoji iz člena 10(1) EFSA državi članici poročevalki v 30 dneh potrdi prejem navedenega poročila.
In exceptional cases where the draft assessment report clearly does not fulfil the requirements concerning the format recommended by the Commission, the Commission shall agree with the EFSA and the rapporteur Member State on a period for resubmission of an amended report.
V izjemnih primerih, v katerih osnutek poročila o presoji očitno ne izpolnjuje zahtev glede oblike, ki jo priporoči Komisija, se Komisija z EFSA in državo članico poročevalko dogovori o obdobju za predložitev popravljenega poročila.
This period shall not exceed two months.
To obdobje ni daljše od dveh mesecev.
The EFSA shall without delay communicate the draft assessment report to the Commission, the other Member States and the notifiers setting a time period of no more than two months for the submission of comments by those Member States and the notifiers.
EFSA osnutek poročila o presoji brez odlašanja pošlje Komisiji, drugim državam članicam in prijaviteljem, pri čemer morajo navedene države članice in prijavitelji svoje pripombe predložiti najpozneje v dveh mesecih.
It shall collate the comments it receives, including available comments from the EFSA, and forward them to the Commission, Member States and the notifiers.
Prejete pripombe, vključno z razpoložljivimi pripombami EFSA, zbere in jih pošlje Komisiji, državam članicam in prijaviteljem.
The EFSA shall make available at specific request or keep available for consultation by any person the following:
EFSA na izrecno zahtevo vsem omogoči dostop do ali da na razpolago naslednje:
the draft assessment report except the elements thereof which have been accepted as confidential in accordance with Article 14 of Directive 91/414/EEC;
osnutek poročila o presoji, razen tistih delov osnutka, ki se v skladu s členom 14 Direktive 91/414/EGS obravnavajo kot zaupni;
the list of any data required for the evaluation in view of the possible inclusion of the active substance in Annex I to that Directive as finalised by the EFSA where it has finalised such a list.
seznam vseh podatkov, potrebnih za oceno glede na možno vključitev aktivne snovi v Prilogo I k navedeni direktivi, kot ga je dokončno oblikovala EFSA, v kolikor je takšen seznam oblikovala.
Examination of the draft assessment report
Pregled osnutka poročila o presoji
The Commission shall, without delay, examine the draft assessment report and the recommendation by the rapporteur Member State and the comments received from other Member States, the EFSA and from the notifiers in accordance with Article 11(2).
Komisija v skladu s členom 11(2) brez odlašanja pregleda osnutek poročila o presoji in priporočilo države članice poročevalke ter pripombe drugih držav članic, EFSA in prijaviteljev.
Active substance with clear indications that they do not have any harmful effects
Aktivne snovi z jasnimi znaki, da nimajo nobenih škodljivih učinkov
If there are clear indications that it may be expected that the active substance does not have any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment, as set out in Annex V, Article 12(1)(a) and (2)(a) shall apply.
Če obstajajo jasni znaki, da se lahko pričakuje, da aktivna snov nima nobenih škodljivih učinkov na zdravje ljudi ali živali ali na podtalnico oz. nobenega nesprejemljivega vpliva na okolje, kakor je določeno v Prilogi V, se uporabljata točki (1)(a) in (2)(a) člena 12.
Consultation of the EFSA
Posvetovanje z EFSA
Where Article 11b does not apply, the Commission may, at any time during the evaluation, ask the EFSA to carry out a peer review of the full draft assessment report or to focus on specific points including points related to criteria set out in Annex VI.
Kadar se člen 11b ne uporablja, lahko Komisija kadar koli med procesom ocenjevanja od EFSA zahteva, da izvede strokovni pregled celotnega osnutka poročila o presoji ali da se osredotoči na določene točke, vključno s točkami, povezanimi z merili iz Priloge VI.
The EFSA shall organise a consultation of Member States experts including the rapporteur Member State.
EFSA organizira posvetovanje s strokovnjaki držav članic, vključno z državo članico poročevalko.
Where the Commission requests the EFSA to carry out a full peer review, the EFSA shall deliver its conclusion at the latest six months after the request.
Kadar Komisija od EFSA zahteva, da izvede popoln strokovni pregled, EFSA svoj sklep predloži najpozneje šest mesecev po zahtevi.
Where the Commission does not request a full peer review, but only a conclusion on specific points, the period shall be reduced to three months.
Kadar Komisija ne zahteva popolnega strokovnega pregleda, temveč samo sklep o določenih točkah, se obdobje skrajša na tri mesece.
The submission of the conclusions shall in any event be no later than 30 September 2008.
Sklepi se v vsakem primeru predložijo najpozneje do 30. septembra 2008.
If during the peer review there are clear indications that an active substance is expected to have harmful effects on human or animal health or on groundwater as set out in Annex VI, the EFSA shall inform the Commission.
Če se med strokovnim pregledom odkrijejo jasni znaki, da se za aktivno snov lahko pričakuje, da ima škodljive učinke na zdravje ljudi ali živali ali na podtalnico, kot je določeno v Prilogi VI, EFSA o tem obvesti Komisijo.
The Commission may take a Decision as referred to in Article 11f.
Komisija lahko sprejme odločitev v skladu s členom 11f.
The Commission and the EFSA shall agree on a schedule for the delivery of the conclusions in order to facilitate the planning of the work.
Komisija in EFSA se dogovorita o časovnem razporedu predložitve sklepov, da se olajša načrtovanje dela.
The Commission and the EFSA shall agree on the format in which the conclusions of the EFSA are submitted.
Komisija in EFSA se dogovorita o obliki predložitve sklepov EFSA.
Submission of additional information after the draft assessment report has been submitted to the EFSA
Predložitev dodatnih informacij po predložitvi osnutka poročila o presoji EFSA
Without prejudice to Article 7 of Directive 91/414/EEC, submission of new studies shall not be accepted.
Brez poseganja v člen 7 Direktive 91/414/EGS se nove študije ne sprejemajo.
Where the EFSA considers that additional information from the notifier is necessary to comply with a request made by the Commission under Article 11c, the rapporteur Member State shall request that information.
Kadar EFSA meni, da mora prijavitelj poslati dodatne informacije za izpolnitev zahteve Komisije iz člena 11c, navedene informacije zahteva država članica poročevalka.
Such requests shall be made explicitly and in writing, setting a time period for submission of one month.
Takšni zahtevki morajo biti nedvoumni in v pisni obliki, predložiti pa jih je treba v enem mesecu.
They shall not concern the submission of new studies.
Ne zadevajo predložitev novih študij.
The rapporteur Member State shall inform the Commission and the EFSA of such requests in writing.
Država članica poročevalka Komisijo in EFSA pisno obvesti o takšnih zahtevkih.
The rapporteur Member State shall, within one month after the receipt of such information, evaluate the information received and send its evaluation to the EFSA.
Država članica poročevalka v enem mesecu po prejemu takšnih informacij oceni prejete informacije in oceno pošlje EFSA.
Information submitted by the notifier but which has not been requested, or which has not been submitted before the end of the time period referred to in paragraph 2, shall not be taken into account unless this information has been submitted in accordance with Article 7 of Directive 91/414/EEC.
Informacije, ki jih predloži prijavitelj, vendar niso bile zahtevane, ali ki niso bile predložene pred koncem obdobja iz odstavka 2, se ne upoštevajo, razen če se te informacije predložijo v skladu s členom 7 Direktive 91/414/EGS.
Where the rapporteur Member State, pursuant to paragraph 1 or to the first subparagraph of this paragraph, refuses to take into account studies or information received from the notifier, it shall inform the Commission and the EFSA and indicate the reasons for such refusal.
Kadar država članica poročevalka v skladu z odstavkom 1 ali prvim pododstavkom tega odstavka zavrne študije ali informacije, ki jih prejme od prijavitelja, o tem obvesti Komisijo in EFSA ter navede razloge za takšno zavrnitev.
Article 11e
Člen 11e
Withdrawal by notifier
Umik zahtevka prijavitelja
Where Article 11b does not apply, the notifier may withdraw his support of the inclusion of the active substance in Annex I to Directive 91/414/EEC within two months from receipt of the draft assessment report referred to in Article 11(2).
Kadar se člen 11b ne uporablja, lahko prijavitelj umakne svoj predlog za vključitev aktivne snovi v Prilogo I k Direktivi 91/414/EGS v dveh mesecih po prejemu osnutka poročila o presoji iz člena 11(2).
Article 11f
Člen 11f
Active substance for which there are clear indications of harmful effects
Aktivne snovi, za katere obstajajo jasni znaki škodljivih učinkov
If there are clear indications that it may be expected that the active substance has harmful effects on human or animal health or on groundwater as set out in Annex VI, the Commission shall take a Decision on the non-inclusion of the active substance in Annex I to Directive 91/414/EEC, in accordance with Article 12(1)(a) and (2)(b) of this Regulation.
Če obstajajo jasni znaki, da se lahko pričakuje, da aktivna snov ima škodljive učinke na zdravje ljudi ali živali ali na podtalnico, kot je določeno v Prilogi VI, Komisija v skladu s točkama (1)(a) in (2)(b) člena 12 te uredbe sprejme odločitev o nevključitvi aktivne snovi v Prilogo I k Direktivi 91/414/EGS.
Presentation of a draft directive or draft decision
Predložitev osnutka direktive ali osnutka odločbe
The Commission shall submit to the Committee a draft review report at the latest six months after:
Komisija Odboru predloži osnutek poročila o pregledu najpozneje šest mesecev po
receipt of the draft assessment report where Article 11b or Article 11f applies;
prejemu osnutka poročila o presoji, kadar se uporabljata člen 11b ali člen 11f;
receipt of the conclusion established by the EFSA where Article 11c applies;
prejemu sklepa EFSA, kadar se uporablja člen 11c;
receipt of a written withdrawal of the notifier’s support where Article 11e applies.
prejemu pisnega umika prijaviteljevega predloga, kadar se uporablja člen 11e.
Together with the draft review report the Commission shall submit to the Committee:
Komisija poleg osnutka poročila o pregledu Odboru predloži tudi:
a draft directive including the active substance in Annex I to Directive 91/414/EEC, setting out where appropriate the conditions, including the time limit, for such inclusion; or
osnutek direktive o vključitvi aktivne snovi v Prilogo I k Direktivi 91/414/EGS, ki po potrebi določa pogoje za takšno vključitev, vključno z obdobjem veljavnosti vključitve; ali
a draft decision addressed to the Member States requiring them to withdraw, within six months, the authorisations of plant protection products containing the active substance, pursuant to the fourth subparagraph of Article 8(2) of Directive 91/414/EEC, whereby that active substance is not included in Annex I to that Directive, mentioning the reasons for the non-inclusion.
osnutek odločbe, naslovljen na države članice, ki od njih zahteva, da v skladu s četrtim pododstavkom člena 8(2) Direktive 91/414/EGS v šestih mesecih umaknejo registracije fitofarmacevtskih sredstev, ki vsebujejo aktivno snov, kar pomeni, da navedena aktivna snov ni vključena v Prilogo I k navedeni direktivi, poleg tega pa navaja razloge za nevključitev.
The Directive or Decision shall be adopted in accordance with the procedure referred to in Article 19(2) of Directive 91/414/EEC.
Direktiva ali odločba sta sprejeti v skladu s postopkom iz člena 19(2) Direktive 91/414/EGS.
By way of derogation from paragraph 2(b), the latest date for Member States to withdraw authorisations shall be 31 December 2010 in the case referred to in paragraph 1(c) unless the Commission has concluded that the substance meets the criteria of Annex VI, if appropriate after having consulted the EFSA.
Z odstopanjem od točke (b) odstavka 2 države članice v primeru iz točke (c) odstavka 1 registracije umaknejo najpozneje do 31. decembra 2010, razen če Komisija sklene, da snov izpolnjuje merila iz Priloge VI, po potrebi po posvetovanju z EFSA.
View by the EFSA
Stališče EFSA
Where an active substance is included in Annex I to Directive 91/414/EEC pursuant to Article 11b of this Regulation, the Commission shall request the EFSA to deliver its view on the draft review report by 31 December 2010 at the latest.
Kadar je aktivna snov vključena v Prilogo I k Direktivi 91/414/EGS v skladu s členom 11b te uredbe, Komisija od EFSA zahteva, da najpozneje do 31. decembra 2010 predloži svoje stališče o osnutku poročila o pregledu.
Member States and notifiers shall cooperate with the EFSA and the Commission.
Države članice in prijavitelji sodelujejo z EFSA in Komisijo.
In order to facilitate the planning of the work, the Commission and the EFSA shall agree on a schedule for the delivery of the view of the EFSA on the draft review report and on the format in which that view is submitted.’
Komisija in EFSA se za olajšanje načrtovanja dela dogovorita o časovnem razporedu za predložitev stališča EFSA o osnutku poročila o pregledu ter o obliki predložitve navedenega stališča.“
The Annexes to Regulation (EC) No 1490/2002 are amended in accordance with Annex I to this Regulation.
Priloge k Uredbi (ES) št. 1490/2002 se spremenijo v skladu s Prilogo I k tej uredbi.
Amendments to Regulation (EC) No 2229/2004
Spremembe Uredbe (ES) št. 2229/2004
Regulation (EC) No 2229/2004 is amended as follows:
Uredba (ES) št. 2229/2004 se spremeni:
Articles 24 and 25 are replaced by the following:
člena 24 in 25 se nadomestita z naslednjim:
After receiving the updated summary dossier and the draft assessment report referred to in Article 21(1) or Article 22(1) the EFSA shall, within 30 days, acknowledge to the rapporteur Member State receipt of that report.
Po prejemu posodobljenega povzetka dokumentacije in osnutka poročila o presoji iz člena 21(1) ali člena 22(1) EFSA državi članici poročevalki v 30 dneh potrdi prejem poročila.
It shall collate the comments it receives, including available comments from the EFSA, and forward them to the Commission, the Member States and the notifiers.
Prejete pripombe, vključno z razpoložljivimi pripombami EFSA, zbere in jih pošlje Komisiji, državam članicam in prijaviteljem.
Evaluation of the draft assessment report
Ocena osnutka poročila o presoji
The Commission shall, without delay, examine the draft assessment report and the recommendation by the rapporteur Member State and the comments received from other Member States, the EFSA and from the notifiers in accordance with Article 24(2).
Komisija v skladu s členom 24(2) brez odlašanja pregleda osnutek poročila o presoji in priporočilo države članice poročevalke ter pripombe, ki jih prejme od drugih držav članic, EFSA in prijaviteljev.
Active substances with clear indications that they do not have any harmful effects
Aktivne snovi z jasnimi znaki, da nimajo nobenih škodljivih učinkov
If there are clear indications that it may be expected that the active substance does not have any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment, as set out in Annex VI, Article 25(1)(a) and (2)(a) shall apply.
Če obstajajo jasni znaki, da se lahko pričakuje, da aktivna snov nima nobenih škodljivih učinkov na zdravje ljudi ali živali ali na podtalnico oz. nobenega nesprejemljivega vpliva na okolje, kakor je določeno v Prilogi VI, se uporabljata točki (1)(a) in (2)(a) člena 25.
Where Article 24b does not apply, the Commission may, at any time during the evaluation, ask the EFSA to carry out a peer review of the full draft assessment report, or to focus on specific points including points related to criteria set out in Annex VII.
Kadar se člen 24b ne uporablja, lahko Komisija kadar koli med procesom ocenjevanja od EFSA zahteva, da izvede strokovni pregled celotnega osnutka poročila o presoji ali da se osredotoči na določene točke, vključno s točkami, povezanimi z merili iz Priloge VII.
If during the peer review there are clear indications that an active substance is expected to have harmful effects on human or animal health or on groundwater as set out in Annex VII, the EFSA shall inform the Commission.
Če se med strokovnim pregledom odkrijejo jasni znaki, da se za aktivno snov lahko pričakuje, da ima škodljive učinke na zdravje ljudi ali živali ali na podtalnico, kot je določeno v Prilogi VII, EFSA o tem obvesti Komisijo.
The Commission may take a Decision as referred to in Article 24f.
Komisija lahko sprejme odločitev v skladu s členom 24f.
Without prejudice to Article 7 of Directive 91/414/EEC submission of new studies shall not be accepted.
Brez poseganja v člen 7 Direktive 91/414/EGS se nove študije ne sprejemajo.
Where the EFSA considers that additional information from the notifier is necessary to comply with a request made by the Commission under Article 24c, the rapporteur Member State shall request that information.
Kadar EFSA meni, da mora prijavitelj poslati dodatne informacije za izpolnitev zahteve Komisije iz člena 24c, navedene informacije zahteva država članica poročevalka.
Where Article 24b does not apply, the notifier may withdraw his support of the inclusion of the active substance in Annex I to Directive 91/414/EEC within two months from receipt of the draft assessment report referred to in Article 24(2).
Kadar se člen 24b ne uporablja, lahko prijavitelj umakne svoj predlog za vključitev aktivne snovi v Prilogo I k Direktivi 91/414/EGS v dveh mesecih po prejemu osnutka poročila o presoji iz člena 24(2).
If there are clear indications that it may be expected that the active substance has harmful effects on human or animal health or on groundwater as set out in Annex VII the Commission shall take a Decision on the non-inclusion of the active substance in Annex I to Directive 91/414/EEC, in accordance with Article 25(1)(a) and (2)(b) of this Regulation.
Če obstajajo jasni znaki, da se lahko pričakuje, da aktivna snov ima škodljive učinke na zdravje ljudi ali živali ali na podtalnico, kot je določeno v Prilogi VII, Komisija v skladu s točkama (1)(a) in (2)(b) člena 25 te uredbe sprejme odločitev o nevključitvi aktivne snovi v Prilogo I k Direktivi 91/414/EGS.
receipt of the draft assessment report where Article 24b or Article 24f applies;
prejemu osnutka poročila o presoji, kadar se uporabljata člen 24b ali člen 24f;