natgillin/translations-raw huggingface dataset:
za vsako točko zahtev po podatkih o fitofarmacevtskih sredstvih iz člena 75(1)(b) povzetke in rezultate preskusov in študij, ime njihovega lastnika ter osebe ali zavoda, ki je izvajal preskuse in študije, ki so povezani z ocenjevanjem meril iz člena 4 za eno ali več fitofarmacevtskih sredstev, reprezentativnih za rabe iz točke (a), ob upoštevanju dejstva, da lahko manjkajoči podatki v dokumentaciji, kot je določeno v odstavku 2, ki so rezultat predlaganega omejenega obsega reprezentativnih rab aktivne snovi, privedejo do omejitev odobritve ;
(c) for each point of the data requirements for the plant protection product referred to in Article 75(1)(b) , the summaries and results of tests and studies, the name of their owner and of the person or institute that carried out the tests and studies, relevant to the assessment of the criteria referred to in Article 4 for one or more plant protection products which are representative of the uses referred to in point (a), taking into account the fact that data gaps in the dossier, as provided for in paragraph 2, resulting from the proposed limited range of representative uses of the active substance, may lead to restrictions in the approval;
(c) za vsako točko zahtev po podatkih o fitofarmacevtskih sredstvih iz odstavka 3 povzetke in rezultate poskusov in študij, ime njihovega lastnika ter osebe ali zavoda, ki je izvajal poskuse in študije, ki so povezani z ocenjevanjem meril iz člena 4 za eno ali več fitofarmacevtskih sredstev, reprezentativnih za rabe iz točke (a), ob upoštevanju dejstva, da zaradi katerih koli manjkajočih podatkov v dokumentaciji, kot je določeno v odstavku 2, ki so rezultat predlaganega omejenega obsega reprezentativnih rab aktivne snovi, aktivna snov ni odobrena ;
(c) for each point of the data requirements for the plant protection product referred to in paragraph 3 , the summaries and results of tests and studies, the name of their owner and of the person or institute that carried out the tests and studies, relevant to the assessment of the criteria referred to in Article 4 for one or more plant protection products which are representative of the uses referred to in point (a), taking into account the fact that any data gaps in the dossier, as provided for in paragraph 2, resulting from the proposed limited range of representative uses of the active substance, shall lead to non-approval of the active substance ;
Dokumentacijo z nepopolnimi ali napačnimi podatki je treba zavrniti.
Dossiers with incomplete or wrong information should be rejected.
Člen 8, odstavek 1, točka (c a) (novo)
Article 8, paragraph 1, point (c a) (new)
(ca) za vsak poskus ali študijo, ki vključuje vretenčarje, utemeljitev ukrepov, sprejetih za preprečitev poskusov na živalih in podvajanja poskusov na vretenčarjih;
(ca) for each test or study involving vertebrate animals, a justification of the steps taken to avoid animal testing and duplicative testing on vertebrate animals;
Da bi poskuse na živalih za namene te uredbe čim bolj omejili, morajo zahtevki vsebovati tudi obrazložitev ukrepov, ki jih je prosilec uvedel, da bi omejil poskuse na živalih.
In order to facilitate that animal testing for the purposes of this Regulation is kept to an absolute minimum, applications should also be required to provide a justification of the steps taken to avoid animal testing in general.
Popolna dokumentacija vključuje celotno besedilo poročil o posameznih poskusih in študijah v zvezi z vsemi informacijami iz odstavkov 1(b) in (c).
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.
Ne vključuje poročil o preskusih ali študijah, ki vključujejo namerno uporabo aktivne snovi ali fitofarmacevtskega sredstva pri človeku.
It shall not contain any reports of tests or studies involving the deliberate administration of the active substance or the plant protection product to humans.
Vse razpoložljive podatke je treba predložiti in oceniti.
All available data must be submitted and assessed.
Zahteve po podatkih iz člena 8(1) se opredelijo v uredbah, ki se sprejmejo v skladu s postopkom iz člena 76(2), skupaj z vključitvijo zahtev za aktivne snovi in fitofarmacevtska sredstva v prilogi II in III k Direktivi 91/414/EGS s kakršnimi koli potrebnimi spremembami.
The data requirements referred to in Article 8(1) shall be defined in Regulations adopted in accordance with the procedure referred to in Article 76(2), incorporating the requirements for active substances and plant protection products in Annexes II and III to Directive 91/414/EEC with any necessary modifications.
Podobne zahteve po podatkih se opredelijo za varovala in sinergiste v skladu s postopkom iz člena 76(3) .
Similar data requirements shall be defined for safeners and synergists in accordance with the procedure referred to in Article 76(3) .
Zahteve po podatkih iz odstavka 1 se določijo v uredbah, ki se sprejmejo v skladu s postopkom iz člena 76(2), skupaj s prenosom zahtev za aktivne snovi in fitofarmacevtska sredstva v prilogi II in III k Direktivi 91/414/EGS s kakršnimi koli spremembami , potrebnimi zaradi spremembe direktive v uredbo .
The data requirements referred to in paragraph 1 shall be laid down in Regulations adopted in accordance with the advisory procedure referred to in Article 76(2) , transferring the requirements for active substances and plant protection products in Annexes II and III to Directive 91/414/EEC with any modifications necessary due to the change from a directive to a regulation .
Podobne zahteve po podatkih se opredelijo za varovala in sinergiste v skladu s postopkom iz člena 251 Pogodbe .
Similar data requirements shall be defined for safeners and synergists in accordance with the procedure referred to in Article 251 of the Treaty.
Sprejetje uredbe o zahtevah po podatkih v postopku svetovanja bi se moralo omejiti zgolj na prenos obstoječih zahtev.
The adoption of a regulation on the data requirements in the advisory procedure should be limited to a mere transfer of existing requirements.
S tem se zagotovi potrebna osnova za oceno aktivnih snovi po prehodu s trenutno veljavne direktive na novo uredbo.
This ensures that the necessary basis for the evaluation of active substances is provided following the transition from the current directive to the new regulation.
Vlagatelj dokumentaciji priloži vso strokovno pregledano javno dostopno znanstveno literaturo o aktivnih snoveh in njihovih metabolitih v zvezi z negativnimi stranskimi učinki na zdravje, okolje in neciljne vrste.
All scientific peer-reviewed open literature on the active substance and its metabolites regarding negative side-effects on health, the environment and non-target species shall be added by the applicant to the dossier.
Vlagatelj mora zbrati in povzeti vso razpoložljivo znanstveno literaturo o posamezni snovi.
The applicant must have the obligation to collect and summarise all scientific literature on the substance.
To bo koristilo nepričakovanim učinkom pri čebelah, ki niso odkriti pri oceni tveganja, ampak so vsesplošno dokazani v znanstveni literaturi.
This will benefit unexpected effects in bees that are not detected in the risk assessment but are widely documented in the scientific literature.
Kadar manjka eden ali več elementov iz člena 8, države članice o tem obvestijo vlagatelja in določijo rok za njihovo predložitev.
Where one or more of the elements provided for in Article 8 are missing, the Member State shall inform the applicant, setting a time period for their submission.
Kadar manjka eden ali več elementov iz člena 8, države članice o tem obvestijo vlagatelja in določijo rok za njihovo predložitev , ki ne presega treh mesecev .
Where one or more of the elements provided for in Article 8 are missing, the Member State shall inform the applicant, setting a time period of no longer than three months for their submission.
Uporablja se člen 7(3).
Article 7(3) shall apply .
Treba je določiti rok za dodajanje manjkajočih podatkov.
The period of time to add to the missing elements should be specified.
Obveščene države članice spoštujejo iste ravni zaščite podatkov in zaupnosti kot država članica poročevalka.
The notified Member States shall respect the same levels of data protection and confidentiality as the rapporteur Member State .
Država članica poročevalka lahko začne z ocenjevanjem poročil o poskusih in študijah, takoj ko jih predloži vlagatelj, med drugim tudi pred datumom uradnega obvestila iz prvega pododstavka člena 9(3).
The rapporteur Member State may start the evaluation of test and study reports as soon as they are submitted by the applicant, including before the date of the notification provided for in the first subparagraph of Article 9(3).
V dvanajstih mesecih po datumu uradnega obvestila iz prvega pododstavka člena 9(3) država članica poročevalka pripravi in Agenciji predloži poročilo (v nadaljnjem besedilu „osnutek poročila o oceni“), v katerem oceni, ali je verjetno, da bo aktivna snov izpolnila zahteve iz člena 4.
Within twelve months of the date of the notification provided for in the first subparagraph of Article 9(3), the rapporteur Member State shall prepare and submit to the Authority a report (hereafter called “draft assessment report”) assessing whether the active substance can be expected to meet the requirements of Article 4.
Če država članica potrebuje dodatne informacije, določi rok, v katerem jih mora vlagatelj predložiti.
Where the Member State needs additional information, it shall set a time period for the applicant to supply it.
V tem primeru se obdobje dvanajstih mesecev podaljša za dodatno časovno obdobje, ki ga odobri država članica.
In that case, the twelve-month period shall be extended by the additional time period granted by the Member State.
O tem obvesti Komisijo in Agencijo.
It shall inform the Commission and the Authority.
Država članica se lahko posvetuje z Agencijo.
The Member State may consult the Authority.
Če država članica potrebuje dodatne informacije, določi razumen rok, v katerem jih mora vlagatelj predložiti skupaj z morebitnimi zahtevami v zvezi z varstvom podatkov v skladu s členom 56 .
Where the Member State needs additional information, it shall set a reasonable time period for the applicant to supply it along with any claims for data protection pursuant to Article 56 .
Pri predložitvi dodatnih informacij vlagatelj hkrati vloži vse zahtevke za varstvo podatkov v skladu s členom 56.
When supplying additional information, the applicant shall at the same time submit any claims for data protection pursuant to Article 56.
Uporablja se člen 7(3).
Article 7(3) shall apply.
Začetek ocenjevanja razpoložljivih informacij še preden je dokumentacija popolna bo pospešilo dostop novih in inovativnih sredstev v promet.
Starting the evaluation of available information before the dossier is complete will speed up access of new, innovative products to the market.
Država članica poročevalka zato ne bi smela porabiti več kot osem mesecev za izdajo svojega poročila o pregledu, čim bo ocenjevanje trenutnih aktivnih snovi v skladu z Direktivo 91/414/EGS zaključeno.
Therefore it should not take more than eight months for the rapporteur Member State to issue its review report once the evaluation of the current active substances under Directive 91/414/EEC is completed.
Potreben je mehanizem za zahtevanje varstva podatkov za dodatne informacije.
There needs to be a mechanism for claiming data protection for additional information .
Člen 12, odstavek 1, pododstavek 3
Article 12, paragraph 1, subparagraph 3
Agencija dovoli obdobje devetdesetih dni za predložitev pisnih pripomb.
The Authority shall allow a period of ninety days for the submission of written comments.
Agencija dovoli obdobje šestdesetih dni za predložitev pisnih pripomb.
The Authority shall allow a period of sixty days for the submission of written comments.
Za zagotovitev visoke ravni zdravstvenega varstva ljudi in varstva okolja je priporočljivo čim bolj zmanjšati trajanje postopka odobritve za nove snovi, varovala, sinergiste in pomožne snovi v formulaciji (brez poseganja v merila za ocenjevanje).
In order to ensure a high level of protection for human health and the environment, it is advisable to reduce as far as possible the duration of the approval procedure for new active substances, safeners, synergists and co-formulants (without prejudice to the evaluation criteria).
To bo omogočilo hitrejši začetek uporabe novih fitofarmacevtskih sredstev z manjšim učinkom na zdravje ljudi in živali ter na okolje.
This will enable new plant protection products with a lower impact on human and animal health and the environment to be put into use more quickly.
Agencija sprejme sklep o tem, ali se pričakuje, da bo aktivna snov izpolnila pogoje iz člena 4 v devetdesetih dneh od konca obdobja iz odstavka 1 tega člena, ter o tem obvesti vlagatelja, države članice in Komisijo.
The Authority shall adopt a conclusion on whether the active substance can be expected to meet the requirements of Article 4 within ninety days of the end of the period provided for in paragraph 1 of this Article and communicate it to the applicant, the Member States and the Commission.
Agencija sprejme ustrezno utemeljen sklep o tem, ali se pričakuje, da bo aktivna snov izpolnila pogoje iz člena 4 v devetdesetih dneh od konca obdobja iz odstavka 1 tega člena z ustrezno utemeljitvijo, vključno z navedbo pripomb javnosti, ki jih bo upoštevala, ter o tem obvesti vlagatelja, države članice in Komisijo.
The Authority shall adopt a conclusion on whether the active substance can be expected to meet the requirements of Article 4 within ninety days of the end of the period provided for in paragraph 1 of this Article , with due justification, including a reference to the consideration of any public comments, and communicate it to the applicant, the Member States and the Commission.
Agencija sklep objavi v enem tednu po sprejetju.
The conclusion shall be published by the Authority within one week after its adoption.
Preglednost postopka je treba povečati.
The transparency of the procedure should be increased
Agencija po potrebi v sklepih obravnava možnosti za zmanjševanje tveganja, določene v osnutku poročila o oceni .
Where appropriate, the Authority shall address in its conclusion the risk mitigation options identified in the draft assessment report.
Če Agencija potrebuje dodatno posvetovanje s strokovnjaki, kot je določeno v odstavku 1, določi rok za zaključek posvetovanja.
Where the Authority needs additional consultations with experts as provided for in paragraph 1, it shall set a time period for concluding the consultations.
V tem primeru se obdobje devetdesetih dni podaljša za dodatno obdobje, ki ga odobri Agencija.
In that case, the ninety-day period shall be extended by the additional period granted by the Authority.
O tem obvesti Komisijo in države članice.
It shall inform the Commission and the Member States .
Če je za zaključek posvetovanja potrebno več časa, bi moralo biti podaljšanje navedenega obdobja jasno navedeno.
If more time to conclude consultations is required the extension of the captioned period should be clearly indicated.
Če Agencija potrebuje dodatne informacije, določi rok, v katerem jih mora vlagatelj predložiti.
Where the Authority needs additional information, it shall set a time period for the applicant to supply it.
V tem primeru se obdobje devetdesetih dni iz odstavka 2 podaljša za dodatno obdobje, ki ga odobri Agencija.
In that case, the ninety-day period provided for in paragraph 2 shall be extended by the additional period granted by the Authority.
O tem obvesti Komisijo in države članice.
It shall inform the Commission and the Member States.
V tem primeru se obdobje šestdesetih dni iz odstavka 2 podaljša za dodatno obdobje, ki ga odobri Agencija , in za čas, ki ga država članica poročevalka potrebuje za oceno teh informacij v svojem osnutku poročila o oceni .
In that case, the sixty-day period provided for in paragraph 2 shall be extended by the additional period granted by the Authority and by the time necessary for the evaluation of that information by the rapporteur Member State in its draft assessment report .
Agencija o tem obvesti Komisijo in države članice.
The Authority shall inform the Commission and the Member States.
EFSA ima pomemben vpliv na oceno aktivnih snovi, saj sprejme sklep o njihovi odobritvi oz. tega ne stori.
EFSA plays a key role in the assessment of active substances, as it will adopt a conclusion on its approval or not.
EFSA je treba za izvedbo natančne ocene zagotoviti dovolj časa.
It is important to ensure that EFSA has enough time to perform a rigorous assessment.
Trenutno ima EFSA na voljo 10 mesecev za sprejem sklepa.
Currently, EFSA has 10 months to adopt a conclusion.
Te informacije bi morala nato oceniti država članica poročevalka, saj najbolje pozna dokumentacijo
This information should then be assessed by the rapporteur Member State, as it is most familiar with the dossier.
Člen 12, odstavek 3, pododstavek 1 a (novo)
Article 12, paragraph 3, subparagraph 1 a (new)
Če mora Agencija organizirati posvetovanje strokovnjakov, se obdobje devetdesetih dni iz odstavka 2 podaljša za čas, ki je potreben za to posvetovanje.
Where the Authority needs to organise consultations of experts, the ninety-day period provided for in paragraph 2 shall be extended by the time necessary for these consultations.
V šestih mesecih po prejemu sklepa Agencije iz člena 12(2) Komisija Odboru iz člena 76(1) predloži poročilo (v nadaljnjem besedilu „poročilo o pregledu“) ob upoštevanju osnutka poročila o oceni, ki ga oblikuje država članica poročevalka v skladu s členom 11, in sklepa Agencije v skladu s členom 12.
Within six months of receiving the conclusion provided for in Article 12(2) from the Authority, the Commission shall present a report, (herinafter referred to as “the review report”, to the Committee referred to in Article 76(1), taking into account the draft assessment report by the Rapporteur Member State under Article 11 and the conclusion of the Authority under Article 12.
V treh mesecih po prejemu sklepa Agencije iz člena 12(2) Komisija Odboru iz člena 76(1) predloži poročilo (v nadaljnjem besedilu „poročilo o pregledu“) ob upoštevanju osnutka poročila o oceni, ki ga oblikuje država članica poročevalka v skladu s členom 11, in sklepa Agencije v skladu s členom 12.
Within three months of receiving the conclusion provided for in Article 12(2) from the Authority, the Commission shall present a report, (herinafter referred to as “the review report”, to the Committee referred to in Article 76(1), taking into account the draft assessment report by the Rapporteur Member State under Article 11 and the conclusion of the Authority under Article 12.
Komisija ne potrebuje pol leta, da sestavi poročilo o dokumentaciji, ki je že bila v celoti pregledana.
The Commission does not need half a year to draft a report on a fully examined dossier.
Postopek je treba pospešiti.
The procedure needs to be accelerated.
Člen 13, odstavek 1, pododstavek 2
Article 13, paragraph 1, subparagraph 2
Vlagatelj ima možnost predložiti pripombe na poročilo o pregledu.
The applicant shall be given the possibility to submit comments on the review report.
Vlagatelj in vsi, ki so predložili pisne pripombe v skladu s postopkom iz člena 12(1), imajo možnost predložiti pripombe na poročilo o pregledu.
The applicant and any others who have submitted written comments under the procedure provided for in Article 12 (1) shall be given the opportunity to submit comments on the review report.
Poročilo o pregledu se objavi in posreduje Evropskemu parlamentu.
The review report shall be available to the public and forwarded to the European Parliament.
Preglednost postopka je treba povečati.
The transparency of the procedure should be increased.
Za zagotovitev visoke ravni varovanja zdravja ljudi in varstva okolja je priporočljivo čim bolj zmanjšati trajanje postopka odobritve za nove snovi, varovala, sinergiste in pomožne snovi v formulaciji (brez poseganja v merila za ocenjevanje).
In order to ensure a high level of protection for human health and the environment, it is advisable to reduce as far as possible the duration of the approval procedure for new active substances, safeners, synergists and co-formulants (without prejudice to the evaluation criteria).
Člen 13, odstavek 2, uvodni del in točka (a)
Article 13, paragraph 2, introduction and point (a)
Na podlagi poročila o pregledu iz odstavka 1, drugih dejavnikov, povezanih z obravnavano zadevo, in previdnostnega načela, kadar so izpolnjeni pogoji iz člena 7(1) Uredbe (ES) št. 178/2002, se Uredba sprejme v skladu s postopkom iz člena 76(3) , če:
On the basis of the review report provided for in paragraph 1, other factors legitimate to the matter under consideration and the precautionary principle where the conditions laid down in Article 7(1) of Regulation (EC) No 178/2002 are relevant, a Regulation shall be adopted in accordance with the procedure referred to in Article 76(3), providing that:
Na podlagi poročila o pregledu iz odstavka 1, drugih dejavnikov, povezanih z obravnavano zadevo, in previdnostnega načela, kadar so izpolnjeni pogoji iz člena 7(1) Uredbe (ES) št. 178/2002, se uredba z ustrezno utemeljitvijo sprejme v skladu z regulativnim postopkom s pregledom iz člena 76(3a) , če:
On the basis of the review report provided for in paragraph 1, other factors legitimate to the matter under consideration and the precautionary principle where the conditions laid down in Article 7(1) of Regulation (EC) No 178/2002 are relevant, a Regulation with due justification shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 76(3a) , providing that:
(a) je aktivna snov odobrena pod pogoji in omejitvami iz člena 6, kadar je to primerno;
(a) an active substance is approved, subject to conditions and restrictions, as referred to in Article 6, where appropriate;
(a) je aktivna snov odobrena pod pogoji in omejitvami iz člena 6, kadar je to primerno , in vključena v Prilogo IIa ;
(a) an active substance is approved, subject to conditions and restrictions, as referred to in Article 6, where appropriate, and included in Annex IIa;
Treba je ohraniti vključitev odobrenih snovi v prilogo uredbe.
Therefore the inclusion of approved substances in an Annex of the Regulation should be maintained.
Komisija vodi seznam odobrenih aktivnih snovi.
The Commission shall maintain a list of approved active substances.
Komisija vodi posodobljeni seznam odobrenih aktivnih snovi v Prilogi IIa in ta seznam ga objavi na internetu .
The Commission shall maintain an updated list of approved active substances in Annex IIa and publish this list on the Internet .
Obnovitev se odobri za nedoločen čas.
The renewal shall be for an unlimited period of time.
Odobritev se lahko enkrat ali večkrat obnovi za največ deset let.
The approval may be renewed once or repeatedly for a period not exceeding 10 years .
V predlaganem besedilu podaljšanje registracije, o čemer odločajo države članice, sledi obnovitvi odobritve aktivne snovi (člen 43(6)).
In the proposed text the renewal of the authorisation by the Member State follows the renewal of the active substance (Article 43(6)).
To pomeni, da bi bila tudi registracija po prvem podaljšanju načeloma časovno neomejena.
This implies that also the authorisation would in principle be unlimited in time, after the first renewal.
To je v nasprotju s previdnostnim načelom, načelom, da se odločitve sprejema ob upoštevanju najnovejših znanstvenih dognanj in tehničnih dosežkov, kot je opredeljeno v členu 4(1) predlaganega besedila, in načelom, da je treba ohranjati visok standard varstva (uvodna izjava 21).
This is contrary to the precautionary principle and to the principle that decisions are made in the light of current scientific and technical knowledge, as is laid down in Article 4(10) of the proposed text, and the principle that a high standard of protection must be ensured (recital 21).