natgillin/translations-raw huggingface dataset:
The Commission shall publish, for each active substance, the names and the addresses of the notifiers concerned.
Komisija za vsako aktivno snov objavi imena in naslove zadevnih prijaviteljev
By 31 August 2008 at the latest, the notifiers concerned shall submit the following to the rapporteur Member State and the co-rapporteur Member State:
Zadevni prijavitelji predložijo do 31. avgusta 2008 državi članici poročevalki in državi članici soporočevalki:
a copy of the notification and, in the case of a joint notification in accordance with Article 4(2), the name of the person designated by the producers concerned as being responsible for the joint dossier and the processing of the dossier in accordance with this Regulation;
izvod prijave in, v primeru skupne prijave v skladu s členom 4(2), ime osebe, ki jo zadevni proizvajalci imenujejo kot odgovorno za skupno dokumentacijo in obravnavo dokumentacije v skladu s to uredbo;
any new data compared to the original dossier relevant to the active substance and any new risk assessments to reflect changes in data requirements under Annexes II and III to Directive 91/414/EEC, or any changes in scientific and technical knowledge since the active substance concerned was first included in Annex I to Directive 91/414/EEC;
nove podatke, ki so glede na prvotno dokumentacijo pomembni za aktivno snov, in ocene tveganj za ustrezen odziv na spremembe zahtevanih podatkov iz prilog II in III k Direktivi 91/414/EGS ali spremembe znanstvenega ali tehničnega znanja od prve uvrstitve aktivne snovi v Prilogo I k Direktivi 91/414/EGS;
a checklist demonstrating that the dossier is complete, indicating which data are new.
spremni seznam, ki potrjuje popolnost dokumentacije in navaja, kateri podatki so novi.
Where the dossier contains studies which are more recent than those found in the original dossier, the notifier must explain for each new study why it is relevant.
Če dokumentacija vsebuje študije, ki so novejše od študij iz prvotne dokumentacije, mora prijavitelj za vsako novo študijo razložiti, zakaj je pomembna.
The range of uses submitted should reflect a representative use pattern.
Predložene vrste uporab morajo odražati reprezentativni vzorec uporabe.
The data submitted by the notifier shall demonstrate that, for one or more preparations, the active substance meets the requirements set out in Article 5(1) of Directive 91/414/EEC.
Prijavitelj na podlagi predloženih podatkov dokaže, da za enega ali več pripravkov aktivna snov izpolnjuje zahteve iz člena 5(1) Direktive 91/414/EGS.
Where for an active substance listed in Annex I there are several notifications, the notifiers concerned shall take all reasonable steps to submit the data collectively.
Če je za aktivno snov iz Priloge I več prijav, zadevni prijavitelji storijo vse, kar je v njihovi moči, da skupaj predložijo podatke.
Where the data are not submitted jointly by all notifiers concerned, the notification shall mention the efforts made and the reasons why certain notifiers have not participated.
Če podatkov ne predložijo skupaj vsi zadevni prijavitelji, se v prijavi navedejo vsa prizadevanja in razlogi, zakaj nekateri prijavitelji niso sodelovali.
For active substances notified by more than one notifier, those notifiers shall for each study involving vertebrate animals, give detailed explanation on the attempts made to avoid duplication of testing and give, if applicable, the reasons and a justification for conducting a duplicate study.
Za aktivne snovi, ki jih prijavi več kot en prijavitelj, ti prijavitelji za vsako študijo, ki vključuje vretenčarje, podrobno razložijo prizadevanja za preprečitev podvajanja testiranja in po potrebi navedejo razloge in utemeljitev za izvedbo dvojnih študij.
If requested by the Authority or a Member State, the notifier shall make available the original dossier and subsequent updates submitted for the first inclusion in Annex I to Directive 91/414/EEC.
Na zahtevo Agencije ali države članice prijavitelj da na voljo prvotno dokumentacijo in naknadne ugotovitve, predložene za prvo uvrstitev v Prilogo I k Direktivi 91/414/EGS.
Subsequent submission
Naknadna predložitev
Without prejudice to Article 7 of Directive 91/414/EEC, the rapporteur Member State shall not accept the submission of additional information after 31 August 2008.
Brez poseganja v člen 7 Direktive 91/414/EGS država članica poročevalka ne sprejme predložitve dodatnih informacij po 31. avgustu 2008.
By way of derogation from paragraph 1, the rapporteur Member State may request additional information setting a time period for its submission ending on 31 March 2009 at the latest.
Z odstopanjem od odstavka 1 lahko država članica poročevalka zahteva dodatne informacije in določi rok za njihovo predložitev, ki je najpozneje 31. marca 2009.
The rapporteur Member State shall inform the Commission and the Authority of any such request it makes.
Država članica poročevalka obvesti Komisijo in Agencijo o vsakem takem zahtevku.
Information which has not been requested, or which has not been submitted before 31 March 2009, shall not be taken into account.
Informacije, ki niso zahtevane ali ki niso predložene do 31. marca 2009, se ne upoštevajo.
The rapporteur Member State shall inform the Commission and the Authority of cases where it receives information from the notifier, which it is required not to take into account under the provisions of this article.
Država članica obvesti Komisijo in Agencijo, če od prijavitelja prejme informacije, ki jih v skladu z določbami tega člena ne sme upoštevati.
End of participation
Konec sodelovanja
When a notifier decides to end its participation in the renewal procedure for an active substance, he shall inform the rapporteur Member State, co-rapporteur Member State, the Commission and the other notifiers for the substance concerned, mentioning the reasons.
Če se prijavitelj odloči končati sodelovanje v postopku podaljšanja aktivne snovi, obvesti državo članico poročevalko, državo članico soporočevalko, Komisijo in druge prijavitelje zadevne snovi ter navede razloge.
Where a notifier ends his participation or fails to fulfil his obligations provided for in this Regulation, the procedures provided for in Articles 10 to 14 shall not be continued for his dossier.
Če prijavitelj konča svoje sodelovanje ali ne izpolni svojih obveznosti iz te uredbe, se postopki iz členov 10 do 14 v zvezi z njegovo dokumentacijo ne nadaljujejo.
In particular, where a notifier does not submit, where requested, the dossier referred to in Article 6(5), his participation will be considered to have ended.
Še zlasti, če prijavitelj na zahtevo ne predloži dokumentacije iz člena 6(5), se šteje, da se je njegovo sodelovanje končalo.
When a notifier agrees with another producer that the notifier shall be replaced for the purposes of further participation in the renewal procedure, the notifier and the other producer shall inform the rapporteur Member State, co-rapporteur Member State and the Commission by a common declaration, agreeing that the other producer shall replace the notifier in carrying out the duties under this Regulation.
Kadar se prijavitelj dogovori z drugim proizvajalcem, da prijavitelja nadomesti za nadaljnje sodelovanje v postopku podaljšanja, prijavitelj in drugi proizvajalec obvestita državo članico poročevalko, državo članico soporočevalko in Komisijo s skupno izjavo, v kateri izrazita soglasje, da drugi proizvajalec nadomesti prijavitelja pri izpolnjevanju obveznosti iz te uredbe.
They shall inform any other notifiers for the substance concerned at the same time.
Vse druge prijavitelje zadevne snovi obvestita istočasno.
In such a case, the other producer may be liable for any fees remaining payable under the regime established by the rapporteur Member State pursuant to Article 15.
V takšnem primeru je drugi proizvajalec lahko zavezan k plačilu kakršnih koli pristojbin, ki jih je treba poravnati v skladu s pravili, ki jih določi država članica poročevalka v skladu s členom 15.
Submission of information by third parties
Predložitev informacij s strani tretjih strank
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 by 31 May 2008 at the latest.
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 najpozneje do 31. maja 2008.
The rapporteur Member State shall submit without delay any information received to the Authority and the notifier.
Država članica poročevalka takoj predloži kakršne koli prejete informacije Agenciji in prijavitelju.
The notifier may send its comments on the submitted information to the rapporteur Member State at the latest by 31 August 2008.
Prijavitelj lahko pošlje svoje pripombe na predložene informacije državi članici poročevalki najpozneje 31. avgusta 2008.
Assessment by the rapporteur Member State
Ocena s strani države članice poročevalke
The rapporteur Member State shall assess the new data and risk assessments submitted under Article 6(1), 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 notifier in accordance with Article 9.
Država članica poročevalka oceni nove podatke in ocene tveganj, predložene v skladu s členom 6(1), 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 prijavitelja v skladu s členom 9.
The rapporteur Member State shall prepare an assessment report in consultation with the co-rapporteur Member State, setting out, where relevant, the points on which the co-rapporteur Member State did not agree.
Država članica poročevalka pripravi po posvetovanju z državo članico soporočevalko poročilo o oceni, v katerem po potrebi navede točke, s katerimi se država članica soporočevalka ni strinjala.
The report shall include a recommendation concerning the decision to be taken with regard to the renewal.
Poročilo vsebuje priporočilo o odločitvi glede podaljšanja.
The report shall also assess whether the new studies identified under Article 6(2) are relevant for the evaluation.
V poročilu se navede tudi, ali so nove študije iz člena 6(2) pomembne za oceno.
The rapporteur Member State shall send the assessment report to the Authority and the Commission by 31 May 2009 at the latest.
Država članica poročevalka pošlje poročilo o oceni Agenciji in Komisiji najpozneje do 31. maja 2009.
The report shall be submitted in the format defined in accordance with the procedure referred to in Article 19(2) of Directive 91/414/EEC.
Poročilo se pošlje v obliki, določeni v skladu s postopkom iz člena 19(2) Direktive 91/414/EGS.
The rapporteur Member State may consult the Authority and request additional technical or scientific information from other Member States.
Država članica poročevalka se lahko posvetuje z Agencijo in zahteva dodatne tehnične ali znanstvene informacije od drugih držav članic.
Access to the assessment report
Dostop do poročila o oceni
After receiving the assessment report the Authority shall communicate it to the other Member States and notifier(s) for comments.
Ko Agencija prejme poročilo o oceni, ga pošlje drugim državam članicam in prijavitelju(-em) za pripombe.
Such comments shall be sent to the Authority, which shall collate them and forward them to the Commission.
Pripombe se pošljejo Agenciji, ki jih zbere in posreduje Komisiji.
The Authority shall make the assessment report available on request or keep it available for consultation by any person, except the elements thereof which have been accepted as confidential in accordance with Article 14 of Directive 91/414/EEC.
Agencija omogoči kateri koli osebi na njeno zahtevo dostop do poročila o oceni ali ga hrani za vpogled, razen elementov, ki se štejejo kot zaupni v skladu s členom 14 Direktive 91/414/EGS.
Evaluation of the assessment report
Ovrednotenje poročila o oceni
The Commission shall evaluate the assessment report and the recommendation by the rapporteur Member State and the comments received.
Komisija ovrednoti poročilo o oceni in priporočilo države članice poročevalke ter prejete pripombe.
The Commission may consult the Authority.
Komisija se lahko posvetuje z Agencijo.
Such consultation may, if appropriate, include a request to arrange a peer review of the rapporteur Member State’s assessment report, to take the form of a conclusion on that report.
Takšno posvetovanje lahko po potrebi vključuje zahtevo po strokovnem pregledu poročila o oceni države članice poročevalke, na podlagi katerega se pripravi sklep o navedenem poročilu.
In cases where the Commission consults the Authority, the Authority shall deliver its response at the latest six months after receipt of that report.
Če se Komisija posvetuje z Agencijo, Agencija pošlje odgovor najpozneje šest mesecev po prejemu navedenega poročila.
The Commission and the Authority shall agree on a schedule for the delivery of the conclusions in order to facilitate the planning of the work.
Komisija in Agencija se dogovorita o časovnem razporedu priprave sklepov, da se olajša načrtovanje dela.
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, v kateri se predložijo sklepi Agencije.
Presentation of a draft directive or draft decision
Predstavitev osnutka direktive ali osnutka odločbe
Without prejudice to any proposal it may submit with a view to amending the Annex to Council Directive 79/117/EEC [2], the Commission shall, at the latest six months after receipt of the assessment report or the conclusion of the Authority, submit to the Committee a draft review report to be finalised at its meeting.That report shall be accompanied by one of the following:
Brez poseganja v kateri koli predlog Komisije za spremembo Priloge k Direktivi Sveta 79/117/EGS [2] Komisija najpozneje šest mesecev po prejemu poročila o oceni ali sklepa Agencije predloži Odboru osnutek poročila o pregledu, da se na njegovem sestanku pripravi končna različica.To poročilo spremlja eden od naslednjih aktov:
a draft directive to renew the inclusion of the active substance concerned in Annex I to Directive 91/414/EEC, setting out, where appropriate, the conditions and restrictions, including the period, for such inclusion; or
osnutek direktive za podaljšanje uvrstitve zadevne aktivne snovi v Prilogo I k Direktivi 91/414/EGS z navedbo, kadar je primerno, pogojev in omejitev, vključno z obdobjem, za takšno uvrstitev; ali
a draft decision addressed to the Member States to withdraw the authorisations of plant protection products containing the active substance concerned, whereby the inclusion of that active substance in Annex I to Directive 91/414/EEC is not renewed, setting out the reasons for the non-inclusion.
osnutek odločbe, naslovljene na države članice, za preklic registracij fitofarmacevtskih sredstev, ki vsebujejo zadevno aktivno snov, pri čemer se uvrstitev navedene aktivne snovi v Prilogo I k Direktivi 91/414/EGS ne podaljša, navedejo pa se razlogi za neuvrstitev.
The directive or decision referred to in paragraph 1 shall be adopted in accordance with the procedure referred to in Article 19(2) of Directive 91/414/EEC.
Direktiva ali odločba iz odstavka 1 se sprejme v skladu s postopkom iz člena 19(2) Direktive 91/414/EGS.
Access to 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 Directive 91/414/EEC, shall be made available for public consultation.
Končna različica poročila o pregledu, razen delov, ki se nanašajo na zaupne informacije iz dokumentacije in so kot takšne določene v skladu s členom 14 Direktive 91/414/EGS, se dajo na voljo za javno razpravo.
Member States shall establish a regime obliging the notifiers to pay a fee for the administrative treatment and the evaluation of notifications as well as the dossiers related thereto, which have been submitted to them in accordance with Article 4 or Article 6 in each case where the Member State has been designated as the rapporteur Member State or co-rapporteur Member State.
Države članice določijo pravila, po katerih morajo prijavitelji plačati pristojbino za upravno obravnavo in oceno prijav ter pripadajoče dokumentacije, ki so jim bile poslane v skladu s členom 4 ali 6, vedno, kadar je bila država članica imenovana za državo članico poročevalko ali državo članico soporočevalko.
Member States shall establish a specific fee for the evaluation of the notification.
Države članice določijo posebno pristojbino za oceno prijave.
For this purpose, the Member States and co-rapporteur Member States shall:
V ta namen države članice in države članice soporočevalke:
require the payment of a fee corresponding as far as possible to their costs in carrying out all the different procedures associated with the evaluation for each submission of a dossier, whether introduced by one notifier or collectively by several interested notifiers;
zahtevajo plačilo pristojbine, ki najbolje ustreza stroškom izvajanja vseh različnih postopkov v zvezi z oceno za vsako predložitev dokumentacije s strani enega prijavitelja ali s strani več zainteresiranih prijaviteljev;
ensure that the amount of the fee is established in a transparent manner with a view to corresponding to the real cost of the examination and administrative treatment of a notification and a dossier; however, Member States may provide for a scale of fixed charges based on average costs for the calculation of the total fee;
zagotovijo, da se pristojbina določi na pregleden način, tako da ustreza dejanskim stroškom pregleda in upravne obravnave prijave in dokumentacije; vendar lahko države članice za izračun celotne pristojbine sestavijo lestvico fiksnih taks na podlagi povprečnih stroškov;
ensure that the fee is received in accordance with the instructions given by the authority in each Member State listed in Annex II and that the income from the fee is used to finance exclusively the costs actually incurred by the rapporteur Member State and co-rapporteur Member State for the evaluation and administrative treatment of the notifications and the dossiers for which that Member State is rapporteur or co-rapporteur Member State or to finance general actions for the implementation of its obligations as rapporteur Member State and co-rapporteur Member State.
zagotovijo, da se pristojbina pobere v skladu z navodili organa vsake države članice, navedenega v Prilogi II, in da se prihodek od pristojbin uporabi izključno za financiranje dejanskih stroškov države članice poročevalke in države članice soporočevalke pri oceni in upravni obravnavi prijav in dokumentacije, za katere je država članica pristojna kot država članica poročevalka ali soporočevalka, ali financiranje splošnih ukrepov za izvajanje njihovih obveznosti kot država članica poročevalka in država članica soporočevalka.
Other charges, levies or fees
Druge takse, dajatve in pristojbine
Article 15 is without prejudice to Member States’ rights to maintain or introduce, in accordance with the Treaty, charges, levies or fees with regard to the authorisation, placing on the market, use and control of active substances and plant protection products other than the fee provided for in Article 15.
Člen 15 ne posega v pravice držav članic, da v skladu s Pogodbo obdržijo ali uvedejo takse, dajatve ali pristojbine za registracijo, dajanje v promet, uporabo in nadzor aktivnih snovi in fitofarmacevtskih sredstev, ki niso pristojbine iz člena 15.
List of active substances referred to in Article 1 and their rapporteur Member States and co-rapporteur Member States
Seznam aktivnih snovi iz člena 1 ter njihovih držav članic poročevalk in držav članic soporočevalk
Co-rapporteur Member State
Država članica soporočevalka
prohexadion-calcium
Proheksadion-kalcij
Coordinating authority in the Member States
Koordinacijski organi v državah članicah
Notification of an active substance according to Article 4
Prijava aktivne snovi v skladu s členom 4
The notification shall be made on paper and sent by registered mail to European Commission, DG Health and Consumer Protection, unit E3, B-1049 Brussels
Prijava se sestavi v papirni obliki in pošlje s priporočeno pošto na naslov: European Commission, DG Health and Consumer Protection, unit E3, B-1049 Bruselj, Belgija
The notification shall be submitted in accordance with the following model.
Prijava se predloži v skladu z naslednjim obrazcem.
MODEL
OBRAZEC
Identification data on the notifier
1 Podatki o prijavitelju
Name and address of the producer including the name of the natural person responsible for the notification and further engagements resulting from this Regulation:
Ime in naslov proizvajalca, vključno z imenom fizične osebe, odgovorne za prijavo in druge obveznosti, ki izhajajo iz te uredbe:
Alternative:
Namestnik:
Information to ensure identification
2 Podatki o aktivni snovi
Common name (proposed or ISO-accepted) specifying, where relevant, any variants thereof such as salts, esters or amines produced by the manufacturer:
Splošno ime snovi (predlagano ali sprejeto po ISO) z navedbo, kjer je primerno, vseh njenih variant, kot so soli, estri ali amini, ki jih proizvaja proizvajalec:
Chemical name (IUPAC and CAS nomenclature):
Kemijsko ime (po nomenklaturi IUPAC in CAS):
CAS, CIPAC and EEC numbers (if available):
Številke CAS, CIPAC in EEC (če so na voljo):
Empirical and structural formula, molecular mass:
Empirična in strukturna formula, molekulska masa:
Specification of purity of the active substance in g/kg or g/l as appropriate:
Opis čistote aktivne snovi v g/kg ali g/l, kar je ustrezno:
Classification and labelling of the active substance in accordance with the provisions of Council Directive 67/548/EEC [1] (health and environment effects).
Razvrstitev in označitev aktivne snovi v skladu z določbami Direktive Sveta 67/548/EGS [1] (učinki na zdravje in okolje).
The notifier confirms that the above information submitted on … (date) is honest and correct.
Prijavitelj potrjuje, da so zgoraj navedeni podatki, predloženi … (datum), resnični in točni.
Signature (of the person competent to act for the company mentioned under 1.1).
Podpis (zastopnika podjetja iz točke 1.1)
OJ 196, 16.8.1967, p. 13.
UL 196, 16.8.1967, str. 13.
Directive as last amended by Directive 2006/121/EC of the European Parliament and of the Council (OJ L 396, 30.12.2006, p. 850), as corrected by OJ L 136, 29.5.2007, p. 281.
Direktiva, kakor je bila nazadnje spremenjena z Direktivo 2006/121/ES Evropskega parlamenta in Sveta (UL L 396, 30.12.2006, str. 850. Popravljena različica v UL L 136, 29.5.2007, str. 281).
Criteria for the admissibility of notifications referred to in Article 4
Merila za sprejemljivost prijav iz člena 4
A notification shall only be considered admissible if the following conditions are satisfied:
Prijava se šteje za sprejemljivo samo, če:
it is presented within the time limit referred to in Article 4(1);
je oddana v roku iz člena 4(1);
it is introduced by a notifier who is a producer of an active substance listed in Annex I;
jo je predložil prijavitelj, ki je proizvajalec aktivne snovi iz Priloge I;
it is presented in the format as provided for in Annex III;
je sestavljena v obliki, določeni v Prilogi III;
a fee as referred to in Article 5 has been paid.
je pristojbina iz člena 15 plačana.
kresoxim-methyl
Kresoksim-metil
fluroxypyr
Fluroksipir
azoxystrobin
Azoksistrobin
spiroxamin
Spiroksamin
Commission Regulation (EC) No 738/2007
Uredba Komisije (ES) št. 738/2007