natgillin/translations-raw huggingface dataset:
Uniform principles for evaluation and authorisation of plant protection products shall contain the requirements set out in Annex VI to Directive 91/414/EEC and shall be laid down in Regulations adopted in accordance with the advisory procedure referred to in Article 79(2) without any substantial modifications.
Enotna načela za oceno in registracijo fitofarmacevtskih sredstev vključujejo zahteve iz Priloge VI k Direktivi 91/414/EGS in se določijo v uredbah, ki se sprejmejo v skladu s svetovalnim postopkom iz člena 79(2) brez bistvenih sprememb.
Subsequent amendments to these Regulations shall be adopted in accordance with Article 78(1)(c).
Nadaljnje spremembe teh uredb se sprejmejo v skladu s členom 78(1)(c).
Following these principles, interaction between the active substance, safeners, synergists and co-formulants shall be taken into account in the evaluation of plant protection products.
Pri ocenjevanju fitofarmacevtskih sredstev se v skladu s temi načeli dosledno upošteva interakcija med aktivno snovjo, varovali, sinergisti in dodatki.
Provisional authorisations
Začasne registracije
By way of derogation from Article 29(1)(a), Member States may authorise for a provisional period not exceeding 3 years, the placing on the market of plant protection products containing an active substance not yet approved, provided that:
Z odstopanjem od člena 29(1)(a) države članice v začasnem obdobju, ki ni daljše od treh let, lahko registrirajo dajanje v promet fitofarmacevtskih sredstev, ki vsebujejo še neodobreno aktivno snov, pod pogojem, da:
the decision on approval could not be finalised within a period of 30 months from the date of admissibility of the application, extended by any additional period set in accordance with Article 9(2), Article 11(3) or Article 12(2) or (3); and
ni mogoče končati postopkov za sprejem sklepa o odobritvi v roku 30 mesecev od datuma sprejemljivosti vloge, podaljšanega za vsako nadaljnje obdobje, določeno v skladu s členom 9(2), členom 11(3) ali členom 12(2) ali (3); ter
pursuant to Article 9 the dossier on the active substance is admissible in relation to the proposed uses; and
je v skladu s členom 9 dokumentacija o aktivni snovi sprejemljiva glede na predlagano uporabo; ter
the Member State concludes that the active substance can satisfy the requirements of Article 4(2) and (3) and that the plant protection product may be expected to satisfy the requirements of Article 29(1)(b) to (h); and
država članica sklene, da aktivna snov izpolnjuje zahteve iz člena 4(2) in (3) ter da se lahko pričakuje, da fitofarmacevtsko sredstvo izpolnjuje zahteve iz člena 29(1)(b) do (h); ter
maximum residue levels have been established in accordance with Regulation (EC) No 396/2005.
so mejne vrednosti ostankov določene v skladu z Uredbo (ES) št. 396/2005.
In such cases the Member State shall immediately inform the other Member States and the Commission of its assessment of the dossier and of the terms of the authorisation, giving at least the information provided for in Article 57(1).
V takih primerih država članica drugim državam članicam in Komisiji takoj sporoči svojo oceno dokumentacije in pogojev registracije ter pri tem navede najmanj podatke, določene v členu 57(1).
The provisions laid down in paragraphs 1 and 2 shall apply until 14 June 2016.
Določbe iz odstavkov 1 in 2 se uporabljajo do 14. junija 2016.
If necessary, that time limit may be extended in accordance with the regulatory procedure with scrutiny referred to in Article 79(4).
To obdobje se po potrebi lahko podaljša v skladu z regulativnim postopkom s pregledom iz člena 79(4).
Contents of authorisations
Vsebina registracij
The authorisation shall define plants or plant products and non-agricultural areas (for example railways, public areas, storage rooms) on which and the purposes for which the plant protection product may be used.
Registracija opredeljuje rastline ali rastlinske proizvode in nekmetijska področja (npr. železnice, javne površine, skladišča), na katerih in za katere namene se lahko uporabi fitofarmacevtsko sredstvo.
The authorisation shall set out the requirements relating to the placing on the market and use of the plant protection product.
Registracija določa zahteve v zvezi z dajanjem v promet in uporabo fitofarmacevtskega sredstva.
Those requirements shall as a minimum include the conditions of use necessary to comply with the conditions and requirements provided for in the Regulation approving the active substances, safeners and synergists.
Te zahteve vključujejo najmanj pogoje uporabe, potrebne za izpolnjevanje pogojev in zahtev iz uredbe, v skladu s katerimi se odobrijo aktivne snovi, varovala in sinergisti.
The authorisation shall include a classification of the plant protection product for the purpose of Directive 1999/45/EC.
Registracija vključuje razvrstitev fitofarmacevtskega sredstva za namen Direktive 1999/45/ES.
Member States may provide that authorisation holders shall classify or update the label without undue delay following any change to the classification and labelling of the plant protection product in accordance with Directive 1999/45/EC.
Države članice lahko določijo, da imetniki registracij brez neupravičene zamude razvrstijo ali posodobijo etiketo zaradi spremembe v razvrščanju ali označevanju fitofarmacevtskega sredstva v skladu z Direktivo 1999/45/ES.
In such cases, they shall immediately inform the competent authority thereof.
V takšnih primerih o tem nemudoma obvestijo pristojni organ.
The requirements referred to in paragraph 2 shall also include where applicable:
Zahteve iz odstavka 2 po potrebi vključujejo tudi:
the maximum dose per hectare in each application;
največji odmerek na hektar pri vsakem nanašanju;
the period between the last application and harvest;
razdobje med zadnjo uporabo in spravilom pridelka,
the maximum number of applications per year.
največje število nanašanj na leto.
The requirements referred to in paragraph 2 may include the following:
Zahteve iz odstavka 2 lahko vključujejo:
a restriction with respect to the distribution and use of the plant protection product in order to protect the health of the distributors, users, bystanders, residents, consumers or workers concerned or the environment, taking into consideration requirements imposed by other Community provisions; such restriction shall be indicated on the label;
omejitev v zvezi z distribucijo in uporabo fitofarmacevtskih sredstev, da bi se varovalo zdravje zadevnih distributerjev, uporabnikov, navzočih oseb, prebivalcev, potrošnikov ali delavcev ter okolje ob upoštevanju zahtev iz drugih določb Skupnosti; tovrstna omejitev se navede na etiketi;
the obligation before the product is used to inform any neighbours who could be exposed to the spray drift and who have requested to be informed;
obveznost, da se pred uporabo sredstva obvestijo vsi sosedi, ki bi lahko bili izpostavljeni zanašanju škropiva in ki so zahtevali, da se jih obvesti;
indications for proper use according to the principles of Integrated Pest Management referred to in Article 14 of and Annex III to Directive 2009/128/EC;
navodila za primerno rabo glede na načela integriranega varstva rastlin pred škodljivimi organizmi iz člena 14 in iz priloge III Direktive 2009/128/ES.
the approved label;
odobreno etiketo;
the interval between applications;
obdobje med nanašanji;
the period between the last application and consumption of the plant product where applicable;
kjer je primerno, obdobje med zadnjim nanašanjem in porabo rastlinskega proizvoda;
the re-entry interval;
delovno karenco;
the packaging size and material.
velikost in material embalaže.
The period of authorisation shall be laid down in the authorisation.
Obdobje registracije je določeno v dovoljenju.
Without prejudice to Article 44, the duration of an authorisation shall be set for a period not exceeding 1 year from the date of expiry of the approval of the active substances, safeners and synergists contained in the plant protection product and thereafter for as long as the active substances, safeners and synergists contained in the plant protection product are approved.
Brez poseganja v člen 44 se trajanja registracije določi za obdobje, ki ne presega enega leta od datuma poteka odobritve aktivnih snovi, varoval in sinergistov v fitofarmacevtskem sredstvu in nato dokler so aktivne snovi, varovala in sinergisti v fitofarmacevtskem sredstvu odobreni.
This period shall allow the examination as provided for in Article 43 to be carried out.
To obdobje omogoča izvajanje pregleda, določenega v členu 43.
Authorisations may be granted for shorter periods to synchronise the re-evaluation of similar products for the purposes of a comparative assessment of products containing candidates for substitution as provided for in Article 50.
Registracije se lahko izdajo za krajša obdobja, da se uskladijo ponovne ocene podobnih sredstev za namene primerjalne ocene sredstev, ki vsebujejo kandidatne snovi za zamenjavo, kakor je določeno v členu 50.
Application for authorisation or amendment of an authorisation
Zahtevek za registracijo ali spremembo registracije
An applicant who wishes to place a plant protection product on the market shall apply for an authorisation or amendment of an authorisation himself, or through a representative, to each Member State where the plant protection product is intended to be placed on the market.
Vlagatelj, ki želi dati fitofarmacevtsko sredstvo v promet, za registracijo zaprosi sam ali prek zastopnika v vsaki posamezni državi članici, v kateri namerava dati fitofarmacevtsko sredstvo v promet.
The application shall include the following:
Zahtevek vsebuje:
a list of intended uses in each zone as indicated in Annex I and the Member States where the applicant has made or intends to make an application;
seznam predvidene uporabe v vsaki coni, kakor je navedeno v Prilogi I, in v državah članicah, kjer je vlagatelj predložil zahtevek ali ga namerava predložiti;
a proposal as to which Member State the applicant expects to evaluate the application in the zone concerned.
predlog, katera država članica naj oceni zahtevek za zadevno cono.
In the case of an application for use in greenhouses, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment, only one Member State shall be proposed, which evaluates the application taking account of all zones.
V primeru zahtevka za uporabo v rastlinjakih, za tretiranje po spravilu, za tretiranje praznih skladišč in za tretiranje semen se predlaga ena sama država članica, ki oceni uporabo upoštevajoč vse cone.
In this case the applicant shall send the summary or complete dossier as referred to in Article 8 to other Member States on request;
V tem primeru vlagatelj drugim državam članicam na zahtevo pošlje popolno dokumentacijo ali njen povzetek iz člena 8;
where relevant, a copy of any authorisations already granted for that plant protection product in a Member State;
kjer je to ustrezno, kopije vseh registracij, ki so že bile izdane za to fitofarmacevtsko sredstvo v državi članici;
where relevant, a copy of any conclusion of the Member State assessing equivalence as referred to in Article 38(2).
kjer je to ustrezno, kopije vseh sklepov države članice, ki ocenjuje ekvivalenco, kakor je navedeno v členu 38(2).
The application shall be accompanied by the following:
Skupaj z vlogo se predložijo:
for the plant protection product concerned, a complete and a summary dossier for each point of the data requirements of the plant protection product;
za zadevno fitofarmacevtsko sredstvo popolna dokumentacija in njen povzetek za vsako točko zahtev po podatkih o fitofarmacevtskem sredstvu;
for each active substance, safener and synergist contained in the plant protection product, a complete and a summary dossier for each point of the data requirements of the active substance, safener and synergist;
za vsako aktivno snov, varovalo in sinergist v fitofarmacevtskem sredstvu popolna dokumentacija in njen povzetek za vsako točko zahtev po podatkih o aktivni snovi, varovalu in sinergistu;
the reasons why the test and study reports submitted are necessary for first authorisation or for amendments to the conditions of the authorisation;
razlogi, zakaj so predložena poročila o preskusih in študijah potrebna za prvo registracijo ali za spremembe pogojev registracije;
where relevant a copy of the application for a maximum residue level as referred to in Article 7 of Regulation (EC) No 396/2005 or a justification for not supplying such information;
kjer je to ustrezno, kopija zahtevka za mejno vrednost ostankov iz člena 7 Uredbe (ES) št. 396/2005, oziroma utemeljitev, zakaj ti podatki niso priloženi;
where relevant for an amendment of an authorisation an assessment of all information submitted in accordance with point (h) of Article 8(1);
ocena vseh podatkov, predloženih v skladu s členom 8(1)(h), kjer je to potrebno za spremembo registracije; ter
a draft label.
osnutek etikete.
When submitting the application, the applicant may pursuant to Article 63, request certain information, including certain parts of the dossier, to be kept confidential and shall physically separate that information.
Ob predložitvi zahtevka lahko vlagatelj v skladu s členom 63 zaprosi, da nekatere informacije in nekateri deli dokumentacije ostanejo zaupni, in te informacije fizično loči.
The applicant shall at the same time submit the complete list of studies submitted pursuant to Article 8(2) and a list of test and study reports for which any claims for data protection pursuant to Article 59 are requested.
Vlagatelj hkrati predloži tudi popoln seznam študij, predloženih v skladu s členom 8(2) in seznam poročil o preskusih in študijah, za katere se vlagajo zahtevki za varovanje podatkov v skladu s členom 59.
Upon a request for access to information the Member State examining the application shall decide what information is to be kept confidential.
Ob predložitvi zahteve za dostop do informacij, se država članica, ki preučuje vlogo za registracijo, odloči, katere informacije ostanejo zaupne.
Where requested by the Member State the applicant shall submit his application in the national or official languages of that Member State or one of those languages.
Na zahtevo države članice vlagatelj predloži zahtevek v nacionalnem ali uradnem jeziku te države članice ali v enem od teh jezikov.
On request, the applicant shall provide the Member State with samples of the plant protection product and analytical standards of its ingredients.
Na zahtevo države članice vlagatelj zagotovi vzorce fitofarmacevtskega sredstva in analitske standarde njegovih sestavin.
Exemption from the submission of studies
Izjema od predložitve študij
Applicants shall be exempted from supplying the test and study reports referred to in Article 33(3) where the Member State to which an application is made has the test and study reports concerned and the applicants demonstrate that they have been granted access in accordance with Article 59, 61 or 62 or that any data protection period has expired.
Vlagatelji so oproščeni obveznosti predložitve poročil o preskusih in študijah iz člena 33(3), če država članica, kateri je bila predložena vloga, zadevna poročila o preskusih in študijah že ima in vlagatelji dokažejo, da jim je bil dodeljen dostop v skladu s členi 59, 61 ali 62 ali da je kakršno koli obdobje varovanja podatkov poteklo.
However, applicants to whom paragraph 1 applies shall provide the following information:
Vendar vlagatelji, za katere se uporablja odstavek 1, zagotovijo:
all necessary data for the identification of the plant protection product including its complete composition as well as a declaration that no unacceptable co-formulants are used;
vse potrebne podatke za identifikacijo fitofarmacevtskega sredstva, vključno z njegovo celotno sestavo, in izjavo, da v formulaciji niso uporabljeni nesprejemljivi dodatki;
the information needed to identify the active substance, safener or synergist, where they have been approved, and to establish whether the conditions for approval are met and comply with point (b) of Article 29(1), where appropriate;
informacije, potrebne za ugotovitev istovetnosti aktivne snovi, varovala ali sinergista, če so bili odobreni, in za določitev, ali so pogoji za odobritev izpolnjeni in kjer je to primerno v skladu s členom 29(1)(b);
on the request of the concerned Member State, the data needed to demonstrate that the plant protection product has comparable effects to the plant protection product for which they show access to the protected data.
na zahtevo zadevne države članice podatke, potrebne za dokaz, da ima fitofarmacevtsko sredstvo primerljive učinke kot fitofarmacevtsko sredstvo, v zvezi s katerim je odobren dostop do zaščitenih podatkov.
Member State examining the application
Država članica, ki preuči vlogo
The application shall be examined by the Member State proposed by the applicant, unless another Member State in the same zone agrees to examine it.
Vlogo preuči država članica, ki jo je predlagal vlagatelj, razen če jo želi preučiti druga država članica iz iste cone.
The Member State which will examine the application shall inform the applicant.
Država članica, ki bo preučila vlogo, o tem obvesti vlagatelja.
At the request of the Member State examining the application, the other Member States in the same zone to which an application has been submitted shall cooperate to ensure a fair division of the workload.
Na zahtevo države članice, ki preučuje vlogo, druge države članice v isti coni, katerim je bila vloga predložena, sodelujejo, da se zagotovi pravična razdelitev delovne obremenitve.
The other Member States within the zone to which an application has been submitted shall refrain from proceeding with the file pending assessment by the Member State examining the application.
Druge države članice znotraj cone, katerim je bila predložena vloga, prenehajo preučevati vlogo, dokler država članica, ki preučuje vlogo, ne predloži ocene.
Where an application has been made in more than one zone, Member States evaluating the application shall agree on the evaluation of data which are not related to the environmental and agricultural conditions.
Če se vloga vloži v več kot eni coni, se države članice, ki vlogo ocenjujejo, sporazumejo o oceni podatkov, ki niso povezani z okoljskimi in kmetijskimi razmerami.
Examination for authorisation
Preučitev za registracijo
The Member State examining the application shall make an independent, objective and transparent assessment in the light of current scientific and technical knowledge using guidance documents available at the time of application.
Država članica, ki preučuje vlogo, opravi neodvisno, objektivno in pregledno oceno ob upoštevanju trenutnih znanstvenih in tehničnih spoznanj s pomočjo smernic, ki so na voljo v času vloge.
It shall give all Member States in the same zone the opportunity to submit comments to be considered in the assessment.
Vsem državam v isti coni omogoči, da dajo pripombe, ki se bodo upoštevale pri oceni.
It shall apply the uniform principles for evaluation and authorisation of plant protection products, referred to in Article 29(6), to establish, as far as possible, whether the plant protection product meets the requirements provided for in Article 29 in the same zone, where used in accordance with Article 55, and under realistic conditions of use.
Uporabi enotna načela za oceno in registracijo fitofarmacevtskih sredstev iz člena 29(6), da – kolikor je to mogoče – določi, ali fitofarmacevtsko sredstvo izpolnjuje zahteve iz člena 29 v isti coni, kadar se uporablja v skladu s členom 55 in v skladu z realnimi pogoji za uporabo.
The Member State examining the application shall make available its assessment to the other Member States within the same zone.
Država članica, ki preučuje vlogo, da svojo oceno na voljo drugim državam članicam znotraj iste cone.
The format of the assessment report shall be established in accordance with the advisory procedure referred to in Article 79(2).
Oblika osnutka poročila o oceni se določi v skladu s svetovalnim postopkom iz člena 79(2).
The Member States concerned shall grant or refuse authorisations accordingly on the basis of the conclusions of the assessment of the Member State examining the application as provided for in Articles 31 and 32.
Zadevne države članice ustrezno izdajo ali zavrnejo registracijo na podlagi sklepov ocene države članice, ki preuči vlogo, kakor je določeno v členih 31 in 32.
By way of derogation from paragraph 2 and subject to Community law, appropriate conditions may be imposed with respect to the requirements referred to in Article 31(3) and (4) and other risk mitigation measures deriving from specific conditions of use.
Z odstopanjem od odstavka 2 in v skladu z zakonodajo Skupnosti se lahko določijo ustrezni pogoji v zvezi z zahtevami iz člena 31(3) in (4) ter drugi ukrepi za zmanjšanje tveganja, ki se sprejmejo zaradi posebnih pogojev uporabe.
Where the concerns of a Member State relating to human or animal health or the environment cannot be controlled by the establishment of the national risk mitigation measures referred to in the first subparagraph, a Member State may refuse authorisation of the plant protection product in its territory if, due to its specific environmental or agricultural circumstances, it has substantiated reasons to consider that the product in question still poses an unacceptable risk to human or animal health or the environment.
Če se pomisleki držav članic glede zdravja ljudi ali živali ter varovanja okolja ne morejo nadzirati z uvedbo nacionalnih ukrepov za zmanjšanje tveganja iz prvega pododstavka, lahko država članica zavrne registracijo fitofarmacevtskih sredstev na svojem območju, če zaradi specifičnih okoljskih ali kmetijskih pogojev utemeljeno meni, da zadevno sredstvo še vedno predstavlja nesprejemljivo tveganje zdravju ljudi ali živali ali okolju.
That Member State shall immediately inform the applicant and the Commission of its decision and provide a technical or scientific justification therefor.
Država članica o svoji odločitvi nemudoma obvesti vlagatelja in Komisijo ter jo podpre s tehničnimi ali znanstvenimi dokazi.
Member States shall provide for the possibility of challenging a decision refusing the authorisation of such products before national courts or other instances of appeal.
Države članice zagotovijo, da se lahko odločitev o zavrnitvi registracije takšnega sredstva izpodbija pred nacionalnim sodiščem ali drugimi organi za pritožbe.
Period for examination
Rok za preučitev
The Member State examining the application shall decide within 12 months of receiving it whether the requirements for authorisation are met.
Država članica, ki preučuje vlogo, v dvanajstih mesecih od prejetja vloge odloči, ali so zahteve za registracijo izpolnjene.
Where the Member State needs additional information, it shall set a period for the applicant to supply it.
Če država članica potrebuje dodatne informacije, določi rok, v katerem jih mora vlagatelj predložiti.
In that case, the 12-month period shall be extended by the additional period granted by the Member State.
V tem primeru se obdobje dvanajstih mesecev podaljša za dodatno časovno obdobje, ki ga odobri država članica.
That additional period shall be a maximum of 6 months and shall cease at the moment when the additional information is received by the Member State.
Dodatno časovno obdobje ni daljše od šestih mesecev in preneha, ko država članica prejme dodatne informacije.
Where at the end of that period the applicant has not submitted the missing elements, the Member State shall inform the applicant that the application is inadmissible.
Če ob koncu tega obdobja vlagatelj ne predloži manjkajočih elementov, ga država članica obvesti, da vloga ni sprejemljiva.
The time limits provided for in paragraph 1 shall be suspended during the application of the procedure set out in Article 38.
Roki iz odstavka 1 se med uporabo postopka, določenega v členu 38, začasno ustavijo.